NOAEL Studies Active Ingredient

Octocrylene NOAEL Studies

Name: Octocrylene NOAEL Studies
Creator: Roots by Benda

INCI: OCTOCRYLENE

CAS: 6197-30-4

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 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
COSMOS DB	LOAEL	4500	ppm	rat	oral	90 day	Subchronic	FCN; Subchronic toxicity study in Wistar rats, administration in the diet for 3 months
COSMOS DB	NOAEL	2250	ppm	rat	oral	90 day	Subchronic	FCN; Subchronic toxicity study in Wistar rats, administration in the diet for 3 months

NTP ICE acute oral 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP ICE acute oral	LD50	>5000	mg/kg bw	Rat	oral	acute	Rat Acute Oral Toxicity	record_id=acute_oral_8467; row=15648; data_type=In Vivo; mixture=Chemical; chemical_name=2-Ethylhexyl-2-cyano-3,3-diphenylacrylate; preferred_name=2-Ethylhexyl-2-cyano-3,3-diphenylacrylate; dtxsid=DTXSID9025299; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9025299; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID9025299; source_file=acute_oral.xlsx

SCCS Opinion 92 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
SCCS Opinion	NOAEL	=1	-	-	oral	-	NOAEL study	{"effect":"Unlabeled table on page 39: BASF 2001 (31) \| Oral \| Study period is only three days. No endocrine effects were observed \| 1 000","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_035"}
SCCS Opinion	NOAEL	=1	-	-	oral	-	NOAEL study	{"effect":"Unlabeled table on page 39: BASF 2001 (31) \| Oral \| Study period is only three days. No endocrine effects were observed \| 1 000","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_035"}
SCCS Opinion	NOAEL	=1	-	-	oral	-	NOAEL study	{"effect":"Unlabeled table on page 39: BASF 2001 (31) \| Oral \| Study period is only three days. No endocrine effects were observed \| 1 000","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_035"}
SCCS Opinion	NOAEL	=1	-	-	oral	-	NOAEL study	{"effect":"Unlabeled table on page 39: BASF 2001 (31) \| Oral \| Study period is only three days. No endocrine effects were observed \| 1 000","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_035"}
SCCS Opinion	NOAEL	=9	%	-	oral	-	NOAEL study	{"dose":"ellant spray, the total SED should be maximally 0.765 mg/kg bw/day.","effect":"ellant spray, the total SED should be maximally 0.765 mg/kg bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex. Table 13 MOS calculations for the different product types and aggregated exposures Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/day) NOAEL (mg/kg bw/day) MOS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 76.5 1 700 Face cream 10 Face 0.020 0 0 0.020 76.5 3 825 Hand cream 10 Hand 0.028 0 0 0.028 76.5 2 732 Sunscreen cream/lotion 10 Whole body 0.566 0 0 0.566 76.5 135 Sunscreen propellant spray 10 Whole body 0.566 0.176 0 0.743 76.5 102","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_021"}
SCCS Opinion	NOAEL	=9	%	-	oral	-	NOAEL study	{"dose":"ellant spray, the total SED should be maximally 0.765 mg/kg bw/day.","effect":"ellant spray, the total SED should be maximally 0.765 mg/kg bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex. Table 13 MOS calculations for the different product types and aggregated exposures Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/day) NOAEL (mg/kg bw/day) MOS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 76.5 1 700 Face cream 10 Face 0.020 0 0 0.020 76.5 3 825 Hand cream 10 Hand 0.028 0 0 0.028 76.5 2 732 Sunscreen cream/lotion 10 Whole body 0.566 0 0 0.566 76.5 135 Sunscreen propellant spray 10 Whole body 0.566 0.176 0 0.743 76.5 102","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_021"}
SCCS Opinion	NOAEL	=9	%	-	oral	-	NOAEL study	{"dose":"ellant spray, the total SED should be maximally 0.765 mg/kg bw/day.","effect":"ellant spray, the total SED should be maximally 0.765 mg/kg bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex. Table 13 MOS calculations for the different product types and aggregated exposures Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/day) NOAEL (mg/kg bw/day) MOS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 76.5 1 700 Face cream 10 Face 0.020 0 0 0.020 76.5 3 825 Hand cream 10 Hand 0.028 0 0 0.028 76.5 2 732 Sunscreen cream/lotion 10 Whole body 0.566 0 0 0.566 76.5 135 Sunscreen propellant spray 10 Whole body 0.566 0.176 0 0.743 76.5 102","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_021"}
SCCS Opinion	NOAEL	=9	%	-	oral	-	NOAEL study	{"dose":"ellant spray, the total SED should be maximally 0.765 mg/kg bw/day.","effect":"ellant spray, the total SED should be maximally 0.765 mg/kg bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex. Table 13 MOS calculations for the different product types and aggregated exposures Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/day) NOAEL (mg/kg bw/day) MOS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 76.5 1 700 Face cream 10 Face 0.020 0 0 0.020 76.5 3 825 Hand cream 10 Hand 0.028 0 0 0.028 76.5 2 732 Sunscreen cream/lotion 10 Whole body 0.566 0 0 0.566 76.5 135 Sunscreen propellant spray 10 Whole body 0.566 0.176 0 0.743 76.5 102","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_021"}
SCCS Opinion	NOAEL	=10	%	-	oral	-	NOAEL study	{"citation":"Ref.: 15, 26 3","dose":"Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex.","effect":"bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex. Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and 10% Octocrylene in lipstick, face cream and hand cream Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/d) NOAEL (mg/kg bw/day) MOS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 76.5 1 700 Face cream 10 Face 0.020 0 0 0.020 76.5 3 825 Hand cream 10 Hand 0.028 0 0 0.028 76.5 2 732 Sunscreen propellant spray 9 Whole body 0.509 0.158 0 0.667 76.5 115 Aggregated exposure (lipstick, face cream, hand cream, sunscreen propellant spray) 0.557 0.158 0.045 0.760 76.5 101 Ref.: 15, 26 3.6 DISCUSSION Physicochemical properties Only one batch of the test item (batch 5132 4997 V0) was chemically characterized by IR, 1H-N","page":41,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_022"}
SCCS Opinion	NOAEL	=10	%	-	oral	-	NOAEL study	{"citation":"Ref.: 15, 26 3","dose":"Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex.","effect":"bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex. Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and 10% Octocrylene in lipstick, face cream and hand cream Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/d) NOAEL (mg/kg bw/day) MOS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 76.5 1 700 Face cream 10 Face 0.020 0 0 0.020 76.5 3 825 Hand cream 10 Hand 0.028 0 0 0.028 76.5 2 732 Sunscreen propellant spray 9 Whole body 0.509 0.158 0 0.667 76.5 115 Aggregated exposure (lipstick, face cream, hand cream, sunscreen propellant spray) 0.557 0.158 0.045 0.760 76.5 101 Ref.: 15, 26 3.6 DISCUSSION Physicochemical properties Only one batch of the test item (batch 5132 4997 V0) was chemically characterized by IR, 1H-N","page":41,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_022"}
SCCS Opinion	NOAEL	=10	%	-	oral	-	NOAEL study	{"citation":"Ref.: 15, 26 3","dose":"Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex.","effect":"bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex. Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and 10% Octocrylene in lipstick, face cream and hand cream Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/d) NOAEL (mg/kg bw/day) MOS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 76.5 1 700 Face cream 10 Face 0.020 0 0 0.020 76.5 3 825 Hand cream 10 Hand 0.028 0 0 0.028 76.5 2 732 Sunscreen propellant spray 9 Whole body 0.509 0.158 0 0.667 76.5 115 Aggregated exposure (lipstick, face cream, hand cream, sunscreen propellant spray) 0.557 0.158 0.045 0.760 76.5 101 Ref.: 15, 26 3.6 DISCUSSION Physicochemical properties Only one batch of the test item (batch 5132 4997 V0) was chemically characterized by IR, 1H-N","page":41,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_022"}
SCCS Opinion	NOAEL	=10	%	-	oral	-	NOAEL study	{"citation":"Ref.: 15, 26 3","dose":"Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex.","effect":"bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex. Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and 10% Octocrylene in lipstick, face cream and hand cream Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/d) NOAEL (mg/kg bw/day) MOS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 76.5 1 700 Face cream 10 Face 0.020 0 0 0.020 76.5 3 825 Hand cream 10 Hand 0.028 0 0 0.028 76.5 2 732 Sunscreen propellant spray 9 Whole body 0.509 0.158 0 0.667 76.5 115 Aggregated exposure (lipstick, face cream, hand cream, sunscreen propellant spray) 0.557 0.158 0.045 0.760 76.5 101 Ref.: 15, 26 3.6 DISCUSSION Physicochemical properties Only one batch of the test item (batch 5132 4997 V0) was chemically characterized by IR, 1H-N","page":41,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_022"}
SCCS Opinion	NOAEL	=12	-	-	-	-	NOAEL study	{"effect":"Table 12 Summary of studies on endocrine activity and indicated NOAEL’s: Study Route of \| Comment \| Parameter \| NOAEL","page":37,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_027"}
SCCS Opinion	NOAEL	=12	-	-	-	-	NOAEL study	{"effect":"Table 12 Summary of studies on endocrine activity and indicated NOAEL’s: Study Route of \| Comment \| Parameter \| NOAEL","page":37,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_027"}
SCCS Opinion	NOAEL	=12	-	-	-	-	NOAEL study	{"effect":"Table 12 Summary of studies on endocrine activity and indicated NOAEL’s: Study Route of \| Comment \| Parameter \| NOAEL","page":37,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_027"}
SCCS Opinion	NOAEL	=12	-	-	-	-	NOAEL study	{"effect":"Table 12 Summary of studies on endocrine activity and indicated NOAEL’s: Study Route of \| Comment \| Parameter \| NOAEL","page":37,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_027"}
SCCS Opinion	NOAEL	=13	-	-	-	-	NOAEL study	{"effect":"Table 13 MOS calculations for the different product types and aggregated exposures: Study \| R \| oute of Com \| me \| nt \| Paramete \| r \| NOAEL","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_036"}
SCCS Opinion	NOAEL	=13	-	-	-	-	NOAEL study	{"effect":"Table 13 MOS calculations for the different product types and aggregated exposures: Study \| R \| oute of Com \| me \| nt \| Paramete \| r \| NOAEL","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_036"}
SCCS Opinion	NOAEL	=13	-	-	-	-	NOAEL study	{"effect":"Table 13 MOS calculations for the different product types and aggregated exposures: Study \| R \| oute of Com \| me \| nt \| Paramete \| r \| NOAEL","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_036"}
SCCS Opinion	NOAEL	=13	-	-	-	-	NOAEL study	{"effect":"Table 13 MOS calculations for the different product types and aggregated exposures: Study \| R \| oute of Com \| me \| nt \| Paramete \| r \| NOAEL","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_036"}
SCCS Opinion	NOAEL	=14	-	-	-	-	NOAEL study	{"dose":"Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS","effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS","page":41,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_038"}
SCCS Opinion	NOAEL	=14	-	-	-	-	NOAEL study	{"dose":"Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS","effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS","page":41,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_038"}
SCCS Opinion	NOAEL	=14	-	-	-	-	NOAEL study	{"dose":"Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS","effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS","page":41,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_038"}
SCCS Opinion	NOAEL	=14	-	-	-	-	NOAEL study	{"dose":"Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS","effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS","page":41,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_038"}
SCCS Opinion	NOAEL	=38	-	-	-	-	NOAEL study	{"dose":"Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 38: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","page":38,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_028"}
SCCS Opinion	NOAEL	=38	-	-	-	-	NOAEL study	{"dose":"Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 38: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","page":38,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_028"}
SCCS Opinion	NOAEL	=38	-	-	-	-	NOAEL study	{"dose":"Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 38: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","page":38,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_028"}
SCCS Opinion	NOAEL	=38	-	-	-	-	NOAEL study	{"dose":"Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 38: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","page":38,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_028"}
SCCS Opinion	NOAEL	=39	-	-	-	-	NOAEL study	{"dose":"Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 39: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_030"}
SCCS Opinion	NOAEL	=39	-	-	-	-	NOAEL study	{"dose":"Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 39: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_030"}
SCCS Opinion	NOAEL	=39	-	-	-	-	NOAEL study	{"dose":"Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 39: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_030"}
SCCS Opinion	NOAEL	=39	-	-	-	-	NOAEL study	{"dose":"Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","effect":"Unlabeled table on page 39: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_030"}
SCCS Opinion	NOAEL	=76.5	mg/kg bw/day	-	oral	-	reproductive toxicity	{"dose":"A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS.","effect":"observed increased liver weights connected with a higher metabolism rate of the substituted androgen testosterone propionate. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) MOS calculations for separate product types and aggregated exposures are shown in Table 13. A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS. Information from Bury et al. (2019) provide some evidence for an oral bioavailability of 50%, giving an adjusted NOAEL of 76.5 mg/kg bw/day. Details of the calculation of systemic exposure dose (SED) are presented in Table A1 in the Annex. In order to derive a MOS of 100 for aggregated exposure for lipstick, face cream, hand cream and sunscreen as a propellant spray, the total SED should be maximally 0.765 mg/kg bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of system","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_020"}
SCCS Opinion	NOAEL	=76.5	-	-	-	-	NOAEL study	{"effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Lipstick \| 10 \| Lips \| 0 \| 0 \| 0.045 \| 0.045 \| 76.5 \| 1 700","page":41,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_039"}
SCCS Opinion	NOAEL	=76.5	mg/kg bw/day	-	oral	-	reproductive toxicity	{"dose":"A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS.","effect":"observed increased liver weights connected with a higher metabolism rate of the substituted androgen testosterone propionate. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) MOS calculations for separate product types and aggregated exposures are shown in Table 13. A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS. Information from Bury et al. (2019) provide some evidence for an oral bioavailability of 50%, giving an adjusted NOAEL of 76.5 mg/kg bw/day. Details of the calculation of systemic exposure dose (SED) are presented in Table A1 in the Annex. In order to derive a MOS of 100 for aggregated exposure for lipstick, face cream, hand cream and sunscreen as a propellant spray, the total SED should be maximally 0.765 mg/kg bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of system","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_020"}
SCCS Opinion	NOAEL	=76.5	-	-	-	-	NOAEL study	{"effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Lipstick \| 10 \| Lips \| 0 \| 0 \| 0.045 \| 0.045 \| 76.5 \| 1 700","page":41,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_039"}
SCCS Opinion	NOAEL	=76.5	mg/kg bw/day	-	oral	-	reproductive toxicity	{"dose":"A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS.","effect":"observed increased liver weights connected with a higher metabolism rate of the substituted androgen testosterone propionate. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) MOS calculations for separate product types and aggregated exposures are shown in Table 13. A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS. Information from Bury et al. (2019) provide some evidence for an oral bioavailability of 50%, giving an adjusted NOAEL of 76.5 mg/kg bw/day. Details of the calculation of systemic exposure dose (SED) are presented in Table A1 in the Annex. In order to derive a MOS of 100 for aggregated exposure for lipstick, face cream, hand cream and sunscreen as a propellant spray, the total SED should be maximally 0.765 mg/kg bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of system","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_020"}
SCCS Opinion	NOAEL	=76.5	-	-	-	-	NOAEL study	{"effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Lipstick \| 10 \| Lips \| 0 \| 0 \| 0.045 \| 0.045 \| 76.5 \| 1 700","page":41,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_039"}
SCCS Opinion	NOAEL	=76.5	mg/kg bw/day	-	oral	-	reproductive toxicity	{"dose":"A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS.","effect":"observed increased liver weights connected with a higher metabolism rate of the substituted androgen testosterone propionate. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) MOS calculations for separate product types and aggregated exposures are shown in Table 13. A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS. Information from Bury et al. (2019) provide some evidence for an oral bioavailability of 50%, giving an adjusted NOAEL of 76.5 mg/kg bw/day. Details of the calculation of systemic exposure dose (SED) are presented in Table A1 in the Annex. In order to derive a MOS of 100 for aggregated exposure for lipstick, face cream, hand cream and sunscreen as a propellant spray, the total SED should be maximally 0.765 mg/kg bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of system","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_020"}
SCCS Opinion	NOAEL	=76.5	-	-	-	-	NOAEL study	{"effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Lipstick \| 10 \| Lips \| 0 \| 0 \| 0.045 \| 0.045 \| 76.5 \| 1 700","page":41,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_039"}
SCCS Opinion	NOAEL	=130	mg/kg/day	rabbit	-	-	NOAEL study	{"dose":"In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts.","effect":"thout showing any signs of adverse clinical responses to Octocrylene, other than those noted at or near the site of compound application. In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts. In both sexes, mid- and high-dose treatments significantly depressed body weight gain relative to the corresponding controls. At the low dose, no significant body weight effect was noted in females (NOEL, 130 mg/kg/day), whereas in male animals, a statistically significant depression of body weight gain was still observed (NOEL not established). The data also indicated no significant effects in kidney weights of male or female rabbits at any of the Octocrylene doses tested. Absolute liver weights of male animals were reduced at all Octocrylene dose levels, but the effect was no longer evident when organ weights were corrected for Octocrylene-associated effects on body weight. In females, on the other hand, absolut","page":26,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_002"}
SCCS Opinion	NOAEL	=130	mg/kg/day	rabbit	-	-	NOAEL study	{"dose":"In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts.","effect":"thout showing any signs of adverse clinical responses to Octocrylene, other than those noted at or near the site of compound application. In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts. In both sexes, mid- and high-dose treatments significantly depressed body weight gain relative to the corresponding controls. At the low dose, no significant body weight effect was noted in females (NOEL, 130 mg/kg/day), whereas in male animals, a statistically significant depression of body weight gain was still observed (NOEL not established). The data also indicated no significant effects in kidney weights of male or female rabbits at any of the Octocrylene doses tested. Absolute liver weights of male animals were reduced at all Octocrylene dose levels, but the effect was no longer evident when organ weights were corrected for Octocrylene-associated effects on body weight. In females, on the other hand, absolut","page":26,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_002"}
SCCS Opinion	NOAEL	=130	mg/kg/day	rabbit	-	-	NOAEL study	{"dose":"In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts.","effect":"thout showing any signs of adverse clinical responses to Octocrylene, other than those noted at or near the site of compound application. In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts. In both sexes, mid- and high-dose treatments significantly depressed body weight gain relative to the corresponding controls. At the low dose, no significant body weight effect was noted in females (NOEL, 130 mg/kg/day), whereas in male animals, a statistically significant depression of body weight gain was still observed (NOEL not established). The data also indicated no significant effects in kidney weights of male or female rabbits at any of the Octocrylene doses tested. Absolute liver weights of male animals were reduced at all Octocrylene dose levels, but the effect was no longer evident when organ weights were corrected for Octocrylene-associated effects on body weight. In females, on the other hand, absolut","page":26,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_002"}
SCCS Opinion	NOAEL	=130	mg/kg/day	rabbit	-	-	NOAEL study	{"dose":"In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts.","effect":"thout showing any signs of adverse clinical responses to Octocrylene, other than those noted at or near the site of compound application. In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts. In both sexes, mid- and high-dose treatments significantly depressed body weight gain relative to the corresponding controls. At the low dose, no significant body weight effect was noted in females (NOEL, 130 mg/kg/day), whereas in male animals, a statistically significant depression of body weight gain was still observed (NOEL not established). The data also indicated no significant effects in kidney weights of male or female rabbits at any of the Octocrylene doses tested. Absolute liver weights of male animals were reduced at all Octocrylene dose levels, but the effect was no longer evident when organ weights were corrected for Octocrylene-associated effects on body weight. In females, on the other hand, absolut","page":26,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_002"}
SCCS Opinion	NOAEL	=153	mg per kg	-	oral	-	reproductive toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females).","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg pe","page":31,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_005"}
SCCS Opinion	NOAEL	=153	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development","dose":"The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females).","effect":"responds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). There were no effects of the test item on neuro(developmental) parameters. The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females). Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development. 3.4.5.2 Developmental Toxicity From SPC/1279/94 In a teratogenicity study, pregnant Wistar rats were fed by gavage 100, 400 and 1000 mg/kg bw of the test substance. In the dams receiving 400 and 1000 mg/kg bw, increases in liver weight were noted. No signs of embryo-/fetotoxicity and no indications for a teratogenic effect were observed. New data Guideline: / Species/strain: Rabbit, New Zealand White Group size: 17/females/dose Test substance: Octocrylene","page":31,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_009"}
SCCS Opinion	NOAEL	=153	mg/kg	-	-	developmental	reproductive toxicity	{"dose":"TS, animals were fed with 750, 2100 and 7000 ppm of the test substance.","effect":"TS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro","page":32,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_011"}
SCCS Opinion	NOAEL	=153	-	-	oral	-	NOAEL study	{"effect":"Unlabeled table on page 39: Triskelion B.V. 2019 (26) \| Feed \| Key study EOGRTS \| F0: -Increased thyroid weight2 -Incidence of activated appearance of the thyroid gland3 - Lower no. of implantation sites and number of pups Cohort 1A F1: -Increased thyroid weight2 -Incidence of activated appearance of the thyroid gland3 Cohort 1B F1 - Lower no. of implantation sites and number of pups \| // // 153 // // 153","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_034"}
SCCS Opinion	NOAEL	=153	mg per kg	-	oral	-	reproductive toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females).","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg pe","page":31,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_005"}
SCCS Opinion	NOAEL	=153	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development","dose":"The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females).","effect":"responds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). There were no effects of the test item on neuro(developmental) parameters. The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females). Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development. 3.4.5.2 Developmental Toxicity From SPC/1279/94 In a teratogenicity study, pregnant Wistar rats were fed by gavage 100, 400 and 1000 mg/kg bw of the test substance. In the dams receiving 400 and 1000 mg/kg bw, increases in liver weight were noted. No signs of embryo-/fetotoxicity and no indications for a teratogenic effect were observed. New data Guideline: / Species/strain: Rabbit, New Zealand White Group size: 17/females/dose Test substance: Octocrylene","page":31,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_009"}
SCCS Opinion	NOAEL	=153	mg/kg	-	-	developmental	reproductive toxicity	{"dose":"TS, animals were fed with 750, 2100 and 7000 ppm of the test substance.","effect":"TS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro","page":32,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_011"}
SCCS Opinion	NOAEL	=153	-	-	oral	-	NOAEL study	{"effect":"Unlabeled table on page 39: Triskelion B.V. 2019 (26) \| Feed \| Key study EOGRTS \| F0: -Increased thyroid weight2 -Incidence of activated appearance of the thyroid gland3 - Lower no. of implantation sites and number of pups Cohort 1A F1: -Increased thyroid weight2 -Incidence of activated appearance of the thyroid gland3 Cohort 1B F1 - Lower no. of implantation sites and number of pups \| // // 153 // // 153","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_034"}
SCCS Opinion	NOAEL	=153	mg per kg	-	oral	-	reproductive toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females).","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg pe","page":31,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_005"}
SCCS Opinion	NOAEL	=153	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development","dose":"The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females).","effect":"responds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). There were no effects of the test item on neuro(developmental) parameters. The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females). Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development. 3.4.5.2 Developmental Toxicity From SPC/1279/94 In a teratogenicity study, pregnant Wistar rats were fed by gavage 100, 400 and 1000 mg/kg bw of the test substance. In the dams receiving 400 and 1000 mg/kg bw, increases in liver weight were noted. No signs of embryo-/fetotoxicity and no indications for a teratogenic effect were observed. New data Guideline: / Species/strain: Rabbit, New Zealand White Group size: 17/females/dose Test substance: Octocrylene","page":31,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_009"}
SCCS Opinion	NOAEL	=153	mg/kg	-	-	developmental	reproductive toxicity	{"dose":"TS, animals were fed with 750, 2100 and 7000 ppm of the test substance.","effect":"TS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro","page":32,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_011"}
SCCS Opinion	NOAEL	=153	-	-	oral	-	NOAEL study	{"effect":"Unlabeled table on page 39: Triskelion B.V. 2019 (26) \| Feed \| Key study EOGRTS \| F0: -Increased thyroid weight2 -Incidence of activated appearance of the thyroid gland3 - Lower no. of implantation sites and number of pups Cohort 1A F1: -Increased thyroid weight2 -Incidence of activated appearance of the thyroid gland3 Cohort 1B F1 - Lower no. of implantation sites and number of pups \| // // 153 // // 153","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_034"}
SCCS Opinion	NOAEL	=153	mg per kg	-	oral	-	reproductive toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females).","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg pe","page":31,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_005"}
SCCS Opinion	NOAEL	=153	mg/kg bw/day	rat	oral	developmental	developmental toxicity	{"citation":"Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development","dose":"The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females).","effect":"responds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). There were no effects of the test item on neuro(developmental) parameters. The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females). Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development. 3.4.5.2 Developmental Toxicity From SPC/1279/94 In a teratogenicity study, pregnant Wistar rats were fed by gavage 100, 400 and 1000 mg/kg bw of the test substance. In the dams receiving 400 and 1000 mg/kg bw, increases in liver weight were noted. No signs of embryo-/fetotoxicity and no indications for a teratogenic effect were observed. New data Guideline: / Species/strain: Rabbit, New Zealand White Group size: 17/females/dose Test substance: Octocrylene","page":31,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_009"}
SCCS Opinion	NOAEL	=153	mg/kg	-	-	developmental	reproductive toxicity	{"dose":"TS, animals were fed with 750, 2100 and 7000 ppm of the test substance.","effect":"TS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro","page":32,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_011"}
SCCS Opinion	NOAEL	=153	-	-	oral	-	NOAEL study	{"effect":"Unlabeled table on page 39: Triskelion B.V. 2019 (26) \| Feed \| Key study EOGRTS \| F0: -Increased thyroid weight2 -Incidence of activated appearance of the thyroid gland3 - Lower no. of implantation sites and number of pups Cohort 1A F1: -Increased thyroid weight2 -Incidence of activated appearance of the thyroid gland3 Cohort 1B F1 - Lower no. of implantation sites and number of pups \| // // 153 // // 153","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_034"}
SCCS Opinion	NOAEL	=163	mg per kg	-	oral	-	reproductive toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females).","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). The differences in reproductive parameters occurred at a maternally toxic dose level. Based on the effects on pup body weights, the NOAEL for general and sexual development was placed at the mid-dose concentration of 2100 mg test substance per kg diet (t","page":31,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_006"}
SCCS Opinion	NOAEL	=163	mg per kg	-	oral	-	reproductive toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females).","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). The differences in reproductive parameters occurred at a maternally toxic dose level. Based on the effects on pup body weights, the NOAEL for general and sexual development was placed at the mid-dose concentration of 2100 mg test substance per kg diet (t","page":31,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_006"}
SCCS Opinion	NOAEL	=163	mg per kg	-	oral	-	reproductive toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females).","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). The differences in reproductive parameters occurred at a maternally toxic dose level. Based on the effects on pup body weights, the NOAEL for general and sexual development was placed at the mid-dose concentration of 2100 mg test substance per kg diet (t","page":31,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_006"}
SCCS Opinion	NOAEL	=163	mg per kg	-	oral	-	reproductive toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females).","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). The differences in reproductive parameters occurred at a maternally toxic dose level. Based on the effects on pup body weights, the NOAEL for general and sexual development was placed at the mid-dose concentration of 2100 mg test substance per kg diet (t","page":31,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_006"}
SCCS Opinion	NOAEL	=175	mg/kg	rat	oral	Sub-chronic	repeated dose toxicity	{"citation":"Ref.: 24 3","dose":"24 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity From SPC/1279/94 Octocrylene was administered to Wistar rats in doses from 750-15000 ppm in the diet over a period of 3 months.","effect":"dose (10000 ppm). Ref.: 24 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity From SPC/1279/94 Octocrylene was administered to Wistar rats in doses from 750-15000 ppm in the diet over a period of 3 months. Substance-related effects were observed at 1085 and 340 mg/kg body weight per day. Target organs were liver, thyroid and pituitary gland. Additional changes were observed in hematological parameters, i.e. the red blood cells of the high dose females. Based upon the above-mentioned findings, the NOAEL under the conditions of this study is 175 mg/kg body weight per day for males and females. New data Guideline: / Species/strain: Rabbit, New Zealand White Group size: 5/sex/dose Test substance: Octocrylene Batch: / Purity: /","page":25,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_001"}
SCCS Opinion	NOAEL	=175	mg/kg	rat	oral	Sub-chronic	repeated dose toxicity	{"citation":"Ref.: 24 3","dose":"24 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity From SPC/1279/94 Octocrylene was administered to Wistar rats in doses from 750-15000 ppm in the diet over a period of 3 months.","effect":"dose (10000 ppm). Ref.: 24 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity From SPC/1279/94 Octocrylene was administered to Wistar rats in doses from 750-15000 ppm in the diet over a period of 3 months. Substance-related effects were observed at 1085 and 340 mg/kg body weight per day. Target organs were liver, thyroid and pituitary gland. Additional changes were observed in hematological parameters, i.e. the red blood cells of the high dose females. Based upon the above-mentioned findings, the NOAEL under the conditions of this study is 175 mg/kg body weight per day for males and females. New data Guideline: / Species/strain: Rabbit, New Zealand White Group size: 5/sex/dose Test substance: Octocrylene Batch: / Purity: /","page":25,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_001"}
SCCS Opinion	NOAEL	=175	mg/kg	rat	oral	Sub-chronic	repeated dose toxicity	{"citation":"Ref.: 24 3","dose":"24 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity From SPC/1279/94 Octocrylene was administered to Wistar rats in doses from 750-15000 ppm in the diet over a period of 3 months.","effect":"dose (10000 ppm). Ref.: 24 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity From SPC/1279/94 Octocrylene was administered to Wistar rats in doses from 750-15000 ppm in the diet over a period of 3 months. Substance-related effects were observed at 1085 and 340 mg/kg body weight per day. Target organs were liver, thyroid and pituitary gland. Additional changes were observed in hematological parameters, i.e. the red blood cells of the high dose females. Based upon the above-mentioned findings, the NOAEL under the conditions of this study is 175 mg/kg body weight per day for males and females. New data Guideline: / Species/strain: Rabbit, New Zealand White Group size: 5/sex/dose Test substance: Octocrylene Batch: / Purity: /","page":25,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_001"}
SCCS Opinion	NOAEL	=175	mg/kg	rat	oral	Sub-chronic	repeated dose toxicity	{"citation":"Ref.: 24 3","dose":"24 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity From SPC/1279/94 Octocrylene was administered to Wistar rats in doses from 750-15000 ppm in the diet over a period of 3 months.","effect":"dose (10000 ppm). Ref.: 24 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity From SPC/1279/94 Octocrylene was administered to Wistar rats in doses from 750-15000 ppm in the diet over a period of 3 months. Substance-related effects were observed at 1085 and 340 mg/kg body weight per day. Target organs were liver, thyroid and pituitary gland. Additional changes were observed in hematological parameters, i.e. the red blood cells of the high dose females. Based upon the above-mentioned findings, the NOAEL under the conditions of this study is 175 mg/kg body weight per day for males and females. New data Guideline: / Species/strain: Rabbit, New Zealand White Group size: 5/sex/dose Test substance: Octocrylene Batch: / Purity: /","page":25,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_001"}
SCCS Opinion	NOAEL	=534	-	rabbit	dermal	90-day	repeated dose toxicity	{"dose":"Odio 1994 (25) \| Dermal \| 90-day repeated dose toxicity study (rabbits) \| No signs of morphological abnormalities in epididymis and testicles, and in epididymal sperm concentrations No signs of significant toxicity after 13 weeks treatment \| 534 534","effect":"Unlabeled table on page 39: Odio 1994 (25) \| Dermal \| 90-day repeated dose toxicity study (rabbits) \| No signs of morphological abnormalities in epididymis and testicles, and in epididymal sperm concentrations No signs of significant toxicity after 13 weeks treatment \| 534 534","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_033"}
SCCS Opinion	NOAEL	=534	-	rabbit	dermal	90-day	repeated dose toxicity	{"dose":"Odio 1994 (25) \| Dermal \| 90-day repeated dose toxicity study (rabbits) \| No signs of morphological abnormalities in epididymis and testicles, and in epididymal sperm concentrations No signs of significant toxicity after 13 weeks treatment \| 534 534","effect":"Unlabeled table on page 39: Odio 1994 (25) \| Dermal \| 90-day repeated dose toxicity study (rabbits) \| No signs of morphological abnormalities in epididymis and testicles, and in epididymal sperm concentrations No signs of significant toxicity after 13 weeks treatment \| 534 534","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_033"}
SCCS Opinion	NOAEL	=534	-	rabbit	dermal	90-day	repeated dose toxicity	{"dose":"Odio 1994 (25) \| Dermal \| 90-day repeated dose toxicity study (rabbits) \| No signs of morphological abnormalities in epididymis and testicles, and in epididymal sperm concentrations No signs of significant toxicity after 13 weeks treatment \| 534 534","effect":"Unlabeled table on page 39: Odio 1994 (25) \| Dermal \| 90-day repeated dose toxicity study (rabbits) \| No signs of morphological abnormalities in epididymis and testicles, and in epididymal sperm concentrations No signs of significant toxicity after 13 weeks treatment \| 534 534","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_033"}
SCCS Opinion	NOAEL	=534	-	rabbit	dermal	90-day	repeated dose toxicity	{"dose":"Odio 1994 (25) \| Dermal \| 90-day repeated dose toxicity study (rabbits) \| No signs of morphological abnormalities in epididymis and testicles, and in epididymal sperm concentrations No signs of significant toxicity after 13 weeks treatment \| 534 534","effect":"Unlabeled table on page 39: Odio 1994 (25) \| Dermal \| 90-day repeated dose toxicity study (rabbits) \| No signs of morphological abnormalities in epididymis and testicles, and in epididymal sperm concentrations No signs of significant toxicity after 13 weeks treatment \| 534 534","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_033"}
SCCS Opinion	NOAEL	=1000	mg/kg bw/day	-	oral	-	NOAEL study	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 40 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) BASF 2003 (32) Gavage Study period is only ten days 1000 mg/kg bw/day4 Decrease of absolute and relative ventral prostate weights and weights of the muscle bulbocavernosus / levator ani 300 mg/kg bw/day No Octocrylene related effects...","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 40 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) BASF 2003 (32) Gavage Study period is only ten days 1000 mg/kg bw/day4 Decrease of absolute and relative ventral prostate weights and weights of the muscle bulbocavernosus / levator ani 300 mg/kg bw/day No Octocrylene related effects 300 Remarks by the Applicant: 1The increase in TSH levels in combination with physiological T4 hormone levels was due to a compensation of the increased liver-related thyroid hormone clearance, resulting in an increased synthesis of the hormones induced by a stimulation","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_018"}
SCCS Opinion	NOAEL	=1000	mg/kg bw/day	-	oral	-	NOAEL study	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 40 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) BASF 2003 (32) Gavage Study period is only ten days 1000 mg/kg bw/day4 Decrease of absolute and relative ventral prostate weights and weights of the muscle bulbocavernosus / levator ani 300 mg/kg bw/day No Octocrylene related effects...","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 40 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) BASF 2003 (32) Gavage Study period is only ten days 1000 mg/kg bw/day4 Decrease of absolute and relative ventral prostate weights and weights of the muscle bulbocavernosus / levator ani 300 mg/kg bw/day No Octocrylene related effects 300 Remarks by the Applicant: 1The increase in TSH levels in combination with physiological T4 hormone levels was due to a compensation of the increased liver-related thyroid hormone clearance, resulting in an increased synthesis of the hormones induced by a stimulation","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_018"}
SCCS Opinion	NOAEL	=1000	mg/kg bw/day	-	oral	-	NOAEL study	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 40 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) BASF 2003 (32) Gavage Study period is only ten days 1000 mg/kg bw/day4 Decrease of absolute and relative ventral prostate weights and weights of the muscle bulbocavernosus / levator ani 300 mg/kg bw/day No Octocrylene related effects...","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 40 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) BASF 2003 (32) Gavage Study period is only ten days 1000 mg/kg bw/day4 Decrease of absolute and relative ventral prostate weights and weights of the muscle bulbocavernosus / levator ani 300 mg/kg bw/day No Octocrylene related effects 300 Remarks by the Applicant: 1The increase in TSH levels in combination with physiological T4 hormone levels was due to a compensation of the increased liver-related thyroid hormone clearance, resulting in an increased synthesis of the hormones induced by a stimulation","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_018"}
SCCS Opinion	NOAEL	=1000	mg/kg bw/day	-	oral	-	NOAEL study	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 40 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) BASF 2003 (32) Gavage Study period is only ten days 1000 mg/kg bw/day4 Decrease of absolute and relative ventral prostate weights and weights of the muscle bulbocavernosus / levator ani 300 mg/kg bw/day No Octocrylene related effects...","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 40 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) BASF 2003 (32) Gavage Study period is only ten days 1000 mg/kg bw/day4 Decrease of absolute and relative ventral prostate weights and weights of the muscle bulbocavernosus / levator ani 300 mg/kg bw/day No Octocrylene related effects 300 Remarks by the Applicant: 1The increase in TSH levels in combination with physiological T4 hormone levels was due to a compensation of the increased liver-related thyroid hormone clearance, resulting in an increased synthesis of the hormones induced by a stimulation","page":40,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_018"}
SCCS Opinion	NOAEL	=1627	-	rat	-	-	reproductive toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al.","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al. 2018 (29) // Non-standardised tests (In vitro mechanistic study) Human sperm cells / 10 μM / 3 hours Octocrylene did not affect sperm functions like sperm acrosome reaction, sperm penetration, proportion of hyperactivated sperm cells or sperm viability indicating absence of effects on male fertility // ToxCast 2020 (30) // In vitro high through- put screening (HTS) assays Various human and rat cell lines / from 0.0006 to 90 μM / 0.5 to 48 hours Octocrylene was found to","page":38,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_016"}
SCCS Opinion	NOAEL	=1627	-	rat	-	-	reproductive toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al.","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al. 2018 (29) // Non-standardised tests (In vitro mechanistic study) Human sperm cells / 10 μM / 3 hours Octocrylene did not affect sperm functions like sperm acrosome reaction, sperm penetration, proportion of hyperactivated sperm cells or sperm viability indicating absence of effects on male fertility // ToxCast 2020 (30) // In vitro high through- put screening (HTS) assays Various human and rat cell lines / from 0.0006 to 90 μM / 0.5 to 48 hours Octocrylene was found to","page":38,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_016"}
SCCS Opinion	NOAEL	=1627	-	rat	-	-	reproductive toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al.","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al. 2018 (29) // Non-standardised tests (In vitro mechanistic study) Human sperm cells / 10 μM / 3 hours Octocrylene did not affect sperm functions like sperm acrosome reaction, sperm penetration, proportion of hyperactivated sperm cells or sperm viability indicating absence of effects on male fertility // ToxCast 2020 (30) // In vitro high through- put screening (HTS) assays Various human and rat cell lines / from 0.0006 to 90 μM / 0.5 to 48 hours Octocrylene was found to","page":38,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_016"}
SCCS Opinion	NOAEL	=1627	-	rat	-	-	reproductive toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al.","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al. 2018 (29) // Non-standardised tests (In vitro mechanistic study) Human sperm cells / 10 μM / 3 hours Octocrylene did not affect sperm functions like sperm acrosome reaction, sperm penetration, proportion of hyperactivated sperm cells or sperm viability indicating absence of effects on male fertility // ToxCast 2020 (30) // In vitro high through- put screening (HTS) assays Various human and rat cell lines / from 0.0006 to 90 μM / 0.5 to 48 hours Octocrylene was found to","page":38,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_016"}
SCCS Opinion	NOAEL	=2100	ppm	-	-	developmental	reproductive toxicity	{"citation":"Ref.: 25 Overall SCCS comment on reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance","dose":"Postnatal survival and body weight gain of pups were unaffected and an observed trend toward decreased survival of pups born to Octocrylene-treated compared to control dams did not achieve statistical significance.","effect":"were the same between the test groups. Postnatal survival and body weight gain of pups were unaffected and an observed trend toward decreased survival of pups born to Octocrylene-treated compared to control dams did not achieve statistical significance. Ref.: 25 Overall SCCS comment on reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro","page":32,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_010"}
SCCS Opinion	NOAEL	=2100	ppm	-	-	developmental	reproductive toxicity	{"citation":"Ref.: 25 Overall SCCS comment on reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance","dose":"Postnatal survival and body weight gain of pups were unaffected and an observed trend toward decreased survival of pups born to Octocrylene-treated compared to control dams did not achieve statistical significance.","effect":"were the same between the test groups. Postnatal survival and body weight gain of pups were unaffected and an observed trend toward decreased survival of pups born to Octocrylene-treated compared to control dams did not achieve statistical significance. Ref.: 25 Overall SCCS comment on reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro","page":32,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_010"}
SCCS Opinion	NOAEL	=2100	ppm	-	-	developmental	reproductive toxicity	{"citation":"Ref.: 25 Overall SCCS comment on reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance","dose":"Postnatal survival and body weight gain of pups were unaffected and an observed trend toward decreased survival of pups born to Octocrylene-treated compared to control dams did not achieve statistical significance.","effect":"were the same between the test groups. Postnatal survival and body weight gain of pups were unaffected and an observed trend toward decreased survival of pups born to Octocrylene-treated compared to control dams did not achieve statistical significance. Ref.: 25 Overall SCCS comment on reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro","page":32,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_010"}
SCCS Opinion	NOAEL	=2100	ppm	-	-	developmental	reproductive toxicity	{"citation":"Ref.: 25 Overall SCCS comment on reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance","dose":"Postnatal survival and body weight gain of pups were unaffected and an observed trend toward decreased survival of pups born to Octocrylene-treated compared to control dams did not achieve statistical significance.","effect":"were the same between the test groups. Postnatal survival and body weight gain of pups were unaffected and an observed trend toward decreased survival of pups born to Octocrylene-treated compared to control dams did not achieve statistical significance. Ref.: 25 Overall SCCS comment on reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro","page":32,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_010"}
SCCS Opinion	NOAEL	=3000	ppm	rat	oral	14 day	repeated dose toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 39 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induct...","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 39 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 193 // // BASF AG 1993a (10) Feed 90-day repeated dose toxicity study (rats) Slight/moderate hypertrophy of the follicular epithelium of the thyroid gland associated with","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_017"}
SCCS Opinion	NOAEL	=3000	ppm	rat	oral	14 day	repeated dose toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 39 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induct...","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 39 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 193 // // BASF AG 1993a (10) Feed 90-day repeated dose toxicity study (rats) Slight/moderate hypertrophy of the follicular epithelium of the thyroid gland associated with","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_017"}
SCCS Opinion	NOAEL	=3000	ppm	rat	oral	14 day	repeated dose toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 39 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induct...","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 39 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 193 // // BASF AG 1993a (10) Feed 90-day repeated dose toxicity study (rats) Slight/moderate hypertrophy of the follicular epithelium of the thyroid gland associated with","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_017"}
SCCS Opinion	NOAEL	=3000	ppm	rat	oral	14 day	repeated dose toxicity	{"dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 39 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induct...","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 39 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 193 // // BASF AG 1993a (10) Feed 90-day repeated dose toxicity study (rats) Slight/moderate hypertrophy of the follicular epithelium of the thyroid gland associated with","page":39,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_017"}
SCCS Opinion	NOAEL	=10000	ppm	rat	oral	28 day	repeated dose toxicity	{"dose":"BASF 2019 (24) \| Feed \| 14/28 day repeated dose toxicity study (rats) \| 10000 ppm1 Clinical Pathology (28 day study) Increased TSH levels in: -females (day 14) -both sexes (days 21, 29) Pathology 28 day study:","effect":"Unlabeled table on page 38: BASF 2019 (24) \| Feed \| 14/28 day repeated dose toxicity study (rats) \| 10000 ppm1 Clinical Pathology (28 day study) Increased TSH levels in: -females (day 14) -both sexes (days 21, 29) Pathology 28 day study: Minimal hypertrophy/hyperplasia of follicular cells in the thyroid glands (2/5 males, 3/5 females), accompanied by altered colloid 14 day study: Minimal hypertrophy/hyperplasia of follicular cells in the thyroid glands (2/5 males, 3/5 females) accompanied by altered colloid (2/5 males, 1/5) Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase activity (both sexes) -Reduction of Thyroxin 5’- deiodinase type D1 (Iodothyronine deiodinase type D1) activity in males \| 215 188 188 193 193 193","page":38,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_029"}
SCCS Opinion	NOAEL	=10000	ppm	rat	oral	28 day	repeated dose toxicity	{"dose":"BASF 2019 (24) \| Feed \| 14/28 day repeated dose toxicity study (rats) \| 10000 ppm1 Clinical Pathology (28 day study) Increased TSH levels in: -females (day 14) -both sexes (days 21, 29) Pathology 28 day study:","effect":"Unlabeled table on page 38: BASF 2019 (24) \| Feed \| 14/28 day repeated dose toxicity study (rats) \| 10000 ppm1 Clinical Pathology (28 day study) Increased TSH levels in: -females (day 14) -both sexes (days 21, 29) Pathology 28 day study: Minimal hypertrophy/hyperplasia of follicular cells in the thyroid glands (2/5 males, 3/5 females), accompanied by altered colloid 14 day study: Minimal hypertrophy/hyperplasia of follicular cells in the thyroid glands (2/5 males, 3/5 females) accompanied by altered colloid (2/5 males, 1/5) Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase activity (both sexes) -Reduction of Thyroxin 5’- deiodinase type D1 (Iodothyronine deiodinase type D1) activity in males \| 215 188 188 193 193 193","page":38,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_029"}
SCCS Opinion	NOAEL	=10000	ppm	rat	oral	28 day	repeated dose toxicity	{"dose":"BASF 2019 (24) \| Feed \| 14/28 day repeated dose toxicity study (rats) \| 10000 ppm1 Clinical Pathology (28 day study) Increased TSH levels in: -females (day 14) -both sexes (days 21, 29) Pathology 28 day study:","effect":"Unlabeled table on page 38: BASF 2019 (24) \| Feed \| 14/28 day repeated dose toxicity study (rats) \| 10000 ppm1 Clinical Pathology (28 day study) Increased TSH levels in: -females (day 14) -both sexes (days 21, 29) Pathology 28 day study: Minimal hypertrophy/hyperplasia of follicular cells in the thyroid glands (2/5 males, 3/5 females), accompanied by altered colloid 14 day study: Minimal hypertrophy/hyperplasia of follicular cells in the thyroid glands (2/5 males, 3/5 females) accompanied by altered colloid (2/5 males, 1/5) Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase activity (both sexes) -Reduction of Thyroxin 5’- deiodinase type D1 (Iodothyronine deiodinase type D1) activity in males \| 215 188 188 193 193 193","page":38,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_029"}
SCCS Opinion	NOAEL	=10000	ppm	rat	oral	28 day	repeated dose toxicity	{"dose":"BASF 2019 (24) \| Feed \| 14/28 day repeated dose toxicity study (rats) \| 10000 ppm1 Clinical Pathology (28 day study) Increased TSH levels in: -females (day 14) -both sexes (days 21, 29) Pathology 28 day study:","effect":"Unlabeled table on page 38: BASF 2019 (24) \| Feed \| 14/28 day repeated dose toxicity study (rats) \| 10000 ppm1 Clinical Pathology (28 day study) Increased TSH levels in: -females (day 14) -both sexes (days 21, 29) Pathology 28 day study: Minimal hypertrophy/hyperplasia of follicular cells in the thyroid glands (2/5 males, 3/5 females), accompanied by altered colloid 14 day study: Minimal hypertrophy/hyperplasia of follicular cells in the thyroid glands (2/5 males, 3/5 females) accompanied by altered colloid (2/5 males, 1/5) Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase activity (both sexes) -Reduction of Thyroxin 5’- deiodinase type D1 (Iodothyronine deiodinase type D1) activity in males \| 215 188 188 193 193 193","page":38,"pdf":"sccs_o_249.pdf","row_type":"noael_study","study_id":"sccs_o_249_noael_029"}

ToxValDB EPA TSCA 8e 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB EPA TSCA 8e	LEL	=2100	ppm	Rat	oral	chronic (developmental)	reproduction developmental	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c96d15e4b02565fc7d3269; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://chemview.epa.gov; SUBSOURCE_URL=https://chemview.epa.gov/chemview/proxy?filename=8EHQ-18-21462_09.21.2018_Combined.pdf; TOXICOLOGICAL_EFFECT=P0: histological changes in thyroid gland; STUDY_GROUP=EPA TSCA 8e_dup_-_15956473_15956474_15956477_15956478_15956479_15956480:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_a285d8c63ebaf55e7e0f29b72da61ca6
ToxValDB EPA TSCA 8e	LEL	=7000	ppm	Rat	oral	chronic (developmental)	reproduction developmental	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c96d15e4b02565fc7d3269; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://chemview.epa.gov; SUBSOURCE_URL=https://chemview.epa.gov/chemview/proxy?filename=8EHQ-18-21462_09.21.2018_Combined.pdf; TOXICOLOGICAL_EFFECT=F1: decreased pup weights, delays in preputial separation , vaginal opening , first estrus stage; STUDY_GROUP=EPA TSCA 8e_dup_-_15956473_15956474_15956477_15956478_15956479_15956480:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_4b76387b5e5db19288d4913c821a7e77
ToxValDB EPA TSCA 8e	LEL	=73923.7	mg/m3	Rat	inhalation	subchronic (developmental)	reproduction developmental	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c96d15e4b02565fc7d3269; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://chemview.epa.gov; SUBSOURCE_URL=https://chemview.epa.gov/chemview/proxy?filename=8EHQ-17-20905_Combined.pdf; TOXICOLOGICAL_EFFECT=P0: decreased premating body weight; STUDY_GROUP=EPA TSCA 8e_dup_-_15956529_15956531:F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_d58839f650b79bc85faa4c7a58c5fe4d
ToxValDB EPA TSCA 8e	LEL	=221771	mg/m3	Rat	inhalation	subchronic (developmental)	reproduction developmental	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c96d15e4b02565fc7d3269; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://chemview.epa.gov; SUBSOURCE_URL=https://chemview.epa.gov/chemview/proxy?filename=8EHQ-17-20905_Combined.pdf; TOXICOLOGICAL_EFFECT=P0: decreased premating body weight, decreased number of pups delivered, decreased implantation sites, decreased viability index; STUDY_GROUP=EPA TSCA 8e_dup_-_15956529_15956531:F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_3b6c80d615f135cda91f769c95fb0c80

ToxValDB GESTIS DNEL 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB GESTIS DNEL	DNEL systemic	=5.4	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:15633900:-:--; 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_88424c221f4345ab47d2bff899440136

Regulatory source 43 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
Regulatory source	-	1	-	-	oral	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=1 000; EFFECT=Unlabeled table on page 39: BASF 2001 (31) \| Oral \| Study period is only three days. No endocrine effects were observed \| 1 000; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 39: BASF 2001 (31) \| Oral \| Study period is only three days. No endocrine effects were observed \| 1 000","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"1 000","page":39,"route":"oral","species":"","study_id":"sccs_o_249_noael_035"}
Regulatory source	-	9	%	-	oral	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=9; DOSE=ellant spray, the total SED should be maximally 0.765 mg/kg bw/day.; EFFECT=ellant spray, the total SED should be maximally 0.765 mg/kg bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex. Table 13 MOS calculations for the different product types and aggregated exposures Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/day) NOAEL (mg/kg bw/day) MOS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 76.5 1 700 Face cream 10 Face 0.020 0 0 0.020 76.5 3 825 Hand cream 10 Hand 0.028 0 0 0.028 76.5 2 732 Sunscreen cream/lotion 10 Whole body 0.566 0 0 0.566 76.5 135 Sunscreen propellant spray 10 Whole body 0.566 0.176 0 0.743 76.5 102; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"ellant spray, the total SED should be maximally 0.765 mg/kg bw/day.","duration":"","effect":"ellant spray, the total SED should be maximally 0.765 mg/kg bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex. Table 13 MOS calculations for the different product types and aggregated exposures Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/day) NOAEL (mg/kg bw/day) MOS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 76.5 1 700 Face cream 10 Face 0.020 0 0 0.020 76.5 3 825 Hand cream 10 Hand 0.028 0 0 0.028 76.5 2 732 Sunscreen cream/lotion 10 Whole body 0.566 0 0 0.566 76.5 135 Sunscreen propellant spray 10 Whole body 0.566 0.176 0 0.743 76.5 102","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"9","page":40,"route":"oral","species":"","study_id":"sccs_o_249_noael_021"}
Regulatory source	-	10	%	-	oral	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=10; DOSE=Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex.; EFFECT=bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex. Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and 10% Octocrylene in lipstick, face cream and hand cream Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/d) NOAEL (mg/kg bw/day) MOS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 76.5 1 700 Face cream 10 Face 0.020 0 0 0.020 76.5 3 825 Hand cream 10 Hand 0.028 0 0 0.028 76.5 2 732 Sunscreen propellant spray 9 Whole body 0.509 0.158 0 0.667 76.5 115 Aggregated exposure (lipstick, face cream, hand cream, sunscreen propellant spray) 0.557 0.158 0.045 0.760 76.5 101 Ref.: 15, 26 3.6 DISCUSSION Physicochemical properties Only one batch of the test item (batch 5132 4997 V0) was chemically characterized by IR, 1H-N; CITATION=Ref.: 15, 26 3; CITATION_NUMBERS=[15,26,3]; REFERENCE=Ref.: 15, 26 3; DETAILS_JSON={"cas_number":"6197-30-4","citation":"Ref.: 15, 26 3","dose":"Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex.","duration":"","effect":"bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of systemic exposure dose (SED) and safe level are presented in the Tables A2-4 in the Annex. Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and 10% Octocrylene in lipstick, face cream and hand cream Products Conc (%) Surface Systemic Exposure Dose (SED) (mg/kg bw/d) NOAEL (mg/kg bw/day) MOS Dermal Inhalation Oral Total Lipstick 10 Lips 0 0 0.045 0.045 76.5 1 700 Face cream 10 Face 0.020 0 0 0.020 76.5 3 825 Hand cream 10 Hand 0.028 0 0 0.028 76.5 2 732 Sunscreen propellant spray 9 Whole body 0.509 0.158 0 0.667 76.5 115 Aggregated exposure (lipstick, face cream, hand cream, sunscreen propellant spray) 0.557 0.158 0.045 0.760 76.5 101 Ref.: 15, 26 3.6 DISCUSSION Physicochemical properties Only one batch of the test item (batch 5132 4997 V0) was chemically characterized by IR, 1H-N","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"10","page":41,"route":"oral","species":"","study_id":"sccs_o_249_noael_022"}
Regulatory source	-	12	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=unclear:Table 12 Summary of studies on endocrine activity and indicated NOAEL’s: Study Route of \| Comment \| Parameter \| NOAEL; EFFECT=Table 12 Summary of studies on endocrine activity and indicated NOAEL’s: Study Route of \| Comment \| Parameter \| NOAEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"","duration":"","effect":"Table 12 Summary of studies on endocrine activity and indicated NOAEL’s: Study Route of \| Comment \| Parameter \| NOAEL","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Table 12 Summary of studies on endocrine activity and indicated NOAEL’s: Study Route of \| Comment \| Parameter \| NOAEL","page":37,"route":"","species":"","study_id":"sccs_o_249_noael_027"}
Regulatory source	-	13	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=unclear:Table 13 MOS calculations for the different product types and aggregated exposures: Study \| R \| oute of Com \| me \| nt \| Paramete \| r \| NOAEL; EFFECT=Table 13 MOS calculations for the different product types and aggregated exposures: Study \| R \| oute of Com \| me \| nt \| Paramete \| r \| NOAEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"","duration":"","effect":"Table 13 MOS calculations for the different product types and aggregated exposures: Study \| R \| oute of Com \| me \| nt \| Paramete \| r \| NOAEL","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Table 13 MOS calculations for the different product types and aggregated exposures: Study \| R \| oute of Com \| me \| nt \| Paramete \| r \| NOAEL","page":40,"route":"","species":"","study_id":"sccs_o_249_noael_036"}
Regulatory source	-	14	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=unclear:Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS; DOSE=Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS; EFFECT=Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS","duration":"","effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Products \| Conc (%) \| Surface \| Systemic Exposure Dose (SED) (mg/kg bw/d) \| NOAEL (mg/kg bw/day) \| MOS","page":41,"route":"","species":"","study_id":"sccs_o_249_noael_038"}
Regulatory source	-	38	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=unclear:Unlabeled table on page 38: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d); DOSE=Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 38: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 38: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 38: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","page":38,"route":"","species":"","study_id":"sccs_o_249_noael_028"}
Regulatory source	-	39	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=unclear:Unlabeled table on page 39: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d); DOSE=Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d); EFFECT=Unlabeled table on page 39: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","duration":"","effect":"Unlabeled table on page 39: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 39: Study \| Route of exposure \| Comment \| Parameter \| NOAEL (mg/kg bw/d)","page":39,"route":"","species":"","study_id":"sccs_o_249_noael_030"}
Regulatory source	-	76.5	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=76.5; EFFECT=Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Lipstick \| 10 \| Lips \| 0 \| 0 \| 0.045 \| 0.045 \| 76.5 \| 1 700; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"","duration":"","effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Lipstick \| 10 \| Lips \| 0 \| 0 \| 0.045 \| 0.045 \| 76.5 \| 1 700","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"76.5","page":41,"route":"","species":"","study_id":"sccs_o_249_noael_039"}
Regulatory source	-	76.5	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=76.5; EFFECT=Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Face cream \| 10 \| Face \| 0.020 \| 0 \| 0 \| 0.020 \| 76.5 \| 3 825; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"","duration":"","effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Face cream \| 10 \| Face \| 0.020 \| 0 \| 0 \| 0.020 \| 76.5 \| 3 825","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"76.5","page":41,"route":"","species":"","study_id":"sccs_o_249_noael_040"}
Regulatory source	-	76.5	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=76.5; EFFECT=Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Hand cream \| 10 \| Hand \| 0.028 \| 0 \| 0 \| 0.028 \| 76.5 \| 2 732; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"","duration":"","effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Hand cream \| 10 \| Hand \| 0.028 \| 0 \| 0 \| 0.028 \| 76.5 \| 2 732","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"76.5","page":41,"route":"","species":"","study_id":"sccs_o_249_noael_041"}
Regulatory source	-	76.5	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=76.5; EFFECT=Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Sunscreen propellant spray \| 9 \| Whole body \| 0.509 \| 0.158 \| 0 \| 0.667 \| 76.5 \| 115; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"","duration":"","effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Sunscreen propellant spray \| 9 \| Whole body \| 0.509 \| 0.158 \| 0 \| 0.667 \| 76.5 \| 115","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"76.5","page":41,"route":"","species":"","study_id":"sccs_o_249_noael_042"}
Regulatory source	-	76.5	-	-	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=76.5; EFFECT=Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Aggregated exposure (lipstick, face cream, hand cream, sunscreen propellant spray) \| 0.557 \| 0.158 \| 0.045 \| 0.760 \| 76.5 \| 101; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"","duration":"","effect":"Table 14 MOS calculations based on 9% Octocrylene in sunscreen as propellant spray, and: Aggregated exposure (lipstick, face cream, hand cream, sunscreen propellant spray) \| 0.557 \| 0.158 \| 0.045 \| 0.760 \| 76.5 \| 101","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"76.5","page":41,"route":"","species":"","study_id":"sccs_o_249_noael_043"}
Regulatory source	-	130	mg/kg/day	rabbit	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=130; DOSE=In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts.; EFFECT=thout showing any signs of adverse clinical responses to Octocrylene, other than those noted at or near the site of compound application. In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts. In both sexes, mid- and high-dose treatments significantly depressed body weight gain relative to the corresponding controls. At the low dose, no significant body weight effect was noted in females (NOEL, 130 mg/kg/day), whereas in male animals, a statistically significant depression of body weight gain was still observed (NOEL not established). The data also indicated no significant effects in kidney weights of male or female rabbits at any of the Octocrylene doses tested. Absolute liver weights of male animals were reduced at all Octocrylene dose levels, but the effect was no longer evident when organ weights were corrected for Octocrylene-associated effects on body weight. In females, on the other hand, absolut; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts.","duration":"","effect":"thout showing any signs of adverse clinical responses to Octocrylene, other than those noted at or near the site of compound application. In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts. In both sexes, mid- and high-dose treatments significantly depressed body weight gain relative to the corresponding controls. At the low dose, no significant body weight effect was noted in females (NOEL, 130 mg/kg/day), whereas in male animals, a statistically significant depression of body weight gain was still observed (NOEL not established). The data also indicated no significant effects in kidney weights of male or female rabbits at any of the Octocrylene doses tested. Absolute liver weights of male animals were reduced at all Octocrylene dose levels, but the effect was no longer evident when organ weights were corrected for Octocrylene-associated effects on body weight. In females, on the other hand, absolut","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"130","page":26,"route":"","species":"rabbit","study_id":"sccs_o_249_noael_002"}
Regulatory source	-	130	mg/kg/day	rabbit	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=130; DOSE=In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts.; EFFECT=pplication. In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts. In both sexes, mid- and high-dose treatments significantly depressed body weight gain relative to the corresponding controls. At the low dose, no significant body weight effect was noted in females (NOEL, 130 mg/kg/day), whereas in male animals, a statistically significant depression of body weight gain was still observed (NOEL not established). The data also indicated no significant effects in kidney weights of male or female rabbits at any of the Octocrylene doses tested. Absolute liver weights of male animals were reduced at all Octocrylene dose levels, but the effect was no longer evident when organ weights were corrected for Octocrylene-associated effects on body weight. In females, on the other hand, absolute liver weights were unaltered at all Octocrylene dose levels, but the organ to body weight ratio increased significantly at t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts.","duration":"","effect":"pplication. In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities (erythema and desquamation) than control counterparts. In both sexes, mid- and high-dose treatments significantly depressed body weight gain relative to the corresponding controls. At the low dose, no significant body weight effect was noted in females (NOEL, 130 mg/kg/day), whereas in male animals, a statistically significant depression of body weight gain was still observed (NOEL not established). The data also indicated no significant effects in kidney weights of male or female rabbits at any of the Octocrylene doses tested. Absolute liver weights of male animals were reduced at all Octocrylene dose levels, but the effect was no longer evident when organ weights were corrected for Octocrylene-associated effects on body weight. In females, on the other hand, absolute liver weights were unaltered at all Octocrylene dose levels, but the organ to body weight ratio increased significantly at t","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"130","page":26,"route":"","species":"rabbit","study_id":"sccs_o_249_noael_003"}
Regulatory source	-	153	mg/kg bw/day	rat	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=153; DOSE=2019) where a NOAEL of 153 mg/kg bw/day was defined based on general and sexual development.; EFFECT=-related thyroid hormone clearance, resulting in an increased synthesis of the hormones induced by a stimulation of the thyroid via the pituitary gland. Since humans, unlike rodents, possess a T4 binding protein that greatly reduces susceptibility to plasma T4 depletion and thyroid stimulation, the effects seen in rats cannot be directly extrapolated to humans. Thus, the SCCS decided not to use these findings in the risk assessment. The key study was considered to be the EOGRT study (Triskelion B.V. 2019) where a NOAEL of 153 mg/kg bw/day was defined based on general and sexual development. The available data on Octocrylene provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. Table 12 Summary of studies on endocrine activity and indicated NOAEL’s Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) In vitro and other assays Kunz; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"2019) where a NOAEL of 153 mg/kg bw/day was defined based on general and sexual development.","duration":"","effect":"-related thyroid hormone clearance, resulting in an increased synthesis of the hormones induced by a stimulation of the thyroid via the pituitary gland. Since humans, unlike rodents, possess a T4 binding protein that greatly reduces susceptibility to plasma T4 depletion and thyroid stimulation, the effects seen in rats cannot be directly extrapolated to humans. Thus, the SCCS decided not to use these findings in the risk assessment. The key study was considered to be the EOGRT study (Triskelion B.V. 2019) where a NOAEL of 153 mg/kg bw/day was defined based on general and sexual development. The available data on Octocrylene provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. Table 12 Summary of studies on endocrine activity and indicated NOAEL’s Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) In vitro and other assays Kunz","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"153","page":37,"route":"","species":"rat","study_id":"sccs_o_249_noael_013"}
Regulatory source	-	153	mg/kg bw/day	human	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=153; DOSE=2019) where a NOAEL of 153 mg/kg bw/day was defined based on general and sexual development.; EFFECT=isk assessment. The key study was considered to be the EOGRT study (Triskelion B.V. 2019) where a NOAEL of 153 mg/kg bw/day was defined based on general and sexual development. The available data on Octocrylene provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. Table 12 Summary of studies on endocrine activity and indicated NOAEL’s Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) In vitro and other assays Kunz and Fent (2006) (27) // Recombinant yeast systems carrying either a human estrogen (hERα) or androgen receptor (hAR) Octocrylene was mainly associated with anti- androgenic/androgenic activities under in vitro conditions, considered as not biologically relevant for the in vivo situation // Rehfeld et al. 2016 (28) // Non-standardised tests (In vitro mechanistic study) Human sperm cells / 10 μM / 3 hours Octocrylene i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"2019) where a NOAEL of 153 mg/kg bw/day was defined based on general and sexual development.","duration":"","effect":"isk assessment. The key study was considered to be the EOGRT study (Triskelion B.V. 2019) where a NOAEL of 153 mg/kg bw/day was defined based on general and sexual development. The available data on Octocrylene provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. Table 12 Summary of studies on endocrine activity and indicated NOAEL’s Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) In vitro and other assays Kunz and Fent (2006) (27) // Recombinant yeast systems carrying either a human estrogen (hERα) or androgen receptor (hAR) Octocrylene was mainly associated with anti- androgenic/androgenic activities under in vitro conditions, considered as not biologically relevant for the in vivo situation // Rehfeld et al. 2016 (28) // Non-standardised tests (In vitro mechanistic study) Human sperm cells / 10 μM / 3 hours Octocrylene i","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"153","page":37,"route":"","species":"human","study_id":"sccs_o_249_noael_014"}
Regulatory source	-	153	mg/kg bw/day	human	-	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=153; DOSE=2019) where a NOAEL of 153 mg/kg bw/day was defined based on general and sexual development.; EFFECT=e the EOGRT study (Triskelion B.V. 2019) where a NOAEL of 153 mg/kg bw/day was defined based on general and sexual development. The available data on Octocrylene provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. Table 12 Summary of studies on endocrine activity and indicated NOAEL’s Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) In vitro and other assays Kunz and Fent (2006) (27) // Recombinant yeast systems carrying either a human estrogen (hERα) or androgen receptor (hAR) Octocrylene was mainly associated with anti- androgenic/androgenic activities under in vitro conditions, considered as not biologically relevant for the in vivo situation // Rehfeld et al. 2016 (28) // Non-standardised tests (In vitro mechanistic study) Human sperm cells / 10 μM / 3 hours Octocrylene induced sustained or slow rising of Ca2+ signals, w; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"2019) where a NOAEL of 153 mg/kg bw/day was defined based on general and sexual development.","duration":"","effect":"e the EOGRT study (Triskelion B.V. 2019) where a NOAEL of 153 mg/kg bw/day was defined based on general and sexual development. The available data on Octocrylene provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. Table 12 Summary of studies on endocrine activity and indicated NOAEL’s Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) In vitro and other assays Kunz and Fent (2006) (27) // Recombinant yeast systems carrying either a human estrogen (hERα) or androgen receptor (hAR) Octocrylene was mainly associated with anti- androgenic/androgenic activities under in vitro conditions, considered as not biologically relevant for the in vivo situation // Rehfeld et al. 2016 (28) // Non-standardised tests (In vitro mechanistic study) Human sperm cells / 10 μM / 3 hours Octocrylene induced sustained or slow rising of Ca2+ signals, w","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"153","page":37,"route":"","species":"human","study_id":"sccs_o_249_noael_015"}
Regulatory source	-	153	-	-	oral	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=// // 153 // // 153; EFFECT=Unlabeled table on page 39: Triskelion B.V. 2019 (26) \| Feed \| Key study EOGRTS \| F0: -Increased thyroid weight2 -Incidence of activated appearance of the thyroid gland3 - Lower no. of implantation sites and number of pups Cohort 1A F1: -Increased thyroid weight2 -Incidence of activated appearance of the thyroid gland3 Cohort 1B F1 - Lower no. of implantation sites and number of pups \| // // 153 // // 153; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 39: Triskelion B.V. 2019 (26) \| Feed \| Key study EOGRTS \| F0: -Increased thyroid weight2 -Incidence of activated appearance of the thyroid gland3 - Lower no. of implantation sites and number of pups Cohort 1A F1: -Increased thyroid weight2 -Incidence of activated appearance of the thyroid gland3 Cohort 1B F1 - Lower no. of implantation sites and number of pups \| // // 153 // // 153","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"// // 153 // // 153","page":39,"route":"oral","species":"","study_id":"sccs_o_249_noael_034"}
Regulatory source	-	1000	mg/kg bw/day	-	oral	-	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=1000; DOSE=SCCS/1627/21 Final Opinion Opinion on Octocrylene 40 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) BASF 2003 (32) Gavage Study period is only ten days 1000 mg/kg bw/day4 Decrease of absolute and relative ventral prostate weights and weights of the muscle bulbocavernosus / levator ani 300 mg/kg bw/day No Octocrylene related effects...; EFFECT=SCCS/1627/21 Final Opinion Opinion on Octocrylene 40 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) BASF 2003 (32) Gavage Study period is only ten days 1000 mg/kg bw/day4 Decrease of absolute and relative ventral prostate weights and weights of the muscle bulbocavernosus / levator ani 300 mg/kg bw/day No Octocrylene related effects 300 Remarks by the Applicant: 1The increase in TSH levels in combination with physiological T4 hormone levels was due to a compensation of the increased liver-related thyroid hormone clearance, resulting in an increased synthesis of the hormones induced by a stimulation; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 40 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) BASF 2003 (32) Gavage Study period is only ten days 1000 mg/kg bw/day4 Decrease of absolute and relative ventral prostate weights and weights of the muscle bulbocavernosus / levator ani 300 mg/kg bw/day No Octocrylene related effects...","duration":"","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 40 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) BASF 2003 (32) Gavage Study period is only ten days 1000 mg/kg bw/day4 Decrease of absolute and relative ventral prostate weights and weights of the muscle bulbocavernosus / levator ani 300 mg/kg bw/day No Octocrylene related effects 300 Remarks by the Applicant: 1The increase in TSH levels in combination with physiological T4 hormone levels was due to a compensation of the increased liver-related thyroid hormone clearance, resulting in an increased synthesis of the hormones induced by a stimulation","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":40,"route":"oral","species":"","study_id":"sccs_o_249_noael_018"}
Regulatory source	-	3000	ppm	-	-	14 day	-	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=3000; EFFECT=Unlabeled table on page 39: -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males \| 193 // //; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"","duration":"14 day","effect":"Unlabeled table on page 39: -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males \| 193 // //","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"ppm","noael_value":"3000","page":39,"route":"","species":"","study_id":"sccs_o_249_noael_031"}
Regulatory source	carcinogenicity	153	mg/kg bw/day	human	-	-	carcinogenicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=153; DOSE=2019) where a NOAEL of 153 mg/kg bw/day was derived based on general and sexual development.; EFFECT=Carcinogenicity No new data was submitted in 2019 and no data on carcinogenicity was available for the ECHA registration dossier on Octocrylene (last modified April 2020). Photo-induced toxicity In the presence of UV light, the test substance did not induce mutations in the E.coli strain WP2, nor chromosome aberrations in CHO-cells. Photosensitisation: See skin sensitisation. Human data / Special investigation Endocrine activity The key study was considered to be the EOGRT study (Triskelion B.V. 2019) where a NOAEL of 153 mg/kg bw/day was derived based on general and sexual development. The available data on Octocrylene provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. This Opinion did not address the potential impact of Octocrylene on the environment.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"2019) where a NOAEL of 153 mg/kg bw/day was derived based on general and sexual development.","duration":"","effect":"Carcinogenicity No new data was submitted in 2019 and no data on carcinogenicity was available for the ECHA registration dossier on Octocrylene (last modified April 2020). Photo-induced toxicity In the presence of UV light, the test substance did not induce mutations in the E.coli strain WP2, nor chromosome aberrations in CHO-cells. Photosensitisation: See skin sensitisation. Human data / Special investigation Endocrine activity The key study was considered to be the EOGRT study (Triskelion B.V. 2019) where a NOAEL of 153 mg/kg bw/day was derived based on general and sexual development. The available data on Octocrylene provide some indications for potential endocrine effects. However, the current level of evidence is not sufficient to derive a toxicological point of departure based on endocrine disrupting properties for use in human health risk assessment. This Opinion did not address the potential impact of Octocrylene on the environment.","endpoint":"carcinogenicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"153","page":43,"route":"","species":"human","study_id":"sccs_o_249_noael_026"}
Regulatory source	developmental toxicity	153	mg/kg bw/day	rat	oral	developmental	developmental toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=153; DOSE=The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females).; EFFECT=responds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). There were no effects of the test item on neuro(developmental) parameters. The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females). Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development. 3.4.5.2 Developmental Toxicity From SPC/1279/94 In a teratogenicity study, pregnant Wistar rats were fed by gavage 100, 400 and 1000 mg/kg bw of the test substance. In the dams receiving 400 and 1000 mg/kg bw, increases in liver weight were noted. No signs of embryo-/fetotoxicity and no indications for a teratogenic effect were observed. New data Guideline: / Species/strain: Rabbit, New Zealand White Group size: 17/females/dose Test substance: Octocrylene; CITATION=Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development; CITATION_NUMBERS=[26,153]; REFERENCE=Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development; DETAILS_JSON={"cas_number":"6197-30-4","citation":"Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development","dose":"The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females).","duration":"developmental","effect":"responds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). There were no effects of the test item on neuro(developmental) parameters. The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females). Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development. 3.4.5.2 Developmental Toxicity From SPC/1279/94 In a teratogenicity study, pregnant Wistar rats were fed by gavage 100, 400 and 1000 mg/kg bw of the test substance. In the dams receiving 400 and 1000 mg/kg bw, increases in liver weight were noted. No signs of embryo-/fetotoxicity and no indications for a teratogenic effect were observed. New data Guideline: / Species/strain: Rabbit, New Zealand White Group size: 17/females/dose Test substance: Octocrylene","endpoint":"developmental toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"153","page":31,"route":"oral","species":"rat","study_id":"sccs_o_249_noael_009"}
Regulatory source	repeated dose toxicity	175	mg/kg	rat	oral	Sub-chronic	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=175; DOSE=24 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity From SPC/1279/94 Octocrylene was administered to Wistar rats in doses from 750-15000 ppm in the diet over a period of 3 months.; EFFECT=dose (10000 ppm). Ref.: 24 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity From SPC/1279/94 Octocrylene was administered to Wistar rats in doses from 750-15000 ppm in the diet over a period of 3 months. Substance-related effects were observed at 1085 and 340 mg/kg body weight per day. Target organs were liver, thyroid and pituitary gland. Additional changes were observed in hematological parameters, i.e. the red blood cells of the high dose females. Based upon the above-mentioned findings, the NOAEL under the conditions of this study is 175 mg/kg body weight per day for males and females. New data Guideline: / Species/strain: Rabbit, New Zealand White Group size: 5/sex/dose Test substance: Octocrylene Batch: / Purity: /; CITATION=Ref.: 24 3; CITATION_NUMBERS=[24,3]; REFERENCE=Ref.: 24 3; DETAILS_JSON={"cas_number":"6197-30-4","citation":"Ref.: 24 3","dose":"24 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity From SPC/1279/94 Octocrylene was administered to Wistar rats in doses from 750-15000 ppm in the diet over a period of 3 months.","duration":"Sub-chronic","effect":"dose (10000 ppm). Ref.: 24 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity From SPC/1279/94 Octocrylene was administered to Wistar rats in doses from 750-15000 ppm in the diet over a period of 3 months. Substance-related effects were observed at 1085 and 340 mg/kg body weight per day. Target organs were liver, thyroid and pituitary gland. Additional changes were observed in hematological parameters, i.e. the red blood cells of the high dose females. Based upon the above-mentioned findings, the NOAEL under the conditions of this study is 175 mg/kg body weight per day for males and females. New data Guideline: / Species/strain: Rabbit, New Zealand White Group size: 5/sex/dose Test substance: Octocrylene Batch: / Purity: /","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg","noael_value":"175","page":25,"route":"oral","species":"rat","study_id":"sccs_o_249_noael_001"}
Regulatory source	repeated dose toxicity	175	mg/kg	rat	oral	-	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=175; DOSE=SCCS/1627/21 Final Opinion Opinion on Octocrylene 27 The newly submitted repeated dose toxicity studies do not provide new data that support a change of the NOAEL of 175 mg/kg body weight per day for males and females described in the previous SCCS Opinion.; EFFECT=SCCS/1627/21 Final Opinion Opinion on Octocrylene 27 The newly submitted repeated dose toxicity studies do not provide new data that support a change of the NOAEL of 175 mg/kg body weight per day for males and females described in the previous SCCS Opinion. 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity New data Dose-range-finding study Guideline: No guideline (Dose-range-finding (DFR) study for extended one- generation reproductive toxicity study (EOGRTS) described below) Species/strain: Rat/Wistar Crl:WI(Han) Group size: 12/sex/dose Test substance: Octocrylene Batch: 5132 4997 V0 Purity: 99.4% Vehicle: Feed Dose levels: 0, 5000 and 15000; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 27 The newly submitted repeated dose toxicity studies do not provide new data that support a change of the NOAEL of 175 mg/kg body weight per day for males and females described in the previous SCCS Opinion.","duration":"","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 27 The newly submitted repeated dose toxicity studies do not provide new data that support a change of the NOAEL of 175 mg/kg body weight per day for males and females described in the previous SCCS Opinion. 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity New data Dose-range-finding study Guideline: No guideline (Dose-range-finding (DFR) study for extended one- generation reproductive toxicity study (EOGRTS) described below) Species/strain: Rat/Wistar Crl:WI(Han) Group size: 12/sex/dose Test substance: Octocrylene Batch: 5132 4997 V0 Purity: 99.4% Vehicle: Feed Dose levels: 0, 5000 and 15000","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg","noael_value":"175","page":27,"route":"oral","species":"rat","study_id":"sccs_o_249_noael_004"}
Regulatory source	repeated dose toxicity	175	mg/kg	rat	dermal	-	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=175; DOSE=Acute toxicity The SCCS agrees that the acute dermal median lethal dose (LD50) in the rat is greater than 2000 mg/kg body weight.; EFFECT=o have previously used topical products containing the non- steroidal anti-inﬂammatory drug ketoprofen. Thus, the majority of photoallergic reactions are probably not induced by Octocrylene itself but occur as a result of previous photosensitisation to ketoprofen. Acute toxicity The SCCS agrees that the acute dermal median lethal dose (LD50) in the rat is greater than 2000 mg/kg body weight. Repeated dose toxicity The newly submitted repeated dose toxicity studies do not provide data that support a change of the NOAEL of 175 mg/kg body weight per day for males and females described in the previous SCCS Opinion. Reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/develo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"Acute toxicity The SCCS agrees that the acute dermal median lethal dose (LD50) in the rat is greater than 2000 mg/kg body weight.","duration":"","effect":"o have previously used topical products containing the non- steroidal anti-inﬂammatory drug ketoprofen. Thus, the majority of photoallergic reactions are probably not induced by Octocrylene itself but occur as a result of previous photosensitisation to ketoprofen. Acute toxicity The SCCS agrees that the acute dermal median lethal dose (LD50) in the rat is greater than 2000 mg/kg body weight. Repeated dose toxicity The newly submitted repeated dose toxicity studies do not provide data that support a change of the NOAEL of 175 mg/kg body weight per day for males and females described in the previous SCCS Opinion. Reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/develo","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg","noael_value":"175","page":42,"route":"dermal","species":"rat","study_id":"sccs_o_249_noael_023"}
Regulatory source	repeated dose toxicity	175	-	rat	oral	90-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=175 340; DOSE=BASF AG 1993a (10) \| Feed \| 90-day repeated dose toxicity study (rats) \| Slight/moderate hypertrophy of the follicular epithelium of the thyroid gland associated with minimal or slight pale staining colloid in the two high dose groups Incidence of hypertrophic cells in the pituitary gland (probably thyroidectomy cells caused by interference in t...; EFFECT=Unlabeled table on page 39: BASF AG 1993a (10) \| Feed \| 90-day repeated dose toxicity study (rats) \| Slight/moderate hypertrophy of the follicular epithelium of the thyroid gland associated with minimal or slight pale staining colloid in the two high dose groups Incidence of hypertrophic cells in the pituitary gland (probably thyroidectomy cells caused by interference in the homeostatic feedback mechanism) \| 175 340; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"BASF AG 1993a (10) \| Feed \| 90-day repeated dose toxicity study (rats) \| Slight/moderate hypertrophy of the follicular epithelium of the thyroid gland associated with minimal or slight pale staining colloid in the two high dose groups Incidence of hypertrophic cells in the pituitary gland (probably thyroidectomy cells caused by interference in t...","duration":"90-day","effect":"Unlabeled table on page 39: BASF AG 1993a (10) \| Feed \| 90-day repeated dose toxicity study (rats) \| Slight/moderate hypertrophy of the follicular epithelium of the thyroid gland associated with minimal or slight pale staining colloid in the two high dose groups Incidence of hypertrophic cells in the pituitary gland (probably thyroidectomy cells caused by interference in the homeostatic feedback mechanism) \| 175 340","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"175 340","page":39,"route":"oral","species":"rat","study_id":"sccs_o_249_noael_032"}
Regulatory source	repeated dose toxicity	534	-	rabbit	dermal	90-day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=534 534; DOSE=Odio 1994 (25) \| Dermal \| 90-day repeated dose toxicity study (rabbits) \| No signs of morphological abnormalities in epididymis and testicles, and in epididymal sperm concentrations No signs of significant toxicity after 13 weeks treatment \| 534 534; EFFECT=Unlabeled table on page 39: Odio 1994 (25) \| Dermal \| 90-day repeated dose toxicity study (rabbits) \| No signs of morphological abnormalities in epididymis and testicles, and in epididymal sperm concentrations No signs of significant toxicity after 13 weeks treatment \| 534 534; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"Odio 1994 (25) \| Dermal \| 90-day repeated dose toxicity study (rabbits) \| No signs of morphological abnormalities in epididymis and testicles, and in epididymal sperm concentrations No signs of significant toxicity after 13 weeks treatment \| 534 534","duration":"90-day","effect":"Unlabeled table on page 39: Odio 1994 (25) \| Dermal \| 90-day repeated dose toxicity study (rabbits) \| No signs of morphological abnormalities in epididymis and testicles, and in epididymal sperm concentrations No signs of significant toxicity after 13 weeks treatment \| 534 534","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"534 534","page":39,"route":"dermal","species":"rabbit","study_id":"sccs_o_249_noael_033"}
Regulatory source	repeated dose toxicity	2100	ppm	rat	-	developmental	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=2100; DOSE=ose (LD50) in the rat is greater than 2000 mg/kg body weight.; EFFECT=ose (LD50) in the rat is greater than 2000 mg/kg body weight. Repeated dose toxicity The newly submitted repeated dose toxicity studies do not provide data that support a change of the NOAEL of 175 mg/kg body weight per day for males and females described in the previous SCCS Opinion. Reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. Mutagenicity / genotoxicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"ose (LD50) in the rat is greater than 2000 mg/kg body weight.","duration":"developmental","effect":"ose (LD50) in the rat is greater than 2000 mg/kg body weight. Repeated dose toxicity The newly submitted repeated dose toxicity studies do not provide data that support a change of the NOAEL of 175 mg/kg body weight per day for males and females described in the previous SCCS Opinion. Reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. Mutagenicity / genotoxicity","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"ppm","noael_value":"2100","page":42,"route":"","species":"rat","study_id":"sccs_o_249_noael_024"}
Regulatory source	repeated dose toxicity	3000	ppm	rat	oral	14 day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=3000; DOSE=SCCS/1627/21 Final Opinion Opinion on Octocrylene 39 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induct...; EFFECT=SCCS/1627/21 Final Opinion Opinion on Octocrylene 39 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 193 // // BASF AG 1993a (10) Feed 90-day repeated dose toxicity study (rats) Slight/moderate hypertrophy of the follicular epithelium of the thyroid gland associated with; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 39 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induct...","duration":"14 day","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 39 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 3000 ppm1 Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase- activities in females -Induction of Thyroxin 5’- deiodinase type D3 (Iodothyronine deiodinase type D3) activity in males 193 // // BASF AG 1993a (10) Feed 90-day repeated dose toxicity study (rats) Slight/moderate hypertrophy of the follicular epithelium of the thyroid gland associated with","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"ppm","noael_value":"3000","page":39,"route":"oral","species":"rat","study_id":"sccs_o_249_noael_017"}
Regulatory source	repeated dose toxicity	10000	ppm	rat	oral	28 day	repeated dose toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=10000; DOSE=BASF 2019 (24) \| Feed \| 14/28 day repeated dose toxicity study (rats) \| 10000 ppm1 Clinical Pathology (28 day study) Increased TSH levels in: -females (day 14) -both sexes (days 21, 29) Pathology 28 day study:; EFFECT=Unlabeled table on page 38: BASF 2019 (24) \| Feed \| 14/28 day repeated dose toxicity study (rats) \| 10000 ppm1 Clinical Pathology (28 day study) Increased TSH levels in: -females (day 14) -both sexes (days 21, 29) Pathology 28 day study: Minimal hypertrophy/hyperplasia of follicular cells in the thyroid glands (2/5 males, 3/5 females), accompanied by altered colloid 14 day study: Minimal hypertrophy/hyperplasia of follicular cells in the thyroid glands (2/5 males, 3/5 females) accompanied by altered colloid (2/5 males, 1/5) Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase activity (both sexes) -Reduction of Thyroxin 5’- deiodinase type D1 (Iodothyronine deiodinase type D1) activity in males \| 215 188 188 193 193 193; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"BASF 2019 (24) \| Feed \| 14/28 day repeated dose toxicity study (rats) \| 10000 ppm1 Clinical Pathology (28 day study) Increased TSH levels in: -females (day 14) -both sexes (days 21, 29) Pathology 28 day study:","duration":"28 day","effect":"Unlabeled table on page 38: BASF 2019 (24) \| Feed \| 14/28 day repeated dose toxicity study (rats) \| 10000 ppm1 Clinical Pathology (28 day study) Increased TSH levels in: -females (day 14) -both sexes (days 21, 29) Pathology 28 day study: Minimal hypertrophy/hyperplasia of follicular cells in the thyroid glands (2/5 males, 3/5 females), accompanied by altered colloid 14 day study: Minimal hypertrophy/hyperplasia of follicular cells in the thyroid glands (2/5 males, 3/5 females) accompanied by altered colloid (2/5 males, 1/5) Bioanalytical Examinations (14 day study) -Increased T4-specific UDP- glucuronosyltransferase activity (both sexes) -Reduction of Thyroxin 5’- deiodinase type D1 (Iodothyronine deiodinase type D1) activity in males \| 215 188 188 193 193 193","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"ppm","noael_value":"10000","page":38,"route":"oral","species":"rat","study_id":"sccs_o_249_noael_029"}
Regulatory source	reproductive toxicity	76.5	mg/kg bw/day	-	oral	-	reproductive toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=76.5; DOSE=A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS.; EFFECT=observed increased liver weights connected with a higher metabolism rate of the substituted androgen testosterone propionate. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) MOS calculations for separate product types and aggregated exposures are shown in Table 13. A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS. Information from Bury et al. (2019) provide some evidence for an oral bioavailability of 50%, giving an adjusted NOAEL of 76.5 mg/kg bw/day. Details of the calculation of systemic exposure dose (SED) are presented in Table A1 in the Annex. In order to derive a MOS of 100 for aggregated exposure for lipstick, face cream, hand cream and sunscreen as a propellant spray, the total SED should be maximally 0.765 mg/kg bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of system; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS.","duration":"","effect":"observed increased liver weights connected with a higher metabolism rate of the substituted androgen testosterone propionate. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) MOS calculations for separate product types and aggregated exposures are shown in Table 13. A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS. Information from Bury et al. (2019) provide some evidence for an oral bioavailability of 50%, giving an adjusted NOAEL of 76.5 mg/kg bw/day. Details of the calculation of systemic exposure dose (SED) are presented in Table A1 in the Annex. In order to derive a MOS of 100 for aggregated exposure for lipstick, face cream, hand cream and sunscreen as a propellant spray, the total SED should be maximally 0.765 mg/kg bw/day. Linear extrapolation of the SED for 10% Octocrylene shows that this can be achieved by reducing the Octocrylene concentration from 10% to 9% in the propellant spray (Table 14). Details of the calculation of system","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"76.5","page":40,"route":"oral","species":"","study_id":"sccs_o_249_noael_020"}
Regulatory source	reproductive toxicity	153	mg per kg	-	oral	-	reproductive toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=153; DOSE=SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females).; EFFECT=SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg pe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females).","duration":"","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg pe","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg per kg","noael_value":"153","page":31,"route":"oral","species":"","study_id":"sccs_o_249_noael_005"}
Regulatory source	reproductive toxicity	153	mg per kg	-	oral	developmental	reproductive toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=153; DOSE=Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day...; EFFECT=t per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). The differences in reproductive parameters occurred at a maternally toxic dose level. Based on the effects on pup body weights, the NOAEL for general and sexual development was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). There were no effects of the test item on neuro(developmental) parameters. The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg b; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day...","duration":"developmental","effect":"t per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). The differences in reproductive parameters occurred at a maternally toxic dose level. Based on the effects on pup body weights, the NOAEL for general and sexual development was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). There were no effects of the test item on neuro(developmental) parameters. The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg b","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg per kg","noael_value":"153","page":31,"route":"oral","species":"","study_id":"sccs_o_249_noael_007"}
Regulatory source	reproductive toxicity	153	mg/kg	-	-	developmental	reproductive toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=153; DOSE=TS, animals were fed with 750, 2100 and 7000 ppm of the test substance.; EFFECT=TS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"TS, animals were fed with 750, 2100 and 7000 ppm of the test substance.","duration":"developmental","effect":"TS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg","noael_value":"153","page":32,"route":"","species":"","study_id":"sccs_o_249_noael_011"}
Regulatory source	reproductive toxicity	153	mg/kg bw/day	rat	oral	-	reproductive toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=153; DOSE=A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS.; EFFECT=but adaptive changes in rats. 4The observed decrease in organ weights of ventral prostate and the muscle bulbocavernosus together with the levator ani may have been fortuitous or is to be explained by an enzyme induction, indicated by the observed increased liver weights connected with a higher metabolism rate of the substituted androgen testosterone propionate. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) MOS calculations for separate product types and aggregated exposures are shown in Table 13. A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS. Information from Bury et al. (2019) provide some evidence for an oral bioavailability of 50%, giving an adjusted NOAEL of 76.5 mg/kg bw/day. Details of the calculation of systemic exposure dose (SED) are presented in Table A1 in the Annex. In order to derive a MOS of 100 for aggregated exposure for lipstick, face cream, hand cream and sunscreen as a propellant spray, the total SED should be max; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS.","duration":"","effect":"but adaptive changes in rats. 4The observed decrease in organ weights of ventral prostate and the muscle bulbocavernosus together with the levator ani may have been fortuitous or is to be explained by an enzyme induction, indicated by the observed increased liver weights connected with a higher metabolism rate of the substituted androgen testosterone propionate. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) MOS calculations for separate product types and aggregated exposures are shown in Table 13. A NOAEL of 153 mg/kg bw/day based on the extended one-generation reproductive toxicity study is used for the calculation of MOS. Information from Bury et al. (2019) provide some evidence for an oral bioavailability of 50%, giving an adjusted NOAEL of 76.5 mg/kg bw/day. Details of the calculation of systemic exposure dose (SED) are presented in Table A1 in the Annex. In order to derive a MOS of 100 for aggregated exposure for lipstick, face cream, hand cream and sunscreen as a propellant spray, the total SED should be max","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"153","page":40,"route":"oral","species":"rat","study_id":"sccs_o_249_noael_019"}
Regulatory source	reproductive toxicity	153	mg/kg	-	-	developmental	reproductive toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=153; DOSE=TS, animals were fed with 750, 2100 and 7000 ppm of the test substance.; EFFECT=TS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. Mutagenicity / genotoxicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"TS, animals were fed with 750, 2100 and 7000 ppm of the test substance.","duration":"developmental","effect":"TS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. Mutagenicity / genotoxicity","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg","noael_value":"153","page":42,"route":"","species":"","study_id":"sccs_o_249_noael_025"}
Regulatory source	reproductive toxicity	153	mg/kg	-	-	-	reproductive toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=153; DOSE=A NOAEL \| of \| 153 mg/kg \| bw/d \| ay based \| on the exte \| nded one \| -generation \| reproductive; EFFECT=Table 13 MOS calculations for the different product types and aggregated exposures: 1 \| 3. A NOAEL \| of \| 153 mg/kg \| bw/d \| ay based \| on the exte \| nded one \| -generation \| reproductive; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"A NOAEL \| of \| 153 mg/kg \| bw/d \| ay based \| on the exte \| nded one \| -generation \| reproductive","duration":"","effect":"Table 13 MOS calculations for the different product types and aggregated exposures: 1 \| 3. A NOAEL \| of \| 153 mg/kg \| bw/d \| ay based \| on the exte \| nded one \| -generation \| reproductive","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg","noael_value":"153","page":40,"route":"","species":"","study_id":"sccs_o_249_noael_037"}
Regulatory source	reproductive toxicity	163	mg per kg	-	oral	-	reproductive toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=163; DOSE=SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females).; EFFECT=SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). The differences in reproductive parameters occurred at a maternally toxic dose level. Based on the effects on pup body weights, the NOAEL for general and sexual development was placed at the mid-dose concentration of 2100 mg test substance per kg diet (t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females).","duration":"","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 31 Based on the effects on body weights, the NOAEL for parental effects was placed at the mid- dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). Based on the lower number of implantation sites and the lower number of pups delivered, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). The differences in reproductive parameters occurred at a maternally toxic dose level. Based on the effects on pup body weights, the NOAEL for general and sexual development was placed at the mid-dose concentration of 2100 mg test substance per kg diet (t","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg per kg","noael_value":"163","page":31,"route":"oral","species":"","study_id":"sccs_o_249_noael_006"}
Regulatory source	reproductive toxicity	163	mg per kg	rat	oral	developmental	reproductive toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=163; DOSE=The differences in reproductive parameters occurred at a maternally toxic dose level.; EFFECT=mg per kg body weight per day for females). The differences in reproductive parameters occurred at a maternally toxic dose level. Based on the effects on pup body weights, the NOAEL for general and sexual development was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). There were no effects of the test item on neuro(developmental) parameters. The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females). Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development. 3.4.5.2 Developmental Toxicity From SPC/1279/94 In a teratogenicity study, pregnant Wistar rats were fed by gavage 100, 400 and 1000 mg/kg bw of the test; CITATION=Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development; CITATION_NUMBERS=[26,153]; REFERENCE=Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development; DETAILS_JSON={"cas_number":"6197-30-4","citation":"Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development","dose":"The differences in reproductive parameters occurred at a maternally toxic dose level.","duration":"developmental","effect":"mg per kg body weight per day for females). The differences in reproductive parameters occurred at a maternally toxic dose level. Based on the effects on pup body weights, the NOAEL for general and sexual development was placed at the mid-dose concentration of 2100 mg test substance per kg diet (this corresponds to a mean test substance of 153 mg per kg body weight per day for males and 163 mg per kg body weight per day for females). There were no effects of the test item on neuro(developmental) parameters. The NOAEL for neuro(developmental) parameters was placed at the high-dose concentration of 7000 mg test substance per kg diet (this corresponds to a mean test substance of 534 mg per kg body weight per day for males and 550 mg per kg body weight per day for females). Ref.: 26 SCCS comment The SCCS agrees on a NOAEL of 153 mg/kg bw/day for general and sexual development. 3.4.5.2 Developmental Toxicity From SPC/1279/94 In a teratogenicity study, pregnant Wistar rats were fed by gavage 100, 400 and 1000 mg/kg bw of the test","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg per kg","noael_value":"163","page":31,"route":"oral","species":"rat","study_id":"sccs_o_249_noael_008"}
Regulatory source	reproductive toxicity	163	mg/kg bw/d	rat	oral	1 days	reproductive toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=163; DOSE=Octocrylene-treated rabbits showed any evidence of macroscopic or histopathological abnormalities in any organs examined, which included kidney, liver, and all other internal organs.; EFFECT=Octocrylene-treated rabbits showed any evidence of macroscopic or histopathological abnormalities in any organs examined, which included kidney, liver, and all other internal organs. No evidence was obtained of adverse Octocrylene effects on the measures of male reproductive system integrity (morphological examination of epididymis, testicles abnormalities, epididymal sperm concentrations and percentage sperm motility). Ref.: 25 Extended one-generation reproductive toxicity As referred to in Chapter 3.4.5.1, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (overall mean: 153/163 mg/kg bw/d for males/females) based on the lower number of implantation sites and the lower number of pups delivered. The differences in reproductive parameters occurred at a maternally-toxic dose level. Ref.: 26 In a supportive uterotrophic assay in immature female Wistar rats (age 20±1 days), Octocrylene in corn oil was administered orally to ten animals per dose group; CITATION=Ref.: 25 Extended one-generation reproductive toxicity As referred to in Chapter 3; CITATION_NUMBERS=[25,3]; REFERENCE=Ref.: 25 Extended one-generation reproductive toxicity As referred to in Chapter 3; DETAILS_JSON={"cas_number":"6197-30-4","citation":"Ref.: 25 Extended one-generation reproductive toxicity As referred to in Chapter 3","dose":"Octocrylene-treated rabbits showed any evidence of macroscopic or histopathological abnormalities in any organs examined, which included kidney, liver, and all other internal organs.","duration":"1 days","effect":"Octocrylene-treated rabbits showed any evidence of macroscopic or histopathological abnormalities in any organs examined, which included kidney, liver, and all other internal organs. No evidence was obtained of adverse Octocrylene effects on the measures of male reproductive system integrity (morphological examination of epididymis, testicles abnormalities, epididymal sperm concentrations and percentage sperm motility). Ref.: 25 Extended one-generation reproductive toxicity As referred to in Chapter 3.4.5.1, the NOAEL for fertility and reproductive performance was placed at the mid-dose concentration of 2100 mg test substance per kg diet (overall mean: 153/163 mg/kg bw/d for males/females) based on the lower number of implantation sites and the lower number of pups delivered. The differences in reproductive parameters occurred at a maternally-toxic dose level. Ref.: 26 In a supportive uterotrophic assay in immature female Wistar rats (age 20±1 days), Octocrylene in corn oil was administered orally to ten animals per dose group","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"163","page":36,"route":"oral","species":"rat","study_id":"sccs_o_249_noael_012"}
Regulatory source	reproductive toxicity	1627	-	rat	-	-	reproductive toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=unclear:SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al. 2018 (29) // Non-standardised tests (In vitro mechanistic study) Human sperm cells / 10 μM / 3 hours Octocrylene did not affect sperm functions like sperm acrosome reaction, sperm penetration, proportion of hyperactivated sperm cells or sperm viability indicating absence of effects on male fertility // ToxCast 2020 (30) // In vitro high through- put screening (HTS) assays Various human and rat cell lines / from 0.0006 to 90 μM / 0.5 to 48 hours Octocrylene was found to; DOSE=SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al.; EFFECT=SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al. 2018 (29) // Non-standardised tests (In vitro mechanistic study) Human sperm cells / 10 μM / 3 hours Octocrylene did not affect sperm functions like sperm acrosome reaction, sperm penetration, proportion of hyperactivated sperm cells or sperm viability indicating absence of effects on male fertility // ToxCast 2020 (30) // In vitro high through- put screening (HTS) assays Various human and rat cell lines / from 0.0006 to 90 μM / 0.5 to 48 hours Octocrylene was found to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6197-30-4","citation":"","dose":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al.","duration":"","effect":"SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al. 2018 (29) // Non-standardised tests (In vitro mechanistic study) Human sperm cells / 10 μM / 3 hours Octocrylene did not affect sperm functions like sperm acrosome reaction, sperm penetration, proportion of hyperactivated sperm cells or sperm viability indicating absence of effects on male fertility // ToxCast 2020 (30) // In vitro high through- put screening (HTS) assays Various human and rat cell lines / from 0.0006 to 90 μM / 0.5 to 48 hours Octocrylene was found to","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1627/21 Final Opinion Opinion on Octocrylene 38 Study Route of exposure Comment Parameter NOAEL (mg/kg bw/d) human sperm cells Rehfeld et al. 2018 (29) // Non-standardised tests (In vitro mechanistic study) Human sperm cells / 10 μM / 3 hours Octocrylene did not affect sperm functions like sperm acrosome reaction, sperm penetration, proportion of hyperactivated sperm cells or sperm viability indicating absence of effects on male fertility // ToxCast 2020 (30) // In vitro high through- put screening (HTS) assays Various human and rat cell lines / from 0.0006 to 90 μM / 0.5 to 48 hours Octocrylene was found to","page":38,"route":"","species":"rat","study_id":"sccs_o_249_noael_016"}
Regulatory source	reproductive toxicity	2100	ppm	-	-	developmental	reproductive toxicity	SOURCE_SUBDIR=sccs_o_249; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Octocrylene; OPINION_NUMBER=SCCS/1627/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=2100; DOSE=Postnatal survival and body weight gain of pups were unaffected and an observed trend toward decreased survival of pups born to Octocrylene-treated compared to control dams did not achieve statistical significance.; EFFECT=were the same between the test groups. Postnatal survival and body weight gain of pups were unaffected and an observed trend toward decreased survival of pups born to Octocrylene-treated compared to control dams did not achieve statistical significance. Ref.: 25 Overall SCCS comment on reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro; CITATION=Ref.: 25 Overall SCCS comment on reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance; CITATION_NUMBERS=[25,750,2100,7000]; REFERENCE=Ref.: 25 Overall SCCS comment on reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance; DETAILS_JSON={"cas_number":"6197-30-4","citation":"Ref.: 25 Overall SCCS comment on reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance","dose":"Postnatal survival and body weight gain of pups were unaffected and an observed trend toward decreased survival of pups born to Octocrylene-treated compared to control dams did not achieve statistical significance.","duration":"developmental","effect":"were the same between the test groups. Postnatal survival and body weight gain of pups were unaffected and an observed trend toward decreased survival of pups born to Octocrylene-treated compared to control dams did not achieve statistical significance. Ref.: 25 Overall SCCS comment on reproductive toxicity In the EOGRTS, animals were fed with 750, 2100 and 7000 ppm of the test substance. Based on effects on parental and pup body weights, a lower number of implantation sites and lower number of pups delivered the NOAEL is 2100 ppm (153/163 mg/kg bodyweight per day for males/females) for parental systemic toxicity, fertility/reproduction performance, and general and sexual development. No neuro-/developmental effects were observed at the highest dose level (7000 ppm corresponding to 534/550 mg/kg bw per day for males/females). A NOAEL of 153 mg/kg bodyweight per day will be used as the point of departure in the safety evaluation. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"ppm","noael_value":"2100","page":32,"route":"","species":"","study_id":"sccs_o_249_noael_010"}

openFDA substances 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
openFDA substances	FDA UNII substance identifier	5A68WGF6WM	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C24H27NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5A68WGF6WM"}
openFDA substances	FDA UNII substance identifier	5A68WGF6WM	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C24H27NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5A68WGF6WM"}
openFDA substances	FDA UNII substance identifier	5A68WGF6WM	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C24H27NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5A68WGF6WM"}
openFDA substances	FDA UNII substance identifier	5A68WGF6WM	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C24H27NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5A68WGF6WM"}