NOAEL Studies Colorant

Resorcinol Cosmetic NOAEL Studies

INCI: RESORCINOL

CAS: 108-46-3

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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COSMOS_DB 14 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
COSMOS_DB	LOAEL	28	mg/kg bw/day	mouse	oral	90 day	Subchronic	PAFA; NTP TR 403 (NIH PBL 92-2858), 1992
COSMOS_DB	LOAEL	32	mg/kg bw/day	rat	oral	90 day	Subchronic	PAFA; NTP TR 403 (NIH PBL 92-2858), 1992
COSMOS_DB	LOAEL	100	mg/kg bw/day	rat	oral	2 year	Chronic	PAFA; NTP TR 403 (NIH PBL 92-2858), 1992
COSMOS_DB	LOAEL	225	mg/kg bw/day	mouse	oral	2 year	Chronic	PAFA; NTP TR 403 (NIH PBL 92-2858), 1992
COSMOS_DB	NOAEL	55	mg/kg bw/day	rat	oral	17 day	Short Term Toxicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	100	mg/kg bw/day	rat	oral	721 day	Carcinogenicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	112	mg/kg bw/day	mouse	oral	728 day	Carcinogenicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	150	mg/kg bw/day	mouse	oral	17 day	Short Term Toxicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	260.7	mg/kg bw/day	rat	oral	28 day	Short Term Toxicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	304	mg/kg bw/day	rat	oral	NA	Multigeneration Reproductive	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	400	mg/kg bw/day	rat	oral	357 day	Chronic	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	420	mg/kg bw/day	mouse	oral	91 day	Subchronic	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	500	mg/kg bw/day	rat	oral	10 day	Developmental	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	520	mg/kg bw/day	rat	oral	91 day	Subchronic	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study

EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=36	mg/kg bw/day	Rat	oral: gavage	721 days	chronic/long term toxicity	EFSA ANS - 2010 - OutputID 399 - neurology - neurotoxicity - Scientific Opinion on the use of Resorcinol as a food additive - doi:10.2903/j.efsa.2010.1411
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=36	mg/kg bw/day	Rat	oral: gavage	721 days	chronic/long term toxicity	EFSA ANS - 2010 - OutputID 399 - neurology - neurotoxicity - Scientific Opinion on the use of Resorcinol as a food additive - doi:10.2903/j.efsa.2010.1411

EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx	ADI	=0.12	mg/kg bw/day	Consumers	-	-	ADI	EFSA ANS - 2010 - OutputID 399 - Consumers - Scientific Opinion on the use of Resorcinol as a food additive - doi:10.2903/j.efsa.2010.1411
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx	ADI	=0.12	mg/kg bw/day	Consumers	-	-	ADI	EFSA ANS - 2010 - OutputID 399 - Consumers - Scientific Opinion on the use of Resorcinol as a food additive - doi:10.2903/j.efsa.2010.1411

EFSA_OpenFoodTox_OpenFoodToxTX22809_2023.xlsx 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
EFSA_OpenFoodTox_OpenFoodToxTX22809_2023.xlsx	NOAEL	=36	mg/kg bw/day	Mouse	-	728 days	chronic/long term toxicity	ENDPOINTSTUDY_ID 690577; TOX_ID 378 - OP_ID 151 - EFSA FEEDAP - 2012 - Scientific Opinion on the safety and efficacy of phenol derivatives containing ring-alkyl, ring-alkoxy and side-chains with an oxygenated functional group (chemical group 25) when used as flavourings for all species - doi:10.2903/j.efsa.2012.2573
EFSA_OpenFoodTox_OpenFoodToxTX22809_2023.xlsx	NOAEL	=36	mg/kg bw/day	Mouse	-	728 days	chronic/long term toxicity	ENDPOINTSTUDY_ID 690577; TOX_ID 378 - OP_ID 151 - EFSA FEEDAP - 2012 - Scientific Opinion on the safety and efficacy of phenol derivatives containing ring-alkyl, ring-alkoxy and side-chains with an oxygenated functional group (chemical group 25) when used as flavourings for all species - doi:10.2903/j.efsa.2012.2573

IARC Monographs 3 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
IARC Monographs	IARC carcinogenicity classification	3	IARC group	-	-	1998	IARC Monographs	{"additional_info":"volume_publication_year=1999","evaluation_year":1998,"source_table":"iarc_classifications","volume":"15, Sup 7, 71"}
IARC Monographs	IARC carcinogenicity classification	3	IARC group	-	-	1998	IARC Monographs	{"additional_info":"volume_publication_year=1999","evaluation_year":1998,"source_table":"iarc_classifications","volume":"15, Sup 7, 71"}
IARC Monographs	IARC carcinogenicity classification	3	IARC group	-	-	1998	IARC Monographs	{"additional_info":"volume_publication_year=1999","evaluation_year":1998,"source_table":"iarc_classifications","volume":"15, Sup 7, 71"}

INCHEM_WHO_cicads_cicads_cicad71 36 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
INCHEM_WHO_cicads_cicads_cicad71	LOAEL	=1.2	mg/kg bw	Rat	oral	30 days	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=19309b504d93ee4a; raw_unit=mg/kg; context=(1979) Rat Oral via drinking-water 30 days Low-iodine, low-protein diet ~510 LOAEL: ~510 Increased thyroid gland weights (~2.5 vs 1.2 mg/kg in controls) T 3 /T 4 levels decr.
INCHEM_WHO_cicads_cicads_cicad71	LOAEL	=1.2	mg/kg bw	Rat	oral	30 days	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=19309b504d93ee4a; raw_unit=mg/kg; context=(1979) Rat Oral via drinking-water 30 days Low-iodine, low-protein diet ~510 LOAEL: ~510 Increased thyroid gland weights (~2.5 vs 1.2 mg/kg in controls) T 3 /T 4 levels decr.
INCHEM_WHO_cicads_cicads_cicad71	LOAEL	=32	mg/kg bw	Rat	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=3a77af50118f9224; raw_unit=mg/kg; context=Lors dune étude de 13 semaines sur des rats F344 et des souris B6C3F1, on a constaté que les LOAEL (dose la plus faible à laquelle un effet nocif a été observé) relatives au poids des surrénales étaient comprises entre 28 et 32 mg/kg de poids corporel et les NOAEL relatives au poids du foie égales à 32 mg/kg de poids corporel (administration 5 jours par semaine) sans relation dose-réponse bien caractérisée.
INCHEM_WHO_cicads_cicads_cicad71	LOAEL	=32	mg/kg bw	Rat	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=3a77af50118f9224; raw_unit=mg/kg; context=Lors dune étude de 13 semaines sur des rats F344 et des souris B6C3F1, on a constaté que les LOAEL (dose la plus faible à laquelle un effet nocif a été observé) relatives au poids des surrénales étaient comprises entre 28 et 32 mg/kg de poids corporel et les NOAEL relatives au poids du foie égales à 32 mg/kg de poids corporel (administration 5 jours par semaine) sans relation dose-réponse bien caractérisée.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=4.57142857142857	mg/kg bw/day	Rat; Mouse	-	5 days	Subchronic toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=37f560b86279dfee; raw_unit=mg/kg body weight; unit_normalization=converted from weekly dose; context=In a 13-week study in F344 rats and B6C3F1 mice, LOAELs for adrenal gland weight were in the range of 2832 mg/kg body weight and the NOAEL for liver weight was 32 mg/kg body weight (dosing 5 days/week), without a clear doseresponse.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=4.57142857142857	mg/kg bw/day	Rat; Mouse	-	5 days	Subchronic toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=37f560b86279dfee; raw_unit=mg/kg body weight; unit_normalization=converted from weekly dose; context=In a 13-week study in F344 rats and B6C3F1 mice, LOAELs for adrenal gland weight were in the range of 2832 mg/kg body weight and the NOAEL for liver weight was 32 mg/kg body weight (dosing 5 days/week), without a clear doseresponse.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=5	mg/kg bw	Rat	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=3036b9ad7a6fd960; raw_unit=mg/kg; context=urs) des rats F344 et des souris B6C3F1 5 jours par semaine à du résorcinol, on a obtenu, pour des signes cliniques consistant en hyperexcitabilité, tachypnée et tremblements, des NOAEL (dose maximale pour laquelle aucun effet na été observé) respectivement égales à 27,5 mg/kg et à 75 mg/kg de poids corporel, les signes observés étant selon toute probabilité imputables à un effet aigu du composé sur le système nerveux central.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=5	mg/kg bw	Rat	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=3036b9ad7a6fd960; raw_unit=mg/kg; context=urs) des rats F344 et des souris B6C3F1 5 jours par semaine à du résorcinol, on a obtenu, pour des signes cliniques consistant en hyperexcitabilité, tachypnée et tremblements, des NOAEL (dose maximale pour laquelle aucun effet na été observé) respectivement égales à 27,5 mg/kg et à 75 mg/kg de poids corporel, les signes observés étant selon toute probabilité imputables à un effet aigu du composé sur le système nerveux central.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=5.14285714285714	mg/kg bw/day	-	-	5 days	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=ec67ed43d57ffcbe; raw_unit=mg/kg body weight per day; unit_normalization=converted from weekly dose; context=NOAEL adjusted for 5 days/week dosing = 36 mg/kg body weight per day).
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=5.14285714285714	mg/kg bw/day	-	-	5 days	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=ec67ed43d57ffcbe; raw_unit=mg/kg body weight per day; unit_normalization=converted from weekly dose; context=NOAEL adjusted for 5 days/week dosing = 36 mg/kg body weight per day).
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=7.14285714285714	mg/kg bw/day	-	-	5 days	Acute toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=298af98145fe6e0c; raw_unit=mg/kg body weight per day; unit_normalization=converted from weekly dose; context=For this reason, the study chosen to derive a tolerable intake was the long-term NTP (1992) study in which a NOAEL of 50 mg/kg body weight per day (about 36 mg/kg body weight per day after correcting for 5 days/week dosing) for neurological effects (acute clinical signs) was derived.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=7.14285714285714	mg/kg bw/day	-	-	5 days	Acute toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=298af98145fe6e0c; raw_unit=mg/kg body weight per day; unit_normalization=converted from weekly dose; context=For this reason, the study chosen to derive a tolerable intake was the long-term NTP (1992) study in which a NOAEL of 50 mg/kg body weight per day (about 36 mg/kg body weight per day after correcting for 5 days/week dosing) for neurological effects (acute clinical signs) was derived.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=27.5	mg/kg bw	-	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=315cbddf783a81b1; raw_unit=mg/kg body weight; context=The NOAEL was 27.5 mg/kg body weight (NTP, 1992).
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=27.5	mg/kg bw	-	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=315cbddf783a81b1; raw_unit=mg/kg body weight; context=The NOAEL was 27.5 mg/kg body weight (NTP, 1992).
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=32	mg/kg bw	-	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=05789abb5d725691; raw_unit=mg/kg; context=staté que les LOAEL (dose la plus faible à laquelle un effet nocif a été observé) relatives au poids des surrénales étaient comprises entre 28 et 32 mg/kg de poids corporel et les NOAEL relatives au poids du foie égales à 32 mg/kg de poids corporel (administration 5 jours par semaine) sans relation dose-réponse bien caractérisée.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=32	mg/kg bw	-	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=05789abb5d725691; raw_unit=mg/kg; context=staté que les LOAEL (dose la plus faible à laquelle un effet nocif a été observé) relatives au poids des surrénales étaient comprises entre 28 et 32 mg/kg de poids corporel et les NOAEL relatives au poids du foie égales à 32 mg/kg de poids corporel (administration 5 jours par semaine) sans relation dose-réponse bien caractérisée.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=50	mg/kg bw	-	-	-	Acute toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=cad80c2606c0b205; raw_unit=mg/kg body weight; context=There was a NOAEL of 50 mg/kg body weight for acute clinical signs indicative of effects on the CNS.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=50	mg/kg bw/day	-	-	5 days	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=bae0192c395081ca; raw_unit=mg/kg body weight; context=The NOAEL was 50 mg/kg body weight (adjusted to 36 mg/kg body weight per day for 5 days/ week dosing).
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=50	mg/kg bw	-	-	-	Acute toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=cad80c2606c0b205; raw_unit=mg/kg body weight; context=There was a NOAEL of 50 mg/kg body weight for acute clinical signs indicative of effects on the CNS.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=50	mg/kg bw/day	-	-	5 days	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=bae0192c395081ca; raw_unit=mg/kg body weight; context=The NOAEL was 50 mg/kg body weight (adjusted to 36 mg/kg body weight per day for 5 days/ week dosing).
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=75	mg/kg bw	-	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=611a03599bf60108; raw_unit=mg/kg body weight; context=The NOAEL was 75 mg/kg body weight (NTP, 1992).
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=75	mg/kg bw	-	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=611a03599bf60108; raw_unit=mg/kg body weight; context=The NOAEL was 75 mg/kg body weight (NTP, 1992).
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=100	mg/kg bw	-	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=2cacd5e5cc1372a6; raw_unit=mg/kg body weight; context=A NOAEL of 100 mg/kg body weight was chosen..
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=100	mg/kg bw	-	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=2cacd5e5cc1372a6; raw_unit=mg/kg body weight; context=A NOAEL of 100 mg/kg body weight was chosen..
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	~233	mg/kg bw/day	-	-	-	Reproductive toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=e0605814f82e97bf; raw_unit=mg/kg body weight per day; context=When expressed on a body weight basis (average of F 0 and F 1 animals), the NOAEL corresponded to approximately 233 mg/kg body weight per day for males over the entire generation, 304 mg/kg body weight per day for females during premating and gestation, and 660 mg/kg body weight per day for females during lactation (RTF, 2005).
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=233	mg/kg bw	-	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=ddb6f252320a925f; raw_unit=mg/kg; context=Rapportée au poids corporel (valeur moyenne pour les animaux des générations F 0 et F 1 ), cette valeur de la NOAEL correspond à une dose journalière denviron 233 mg/kg de poids corporel pour les mâles sur toute une génération, 304 mg/kg pour les femelles pendant la période avant laccouplement et la gestation et 660 mg/kg pour les femelle pendant la période de lactation (RTF, 2005).
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	~233	mg/kg bw/day	-	-	-	Reproductive toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=e0605814f82e97bf; raw_unit=mg/kg body weight per day; context=When expressed on a body weight basis (average of F 0 and F 1 animals), the NOAEL corresponded to approximately 233 mg/kg body weight per day for males over the entire generation, 304 mg/kg body weight per day for females during premating and gestation, and 660 mg/kg body weight per day for females during lactation (RTF, 2005).
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=233	mg/kg bw	-	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=ddb6f252320a925f; raw_unit=mg/kg; context=Rapportée au poids corporel (valeur moyenne pour les animaux des générations F 0 et F 1 ), cette valeur de la NOAEL correspond à une dose journalière denviron 233 mg/kg de poids corporel pour les mâles sur toute une génération, 304 mg/kg pour les femelles pendant la période avant laccouplement et la gestation et 660 mg/kg pour les femelle pendant la période de lactation (RTF, 2005).
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=520	mg/kg bw	-	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=fba8711cfb6d633a; raw_unit=mg/kg; context=En el estudio prolongado (104 semanas), las NOAEL para los efectos en el tiroides fueron de 150520 mg/kg de peso corporal al día (cinco días/semana); sin embargo, estos estudios no tenían por objeto investigar este efecto final.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=520	mg/kg bw	-	-	-	Toxicology study	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=fba8711cfb6d633a; raw_unit=mg/kg; context=En el estudio prolongado (104 semanas), las NOAEL para los efectos en el tiroides fueron de 150520 mg/kg de peso corporal al día (cinco días/semana); sin embargo, estos estudios no tenían por objeto investigar este efecto final.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=3000	mg/L	-	-	-	Reproductive toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=f5f43915d7009de6; raw_unit=mg/l; context=A NOEL of 1000 mg/l and a NOAEL of 3000 mg/l for parental systemic and reproductive toxicity as well as neonatal toxicity were derived.
INCHEM_WHO_cicads_cicads_cicad71	NOAEL	=3000	mg/L	-	-	-	Reproductive toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=f5f43915d7009de6; raw_unit=mg/l; context=A NOEL of 1000 mg/l and a NOAEL of 3000 mg/l for parental systemic and reproductive toxicity as well as neonatal toxicity were derived.
INCHEM_WHO_cicads_cicads_cicad71	NOEL	=1000	mg/L	-	-	-	Reproductive toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=c7bd1b67661f6650; raw_unit=mg/l; context=A NOEL of 1000 mg/l and a NOAEL of 3000 mg/l for parental systemic and reproductive toxicity as well as neonatal toxicity were derived.
INCHEM_WHO_cicads_cicads_cicad71	NOEL	=1000	mg/L	-	-	-	Reproductive toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=c7bd1b67661f6650; raw_unit=mg/l; context=A NOEL of 1000 mg/l and a NOAEL of 3000 mg/l for parental systemic and reproductive toxicity as well as neonatal toxicity were derived.
INCHEM_WHO_cicads_cicads_cicad71	NOEL	=3000	mg/L	Rat	-	-	Reproductive toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=d027e84b49189e83; raw_unit=mg/l; context=On en a tiré une valeur de 1000 mg/l pour la NOEL (dose sans effet observé) et une valeur de 3000 mg/l pour la NOAEL, les critères retenus étant la toxicité systémique ou les effets toxiques sur la reproduction dans la génération parentale et la toxicité en général chez les rats nouveau-nés.
INCHEM_WHO_cicads_cicads_cicad71	NOEL	=3000	mg/L	Rat	-	-	Reproductive toxicity	document_id=cicads_cicads_cicad71; title=Resorcinol (CICADS 71, 2006); path=mirror/documents/cicads/cicads/cicad71.htm; row_hash=d027e84b49189e83; raw_unit=mg/l; context=On en a tiré une valeur de 1000 mg/l pour la NOEL (dose sans effet observé) et une valeur de 3000 mg/l pour la NOAEL, les critères retenus étant la toxicité systémique ou les effets toxiques sur la reproduction dans la génération parentale et la toxicité en général chez les rats nouveau-nés.

NTP_ICE_acute_oral 6 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_acute_oral	LD50	=301	mg/kg bw	Rat	oral	acute	Rat Acute Oral Toxicity	NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_738; row=3912; data_type=In Vivo; mixture=Chemical; chemical_name=Resorcinol; preferred_name=Resorcinol; dtxsid=DTXSID2021238; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021238; source_file=acute_oral.xlsx
NTP_ICE_acute_oral	LD50	=370	mg/kg bw	Rat (Male/Female)	oral	acute	Rat Acute Oral Toxicity	JRC AcutoxBase (undated); record_id=acute_oral_739; row=3913; data_type=In Vivo; mixture=Chemical; chemical_name=Resorcinol; preferred_name=Resorcinol; dtxsid=DTXSID2021238; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021238; source_file=acute_oral.xlsx
NTP_ICE_acute_oral	LD50	=489	mg/kg bw	Rat (Female)	oral	acute	Rat Acute Oral Toxicity	JRC AcutoxBase (undated); record_id=acute_oral_740; row=3911; data_type=In Vivo; mixture=Chemical; chemical_name=Resorcinol; preferred_name=Resorcinol; dtxsid=DTXSID2021238; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021238; source_file=acute_oral.xlsx
NTP_ICE_acute_oral	LD50	=510	mg/kg bw	Rat	oral	acute	Rat Acute Oral Toxicity	ECHA ChemProp (undated); record_id=acute_oral_741; row=3914; data_type=In Vivo; mixture=Chemical; chemical_name=Resorcinol; preferred_name=Resorcinol; dtxsid=DTXSID2021238; url=https://echa.europa.eu/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021238; source_file=acute_oral.xlsx
NTP_ICE_acute_oral	LD50	=533	mg/kg bw	Rat (Male)	oral	acute	Rat Acute Oral Toxicity	JRC AcutoxBase (undated); record_id=acute_oral_742; row=3915; data_type=In Vivo; mixture=Chemical; chemical_name=Resorcinol; preferred_name=Resorcinol; dtxsid=DTXSID2021238; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021238; source_file=acute_oral.xlsx
NTP_ICE_acute_oral	LD50	=980	mg/kg bw	Rat (Male)	oral	acute	Rat Acute Oral Toxicity	JRC AcutoxBase (undated); record_id=acute_oral_743; row=3910; data_type=In Vivo; mixture=Chemical; chemical_name=Resorcinol; preferred_name=Resorcinol; dtxsid=DTXSID2021238; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021238; source_file=acute_oral.xlsx

NTP_ICE_adme_parameters 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_adme_parameters	Clint	14.48	uL/min/10^6 cells	Human	-	-	Measured; httk, Human Hepatic Intrinsic Clearance	sheet=Data; excel_row=821; Record_ID=adme_parameters_254; Data_Type=Measured; DTXSID=DTXSID2021238; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=14.48; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wetmore 2015; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_adme_parameters	Fu	0.7448	fraction	Human	-	-	Measured; httk, Human Plasma Fraction Unbound	sheet=Data; excel_row=822; Record_ID=adme_parameters_254; Data_Type=Measured; DTXSID=DTXSID2021238; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.7448; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Wetmore 2015; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238

NTP_ICE_cancer 3 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_cancer	IARC group	3	unitless	-	-	-	WOE; IARC Carcinogenicity	sheet=Data; excel_row=2622; Record_ID=cancer_4745; Data_Type=WOE; Formulation_Name=Resorcinol; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/33; http://publications.iarc.fr/139; http://publications.iarc.fr/89; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_cancer	Top dose	150	mg/kg	Rat	Gavage	-	In Vivo; NTP Carcinogenicity	sheet=Data; excel_row=2625; Record_ID=cancer_4747; Data_Type=In Vivo; Formulation_Name=Resorcinol; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=150; Response_Unit=mg/kg; Species=Rat; Strain=F344/N; Sex=Female; Route=Gavage; Reference=TR-403; URL=https://ntp.niehs.nih.gov/publications/reports/tr/400s/tr403/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_cancer	Top dose	225	mg/kg	Rat	Gavage	-	In Vivo; NTP Carcinogenicity	sheet=Data; excel_row=2618; Record_ID=cancer_4743; Data_Type=In Vivo; Formulation_Name=Resorcinol; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=225; Response_Unit=mg/kg; Species=Rat; Strain=F344/N; Sex=Male; Route=Gavage; Reference=TR-403; URL=https://ntp.niehs.nih.gov/publications/reports/tr/400s/tr403/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238

NTP_ICE_endocrine 5 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_endocrine	AC50	32.084017601991	uM	-	-	-	ERPathway2016; ER Pathway Model, Agonist	sheet=Integrated_approaches; excel_row=14044; RecordID=ERPathway2016_41; DatasetName=ERPathway2016; DTXSID=DTXSID2021238; Assay=ER Pathway Model, Agonist; Endpoint=AC50; Response=32.084017601991; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_endocrine	ACC	28.6225831546908	uM	-	-	-	ERPathway2016; ER Pathway Model, Agonist	sheet=Integrated_approaches; excel_row=14045; RecordID=ERPathway2016_41; DatasetName=ERPathway2016; DTXSID=DTXSID2021238; Assay=ER Pathway Model, Agonist; Endpoint=ACC; Response=28.6225831546908; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_endocrine	Model Score	0	unitless	-	-	-	ARPathway2016; AR Pathway Model, Antagonist	sheet=Integrated_approaches; excel_row=14040; RecordID=ARPathway2016_512; DatasetName=ARPathway2016; DTXSID=DTXSID2021238; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_endocrine	Model Score	0.00321	unitless	-	-	-	ERPathway2016; ER Pathway Model, Agonist	sheet=Integrated_approaches; excel_row=14046; RecordID=ERPathway2016_41; DatasetName=ERPathway2016; DTXSID=DTXSID2021238; Assay=ER Pathway Model, Agonist; Endpoint=Model Score; Response=0.00321; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_endocrine	Model Score	0.0101	unitless	-	-	-	ERPathway2016; ER Pathway Model, Antagonist	sheet=Integrated_approaches; excel_row=14047; RecordID=ERPathway2016_41; DatasetName=ERPathway2016; DTXSID=DTXSID2021238; Assay=ER Pathway Model, Antagonist; Endpoint=Model Score; Response=0.0101; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238

NTP_ICE_skin_sensitization 25 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_skin_sensitization	CD54, EC200	201	ug/mL	-	Dermal	-	In Vitro; hCLAT2015; h-CLAT	sheet=Data_invitro; excel_row=3190; Record_ID=skin_sensitization_invitro_740; Data_Type=In Vitro; Internal_Data_Source=hCLAT2015; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=h-CLAT; Endpoint=CD54, EC200; Reported_Response=201; Reported_Response_Unit=ug/mL; Response=201; Response_Unit=ug/mL; Reference=Ashikaga et al. 2010; 20822320; 10.1177/026119291003800403\|Nukada et al. 2011; 21767275; 10.1111/j.1600-0536.2011.01952.x\|Nukada et al. 2012; 22796097; 10.1016/j.tiv.2012.07.001\|Nukada personal communication (undated)\|Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	CD54, EC200	201.5	ug/mL	-	Dermal	-	In Vitro; CE_hCLAT2018; h-CLAT	sheet=Data_invitro; excel_row=2074; Record_ID=skin_sensitization_invitro_516; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=h-CLAT; Endpoint=CD54, EC200; Reported_Response=201.5; Reported_Response_Unit=ug/mL; Response=201.5; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	CD86, EC150	4.75	ug/mL	-	Dermal	-	In Vitro; CE_USENSE2018; U-SENS	sheet=Data_invitro; excel_row=8556; Record_ID=skin_sensitization_invitro_2361; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=4.75; Reported_Response_Unit=ug/mL; Response=4.75; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	CD86, EC150	29.603	ug/mL	-	Dermal	-	In Vitro; Urbisch_SkinSensitization2020; U-SENS	sheet=Data_invitro; excel_row=8244; Record_ID=skin_sensitization_invitro_2267; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=268.8465032; Reported_Response_Unit=uM; Conversion_Factor_Value=110.112; Conversion_Factor_Source=EPA Dashboard; Converted_Response=29.603; Converted_Response_Unit=ug/mL; Response=29.603; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	CV70	172.97	ug/mL	-	Dermal	-	In Vitro; CE_USENSE2018; U-SENS	sheet=Data_invitro; excel_row=8555; Record_ID=skin_sensitization_invitro_2361; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=U-SENS; Endpoint=CV70; Reported_Response=172.97; Reported_Response_Unit=ug/mL; Response=172.97; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	CV75	613.4	ug/mL	-	Dermal	-	In Vitro; CE_hCLAT2018; h-CLAT	sheet=Data_invitro; excel_row=2075; Record_ID=skin_sensitization_invitro_516; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=h-CLAT; Endpoint=CV75; Reported_Response=613.4; Reported_Response_Unit=ug/mL; Response=613.4; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	Depletion Cys	-1	%	-	Dermal	-	In Vitro; DPRA2015; DPRA	sheet=Data_invitro; excel_row=1062; Record_ID=skin_sensitization_invitro_289; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=-1; Reported_Response_Unit=%; Response=-1; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006\|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	Depletion Cys	1.6	%	-	Dermal	-	In Vitro; DPRA2015; DPRA	sheet=Data_invitro; excel_row=1058; Record_ID=skin_sensitization_invitro_288; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=1.6; Reported_Response_Unit=%; Response=1.6; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064\|Jaworska 2011; 23670904; 10.1002/jat.2869; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	Depletion Lys	-0.8	%	-	Dermal	-	In Vitro; DPRA2015; DPRA	sheet=Data_invitro; excel_row=1057; Record_ID=skin_sensitization_invitro_288; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=-0.8; Reported_Response_Unit=%; Response=-0.8; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064\|Jaworska 2011; 23670904; 10.1002/jat.2869; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	Depletion Lys	13.1	%	-	Dermal	-	In Vitro; DPRA2015; DPRA	sheet=Data_invitro; excel_row=1061; Record_ID=skin_sensitization_invitro_289; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=13.1; Reported_Response_Unit=%; Response=13.1; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006\|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	Depletion Lys + Cys	0.8	%	-	Dermal	-	In Vitro; DPRA2015; DPRA	sheet=Data_invitro; excel_row=1059; Record_ID=skin_sensitization_invitro_288; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=0.8; Reported_Response_Unit=%; Response=0.8; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064\|Jaworska 2011; 23670904; 10.1002/jat.2869; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	Depletion Lys + Cys	6.6	%	-	Dermal	-	In Vitro; DPRA2015; DPRA	sheet=Data_invitro; excel_row=1063; Record_ID=skin_sensitization_invitro_289; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=6.6; Reported_Response_Unit=%; Response=6.6; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006\|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	EC1.5	>920.74	uM	-	Dermal	-	In Vitro; Urbisch_SkinSensitization2020; LuSens	sheet=Data_invitro; excel_row=7597; Record_ID=skin_sensitization_invitro_1836; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=LuSens; Endpoint=EC1.5; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=920.74; Reported_Response_Unit=uM; Response=920.74; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	EC1.5	>2000	uM	-	Dermal	-	In Vitro; CE_KeratinoSense2018; KeratinoSens	sheet=Data_invitro; excel_row=4569; Record_ID=skin_sensitization_invitro_1053; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=KeratinoSens; Endpoint=EC1.5; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=2000; Reported_Response_Unit=uM; Response=2000; Response_Unit=uM; Reference=Emter et al. 2010; 20307559; 10.1016/j.taap.2010.03.009\|Natsch et al. 2013; 23576290; 10.1002/jat.2868\|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	EC3	5.5	%	Mouse	Dermal	-	In Vivo; LLNAdb2013; LLNA	sheet=Data_invivo; excel_row=13602; Record_ID=skin_sensitization_invivo_3830; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=LLNA; Endpoint=EC3; Response=5.5; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	EC3	5.5	%	Mouse	Dermal	-	In Vivo; LLNAdb2013; LLNA	sheet=Data_invivo; excel_row=13602; Record_ID=skin_sensitization_invivo_3830; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=LLNA; Endpoint=EC3; Response=5.5; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	EC3	5.5	%	Mouse	Dermal	-	In Vivo; LLNAdb2013; LLNA	sheet=Data_invivo; excel_row=13602; Record_ID=skin_sensitization_invivo_3830; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=LLNA; Endpoint=EC3; Response=5.5; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	EC3	5.5	%	Mouse	Dermal	-	In Vivo; LLNAdb2013; LLNA	sheet=Data_invivo; excel_row=13602; Record_ID=skin_sensitization_invivo_3830; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=LLNA; Endpoint=EC3; Response=5.5; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	EC3	5.92	%	Mouse	Dermal	-	In Vivo; Urbisch_SkinSensitization2020; LLNA	sheet=Data_invivo; excel_row=12948; Record_ID=skin_sensitization_invivo_2873; Data_Type=In Vivo; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=LLNA; Endpoint=EC3; Response=5.92; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	IC50	>1105	uM	-	Dermal	-	In Vitro; Urbisch_SkinSensitization2020; LuSens	sheet=Data_invitro; excel_row=7667; Record_ID=skin_sensitization_invitro_1836; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=LuSens; Endpoint=IC50; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=1104.8900000000001; Reported_Response_Unit=uM; Response=1105; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	Imax	0.5787	ratio	-	Dermal	-	In Vitro; Urbisch_SkinSensitization2020; LuSens	sheet=Data_invitro; excel_row=7570; Record_ID=skin_sensitization_invitro_1836; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=LuSens; Endpoint=Imax; Reported_Response=0.578706931; Reported_Response_Unit=Unitless; Response=0.5787; Response_Unit=Ratio; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	Imax	1.02	ratio	-	Dermal	-	In Vitro; CE_KeratinoSense2018; KeratinoSens	sheet=Data_invitro; excel_row=4575; Record_ID=skin_sensitization_invitro_1053; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.02; Reported_Response_Unit=Unitless; Response=1.02; Response_Unit=Ratio; Reference=Emter et al. 2010; 20307559; 10.1016/j.taap.2010.03.009\|Natsch et al. 2013; 23576290; 10.1002/jat.2868\|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	Incidence of positive responses	0	%	Human	Dermal	-	In Vivo; HPPT2020WIP; Human Maximization Test	sheet=Data_invivo; excel_row=3357; Record_ID=skin_sensitization_invivo_849; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=15.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160\|Basketter et al. 1994; 8045461; 10.1016/0278-6915(94)90112-0\|Basketter et al. 1999; 10654593; 10.1016/S0278-6915(99)00112-x\|Gerberick et al. 2000; 10684384; 10.1053/ajcd.2000.0003\|Schneider and Akkan 2004; 15135206; 10.1016/j.yrtph.2004.02.002; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	Induction dose per skin area	9310	ug/cm2	Human	Dermal	-	In Vivo; HPPT2020WIP; Human Maximization Test	sheet=Data_invivo; excel_row=3355; Record_ID=skin_sensitization_invivo_849; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=15.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=9310; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160\|Basketter et al. 1994; 8045461; 10.1016/0278-6915(94)90112-0\|Basketter et al. 1999; 10654593; 10.1016/S0278-6915(99)00112-x\|Gerberick et al. 2000; 10684384; 10.1053/ajcd.2000.0003\|Schneider and Akkan 2004; 15135206; 10.1016/j.yrtph.2004.02.002; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238
NTP_ICE_skin_sensitization	Relative reliability score	1	unitless	Human	Dermal	-	In Vivo; HPPT2020WIP; Human Maximization Test	sheet=Data_invivo; excel_row=3362; Record_ID=skin_sensitization_invivo_849; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=15.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID2021238; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=1; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160\|Basketter et al. 1994; 8045461; 10.1016/0278-6915(94)90112-0\|Basketter et al. 1999; 10654593; 10.1016/S0278-6915(99)00112-x\|Gerberick et al. 2000; 10684384; 10.1053/ajcd.2000.0003\|Schneider and Akkan 2004; 15135206; 10.1016/j.yrtph.2004.02.002; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021238; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021238

SCCS_vision_codex 168 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
SCCS_vision_codex	NOAEL	=0	-	-	-	-	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: USR 2005a, \| drinking \| Key study \| F0: \| F0:","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_042"}
SCCS_vision_codex	NOAEL	=0	-	-	-	-	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: USR 2005a, \| drinking \| Key study \| F0: \| F0:","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_042"}
SCCS_vision_codex	NOAEL	=0	-	-	-	-	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: USR 2005a, \| drinking \| Key study \| F0: \| F0:","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_042"}
SCCS_vision_codex	NOAEL	=0	-	-	-	-	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: USR 2005a, \| drinking \| Key study \| F0: \| F0:","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_042"}
SCCS_vision_codex	NOAEL	=0.02	mg/kg bw	rat	oral	90-day	dermal absorption	{"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"______________________________________________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroi","page":26,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_015"}
SCCS_vision_codex	NOAEL	=0.02	mg/kg bw	rat	oral	90-day	dermal absorption	{"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"______________________________________________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroi","page":26,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_015"}
SCCS_vision_codex	NOAEL	=0.02	mg/kg bw	rat	oral	90-day	dermal absorption	{"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"______________________________________________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroi","page":26,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_015"}
SCCS_vision_codex	NOAEL	=0.02	mg/kg bw	rat	oral	90-day	dermal absorption	{"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"______________________________________________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroi","page":26,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_015"}
SCCS_vision_codex	NOAEL	=1	-	rat	oral	2 years	carcinogenicity	{"dose":"Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies.","effect":"he response in reaction to thyroid disturbance is not fully characterised and understood. Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies. SCCS comment After reviewing studies listed in table 1 above, the following NOAELs regarding endocrine activity in rats could be derived from each study. From the drinking water main study (USR 2005a), the lowest water intake values were taken. Table 2. NOAEL’s for endocrine activity derived by the SCCS. Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) NTP 1992 gavage 2 years carcinogenicity study No changes in thyroid parameters 520 USR 2004a / Foulon 2005 gavage 90-day study Decreased thyroid weight Females 80 *) Cooksey 1985 drinking water Effects noted, but only single dose was used, insufficient reporting, not complying with current guidelines // Seffner 1995 drinking water Effects noted, but publication lacking in details about methods, calculation","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_019"}
SCCS_vision_codex	NOAEL	=1	-	rat	oral	2 years	carcinogenicity	{"dose":"Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies.","effect":"he response in reaction to thyroid disturbance is not fully characterised and understood. Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies. SCCS comment After reviewing studies listed in table 1 above, the following NOAELs regarding endocrine activity in rats could be derived from each study. From the drinking water main study (USR 2005a), the lowest water intake values were taken. Table 2. NOAEL’s for endocrine activity derived by the SCCS. Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) NTP 1992 gavage 2 years carcinogenicity study No changes in thyroid parameters 520 USR 2004a / Foulon 2005 gavage 90-day study Decreased thyroid weight Females 80 *) Cooksey 1985 drinking water Effects noted, but only single dose was used, insufficient reporting, not complying with current guidelines // Seffner 1995 drinking water Effects noted, but publication lacking in details about methods, calculation","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_019"}
SCCS_vision_codex	NOAEL	=1	-	rat	oral	2 years	carcinogenicity	{"dose":"Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies.","effect":"he response in reaction to thyroid disturbance is not fully characterised and understood. Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies. SCCS comment After reviewing studies listed in table 1 above, the following NOAELs regarding endocrine activity in rats could be derived from each study. From the drinking water main study (USR 2005a), the lowest water intake values were taken. Table 2. NOAEL’s for endocrine activity derived by the SCCS. Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) NTP 1992 gavage 2 years carcinogenicity study No changes in thyroid parameters 520 USR 2004a / Foulon 2005 gavage 90-day study Decreased thyroid weight Females 80 *) Cooksey 1985 drinking water Effects noted, but only single dose was used, insufficient reporting, not complying with current guidelines // Seffner 1995 drinking water Effects noted, but publication lacking in details about methods, calculation","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_019"}
SCCS_vision_codex	NOAEL	=1	-	rat	oral	2 years	carcinogenicity	{"dose":"Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies.","effect":"he response in reaction to thyroid disturbance is not fully characterised and understood. Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies. SCCS comment After reviewing studies listed in table 1 above, the following NOAELs regarding endocrine activity in rats could be derived from each study. From the drinking water main study (USR 2005a), the lowest water intake values were taken. Table 2. NOAEL’s for endocrine activity derived by the SCCS. Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) NTP 1992 gavage 2 years carcinogenicity study No changes in thyroid parameters 520 USR 2004a / Foulon 2005 gavage 90-day study Decreased thyroid weight Females 80 *) Cooksey 1985 drinking water Effects noted, but only single dose was used, insufficient reporting, not complying with current guidelines // Seffner 1995 drinking water Effects noted, but publication lacking in details about methods, calculation","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_019"}
SCCS_vision_codex	NOAEL	=2	-	-	-	-	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Study \| Route of \| Comment \| Parameter \| NOAEL","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_039"}
SCCS_vision_codex	NOAEL	=2	-	-	-	-	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Study \| Route of \| Comment \| Parameter \| NOAEL","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_039"}
SCCS_vision_codex	NOAEL	=2	-	-	-	-	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Study \| Route of \| Comment \| Parameter \| NOAEL","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_039"}
SCCS_vision_codex	NOAEL	=2	-	-	-	-	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Study \| Route of \| Comment \| Parameter \| NOAEL","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_039"}
SCCS_vision_codex	NOAEL	=2.06	µg/cm	rat	oral	prenatal	developmental toxicity	{"dose":"This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004).","effect":"he different toxicological endpoints will be used, in accordance with the SCCS Opinion SCCS/1270/09. This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004). Because of the rapid and almost complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment will not be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 D","page":31,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_026"}
SCCS_vision_codex	NOAEL	=2.06	µg/cm	rat	oral	prenatal	developmental toxicity	{"dose":"This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004).","effect":"he different toxicological endpoints will be used, in accordance with the SCCS Opinion SCCS/1270/09. This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004). Because of the rapid and almost complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment will not be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 D","page":31,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_026"}
SCCS_vision_codex	NOAEL	=2.06	µg/cm	rat	oral	prenatal	developmental toxicity	{"dose":"This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004).","effect":"he different toxicological endpoints will be used, in accordance with the SCCS Opinion SCCS/1270/09. This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004). Because of the rapid and almost complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment will not be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 D","page":31,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_026"}
SCCS_vision_codex	NOAEL	=2.06	µg/cm	rat	oral	prenatal	developmental toxicity	{"dose":"This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004).","effect":"he different toxicological endpoints will be used, in accordance with the SCCS Opinion SCCS/1270/09. This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004). Because of the rapid and almost complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment will not be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 D","page":31,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_026"}
SCCS_vision_codex	NOAEL	=5	%	rat	oral	90-day	developmental toxicity	{"dose":"Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos:","effect":"t be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 DISCUSSION Physicochemical properties Toxicokinetics In the skin, metabolism is slow and 5-77% of resorcinol is present as parent resorcinol after 24h. In hepatic cells, metabolism is efficient (half-life of 22 to 55 min). Fast systemic metabolism and excretion is observed but small amounts of free resorcinol (1.2-4.6%) are detected in urine after gavage administration. The available data do not show accumulation in any organ or tissue, including the thyroid gland. Exposure Toxicological Ev","page":31,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_029"}
SCCS_vision_codex	NOAEL	=5	%	rat	oral	90-day	developmental toxicity	{"dose":"Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos:","effect":"t be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 DISCUSSION Physicochemical properties Toxicokinetics In the skin, metabolism is slow and 5-77% of resorcinol is present as parent resorcinol after 24h. In hepatic cells, metabolism is efficient (half-life of 22 to 55 min). Fast systemic metabolism and excretion is observed but small amounts of free resorcinol (1.2-4.6%) are detected in urine after gavage administration. The available data do not show accumulation in any organ or tissue, including the thyroid gland. Exposure Toxicological Ev","page":31,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_029"}
SCCS_vision_codex	NOAEL	=5	%	rat	oral	90-day	developmental toxicity	{"dose":"Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos:","effect":"t be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 DISCUSSION Physicochemical properties Toxicokinetics In the skin, metabolism is slow and 5-77% of resorcinol is present as parent resorcinol after 24h. In hepatic cells, metabolism is efficient (half-life of 22 to 55 min). Fast systemic metabolism and excretion is observed but small amounts of free resorcinol (1.2-4.6%) are detected in urine after gavage administration. The available data do not show accumulation in any organ or tissue, including the thyroid gland. Exposure Toxicological Ev","page":31,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_029"}
SCCS_vision_codex	NOAEL	=5	%	rat	oral	90-day	developmental toxicity	{"dose":"Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos:","effect":"t be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 DISCUSSION Physicochemical properties Toxicokinetics In the skin, metabolism is slow and 5-77% of resorcinol is present as parent resorcinol after 24h. In hepatic cells, metabolism is efficient (half-life of 22 to 55 min). Fast systemic metabolism and excretion is observed but small amounts of free resorcinol (1.2-4.6%) are detected in urine after gavage administration. The available data do not show accumulation in any organ or tissue, including the thyroid gland. Exposure Toxicological Ev","page":31,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_029"}
SCCS_vision_codex	NOAEL	=36	mg/kg/d	rat	oral	5-day	reproductive toxicity	{"citation":"Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg","dose":"Conclusions on carcinogenicity Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw.","effect":". Conclusions on carcinogenicity Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw. Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.","page":23,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_008"}
SCCS_vision_codex	NOAEL	=36	mg/kg/d	rat	oral	5-day	carcinogenicity	{"dose":"Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day.","effect":"4/N rats and B6C3F1 mice of each sex. Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw/day. Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / pho","page":21,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_014"}
SCCS_vision_codex	NOAEL	=36	mg/kg/d	rat	oral	5-day	reproductive toxicity	{"citation":"Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg","dose":"Conclusions on carcinogenicity Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw.","effect":". Conclusions on carcinogenicity Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw. Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.","page":23,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_008"}
SCCS_vision_codex	NOAEL	=36	mg/kg/d	rat	oral	5-day	reproductive toxicity	{"citation":"Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg","dose":"Conclusions on carcinogenicity Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw.","effect":". Conclusions on carcinogenicity Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw. Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.","page":23,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_008"}
SCCS_vision_codex	NOAEL	=36	mg/kg/d	rat	oral	5-day	carcinogenicity	{"dose":"Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day.","effect":"4/N rats and B6C3F1 mice of each sex. Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw/day. Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / pho","page":21,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_014"}
SCCS_vision_codex	NOAEL	=36	mg/kg/d	rat	oral	5-day	carcinogenicity	{"dose":"Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day.","effect":"4/N rats and B6C3F1 mice of each sex. Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw/day. Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / pho","page":21,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_014"}
SCCS_vision_codex	NOAEL	=36	mg/kg/d	rat	oral	5-day	reproductive toxicity	{"citation":"Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg","dose":"Conclusions on carcinogenicity Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw.","effect":". Conclusions on carcinogenicity Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw. Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.","page":23,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_008"}
SCCS_vision_codex	NOAEL	=36	mg/kg/d	rat	oral	5-day	carcinogenicity	{"dose":"Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day.","effect":"4/N rats and B6C3F1 mice of each sex. Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw/day. Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / pho","page":21,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_014"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	30 days	repeated dose toxicity	{"dose":"In contrast, multiple (2/day) subcutaneous daily doses of 100 mg/kg bw for 14 or 30 days to male Sprague-Dawley rats did not result in adverse changes in thyroid function indicated by serum T3 and T4 (Merker et al, 1982).","effect":"985) a similar exposure to 5 mg bw/day for 30 days had resulted in significant enlargement of the thyroid gland and decreased T3 and T4 levels in Wistar rats. In contrast, multiple (2/day) subcutaneous daily doses of 100 mg/kg bw for 14 or 30 days to male Sprague-Dawley rats did not result in adverse changes in thyroid function indicated by serum T3 and T4 (Merker et al, 1982). Also, in subacute, subchronic, and chronic oral studies performed in rats by the NTP no detectable effects on thyroid function were found (NOAEL 27.5, 32 and 50 mg/kg bw/day, respectively). Based on these data, the thyroid was considered to be a target organ for (sub-chronic) exposure to resorcinol. However, the Health Council of the Netherlands (Committee on Updating of Occupational Exposure Limits) attached more importance to the NTP studies than to the studies of Seffner et al. and Cooksey et al. and questioned the relevance of the thyroid effects found by these authors because in each case only one concentration was used and thyroidal effects were not","page":22,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_006"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	5-day	reproductive toxicity	{"dose":"This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.","effect":"were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.3.8.1. Two generation reproduction toxicity Guideline: OECD 416 Species/strain: rat, Crl:CD®(SD) (prior to 01/01/2005 this strain was named Crl:CD®(SD)IGS BR Group size: 30/sex group, 4 groups Test substance: Resorcinol Batch: Lot no. 706010501 Purity: 99.8%","page":23,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_010"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	human	oral	5-day	irritation	{"dose":"This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.","effect":"dered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.4.8.2 Photomutagenicity / photoclastogenicity No data submitted. 3.4.9 Human data 3.4.10 Special investigations Endocrine activity Information from SCCS/1270/09","page":21,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_016"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	30 days	repeated dose toxicity	{"dose":"In contrast, multiple (2/day) subcutaneous daily doses of 100 mg/kg bw for 14 or 30 days to male Sprague-Dawley rats did not result in adverse changes in thyroid function indicated by serum T3 and T4 (Merker et al, 1982).","effect":"985) a similar exposure to 5 mg bw/day for 30 days had resulted in significant enlargement of the thyroid gland and decreased T3 and T4 levels in Wistar rats. In contrast, multiple (2/day) subcutaneous daily doses of 100 mg/kg bw for 14 or 30 days to male Sprague-Dawley rats did not result in adverse changes in thyroid function indicated by serum T3 and T4 (Merker et al, 1982). Also, in subacute, subchronic, and chronic oral studies performed in rats by the NTP no detectable effects on thyroid function were found (NOAEL 27.5, 32 and 50 mg/kg bw/day, respectively). Based on these data, the thyroid was considered to be a target organ for (sub-chronic) exposure to resorcinol. However, the Health Council of the Netherlands (Committee on Updating of Occupational Exposure Limits) attached more importance to the NTP studies than to the studies of Seffner et al. and Cooksey et al. and questioned the relevance of the thyroid effects found by these authors because in each case only one concentration was used and thyroidal effects were not","page":22,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_006"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	30 days	repeated dose toxicity	{"dose":"In contrast, multiple (2/day) subcutaneous daily doses of 100 mg/kg bw for 14 or 30 days to male Sprague-Dawley rats did not result in adverse changes in thyroid function indicated by serum T3 and T4 (Merker et al, 1982).","effect":"985) a similar exposure to 5 mg bw/day for 30 days had resulted in significant enlargement of the thyroid gland and decreased T3 and T4 levels in Wistar rats. In contrast, multiple (2/day) subcutaneous daily doses of 100 mg/kg bw for 14 or 30 days to male Sprague-Dawley rats did not result in adverse changes in thyroid function indicated by serum T3 and T4 (Merker et al, 1982). Also, in subacute, subchronic, and chronic oral studies performed in rats by the NTP no detectable effects on thyroid function were found (NOAEL 27.5, 32 and 50 mg/kg bw/day, respectively). Based on these data, the thyroid was considered to be a target organ for (sub-chronic) exposure to resorcinol. However, the Health Council of the Netherlands (Committee on Updating of Occupational Exposure Limits) attached more importance to the NTP studies than to the studies of Seffner et al. and Cooksey et al. and questioned the relevance of the thyroid effects found by these authors because in each case only one concentration was used and thyroidal effects were not","page":22,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_006"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	5-day	reproductive toxicity	{"dose":"This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.","effect":"were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.3.8.1. Two generation reproduction toxicity Guideline: OECD 416 Species/strain: rat, Crl:CD®(SD) (prior to 01/01/2005 this strain was named Crl:CD®(SD)IGS BR Group size: 30/sex group, 4 groups Test substance: Resorcinol Batch: Lot no. 706010501 Purity: 99.8%","page":23,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_010"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	5-day	reproductive toxicity	{"dose":"This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.","effect":"were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.3.8.1. Two generation reproduction toxicity Guideline: OECD 416 Species/strain: rat, Crl:CD®(SD) (prior to 01/01/2005 this strain was named Crl:CD®(SD)IGS BR Group size: 30/sex group, 4 groups Test substance: Resorcinol Batch: Lot no. 706010501 Purity: 99.8%","page":23,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_010"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	human	oral	5-day	irritation	{"dose":"This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.","effect":"dered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.4.8.2 Photomutagenicity / photoclastogenicity No data submitted. 3.4.9 Human data 3.4.10 Special investigations Endocrine activity Information from SCCS/1270/09","page":21,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_016"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	human	oral	5-day	irritation	{"dose":"This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.","effect":"dered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.4.8.2 Photomutagenicity / photoclastogenicity No data submitted. 3.4.9 Human data 3.4.10 Special investigations Endocrine activity Information from SCCS/1270/09","page":21,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_016"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	30 days	repeated dose toxicity	{"dose":"In contrast, multiple (2/day) subcutaneous daily doses of 100 mg/kg bw for 14 or 30 days to male Sprague-Dawley rats did not result in adverse changes in thyroid function indicated by serum T3 and T4 (Merker et al, 1982).","effect":"985) a similar exposure to 5 mg bw/day for 30 days had resulted in significant enlargement of the thyroid gland and decreased T3 and T4 levels in Wistar rats. In contrast, multiple (2/day) subcutaneous daily doses of 100 mg/kg bw for 14 or 30 days to male Sprague-Dawley rats did not result in adverse changes in thyroid function indicated by serum T3 and T4 (Merker et al, 1982). Also, in subacute, subchronic, and chronic oral studies performed in rats by the NTP no detectable effects on thyroid function were found (NOAEL 27.5, 32 and 50 mg/kg bw/day, respectively). Based on these data, the thyroid was considered to be a target organ for (sub-chronic) exposure to resorcinol. However, the Health Council of the Netherlands (Committee on Updating of Occupational Exposure Limits) attached more importance to the NTP studies than to the studies of Seffner et al. and Cooksey et al. and questioned the relevance of the thyroid effects found by these authors because in each case only one concentration was used and thyroidal effects were not","page":22,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_006"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	5-day	reproductive toxicity	{"dose":"This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.","effect":"were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.3.8.1. Two generation reproduction toxicity Guideline: OECD 416 Species/strain: rat, Crl:CD®(SD) (prior to 01/01/2005 this strain was named Crl:CD®(SD)IGS BR Group size: 30/sex group, 4 groups Test substance: Resorcinol Batch: Lot no. 706010501 Purity: 99.8%","page":23,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_010"}
SCCS_vision_codex	NOAEL	=50	mg/kg bw/day	human	oral	5-day	irritation	{"dose":"This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.","effect":"dered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.4.8.2 Photomutagenicity / photoclastogenicity No data submitted. 3.4.9 Human data 3.4.10 Special investigations Endocrine activity Information from SCCS/1270/09","page":21,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_016"}
SCCS_vision_codex	NOAEL	=75	mg/kg bw/d	rat	oral	Sub-chronic	repeated dose toxicity	{"citation":"Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage","dose":"d tremors were recorded among males from the 150, 300, and 600 mg/kg bw/d groups, and among females from the 300 and 600 mg/kg bw/d groups.","effect":"d tremors were recorded among males from the 150, 300, and 600 mg/kg bw/d groups, and among females from the 300 and 600 mg/kg bw/d groups. The clinical signs in both rats and mice appeared usually within one-half hour after dosing and lasted 1 to 2 hours in surviving animals. No biologically significant changes in organ weights were recorded. No gross and microscopic lesions attributable to resorcinol administration were observed Conclusion Based on the clinical signs reported, the EFSA Panel concluded that the NOAEL in rats was 27.5 mg resorcinol/kg bw/d. Based on the clinical effects reported the EFSA Panel concluded that the NOAEL in mice was 75 mg/kg bw/d. Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1117/07 Guideline: OECD 408 Species/strain: rat, Sprague-Dawley, Crl CD® (SD) IGS BR Group size: 20/group (10 males and 10 females), 12 (6 males and 6 females) in satellite group Test sub","page":15,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_001"}
SCCS_vision_codex	NOAEL	=75	mg/kg bw/d	rat	oral	28 days	repeated dose toxicity	{"dose":"ed dose (28 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 6...","effect":"ed dose (28 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 600 mg/kg bw/d in male and female mice (5 animals per sex / dose). The following NOAELs based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid glan","page":15,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_001"}
SCCS_vision_codex	NOAEL	=75	mg/kg bw/d	rat	oral	Sub-chronic	repeated dose toxicity	{"citation":"Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage","dose":"d tremors were recorded among males from the 150, 300, and 600 mg/kg bw/d groups, and among females from the 300 and 600 mg/kg bw/d groups.","effect":"d tremors were recorded among males from the 150, 300, and 600 mg/kg bw/d groups, and among females from the 300 and 600 mg/kg bw/d groups. The clinical signs in both rats and mice appeared usually within one-half hour after dosing and lasted 1 to 2 hours in surviving animals. No biologically significant changes in organ weights were recorded. No gross and microscopic lesions attributable to resorcinol administration were observed Conclusion Based on the clinical signs reported, the EFSA Panel concluded that the NOAEL in rats was 27.5 mg resorcinol/kg bw/d. Based on the clinical effects reported the EFSA Panel concluded that the NOAEL in mice was 75 mg/kg bw/d. Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1117/07 Guideline: OECD 408 Species/strain: rat, Sprague-Dawley, Crl CD® (SD) IGS BR Group size: 20/group (10 males and 10 females), 12 (6 males and 6 females) in satellite group Test sub","page":15,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_001"}
SCCS_vision_codex	NOAEL	=75	mg/kg bw/d	rat	oral	Sub-chronic	repeated dose toxicity	{"citation":"Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage","dose":"d tremors were recorded among males from the 150, 300, and 600 mg/kg bw/d groups, and among females from the 300 and 600 mg/kg bw/d groups.","effect":"d tremors were recorded among males from the 150, 300, and 600 mg/kg bw/d groups, and among females from the 300 and 600 mg/kg bw/d groups. The clinical signs in both rats and mice appeared usually within one-half hour after dosing and lasted 1 to 2 hours in surviving animals. No biologically significant changes in organ weights were recorded. No gross and microscopic lesions attributable to resorcinol administration were observed Conclusion Based on the clinical signs reported, the EFSA Panel concluded that the NOAEL in rats was 27.5 mg resorcinol/kg bw/d. Based on the clinical effects reported the EFSA Panel concluded that the NOAEL in mice was 75 mg/kg bw/d. Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1117/07 Guideline: OECD 408 Species/strain: rat, Sprague-Dawley, Crl CD® (SD) IGS BR Group size: 20/group (10 males and 10 females), 12 (6 males and 6 females) in satellite group Test sub","page":15,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_001"}
SCCS_vision_codex	NOAEL	=75	mg/kg bw/d	rat	oral	28 days	repeated dose toxicity	{"dose":"ed dose (28 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 6...","effect":"ed dose (28 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 600 mg/kg bw/d in male and female mice (5 animals per sex / dose). The following NOAELs based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid glan","page":15,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_001"}
SCCS_vision_codex	NOAEL	=75	mg/kg bw/d	rat	oral	28 days	repeated dose toxicity	{"dose":"ed dose (28 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 6...","effect":"ed dose (28 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 600 mg/kg bw/d in male and female mice (5 animals per sex / dose). The following NOAELs based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid glan","page":15,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_001"}
SCCS_vision_codex	NOAEL	=75	mg/kg bw/d	rat	oral	Sub-chronic	repeated dose toxicity	{"citation":"Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage","dose":"d tremors were recorded among males from the 150, 300, and 600 mg/kg bw/d groups, and among females from the 300 and 600 mg/kg bw/d groups.","effect":"d tremors were recorded among males from the 150, 300, and 600 mg/kg bw/d groups, and among females from the 300 and 600 mg/kg bw/d groups. The clinical signs in both rats and mice appeared usually within one-half hour after dosing and lasted 1 to 2 hours in surviving animals. No biologically significant changes in organ weights were recorded. No gross and microscopic lesions attributable to resorcinol administration were observed Conclusion Based on the clinical signs reported, the EFSA Panel concluded that the NOAEL in rats was 27.5 mg resorcinol/kg bw/d. Based on the clinical effects reported the EFSA Panel concluded that the NOAEL in mice was 75 mg/kg bw/d. Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1117/07 Guideline: OECD 408 Species/strain: rat, Sprague-Dawley, Crl CD® (SD) IGS BR Group size: 20/group (10 males and 10 females), 12 (6 males and 6 females) in satellite group Test sub","page":15,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_001"}
SCCS_vision_codex	NOAEL	=75	mg/kg bw/d	rat	oral	28 days	repeated dose toxicity	{"dose":"ed dose (28 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 6...","effect":"ed dose (28 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 600 mg/kg bw/d in male and female mice (5 animals per sex / dose). The following NOAELs based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid glan","page":15,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_001"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/day	-	-	4 to week	reproductive toxicity	{"citation":"Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group","dose":"Under the experimental conditions of the study, the NOEL was reported to be 80 mg/kg bw/day.","effect":"SCCP/1117/07 Opinion on resorcinol 15 from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported to be 80 mg/kg bw/day. Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of relevance. For more","page":15,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_001"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/day	-	-	4 to week	reproductive toxicity	{"citation":"Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group","dose":"ulsions and died, no clinical observations were recorded at 80 mg/kg bw/day.","effect":"ulsions and died, no clinical observations were recorded at 80 mg/kg bw/day. No treatment-related effects on body weight, food consumption, blood and urine parameters, organ weights and necropsy findings were noted. The female group receiving 250 mg/kg bw/day gained slightly less weight (86% of the weight gained by the controls) from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of re","page":16,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_003"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw	rat	oral	90-day	dermal absorption	{"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"_____________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroid effe","page":26,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_016"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/day	rat	oral	Sub-chronic	repeated dose toxicity	{"dose":"s based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d.","effect":"s based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose response relationship and without relevant histopathological abnormalities). However, in the opinion of the SCCS, since in the reproductive study some effects on the thyroid were also observed, these effects might be of relevance. The SCC","page":15,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_003"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/d	-	oral	prenatal	developmental toxicity	{"dose":"This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004).","effect":"SCCS/1619/20 Final Opinion Opinion on Resorcinol ___________________________________________________________________________________________ ___________________________________________________________________________________________ 31 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) For the calculation of the MoS, the lowest NOAEL among those obtained from the different toxicological endpoints will be used, in accordance with the SCCS Opinion SCCS/1270/09. This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004). Because of the rapid and almost complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment","page":31,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_025"}
SCCS_vision_codex	NOAEL	=80	-	-	oral	90-day	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: USR 2004a / \| gavage \| 90-day study \| Decreased thyroid weight \| 80 *)","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_041"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/day	-	-	4 to week	reproductive toxicity	{"citation":"Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group","dose":"Under the experimental conditions of the study, the NOEL was reported to be 80 mg/kg bw/day.","effect":"SCCP/1117/07 Opinion on resorcinol 15 from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported to be 80 mg/kg bw/day. Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of relevance. For more","page":15,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_001"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/day	-	-	4 to week	reproductive toxicity	{"citation":"Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group","dose":"Under the experimental conditions of the study, the NOEL was reported to be 80 mg/kg bw/day.","effect":"SCCP/1117/07 Opinion on resorcinol 15 from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported to be 80 mg/kg bw/day. Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of relevance. For more","page":15,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_001"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/day	-	-	4 to week	reproductive toxicity	{"citation":"Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group","dose":"ulsions and died, no clinical observations were recorded at 80 mg/kg bw/day.","effect":"ulsions and died, no clinical observations were recorded at 80 mg/kg bw/day. No treatment-related effects on body weight, food consumption, blood and urine parameters, organ weights and necropsy findings were noted. The female group receiving 250 mg/kg bw/day gained slightly less weight (86% of the weight gained by the controls) from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of re","page":16,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_003"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/day	-	-	4 to week	reproductive toxicity	{"citation":"Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group","dose":"ulsions and died, no clinical observations were recorded at 80 mg/kg bw/day.","effect":"ulsions and died, no clinical observations were recorded at 80 mg/kg bw/day. No treatment-related effects on body weight, food consumption, blood and urine parameters, organ weights and necropsy findings were noted. The female group receiving 250 mg/kg bw/day gained slightly less weight (86% of the weight gained by the controls) from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of re","page":16,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_003"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw	rat	oral	90-day	dermal absorption	{"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"_____________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroid effe","page":26,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_016"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw	rat	oral	90-day	dermal absorption	{"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"_____________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroid effe","page":26,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_016"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/day	rat	oral	Sub-chronic	repeated dose toxicity	{"dose":"s based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d.","effect":"s based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose response relationship and without relevant histopathological abnormalities). However, in the opinion of the SCCS, since in the reproductive study some effects on the thyroid were also observed, these effects might be of relevance. The SCC","page":15,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_003"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/d	-	oral	prenatal	developmental toxicity	{"dose":"This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004).","effect":"SCCS/1619/20 Final Opinion Opinion on Resorcinol ___________________________________________________________________________________________ ___________________________________________________________________________________________ 31 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) For the calculation of the MoS, the lowest NOAEL among those obtained from the different toxicological endpoints will be used, in accordance with the SCCS Opinion SCCS/1270/09. This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004). Because of the rapid and almost complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment","page":31,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_025"}
SCCS_vision_codex	NOAEL	=80	-	-	oral	90-day	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: USR 2004a / \| gavage \| 90-day study \| Decreased thyroid weight \| 80 *)","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_041"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/day	rat	oral	Sub-chronic	repeated dose toxicity	{"dose":"s based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d.","effect":"s based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose response relationship and without relevant histopathological abnormalities). However, in the opinion of the SCCS, since in the reproductive study some effects on the thyroid were also observed, these effects might be of relevance. The SCC","page":15,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_003"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/d	-	oral	prenatal	developmental toxicity	{"dose":"This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004).","effect":"SCCS/1619/20 Final Opinion Opinion on Resorcinol ___________________________________________________________________________________________ ___________________________________________________________________________________________ 31 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) For the calculation of the MoS, the lowest NOAEL among those obtained from the different toxicological endpoints will be used, in accordance with the SCCS Opinion SCCS/1270/09. This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004). Because of the rapid and almost complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment","page":31,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_025"}
SCCS_vision_codex	NOAEL	=80	-	-	oral	90-day	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: USR 2004a / \| gavage \| 90-day study \| Decreased thyroid weight \| 80 *)","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_041"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/day	-	-	4 to week	reproductive toxicity	{"citation":"Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group","dose":"Under the experimental conditions of the study, the NOEL was reported to be 80 mg/kg bw/day.","effect":"SCCP/1117/07 Opinion on resorcinol 15 from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported to be 80 mg/kg bw/day. Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of relevance. For more","page":15,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_001"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/day	-	-	4 to week	reproductive toxicity	{"citation":"Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group","dose":"ulsions and died, no clinical observations were recorded at 80 mg/kg bw/day.","effect":"ulsions and died, no clinical observations were recorded at 80 mg/kg bw/day. No treatment-related effects on body weight, food consumption, blood and urine parameters, organ weights and necropsy findings were noted. The female group receiving 250 mg/kg bw/day gained slightly less weight (86% of the weight gained by the controls) from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of re","page":16,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_003"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw	rat	oral	90-day	dermal absorption	{"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"_____________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroid effe","page":26,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_016"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/day	rat	oral	Sub-chronic	repeated dose toxicity	{"dose":"s based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d.","effect":"s based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose response relationship and without relevant histopathological abnormalities). However, in the opinion of the SCCS, since in the reproductive study some effects on the thyroid were also observed, these effects might be of relevance. The SCC","page":15,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_003"}
SCCS_vision_codex	NOAEL	=80	mg/kg bw/d	-	oral	prenatal	developmental toxicity	{"dose":"This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004).","effect":"SCCS/1619/20 Final Opinion Opinion on Resorcinol ___________________________________________________________________________________________ ___________________________________________________________________________________________ 31 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) For the calculation of the MoS, the lowest NOAEL among those obtained from the different toxicological endpoints will be used, in accordance with the SCCS Opinion SCCS/1270/09. This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004). Because of the rapid and almost complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment","page":31,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_025"}
SCCS_vision_codex	NOAEL	=80	-	-	oral	90-day	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: USR 2004a / \| gavage \| 90-day study \| Decreased thyroid weight \| 80 *)","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_041"}
SCCS_vision_codex	NOAEL	=101	mg/kg bw/d	human	-	-	NOAEL study	{"dose":"21 (table 213, page 2046-2050 of the USR 2005a study report), the SCCS did not see a clear dose- response, but noted that a statistical test on outliers allowed one value in the mid- concentration of 360 mg/L to be excluded and 2 outlying values in the highest drinking- water exposure to be taken into account for statistical analysis.","effect":"21 (table 213, page 2046-2050 of the USR 2005a study report), the SCCS did not see a clear dose- response, but noted that a statistical test on outliers allowed one value in the mid- concentration of 360 mg/L to be excluded and 2 outlying values in the highest drinking- water exposure to be taken into account for statistical analysis. Based on the analysis, the highest drinking-water exposure (3000 mg/L, converted to 304 mg/kg bw/d based on the drinking-water intake) can be designated as a LOAEL. Consequently, the NOAEL for endocrine effects will be 101 mg/kg bw/d. 4) Human data: The CEHOS (2012) evaluation states that according to human case reports, resorcinol indeed exerts antithyroid functions. Data are old (all from before 1973), but quite clear:","page":29,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_023"}
SCCS_vision_codex	NOAEL	=101	mg/kg/d	rat	oral	-	NOAEL study	{"dose":"From this study, an overall NOAEL of 101 mg/kg/d is derived from the LOAEL of 304, which is based on the slightly increased TSH in F1 male rates receiving 3000 mg/L resorcinol in their drinking water.","effect":") that resorcinol exerts anti-thyroid effects. However, while a clear level of exposure needed for such an effect cannot be derived from the available studies in humans, most of these studies point to a relatively much higher level of exposure than is the case from cosmetics. The SCCS concurs with the ECHA (2020) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is relevant and regards it as the key study to evaluate the effects on the thyroid in rats. From this study, an overall NOAEL of 101 mg/kg/d is derived from the LOAEL of 304, which is based on the slightly increased TSH in F1 male rates receiving 3000 mg/L resorcinol in their drinking water.","page":30,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_024"}
SCCS_vision_codex	NOAEL	=101	mg/kg bw/d	human	-	-	NOAEL study	{"dose":"21 (table 213, page 2046-2050 of the USR 2005a study report), the SCCS did not see a clear dose- response, but noted that a statistical test on outliers allowed one value in the mid- concentration of 360 mg/L to be excluded and 2 outlying values in the highest drinking- water exposure to be taken into account for statistical analysis.","effect":"21 (table 213, page 2046-2050 of the USR 2005a study report), the SCCS did not see a clear dose- response, but noted that a statistical test on outliers allowed one value in the mid- concentration of 360 mg/L to be excluded and 2 outlying values in the highest drinking- water exposure to be taken into account for statistical analysis. Based on the analysis, the highest drinking-water exposure (3000 mg/L, converted to 304 mg/kg bw/d based on the drinking-water intake) can be designated as a LOAEL. Consequently, the NOAEL for endocrine effects will be 101 mg/kg bw/d. 4) Human data: The CEHOS (2012) evaluation states that according to human case reports, resorcinol indeed exerts antithyroid functions. Data are old (all from before 1973), but quite clear:","page":29,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_023"}
SCCS_vision_codex	NOAEL	=101	mg/kg/d	rat	oral	-	NOAEL study	{"dose":"From this study, an overall NOAEL of 101 mg/kg/d is derived from the LOAEL of 304, which is based on the slightly increased TSH in F1 male rates receiving 3000 mg/L resorcinol in their drinking water.","effect":") that resorcinol exerts anti-thyroid effects. However, while a clear level of exposure needed for such an effect cannot be derived from the available studies in humans, most of these studies point to a relatively much higher level of exposure than is the case from cosmetics. The SCCS concurs with the ECHA (2020) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is relevant and regards it as the key study to evaluate the effects on the thyroid in rats. From this study, an overall NOAEL of 101 mg/kg/d is derived from the LOAEL of 304, which is based on the slightly increased TSH in F1 male rates receiving 3000 mg/L resorcinol in their drinking water.","page":30,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_024"}
SCCS_vision_codex	NOAEL	=101	mg/kg bw/d	human	-	-	NOAEL study	{"dose":"21 (table 213, page 2046-2050 of the USR 2005a study report), the SCCS did not see a clear dose- response, but noted that a statistical test on outliers allowed one value in the mid- concentration of 360 mg/L to be excluded and 2 outlying values in the highest drinking- water exposure to be taken into account for statistical analysis.","effect":"21 (table 213, page 2046-2050 of the USR 2005a study report), the SCCS did not see a clear dose- response, but noted that a statistical test on outliers allowed one value in the mid- concentration of 360 mg/L to be excluded and 2 outlying values in the highest drinking- water exposure to be taken into account for statistical analysis. Based on the analysis, the highest drinking-water exposure (3000 mg/L, converted to 304 mg/kg bw/d based on the drinking-water intake) can be designated as a LOAEL. Consequently, the NOAEL for endocrine effects will be 101 mg/kg bw/d. 4) Human data: The CEHOS (2012) evaluation states that according to human case reports, resorcinol indeed exerts antithyroid functions. Data are old (all from before 1973), but quite clear:","page":29,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_023"}
SCCS_vision_codex	NOAEL	=101	mg/kg/d	rat	oral	-	NOAEL study	{"dose":"From this study, an overall NOAEL of 101 mg/kg/d is derived from the LOAEL of 304, which is based on the slightly increased TSH in F1 male rates receiving 3000 mg/L resorcinol in their drinking water.","effect":") that resorcinol exerts anti-thyroid effects. However, while a clear level of exposure needed for such an effect cannot be derived from the available studies in humans, most of these studies point to a relatively much higher level of exposure than is the case from cosmetics. The SCCS concurs with the ECHA (2020) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is relevant and regards it as the key study to evaluate the effects on the thyroid in rats. From this study, an overall NOAEL of 101 mg/kg/d is derived from the LOAEL of 304, which is based on the slightly increased TSH in F1 male rates receiving 3000 mg/L resorcinol in their drinking water.","page":30,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_024"}
SCCS_vision_codex	NOAEL	=101	mg/kg bw/d	human	-	-	NOAEL study	{"dose":"21 (table 213, page 2046-2050 of the USR 2005a study report), the SCCS did not see a clear dose- response, but noted that a statistical test on outliers allowed one value in the mid- concentration of 360 mg/L to be excluded and 2 outlying values in the highest drinking- water exposure to be taken into account for statistical analysis.","effect":"21 (table 213, page 2046-2050 of the USR 2005a study report), the SCCS did not see a clear dose- response, but noted that a statistical test on outliers allowed one value in the mid- concentration of 360 mg/L to be excluded and 2 outlying values in the highest drinking- water exposure to be taken into account for statistical analysis. Based on the analysis, the highest drinking-water exposure (3000 mg/L, converted to 304 mg/kg bw/d based on the drinking-water intake) can be designated as a LOAEL. Consequently, the NOAEL for endocrine effects will be 101 mg/kg bw/d. 4) Human data: The CEHOS (2012) evaluation states that according to human case reports, resorcinol indeed exerts antithyroid functions. Data are old (all from before 1973), but quite clear:","page":29,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_023"}
SCCS_vision_codex	NOAEL	=101	mg/kg/d	rat	oral	-	NOAEL study	{"dose":"From this study, an overall NOAEL of 101 mg/kg/d is derived from the LOAEL of 304, which is based on the slightly increased TSH in F1 male rates receiving 3000 mg/L resorcinol in their drinking water.","effect":") that resorcinol exerts anti-thyroid effects. However, while a clear level of exposure needed for such an effect cannot be derived from the available studies in humans, most of these studies point to a relatively much higher level of exposure than is the case from cosmetics. The SCCS concurs with the ECHA (2020) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is relevant and regards it as the key study to evaluate the effects on the thyroid in rats. From this study, an overall NOAEL of 101 mg/kg/d is derived from the LOAEL of 304, which is based on the slightly increased TSH in F1 male rates receiving 3000 mg/L resorcinol in their drinking water.","page":30,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_024"}
SCCS_vision_codex	NOAEL	=112	mg/kg bw	mouse	oral	-	NOAEL study	{"dose":"The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992).","effect":"l glands in males from all dosed groups were statistically significantly increased (p<0.01) compared to the controls. The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992). Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group the Panel concluded that this dose-group should not be used to define the NOAEL. Mice In the high-dose group seven mice of each sex died during the first week of the study, another male died during week 4 and another female died during week 12. The authors of the study attributed these deaths to resorcinol-related toxicity. Furthermore, one male died in the 112 mg/kg bw group due to improper gavage technique. The final body weights of the 2 surviving high-dose male mice were statistically significantly less than controls. The final body weights and changes in body weights of all other mice r","page":17,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_005"}
SCCS_vision_codex	NOAEL	=112	mg/kg bw	mouse	oral	-	NOAEL study	{"dose":"The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992).","effect":"al glands in males from all dosed groups were statistically significantly increased (p<0.01) compared to the controls. The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992). Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group, the Panel concluded that this dose-group should not be used to derive a NOAEL. In mice, seven animals in the high-dose group of each sex died during the first week of the study, another male died during week 4 and another female died during week 12. The authors of the study attributed these deaths to resorcinol-related toxicity. Furthermore, one male died in the 112 mg/kg bw group due to improper gavage technique. The final body weights of the 2 surviving high-dose male mice were statistically significantly lower compared to controls. The final body weights and changes in body weights of a","page":16,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_005"}
SCCS_vision_codex	NOAEL	=112	mg/kg bw	mouse	oral	-	NOAEL study	{"dose":"The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992).","effect":"l glands in males from all dosed groups were statistically significantly increased (p<0.01) compared to the controls. The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992). Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group the Panel concluded that this dose-group should not be used to define the NOAEL. Mice In the high-dose group seven mice of each sex died during the first week of the study, another male died during week 4 and another female died during week 12. The authors of the study attributed these deaths to resorcinol-related toxicity. Furthermore, one male died in the 112 mg/kg bw group due to improper gavage technique. The final body weights of the 2 surviving high-dose male mice were statistically significantly less than controls. The final body weights and changes in body weights of all other mice r","page":17,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_005"}
SCCS_vision_codex	NOAEL	=112	mg/kg bw	mouse	oral	-	NOAEL study	{"dose":"The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992).","effect":"l glands in males from all dosed groups were statistically significantly increased (p<0.01) compared to the controls. The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992). Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group the Panel concluded that this dose-group should not be used to define the NOAEL. Mice In the high-dose group seven mice of each sex died during the first week of the study, another male died during week 4 and another female died during week 12. The authors of the study attributed these deaths to resorcinol-related toxicity. Furthermore, one male died in the 112 mg/kg bw group due to improper gavage technique. The final body weights of the 2 surviving high-dose male mice were statistically significantly less than controls. The final body weights and changes in body weights of all other mice r","page":17,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_005"}
SCCS_vision_codex	NOAEL	=112	mg/kg bw	mouse	oral	-	NOAEL study	{"dose":"The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992).","effect":"al glands in males from all dosed groups were statistically significantly increased (p<0.01) compared to the controls. The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992). Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group, the Panel concluded that this dose-group should not be used to derive a NOAEL. In mice, seven animals in the high-dose group of each sex died during the first week of the study, another male died during week 4 and another female died during week 12. The authors of the study attributed these deaths to resorcinol-related toxicity. Furthermore, one male died in the 112 mg/kg bw group due to improper gavage technique. The final body weights of the 2 surviving high-dose male mice were statistically significantly lower compared to controls. The final body weights and changes in body weights of a","page":16,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_005"}
SCCS_vision_codex	NOAEL	=112	mg/kg bw	mouse	oral	-	NOAEL study	{"dose":"The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992).","effect":"al glands in males from all dosed groups were statistically significantly increased (p<0.01) compared to the controls. The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992). Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group, the Panel concluded that this dose-group should not be used to derive a NOAEL. In mice, seven animals in the high-dose group of each sex died during the first week of the study, another male died during week 4 and another female died during week 12. The authors of the study attributed these deaths to resorcinol-related toxicity. Furthermore, one male died in the 112 mg/kg bw group due to improper gavage technique. The final body weights of the 2 surviving high-dose male mice were statistically significantly lower compared to controls. The final body weights and changes in body weights of a","page":16,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_005"}
SCCS_vision_codex	NOAEL	=112	mg/kg bw	mouse	oral	-	NOAEL study	{"dose":"The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992).","effect":"l glands in males from all dosed groups were statistically significantly increased (p<0.01) compared to the controls. The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992). Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group the Panel concluded that this dose-group should not be used to define the NOAEL. Mice In the high-dose group seven mice of each sex died during the first week of the study, another male died during week 4 and another female died during week 12. The authors of the study attributed these deaths to resorcinol-related toxicity. Furthermore, one male died in the 112 mg/kg bw group due to improper gavage technique. The final body weights of the 2 surviving high-dose male mice were statistically significantly less than controls. The final body weights and changes in body weights of all other mice r","page":17,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_005"}
SCCS_vision_codex	NOAEL	=112	mg/kg bw	mouse	oral	-	NOAEL study	{"dose":"The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992).","effect":"al glands in males from all dosed groups were statistically significantly increased (p<0.01) compared to the controls. The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992). Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group, the Panel concluded that this dose-group should not be used to derive a NOAEL. In mice, seven animals in the high-dose group of each sex died during the first week of the study, another male died during week 4 and another female died during week 12. The authors of the study attributed these deaths to resorcinol-related toxicity. Furthermore, one male died in the 112 mg/kg bw group due to improper gavage technique. The final body weights of the 2 surviving high-dose male mice were statistically significantly lower compared to controls. The final body weights and changes in body weights of a","page":16,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_005"}
SCCS_vision_codex	NOAEL	=130	mg/kg/day	rat	oral	30 days	NOAEL study	{"dose":"d only one dose level.","effect":"d only one dose level. In the first study resorcinol caused decreases in T3 and T4 levels and increased size of the thyroid after 30 days of dosing (Cooksey et al. 1985) while altered thyroid histopathology was seen after 12 weeks of dosing in the other study (Seffner et al. 1995). In both studies, resorcinol was added to the drinking water. In 1992, the National Toxicology Program of the US EPA tested the effects of resorcinol given to rats by gavage for 13 weeks and no significant effects on T4 levels were seen (NOAEL 130 mg/kg/day). In a more recent two-generation study examining the effects of resorcinol dosing through the drinking water on the thyroid system in rats, the only significant effect was histopathological changes in the thyroid of males from the parental generation, while no effects on thyroid hormone levels or thyroid gland weights were seen at any time point in the parental or offspring generations (Welsch et al. 2008a). The LOAEL from this study was 233 mg/kg/day in males and 340-660 mg/kg/day in females. The d","page":23,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_018"}
SCCS_vision_codex	NOAEL	=130	mg/kg/day	rat	oral	30 days	NOAEL study	{"dose":"d only one dose level.","effect":"d only one dose level. In the first study resorcinol caused decreases in T3 and T4 levels and increased size of the thyroid after 30 days of dosing (Cooksey et al. 1985) while altered thyroid histopathology was seen after 12 weeks of dosing in the other study (Seffner et al. 1995). In both studies, resorcinol was added to the drinking water. In 1992, the National Toxicology Program of the US EPA tested the effects of resorcinol given to rats by gavage for 13 weeks and no significant effects on T4 levels were seen (NOAEL 130 mg/kg/day). In a more recent two-generation study examining the effects of resorcinol dosing through the drinking water on the thyroid system in rats, the only significant effect was histopathological changes in the thyroid of males from the parental generation, while no effects on thyroid hormone levels or thyroid gland weights were seen at any time point in the parental or offspring generations (Welsch et al. 2008a). The LOAEL from this study was 233 mg/kg/day in males and 340-660 mg/kg/day in females. The d","page":23,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_018"}
SCCS_vision_codex	NOAEL	=130	mg/kg/day	rat	oral	30 days	NOAEL study	{"dose":"d only one dose level.","effect":"d only one dose level. In the first study resorcinol caused decreases in T3 and T4 levels and increased size of the thyroid after 30 days of dosing (Cooksey et al. 1985) while altered thyroid histopathology was seen after 12 weeks of dosing in the other study (Seffner et al. 1995). In both studies, resorcinol was added to the drinking water. In 1992, the National Toxicology Program of the US EPA tested the effects of resorcinol given to rats by gavage for 13 weeks and no significant effects on T4 levels were seen (NOAEL 130 mg/kg/day). In a more recent two-generation study examining the effects of resorcinol dosing through the drinking water on the thyroid system in rats, the only significant effect was histopathological changes in the thyroid of males from the parental generation, while no effects on thyroid hormone levels or thyroid gland weights were seen at any time point in the parental or offspring generations (Welsch et al. 2008a). The LOAEL from this study was 233 mg/kg/day in males and 340-660 mg/kg/day in females. The d","page":23,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_018"}
SCCS_vision_codex	NOAEL	=130	mg/kg/day	rat	oral	30 days	NOAEL study	{"dose":"d only one dose level.","effect":"d only one dose level. In the first study resorcinol caused decreases in T3 and T4 levels and increased size of the thyroid after 30 days of dosing (Cooksey et al. 1985) while altered thyroid histopathology was seen after 12 weeks of dosing in the other study (Seffner et al. 1995). In both studies, resorcinol was added to the drinking water. In 1992, the National Toxicology Program of the US EPA tested the effects of resorcinol given to rats by gavage for 13 weeks and no significant effects on T4 levels were seen (NOAEL 130 mg/kg/day). In a more recent two-generation study examining the effects of resorcinol dosing through the drinking water on the thyroid system in rats, the only significant effect was histopathological changes in the thyroid of males from the parental generation, while no effects on thyroid hormone levels or thyroid gland weights were seen at any time point in the parental or offspring generations (Welsch et al. 2008a). The LOAEL from this study was 233 mg/kg/day in males and 340-660 mg/kg/day in females. The d","page":23,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_018"}
SCCS_vision_codex	NOAEL	=173	mg/kg/d	-	-	-	NOAEL study	{"dose":"NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 173 mg/kg/d","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 173 mg/kg/d","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_048"}
SCCS_vision_codex	NOAEL	=173	mg/kg/d	-	-	-	NOAEL study	{"dose":"NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 173 mg/kg/d","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 173 mg/kg/d","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_048"}
SCCS_vision_codex	NOAEL	=173	mg/kg/d	-	-	-	NOAEL study	{"dose":"NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 173 mg/kg/d","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 173 mg/kg/d","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_048"}
SCCS_vision_codex	NOAEL	=173	mg/kg/d	-	-	-	NOAEL study	{"dose":"NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 173 mg/kg/d","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 173 mg/kg/d","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_048"}
SCCS_vision_codex	NOAEL	=177	mg/kg/d	-	-	-	NOAEL study	{"dose":"Welsch 2008a \| water \| 2 generation \| -colloid decrease Males \| 177 mg/kg/d","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Welsch 2008a \| water \| 2 generation \| -colloid decrease Males \| 177 mg/kg/d","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_043"}
SCCS_vision_codex	NOAEL	=177	-	-	-	-	reproductive toxicity	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: reproductive toxicity \| -thyroid weight \| 177","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_044"}
SCCS_vision_codex	NOAEL	=177	mg/kg/d	-	-	-	NOAEL study	{"dose":"Welsch 2008a \| water \| 2 generation \| -colloid decrease Males \| 177 mg/kg/d","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Welsch 2008a \| water \| 2 generation \| -colloid decrease Males \| 177 mg/kg/d","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_043"}
SCCS_vision_codex	NOAEL	=177	-	-	-	-	reproductive toxicity	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: reproductive toxicity \| -thyroid weight \| 177","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_044"}
SCCS_vision_codex	NOAEL	=177	mg/kg/d	-	-	-	NOAEL study	{"dose":"Welsch 2008a \| water \| 2 generation \| -colloid decrease Males \| 177 mg/kg/d","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Welsch 2008a \| water \| 2 generation \| -colloid decrease Males \| 177 mg/kg/d","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_043"}
SCCS_vision_codex	NOAEL	=177	-	-	-	-	reproductive toxicity	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: reproductive toxicity \| -thyroid weight \| 177","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_044"}
SCCS_vision_codex	NOAEL	=177	mg/kg/d	-	-	-	NOAEL study	{"dose":"Welsch 2008a \| water \| 2 generation \| -colloid decrease Males \| 177 mg/kg/d","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Welsch 2008a \| water \| 2 generation \| -colloid decrease Males \| 177 mg/kg/d","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_043"}
SCCS_vision_codex	NOAEL	=177	-	-	-	-	reproductive toxicity	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: reproductive toxicity \| -thyroid weight \| 177","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_044"}
SCCS_vision_codex	NOAEL	=186	mg/kg bw/day	rat	oral	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation.","effect":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. 3.3.8.2. Teratogenicity Guideline: OECD Guideline 414 Species/strain: rat, Sprague-Dawley Crl CD® (SD) IGS BR Group size: 24 females/group; 4 groups Test substance: Resorcinol Batch: 706030517 Purity: 98.8% Dose: 40, 80 or 250 mg/kg bw/day, control group received vehicle (purified water) Route: oral","page":20,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_003"}
SCCS_vision_codex	NOAEL	=186	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation.","effect":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. 3.3.8.2. Teratogenicity","page":24,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_012"}
SCCS_vision_codex	NOAEL	=186	mg/kg bw/day	rat	-	-	reproductive toxicity	{"citation":"Ref: USR 2005a (also cited as Nemec, 2005) TUKES, 2017: No indications of reproductive toxicity were seen in the dose range-finding study or in the two-generation reproductive toxicity","dose":"This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation.","effect":"SCCS-rejected applicant NOAEL: ed test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Ref: USR 2005a (also cited as Nemec, 2005) TUKES, 2017: No indications of reproductive toxicity were seen in the dose range-finding study or in the two-generation reproductive toxicity study in rats (USR 2003, 2005, Welsch et al. 2008a). Endpoints for neurotoxicity (i.e. brain weight and width, brain histology, functional obs","page":18,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_009"}
SCCS_vision_codex	NOAEL	=186	mg/kg bw/day	rat	oral	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation.","effect":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. 3.3.8.2. Teratogenicity Guideline: OECD Guideline 414 Species/strain: rat, Sprague-Dawley Crl CD® (SD) IGS BR Group size: 24 females/group; 4 groups Test substance: Resorcinol Batch: 706030517 Purity: 98.8% Dose: 40, 80 or 250 mg/kg bw/day, control group received vehicle (purified water) Route: oral","page":20,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_003"}
SCCS_vision_codex	NOAEL	=186	mg/kg bw/day	rat	oral	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation.","effect":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. 3.3.8.2. Teratogenicity Guideline: OECD Guideline 414 Species/strain: rat, Sprague-Dawley Crl CD® (SD) IGS BR Group size: 24 females/group; 4 groups Test substance: Resorcinol Batch: 706030517 Purity: 98.8% Dose: 40, 80 or 250 mg/kg bw/day, control group received vehicle (purified water) Route: oral","page":20,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_003"}
SCCS_vision_codex	NOAEL	=186	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation.","effect":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. 3.3.8.2. Teratogenicity","page":24,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_012"}
SCCS_vision_codex	NOAEL	=186	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation.","effect":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. 3.3.8.2. Teratogenicity","page":24,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_012"}
SCCS_vision_codex	NOAEL	=186	mg/kg bw/day	rat	-	-	reproductive toxicity	{"citation":"Ref: USR 2005a (also cited as Nemec, 2005) TUKES, 2017: No indications of reproductive toxicity were seen in the dose range-finding study or in the two-generation reproductive toxicity","dose":"This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation.","effect":"SCCS-rejected applicant NOAEL: ed test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Ref: USR 2005a (also cited as Nemec, 2005) TUKES, 2017: No indications of reproductive toxicity were seen in the dose range-finding study or in the two-generation reproductive toxicity study in rats (USR 2003, 2005, Welsch et al. 2008a). Endpoints for neurotoxicity (i.e. brain weight and width, brain histology, functional obs","page":18,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_009"}
SCCS_vision_codex	NOAEL	=186	mg/kg bw/day	rat	-	-	reproductive toxicity	{"citation":"Ref: USR 2005a (also cited as Nemec, 2005) TUKES, 2017: No indications of reproductive toxicity were seen in the dose range-finding study or in the two-generation reproductive toxicity","dose":"This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation.","effect":"SCCS-rejected applicant NOAEL: ed test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Ref: USR 2005a (also cited as Nemec, 2005) TUKES, 2017: No indications of reproductive toxicity were seen in the dose range-finding study or in the two-generation reproductive toxicity study in rats (USR 2003, 2005, Welsch et al. 2008a). Endpoints for neurotoxicity (i.e. brain weight and width, brain histology, functional obs","page":18,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_009"}
SCCS_vision_codex	NOAEL	=186	mg/kg bw/day	rat	oral	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation.","effect":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. 3.3.8.2. Teratogenicity Guideline: OECD Guideline 414 Species/strain: rat, Sprague-Dawley Crl CD® (SD) IGS BR Group size: 24 females/group; 4 groups Test substance: Resorcinol Batch: 706030517 Purity: 98.8% Dose: 40, 80 or 250 mg/kg bw/day, control group received vehicle (purified water) Route: oral","page":20,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_003"}
SCCS_vision_codex	NOAEL	=186	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation.","effect":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. 3.3.8.2. Teratogenicity","page":24,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_012"}
SCCS_vision_codex	NOAEL	=186	mg/kg bw/day	rat	-	-	reproductive toxicity	{"citation":"Ref: USR 2005a (also cited as Nemec, 2005) TUKES, 2017: No indications of reproductive toxicity were seen in the dose range-finding study or in the two-generation reproductive toxicity","dose":"This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation.","effect":"SCCS-rejected applicant NOAEL: ed test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Ref: USR 2005a (also cited as Nemec, 2005) TUKES, 2017: No indications of reproductive toxicity were seen in the dose range-finding study or in the two-generation reproductive toxicity study in rats (USR 2003, 2005, Welsch et al. 2008a). Endpoints for neurotoxicity (i.e. brain weight and width, brain histology, functional obs","page":18,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_009"}
SCCS_vision_codex	NOAEL	=233	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings.","effect":"SCCS-rejected applicant NOAEL: pups selected for analysis (PND 4 or PND 21). The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. Conclusions Based on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/d","page":20,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_002"}
SCCS_vision_codex	NOAEL	=233	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings.","effect":"SCCS-rejected applicant NOAEL: pups selected for analysis (PND 4 or PND 21). The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. Conclusions Based on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/d","page":24,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_011"}
SCCS_vision_codex	NOAEL	=233	mg/kg bw/day	-	-	-	reproductive toxicity	{"dose":"However, high-dose exposure has been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time.","effect":"d based on the application of a threefold safety factor. However, high-dose exposure has been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time. Based on Lynch et al. (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects. Based on the results of the 2-generation reproductive study (USR 2005a, also cited as Nemec, 2005) study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Additional information 1) Non-test information, in silico, in chemico, read across: The proposed identification of Resorcinol as endocrine disrupter has been reviewed in an evaluation by the Danish Centre on Endocrine Disrupters (CEHOS, 2012) and the ECHA support document (ECHA, 2020a)","page":22,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_017"}
SCCS_vision_codex	NOAEL	=233	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings.","effect":"SCCS-rejected applicant NOAEL: pups selected for analysis (PND 4 or PND 21). The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. Conclusions Based on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/d","page":20,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_002"}
SCCS_vision_codex	NOAEL	=233	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings.","effect":"SCCS-rejected applicant NOAEL: pups selected for analysis (PND 4 or PND 21). The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. Conclusions Based on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/d","page":20,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_002"}
SCCS_vision_codex	NOAEL	=233	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings.","effect":"SCCS-rejected applicant NOAEL: pups selected for analysis (PND 4 or PND 21). The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. Conclusions Based on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/d","page":24,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_011"}
SCCS_vision_codex	NOAEL	=233	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings.","effect":"SCCS-rejected applicant NOAEL: pups selected for analysis (PND 4 or PND 21). The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. Conclusions Based on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/d","page":24,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_011"}
SCCS_vision_codex	NOAEL	=233	mg/kg bw/day	-	-	-	reproductive toxicity	{"dose":"However, high-dose exposure has been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time.","effect":"d based on the application of a threefold safety factor. However, high-dose exposure has been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time. Based on Lynch et al. (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects. Based on the results of the 2-generation reproductive study (USR 2005a, also cited as Nemec, 2005) study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Additional information 1) Non-test information, in silico, in chemico, read across: The proposed identification of Resorcinol as endocrine disrupter has been reviewed in an evaluation by the Danish Centre on Endocrine Disrupters (CEHOS, 2012) and the ECHA support document (ECHA, 2020a)","page":22,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_017"}
SCCS_vision_codex	NOAEL	=233	mg/kg bw/day	-	-	-	reproductive toxicity	{"dose":"However, high-dose exposure has been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time.","effect":"d based on the application of a threefold safety factor. However, high-dose exposure has been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time. Based on Lynch et al. (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects. Based on the results of the 2-generation reproductive study (USR 2005a, also cited as Nemec, 2005) study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Additional information 1) Non-test information, in silico, in chemico, read across: The proposed identification of Resorcinol as endocrine disrupter has been reviewed in an evaluation by the Danish Centre on Endocrine Disrupters (CEHOS, 2012) and the ECHA support document (ECHA, 2020a)","page":22,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_017"}
SCCS_vision_codex	NOAEL	=233	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings.","effect":"SCCS-rejected applicant NOAEL: pups selected for analysis (PND 4 or PND 21). The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. Conclusions Based on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/d","page":20,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_002"}
SCCS_vision_codex	NOAEL	=233	mg/kg bw/day	-	-	-	NOAEL study	{"citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings.","effect":"SCCS-rejected applicant NOAEL: pups selected for analysis (PND 4 or PND 21). The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. Conclusions Based on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/d","page":24,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_011"}
SCCS_vision_codex	NOAEL	=233	mg/kg bw/day	-	-	-	reproductive toxicity	{"dose":"However, high-dose exposure has been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time.","effect":"d based on the application of a threefold safety factor. However, high-dose exposure has been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time. Based on Lynch et al. (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects. Based on the results of the 2-generation reproductive study (USR 2005a, also cited as Nemec, 2005) study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Additional information 1) Non-test information, in silico, in chemico, read across: The proposed identification of Resorcinol as endocrine disrupter has been reviewed in an evaluation by the Danish Centre on Endocrine Disrupters (CEHOS, 2012) and the ECHA support document (ECHA, 2020a)","page":22,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_017"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref.: 11 3","dose":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).","effect":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature3, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3 Lynch B.S et al. Toxicology Review and Risk A","page":21,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_005"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref.: 11 3","dose":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).","effect":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature2, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 2 Lynch B.S et al. Toxicology Review and Risk Assessment of Resorcinol: Thyroid Effects (2002). Reg. Tox. Pharm 36, 198-210","page":25,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_014"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the devel","dose":"etely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively).","effect":"SCCS-rejected applicant NOAEL: etely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related. In the opinion of the SCCS, the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the developmental toxicity study with resorcinol bis- diphenylphosphate (BDP) do not raise concern of resorcinol-induced developmental effects. This conclusion is also drawn in each individual study. ECHA 2020: Regarding the abovementioned study (USR, 2005b), the ECHA support document to identify Resorcinol as a Subst","page":19,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_011"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref.: 11 3","dose":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).","effect":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature3, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3 Lynch B.S et al. Toxicology Review and Risk A","page":21,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_005"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref.: 11 3","dose":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).","effect":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature3, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3 Lynch B.S et al. Toxicology Review and Risk A","page":21,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_005"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref.: 11 3","dose":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).","effect":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature2, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 2 Lynch B.S et al. Toxicology Review and Risk Assessment of Resorcinol: Thyroid Effects (2002). Reg. Tox. Pharm 36, 198-210","page":25,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_014"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref.: 11 3","dose":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).","effect":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature2, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 2 Lynch B.S et al. Toxicology Review and Risk Assessment of Resorcinol: Thyroid Effects (2002). Reg. Tox. Pharm 36, 198-210","page":25,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_014"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the devel","dose":"etely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively).","effect":"SCCS-rejected applicant NOAEL: etely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related. In the opinion of the SCCS, the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the developmental toxicity study with resorcinol bis- diphenylphosphate (BDP) do not raise concern of resorcinol-induced developmental effects. This conclusion is also drawn in each individual study. ECHA 2020: Regarding the abovementioned study (USR, 2005b), the ECHA support document to identify Resorcinol as a Subst","page":19,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_011"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the devel","dose":"etely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively).","effect":"SCCS-rejected applicant NOAEL: etely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related. In the opinion of the SCCS, the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the developmental toxicity study with resorcinol bis- diphenylphosphate (BDP) do not raise concern of resorcinol-induced developmental effects. This conclusion is also drawn in each individual study. ECHA 2020: Regarding the abovementioned study (USR, 2005b), the ECHA support document to identify Resorcinol as a Subst","page":19,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_011"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref.: 11 3","dose":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).","effect":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature3, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3 Lynch B.S et al. Toxicology Review and Risk A","page":21,"pdf":"sccp_o_124.pdf","row_type":"noael_study","study_id":"sccp_o_124_noael_005"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref.: 11 3","dose":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).","effect":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature2, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 2 Lynch B.S et al. Toxicology Review and Risk Assessment of Resorcinol: Thyroid Effects (2002). Reg. Tox. Pharm 36, 198-210","page":25,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_014"}
SCCS_vision_codex	NOAEL	=250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the devel","dose":"etely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively).","effect":"SCCS-rejected applicant NOAEL: etely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related. In the opinion of the SCCS, the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the developmental toxicity study with resorcinol bis- diphenylphosphate (BDP) do not raise concern of resorcinol-induced developmental effects. This conclusion is also drawn in each individual study. ECHA 2020: Regarding the abovementioned study (USR, 2005b), the ECHA support document to identify Resorcinol as a Subst","page":19,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_011"}
SCCS_vision_codex	NOAEL	=304	mg/kg bw/d	-	oral	-	NOAEL study	{"dose":"d thyroid weight in contradiction with other studies. ) Increase of T3 noted at intake of 360 mg/L drinking water (46.6 mg/kg bw/d), but absence of any effect on T3 at much higher doses in the main study (USR 2005a). ) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implau...","effect":"d thyroid weight in contradiction with other studies. ) Increase of T3 noted at intake of 360 mg/L drinking water (46.6 mg/kg bw/d), but absence of any effect on T3 at much higher doses in the main study (USR 2005a). ) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implausible because of single outliers and absence of effect at higher dose steps. **) LOAEL based on exposure to 3000 mg/L resorcinol in drinking water (304 mg/kg bw/d), hence NOAEL = 101. The SCCS concurs with the ECHA SVHC (2020a) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is a reliable study to evaluate the effects on the thyroid. The NOAEL in the table above, derived from the 2004 gavage study (USR 2004a) will not be taken into account for the endocrine activity because the decreased thyroid weight is in contradiction with the findings in other studies. In this study only thyroid weight was monitored without providing any supportive measurements","page":29,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_021"}
SCCS_vision_codex	NOAEL	=304	mg/kg bw/d	-	oral	-	NOAEL study	{"dose":"d thyroid weight in contradiction with other studies. ) Increase of T3 noted at intake of 360 mg/L drinking water (46.6 mg/kg bw/d), but absence of any effect on T3 at much higher doses in the main study (USR 2005a). ) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implau...","effect":"d thyroid weight in contradiction with other studies. ) Increase of T3 noted at intake of 360 mg/L drinking water (46.6 mg/kg bw/d), but absence of any effect on T3 at much higher doses in the main study (USR 2005a). ) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implausible because of single outliers and absence of effect at higher dose steps. **) LOAEL based on exposure to 3000 mg/L resorcinol in drinking water (304 mg/kg bw/d), hence NOAEL = 101. The SCCS concurs with the ECHA SVHC (2020a) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is a reliable study to evaluate the effects on the thyroid. The NOAEL in the table above, derived from the 2004 gavage study (USR 2004a) will not be taken into account for the endocrine activity because the decreased thyroid weight is in contradiction with the findings in other studies. In this study only thyroid weight was monitored without providing any supportive measurements","page":29,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_021"}
SCCS_vision_codex	NOAEL	=304	mg/kg bw/d	-	oral	-	NOAEL study	{"dose":"d thyroid weight in contradiction with other studies. ) Increase of T3 noted at intake of 360 mg/L drinking water (46.6 mg/kg bw/d), but absence of any effect on T3 at much higher doses in the main study (USR 2005a). ) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implau...","effect":"d thyroid weight in contradiction with other studies. ) Increase of T3 noted at intake of 360 mg/L drinking water (46.6 mg/kg bw/d), but absence of any effect on T3 at much higher doses in the main study (USR 2005a). ) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implausible because of single outliers and absence of effect at higher dose steps. **) LOAEL based on exposure to 3000 mg/L resorcinol in drinking water (304 mg/kg bw/d), hence NOAEL = 101. The SCCS concurs with the ECHA SVHC (2020a) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is a reliable study to evaluate the effects on the thyroid. The NOAEL in the table above, derived from the 2004 gavage study (USR 2004a) will not be taken into account for the endocrine activity because the decreased thyroid weight is in contradiction with the findings in other studies. In this study only thyroid weight was monitored without providing any supportive measurements","page":29,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_021"}
SCCS_vision_codex	NOAEL	=304	mg/kg bw/d	-	oral	-	NOAEL study	{"dose":"d thyroid weight in contradiction with other studies. ) Increase of T3 noted at intake of 360 mg/L drinking water (46.6 mg/kg bw/d), but absence of any effect on T3 at much higher doses in the main study (USR 2005a). ) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implau...","effect":"d thyroid weight in contradiction with other studies. ) Increase of T3 noted at intake of 360 mg/L drinking water (46.6 mg/kg bw/d), but absence of any effect on T3 at much higher doses in the main study (USR 2005a). ) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implausible because of single outliers and absence of effect at higher dose steps. **) LOAEL based on exposure to 3000 mg/L resorcinol in drinking water (304 mg/kg bw/d), hence NOAEL = 101. The SCCS concurs with the ECHA SVHC (2020a) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is a reliable study to evaluate the effects on the thyroid. The NOAEL in the table above, derived from the 2004 gavage study (USR 2004a) will not be taken into account for the endocrine activity because the decreased thyroid weight is in contradiction with the findings in other studies. In this study only thyroid weight was monitored without providing any supportive measurements","page":29,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_021"}
SCCS_vision_codex	NOAEL	=520	mg/kg bw/day	rat	-	Chronic	repeated dose toxicity	{"citation":"Ref.: 10, EFSA (2010) Comment The SCCS agrees with this evaluation","dose":"The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.","effect":"SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 18 Based on the clinical effects reported the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: 10, EFSA (2010) Comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in this study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice). 3.3.5.3. Chronic (> 12 months) toxicity See section 3.3.7. Carcinogenicity 3.3.6. Mutagenicity / Genotoxic","page":18,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_007"}
SCCS_vision_codex	NOAEL	=520	mg/kg bw/day	rat	-	-	repeated dose toxicity	{"citation":"Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation","dose":"The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.","effect":"e not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice).","page":16,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_007"}
SCCS_vision_codex	NOAEL	=520	-	-	oral	2 years	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: NTP 1992 \| gavage \| 2 years \| No changes in thyroid \| 520","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_040"}
SCCS_vision_codex	NOAEL	=520	mg/kg bw/day	rat	-	Chronic	repeated dose toxicity	{"citation":"Ref.: 10, EFSA (2010) Comment The SCCS agrees with this evaluation","dose":"The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.","effect":"SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 18 Based on the clinical effects reported the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: 10, EFSA (2010) Comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in this study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice). 3.3.5.3. Chronic (> 12 months) toxicity See section 3.3.7. Carcinogenicity 3.3.6. Mutagenicity / Genotoxic","page":18,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_007"}
SCCS_vision_codex	NOAEL	=520	mg/kg bw/day	rat	-	Chronic	repeated dose toxicity	{"citation":"Ref.: 10, EFSA (2010) Comment The SCCS agrees with this evaluation","dose":"The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.","effect":"SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 18 Based on the clinical effects reported the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: 10, EFSA (2010) Comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in this study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice). 3.3.5.3. Chronic (> 12 months) toxicity See section 3.3.7. Carcinogenicity 3.3.6. Mutagenicity / Genotoxic","page":18,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_007"}
SCCS_vision_codex	NOAEL	=520	mg/kg bw/day	rat	-	-	repeated dose toxicity	{"citation":"Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation","dose":"The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.","effect":"e not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice).","page":16,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_007"}
SCCS_vision_codex	NOAEL	=520	-	-	oral	2 years	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: NTP 1992 \| gavage \| 2 years \| No changes in thyroid \| 520","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_040"}
SCCS_vision_codex	NOAEL	=520	mg/kg bw/day	rat	-	-	repeated dose toxicity	{"citation":"Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation","dose":"The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.","effect":"e not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice).","page":16,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_007"}
SCCS_vision_codex	NOAEL	=520	-	-	oral	2 years	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: NTP 1992 \| gavage \| 2 years \| No changes in thyroid \| 520","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_040"}
SCCS_vision_codex	NOAEL	=520	mg/kg bw/day	rat	-	Chronic	repeated dose toxicity	{"citation":"Ref.: 10, EFSA (2010) Comment The SCCS agrees with this evaluation","dose":"The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.","effect":"SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 18 Based on the clinical effects reported the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: 10, EFSA (2010) Comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in this study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice). 3.3.5.3. Chronic (> 12 months) toxicity See section 3.3.7. Carcinogenicity 3.3.6. Mutagenicity / Genotoxic","page":18,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_007"}
SCCS_vision_codex	NOAEL	=520	mg/kg bw/day	rat	-	-	repeated dose toxicity	{"citation":"Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation","dose":"The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.","effect":"e not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice).","page":16,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_007"}
SCCS_vision_codex	NOAEL	=520	-	-	oral	2 years	NOAEL study	{"effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: NTP 1992 \| gavage \| 2 years \| No changes in thyroid \| 520","page":28,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_040"}
SCCS_vision_codex	NOAEL	=1992	-	rat	-	-	NOAEL study	{"dose":"The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings.","effect":"eights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP, 1992). Conclusion The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats.","page":17,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_006"}
SCCS_vision_codex	NOAEL	=1992	-	rat	-	-	repeated dose toxicity	{"citation":"Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation","dose":"The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings.","effect":"enal gland weights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only obse","page":16,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_006"}
SCCS_vision_codex	NOAEL	=1992	-	rat	-	-	NOAEL study	{"dose":"The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings.","effect":"eights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP, 1992). Conclusion The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats.","page":17,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_006"}
SCCS_vision_codex	NOAEL	=1992	-	rat	-	-	NOAEL study	{"dose":"The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings.","effect":"eights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP, 1992). Conclusion The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats.","page":17,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_006"}
SCCS_vision_codex	NOAEL	=1992	-	rat	-	-	repeated dose toxicity	{"citation":"Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation","dose":"The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings.","effect":"enal gland weights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only obse","page":16,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_006"}
SCCS_vision_codex	NOAEL	=1992	-	rat	-	-	repeated dose toxicity	{"citation":"Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation","dose":"The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings.","effect":"enal gland weights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only obse","page":16,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_006"}
SCCS_vision_codex	NOAEL	=1992	-	rat	-	-	NOAEL study	{"dose":"The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings.","effect":"eights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP, 1992). Conclusion The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats.","page":17,"pdf":"sccs_o_015.pdf","row_type":"noael_study","study_id":"sccs_o_015_noael_006"}
SCCS_vision_codex	NOAEL	=1992	-	rat	-	-	repeated dose toxicity	{"citation":"Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation","dose":"The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings.","effect":"enal gland weights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only obse","page":16,"pdf":"sccs_o_241.pdf","row_type":"noael_study","study_id":"sccs_o_241_noael_006"}

ToxRefDB_ToxRefDB_v3_pod.csv 11 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxRefDB_ToxRefDB_v3_pod.csv	LEL	=28	mg/kg bw/day	mouse (b6c3f1; B6C3F1)	oral	0 day to 13 week	SUB	study_id=4990; toxval_study_source_id=studyid4990_Adult_F0_M_systemic; toxval_effect_list=organ weight-adrenal gland-relative to body weight\|organ weight-adrenal gland-absolute\|in life observation-mortality-mortality\|in life observation-clinical signs-tremors\|in life observation-body weight-body weight\|in life observation-clinical signs-respiration (dyspnea)\|in life observation-clinical signs-prostration; dose_level=1; study_year=1992; study_citation=(1992). 'Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies).' Natl Toxicol Program Tech Rep Ser 403: 1-234. (Subchronic Mouse); dsstox_substance_id=DTXSID2021238; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv	LEL	=65	mg/kg bw/day	rat (fischer; Fischer 344)	oral	0 day to 13 week	SUB	study_id=4989; toxval_study_source_id=studyid4989_Adult_F0_F_systemic; toxval_effect_list=organ weight-liver-relative to body weight\|organ weight-liver-absolute\|in life observation-mortality-mortality\|in life observation-clinical signs-tremors; dose_level=2; study_year=1992; study_citation=(1992). 'Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies).' Natl Toxicol Program Tech Rep Ser 403: 1-234. (Subchronic Rat); dsstox_substance_id=DTXSID2021238; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv	LEL	=100	mg/kg bw/day	rat (fischer; Fischer 344)	oral	0 day to 2 year	CHR	study_id=4991; toxval_study_source_id=studyid4991_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-prostration\|in life observation-clinical signs-tremors\|in life observation-clinical signs-ataxia\|in life observation-clinical signs-salivation\|in life observation-mortality-mortality\|in life observation-body weight-body weight; dose_level=2; study_year=1992; study_citation=(1992). "Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies)." Natl Toxicol Program Tech Rep Ser 403: 1-234. (Chronic Rat); dsstox_substance_id=DTXSID2021238; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv	LEL	=112	mg/kg bw/day	rat (fischer; Fischer 344)	oral	0 day to 2 year	CHR	study_id=4991; toxval_study_source_id=studyid4991_Adult_F0_M_systemic; toxval_effect_list=in life observation-clinical signs-salivation\|in life observation-clinical signs-tremors\|in life observation-clinical signs-prostration\|in life observation-clinical signs-ataxia\|in life observation-body weight-body weight\|in life observation-mortality-mortality; dose_level=1; study_year=1992; study_citation=(1992). "Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies)." Natl Toxicol Program Tech Rep Ser 403: 1-234. (Chronic Rat); dsstox_substance_id=DTXSID2021238; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv	LEL	=225	mg/kg bw/day	mouse (b6c3f1; B6C3F1)	oral	0 day to 2 year	CHR	study_id=4992; toxval_study_source_id=studyid4992_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-[other]\|in life observation-body weight-body weight\|in life observation-clinical signs-tremors; dose_level=2; study_year=1992; study_citation=(1992). 'Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies).' Natl Toxicol Program Tech Rep Ser 403: 1-234. (Chronic Mouse); dsstox_substance_id=DTXSID2021238; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv	LEL	=420	mg/kg bw/day	mouse (b6c3f1; B6C3F1)	oral	0 day to 13 week	SUB	study_id=4990; toxval_study_source_id=studyid4990_Adult_F0_F_systemic; toxval_effect_list=in life observation-mortality-mortality\|in life observation-clinical signs-respiration (dyspnea)\|in life observation-clinical signs-prostration\|in life observation-clinical signs-tremors; dose_level=5; study_year=1992; study_citation=(1992). 'Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies).' Natl Toxicol Program Tech Rep Ser 403: 1-234. (Subchronic Mouse); dsstox_substance_id=DTXSID2021238; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv	NEL	>0	mg/kg bw/day	rat (fischer; Fischer 344)	oral	0 day to 13 week	SUB	study_id=4989; toxval_study_source_id=studyid4989_Adult_F0_M_systemic; toxval_effect_list=organ weight-liver-relative to body weight\|organ weight-adrenal gland-relative to body weight\|organ weight-liver-absolute\|in life observation-mortality-mortality\|organ weight-adrenal gland-absolute\|in life observation-clinical signs-tremors; dose_level=0; study_year=1992; study_citation=(1992). 'Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies).' Natl Toxicol Program Tech Rep Ser 403: 1-234. (Subchronic Rat); dsstox_substance_id=DTXSID2021238; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv	NEL	=32	mg/kg bw/day	rat (fischer; Fischer 344)	oral	0 day to 13 week	SUB	study_id=4989; toxval_study_source_id=studyid4989_Adult_F0_F_systemic; toxval_effect_list=in life observation-mortality-mortality\|organ weight-liver-relative to body weight\|in life observation-clinical signs-tremors\|organ weight-liver-absolute; dose_level=1; study_year=1992; study_citation=(1992). 'Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies).' Natl Toxicol Program Tech Rep Ser 403: 1-234. (Subchronic Rat); dsstox_substance_id=DTXSID2021238; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv	NEL	=50	mg/kg bw/day	rat (fischer; Fischer 344)	oral	0 day to 2 year	CHR	study_id=4991; toxval_study_source_id=studyid4991_Adult_F0_F_systemic; toxval_effect_list=in life observation-mortality-mortality\|in life observation-clinical signs-ataxia\|in life observation-clinical signs-salivation\|in life observation-clinical signs-prostration\|in life observation-body weight-body weight\|in life observation-clinical signs-tremors; dose_level=1; study_year=1992; study_citation=(1992). "Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies)." Natl Toxicol Program Tech Rep Ser 403: 1-234. (Chronic Rat); dsstox_substance_id=DTXSID2021238; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv	NEL	=112	mg/kg bw/day	mouse (b6c3f1; B6C3F1)	oral	0 day to 2 year	CHR	study_id=4992; toxval_study_source_id=studyid4992_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight\|in life observation-clinical signs-[other]\|in life observation-clinical signs-tremors; dose_level=1; study_year=1992; study_citation=(1992). 'Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies).' Natl Toxicol Program Tech Rep Ser 403: 1-234. (Chronic Mouse); dsstox_substance_id=DTXSID2021238; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5
ToxRefDB_ToxRefDB_v3_pod.csv	NEL	=225	mg/kg bw/day	mouse (b6c3f1; B6C3F1)	oral	0 day to 13 week	SUB	study_id=4990; toxval_study_source_id=studyid4990_Adult_F0_F_systemic; toxval_effect_list=in life observation-mortality-mortality\|in life observation-clinical signs-prostration\|in life observation-clinical signs-respiration (dyspnea)\|in life observation-clinical signs-tremors; dose_level=4; study_year=1992; study_citation=(1992). 'Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies).' Natl Toxicol Program Tech Rep Ser 403: 1-234. (Subchronic Mouse); dsstox_substance_id=DTXSID2021238; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5

ToxValDB_DOE_Protective_Action_Criteria 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_DOE_Protective_Action_Criteria	LEL	=63050.1	mg/m3	Human	inhalation	-	acute	LONG_REF=U.S. Department of Energy (DOE) Protective Action Criteria (PAC). 2023. PAC Chemical Database. Updated 11 October 2023. Available: https://edms3.energy.gov/pac/ (Accessed November 16, 2023); TITLE=U.S. Department of Energy (DOE) Protective Action Criteria (PAC) Chemical Database; AUTHOR=U.S. Department of Energy; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65428efee4b045b9ff7cc432; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://edms3.energy.gov/pac/TeelDocs; YEAR=2013; ORIGINAL_YEAR=2013; STUDY_GROUP=DOE Protective Action Criteria:15519182:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4d5024ed5b4ba0e9639f067f28f47049

ToxValDB_ECHA_IUCLID 5 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_ECHA_IUCLID	NOAEL	=27.5	mg/kg bw/day	Rat	oral	short-term; 17 days	short-term	QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cc1be4b0a7c65d229040; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/12506/7/6/2?documentUUID=e97a6203-6393-40bc-88ed-f53c5f4a10ee; YEAR=2012; ORIGINAL_YEAR=2012; STUDY_GROUP=ECHA IUCLID:15848520:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_af2a41ae5b93223990c77117a2112796
ToxValDB_ECHA_IUCLID	NOAEL	=75	mg/kg bw/day	Mouse	oral	short-term; 17 days	short-term	QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cc1be4b0a7c65d229048; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/12506/7/6/2?documentUUID=e97a6203-6393-40bc-88ed-f53c5f4a10ee; YEAR=2012; ORIGINAL_YEAR=2012; STUDY_GROUP=ECHA IUCLID:15848038:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_8bd96cb608fc2852c68c8493423c02e4
ToxValDB_ECHA_IUCLID	NOAEL	=110	mg/kg bw/day	Rat	oral	short-term; 17 days	short-term	QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cc1be4b0a7c65d229040; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/12506/7/6/2?documentUUID=e97a6203-6393-40bc-88ed-f53c5f4a10ee; YEAR=2012; ORIGINAL_YEAR=2012; STUDY_GROUP=ECHA IUCLID:15847859:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_bfbd166793f2858ec9655fd90bbae36b
ToxValDB_ECHA_IUCLID	NOAEL	=150	mg/kg bw/day	Mouse	oral	short-term; 17 days	short-term	QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cc1be4b0a7c65d229048; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/12506/7/6/2?documentUUID=e97a6203-6393-40bc-88ed-f53c5f4a10ee; YEAR=2012; ORIGINAL_YEAR=2012; STUDY_GROUP=ECHA IUCLID:15849035:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_e55eaaf611ed0cdf5e865f7de6a1fead
ToxValDB_ECHA_IUCLID	NOAEL	=225	mg/kg bw/day	Mouse	oral	subchronic; 13 weeks	subchronic	QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf61e4b0a7c65d1cda92; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/12506/7/6/2?documentUUID=e97a6203-6393-40bc-88ed-f53c5f4a10ee; YEAR=2012; ORIGINAL_YEAR=2012; STUDY_GROUP=ECHA IUCLID:15848308:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_90857317c1fd0763e103be50da02a11c

ToxValDB_ECOTOX 15 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_ECOTOX	LOEL	=0.06	mmol	Rat	injection	acute; 0.0833 days	acute	LONG_REF=Biochem. J. (Lond.)50:473-479 Arnott,D.G., and I. Doniach The Effect of Compounds Allied to Resorcinol upon the Uptake of Radioactive Iodine (131I) by the Thyroid of the Rat 1952; TITLE=The Effect of Compounds Allied to Resorcinol upon the Uptake of Radioactive Iodine (131I) by the Thyroid of the Rat; AUTHOR=Arnott,D.G., and I. Doniach; DOI=10.1042/bj0500473; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=97800; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1952; ORIGINAL_YEAR=1952; TOXICOLOGICAL_EFFECT=Physiology: Iodine uptake; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15595289_15597614:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=b8c1669f39c24bbbd9a01f88837caf5a
ToxValDB_ECOTOX	LOEL	=0.1	mmol	Rat	injection	acute; 0.0833 days	acute	LONG_REF=Biochem. J. (Lond.)50:473-479 Arnott,D.G., and I. Doniach The Effect of Compounds Allied to Resorcinol upon the Uptake of Radioactive Iodine (131I) by the Thyroid of the Rat 1952; TITLE=The Effect of Compounds Allied to Resorcinol upon the Uptake of Radioactive Iodine (131I) by the Thyroid of the Rat; AUTHOR=Arnott,D.G., and I. Doniach; DOI=10.1042/bj0500473; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=97800; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1952; ORIGINAL_YEAR=1952; TOXICOLOGICAL_EFFECT=Physiology: Iodine uptake; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15595289_15597614:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=29638e5fc48c5a0490417b1524cd949c
ToxValDB_ECOTOX	LOEL	=28	mg/kg bw/day	Mouse	oral	subchronic; 13 weeks	subchronic	LONG_REF=- \| Technical Report, TR-403,National Toxicology Program, Research Triangle Park, NC:246 p. National Toxicology Program (NTP) Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies) 1992; TITLE=Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies); AUTHOR=National Toxicology Program (NTP); QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=107915; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=body weight decrease, relative liver weight increase, relative kidney weight increase, absolute adrenal gland decrease, relative adrenal gland decrease \| hematology: monocytes; TOXICOLOGICAL_EFFECT_CATEGORY=hematology\|multiple; STUDY_GROUP=ECOTOX:15613589:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=4d0dc8c5bec293db0ec88a909b3e7ae3
ToxValDB_ECOTOX	LOEL	=32	mg/kg bw/day	Rat	oral	subchronic; 13 weeks	subchronic	LONG_REF=- \| Technical Report, TR-403,National Toxicology Program, Research Triangle Park, NC:246 p. National Toxicology Program (NTP) Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies) 1992; TITLE=Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies); AUTHOR=National Toxicology Program (NTP); QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=107915; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=relative liver weight, relative and and absolute thymus weight\|clinical chemistry: total protein; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry\|organ weight; STUDY_GROUP=ECOTOX:15613523:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=80a8abf7c7d9f9c0b19c6bad3e5ef4fe
ToxValDB_ECOTOX	LOEL	=112	mg/kg bw/day	Rat	oral	chronic; 15 months	chronic	LONG_REF=- \| Technical Report, TR-403,National Toxicology Program, Research Triangle Park, NC:246 p. National Toxicology Program (NTP) Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies) 1992; TITLE=Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies); AUTHOR=National Toxicology Program (NTP); QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=107915; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=decreased body weight and increased relative brain weight; TOXICOLOGICAL_EFFECT_CATEGORY=multiple; STUDY_GROUP=ECOTOX:15613072:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=7a685254693e31b919039e2a502aefe4
ToxValDB_ECOTOX	LOEL	=420	mg/kg bw/day	Mouse	oral	subchronic; 13 weeks	subchronic	LONG_REF=- \| Technical Report, TR-403,National Toxicology Program, Research Triangle Park, NC:246 p. National Toxicology Program (NTP) Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies) 1992; TITLE=Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies); AUTHOR=National Toxicology Program (NTP); QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=107915; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=relative kidney weight; TOXICOLOGICAL_EFFECT_CATEGORY=organ weight; STUDY_GROUP=ECOTOX:15612982:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=9ebf607ef40d703d8cdb50dbfdcebea2
ToxValDB_ECOTOX	LOEL	=450	mg/kg bw/day	Rat	oral	short-term; 17 days	short-term	LONG_REF=- \| Technical Report, TR-403,National Toxicology Program, Research Triangle Park, NC:246 p. National Toxicology Program (NTP) Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies) 1992; TITLE=Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies); AUTHOR=National Toxicology Program (NTP); QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=107915; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=Relative and absolute thymus weight; TOXICOLOGICAL_EFFECT_CATEGORY=organ weight; STUDY_GROUP=ECOTOX:15613051:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=0ce0b7bc08d7e2fedf8dec16430b32ba
ToxValDB_ECOTOX	LOEL	=1000	mg/L	Rat	oral	chronic; 157 days	reproduction developmental	LONG_REF=Int. J. Toxicol.27(1): 43-57 Welsch,F., M.D. Nemec, and W.B. Lawrence Two-Generation Reproductive Toxicity Study of Resorcinol Administered via Drinking Water to Crl:CD(SD) Rats 2008; TITLE=Two-Generation Reproductive Toxicity Study of Resorcinol Administered via Drinking Water to Crl:CD(SD) Rats; AUTHOR=Welsch,F., M.D. Nemec, and W.B. Lawrence; DOI=10.1080/10915810701876679; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=108047; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=Reproduction: Number of implantations; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ECOTOX_dup_EPA ORD_15603300_15603301_15603302_15610984:M/F:F1-; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=a8628c21a0fa715ee19cd6073a7a1142
ToxValDB_ECOTOX	NOEL	=0.8	%	Rat	oral	chronic; 273 days	chronic	LONG_REF=Cancer Lett.58(3): 241-246 Nakamura,A., T. Shirai, S. Takahashi, K. Ogawa, M. Hirose, and N. Ito Lack of Modification by Naturally Occurring Antioxidants of 3,2\'-Dimethyl-4-Aminobiphenyl-Initiated Rat Prostate Carcinogenesis 1991; TITLE=Lack of Modification by Naturally Occurring Antioxidants of 3,2'-Dimethyl-4-Aminobiphenyl-Initiated Rat Prostate Carcinogenesis; AUTHOR=Nakamura,A., T. Shirai, S. Takahashi, K. Ogawa, M. Hirose, and N. Ito; DOI=10.1016/0304-3835(91)90107-s; QUALITY=Control type: Positive control; EXTERNAL_SOURCE_ID=109132; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=Growth: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX:15608712:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=07133b2235257c6f104b0fbe576cfe22
ToxValDB_ECOTOX	NOEL	=50	mg/kg bw/day	Rat	oral	chronic; 15 months	chronic	LONG_REF=- \| Technical Report, TR-403,National Toxicology Program, Research Triangle Park, NC:246 p. National Toxicology Program (NTP) Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies) 1992; TITLE=Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies); AUTHOR=National Toxicology Program (NTP); QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=107915; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=Enzyme(s): Sorbitol dehydrogenase; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry; STUDY_GROUP=ECOTOX:15613561:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=7c8509ce1abbcd0b2127bfdcc7f09ca6
ToxValDB_ECOTOX	NOEL	=112	mg/kg bw/day	Mouse	oral	chronic; 15 months	chronic	LONG_REF=- \| Technical Report, TR-403,National Toxicology Program, Research Triangle Park, NC:246 p. National Toxicology Program (NTP) Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies) 1992; TITLE=Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies); AUTHOR=National Toxicology Program (NTP); QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=107915; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=Enzyme(s): Alkaline phosphatase (ALP); TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry; STUDY_GROUP=ECOTOX:15613590:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=68e1e43728bffda8bde51cfd316f1156
ToxValDB_ECOTOX	NOEL	=120	mg/L	Rat	oral	chronic; 157 days	reproduction developmental	LONG_REF=Int. J. Toxicol.27(1): 43-57 Welsch,F., M.D. Nemec, and W.B. Lawrence Two-Generation Reproductive Toxicity Study of Resorcinol Administered via Drinking Water to Crl:CD(SD) Rats 2008; TITLE=Two-Generation Reproductive Toxicity Study of Resorcinol Administered via Drinking Water to Crl:CD(SD) Rats; AUTHOR=Welsch,F., M.D. Nemec, and W.B. Lawrence; DOI=10.1080/10915810701876679; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=108047; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=Histology: Histological changes, general; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECOTOX_dup_EPA ORD_15603300_15603301_15603302_15610984:M/F:F1-; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=82f50b188fccc773245e3ab99f34a01c
ToxValDB_ECOTOX	NOEL	=300	mg/kg bw/day	Mouse	oral	short-term; 17 days	short-term	LONG_REF=- \| Technical Report, TR-403,National Toxicology Program, Research Triangle Park, NC:246 p. National Toxicology Program (NTP) Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies) 1992; TITLE=Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies); AUTHOR=National Toxicology Program (NTP); QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=107915; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=Growth: Weight \|Morphology: Organ weight in relationship to body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight\|organ weight; STUDY_GROUP=ECOTOX:15613081:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=4ca723c59f087e0a96764aa3314af1c5
ToxValDB_ECOTOX	NOEL	=360	mg/L	Rat	oral	chronic; 157 days	reproduction developmental	LONG_REF=Int. J. Toxicol.27(1): 43-57 Welsch,F., M.D. Nemec, and W.B. Lawrence Two-Generation Reproductive Toxicity Study of Resorcinol Administered via Drinking Water to Crl:CD(SD) Rats 2008; TITLE=Two-Generation Reproductive Toxicity Study of Resorcinol Administered via Drinking Water to Crl:CD(SD) Rats; AUTHOR=Welsch,F., M.D. Nemec, and W.B. Lawrence; DOI=10.1080/10915810701876679; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=108047; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=Reproduction: Number of implantations; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ECOTOX_dup_EPA ORD_15603300_15603301_15603302_15610984:M/F:F1-; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=8639b6cae253e7aa8186ebc7ca7f783b
ToxValDB_ECOTOX	NOEL	=3000	mg/L	Rat	oral	chronic; 157 days	reproduction developmental	LONG_REF=Int. J. Toxicol.27(1): 43-57 Welsch,F., M.D. Nemec, and W.B. Lawrence Two-Generation Reproductive Toxicity Study of Resorcinol Administered via Drinking Water to Crl:CD(SD) Rats 2008; TITLE=Two-Generation Reproductive Toxicity Study of Resorcinol Administered via Drinking Water to Crl:CD(SD) Rats; AUTHOR=Welsch,F., M.D. Nemec, and W.B. Lawrence; DOI=10.1080/10915810701876679; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=108047; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=Growth: Weight gain\|Hormone(s): Thyrotropin\|Morphology: Weight\|Physiology: Estrous cycle\|Reproduction: Motility; TOXICOLOGICAL_EFFECT_CATEGORY=body weight\|clinical chemistry\|other\|reproduction; STUDY_GROUP=ECOTOX_dup_EPA ORD_15603300_15603301_15603302_15610984:M/F:F1-; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=91b062eebb18874ff6daac8b4e40cf6d

ToxValDB_EFSA 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_EFSA	NOAEL	=36	mg/kg bw/day	Mouse	oral	chronic; 104 weeks	chronic	LONG_REF=EFSA FEEDAP (2012). Scientific Opinion on the safety and efficacy of phenol derivatives containing ring-alkyl, ring-alkoxy and side-chains with an oxygenated functional group (chemical group 25) when used as flavourings for all species. doi:10.2903/j.efsa.2012.2573.; TITLE=Scientific Opinion on the safety and efficacy of phenol derivatives containing ring-alkyl, ring-alkoxy and side-chains with an oxygenated functional group (chemical group 25) when used as flavourings for all species; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2012.2573; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=clinical signs; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=EFSA:15614316:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_20a9b304e1110fc8e8c17939b55fb263

ToxValDB_GESTIS_DNEL 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_GESTIS_DNEL	DNEL local	=132.8	mg/m3	Human	inhalation	-	Toxicity Value	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL_dup_-_15634595_15634596:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c509ae52f613cef79dea5a80939ba76e
ToxValDB_GESTIS_DNEL	DNEL systemic	=5.6	mg/m3	Human	inhalation	-	Toxicity Value	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL_dup_-_15634595_15634596:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_53b3b96af85ffbc91b0d6dcb1147b03b

ToxValDB_Pennsylvania_DEP_ToxValues 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_Pennsylvania_DEP_ToxValues	RfD	=2	mg/kg bw/day	Human	oral	-	Toxicity Value	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67599fbae4b0a7c65d37b2e3; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://files.dep.state.pa.us/EnvironmentalCleanupBrownfields/LandRecyclingProgram/LandRecyclingProgramPortalFiles/GuidanceTechTools/VaporIntrusion/November_2021/Table%205a.pdf; STUDY_GROUP=Pennsylvania DEP ToxValues:15650330:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_cb5cd500b66c2a6a12818291394a96a6

ToxValDB_ToxRefDB 3 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_ToxRefDB	LEL	=65	mg/kg bw/day	Rat	oral	subchronic; 13 weeks	subchronic	LONG_REF=(1992). \'Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies).\' Natl Toxicol Program Tech Rep Ser 403: 1-234. (Subchronic Rat); TITLE=Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies); AUTHOR=NTP; EXTERNAL_SOURCE_ID=4989; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=systemic: organ weight-liver-absolute\|systemic: organ weight-liver-relative to body weight\|systemic: in life observation-clinical signs-tremors\|systemic: in life observation-mortality-mortality; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs\|mortality/survival\|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15708159_15708160:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_24c5a0af83925317ba0f06c5c3bb1eda
ToxValDB_ToxRefDB	LEL	=100	mg/kg bw/day	Rat	oral	chronic; 2 years	chronic	LONG_REF=(1992). \"Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies).\" Natl Toxicol Program Tech Rep Ser 403: 1-234. (Chronic Rat); TITLE=Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies); AUTHOR=NTP; EXTERNAL_SOURCE_ID=4991; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-ataxia\|systemic: in life observation-clinical signs-prostration\|systemic: in life observation-clinical signs-salivation\|systemic: in life observation-clinical signs-tremors\|systemic: in life observation-mortality-mortality\|systemic: in life observation-body weight-body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight\|clinical signs\|mortality/survival; STUDY_GROUP=ToxRefDB_dup_-_15708165_15708166_15708167_15708168:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_36e20c34d695ad8b02346b3ab941c08d
ToxValDB_ToxRefDB	LEL	=225	mg/kg bw/day	Mouse	oral	chronic; 2 years	chronic	LONG_REF=(1992). \'Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies).\' Natl Toxicol Program Tech Rep Ser 403: 1-234. (Chronic Mouse); TITLE=Toxicology and Carcinogenesis Studies of Resorcinol (CAS No. 108-46-3) in F344 Rats and B6C3F1 Mice (Gavage Studies); AUTHOR=NTP; EXTERNAL_SOURCE_ID=4992; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-[other]\|systemic: in life observation-body weight-body weight\|systemic: in life observation-clinical signs-tremors; TOXICOLOGICAL_EFFECT_CATEGORY=body weight\|clinical signs; STUDY_GROUP=ToxRefDB_dup_-_15708170_15708171_15708172_15708173:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7c4396e6df06cd873ca4e9b03bb85900

UnifiedCodex:SCCS_SHADOW:beta.noael_studies 91 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	0	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=F0:; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: USR 2005a, \| drinking \| Key study \| F0: \| F0:; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: USR 2005a, \| drinking \| Key study \| F0: \| F0:","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"F0:","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_042"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	2	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=unclear:Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Study \| Route of \| Comment \| Parameter \| NOAEL; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Study \| Route of \| Comment \| Parameter \| NOAEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Study \| Route of \| Comment \| Parameter \| NOAEL","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"unclear:Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Study \| Route of \| Comment \| Parameter \| NOAEL","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_039"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	80	mg/kg bw/day	rat	oral	4 to week	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=80; DOSE=he exception of the two males that had convulsions and died, no clinical observations were recorded at 80 mg/kg bw/day.; EFFECT=he exception of the two males that had convulsions and died, no clinical observations were recorded at 80 mg/kg bw/day. No treatment-related effects on body weight, food consumption, blood and urine parameters, organ weights and necropsy findings were noted. The female group receiving 250 mg/kg bw/day gained slightly less weight from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. In a 13-week oral toxicity study (NTP 1992) all female and 8 male rats from the high-dose group died from resorcinol-related toxicity during the first four weeks of the study. On day 2 of the study, rats from the 260 mg/kg bw/d group were given 520 mg/kg bw/d by mistake. Within 5 days, two males and four females in this group died. These deaths were attributed to incorrect dosing because no further deaths occurred among rats receiving the correct dose during th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"he exception of the two males that had convulsions and died, no clinical observations were recorded at 80 mg/kg bw/day.","duration":"4 to week","effect":"he exception of the two males that had convulsions and died, no clinical observations were recorded at 80 mg/kg bw/day. No treatment-related effects on body weight, food consumption, blood and urine parameters, organ weights and necropsy findings were noted. The female group receiving 250 mg/kg bw/day gained slightly less weight from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. In a 13-week oral toxicity study (NTP 1992) all female and 8 male rats from the high-dose group died from resorcinol-related toxicity during the first four weeks of the study. On day 2 of the study, rats from the 260 mg/kg bw/d group were given 520 mg/kg bw/d by mistake. Within 5 days, two males and four females in this group died. These deaths were attributed to incorrect dosing because no further deaths occurred among rats receiving the correct dose during th","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":32,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_030"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	80	-	-	oral	90-day	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=80 ); EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: USR 2004a / \| gavage \| 90-day study \| Decreased thyroid weight \| 80 ); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"90-day","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: USR 2004a / \| gavage \| 90-day study \| Decreased thyroid weight \| 80 )","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"80 )","page":28,"route":"oral","species":"","study_id":"sccs_o_241_noael_041"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	101	mg/kg bw/d	human	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=101; DOSE=21 (table 213, page 2046-2050 of the USR 2005a study report), the SCCS did not see a clear dose- response, but noted that a statistical test on outliers allowed one value in the mid- concentration of 360 mg/L to be excluded and 2 outlying values in the highest drinking- water exposure to be taken into account for statistical analysis.; LOAEL_VALUE=101 mg/kg bw/d; EFFECT=21 (table 213, page 2046-2050 of the USR 2005a study report), the SCCS did not see a clear dose- response, but noted that a statistical test on outliers allowed one value in the mid- concentration of 360 mg/L to be excluded and 2 outlying values in the highest drinking- water exposure to be taken into account for statistical analysis. Based on the analysis, the highest drinking-water exposure (3000 mg/L, converted to 304 mg/kg bw/d based on the drinking-water intake) can be designated as a LOAEL. Consequently, the NOAEL for endocrine effects will be 101 mg/kg bw/d. 4) Human data: The CEHOS (2012) evaluation states that according to human case reports, resorcinol indeed exerts antithyroid functions. Data are old (all from before 1973), but quite clear:; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"21 (table 213, page 2046-2050 of the USR 2005a study report), the SCCS did not see a clear dose- response, but noted that a statistical test on outliers allowed one value in the mid- concentration of 360 mg/L to be excluded and 2 outlying values in the highest drinking- water exposure to be taken into account for statistical analysis.","duration":"","effect":"21 (table 213, page 2046-2050 of the USR 2005a study report), the SCCS did not see a clear dose- response, but noted that a statistical test on outliers allowed one value in the mid- concentration of 360 mg/L to be excluded and 2 outlying values in the highest drinking- water exposure to be taken into account for statistical analysis. Based on the analysis, the highest drinking-water exposure (3000 mg/L, converted to 304 mg/kg bw/d based on the drinking-water intake) can be designated as a LOAEL. Consequently, the NOAEL for endocrine effects will be 101 mg/kg bw/d. 4) Human data: The CEHOS (2012) evaluation states that according to human case reports, resorcinol indeed exerts antithyroid functions. Data are old (all from before 1973), but quite clear:","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"101 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"101","page":29,"route":"","species":"human","study_id":"sccs_o_241_noael_023"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	101	mg/kg/d	rat	oral	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=101; DOSE=From this study, an overall NOAEL of 101 mg/kg/d is derived from the LOAEL of 304, which is based on the slightly increased TSH in F1 male rates receiving 3000 mg/L resorcinol in their drinking water.; EFFECT=) that resorcinol exerts anti-thyroid effects. However, while a clear level of exposure needed for such an effect cannot be derived from the available studies in humans, most of these studies point to a relatively much higher level of exposure than is the case from cosmetics. The SCCS concurs with the ECHA (2020) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is relevant and regards it as the key study to evaluate the effects on the thyroid in rats. From this study, an overall NOAEL of 101 mg/kg/d is derived from the LOAEL of 304, which is based on the slightly increased TSH in F1 male rates receiving 3000 mg/L resorcinol in their drinking water.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"From this study, an overall NOAEL of 101 mg/kg/d is derived from the LOAEL of 304, which is based on the slightly increased TSH in F1 male rates receiving 3000 mg/L resorcinol in their drinking water.","duration":"","effect":") that resorcinol exerts anti-thyroid effects. However, while a clear level of exposure needed for such an effect cannot be derived from the available studies in humans, most of these studies point to a relatively much higher level of exposure than is the case from cosmetics. The SCCS concurs with the ECHA (2020) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is relevant and regards it as the key study to evaluate the effects on the thyroid in rats. From this study, an overall NOAEL of 101 mg/kg/d is derived from the LOAEL of 304, which is based on the slightly increased TSH in F1 male rates receiving 3000 mg/L resorcinol in their drinking water.","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg/d","noael_value":"101","page":30,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_024"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	101	mg/kg bw/d	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=101; DOSE=A statistical test on outliers allowed the outlying values in the highest drinking-water concentration to be taken into account and therefore, 3000 mg/L, converted to 304 mg/kg bw/d based on the drinking-water intake can be designated as a LOAEL.; EFFECT=, this was clearly based on a single outlier. A statistical test on outliers allowed the outlying values in the highest drinking-water concentration to be taken into account and therefore, 3000 mg/L, converted to 304 mg/kg bw/d based on the drinking-water intake can be designated as a LOAEL. Overall from the 2-generation key study, for the majority of the thyroid parameters NOAELs can be derived from the absence of a biologically relevant effect at the highest test dose. From the TSH values in F1 males, an overall NOAEL for endocrine (thyroid) effects of 101 mg/kg bw/d can be derived.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"A statistical test on outliers allowed the outlying values in the highest drinking-water concentration to be taken into account and therefore, 3000 mg/L, converted to 304 mg/kg bw/d based on the drinking-water intake can be designated as a LOAEL.","duration":"","effect":", this was clearly based on a single outlier. A statistical test on outliers allowed the outlying values in the highest drinking-water concentration to be taken into account and therefore, 3000 mg/L, converted to 304 mg/kg bw/d based on the drinking-water intake can be designated as a LOAEL. Overall from the 2-generation key study, for the majority of the thyroid parameters NOAELs can be derived from the absence of a biologically relevant effect at the highest test dose. From the TSH values in F1 males, an overall NOAEL for endocrine (thyroid) effects of 101 mg/kg bw/d can be derived.","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"101","page":34,"route":"","species":"","study_id":"sccs_o_241_noael_038"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	101	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=101; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -TSH increase Males **) \| 101; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -TSH increase Males **) \| 101","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"101","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_050"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	112	mg/kg bw	mouse	oral	-	-	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=112; DOSE=The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992).; EFFECT=l glands in males from all dosed groups were statistically significantly increased (p<0.01) compared to the controls. The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992). Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group the Panel concluded that this dose-group should not be used to define the NOAEL. Mice In the high-dose group seven mice of each sex died during the first week of the study, another male died during week 4 and another female died during week 12. The authors of the study attributed these deaths to resorcinol-related toxicity. Furthermore, one male died in the 112 mg/kg bw group due to improper gavage technique. The final body weights of the 2 surviving high-dose male mice were statistically significantly less than controls. The final body weights and changes in body weights of all other mice r; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992).","duration":"","effect":"l glands in males from all dosed groups were statistically significantly increased (p<0.01) compared to the controls. The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992). Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group the Panel concluded that this dose-group should not be used to define the NOAEL. Mice In the high-dose group seven mice of each sex died during the first week of the study, another male died during week 4 and another female died during week 12. The authors of the study attributed these deaths to resorcinol-related toxicity. Furthermore, one male died in the 112 mg/kg bw group due to improper gavage technique. The final body weights of the 2 surviving high-dose male mice were statistically significantly less than controls. The final body weights and changes in body weights of all other mice r","endpoint":"","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw","noael_value":"112","page":17,"route":"oral","species":"mouse","study_id":"sccs_o_015_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	112	mg/kg bw	mouse	oral	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=112; DOSE=The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992).; EFFECT=al glands in males from all dosed groups were statistically significantly increased (p<0.01) compared to the controls. The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992). Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group, the Panel concluded that this dose-group should not be used to derive a NOAEL. In mice, seven animals in the high-dose group of each sex died during the first week of the study, another male died during week 4 and another female died during week 12. The authors of the study attributed these deaths to resorcinol-related toxicity. Furthermore, one male died in the 112 mg/kg bw group due to improper gavage technique. The final body weights of the 2 surviving high-dose male mice were statistically significantly lower compared to controls. The final body weights and changes in body weights of a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992).","duration":"","effect":"al glands in males from all dosed groups were statistically significantly increased (p<0.01) compared to the controls. The EFSA Panel noted that the absolute adrenal weights were low in the male controls, that no dose-response relationship was apparent, and that the changes in adrenal weights were not accompanied by histopathological findings (NTP, 1992). Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group, the Panel concluded that this dose-group should not be used to derive a NOAEL. In mice, seven animals in the high-dose group of each sex died during the first week of the study, another male died during week 4 and another female died during week 12. The authors of the study attributed these deaths to resorcinol-related toxicity. Furthermore, one male died in the 112 mg/kg bw group due to improper gavage technique. The final body weights of the 2 surviving high-dose male mice were statistically significantly lower compared to controls. The final body weights and changes in body weights of a","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw","noael_value":"112","page":16,"route":"oral","species":"mouse","study_id":"sccs_o_241_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	130	mg/kg/day	rat	oral	30 days	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=130; DOSE=d only one dose level.; LOAEL_VALUE=233 mg/kg/day; EFFECT=d only one dose level. In the first study resorcinol caused decreases in T3 and T4 levels and increased size of the thyroid after 30 days of dosing (Cooksey et al. 1985) while altered thyroid histopathology was seen after 12 weeks of dosing in the other study (Seffner et al. 1995). In both studies, resorcinol was added to the drinking water. In 1992, the National Toxicology Program of the US EPA tested the effects of resorcinol given to rats by gavage for 13 weeks and no significant effects on T4 levels were seen (NOAEL 130 mg/kg/day). In a more recent two-generation study examining the effects of resorcinol dosing through the drinking water on the thyroid system in rats, the only significant effect was histopathological changes in the thyroid of males from the parental generation, while no effects on thyroid hormone levels or thyroid gland weights were seen at any time point in the parental or offspring generations (Welsch et al. 2008a). The LOAEL from this study was 233 mg/kg/day in males and 340-660 mg/kg/day in females. The d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"d only one dose level.","duration":"30 days","effect":"d only one dose level. In the first study resorcinol caused decreases in T3 and T4 levels and increased size of the thyroid after 30 days of dosing (Cooksey et al. 1985) while altered thyroid histopathology was seen after 12 weeks of dosing in the other study (Seffner et al. 1995). In both studies, resorcinol was added to the drinking water. In 1992, the National Toxicology Program of the US EPA tested the effects of resorcinol given to rats by gavage for 13 weeks and no significant effects on T4 levels were seen (NOAEL 130 mg/kg/day). In a more recent two-generation study examining the effects of resorcinol dosing through the drinking water on the thyroid system in rats, the only significant effect was histopathological changes in the thyroid of males from the parental generation, while no effects on thyroid hormone levels or thyroid gland weights were seen at any time point in the parental or offspring generations (Welsch et al. 2008a). The LOAEL from this study was 233 mg/kg/day in males and 340-660 mg/kg/day in females. The d","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"233 mg/kg/day","noael_unit":"mg/kg/day","noael_value":"130","page":23,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_018"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	130	mg/kg bw/d	rat	oral	13-week	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=130; DOSE=The absolute adrenal weights were low in the male controls, but no dose-response relationship was apparent, and changes in adrenal weights were not accompanied by histopathological findings.; EFFECT=ficant. The absolute and relative weights of the adrenal glands in males from all dosed groups were significantly increased statistically compared to the controls. The absolute adrenal weights were low in the male controls, but no dose-response relationship was apparent, and changes in adrenal weights were not accompanied by histopathological findings. Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group EFSA (2010) concluded that this dose-group should not be used to define the NOAEL, and established 130 mg/kg bw/d as the NOAEL in rats. The 13-week oral toxicity study was also conducted in mice. Clinical signs of toxicity recorded for the high-dose animals were dyspnoea, prostration, and tremors. These signs appeared within 30 minutes of dosing. No resorcinol-related, biologically significant changes in haematology or clinical chemistry parameters were seen. Statistically significant; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"The absolute adrenal weights were low in the male controls, but no dose-response relationship was apparent, and changes in adrenal weights were not accompanied by histopathological findings.","duration":"13-week","effect":"ficant. The absolute and relative weights of the adrenal glands in males from all dosed groups were significantly increased statistically compared to the controls. The absolute adrenal weights were low in the male controls, but no dose-response relationship was apparent, and changes in adrenal weights were not accompanied by histopathological findings. Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group EFSA (2010) concluded that this dose-group should not be used to define the NOAEL, and established 130 mg/kg bw/d as the NOAEL in rats. The 13-week oral toxicity study was also conducted in mice. Clinical signs of toxicity recorded for the high-dose animals were dyspnoea, prostration, and tremors. These signs appeared within 30 minutes of dosing. No resorcinol-related, biologically significant changes in haematology or clinical chemistry parameters were seen. Statistically significant","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"130","page":32,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_031"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	130	mg/kg bw/d	rat	oral	13-week	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=130; DOSE=The absolute adrenal weights were low in the male controls, but no dose-response relationship was apparent, and changes in adrenal weights were not accompanied by histopathological findings.; EFFECT=the adrenal glands in males from all dosed groups were significantly increased statistically compared to the controls. The absolute adrenal weights were low in the male controls, but no dose-response relationship was apparent, and changes in adrenal weights were not accompanied by histopathological findings. Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group EFSA (2010) concluded that this dose-group should not be used to define the NOAEL, and established 130 mg/kg bw/d as the NOAEL in rats. The 13-week oral toxicity study was also conducted in mice. Clinical signs of toxicity recorded for the high-dose animals were dyspnoea, prostration, and tremors. These signs appeared within 30 minutes of dosing. No resorcinol-related, biologically significant changes in haematology or clinical chemistry parameters were seen. Statistically significant; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"The absolute adrenal weights were low in the male controls, but no dose-response relationship was apparent, and changes in adrenal weights were not accompanied by histopathological findings.","duration":"13-week","effect":"the adrenal glands in males from all dosed groups were significantly increased statistically compared to the controls. The absolute adrenal weights were low in the male controls, but no dose-response relationship was apparent, and changes in adrenal weights were not accompanied by histopathological findings. Due to the incorrect dosing of the animals in the 260 mg resorcinol/kg bw/day dose-group EFSA (2010) concluded that this dose-group should not be used to define the NOAEL, and established 130 mg/kg bw/d as the NOAEL in rats. The 13-week oral toxicity study was also conducted in mice. Clinical signs of toxicity recorded for the high-dose animals were dyspnoea, prostration, and tremors. These signs appeared within 30 minutes of dosing. No resorcinol-related, biologically significant changes in haematology or clinical chemistry parameters were seen. Statistically significant","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"130","page":32,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_032"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	173	mg/kg/d	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=173; DOSE=NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 173 mg/kg/d; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 173 mg/kg/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 173 mg/kg/d","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 173 mg/kg/d","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg/d","noael_value":"173","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_048"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	173	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=173; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -thyroid weight \| 173; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -thyroid weight \| 173","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"173","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_049"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	173	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=173; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -T3 changes \| 173; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -T3 changes \| 173","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"173","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_051"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	173	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=173; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -T4 changes \| 173; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -T4 changes \| 173","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"173","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_052"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	177	mg/kg/d	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=177; DOSE=Welsch 2008a \| water \| 2 generation \| -colloid decrease Males \| 177 mg/kg/d; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Welsch 2008a \| water \| 2 generation \| -colloid decrease Males \| 177 mg/kg/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"Welsch 2008a \| water \| 2 generation \| -colloid decrease Males \| 177 mg/kg/d","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: Welsch 2008a \| water \| 2 generation \| -colloid decrease Males \| 177 mg/kg/d","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg/d","noael_value":"177","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_043"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	177	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=177; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: study \| -increased TSH \| 177; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: study \| -increased TSH \| 177","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"177","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_045"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	177	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=177; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -T3 increase males \| 177; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -T3 increase males \| 177","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"177","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_046"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	177	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=177; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -T4 changes \| 177; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -T4 changes \| 177","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"177","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_047"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	177	mg/kg/d	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=177; DOSE=NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 177 mg/kg/d; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 177 mg/kg/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 177 mg/kg/d","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -decreased colloid \| 177 mg/kg/d","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg/d","noael_value":"177","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_053"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	177	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=177; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -thyroid weight Female *) \| 177; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -thyroid weight Female *) \| 177","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"177","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_054"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	177	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=177; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -increased TSH \| 177; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -increased TSH \| 177","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"177","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_055"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	177	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=177; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -T3 changes \| 177; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: -T3 changes \| 177","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"177","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_056"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	~186	mg/kg bw/day	rat	oral	-	-	SOURCE_SUBDIR=sccp_o_124; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCP/1117/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=~186; DOSE=ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation.; EFFECT=ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. 3.3.8.2. Teratogenicity Guideline: OECD Guideline 414 Species/strain: rat, Sprague-Dawley Crl CD® (SD) IGS BR Group size: 24 females/group; 4 groups Test substance: Resorcinol Batch: 706030517 Purity: 98.8% Dose: 40, 80 or 250 mg/kg bw/day, control group received vehicle (purified water) Route: oral; CITATION=Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals; CITATION_NUMBERS=[12,10,1000,20,3000,1]; REFERENCE=Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation.","duration":"","effect":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. 3.3.8.2. Teratogenicity Guideline: OECD Guideline 414 Species/strain: rat, Sprague-Dawley Crl CD® (SD) IGS BR Group size: 24 females/group; 4 groups Test substance: Resorcinol Batch: 706030517 Purity: 98.8% Dose: 40, 80 or 250 mg/kg bw/day, control group received vehicle (purified water) Route: oral","endpoint":"","ingredient":"1.3-dihydroxybenzene was submitted in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"~186","page":20,"route":"oral","species":"rat","study_id":"sccp_o_124_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	~186	mg/kg bw/day	-	-	-	-	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=~186; DOSE=ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation.; EFFECT=ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. 3.3.8.2. Teratogenicity; CITATION=Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals; CITATION_NUMBERS=[12,10,1000,20,3000,1]; REFERENCE=Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation.","duration":"","effect":"ed on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. 3.3.8.2. Teratogenicity","endpoint":"","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"~186","page":24,"route":"","species":"","study_id":"sccs_o_015_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	~233	mg/kg bw/day	-	-	-	-	SOURCE_SUBDIR=sccp_o_124; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCP/1117/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=~233; DOSE=The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings.; EFFECT=SCCS-rejected applicant NOAEL: pups selected for analysis (PND 4 or PND 21). The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. Conclusions Based on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/d; CITATION=Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals; CITATION_NUMBERS=[12,10,1000,20,3000,1]; REFERENCE=Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings.","duration":"","effect":"SCCS-rejected applicant NOAEL: pups selected for analysis (PND 4 or PND 21). The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. Conclusions Based on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/d","endpoint":"","ingredient":"1.3-dihydroxybenzene was submitted in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"~233","page":20,"route":"","species":"","study_id":"sccp_o_124_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	~233	mg/kg bw/day	-	-	-	-	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=~233; DOSE=The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings.; EFFECT=SCCS-rejected applicant NOAEL: pups selected for analysis (PND 4 or PND 21). The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. Conclusions Based on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/d; CITATION=Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals; CITATION_NUMBERS=[12,10,1000,20,3000,1]; REFERENCE=Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals","dose":"The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings.","duration":"","effect":"SCCS-rejected applicant NOAEL: pups selected for analysis (PND 4 or PND 21). The higher (but non-significant) TSH values noted at all dose levels in the F0 males at the scheduled necropsy were not considered test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. Conclusions Based on the results of this study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Ref.: 12 Comments As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/d","endpoint":"","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"~233","page":24,"route":"","species":"","study_id":"sccs_o_015_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	304	mg/kg bw/d	-	oral	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=304; DOSE=d thyroid weight in contradiction with other studies. ) Increase of T3 noted at intake of 360 mg/L drinking water (46.6 mg/kg bw/d), but absence of any effect on T3 at much higher doses in the main study (USR 2005a). ) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implau...; LOAEL_VALUE=304 mg/kg bw/d; EFFECT=d thyroid weight in contradiction with other studies. ) Increase of T3 noted at intake of 360 mg/L drinking water (46.6 mg/kg bw/d), but absence of any effect on T3 at much higher doses in the main study (USR 2005a). ) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implausible because of single outliers and absence of effect at higher dose steps. ) LOAEL based on exposure to 3000 mg/L resorcinol in drinking water (304 mg/kg bw/d), hence NOAEL = 101. The SCCS concurs with the ECHA SVHC (2020a) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is a reliable study to evaluate the effects on the thyroid. The NOAEL in the table above, derived from the 2004 gavage study (USR 2004a) will not be taken into account for the endocrine activity because the decreased thyroid weight is in contradiction with the findings in other studies. In this study only thyroid weight was monitored without providing any supportive measurements; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"d thyroid weight in contradiction with other studies. ) Increase of T3 noted at intake of 360 mg/L drinking water (46.6 mg/kg bw/d), but absence of any effect on T3 at much higher doses in the main study (USR 2005a). *) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implau...","duration":"","effect":"d thyroid weight in contradiction with other studies. ) Increase of T3 noted at intake of 360 mg/L drinking water (46.6 mg/kg bw/d), but absence of any effect on T3 at much higher doses in the main study (USR 2005a). *) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implausible because of single outliers and absence of effect at higher dose steps. **) LOAEL based on exposure to 3000 mg/L resorcinol in drinking water (304 mg/kg bw/d), hence NOAEL = 101. The SCCS concurs with the ECHA SVHC (2020a) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is a reliable study to evaluate the effects on the thyroid. The NOAEL in the table above, derived from the 2004 gavage study (USR 2004a) will not be taken into account for the endocrine activity because the decreased thyroid weight is in contradiction with the findings in other studies. In this study only thyroid weight was monitored without providing any supportive measurements","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"304 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"304","page":29,"route":"oral","species":"","study_id":"sccs_o_241_noael_021"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	304	mg/kg bw/d	-	oral	-	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=304; DOSE=SR 2005a). *) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implausible because of single outliers and absence of effect at higher dose steps. ) LOAEL based on exposure to 3000 mg/L resorcinol in drinking water (304 mg/kg bw/d), hence NOAEL = 101.; LOAEL_VALUE=304 mg/kg bw/d; EFFECT=SR 2005a). ) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implausible because of single outliers and absence of effect at higher dose steps. *) LOAEL based on exposure to 3000 mg/L resorcinol in drinking water (304 mg/kg bw/d), hence NOAEL = 101. The SCCS concurs with the ECHA SVHC (2020a) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is a reliable study to evaluate the effects on the thyroid. The NOAEL in the table above, derived from the 2004 gavage study (USR 2004a) will not be taken into account for the endocrine activity because the decreased thyroid weight is in contradiction with the findings in other studies. In this study only thyroid weight was monitored without providing any supportive measurements of thyroid hormones. Furthermore, the animals were exposed by gavage leading to short peak doses. Based on these uncertainties concluding on the endocrine disrupting effect in this study is difficult. Change; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"SR 2005a). ) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implausible because of single outliers and absence of effect at higher dose steps. *) LOAEL based on exposure to 3000 mg/L resorcinol in drinking water (304 mg/kg bw/d), hence NOAEL = 101.","duration":"","effect":"SR 2005a). ) statistical differences in the mean values for the different doses reported in ECHA (2020), but biological relevance implausible because of single outliers and absence of effect at higher dose steps. ***) LOAEL based on exposure to 3000 mg/L resorcinol in drinking water (304 mg/kg bw/d), hence NOAEL = 101. The SCCS concurs with the ECHA SVHC (2020a) evaluation that the USR 2005a report (with the overlapping Welsch 2008a publication) is a reliable study to evaluate the effects on the thyroid. The NOAEL in the table above, derived from the 2004 gavage study (USR 2004a) will not be taken into account for the endocrine activity because the decreased thyroid weight is in contradiction with the findings in other studies. In this study only thyroid weight was monitored without providing any supportive measurements of thyroid hormones. Furthermore, the animals were exposed by gavage leading to short peak doses. Based on these uncertainties concluding on the endocrine disrupting effect in this study is difficult. Change","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"304 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"304","page":29,"route":"oral","species":"","study_id":"sccs_o_241_noael_022"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	520	-	-	oral	2 years	-	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=520; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: NTP 1992 \| gavage \| 2 years \| No changes in thyroid \| 520; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"2 years","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: NTP 1992 \| gavage \| 2 years \| No changes in thyroid \| 520","endpoint":"","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"520","page":28,"route":"oral","species":"","study_id":"sccs_o_241_noael_040"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	1992	-	rat	-	-	-	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=unclear:eights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP, 1992). Conclusion The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats.; DOSE=The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings.; EFFECT=eights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP, 1992). Conclusion The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings.","duration":"","effect":"eights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP, 1992). Conclusion The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats.","endpoint":"","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"","noael_value":"unclear:eights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP, 1992). Conclusion The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats.","page":17,"route":"","species":"rat","study_id":"sccs_o_015_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	carcinogenicity	1	-	rat	oral	2 years	carcinogenicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=unclear:he response in reaction to thyroid disturbance is not fully characterised and understood. Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies. SCCS comment After reviewing studies listed in table 1 above, the following NOAELs regarding endocrine activity in rats could be derived from each study. From the drinking water main study (USR 2005a), the lowest water intake values were taken. Table 2. NOAEL’s for endocrine activity derived by the SCCS. Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) NTP 1992 gavage 2 years carcinogenicity study No changes in thyroid parameters 520 USR 2004a / Foulon 2005 gavage 90-day study Decreased thyroid weight Females 80 ) Cooksey 1985 drinking water Effects noted, but only single dose was used, insufficient reporting, not complying with current guidelines // Seffner 1995 drinking water Effects noted, but publication lacking in details about methods, calculation; DOSE=Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies.; EFFECT=he response in reaction to thyroid disturbance is not fully characterised and understood. Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies. SCCS comment After reviewing studies listed in table 1 above, the following NOAELs regarding endocrine activity in rats could be derived from each study. From the drinking water main study (USR 2005a), the lowest water intake values were taken. Table 2. NOAEL’s for endocrine activity derived by the SCCS. Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) NTP 1992 gavage 2 years carcinogenicity study No changes in thyroid parameters 520 USR 2004a / Foulon 2005 gavage 90-day study Decreased thyroid weight Females 80 ) Cooksey 1985 drinking water Effects noted, but only single dose was used, insufficient reporting, not complying with current guidelines // Seffner 1995 drinking water Effects noted, but publication lacking in details about methods, calculation; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies.","duration":"2 years","effect":"he response in reaction to thyroid disturbance is not fully characterised and understood. Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies. SCCS comment After reviewing studies listed in table 1 above, the following NOAELs regarding endocrine activity in rats could be derived from each study. From the drinking water main study (USR 2005a), the lowest water intake values were taken. Table 2. NOAEL’s for endocrine activity derived by the SCCS. Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) NTP 1992 gavage 2 years carcinogenicity study No changes in thyroid parameters 520 USR 2004a / Foulon 2005 gavage 90-day study Decreased thyroid weight Females 80 ) Cooksey 1985 drinking water Effects noted, but only single dose was used, insufficient reporting, not complying with current guidelines // Seffner 1995 drinking water Effects noted, but publication lacking in details about methods, calculation","endpoint":"carcinogenicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"unclear:he response in reaction to thyroid disturbance is not fully characterised and understood. Considering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies. SCCS comment After reviewing studies listed in table 1 above, the following NOAELs regarding endocrine activity in rats could be derived from each study. From the drinking water main study (USR 2005a), the lowest water intake values were taken. Table 2. NOAEL’s for endocrine activity derived by the SCCS. Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) NTP 1992 gavage 2 years carcinogenicity study No changes in thyroid parameters 520 USR 2004a / Foulon 2005 gavage 90-day study Decreased thyroid weight Females 80 ) Cooksey 1985 drinking water Effects noted, but only single dose was used, insufficient reporting, not complying with current guidelines // Seffner 1995 drinking water Effects noted, but publication lacking in details about methods, calculation","page":28,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_019"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	carcinogenicity	1	-	rat	oral	2 years	carcinogenicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=unclear:dering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies. SCCS comment After reviewing studies listed in table 1 above, the following NOAELs regarding endocrine activity in rats could be derived from each study. From the drinking water main study (USR 2005a), the lowest water intake values were taken. Table 2. NOAEL’s for endocrine activity derived by the SCCS. Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) NTP 1992 gavage 2 years carcinogenicity study No changes in thyroid parameters 520 USR 2004a / Foulon 2005 gavage 90-day study Decreased thyroid weight Females 80 ) Cooksey 1985 drinking water Effects noted, but only single dose was used, insufficient reporting, not complying with current guidelines // Seffner 1995 drinking water Effects noted, but publication lacking in details about methods, calculation of oral dose // USR 2003 drinking water Dose range finding study for key study USR 2005a F0: T; DOSE=dering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies.; EFFECT=dering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies. SCCS comment After reviewing studies listed in table 1 above, the following NOAELs regarding endocrine activity in rats could be derived from each study. From the drinking water main study (USR 2005a), the lowest water intake values were taken. Table 2. NOAEL’s for endocrine activity derived by the SCCS. Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) NTP 1992 gavage 2 years carcinogenicity study No changes in thyroid parameters 520 USR 2004a / Foulon 2005 gavage 90-day study Decreased thyroid weight Females 80 ) Cooksey 1985 drinking water Effects noted, but only single dose was used, insufficient reporting, not complying with current guidelines // Seffner 1995 drinking water Effects noted, but publication lacking in details about methods, calculation of oral dose // USR 2003 drinking water Dose range finding study for key study USR 2005a F0: T; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"dering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies.","duration":"2 years","effect":"dering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies. SCCS comment After reviewing studies listed in table 1 above, the following NOAELs regarding endocrine activity in rats could be derived from each study. From the drinking water main study (USR 2005a), the lowest water intake values were taken. Table 2. NOAEL’s for endocrine activity derived by the SCCS. Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) NTP 1992 gavage 2 years carcinogenicity study No changes in thyroid parameters 520 USR 2004a / Foulon 2005 gavage 90-day study Decreased thyroid weight Females 80 ) Cooksey 1985 drinking water Effects noted, but only single dose was used, insufficient reporting, not complying with current guidelines // Seffner 1995 drinking water Effects noted, but publication lacking in details about methods, calculation of oral dose // USR 2003 drinking water Dose range finding study for key study USR 2005a F0: T","endpoint":"carcinogenicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"unclear:dering the wide range of functions influenced by TH, it is also highly challenging to fully characterise these effects and their dose-response in experimental studies. SCCS comment After reviewing studies listed in table 1 above, the following NOAELs regarding endocrine activity in rats could be derived from each study. From the drinking water main study (USR 2005a), the lowest water intake values were taken. Table 2. NOAEL’s for endocrine activity derived by the SCCS. Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) NTP 1992 gavage 2 years carcinogenicity study No changes in thyroid parameters 520 USR 2004a / Foulon 2005 gavage 90-day study Decreased thyroid weight Females 80 ) Cooksey 1985 drinking water Effects noted, but only single dose was used, insufficient reporting, not complying with current guidelines // Seffner 1995 drinking water Effects noted, but publication lacking in details about methods, calculation of oral dose // USR 2003 drinking water Dose range finding study for key study USR 2005a F0: T","page":28,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_020"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	carcinogenicity	36	mg/kg/d	rat	oral	5-day	carcinogenicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=36; DOSE=Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day.; EFFECT=4/N rats and B6C3F1 mice of each sex. Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw/day. Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / pho; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day.","duration":"5-day","effect":"4/N rats and B6C3F1 mice of each sex. Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw/day. Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / pho","endpoint":"carcinogenicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg/d","noael_value":"36","page":21,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	carcinogenicity	36	mg/kg/d	rat	oral	5-day	carcinogenicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=36; DOSE=er the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day.; EFFECT=er the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw/day. Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / photo-irritation and photosensitisation No; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"er the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day.","duration":"5-day","effect":"er the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw/day or female F344/N rats given 50, 100, or 150 mg/kg bw/day. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw/day. Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / photo-irritation and photosensitisation No","endpoint":"carcinogenicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg/d","noael_value":"36","page":21,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	dermal absorption	=0.02	mg/kg bw	rat	oral	90-day	dermal absorption	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT== 0.02; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...; EFFECT=______________________________________________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","duration":"90-day","effect":"______________________________________________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroi","endpoint":"dermal absorption","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.02","page":26,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	dermal absorption	=80	mg/kg bw	rat	oral	90-day	dermal absorption	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT== 80; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...; EFFECT=_____________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroid effe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","duration":"90-day","effect":"_____________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroid effe","endpoint":"dermal absorption","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 80","page":26,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	dermal absorption	=80	mg/kg bw	rat	oral	90-day	dermal absorption	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT== 80; DOSE=afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...; EFFECT=afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroid effects of Resorcinol In the review on resorcinol published by the Health Council of the Netherlands in 2004 (Comm; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","duration":"90-day","effect":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Resorcinol) (oxidative conditions) Absorption through the skin (mean + 2SD) A = 2.06 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.02 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90-day study and maternal toxicity in teratogenicity study, oral, rat) Margin of Safety NOAEL / SED = 4000 3.3.14. Discussion Physico-chemical properties Resorcinol is used in oxidative hair colouring products at a maximum concentration of 2.5%, which after mixing in a 1:1 ratio with hydrogen peroxide just prior to use, corresponds to a concentration of 1.25% upon application. The stability of resorcinol in the marketed products is not reported. General toxicity Relevance of anti-thyroid effects of Resorcinol In the review on resorcinol published by the Health Council of the Netherlands in 2004 (Comm","endpoint":"dermal absorption","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 80","page":26,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_017"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	=2.06	µg/cm	rat	oral	prenatal	developmental toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT== 2.06; DOSE=This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004).; EFFECT=he different toxicological endpoints will be used, in accordance with the SCCS Opinion SCCS/1270/09. This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004). Because of the rapid and almost complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment will not be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 D; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004).","duration":"prenatal","effect":"he different toxicological endpoints will be used, in accordance with the SCCS Opinion SCCS/1270/09. This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004). Because of the rapid and almost complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment will not be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 D","endpoint":"developmental toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"µg/cm","noael_value":"= 2.06","page":31,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_026"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	5	%	rat	oral	90-day	developmental toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=5-77; DOSE=Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos:; EFFECT=t be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 DISCUSSION Physicochemical properties Toxicokinetics In the skin, metabolism is slow and 5-77% of resorcinol is present as parent resorcinol after 24h. In hepatic cells, metabolism is efficient (half-life of 22 to 55 min). Fast systemic metabolism and excretion is observed but small amounts of free resorcinol (1.2-4.6%) are detected in urine after gavage administration. The available data do not show accumulation in any organ or tissue, including the thyroid gland. Exposure Toxicological Ev; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos:","duration":"90-day","effect":"t be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 DISCUSSION Physicochemical properties Toxicokinetics In the skin, metabolism is slow and 5-77% of resorcinol is present as parent resorcinol after 24h. In hepatic cells, metabolism is efficient (half-life of 22 to 55 min). Fast systemic metabolism and excretion is observed but small amounts of free resorcinol (1.2-4.6%) are detected in urine after gavage administration. The available data do not show accumulation in any organ or tissue, including the thyroid gland. Exposure Toxicological Ev","endpoint":"developmental toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"%","noael_value":"5-77","page":31,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_029"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	50	mg/kg bw/day	rat	oral	developmental	developmental toxicity	SOURCE_SUBDIR=sccp_o_124; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCP/1117/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=50; DOSE=80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day.; EFFECT=80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day. In the chronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. For the calculation of the MOS, the NOAEL of 80 mg/kg bw/day in the rat developmental toxicity study can be used. The threshold for the thyroid effects of 10 mg/kg bw/day in humans would, therefore, be adequately covered in the MOS. Irritation / sensitisation A 2.5% aqueous solution of resorcinol was not irritant when applied to rabbit skin. A 2.5% concentration of resorcinol caused mild conjunctival irritation to the rabbit eye. 4 Lynch B.S, Delzell E.S., Bechtel D.H. Toxicolog; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day.","duration":"developmental","effect":"80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day. In the chronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. For the calculation of the MOS, the NOAEL of 80 mg/kg bw/day in the rat developmental toxicity study can be used. The threshold for the thyroid effects of 10 mg/kg bw/day in humans would, therefore, be adequately covered in the MOS. Irritation / sensitisation A 2.5% aqueous solution of resorcinol was not irritant when applied to rabbit skin. A 2.5% concentration of resorcinol caused mild conjunctival irritation to the rabbit eye. 4 Lynch B.S, Delzell E.S., Bechtel D.H. Toxicolog","endpoint":"developmental toxicity","ingredient":"1.3-dihydroxybenzene was submitted in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":23,"route":"oral","species":"rat","study_id":"sccp_o_124_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	80	mg/kg bw/day	rat	oral	developmental	developmental toxicity	SOURCE_SUBDIR=sccp_o_124; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCP/1117/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=80; DOSE=There was a significantly increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).; EFFECT=ns were considered to be treatment-related. There was a significantly increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature3, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of t; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 11 3","dose":"There was a significantly increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).","duration":"developmental","effect":"ns were considered to be treatment-related. There was a significantly increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature3, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of t","endpoint":"developmental toxicity","ingredient":"1.3-dihydroxybenzene was submitted in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":21,"route":"oral","species":"rat","study_id":"sccp_o_124_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	80	mg/kg bw/day	rat	oral	developmental	developmental toxicity	SOURCE_SUBDIR=sccp_o_124; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCP/1117/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=80; DOSE=ronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day).; EFFECT=ronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. For the calculation of the MOS, the NOAEL of 80 mg/kg bw/day in the rat developmental toxicity study can be used. The threshold for the thyroid effects of 10 mg/kg bw/day in humans would, therefore, be adequately covered in the MOS. Irritation / sensitisation A 2.5% aqueous solution of resorcinol was not irritant when applied to rabbit skin. A 2.5% concentration of resorcinol caused mild conjunctival irritation to the rabbit eye. 4 Lynch B.S, Delzell E.S., Bechtel D.H. Toxicology Review and Risk Assessment of Resorcinol: Thyroid Effects (2002). Reg. To; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"ronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day).","duration":"developmental","effect":"ronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. For the calculation of the MOS, the NOAEL of 80 mg/kg bw/day in the rat developmental toxicity study can be used. The threshold for the thyroid effects of 10 mg/kg bw/day in humans would, therefore, be adequately covered in the MOS. Irritation / sensitisation A 2.5% aqueous solution of resorcinol was not irritant when applied to rabbit skin. A 2.5% concentration of resorcinol caused mild conjunctival irritation to the rabbit eye. 4 Lynch B.S, Delzell E.S., Bechtel D.H. Toxicology Review and Risk Assessment of Resorcinol: Thyroid Effects (2002). Reg. To","endpoint":"developmental toxicity","ingredient":"1.3-dihydroxybenzene was submitted in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":23,"route":"oral","species":"rat","study_id":"sccp_o_124_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	80	mg/kg bw/day	rat	oral	developmental	developmental toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=80; DOSE=There was a significantly increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).; EFFECT=ns were considered to be treatment-related. There was a significantly increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature2, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 2 Lynch B.S et al. Toxicology Review and Risk Assessment of Resorcinol: Thyroid Effects (2002). Reg. To; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 11 3","dose":"There was a significantly increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).","duration":"developmental","effect":"ns were considered to be treatment-related. There was a significantly increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature2, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 2 Lynch B.S et al. Toxicology Review and Risk Assessment of Resorcinol: Thyroid Effects (2002). Reg. To","endpoint":"developmental toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":25,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	80	mg/kg bw/day	rat	oral	developmental	developmental toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=80; DOSE=There was a significant increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively).; EFFECT=SCCS-rejected applicant NOAEL: idered to be treatment-related. There was a significant increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related. In the opinion of the SCCS, the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the developmental toxicity study with resorcinol bis- diphenylphosphate (BDP) do not raise concern of resorcinol-induced developmental effects. This conclusion is also drawn in each individual study. ECHA 2020:; CITATION=Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the devel; CITATION_NUMBERS=[2005,2017]; REFERENCE=Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the devel; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the devel","dose":"There was a significant increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively).","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: idered to be treatment-related. There was a significant increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related. In the opinion of the SCCS, the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the developmental toxicity study with resorcinol bis- diphenylphosphate (BDP) do not raise concern of resorcinol-induced developmental effects. This conclusion is also drawn in each individual study. ECHA 2020:","endpoint":"developmental toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":19,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	80	mg/kg bw/day	rat	oral	developmental	developmental toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=80; DOSE=___________________________________________________________________________________________ 20 A teratogenicity study with New Zealand White rabbits (n=20-26/group) that were exposed to 0, 25, 50 or 100 mg/kg/d resorcinol in distilled water from GD 6 to 18 showed no effect on the number of corpora lutea, implantations, foetal viability, foetal w...; EFFECT=___________________________________________________________________________________________ 20 A teratogenicity study with New Zealand White rabbits (n=20-26/group) that were exposed to 0, 25, 50 or 100 mg/kg/d resorcinol in distilled water from GD 6 to 18 showed no effect on the number of corpora lutea, implantations, foetal viability, foetal weight and foetal malformations and variations (Unpublished study report, 1982b). SCCS comment The SCCS maintains the conclusion of its previous opinion that the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro New data from the open literature In TK6 cells resorcinol caused concentration-dependent reductions to the relative nuclei count both in the presence and absence of S9, with a considerable attenuating effect in the presence of 0.25% S9. Whereas the p53 responses were modest at 4 hr, strong induction of p5; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"___________________________________________________________________________________________ 20 A teratogenicity study with New Zealand White rabbits (n=20-26/group) that were exposed to 0, 25, 50 or 100 mg/kg/d resorcinol in distilled water from GD 6 to 18 showed no effect on the number of corpora lutea, implantations, foetal viability, foetal w...","duration":"developmental","effect":"___________________________________________________________________________________________ 20 A teratogenicity study with New Zealand White rabbits (n=20-26/group) that were exposed to 0, 25, 50 or 100 mg/kg/d resorcinol in distilled water from GD 6 to 18 showed no effect on the number of corpora lutea, implantations, foetal viability, foetal weight and foetal malformations and variations (Unpublished study report, 1982b). SCCS comment The SCCS maintains the conclusion of its previous opinion that the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro New data from the open literature In TK6 cells resorcinol caused concentration-dependent reductions to the relative nuclei count both in the presence and absence of S9, with a considerable attenuating effect in the presence of 0.25% S9. Whereas the p53 responses were modest at 4 hr, strong induction of p5","endpoint":"developmental toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":20,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	80	mg/kg bw/d	-	oral	prenatal	developmental toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=80; DOSE=This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004).; EFFECT=SCCS/1619/20 Final Opinion Opinion on Resorcinol ___________________________________________________________________________________________ ___________________________________________________________________________________________ 31 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) For the calculation of the MoS, the lowest NOAEL among those obtained from the different toxicological endpoints will be used, in accordance with the SCCS Opinion SCCS/1270/09. This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004). Because of the rapid and almost complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004).","duration":"prenatal","effect":"SCCS/1619/20 Final Opinion Opinion on Resorcinol ___________________________________________________________________________________________ ___________________________________________________________________________________________ 31 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) For the calculation of the MoS, the lowest NOAEL among those obtained from the different toxicological endpoints will be used, in accordance with the SCCS Opinion SCCS/1270/09. This NOAEL is 80 mg/kg bw/d, and was derived from the prenatal developmental toxicity study by gavage (USR 2005b, also cited as Foulon, 2005) and the 13-week toxicity study (USR 2004, also cited as Foulon, 2004). Because of the rapid and almost complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment","endpoint":"developmental toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"80","page":31,"route":"oral","species":"","study_id":"sccs_o_241_noael_025"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	=80	mg/kg bw/d	rat	oral	90-day	developmental toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT== 80; DOSE=Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos:; EFFECT=complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment will not be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 DISCUSSION Physicochemical properties Toxicokinetics In the skin, metabolism is slow and 5-77% of resorcinol is present as parent resorcinol after 24h. In hepatic cells, metabolism is efficient (half-life of 22 to 55 min). Fast systemic metabolism and excretion is observed but small amounts of free resorcinol (1.2-4.6%) are detected in urine after gavage administratio; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos:","duration":"90-day","effect":"complete absorption from the stomach, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment will not be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 DISCUSSION Physicochemical properties Toxicokinetics In the skin, metabolism is slow and 5-77% of resorcinol is present as parent resorcinol after 24h. In hepatic cells, metabolism is efficient (half-life of 22 to 55 min). Fast systemic metabolism and excretion is observed but small amounts of free resorcinol (1.2-4.6%) are detected in urine after gavage administratio","endpoint":"developmental toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 80","page":31,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_027"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	=80	mg/kg bw/d	rat	oral	90-day	developmental toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT== 80; DOSE=Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos:; EFFECT=ch, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment will not be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 DISCUSSION Physicochemical properties Toxicokinetics In the skin, metabolism is slow and 5-77% of resorcinol is present as parent resorcinol after 24h. In hepatic cells, metabolism is efficient (half-life of 22 to 55 min). Fast systemic metabolism and excretion is observed but small amounts of free resorcinol (1.2-4.6%) are detected in urine after gavage administration. The; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos:","duration":"90-day","effect":"ch, and because there is almost no metabolism in the skin upon topical application, a bioavailability adjustment will not be applied to the NOAEL. Absorption through the skin (mean + 2SD) DA = 2.06 µg/cm² Skin Surface area SSA = 580 cm2 Dermal Absorption per treatment SSA x DA x 0.001 = 1.19 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DA x 0.001 / 60 = 0.02 mg/kg bw Hair and eyelashes up to 1.25 % and up to 0.5 % in hair lotions and shampoos: No observed adverse effect level NOAEL = 80 mg/kg bw/d (90-day study and maternal toxicity in prenatal developmental study, oral, rat) Margin of Safety NOAEL/SED = 4000 3.5 DISCUSSION Physicochemical properties Toxicokinetics In the skin, metabolism is slow and 5-77% of resorcinol is present as parent resorcinol after 24h. In hepatic cells, metabolism is efficient (half-life of 22 to 55 min). Fast systemic metabolism and excretion is observed but small amounts of free resorcinol (1.2-4.6%) are detected in urine after gavage administration. The","endpoint":"developmental toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 80","page":31,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_028"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	SOURCE_SUBDIR=sccp_o_124; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCP/1117/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=250; DOSE=ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).; EFFECT=ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature3, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3 Lynch B.S et al. Toxicology Review and Risk A; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 11 3","dose":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).","duration":"developmental","effect":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature3, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3 Lynch B.S et al. Toxicology Review and Risk A","endpoint":"developmental toxicity","ingredient":"1.3-dihydroxybenzene was submitted in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":21,"route":"oral","species":"rat","study_id":"sccp_o_124_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=250; DOSE=ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).; EFFECT=ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature2, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 2 Lynch B.S et al. Toxicology Review and Risk Assessment of Resorcinol: Thyroid Effects (2002). Reg. Tox. Pharm 36, 198-210; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 11 3","dose":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively).","duration":"developmental","effect":"ith an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p < 0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment- related. Conclusion The maternal NOAEL of Resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref.: 11 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data In publicly available literature2, resorcinol has also been described to exert effects on the thyroid due to interruption of the synthesis of thyroid hormones. 2 Lynch B.S et al. Toxicology Review and Risk Assessment of Resorcinol: Thyroid Effects (2002). Reg. Tox. Pharm 36, 198-210","endpoint":"developmental toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":25,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=250; DOSE=etely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively).; EFFECT=SCCS-rejected applicant NOAEL: etely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related. In the opinion of the SCCS, the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the developmental toxicity study with resorcinol bis- diphenylphosphate (BDP) do not raise concern of resorcinol-induced developmental effects. This conclusion is also drawn in each individual study. ECHA 2020: Regarding the abovementioned study (USR, 2005b), the ECHA support document to identify Resorcinol as a Subst; CITATION=Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the devel; CITATION_NUMBERS=[2005,2017]; REFERENCE=Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the devel; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the devel","dose":"etely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively).","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: etely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls (p < 0.05 and p <0.01, respectively). The incidence of incompletely ossified parietals was also significantly greater at 80 mg/kg bw/day, when compared to controls (p<0.05). In the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related. In the opinion of the SCCS, the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. Ref: USR 2005b (also cited as Foulon, 2005) TUKES, 2017: The eMSCA considered that the findings observed in the evaluated developmental toxicity studies with resorcinol and in the developmental toxicity study with resorcinol bis- diphenylphosphate (BDP) do not raise concern of resorcinol-induced developmental effects. This conclusion is also drawn in each individual study. ECHA 2020: Regarding the abovementioned study (USR, 2005b), the ECHA support document to identify Resorcinol as a Subst","endpoint":"developmental toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":19,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	250	mg/kg bw/day	rat	oral	developmental	developmental toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=250; DOSE=city study with New Zealand White rabbits (n=20-26/group) that were exposed to 0, 25, 50 or 100 mg/kg/d resorcinol in distilled water from GD 6 to 18 showed no effect on the number of corpora lutea, implantations, foetal viability, foetal weight and foetal malformations and variations (Unpublished study report, 1982b).; EFFECT=city study with New Zealand White rabbits (n=20-26/group) that were exposed to 0, 25, 50 or 100 mg/kg/d resorcinol in distilled water from GD 6 to 18 showed no effect on the number of corpora lutea, implantations, foetal viability, foetal weight and foetal malformations and variations (Unpublished study report, 1982b). SCCS comment The SCCS maintains the conclusion of its previous opinion that the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro New data from the open literature In TK6 cells resorcinol caused concentration-dependent reductions to the relative nuclei count both in the presence and absence of S9, with a considerable attenuating effect in the presence of 0.25% S9. Whereas the p53 responses were modest at 4 hr, strong induction of p53 with and without S9 occurred at 24 hr. The magnitudes of the γH2AX biomarker responses were pronounced at b; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"city study with New Zealand White rabbits (n=20-26/group) that were exposed to 0, 25, 50 or 100 mg/kg/d resorcinol in distilled water from GD 6 to 18 showed no effect on the number of corpora lutea, implantations, foetal viability, foetal weight and foetal malformations and variations (Unpublished study report, 1982b).","duration":"developmental","effect":"city study with New Zealand White rabbits (n=20-26/group) that were exposed to 0, 25, 50 or 100 mg/kg/d resorcinol in distilled water from GD 6 to 18 showed no effect on the number of corpora lutea, implantations, foetal viability, foetal weight and foetal malformations and variations (Unpublished study report, 1982b). SCCS comment The SCCS maintains the conclusion of its previous opinion that the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro New data from the open literature In TK6 cells resorcinol caused concentration-dependent reductions to the relative nuclei count both in the presence and absence of S9, with a considerable attenuating effect in the presence of 0.25% S9. Whereas the p53 responses were modest at 4 hr, strong induction of p53 with and without S9 occurred at 24 hr. The magnitudes of the γH2AX biomarker responses were pronounced at b","endpoint":"developmental toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":20,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	irritation	50	mg/kg bw/day	human	oral	5-day	irritation	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=50; DOSE=This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.; EFFECT=dered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.4.8.2 Photomutagenicity / photoclastogenicity No data submitted. 3.4.9 Human data 3.4.10 Special investigations Endocrine activity Information from SCCS/1270/09; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.","duration":"5-day","effect":"dered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.4.8 Photo-induced toxicity 3.4.8.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.4.8.2 Photomutagenicity / photoclastogenicity No data submitted. 3.4.9 Human data 3.4.10 Special investigations Endocrine activity Information from SCCS/1270/09","endpoint":"irritation","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":21,"route":"oral","species":"human","study_id":"sccs_o_241_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	50	mg/kg bw/day	rat	oral	30 days	repeated dose toxicity	SOURCE_SUBDIR=sccp_o_124; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCP/1117/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=50; DOSE=In contrast, multiple (2/day) subcutaneous daily doses of 100 mg/kg bw for 14 or 30 days to male Sprague-Dawley rats did not result in adverse changes in thyroid function indicated by serum T3 and T4 (Merker et al, 1982).; EFFECT=985) a similar exposure to 5 mg bw/day for 30 days had resulted in significant enlargement of the thyroid gland and decreased T3 and T4 levels in Wistar rats. In contrast, multiple (2/day) subcutaneous daily doses of 100 mg/kg bw for 14 or 30 days to male Sprague-Dawley rats did not result in adverse changes in thyroid function indicated by serum T3 and T4 (Merker et al, 1982). Also, in subacute, subchronic, and chronic oral studies performed in rats by the NTP no detectable effects on thyroid function were found (NOAEL 27.5, 32 and 50 mg/kg bw/day, respectively). Based on these data, the thyroid was considered to be a target organ for (sub-chronic) exposure to resorcinol. However, the Health Council of the Netherlands (Committee on Updating of Occupational Exposure Limits) attached more importance to the NTP studies than to the studies of Seffner et al. and Cooksey et al. and questioned the relevance of the thyroid effects found by these authors because in each case only one concentration was used and thyroidal effects were not; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"In contrast, multiple (2/day) subcutaneous daily doses of 100 mg/kg bw for 14 or 30 days to male Sprague-Dawley rats did not result in adverse changes in thyroid function indicated by serum T3 and T4 (Merker et al, 1982).","duration":"30 days","effect":"985) a similar exposure to 5 mg bw/day for 30 days had resulted in significant enlargement of the thyroid gland and decreased T3 and T4 levels in Wistar rats. In contrast, multiple (2/day) subcutaneous daily doses of 100 mg/kg bw for 14 or 30 days to male Sprague-Dawley rats did not result in adverse changes in thyroid function indicated by serum T3 and T4 (Merker et al, 1982). Also, in subacute, subchronic, and chronic oral studies performed in rats by the NTP no detectable effects on thyroid function were found (NOAEL 27.5, 32 and 50 mg/kg bw/day, respectively). Based on these data, the thyroid was considered to be a target organ for (sub-chronic) exposure to resorcinol. However, the Health Council of the Netherlands (Committee on Updating of Occupational Exposure Limits) attached more importance to the NTP studies than to the studies of Seffner et al. and Cooksey et al. and questioned the relevance of the thyroid effects found by these authors because in each case only one concentration was used and thyroidal effects were not","endpoint":"repeated dose toxicity","ingredient":"1.3-dihydroxybenzene was submitted in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":22,"route":"oral","species":"rat","study_id":"sccp_o_124_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	50	mg/kg bw/day	-	-	sub-chronic	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=50; DOSE=SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 27 effects on thyroid function were found (NOAEL 27.5, 32 and 50 mg/kg bw/day, respectively).; EFFECT=SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 27 effects on thyroid function were found (NOAEL 27.5, 32 and 50 mg/kg bw/day, respectively). Based on these data, the thyroid was considered to be a target organ for (sub-chronic) exposure to resorcinol. However, the Health Council of the Netherlands (Committee on Updating of Occupational Exposure Limits) attached more importance to the NTP studies than to the studies of Seffner et al. and Cooksey et al. and questioned the relevance of the thyroid effects found by these authors because in each case only one concentration was used and thyroidal effects were not; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 27 effects on thyroid function were found (NOAEL 27.5, 32 and 50 mg/kg bw/day, respectively).","duration":"sub-chronic","effect":"SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 27 effects on thyroid function were found (NOAEL 27.5, 32 and 50 mg/kg bw/day, respectively). Based on these data, the thyroid was considered to be a target organ for (sub-chronic) exposure to resorcinol. However, the Health Council of the Netherlands (Committee on Updating of Occupational Exposure Limits) attached more importance to the NTP studies than to the studies of Seffner et al. and Cooksey et al. and questioned the relevance of the thyroid effects found by these authors because in each case only one concentration was used and thyroidal effects were not","endpoint":"repeated dose toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":27,"route":"","species":"","study_id":"sccs_o_015_noael_018"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	50	mg/kg bw/day	rat	oral	90-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=50; DOSE=nicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day).; EFFECT=nicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. The SCCS considers that in the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. For the calculation of the MOS, the NOAEL of 80 mg/kg bw/day of maternal toxicity in the rat teratogenicity study and of the 90-day sub-chronic oral toxicity study in rats can be used. The threshold for the thyroid effects of 10 mg/kg bw/day in humans would, therefore, be adequately covered by the MOS. Irritation / sensitisation A 2.5% aqueous solution of resorcinol was not irritant when applied to rabbit skin. A 2.5% concentration of resorcinol caused mild conjunctival irritatio; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"nicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day).","duration":"90-day","effect":"nicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. The SCCS considers that in the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. For the calculation of the MOS, the NOAEL of 80 mg/kg bw/day of maternal toxicity in the rat teratogenicity study and of the 90-day sub-chronic oral toxicity study in rats can be used. The threshold for the thyroid effects of 10 mg/kg bw/day in humans would, therefore, be adequately covered by the MOS. Irritation / sensitisation A 2.5% aqueous solution of resorcinol was not irritant when applied to rabbit skin. A 2.5% concentration of resorcinol caused mild conjunctival irritatio","endpoint":"repeated dose toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":28,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_022"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	75	mg/kg bw/d	rat	oral	Sub-chronic	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=75; DOSE=d tremors were recorded among males from the 150, 300, and 600 mg/kg bw/d groups, and among females from the 300 and 600 mg/kg bw/d groups.; EFFECT=d tremors were recorded among males from the 150, 300, and 600 mg/kg bw/d groups, and among females from the 300 and 600 mg/kg bw/d groups. The clinical signs in both rats and mice appeared usually within one-half hour after dosing and lasted 1 to 2 hours in surviving animals. No biologically significant changes in organ weights were recorded. No gross and microscopic lesions attributable to resorcinol administration were observed Conclusion Based on the clinical signs reported, the EFSA Panel concluded that the NOAEL in rats was 27.5 mg resorcinol/kg bw/d. Based on the clinical effects reported the EFSA Panel concluded that the NOAEL in mice was 75 mg/kg bw/d. Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1117/07 Guideline: OECD 408 Species/strain: rat, Sprague-Dawley, Crl CD® (SD) IGS BR Group size: 20/group (10 males and 10 females), 12 (6 males and 6 females) in satellite group Test sub; CITATION=Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage; CITATION_NUMBERS=[10,2010]; REFERENCE=Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage","dose":"d tremors were recorded among males from the 150, 300, and 600 mg/kg bw/d groups, and among females from the 300 and 600 mg/kg bw/d groups.","duration":"Sub-chronic","effect":"d tremors were recorded among males from the 150, 300, and 600 mg/kg bw/d groups, and among females from the 300 and 600 mg/kg bw/d groups. The clinical signs in both rats and mice appeared usually within one-half hour after dosing and lasted 1 to 2 hours in surviving animals. No biologically significant changes in organ weights were recorded. No gross and microscopic lesions attributable to resorcinol administration were observed Conclusion Based on the clinical signs reported, the EFSA Panel concluded that the NOAEL in rats was 27.5 mg resorcinol/kg bw/d. Based on the clinical effects reported the EFSA Panel concluded that the NOAEL in mice was 75 mg/kg bw/d. Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1117/07 Guideline: OECD 408 Species/strain: rat, Sprague-Dawley, Crl CD® (SD) IGS BR Group size: 20/group (10 males and 10 females), 12 (6 males and 6 females) in satellite group Test sub","endpoint":"repeated dose toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":15,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	75	mg/kg bw/d	rat	oral	Sub-chronic	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=75; DOSE=0 mg/kg bw/d groups.; EFFECT=0 mg/kg bw/d groups. The clinical signs in both rats and mice appeared usually within one-half hour after dosing and lasted 1 to 2 hours in surviving animals. No biologically significant changes in organ weights were recorded. No gross and microscopic lesions attributable to resorcinol administration were observed Conclusion Based on the clinical signs reported, the EFSA Panel concluded that the NOAEL in rats was 27.5 mg resorcinol/kg bw/d. Based on the clinical effects reported the EFSA Panel concluded that the NOAEL in mice was 75 mg/kg bw/d. Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1117/07 Guideline: OECD 408 Species/strain: rat, Sprague-Dawley, Crl CD® (SD) IGS BR Group size: 20/group (10 males and 10 females), 12 (6 males and 6 females) in satellite group Test substance: Resorcinol Batch: 706030517 Purity: 98.8% Dose: 0, 40, 80, 250 mg/kg bw Route: oral Exposure: once a day by ora; CITATION=Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage; CITATION_NUMBERS=[10,2010]; REFERENCE=Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage","dose":"0 mg/kg bw/d groups.","duration":"Sub-chronic","effect":"0 mg/kg bw/d groups. The clinical signs in both rats and mice appeared usually within one-half hour after dosing and lasted 1 to 2 hours in surviving animals. No biologically significant changes in organ weights were recorded. No gross and microscopic lesions attributable to resorcinol administration were observed Conclusion Based on the clinical signs reported, the EFSA Panel concluded that the NOAEL in rats was 27.5 mg resorcinol/kg bw/d. Based on the clinical effects reported the EFSA Panel concluded that the NOAEL in mice was 75 mg/kg bw/d. Ref.: 10, EFSA (2010) Comment The NOAELs were based on short term acute effects after oral gavage. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1117/07 Guideline: OECD 408 Species/strain: rat, Sprague-Dawley, Crl CD® (SD) IGS BR Group size: 20/group (10 males and 10 females), 12 (6 males and 6 females) in satellite group Test substance: Resorcinol Batch: 706030517 Purity: 98.8% Dose: 0, 40, 80, 250 mg/kg bw Route: oral Exposure: once a day by ora","endpoint":"repeated dose toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":15,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	75	mg/kg bw/d	rat	oral	28 days	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=75; DOSE=ed dose (28 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 6...; EFFECT=ed dose (28 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 600 mg/kg bw/d in male and female mice (5 animals per sex / dose). The following NOAELs based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid glan; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"ed dose (28 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 6...","duration":"28 days","effect":"ed dose (28 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 600 mg/kg bw/d in male and female mice (5 animals per sex / dose). The following NOAELs based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid glan","endpoint":"repeated dose toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":15,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	75	mg/kg bw/d	rat	oral	17-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=75; DOSE=Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 600 mg/kg bw/d in male and female mice (5 animals per s...; EFFECT=Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 600 mg/kg bw/d in male and female mice (5 animals per sex / dose). The following NOAELs based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid gland weight was slightly decreased (respectively -19% an; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 600 mg/kg bw/d in male and female mice (5 animals per s...","duration":"17-day","effect":"Information from SCCS/1270/09 In a 17-day Oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered by gavage 5 days per week at dose levels of 0, 27.5, 55, 110, 225 and 450 mg/kg bw/d in male and female rats (5 animals per sex / dose), and at 0, 37.5, 75, 150, 300 and 600 mg/kg bw/d in male and female mice (5 animals per sex / dose). The following NOAELs based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid gland weight was slightly decreased (respectively -19% an","endpoint":"repeated dose toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":15,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	80	mg/kg bw/day	-	oral	90-day	repeated dose toxicity	SOURCE_SUBDIR=sccp_o_124; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCP/1117/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=80; DOSE=Based on Lynch et al (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects.; EFFECT=as been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time. Based on Lynch et al (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects. Summary of general toxicity studies Based on acute oral toxicity study, resorcinol was found to be non-lethal at 200 mg/kg bw. Based on the results of a 90-day sub-chronic oral toxicity study, the NOEL following oral gavage administration of resorcinol was 80 mg/kg bw/day. Based on data from a two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorci; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"Based on Lynch et al (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects.","duration":"90-day","effect":"as been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time. Based on Lynch et al (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects. Summary of general toxicity studies Based on acute oral toxicity study, resorcinol was found to be non-lethal at 200 mg/kg bw. Based on the results of a 90-day sub-chronic oral toxicity study, the NOEL following oral gavage administration of resorcinol was 80 mg/kg bw/day. Based on data from a two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorci","endpoint":"repeated dose toxicity","ingredient":"1.3-dihydroxybenzene was submitted in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":23,"route":"oral","species":"","study_id":"sccp_o_124_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	80	mg/kg bw/day	rat	oral	90-day	repeated dose toxicity	SOURCE_SUBDIR=sccp_o_124; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCP/1117/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=80; DOSE=Based on Lynch et al (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects.; EFFECT=for a long period of time. Based on Lynch et al (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects. Summary of general toxicity studies Based on acute oral toxicity study, resorcinol was found to be non-lethal at 200 mg/kg bw. Based on the results of a 90-day sub-chronic oral toxicity study, the NOEL following oral gavage administration of resorcinol was 80 mg/kg bw/day. Based on data from a two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day. In the chroni; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"Based on Lynch et al (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects.","duration":"90-day","effect":"for a long period of time. Based on Lynch et al (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects. Summary of general toxicity studies Based on acute oral toxicity study, resorcinol was found to be non-lethal at 200 mg/kg bw. Based on the results of a 90-day sub-chronic oral toxicity study, the NOEL following oral gavage administration of resorcinol was 80 mg/kg bw/day. Based on data from a two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day. In the chroni","endpoint":"repeated dose toxicity","ingredient":"1.3-dihydroxybenzene was submitted in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":23,"route":"oral","species":"rat","study_id":"sccp_o_124_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	80	mg/kg bw/day	-	oral	90-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=80; DOSE=SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 28 Based on acute oral toxicity study, resorcinol was found to be non-lethal at 200 mg/kg bw.; EFFECT=SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 28 Based on acute oral toxicity study, resorcinol was found to be non-lethal at 200 mg/kg bw. Based on the results of a 90-day sub-chronic oral toxicity study, the NOAEL following oral gavage administration of resorcinol was 80 mg/kg bw/day. Based on data from a two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorci; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 28 Based on acute oral toxicity study, resorcinol was found to be non-lethal at 200 mg/kg bw.","duration":"90-day","effect":"SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 28 Based on acute oral toxicity study, resorcinol was found to be non-lethal at 200 mg/kg bw. Based on the results of a 90-day sub-chronic oral toxicity study, the NOAEL following oral gavage administration of resorcinol was 80 mg/kg bw/day. Based on data from a two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorci","endpoint":"repeated dose toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":28,"route":"oral","species":"","study_id":"sccs_o_015_noael_019"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	80	mg/kg bw/day	rat	oral	90-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=80; DOSE=females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day).; EFFECT=females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. The SCCS considers that in the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. For the calculation of the MOS, the NOAEL of 80 mg/kg bw/day of maternal toxicity in the rat teratogenicity study and of the 90-day sub-chronic oral toxicity study in rats can be used. The threshold for the thyroid effects of 10 mg/kg bw/day in humans would, therefore, be adequately covered by the MOS. Irritation / sensitisation A 2.5% aqueous solution of resorcinol was not irritant when applied to rabbit skin. A 2.5% concentration of resorcinol caused mild conjunctival irritation to the rabbit eye. Resorcinol induced contact sensitisation in a LLNA. Ac; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day).","duration":"90-day","effect":"females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. The SCCS considers that in the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. For the calculation of the MOS, the NOAEL of 80 mg/kg bw/day of maternal toxicity in the rat teratogenicity study and of the 90-day sub-chronic oral toxicity study in rats can be used. The threshold for the thyroid effects of 10 mg/kg bw/day in humans would, therefore, be adequately covered by the MOS. Irritation / sensitisation A 2.5% aqueous solution of resorcinol was not irritant when applied to rabbit skin. A 2.5% concentration of resorcinol caused mild conjunctival irritation to the rabbit eye. Resorcinol induced contact sensitisation in a LLNA. Ac","endpoint":"repeated dose toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":28,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_023"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	80	mg/kg bw/day	rat	oral	Sub-chronic	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=80; DOSE=s based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d.; EFFECT=s based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose response relationship and without relevant histopathological abnormalities). However, in the opinion of the SCCS, since in the reproductive study some effects on the thyroid were also observed, these effects might be of relevance. The SCC; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"s based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d.","duration":"Sub-chronic","effect":"s based on short term acute effects after oral gavage were derived by EFSA (2010): the NOAEL in rats was 27.5 mg resorcinol/kg bw/d and the NOAEL in mice was 75 mg/kg bw/d. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity Information from SCCS/1270/09 In a CIT study, four groups of 10 male and 10 female Sprague-Dawley rats received the test item (A011, batch No 70603051) daily by gavage at 0, 40, 80 or 250 mg/kg bw/day for at least 13 weeks. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose response relationship and without relevant histopathological abnormalities). However, in the opinion of the SCCS, since in the reproductive study some effects on the thyroid were also observed, these effects might be of relevance. The SCC","endpoint":"repeated dose toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":15,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	520	mg/kg bw/day	rat	-	Chronic	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=520; DOSE=The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.; EFFECT=SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 18 Based on the clinical effects reported the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: 10, EFSA (2010) Comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in this study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice). 3.3.5.3. Chronic (> 12 months) toxicity See section 3.3.7. Carcinogenicity 3.3.6. Mutagenicity / Genotoxic; CITATION=Ref.: 10, EFSA (2010) Comment The SCCS agrees with this evaluation; CITATION_NUMBERS=[10,2010]; REFERENCE=Ref.: 10, EFSA (2010) Comment The SCCS agrees with this evaluation; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 10, EFSA (2010) Comment The SCCS agrees with this evaluation","dose":"The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.","duration":"Chronic","effect":"SCCS/1270/09 Opinion on resorcinol ___________________________________________________________________________________________ 18 Based on the clinical effects reported the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: 10, EFSA (2010) Comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in this study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice). 3.3.5.3. Chronic (> 12 months) toxicity See section 3.3.7. Carcinogenicity 3.3.6. Mutagenicity / Genotoxic","endpoint":"repeated dose toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"520","page":18,"route":"","species":"rat","study_id":"sccs_o_015_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	520	mg/kg bw/day	rat	-	-	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=520; DOSE=The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.; EFFECT=e not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice).; CITATION=Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation; CITATION_NUMBERS=[1992,2010]; REFERENCE=Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation","dose":"The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.","duration":"","effect":"e not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice).","endpoint":"repeated dose toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"520","page":16,"route":"","species":"rat","study_id":"sccs_o_241_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	520	mg/kg bw/day	rat	-	-	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=520; DOSE=The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.; EFFECT=ere considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice).; CITATION=Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation; CITATION_NUMBERS=[1992,2010]; REFERENCE=Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation","dose":"The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL.","duration":"","effect":"ere considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only observed at the highest dose of 520 mg/kg bw/day (rats) and 420 mg/kg bw/day (mice).","endpoint":"repeated dose toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"520","page":16,"route":"","species":"rat","study_id":"sccs_o_241_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	1992	-	rat	-	-	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=unclear:enal gland weights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only obse; DOSE=The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings.; EFFECT=enal gland weights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only obse; CITATION=Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation; CITATION_NUMBERS=[1992,2010]; REFERENCE=Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation","dose":"The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings.","duration":"","effect":"enal gland weights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only obse","endpoint":"repeated dose toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"unclear:enal gland weights in males from all dosed groups. The EFSA Panel noticed that there was no dose-response relationship for the decreased adrenal weights and that the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration (NTP 1992). The EFSA Panel considered 130 mg resorcinol/kg bw/day as the NOAEL in rats. There were no gross or microscopical lesions attributable to resorcinol administration. Based on the clinical effects reported, the EFSA Panel concluded that the NOAEL was 225 mg resorcinol/kg bw/d in B6C3F1 mice. The Panel noticed that the dose causing mortality was less than two-fold greater than this NOAEL. Ref.: NTP 1992, EFSA 2010 SCCS comment The SCCS agrees with this evaluation. Interestingly, in contrast to other repeated dose toxicity studies, in the NTP study acute toxic effects were only obse","page":16,"route":"","species":"rat","study_id":"sccs_o_241_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	36	mg/kg/d	rat	oral	5-day	reproductive toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=36; DOSE=Conclusions on carcinogenicity Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw.; EFFECT=. Conclusions on carcinogenicity Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw. Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.; CITATION=Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg; CITATION_NUMBERS=[10,2010,50]; REFERENCE=Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg","dose":"Conclusions on carcinogenicity Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw.","duration":"5-day","effect":". Conclusions on carcinogenicity Under the conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw. Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.","endpoint":"reproductive toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg/d","noael_value":"36","page":23,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	36	mg/kg/d	rat	oral	5-day	reproductive toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=36; DOSE=he conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw.; EFFECT=he conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw. Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.3.8.1. Two generation reproduction toxici; CITATION=Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg; CITATION_NUMBERS=[10,2010,50]; REFERENCE=Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg","dose":"he conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw.","duration":"5-day","effect":"he conditions of the study, there was no evidence of carcinogenic activity of resorcinol in male F344/N rats given 112 or 225 mg/kg bw or female F344/N rats given 50, 100, or 150 mg/kg bw. There was no evidence of carcinogenic activity of resorcinol in male or female B6C3F1 mice given 112 or 225 mg/kg bw. Ref.: 10, EFSA 2010 Comment Based on the acute clinical signs of toxicity, which were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.3.8.1. Two generation reproduction toxici","endpoint":"reproductive toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg/d","noael_value":"36","page":23,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	36	mg/kg/d	-	oral	5-day	reproductive toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=36; DOSE=This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.; EFFECT=e decreased adrenal weights and the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered to be biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration. From the carcinogenicity study (NTP 1992), based on the acute clinical signs of toxicity that were considered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. Reproductive toxicity In a prenatal developmental study i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.","duration":"5-day","effect":"e decreased adrenal weights and the changes were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered to be biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration. From the carcinogenicity study (NTP 1992), based on the acute clinical signs of toxicity that were considered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. Reproductive toxicity In a prenatal developmental study i","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg/d","noael_value":"36","page":33,"route":"oral","species":"","study_id":"sccs_o_241_noael_033"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	36	mg/kg/d	rat	oral	5-day	reproductive toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=36; DOSE=This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.; EFFECT=es were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered to be biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration. From the carcinogenicity study (NTP 1992), based on the acute clinical signs of toxicity that were considered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. Reproductive toxicity In a prenatal developmental study in rats (USR 2005b) there were no effects; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.","duration":"5-day","effect":"es were not accompanied by microscopical findings. A few other differences in various organ weights were scattered among the study groups, and none were considered to be biologically significant. There were no gross or microscopic lesions attributable to resorcinol administration. From the carcinogenicity study (NTP 1992), based on the acute clinical signs of toxicity that were considered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. Reproductive toxicity In a prenatal developmental study in rats (USR 2005b) there were no effects","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg/d","noael_value":"36","page":33,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_034"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	50	mg/kg bw/day	rat	oral	5-day	reproductive toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=50; DOSE=This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.; EFFECT=were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.3.8.1. Two generation reproduction toxicity Guideline: OECD 416 Species/strain: rat, Crl:CD®(SD) (prior to 01/01/2005 this strain was named Crl:CD®(SD)IGS BR Group size: 30/sex group, 4 groups Test substance: Resorcinol Batch: Lot no. 706010501 Purity: 99.8%; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.","duration":"5-day","effect":"were considered a resorcinol-related effect on the CNS, the EFSA Panel concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. 3.3.8. Reproductive toxicity Taken from SCCP/1117/07 3.3.8.1. Two generation reproduction toxicity Guideline: OECD 416 Species/strain: rat, Crl:CD®(SD) (prior to 01/01/2005 this strain was named Crl:CD®(SD)IGS BR Group size: 30/sex group, 4 groups Test substance: Resorcinol Batch: Lot no. 706010501 Purity: 99.8%","endpoint":"reproductive toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":23,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	50	mg/kg bw/day	rat	oral	5-day	reproductive toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=50; DOSE=This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.; EFFECT=dered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. Reproductive toxicity In a prenatal developmental study in rats (USR 2005b) there were no effects of treatment on foetal body weight. In the litters, no external, soft tissue or skeletal malformations or variations were considered to be treatment-related. There was an increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls, but in the absence of any effects at 250 mg/kg bw/day these observations were no; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week.","duration":"5-day","effect":"dered a resorcinol-related effect on the CNS, the EFSA Panel (EFSA 2010) concluded that the NOAEL was 50 mg resorcinol/kg bw/d. This NOAEL corresponds to a daily dose of 36 mg/kg/d when adjusted from the 5-day dosing week to a 7-day dosing week. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. In the case of dermal application, such effects are not relevant. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. Reproductive toxicity In a prenatal developmental study in rats (USR 2005b) there were no effects of treatment on foetal body weight. In the litters, no external, soft tissue or skeletal malformations or variations were considered to be treatment-related. There was an increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls, but in the absence of any effects at 250 mg/kg bw/day these observations were no","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":33,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_035"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	80	mg/kg bw/day	-	-	4 to week	reproductive toxicity	SOURCE_SUBDIR=sccp_o_124; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCP/1117/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=80; DOSE=Under the experimental conditions of the study, the NOEL was reported to be 80 mg/kg bw/day.; EFFECT=SCCP/1117/07 Opinion on resorcinol 15 from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported to be 80 mg/kg bw/day. Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of relevance. For more; CITATION=Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group; CITATION_NUMBERS=[5,19,13,250]; REFERENCE=Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group","dose":"Under the experimental conditions of the study, the NOEL was reported to be 80 mg/kg bw/day.","duration":"4 to week","effect":"SCCP/1117/07 Opinion on resorcinol 15 from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported to be 80 mg/kg bw/day. Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of relevance. For more","endpoint":"reproductive toxicity","ingredient":"1.3-dihydroxybenzene was submitted in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":15,"route":"","species":"","study_id":"sccp_o_124_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	80	mg/kg bw/day	rat	oral	prenatal	reproductive toxicity	SOURCE_SUBDIR=sccp_o_124; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCP/1117/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=80; DOSE=study, the NOEL following oral gavage administration of resorcinol was 80 mg/kg bw/day.; EFFECT=study, the NOEL following oral gavage administration of resorcinol was 80 mg/kg bw/day. Based on data from a two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day. In the chronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"study, the NOEL following oral gavage administration of resorcinol was 80 mg/kg bw/day.","duration":"prenatal","effect":"study, the NOEL following oral gavage administration of resorcinol was 80 mg/kg bw/day. Based on data from a two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day. In the chronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high","endpoint":"reproductive toxicity","ingredient":"1.3-dihydroxybenzene was submitted in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":23,"route":"oral","species":"rat","study_id":"sccp_o_124_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	80	mg/kg bw/day	-	-	4 to week	reproductive toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=80; DOSE=ulsions and died, no clinical observations were recorded at 80 mg/kg bw/day.; EFFECT=ulsions and died, no clinical observations were recorded at 80 mg/kg bw/day. No treatment-related effects on body weight, food consumption, blood and urine parameters, organ weights and necropsy findings were noted. The female group receiving 250 mg/kg bw/day gained slightly less weight (86% of the weight gained by the controls) from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of re; CITATION=Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group; CITATION_NUMBERS=[5,19,13,250]; REFERENCE=Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group","dose":"ulsions and died, no clinical observations were recorded at 80 mg/kg bw/day.","duration":"4 to week","effect":"ulsions and died, no clinical observations were recorded at 80 mg/kg bw/day. No treatment-related effects on body weight, food consumption, blood and urine parameters, organ weights and necropsy findings were noted. The female group receiving 250 mg/kg bw/day gained slightly less weight (86% of the weight gained by the controls) from week 4 to week 8. Examination of the animals during the Functional Observation Battery did not reveal any treatment-related effect. Under the experimental conditions of the study, the NOEL was reported by the applicant to be 80 mg/kg bw/day. Ref.: 5 Comments In the study described above, absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of re","endpoint":"reproductive toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":16,"route":"","species":"","study_id":"sccs_o_015_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	80	mg/kg bw/day	rat	oral	13-week	reproductive toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=80; DOSE=nd weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group.; EFFECT=nd weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of relevance. For more discussion on the goitrogenic effects of resorcinol see section 3.3.14. The SCCS considers the 80 mg/kg bw/day as a NOAEL. NTP study In this 13-week oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered 5 days per week by gavage at dose levels of 0, 32, 65, 130, 260 and 520 mg/kg bw/d to male and female rats (10 animals per dose), and 0, 28, 56, 112, 225 and 420 mg/kg bw/d to male and female mice (10 animals per dose). Animals were observed twice daily for mortality and weekly for signs of toxicity. Animals were weighed at the start of the study and weekly thereafter. Blood samples for haematology and cli; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"nd weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group.","duration":"13-week","effect":"nd weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose- response relationship and without relevant histopathological abnormalities). However, since also in the reproductive study effects on the thyroid were observed, these effects might be of relevance. For more discussion on the goitrogenic effects of resorcinol see section 3.3.14. The SCCS considers the 80 mg/kg bw/day as a NOAEL. NTP study In this 13-week oral Toxicity Study in F344/N rats and B6C3F1 mice, resorcinol was administered 5 days per week by gavage at dose levels of 0, 32, 65, 130, 260 and 520 mg/kg bw/d to male and female rats (10 animals per dose), and 0, 28, 56, 112, 225 and 420 mg/kg bw/d to male and female mice (10 animals per dose). Animals were observed twice daily for mortality and weekly for signs of toxicity. Animals were weighed at the start of the study and weekly thereafter. Blood samples for haematology and cli","endpoint":"reproductive toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":16,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	80	mg/kg bw/day	rat	oral	prenatal	reproductive toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=80; DOSE=tudy, the NOAEL following oral gavage administration of resorcinol was 80 mg/kg bw/day.; EFFECT=tudy, the NOAEL following oral gavage administration of resorcinol was 80 mg/kg bw/day. Based on data from a two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day. In the chronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"tudy, the NOAEL following oral gavage administration of resorcinol was 80 mg/kg bw/day.","duration":"prenatal","effect":"tudy, the NOAEL following oral gavage administration of resorcinol was 80 mg/kg bw/day. Based on data from a two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day. In the chronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high","endpoint":"reproductive toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":28,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_020"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	80	mg/kg bw/day	rat	oral	13-week	reproductive toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=80; DOSE=Absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group.; EFFECT=0 mg/kg bw/day. Absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose response relationship and without relevant histopathological abnormalities). However, in the opinion of the SCCS, since in the reproductive study some effects on the thyroid were also observed, these effects might be of relevance. The SCCS considered the 80 mg/kg bw/day as a NOAEL. Ref.: USR 2004 (also cited as Foulon, 2004) In the NTP 13-week oral toxicity study in F344/N rats and B6C3F1 mice, resorcinol was administered 5 days per week by gavage at dose levels of 0, 32, 65, 130, 260 and 520 mg/kg bw/d to male and female rats (10 animals per dose), and 0, 28, 56, 112, 225 and 420 mg/kg bw/d to male and female mice (10 animals per dose).; CITATION=Ref.: USR 2004 (also cited as Foulon, 2004) In the NTP 13-week oral toxicity study in F344/N rats and B6C3F1 mice, resorcinol was administered 5 days per week by gavage at dose levels of; CITATION_NUMBERS=[2004,13,344,6,3,1,5]; REFERENCE=Ref.: USR 2004 (also cited as Foulon, 2004) In the NTP 13-week oral toxicity study in F344/N rats and B6C3F1 mice, resorcinol was administered 5 days per week by gavage at dose levels of; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref.: USR 2004 (also cited as Foulon, 2004) In the NTP 13-week oral toxicity study in F344/N rats and B6C3F1 mice, resorcinol was administered 5 days per week by gavage at dose levels of","dose":"Absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group.","duration":"13-week","effect":"0 mg/kg bw/day. Absolute and relative thyroid gland weight was slightly decreased (respectively -19% and -13%) in the 250 mg/kg bw/day group. According to the study authors, these effects were considered of no toxicological importance (no dose response relationship and without relevant histopathological abnormalities). However, in the opinion of the SCCS, since in the reproductive study some effects on the thyroid were also observed, these effects might be of relevance. The SCCS considered the 80 mg/kg bw/day as a NOAEL. Ref.: USR 2004 (also cited as Foulon, 2004) In the NTP 13-week oral toxicity study in F344/N rats and B6C3F1 mice, resorcinol was administered 5 days per week by gavage at dose levels of 0, 32, 65, 130, 260 and 520 mg/kg bw/d to male and female rats (10 animals per dose), and 0, 28, 56, 112, 225 and 420 mg/kg bw/d to male and female mice (10 animals per dose).","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":15,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	80	mg/kg bw/day	rat	oral	developmental	reproductive toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=80; DOSE=There was an increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls, but in the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related.; EFFECT=SCCS-rejected applicant NOAEL: mental study in rats (USR 2005b) there were no effects of treatment on foetal body weight. In the litters, no external, soft tissue or skeletal malformations or variations were considered to be treatment-related. There was an increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls, but in the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related. In the opinion of the SCCS the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. According to TUKES (2017), no indications of reproductive toxicity were seen in a dose- range finding study (USR, 2003) or in the two-generation reproductive toxicity study in rats (USR 2005a, Welsch 2008a). Endpoints for neurotoxicity (i.e. brain weight and width, brain histology, functional observation battery (FOB), locomotor activity, acoustic startle response and Biel maze swimmi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"There was an increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls, but in the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: mental study in rats (USR 2005b) there were no effects of treatment on foetal body weight. In the litters, no external, soft tissue or skeletal malformations or variations were considered to be treatment-related. There was an increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls, but in the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related. In the opinion of the SCCS the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. According to TUKES (2017), no indications of reproductive toxicity were seen in a dose- range finding study (USR, 2003) or in the two-generation reproductive toxicity study in rats (USR 2005a, Welsch 2008a). Endpoints for neurotoxicity (i.e. brain weight and width, brain histology, functional observation battery (FOB), locomotor activity, acoustic startle response and Biel maze swimmi","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":33,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_036"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	177	-	-	-	-	reproductive toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=177; EFFECT=Table 2. NOAEL’s for endocrine activity derived by the SCCS.: reproductive toxicity \| -thyroid weight \| 177; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"","duration":"","effect":"Table 2. NOAEL’s for endocrine activity derived by the SCCS.: reproductive toxicity \| -thyroid weight \| 177","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"","noael_value":"177","page":28,"route":"","species":"","study_id":"sccs_o_241_noael_044"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	~186	mg/kg bw/day	rat	-	-	reproductive toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=~186; DOSE=This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation.; EFFECT=SCCS-rejected applicant NOAEL: ed test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Ref: USR 2005a (also cited as Nemec, 2005) TUKES, 2017: No indications of reproductive toxicity were seen in the dose range-finding study or in the two-generation reproductive toxicity study in rats (USR 2003, 2005, Welsch et al. 2008a). Endpoints for neurotoxicity (i.e. brain weight and width, brain histology, functional obs; CITATION=Ref: USR 2005a (also cited as Nemec, 2005) TUKES, 2017: No indications of reproductive toxicity were seen in the dose range-finding study or in the two-generation reproductive toxicity; CITATION_NUMBERS=[2005,2017]; REFERENCE=Ref: USR 2005a (also cited as Nemec, 2005) TUKES, 2017: No indications of reproductive toxicity were seen in the dose range-finding study or in the two-generation reproductive toxicity; DETAILS_JSON={"cas_number":"108-46-3","citation":"Ref: USR 2005a (also cited as Nemec, 2005) TUKES, 2017: No indications of reproductive toxicity were seen in the dose range-finding study or in the two-generation reproductive toxicity","dose":"This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation.","duration":"","effect":"SCCS-rejected applicant NOAEL: ed test article-related in the absence of effects on T3 or T4, organ weights or adverse macroscopic or microscopic findings. Test article-related decreased colloid within the thyroid glands of the 3000 mg/L F0 males was not considered adverse due to the lack of associated functional effects. As the mean water consumption was significantly decreased with ~10% in the 1000 mg/L (F0 animals only) and with ~20% in the 3000 mg/L treatment group (F0 and F1 animals), SCCP considers 0.8 * 3000 = 2400 mg Resorcinol/L as the NOAEL. This corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Ref: USR 2005a (also cited as Nemec, 2005) TUKES, 2017: No indications of reproductive toxicity were seen in the dose range-finding study or in the two-generation reproductive toxicity study in rats (USR 2003, 2005, Welsch et al. 2008a). Endpoints for neurotoxicity (i.e. brain weight and width, brain histology, functional obs","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"~186","page":18,"route":"","species":"rat","study_id":"sccs_o_241_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	~233	mg/kg bw/day	-	-	-	reproductive toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=~233; DOSE=However, high-dose exposure has been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time.; EFFECT=d based on the application of a threefold safety factor. However, high-dose exposure has been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time. Based on Lynch et al. (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects. Based on the results of the 2-generation reproductive study (USR 2005a, also cited as Nemec, 2005) study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Additional information 1) Non-test information, in silico, in chemico, read across: The proposed identification of Resorcinol as endocrine disrupter has been reviewed in an evaluation by the Danish Centre on Endocrine Disrupters (CEHOS, 2012) and the ECHA support document (ECHA, 2020a); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"However, high-dose exposure has been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time.","duration":"","effect":"d based on the application of a threefold safety factor. However, high-dose exposure has been rare in the past and has occurred mainly in patients as a result of the treatment of ulcers with large amounts of Resorcinol for a long period of time. Based on Lynch et al. (2002), there is no evidence that intermittent or low-dose exposure to Resorcinol causes hypothyroidism or any other adverse health effects. Based on the results of the 2-generation reproductive study (USR 2005a, also cited as Nemec, 2005) study, the NOAEL was considered to be 3000 mg Resorcinol/L, which corresponds to ~233 mg/kg bw/day for males over the entire generation, 304 mg/kg bw/day for females during premating and gestation and 660 mg/kg bw/day for females during lactation. Additional information 1) Non-test information, in silico, in chemico, read across: The proposed identification of Resorcinol as endocrine disrupter has been reviewed in an evaluation by the Danish Centre on Endocrine Disrupters (CEHOS, 2012) and the ECHA support document (ECHA, 2020a)","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"~233","page":22,"route":"","species":"","study_id":"sccs_o_241_noael_017"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	250	mg/kg bw/day	rat	oral	prenatal	reproductive toxicity	SOURCE_SUBDIR=sccp_o_124; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCP/1117/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=250; DOSE=two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation.; EFFECT=two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day. In the chronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. For; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation.","duration":"prenatal","effect":"two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day. In the chronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. Therefore, 50 mg/kg bw/day will not be used as the NOAEL for the calculation of the MOS. For","endpoint":"reproductive toxicity","ingredient":"1.3-dihydroxybenzene was submitted in","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":23,"route":"oral","species":"rat","study_id":"sccp_o_124_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	250	mg/kg bw/day	rat	oral	prenatal	reproductive toxicity	SOURCE_SUBDIR=sccs_o_015; REPORT_TITLE=OPINION ON Resorcinol COLIPA n° A11; OPINION_NUMBER=SCCS/1270/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=23 March 2010; VALUE_TEXT=250; DOSE=two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation.; EFFECT=two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day. In the chronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. The SCCS considers that in the case of dermal application, such effects are not relevant. Ther; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation.","duration":"prenatal","effect":"two-generation toxicity study the NOAEL for parental systemic and reproductive toxicity, as well as neonatal toxicity was 2400 mg resorcinol/L, which corresponds to ~186 mg/kg bw/day for males over the entire generation, ~243 mg/kg bw/day for females during premating and gestation and ~528 mg/kg bw/day for females during lactation. Based on the results of a prenatal developmental toxicity study the maternal NOEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOEL was 250 mg/kg bw/day. In the chronic/carcinogenicity study in rats, clinical signs were observed in the mid-and high dose females (112 and 150 mg/kg bw/day) and in both male groups (112 and 225 mg/kg bw/day). No effects were seen in females receiving 50 mg/kg bw/day. Since the dosing was performed by gavage and the clinical signs lasted 30-60 minutes after dosing, these signs might be the result of the high (local) dose. The SCCS considers that in the case of dermal application, such effects are not relevant. Ther","endpoint":"reproductive toxicity","ingredient":"1.3-Di-hydroxybenzene was submitted","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":28,"route":"oral","species":"rat","study_id":"sccs_o_015_noael_021"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	250	mg/kg bw/day	rat	oral	developmental	reproductive toxicity	SOURCE_SUBDIR=sccs_o_241; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Resorcinol; OPINION_NUMBER=SCCS/1619/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=250; DOSE=There was an increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls, but in the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related.; EFFECT=SCCS-rejected applicant NOAEL: external, soft tissue or skeletal malformations or variations were considered to be treatment-related. There was an increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls, but in the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related. In the opinion of the SCCS the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. According to TUKES (2017), no indications of reproductive toxicity were seen in a dose- range finding study (USR, 2003) or in the two-generation reproductive toxicity study in rats (USR 2005a, Welsch 2008a). Endpoints for neurotoxicity (i.e. brain weight and width, brain histology, functional observation battery (FOB), locomotor activity, acoustic startle response and Biel maze swimming trials) were investigated in the dose range-finding study (USR 2003), where dose-related effects on locomo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"108-46-3","citation":"","dose":"There was an increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls, but in the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: external, soft tissue or skeletal malformations or variations were considered to be treatment-related. There was an increase in the incidence of foetuses with an incompletely ossified interparietal at 40 and 80 mg/kg bw/day, when compared to controls, but in the absence of any effects at 250 mg/kg bw/day these observations were not considered to be treatment related. In the opinion of the SCCS the maternal NOAEL of resorcinol administered by gavage to pregnant female rats was 80 mg/kg bw/day and the developmental NOAEL was 250 mg/kg bw/day. According to TUKES (2017), no indications of reproductive toxicity were seen in a dose- range finding study (USR, 2003) or in the two-generation reproductive toxicity study in rats (USR 2005a, Welsch 2008a). Endpoints for neurotoxicity (i.e. brain weight and width, brain histology, functional observation battery (FOB), locomotor activity, acoustic startle response and Biel maze swimming trials) were investigated in the dose range-finding study (USR 2003), where dose-related effects on locomo","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":33,"route":"oral","species":"rat","study_id":"sccs_o_241_noael_037"}

openFDA substances 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
openFDA substances	FDA UNII substance identifier	YUL4LO94HK	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C6H6O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"YUL4LO94HK"}
openFDA substances	FDA UNII substance identifier	YUL4LO94HK	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C6H6O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"YUL4LO94HK"}
openFDA substances	FDA UNII substance identifier	YUL4LO94HK	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C6H6O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"YUL4LO94HK"}
openFDA substances	FDA UNII substance identifier	YUL4LO94HK	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C6H6O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"YUL4LO94HK"}