CURRY RED NOAEL Studies

COSMOS_DB 16 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
COSMOS_DB	LOAEL	250	mg/kg bw/day	dog	oral	42 day	Subchronic	PAFA
COSMOS_DB	NOAEL	250	mg/kg bw/day	dog	oral	42 day	Short Term Toxicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	5190	mg/kg bw/day	rat	oral	42 day	Short Term Toxicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	2595	mg/kg bw/day	rat	oral	847 day	Chronic	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	7785	mg/kg bw/day	mouse	oral	728 day	Chronic	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	200	mg/kg bw/day	rat	oral	21 day	Developmental	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	1500	mg/kg bw/day	swine	oral	76 day	Short Term Toxicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	3604	mg/kg bw/day	rat	oral	847 day	Chronic	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	1000	mg/kg bw/day	rat	oral	20 day	Developmental	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	939.3	mg/kg bw/day	rat	oral	20 day	Reproductive-developmental	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	7422	mg/kg bw/day	mouse	oral	728 day	Carcinogenicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	7318	mg/kg bw/day	mouse	oral	763 day	Carcinogenicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	5000	mg/kg bw/day	rat	oral	14 day	Short Term Toxicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	2550	mg/kg bw/day	mouse	oral	NA	Reproductive	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	700	mg/kg bw/day	rabbit	oral	13 day	Developmental	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	125	mg/kg bw/day	dog	oral	42 day	Subchronic	PAFA

EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 10 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	LOAEL	=50	mg/kg bw/day	Mouse	-	-	reproduction toxicity	EFSA AFC - 2008 - OutputID 295 - neurology - developmental - Safety of aluminium from dietary intake - doi:10.2903/j.efsa.2008.754
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	LOAEL	=50	mg/kg bw/day	Mouse	-	-	reproduction toxicity	EFSA AFC - 2008 - OutputID 295 - neurology - developmental - Safety of aluminium from dietary intake - doi:10.2903/j.efsa.2008.754
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=701	mg/kg bw/day	Rat	oral: unspecified	-	chronic/long term toxicity	EFSA ANS - 2009 - OutputID 391 - body weight - systemic - Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive - doi:10.2903/j.efsa.2009.1327
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=695	mg/kg bw/day	Rat	oral: unspecified	-	reproduction toxicity	EFSA ANS - 2009 - OutputID 391 - growth - developmental - Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive - doi:10.2903/j.efsa.2009.1327
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=13900	mg/kg	Rat	-	-	reproduction toxicity	EFSA FEEDAP - 2021 - OutputID 4068 - reproduction - reproductive - Safety and efficacy of a feed additive consisting of Allura Red AC for small non-food-producing mammals and ornamental birds (Versele-Laga) - doi:10.2903/j.efsa.2021.6987
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=10	mg/kg bw/day	Mouse	oral: feed	-	reproduction toxicity	EFSA AFC - 2008 - OutputID 295 - neurology - reproductive - Safety of aluminium from dietary intake - doi:10.2903/j.efsa.2008.754
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=701	mg/kg bw/day	Rat	oral: unspecified	-	chronic/long term toxicity	EFSA ANS - 2009 - OutputID 391 - body weight - systemic - Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive - doi:10.2903/j.efsa.2009.1327
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=695	mg/kg bw/day	Rat	oral: unspecified	-	reproduction toxicity	EFSA ANS - 2009 - OutputID 391 - growth - developmental - Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive - doi:10.2903/j.efsa.2009.1327
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=13900	mg/kg	Rat	-	-	reproduction toxicity	EFSA FEEDAP - 2021 - OutputID 4068 - reproduction - reproductive - Safety and efficacy of a feed additive consisting of Allura Red AC for small non-food-producing mammals and ornamental birds (Versele-Laga) - doi:10.2903/j.efsa.2021.6987
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=10	mg/kg bw/day	Mouse	oral: feed	-	reproduction toxicity	EFSA AFC - 2008 - OutputID 295 - neurology - reproductive - Safety of aluminium from dietary intake - doi:10.2903/j.efsa.2008.754

EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 6 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx	ADI	=7	mg/kg bw/day	Consumers	-	-	ADI	EFSA ANS - 2009 - OutputID 391 - Consumers - Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive - doi:10.2903/j.efsa.2009.1327
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx	ADI	=0.14	mg/kg bw/day	Consumers	-	-	ADI	EFSA - 2018 - OutputID 3111 - Consumers - Peer review of the pesticide risk assessment of the active substance fosetyl - doi:10.2903/j.efsa.2018.5307
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx	ADI	=7	mg/kg bw/day	Consumers	-	-	ADI	EFSA ANS - 2009 - OutputID 391 - Consumers - Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive - doi:10.2903/j.efsa.2009.1327
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx	ADI	=0.14	mg/kg bw/day	Consumers	-	-	ADI	EFSA - 2018 - OutputID 3111 - Consumers - Peer review of the pesticide risk assessment of the active substance fosetyl - doi:10.2903/j.efsa.2018.5307
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx	ARfD	=0.14	mg/kg bw	Consumers	-	-	ARfD	EFSA - 2018 - OutputID 3111 - Consumers - Peer review of the pesticide risk assessment of the active substance fosetyl - doi:10.2903/j.efsa.2018.5307
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx	ARfD	=0.14	mg/kg bw	Consumers	-	-	ARfD	EFSA - 2018 - OutputID 3111 - Consumers - Peer review of the pesticide risk assessment of the active substance fosetyl - doi:10.2903/j.efsa.2018.5307

NTP_ICE_acute_oral 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_acute_oral	LD50	>10000	mg/kg bw	Rat	oral	acute	Rat Acute Oral Toxicity	record_id=acute_oral_4744; row=7258; data_type=In Vivo; mixture=Chemical; chemical_name=Allura Red C.I.16035; preferred_name=Allura Red C.I.16035; dtxsid=DTXSID4024436; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4024436; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID4024436; source_file=acute_oral.xlsx

NTP_ICE_adme_parameters 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_adme_parameters	Clint	0	uL/min/10^6 cells	Human	-	-	Measured; httk, Human Hepatic Intrinsic Clearance	sheet=Data; excel_row=1732; Record_ID=adme_parameters_884; Data_Type=Measured; DTXSID=DTXSID4024436; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=0.0; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4024436; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4024436
NTP_ICE_adme_parameters	Fu	0.0137	fraction	Human	-	-	Measured; httk, Human Plasma Fraction Unbound	sheet=Data; excel_row=1731; Record_ID=adme_parameters_884; Data_Type=Measured; DTXSID=DTXSID4024436; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.0137; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4024436; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4024436

NTP_ICE_endocrine 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_endocrine	AC50	57.1229775240489	uM	-	-	-	ERPathway2016; ER Pathway Model, Agonist	sheet=Integrated_approaches; excel_row=4734; RecordID=ERPathway2016_110; DatasetName=ERPathway2016; DTXSID=DTXSID4024436; Assay=ER Pathway Model, Agonist; Endpoint=AC50; Response=57.1229775240489; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4024436; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4024436
NTP_ICE_endocrine	ACC	63.4118100206417	uM	-	-	-	ERPathway2016; ER Pathway Model, Agonist	sheet=Integrated_approaches; excel_row=4735; RecordID=ERPathway2016_110; DatasetName=ERPathway2016; DTXSID=DTXSID4024436; Assay=ER Pathway Model, Agonist; Endpoint=ACC; Response=63.4118100206417; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4024436; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4024436
NTP_ICE_endocrine	Model Score	0	unitless	-	-	-	ARPathway2016; AR Pathway Model, Antagonist	sheet=Integrated_approaches; excel_row=4730; RecordID=ARPathway2016_1063; DatasetName=ARPathway2016; DTXSID=DTXSID4024436; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4024436; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4024436
NTP_ICE_endocrine	Model Score	0.0157	unitless	-	-	-	ERPathway2016; ER Pathway Model, Antagonist	sheet=Integrated_approaches; excel_row=4737; RecordID=ERPathway2016_110; DatasetName=ERPathway2016; DTXSID=DTXSID4024436; Assay=ER Pathway Model, Antagonist; Endpoint=Model Score; Response=0.0157; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4024436; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4024436

SCCNFP_vision_codex 40 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
SCCNFP_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	6-week	repeated dose toxicity	{"citation":"Ref.: 2 2","dose":"Acute oral toxicity Rat LD50 > 10000 mg/kg bw Dog LD50 > 5000 mg/kg bw Ref.:","effect":"2, 3). 2.3. Toxicity 2.3.1. Acute oral toxicity Rat LD50 > 10000 mg/kg bw Dog LD50 > 5000 mg/kg bw Ref.: 2 2.3.2. Acute dermal toxicity No data 2.3.3. Acute inhalation toxicity No data 2.3.4. Repeated dose oral toxicity Mouse In a 6-week drinking water study groups of six male per group received doses of 0, 0.05 and 0.25 mg/ml Curry Red respectively in the drinking water. Bodyweight, drinking water consumption and investigations of brain, kidney, liver and spleen revealed no substance-related effects. A NOEL of 0.25 mg/ml in drinking water (equal to about 50 mg/kg bw/day, assuming a bodyweight of 25 g and a drinking water consumption of about 5 ml/day) can be derived from this study. Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5.0 % Curry Red in a standard and a specially purified diet for 7 or 14 days. No effects on weight development were noted for the standard diet, whereas a slight reduction of bodyweight was noted for the purified diet. Based on this study administering 5 % Curry Red in the diet (equals abou","page":6,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=3750	mg/kg bw/day	rat	oral	14 days	NOAEL study	{"citation":"Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5","dose":"Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived.","effect":"water consumption of about 5 ml/day) can be derived from this study. Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5.0 % Curry Red in a standard and a specially purified diet for 7 or 14 days. No effects on weight development were noted for the standard diet, whereas a slight reduction of bodyweight was noted for the purified diet. Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived. Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights. Clinical, macroscopic and microscopic investigations did not reveal substance related effects; a NOEL of 500 mg/kg bw/day for the dog can be deduced.","page":6,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=500	mg/kg bw/day	dog	oral	14 days	NOAEL study	{"citation":"Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights","dose":"Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived.","effect":"rified diet. Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived. Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights. Clinical, macroscopic and microscopic investigations did not reveal substance related effects; a NOEL of 500 mg/kg bw/day for the dog can be deduced.","page":6,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_003"}
SCCNFP_vision_codex	NOAEL	=5.19	%	dog	oral	1 year	NOAEL study	{"dose":"From this 2-year feeding study a NOEL of 5.19 % Curry Red in the diet can be derived which is equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg).","effect":"d, respectively, were fed to groups of four dogs (two female/two male) each. Eight animals (four per sex) were used for the concurrent control group. An interim sacrifice took place after 1 year (one animal per sex and group). Behaviour and clinical chemistry as well as macroscopic and microscopic investigations were performed. Besides some not further specified tissue effects after 1 year which were not seen after the final 2-year treatment no substance related effects were noted. From this 2-year feeding study a NOEL of 5.19 % Curry Red in the diet can be derived which is equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg). Pig Pigs (number of animals not indicated) were treated with Curry Red at an oral dose of 1000 mg/kg bw/day for 21 days followed by a dose of 1500 mg/kg bw/day until necropsy at day 76 (11 w). No effects were noted with regard to organ weights of liver, kidney and spleen. Haematology, clinical chemistry and histology did not reveal any substance","page":7,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_004"}
SCCNFP_vision_codex	NOAEL	=1500	mg/kg bw/day	pig	oral	21 days	repeated dose toxicity	{"dose":"s equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg).","effect":"s equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg). Pig Pigs (number of animals not indicated) were treated with Curry Red at an oral dose of 1000 mg/kg bw/day for 21 days followed by a dose of 1500 mg/kg bw/day until necropsy at day 76 (11 w). No effects were noted with regard to organ weights of liver, kidney and spleen. Haematology, clinical chemistry and histology did not reveal any substance related effects. For the described exposure scenario a NOAEL in pigs of 1500 mg/kg bw/day can be assumed. 2.3.5 Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity See 2.3.4 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity See also point 2.9. (combination studies chronic toxicity/carcinogenicity)","page":7,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_005"}
SCCNFP_vision_codex	NOAEL	=1000	mg/kg bw/day	rat	-	prenatal	developmental toxicity	{"citation":"Ref.: 10 In the literature, there are additional prenatal developmental studies in rats and rabbits cited","dose":"In summary, the prenatal developmental toxicity study in Osborn Mendel rats investigating doses up to the limit dose of 1000 mg/kg bw Curry Red, did not reveal any indication for the test item to be embryo- or foetotoxic or teratogenic.","effect":"of these variations were therefore considered to be accidental, moreover as they were within the historical controls range. In summary, the prenatal developmental toxicity study in Osborn Mendel rats investigating doses up to the limit dose of 1000 mg/kg bw Curry Red, did not reveal any indication for the test item to be embryo- or foetotoxic or teratogenic. Neither in the dams nor in the foetuses indications were noted for treatment-related adverse effects. Thus, for both the maternal and developmental toxicity a NOEL of ≥ 1000 mg/kg bw/day can be deduced from this study. Ref.: 10 In the literature, there are additional prenatal developmental studies in rats and rabbits cited. Based on this information Curry Red is not a teratogen in rabbits (cited in reference 5) and no embryo-, foetotoxic or teratogenic effects were noted in rats treated during pregnancy with up to 200 mg/kg bw/day; highest dose tested in this test (cited in reference 2). Furthermore, the findings of a 2-generation study in rats are summarised in the mentio","page":12,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_006"}
SCCNFP_vision_codex	NOAEL	=700	mg/kg	dog	oral	-	NOAEL study	{"dose":"Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 30...","effect":"ndicate a weekly use of 35 ml for a semi-permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation) : Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 3000 2.12. Conclusions Toxicity Numerous oral toxicity studies administering Curry Red via gavage, drinking water or feeding to different species and for different treatment lengths are reported in the literature. The data package also covers long-term toxicity studies in two different rodent species and in dogs. Although the studies do not fulfil the current OECD, EU or EPA guidelines, a scientifically sound evaluation of the systemic toxic poten","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_007"}
SCCNFP_vision_codex	NOAEL	=1.39	%	-	oral	-	carcinogenicity	{"dose":"In summary, toxic effects were only noted, if at all, at high doses (> 1000 mg/kg bw/day) independent of the exposure duration and species.","effect":"ng together all available data obtained with different species under different exposure scenarios. In summary, toxic effects were only noted, if at all, at high doses (> 1000 mg/kg bw/day) independent of the exposure duration and species. No specific target organ for the systemic toxicity of Curry Red was found in rodents or any other species. In none of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_010"}
SCCNFP_vision_codex	NOAEL	=7	mg/kg bw/day	-	oral	-	carcinogenicity	{"dose":"The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.","effect":"endent of the exposure duration and species. No specific target organ for the systemic toxicity of Curry Red was found in rodents or any other species. In none of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_011"}
SCCNFP_vision_codex	NOAEL	=700	mg/kg bw/day	-	oral	-	NOAEL study	{"dose":"The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.","effect":"this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in hair colorants, the exposure duration in this study clearly represents a worst case scenario.","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_013"}
SCCNFP_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	6-week	repeated dose toxicity	{"citation":"Ref.: 2 2","dose":"Acute oral toxicity Rat LD50 > 10000 mg/kg bw Dog LD50 > 5000 mg/kg bw Ref.:","effect":"2, 3). 2.3. Toxicity 2.3.1. Acute oral toxicity Rat LD50 > 10000 mg/kg bw Dog LD50 > 5000 mg/kg bw Ref.: 2 2.3.2. Acute dermal toxicity No data 2.3.3. Acute inhalation toxicity No data 2.3.4. Repeated dose oral toxicity Mouse In a 6-week drinking water study groups of six male per group received doses of 0, 0.05 and 0.25 mg/ml Curry Red respectively in the drinking water. Bodyweight, drinking water consumption and investigations of brain, kidney, liver and spleen revealed no substance-related effects. A NOEL of 0.25 mg/ml in drinking water (equal to about 50 mg/kg bw/day, assuming a bodyweight of 25 g and a drinking water consumption of about 5 ml/day) can be derived from this study. Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5.0 % Curry Red in a standard and a specially purified diet for 7 or 14 days. No effects on weight development were noted for the standard diet, whereas a slight reduction of bodyweight was noted for the purified diet. Based on this study administering 5 % Curry Red in the diet (equals abou","page":6,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=3750	mg/kg bw/day	rat	oral	14 days	NOAEL study	{"citation":"Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5","dose":"Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived.","effect":"water consumption of about 5 ml/day) can be derived from this study. Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5.0 % Curry Red in a standard and a specially purified diet for 7 or 14 days. No effects on weight development were noted for the standard diet, whereas a slight reduction of bodyweight was noted for the purified diet. Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived. Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights. Clinical, macroscopic and microscopic investigations did not reveal substance related effects; a NOEL of 500 mg/kg bw/day for the dog can be deduced.","page":6,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=500	mg/kg bw/day	dog	oral	14 days	NOAEL study	{"citation":"Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights","dose":"Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived.","effect":"rified diet. Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived. Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights. Clinical, macroscopic and microscopic investigations did not reveal substance related effects; a NOEL of 500 mg/kg bw/day for the dog can be deduced.","page":6,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_003"}
SCCNFP_vision_codex	NOAEL	=5.19	%	dog	oral	1 year	NOAEL study	{"dose":"From this 2-year feeding study a NOEL of 5.19 % Curry Red in the diet can be derived which is equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg).","effect":"d, respectively, were fed to groups of four dogs (two female/two male) each. Eight animals (four per sex) were used for the concurrent control group. An interim sacrifice took place after 1 year (one animal per sex and group). Behaviour and clinical chemistry as well as macroscopic and microscopic investigations were performed. Besides some not further specified tissue effects after 1 year which were not seen after the final 2-year treatment no substance related effects were noted. From this 2-year feeding study a NOEL of 5.19 % Curry Red in the diet can be derived which is equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg). Pig Pigs (number of animals not indicated) were treated with Curry Red at an oral dose of 1000 mg/kg bw/day for 21 days followed by a dose of 1500 mg/kg bw/day until necropsy at day 76 (11 w). No effects were noted with regard to organ weights of liver, kidney and spleen. Haematology, clinical chemistry and histology did not reveal any substance","page":7,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_004"}
SCCNFP_vision_codex	NOAEL	=1500	mg/kg bw/day	pig	oral	21 days	repeated dose toxicity	{"dose":"s equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg).","effect":"s equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg). Pig Pigs (number of animals not indicated) were treated with Curry Red at an oral dose of 1000 mg/kg bw/day for 21 days followed by a dose of 1500 mg/kg bw/day until necropsy at day 76 (11 w). No effects were noted with regard to organ weights of liver, kidney and spleen. Haematology, clinical chemistry and histology did not reveal any substance related effects. For the described exposure scenario a NOAEL in pigs of 1500 mg/kg bw/day can be assumed. 2.3.5 Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity See 2.3.4 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity See also point 2.9. (combination studies chronic toxicity/carcinogenicity)","page":7,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_005"}
SCCNFP_vision_codex	NOAEL	=1000	mg/kg bw/day	rat	-	prenatal	developmental toxicity	{"citation":"Ref.: 10 In the literature, there are additional prenatal developmental studies in rats and rabbits cited","dose":"In summary, the prenatal developmental toxicity study in Osborn Mendel rats investigating doses up to the limit dose of 1000 mg/kg bw Curry Red, did not reveal any indication for the test item to be embryo- or foetotoxic or teratogenic.","effect":"of these variations were therefore considered to be accidental, moreover as they were within the historical controls range. In summary, the prenatal developmental toxicity study in Osborn Mendel rats investigating doses up to the limit dose of 1000 mg/kg bw Curry Red, did not reveal any indication for the test item to be embryo- or foetotoxic or teratogenic. Neither in the dams nor in the foetuses indications were noted for treatment-related adverse effects. Thus, for both the maternal and developmental toxicity a NOEL of ≥ 1000 mg/kg bw/day can be deduced from this study. Ref.: 10 In the literature, there are additional prenatal developmental studies in rats and rabbits cited. Based on this information Curry Red is not a teratogen in rabbits (cited in reference 5) and no embryo-, foetotoxic or teratogenic effects were noted in rats treated during pregnancy with up to 200 mg/kg bw/day; highest dose tested in this test (cited in reference 2). Furthermore, the findings of a 2-generation study in rats are summarised in the mentio","page":12,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_006"}
SCCNFP_vision_codex	NOAEL	=700	mg/kg	dog	oral	-	NOAEL study	{"dose":"Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 30...","effect":"ndicate a weekly use of 35 ml for a semi-permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation) : Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 3000 2.12. Conclusions Toxicity Numerous oral toxicity studies administering Curry Red via gavage, drinking water or feeding to different species and for different treatment lengths are reported in the literature. The data package also covers long-term toxicity studies in two different rodent species and in dogs. Although the studies do not fulfil the current OECD, EU or EPA guidelines, a scientifically sound evaluation of the systemic toxic poten","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_007"}
SCCNFP_vision_codex	NOAEL	=1.39	%	-	oral	-	carcinogenicity	{"dose":"In summary, toxic effects were only noted, if at all, at high doses (> 1000 mg/kg bw/day) independent of the exposure duration and species.","effect":"ng together all available data obtained with different species under different exposure scenarios. In summary, toxic effects were only noted, if at all, at high doses (> 1000 mg/kg bw/day) independent of the exposure duration and species. No specific target organ for the systemic toxicity of Curry Red was found in rodents or any other species. In none of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_010"}
SCCNFP_vision_codex	NOAEL	=7	mg/kg bw/day	-	oral	-	carcinogenicity	{"dose":"The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.","effect":"endent of the exposure duration and species. No specific target organ for the systemic toxicity of Curry Red was found in rodents or any other species. In none of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_011"}
SCCNFP_vision_codex	NOAEL	=700	mg/kg bw/day	-	oral	-	NOAEL study	{"dose":"The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.","effect":"this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in hair colorants, the exposure duration in this study clearly represents a worst case scenario.","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_013"}
SCCNFP_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	6-week	repeated dose toxicity	{"citation":"Ref.: 2 2","dose":"Acute oral toxicity Rat LD50 > 10000 mg/kg bw Dog LD50 > 5000 mg/kg bw Ref.:","effect":"2, 3). 2.3. Toxicity 2.3.1. Acute oral toxicity Rat LD50 > 10000 mg/kg bw Dog LD50 > 5000 mg/kg bw Ref.: 2 2.3.2. Acute dermal toxicity No data 2.3.3. Acute inhalation toxicity No data 2.3.4. Repeated dose oral toxicity Mouse In a 6-week drinking water study groups of six male per group received doses of 0, 0.05 and 0.25 mg/ml Curry Red respectively in the drinking water. Bodyweight, drinking water consumption and investigations of brain, kidney, liver and spleen revealed no substance-related effects. A NOEL of 0.25 mg/ml in drinking water (equal to about 50 mg/kg bw/day, assuming a bodyweight of 25 g and a drinking water consumption of about 5 ml/day) can be derived from this study. Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5.0 % Curry Red in a standard and a specially purified diet for 7 or 14 days. No effects on weight development were noted for the standard diet, whereas a slight reduction of bodyweight was noted for the purified diet. Based on this study administering 5 % Curry Red in the diet (equals abou","page":6,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=3750	mg/kg bw/day	rat	oral	14 days	NOAEL study	{"citation":"Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5","dose":"Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived.","effect":"water consumption of about 5 ml/day) can be derived from this study. Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5.0 % Curry Red in a standard and a specially purified diet for 7 or 14 days. No effects on weight development were noted for the standard diet, whereas a slight reduction of bodyweight was noted for the purified diet. Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived. Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights. Clinical, macroscopic and microscopic investigations did not reveal substance related effects; a NOEL of 500 mg/kg bw/day for the dog can be deduced.","page":6,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=500	mg/kg bw/day	dog	oral	14 days	NOAEL study	{"citation":"Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights","dose":"Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived.","effect":"rified diet. Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived. Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights. Clinical, macroscopic and microscopic investigations did not reveal substance related effects; a NOEL of 500 mg/kg bw/day for the dog can be deduced.","page":6,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_003"}
SCCNFP_vision_codex	NOAEL	=5.19	%	dog	oral	1 year	NOAEL study	{"dose":"From this 2-year feeding study a NOEL of 5.19 % Curry Red in the diet can be derived which is equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg).","effect":"d, respectively, were fed to groups of four dogs (two female/two male) each. Eight animals (four per sex) were used for the concurrent control group. An interim sacrifice took place after 1 year (one animal per sex and group). Behaviour and clinical chemistry as well as macroscopic and microscopic investigations were performed. Besides some not further specified tissue effects after 1 year which were not seen after the final 2-year treatment no substance related effects were noted. From this 2-year feeding study a NOEL of 5.19 % Curry Red in the diet can be derived which is equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg). Pig Pigs (number of animals not indicated) were treated with Curry Red at an oral dose of 1000 mg/kg bw/day for 21 days followed by a dose of 1500 mg/kg bw/day until necropsy at day 76 (11 w). No effects were noted with regard to organ weights of liver, kidney and spleen. Haematology, clinical chemistry and histology did not reveal any substance","page":7,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_004"}
SCCNFP_vision_codex	NOAEL	=1500	mg/kg bw/day	pig	oral	21 days	repeated dose toxicity	{"dose":"s equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg).","effect":"s equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg). Pig Pigs (number of animals not indicated) were treated with Curry Red at an oral dose of 1000 mg/kg bw/day for 21 days followed by a dose of 1500 mg/kg bw/day until necropsy at day 76 (11 w). No effects were noted with regard to organ weights of liver, kidney and spleen. Haematology, clinical chemistry and histology did not reveal any substance related effects. For the described exposure scenario a NOAEL in pigs of 1500 mg/kg bw/day can be assumed. 2.3.5 Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity See 2.3.4 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity See also point 2.9. (combination studies chronic toxicity/carcinogenicity)","page":7,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_005"}
SCCNFP_vision_codex	NOAEL	=1000	mg/kg bw/day	rat	-	prenatal	developmental toxicity	{"citation":"Ref.: 10 In the literature, there are additional prenatal developmental studies in rats and rabbits cited","dose":"In summary, the prenatal developmental toxicity study in Osborn Mendel rats investigating doses up to the limit dose of 1000 mg/kg bw Curry Red, did not reveal any indication for the test item to be embryo- or foetotoxic or teratogenic.","effect":"of these variations were therefore considered to be accidental, moreover as they were within the historical controls range. In summary, the prenatal developmental toxicity study in Osborn Mendel rats investigating doses up to the limit dose of 1000 mg/kg bw Curry Red, did not reveal any indication for the test item to be embryo- or foetotoxic or teratogenic. Neither in the dams nor in the foetuses indications were noted for treatment-related adverse effects. Thus, for both the maternal and developmental toxicity a NOEL of ≥ 1000 mg/kg bw/day can be deduced from this study. Ref.: 10 In the literature, there are additional prenatal developmental studies in rats and rabbits cited. Based on this information Curry Red is not a teratogen in rabbits (cited in reference 5) and no embryo-, foetotoxic or teratogenic effects were noted in rats treated during pregnancy with up to 200 mg/kg bw/day; highest dose tested in this test (cited in reference 2). Furthermore, the findings of a 2-generation study in rats are summarised in the mentio","page":12,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_006"}
SCCNFP_vision_codex	NOAEL	=700	mg/kg	dog	oral	-	NOAEL study	{"dose":"Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 30...","effect":"ndicate a weekly use of 35 ml for a semi-permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation) : Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 3000 2.12. Conclusions Toxicity Numerous oral toxicity studies administering Curry Red via gavage, drinking water or feeding to different species and for different treatment lengths are reported in the literature. The data package also covers long-term toxicity studies in two different rodent species and in dogs. Although the studies do not fulfil the current OECD, EU or EPA guidelines, a scientifically sound evaluation of the systemic toxic poten","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_007"}
SCCNFP_vision_codex	NOAEL	=1.39	%	-	oral	-	carcinogenicity	{"dose":"In summary, toxic effects were only noted, if at all, at high doses (> 1000 mg/kg bw/day) independent of the exposure duration and species.","effect":"ng together all available data obtained with different species under different exposure scenarios. In summary, toxic effects were only noted, if at all, at high doses (> 1000 mg/kg bw/day) independent of the exposure duration and species. No specific target organ for the systemic toxicity of Curry Red was found in rodents or any other species. In none of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_010"}
SCCNFP_vision_codex	NOAEL	=7	mg/kg bw/day	-	oral	-	carcinogenicity	{"dose":"The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.","effect":"endent of the exposure duration and species. No specific target organ for the systemic toxicity of Curry Red was found in rodents or any other species. In none of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_011"}
SCCNFP_vision_codex	NOAEL	=700	mg/kg bw/day	-	oral	-	NOAEL study	{"dose":"The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.","effect":"this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in hair colorants, the exposure duration in this study clearly represents a worst case scenario.","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_013"}
SCCNFP_vision_codex	NOAEL	=50	mg/kg bw/day	rat	oral	6-week	repeated dose toxicity	{"citation":"Ref.: 2 2","dose":"Acute oral toxicity Rat LD50 > 10000 mg/kg bw Dog LD50 > 5000 mg/kg bw Ref.:","effect":"2, 3). 2.3. Toxicity 2.3.1. Acute oral toxicity Rat LD50 > 10000 mg/kg bw Dog LD50 > 5000 mg/kg bw Ref.: 2 2.3.2. Acute dermal toxicity No data 2.3.3. Acute inhalation toxicity No data 2.3.4. Repeated dose oral toxicity Mouse In a 6-week drinking water study groups of six male per group received doses of 0, 0.05 and 0.25 mg/ml Curry Red respectively in the drinking water. Bodyweight, drinking water consumption and investigations of brain, kidney, liver and spleen revealed no substance-related effects. A NOEL of 0.25 mg/ml in drinking water (equal to about 50 mg/kg bw/day, assuming a bodyweight of 25 g and a drinking water consumption of about 5 ml/day) can be derived from this study. Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5.0 % Curry Red in a standard and a specially purified diet for 7 or 14 days. No effects on weight development were noted for the standard diet, whereas a slight reduction of bodyweight was noted for the purified diet. Based on this study administering 5 % Curry Red in the diet (equals abou","page":6,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=3750	mg/kg bw/day	rat	oral	14 days	NOAEL study	{"citation":"Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5","dose":"Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived.","effect":"water consumption of about 5 ml/day) can be derived from this study. Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5.0 % Curry Red in a standard and a specially purified diet for 7 or 14 days. No effects on weight development were noted for the standard diet, whereas a slight reduction of bodyweight was noted for the purified diet. Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived. Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights. Clinical, macroscopic and microscopic investigations did not reveal substance related effects; a NOEL of 500 mg/kg bw/day for the dog can be deduced.","page":6,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=500	mg/kg bw/day	dog	oral	14 days	NOAEL study	{"citation":"Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights","dose":"Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived.","effect":"rified diet. Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived. Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights. Clinical, macroscopic and microscopic investigations did not reveal substance related effects; a NOEL of 500 mg/kg bw/day for the dog can be deduced.","page":6,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_003"}
SCCNFP_vision_codex	NOAEL	=5.19	%	dog	oral	1 year	NOAEL study	{"dose":"From this 2-year feeding study a NOEL of 5.19 % Curry Red in the diet can be derived which is equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg).","effect":"d, respectively, were fed to groups of four dogs (two female/two male) each. Eight animals (four per sex) were used for the concurrent control group. An interim sacrifice took place after 1 year (one animal per sex and group). Behaviour and clinical chemistry as well as macroscopic and microscopic investigations were performed. Besides some not further specified tissue effects after 1 year which were not seen after the final 2-year treatment no substance related effects were noted. From this 2-year feeding study a NOEL of 5.19 % Curry Red in the diet can be derived which is equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg). Pig Pigs (number of animals not indicated) were treated with Curry Red at an oral dose of 1000 mg/kg bw/day for 21 days followed by a dose of 1500 mg/kg bw/day until necropsy at day 76 (11 w). No effects were noted with regard to organ weights of liver, kidney and spleen. Haematology, clinical chemistry and histology did not reveal any substance","page":7,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_004"}
SCCNFP_vision_codex	NOAEL	=1500	mg/kg bw/day	pig	oral	21 days	repeated dose toxicity	{"dose":"s equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg).","effect":"s equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg). Pig Pigs (number of animals not indicated) were treated with Curry Red at an oral dose of 1000 mg/kg bw/day for 21 days followed by a dose of 1500 mg/kg bw/day until necropsy at day 76 (11 w). No effects were noted with regard to organ weights of liver, kidney and spleen. Haematology, clinical chemistry and histology did not reveal any substance related effects. For the described exposure scenario a NOAEL in pigs of 1500 mg/kg bw/day can be assumed. 2.3.5 Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity See 2.3.4 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity See also point 2.9. (combination studies chronic toxicity/carcinogenicity)","page":7,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_005"}
SCCNFP_vision_codex	NOAEL	=1000	mg/kg bw/day	rat	-	prenatal	developmental toxicity	{"citation":"Ref.: 10 In the literature, there are additional prenatal developmental studies in rats and rabbits cited","dose":"In summary, the prenatal developmental toxicity study in Osborn Mendel rats investigating doses up to the limit dose of 1000 mg/kg bw Curry Red, did not reveal any indication for the test item to be embryo- or foetotoxic or teratogenic.","effect":"of these variations were therefore considered to be accidental, moreover as they were within the historical controls range. In summary, the prenatal developmental toxicity study in Osborn Mendel rats investigating doses up to the limit dose of 1000 mg/kg bw Curry Red, did not reveal any indication for the test item to be embryo- or foetotoxic or teratogenic. Neither in the dams nor in the foetuses indications were noted for treatment-related adverse effects. Thus, for both the maternal and developmental toxicity a NOEL of ≥ 1000 mg/kg bw/day can be deduced from this study. Ref.: 10 In the literature, there are additional prenatal developmental studies in rats and rabbits cited. Based on this information Curry Red is not a teratogen in rabbits (cited in reference 5) and no embryo-, foetotoxic or teratogenic effects were noted in rats treated during pregnancy with up to 200 mg/kg bw/day; highest dose tested in this test (cited in reference 2). Furthermore, the findings of a 2-generation study in rats are summarised in the mentio","page":12,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_006"}
SCCNFP_vision_codex	NOAEL	=700	mg/kg	dog	oral	-	NOAEL study	{"dose":"Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 30...","effect":"ndicate a weekly use of 35 ml for a semi-permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation) : Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 3000 2.12. Conclusions Toxicity Numerous oral toxicity studies administering Curry Red via gavage, drinking water or feeding to different species and for different treatment lengths are reported in the literature. The data package also covers long-term toxicity studies in two different rodent species and in dogs. Although the studies do not fulfil the current OECD, EU or EPA guidelines, a scientifically sound evaluation of the systemic toxic poten","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_007"}
SCCNFP_vision_codex	NOAEL	=1.39	%	-	oral	-	carcinogenicity	{"dose":"In summary, toxic effects were only noted, if at all, at high doses (> 1000 mg/kg bw/day) independent of the exposure duration and species.","effect":"ng together all available data obtained with different species under different exposure scenarios. In summary, toxic effects were only noted, if at all, at high doses (> 1000 mg/kg bw/day) independent of the exposure duration and species. No specific target organ for the systemic toxicity of Curry Red was found in rodents or any other species. In none of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_010"}
SCCNFP_vision_codex	NOAEL	=7	mg/kg bw/day	-	oral	-	carcinogenicity	{"dose":"The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.","effect":"endent of the exposure duration and species. No specific target organ for the systemic toxicity of Curry Red was found in rodents or any other species. In none of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_011"}
SCCNFP_vision_codex	NOAEL	=700	mg/kg bw/day	-	oral	-	NOAEL study	{"dose":"The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.","effect":"this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in hair colorants, the exposure duration in this study clearly represents a worst case scenario.","page":19,"pdf":"out264_en.pdf","row_type":"noael_study","study_id":"out264_en_noael_013"}

ToxValDB_ECHA_IUCLID 5 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_ECHA_IUCLID	NOAEL	=260.2	mg/kg bw/day	Rat	oral	-	reproduction developmental	QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac26e4b0a7c65d1bdaaa; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17284/7/9/3?documentUUID=4ef657bb-2068-4ffe-ae1d-0d0d195e59c0; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=ECHA IUCLID:15823265:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_ce8d0b033fc53591e0682796393538ac
ToxValDB_ECHA_IUCLID	NOAEL	=200	mg/kg bw/day	Rat	oral	-	developmental	QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac26e4b0a7c65d1bdaa4; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17284/7/9/3?documentUUID=4ef657bb-2068-4ffe-ae1d-0d0d195e59c0; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=ECHA IUCLID:15823529:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_85663e4e89b28f76b90f934ded2ac524
ToxValDB_ECHA_IUCLID	NOAEL	=1000	mg/kg bw/day	Rat	oral	-	reproduction developmental	QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac0de4b0a7c65d1bd2db; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/11604/7/9/3?documentUUID=17a6d5cd-1cbd-41b3-b200-263e0a0215cb; YEAR=1980; ORIGINAL_YEAR=1980; STUDY_GROUP=ECHA IUCLID:15824706:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_ac3438077009d6b72a525a2c41367859
ToxValDB_ECHA_IUCLID	NOAEL	=901	mg/kg bw/day	Rat	oral	chronic; 121 weeks	chronic	QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead10e4b0a7c65d1c2564; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/12236?documentUUID=99b7317c-4c1d-4b46-8d69-c269b8cd8271; YEAR=2019; ORIGINAL_YEAR=2019; TOXICOLOGICAL_EFFECT=body weight and weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECHA IUCLID:15847777:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_569b0c0e066c4924dcd7b695f383f204
ToxValDB_ECHA_IUCLID	NOAEL	=2829	mg/kg bw/day	Rat	oral	chronic; 118 weeks	chronic	QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead10e4b0a7c65d1c2564; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/12236?documentUUID=99b7317c-4c1d-4b46-8d69-c269b8cd8271; YEAR=2019; ORIGINAL_YEAR=2019; STUDY_GROUP=ECHA IUCLID:15850590:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c3d6967638d07309d964cafb0ee729e6

ToxValDB_ECOTOX 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_ECOTOX	LOEL	=10	mg/kg bw/day	Mouse	oral	acute; 1 days	acute	LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15597275_15597276:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=f03ea79a82ef88eb18595d3e52aabf1e
ToxValDB_ECOTOX	NOEL	=1	mg/kg bw/day	Mouse	oral	acute; 1 days	acute	LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15597275_15597276:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=f2859d07d0110c4e3e70fb3be0e6267b

ToxValDB_EFSA 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_EFSA	NOAEL	=695	mg/kg bw/day	Rat	oral	-	reproduction developmental	LONG_REF=EFSA ANS (2009). Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. doi:10.2903/j.efsa.2009.1327.; TITLE=Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2009.1327; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=growth; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=EFSA:15614076:M/F:--; 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_ab205ca464e4f57c37f757f3f6d89f17
ToxValDB_EFSA	NOAEL	=701	mg/kg bw/day	Rat	oral	-	chronic	LONG_REF=EFSA ANS (2009). Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. doi:10.2903/j.efsa.2009.1327.; TITLE=Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2009.1327; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=EFSA:15614077:M/F:--; 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_28b89b1a96c261f601c5bdbf337637f9

ToxValDB_GESTIS_DNEL 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_GESTIS_DNEL	DNEL systemic	=16.4	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:15631641:-:--; 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_1b60b2d366262f90a31ef05e9294233e

ToxValDB_HPVIS 9 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_HPVIS	LOAEL	>2829	mg/kg bw/day	Rat	oral	chronic; 118 weeks	reproduction developmental	LONG_REF=Borzelleca J.F., Olson J.W. and Reno F.E. (1991a) Lifetime toxicity/ carcinogenicity studies of FD&C Red No. 40 (Allura Red) in Sprague Dawley Rats. Food and Chemical Toxicology, 27, 701-705.Posting dates of the documents from the HPV Challenge Program website from which data have been entered into the HPVIS:Test Plan: Dec. 12, 2006; CBIC Received: Nov. 13, 2006Robust Summary: Dec. 12, 2006; CBIC Received: Nov. 13, 2006. Study is also summarized in the initial robust summary posted Dec. 17, 2003.; QUALITY=1; EXTERNAL_SOURCE_ID=61953; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Repeat Dose_15639253_15639304:M:-paternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_b3d44474749b38af6d1ca91b267b7ba3
ToxValDB_HPVIS	LOAEL	=3604	mg/kg bw/day	Rat	oral	chronic; 118 weeks	chronic	LONG_REF=Borzelleca J.F., Olson J.W. and Reno F.E. (1991a) Lifetimetoxicity/ carcinogenicity studies of FD&C Red No. 40 (AlluraRed) in Sprague Dawley Rats. Food and Chemical Toxicology, 27, 701-705.Data extracted from the robust summary posted to the HPV Challenge Program website Dec. 22, 2006.; QUALITY=1; EXTERNAL_SOURCE_ID=62758; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Repeat Dose_15639334_15639335:F:--; 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_ffbebc819aafec5e1b3518a88e35b887
ToxValDB_HPVIS	LOAEL	=545.68	mg/kg bw/day	Rat	oral	short-term; 20 days	reproduction developmental	LONG_REF=Collins T., Black T.N., Welsch J.J., and Brown L.H. (1989a) Study of the teratogenic potential of FD & C Red No. 40 when given in drinking water. Toxicology and Industrial Health 5, 937-948.Posting dates of the documents from the HPV Challenge Program website from which data have been entered into the HPVIS:Test Plan: Dec. 12, 2006; CBIC Received: Nov. 13, 2006Robust Summary: Dec. 12, 2006; CBIC Received: Nov. 13, 2006. Study is also summarized in the initial robust summary posted Dec. 17, 2003.; QUALITY=1; EXTERNAL_SOURCE_ID=58378; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480590; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=HPVIS:15642432:-:F1offspring; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_9e09b413a9ab9a829b4e78b3ceab64da
ToxValDB_HPVIS	LOAEL	=51900	ppm	Rat	oral	-	reproduction developmental	LONG_REF=Hazelton Laboratories Inc. (1969) Two-generation reproductive study in rats. Red Z4576 (FD&C Red 40). Unpublished report 165-125.Data extracted from the robust summary posted to the HPV Challenge Program website Dec. 22, 2006.; QUALITY=1; EXTERNAL_SOURCE_ID=65291; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480598; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1969; ORIGINAL_YEAR=1969; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Reprotox_15643168_15643169:-:--; 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_7aa59f81ab49a396a352ae7fd50725cd
ToxValDB_HPVIS	NOAEL	>5.19	% diet	Mouse	oral	chronic; 104 weeks	chronic	LONG_REF=Borzelleca J.F., Olson J.W. and Reno F.E. (1991b) Lifetime toxicity/ carcinogenicity studies of FD&C Red No. 40 (Allura Red) in mice. Food and Chemical Toxicology, 29, 313-319.Data extracted from the robust summary posted to the HPV Challenge Program website Dec. 22, 2006.; QUALITY=1; EXTERNAL_SOURCE_ID=60646; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Repeat Dose_15639083_15639185:-:--; 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_91fa6f06a7ad778e73bb5d1e8d5ab761
ToxValDB_HPVIS	NOAEL	=901	mg/kg bw/day	Rat	oral	chronic; 118 weeks	reproduction developmental	LONG_REF=Borzelleca J.F., Olson J.W. and Reno F.E. (1991a) Lifetime toxicity/ carcinogenicity studies of FD&C Red No. 40 (Allura Red) in Sprague Dawley Rats. Food and Chemical Toxicology, 27, 701-705.Posting dates of the documents from the HPV Challenge Program website from which data have been entered into the HPVIS:Test Plan: Dec. 12, 2006; CBIC Received: Nov. 13, 2006Robust Summary: Dec. 12, 2006; CBIC Received: Nov. 13, 2006. Study is also summarized in the initial robust summary posted Dec. 17, 2003.; QUALITY=1; EXTERNAL_SOURCE_ID=63269; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Repeat Dose_15639388_15639416:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_a4ca51ab75224de5cc8a44f211bf1c54
ToxValDB_HPVIS	NOAEL	=939.29	mg/kg bw/day	Rat	oral	short-term; 20 days	reproduction developmental	LONG_REF=Collins T., Black T.N., Welsch J.J., and Brown L.H. (1989a) Study of the teratogenic potential of FD & C Red No. 40 when given in drinking water. Toxicology and Industrial Health 5, 937-948.Posting dates of the documents from the HPV Challenge Program website from which data have been entered into the HPVIS:Test Plan: Dec. 12, 2006; CBIC Received: Nov. 13, 2006Robust Summary: Dec. 12, 2006; CBIC Received: Nov. 13, 2006. Study is also summarized in the initial robust summary posted Dec. 17, 2003.; QUALITY=1; EXTERNAL_SOURCE_ID=58377; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480590; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Devtox_15642431_15642689:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_1bfba8bdabfad08e294c357beb38279a
ToxValDB_HPVIS	NOAEL	=273.58	mg/kg bw/day	Rat	oral	short-term; 20 days	developmental	LONG_REF=Collins T., Black T.N., Welsch J.J., and Brown L.H. (1989a) Study of the teratogenic potential of FD & C Red No. 40 when given in drinking water. Toxicology and Industrial Health 5, 937-948.Data extracted from the robust summary posted to the HPV Challenge Program website Dec. 22, 2006.; QUALITY=1; EXTERNAL_SOURCE_ID=59595; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480590; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Devtox_15642798_15642927:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_e03112f87a55b9b3bfbc6b5a9d2cf7bf
ToxValDB_HPVIS	NOAEL	=13900	ppm	Rat	oral	-	reproduction developmental	LONG_REF=Hazelton Laboratories Inc. (1969) Two-generation reproductive study in rats. Red Z4576 (FD&C Red 40). Unpublished report 165-125.Data extracted from the robust summary posted to the HPV Challenge Program website Dec. 22, 2006.; QUALITY=1; EXTERNAL_SOURCE_ID=65290; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480598; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1969; ORIGINAL_YEAR=1969; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Reprotox_15643168_15643169:-:--; 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_0138e572caeedbcc487fb65df8119910

ToxValDB_WHO_JECFA_ADI 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_WHO_JECFA_ADI	ADI	<=7	mg/kg	Human	oral	-	Toxicity Value	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650af6c4e4b0d99f5a875bc9; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/; SUBSOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/2361; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=WHO JECFA ADI:15715299:-:--; 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_8d79c69f96873097eddcb2b00ccfe4e9

UnifiedCodex:SCCNFP:beta.noael_studies 14 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
UnifiedCodex:SCCNFP:beta.noael_studies	-	3750	mg/kg bw/day	rat	oral	14 days	-	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=3750; DOSE=Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived.; EFFECT=water consumption of about 5 ml/day) can be derived from this study. Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5.0 % Curry Red in a standard and a specially purified diet for 7 or 14 days. No effects on weight development were noted for the standard diet, whereas a slight reduction of bodyweight was noted for the purified diet. Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived. Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights. Clinical, macroscopic and microscopic investigations did not reveal substance related effects; a NOEL of 500 mg/kg bw/day for the dog can be deduced.; CITATION=Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5; CITATION_NUMBERS=[2,6,5]; REFERENCE=Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5; DETAILS_JSON={"cas_number":"25956-17-6","citation":"Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5","dose":"Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived.","duration":"14 days","effect":"water consumption of about 5 ml/day) can be derived from this study. Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5.0 % Curry Red in a standard and a specially purified diet for 7 or 14 days. No effects on weight development were noted for the standard diet, whereas a slight reduction of bodyweight was noted for the purified diet. Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived. Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights. Clinical, macroscopic and microscopic investigations did not reveal substance related effects; a NOEL of 500 mg/kg bw/day for the dog can be deduced.","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3750","page":6,"route":"oral","species":"rat","study_id":"out264_en_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies	-	500	mg/kg bw/day	dog	oral	14 days	-	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=500; DOSE=Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived.; EFFECT=rified diet. Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived. Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights. Clinical, macroscopic and microscopic investigations did not reveal substance related effects; a NOEL of 500 mg/kg bw/day for the dog can be deduced.; CITATION=Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights; CITATION_NUMBERS=[2,6,125,250,500]; REFERENCE=Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights; DETAILS_JSON={"cas_number":"25956-17-6","citation":"Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights","dose":"Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived.","duration":"14 days","effect":"rified diet. Based on this study administering 5 % Curry Red in the diet (equals about 3750 mg/kg bw/day, assuming an average bodyweight of 200 g and a food consumption of 15 g/day) for 14 days a NOAEL of about 3750 mg/kg bw/day can be derived. Ref.: 2 Dog In dogs (one female, one male), the oral administration of Curry Red for 6 weeks at doses of 125, 250 and 500 mg/kg bw/day did not effect the body and organ weights. Clinical, macroscopic and microscopic investigations did not reveal substance related effects; a NOEL of 500 mg/kg bw/day for the dog can be deduced.","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":6,"route":"oral","species":"dog","study_id":"out264_en_noael_003"}
UnifiedCodex:SCCNFP:beta.noael_studies	-	5.19	%	dog	oral	1 year	-	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=5.19; DOSE=From this 2-year feeding study a NOEL of 5.19 % Curry Red in the diet can be derived which is equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg).; EFFECT=d, respectively, were fed to groups of four dogs (two female/two male) each. Eight animals (four per sex) were used for the concurrent control group. An interim sacrifice took place after 1 year (one animal per sex and group). Behaviour and clinical chemistry as well as macroscopic and microscopic investigations were performed. Besides some not further specified tissue effects after 1 year which were not seen after the final 2-year treatment no substance related effects were noted. From this 2-year feeding study a NOEL of 5.19 % Curry Red in the diet can be derived which is equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg). Pig Pigs (number of animals not indicated) were treated with Curry Red at an oral dose of 1000 mg/kg bw/day for 21 days followed by a dose of 1500 mg/kg bw/day until necropsy at day 76 (11 w). No effects were noted with regard to organ weights of liver, kidney and spleen. Haematology, clinical chemistry and histology did not reveal any substance; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"25956-17-6","citation":"","dose":"From this 2-year feeding study a NOEL of 5.19 % Curry Red in the diet can be derived which is equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg).","duration":"1 year","effect":"d, respectively, were fed to groups of four dogs (two female/two male) each. Eight animals (four per sex) were used for the concurrent control group. An interim sacrifice took place after 1 year (one animal per sex and group). Behaviour and clinical chemistry as well as macroscopic and microscopic investigations were performed. Besides some not further specified tissue effects after 1 year which were not seen after the final 2-year treatment no substance related effects were noted. From this 2-year feeding study a NOEL of 5.19 % Curry Red in the diet can be derived which is equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg). Pig Pigs (number of animals not indicated) were treated with Curry Red at an oral dose of 1000 mg/kg bw/day for 21 days followed by a dose of 1500 mg/kg bw/day until necropsy at day 76 (11 w). No effects were noted with regard to organ weights of liver, kidney and spleen. Haematology, clinical chemistry and histology did not reveal any substance","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"5.19","page":7,"route":"oral","species":"dog","study_id":"out264_en_noael_004"}
UnifiedCodex:SCCNFP:beta.noael_studies	-	=700	mg/kg	dog	oral	-	-	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT== 700; DOSE=Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 30...; EFFECT=ndicate a weekly use of 35 ml for a semi-permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation) : Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 3000 2.12. Conclusions Toxicity Numerous oral toxicity studies administering Curry Red via gavage, drinking water or feeding to different species and for different treatment lengths are reported in the literature. The data package also covers long-term toxicity studies in two different rodent species and in dogs. Although the studies do not fulfil the current OECD, EU or EPA guidelines, a scientifically sound evaluation of the systemic toxic poten; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"25956-17-6","citation":"","dose":"Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 30...","duration":"","effect":"ndicate a weekly use of 35 ml for a semi-permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation) : Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 3000 2.12. Conclusions Toxicity Numerous oral toxicity studies administering Curry Red via gavage, drinking water or feeding to different species and for different treatment lengths are reported in the literature. The data package also covers long-term toxicity studies in two different rodent species and in dogs. Although the studies do not fulfil the current OECD, EU or EPA guidelines, a scientifically sound evaluation of the systemic toxic poten","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"= 700","page":19,"route":"oral","species":"dog","study_id":"out264_en_noael_007"}
UnifiedCodex:SCCNFP:beta.noael_studies	-	=700	mg/kg	dog	oral	-	-	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT== 700; DOSE=Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 30...; EFFECT=permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation) : Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 3000 2.12. Conclusions Toxicity Numerous oral toxicity studies administering Curry Red via gavage, drinking water or feeding to different species and for different treatment lengths are reported in the literature. The data package also covers long-term toxicity studies in two different rodent species and in dogs. Although the studies do not fulfil the current OECD, EU or EPA guidelines, a scientifically sound evaluation of the systemic toxic potential of Curry; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"25956-17-6","citation":"","dose":"Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 30...","duration":"","effect":"permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation) : Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 3000 2.12. Conclusions Toxicity Numerous oral toxicity studies administering Curry Red via gavage, drinking water or feeding to different species and for different treatment lengths are reported in the literature. The data package also covers long-term toxicity studies in two different rodent species and in dogs. Although the studies do not fulfil the current OECD, EU or EPA guidelines, a scientifically sound evaluation of the systemic toxic potential of Curry","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"= 700","page":19,"route":"oral","species":"dog","study_id":"out264_en_noael_008"}
UnifiedCodex:SCCNFP:beta.noael_studies	-	=700	mg/kg	dog	oral	-	-	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT== 700; DOSE=Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 30...; EFFECT=of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation) : Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 3000 2.12. Conclusions Toxicity Numerous oral toxicity studies administering Curry Red via gavage, drinking water or feeding to different species and for different treatment lengths are reported in the literature. The data package also covers long-term toxicity studies in two different rodent species and in dogs. Although the studies do not fulfil the current OECD, EU or EPA guidelines, a scientifically sound evaluation of the systemic toxic potential of Curry Red after repeated application can be drawn; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"25956-17-6","citation":"","dose":"Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 30...","duration":"","effect":"of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation) : Maximum absorption through the skin A (%) = 100 % Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35 g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.4 % Systemic exposure dose (SED) = 0.233 mg/kg/day No observed adverse effect level (mg/kg) NOAEL = 700 mg/kg Margin of Safety NOAEL / SED = 3000 2.12. Conclusions Toxicity Numerous oral toxicity studies administering Curry Red via gavage, drinking water or feeding to different species and for different treatment lengths are reported in the literature. The data package also covers long-term toxicity studies in two different rodent species and in dogs. Although the studies do not fulfil the current OECD, EU or EPA guidelines, a scientifically sound evaluation of the systemic toxic potential of Curry Red after repeated application can be drawn","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"= 700","page":19,"route":"oral","species":"dog","study_id":"out264_en_noael_009"}
UnifiedCodex:SCCNFP:beta.noael_studies	-	700	mg/kg bw/day	-	oral	-	-	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=700; DOSE=The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.; EFFECT=this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in hair colorants, the exposure duration in this study clearly represents a worst case scenario.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"25956-17-6","citation":"","dose":"The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.","duration":"","effect":"this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in hair colorants, the exposure duration in this study clearly represents a worst case scenario.","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"700","page":19,"route":"oral","species":"","study_id":"out264_en_noael_013"}
UnifiedCodex:SCCNFP:beta.noael_studies	-	700	mg/kg	-	-	-	-	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=700; DOSE=No observed adverse effect level (mg/kg) | NOAEL | 700 mg/kg; EFFECT=CALCULATION OF THE MARGIN OF SAFETY: No observed adverse effect level (mg/kg) | NOAEL | 700 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"25956-17-6","citation":"","dose":"No observed adverse effect level (mg/kg) | NOAEL | 700 mg/kg","duration":"","effect":"CALCULATION OF THE MARGIN OF SAFETY: No observed adverse effect level (mg/kg) | NOAEL | 700 mg/kg","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"700","page":19,"route":"","species":"","study_id":"out264_en_noael_014"}
UnifiedCodex:SCCNFP:beta.noael_studies	carcinogenicity	1.39	%	-	oral	-	carcinogenicity	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=1.39; DOSE=In summary, toxic effects were only noted, if at all, at high doses (> 1000 mg/kg bw/day) independent of the exposure duration and species.; EFFECT=ng together all available data obtained with different species under different exposure scenarios. In summary, toxic effects were only noted, if at all, at high doses (> 1000 mg/kg bw/day) independent of the exposure duration and species. No specific target organ for the systemic toxicity of Curry Red was found in rodents or any other species. In none of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"25956-17-6","citation":"","dose":"In summary, toxic effects were only noted, if at all, at high doses (> 1000 mg/kg bw/day) independent of the exposure duration and species.","duration":"","effect":"ng together all available data obtained with different species under different exposure scenarios. In summary, toxic effects were only noted, if at all, at high doses (> 1000 mg/kg bw/day) independent of the exposure duration and species. No specific target organ for the systemic toxicity of Curry Red was found in rodents or any other species. In none of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw","endpoint":"carcinogenicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"1.39","page":19,"route":"oral","species":"","study_id":"out264_en_noael_010"}
UnifiedCodex:SCCNFP:beta.noael_studies	carcinogenicity	7	mg/kg bw/day	-	oral	-	carcinogenicity	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=7; DOSE=The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.; EFFECT=endent of the exposure duration and species. No specific target organ for the systemic toxicity of Curry Red was found in rodents or any other species. In none of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"25956-17-6","citation":"","dose":"The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.","duration":"","effect":"endent of the exposure duration and species. No specific target organ for the systemic toxicity of Curry Red was found in rodents or any other species. In none of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in","endpoint":"carcinogenicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"7","page":19,"route":"oral","species":"","study_id":"out264_en_noael_011"}
UnifiedCodex:SCCNFP:beta.noael_studies	carcinogenicity	1.39	%	-	oral	-	carcinogenicity	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=1.39; DOSE=The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.; EFFECT=e of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in hair colorants, the exposure duration in this study clearly represents a worst case scenario.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"25956-17-6","citation":"","dose":"The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound.","duration":"","effect":"e of the combined long term toxicity/carcinogenicity studies in two rodent species any indication was found, for Curry Red being carcinogenic. Based on this finding, a NOEL of 1.39 % Curry Red in the diet, was deduced from this study by the study authors. Based on the available information, the study is considered to be scientifically valid and suitable for a NOEL deduction for a repeated exposure scenario. The SCF and the JECFA also used this study to derive an ADI of 7 mg/kg bw/day for this compound. The derived NOEL would be based on the mid dose male group receiving 1.39 % Curry Red in the diet and being equivalent to 701 mg/kg bw/day. Thus the corresponding NOAEL of 700 mg/kg bw/day can be used as the reference figure for the final risk assessment according to the SCCNFP-guidelines. However, it should be noted that compared to the expected frequency via application in hair colorants, the exposure duration in this study clearly represents a worst case scenario.","endpoint":"carcinogenicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"1.39","page":19,"route":"oral","species":"","study_id":"out264_en_noael_012"}
UnifiedCodex:SCCNFP:beta.noael_studies	developmental toxicity	1000	mg/kg bw/day	rat	-	prenatal	developmental toxicity	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=1000; DOSE=In summary, the prenatal developmental toxicity study in Osborn Mendel rats investigating doses up to the limit dose of 1000 mg/kg bw Curry Red, did not reveal any indication for the test item to be embryo- or foetotoxic or teratogenic.; EFFECT=of these variations were therefore considered to be accidental, moreover as they were within the historical controls range. In summary, the prenatal developmental toxicity study in Osborn Mendel rats investigating doses up to the limit dose of 1000 mg/kg bw Curry Red, did not reveal any indication for the test item to be embryo- or foetotoxic or teratogenic. Neither in the dams nor in the foetuses indications were noted for treatment-related adverse effects. Thus, for both the maternal and developmental toxicity a NOEL of ≥ 1000 mg/kg bw/day can be deduced from this study. Ref.: 10 In the literature, there are additional prenatal developmental studies in rats and rabbits cited. Based on this information Curry Red is not a teratogen in rabbits (cited in reference 5) and no embryo-, foetotoxic or teratogenic effects were noted in rats treated during pregnancy with up to 200 mg/kg bw/day; highest dose tested in this test (cited in reference 2). Furthermore, the findings of a 2-generation study in rats are summarised in the mentio; CITATION=Ref.: 10 In the literature, there are additional prenatal developmental studies in rats and rabbits cited; CITATION_NUMBERS=[10]; REFERENCE=Ref.: 10 In the literature, there are additional prenatal developmental studies in rats and rabbits cited; DETAILS_JSON={"cas_number":"25956-17-6","citation":"Ref.: 10 In the literature, there are additional prenatal developmental studies in rats and rabbits cited","dose":"In summary, the prenatal developmental toxicity study in Osborn Mendel rats investigating doses up to the limit dose of 1000 mg/kg bw Curry Red, did not reveal any indication for the test item to be embryo- or foetotoxic or teratogenic.","duration":"prenatal","effect":"of these variations were therefore considered to be accidental, moreover as they were within the historical controls range. In summary, the prenatal developmental toxicity study in Osborn Mendel rats investigating doses up to the limit dose of 1000 mg/kg bw Curry Red, did not reveal any indication for the test item to be embryo- or foetotoxic or teratogenic. Neither in the dams nor in the foetuses indications were noted for treatment-related adverse effects. Thus, for both the maternal and developmental toxicity a NOEL of ≥ 1000 mg/kg bw/day can be deduced from this study. Ref.: 10 In the literature, there are additional prenatal developmental studies in rats and rabbits cited. Based on this information Curry Red is not a teratogen in rabbits (cited in reference 5) and no embryo-, foetotoxic or teratogenic effects were noted in rats treated during pregnancy with up to 200 mg/kg bw/day; highest dose tested in this test (cited in reference 2). Furthermore, the findings of a 2-generation study in rats are summarised in the mentio","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":12,"route":"","species":"rat","study_id":"out264_en_noael_006"}
UnifiedCodex:SCCNFP:beta.noael_studies	repeated dose toxicity	50	mg/kg bw/day	rat	oral	6-week	repeated dose toxicity	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=50; DOSE=Acute oral toxicity Rat LD50 > 10000 mg/kg bw Dog LD50 > 5000 mg/kg bw Ref.:; EFFECT=2, 3). 2.3. Toxicity 2.3.1. Acute oral toxicity Rat LD50 > 10000 mg/kg bw Dog LD50 > 5000 mg/kg bw Ref.: 2 2.3.2. Acute dermal toxicity No data 2.3.3. Acute inhalation toxicity No data 2.3.4. Repeated dose oral toxicity Mouse In a 6-week drinking water study groups of six male per group received doses of 0, 0.05 and 0.25 mg/ml Curry Red respectively in the drinking water. Bodyweight, drinking water consumption and investigations of brain, kidney, liver and spleen revealed no substance-related effects. A NOEL of 0.25 mg/ml in drinking water (equal to about 50 mg/kg bw/day, assuming a bodyweight of 25 g and a drinking water consumption of about 5 ml/day) can be derived from this study. Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5.0 % Curry Red in a standard and a specially purified diet for 7 or 14 days. No effects on weight development were noted for the standard diet, whereas a slight reduction of bodyweight was noted for the purified diet. Based on this study administering 5 % Curry Red in the diet (equals abou; CITATION=Ref.: 2 2; CITATION_NUMBERS=[2]; REFERENCE=Ref.: 2 2; DETAILS_JSON={"cas_number":"25956-17-6","citation":"Ref.: 2 2","dose":"Acute oral toxicity Rat LD50 > 10000 mg/kg bw Dog LD50 > 5000 mg/kg bw Ref.:","duration":"6-week","effect":"2, 3). 2.3. Toxicity 2.3.1. Acute oral toxicity Rat LD50 > 10000 mg/kg bw Dog LD50 > 5000 mg/kg bw Ref.: 2 2.3.2. Acute dermal toxicity No data 2.3.3. Acute inhalation toxicity No data 2.3.4. Repeated dose oral toxicity Mouse In a 6-week drinking water study groups of six male per group received doses of 0, 0.05 and 0.25 mg/ml Curry Red respectively in the drinking water. Bodyweight, drinking water consumption and investigations of brain, kidney, liver and spleen revealed no substance-related effects. A NOEL of 0.25 mg/ml in drinking water (equal to about 50 mg/kg bw/day, assuming a bodyweight of 25 g and a drinking water consumption of about 5 ml/day) can be derived from this study. Ref.: 2 Rat Groups of 6 male rats were fed 0 or 5.0 % Curry Red in a standard and a specially purified diet for 7 or 14 days. No effects on weight development were noted for the standard diet, whereas a slight reduction of bodyweight was noted for the purified diet. Based on this study administering 5 % Curry Red in the diet (equals abou","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":6,"route":"oral","species":"rat","study_id":"out264_en_noael_001"}
UnifiedCodex:SCCNFP:beta.noael_studies	repeated dose toxicity	1500	mg/kg bw/day	pig	oral	21 days	repeated dose toxicity	SOURCE_SUBDIR=out264_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING CURRY RED COLIPA n° C174; OPINION_NUMBER=SCCNFP/0791/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=1500; DOSE=s equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg).; EFFECT=s equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg). Pig Pigs (number of animals not indicated) were treated with Curry Red at an oral dose of 1000 mg/kg bw/day for 21 days followed by a dose of 1500 mg/kg bw/day until necropsy at day 76 (11 w). No effects were noted with regard to organ weights of liver, kidney and spleen. Haematology, clinical chemistry and histology did not reveal any substance related effects. For the described exposure scenario a NOAEL in pigs of 1500 mg/kg bw/day can be assumed. 2.3.5 Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity See 2.3.4 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity See also point 2.9. (combination studies chronic toxicity/carcinogenicity); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"25956-17-6","citation":"","dose":"s equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg).","duration":"21 days","effect":"s equal to about 1500 mg/kg bw/day (assuming a feed consumption of 250 g/day and an average bodyweight of 8-9 kg). Pig Pigs (number of animals not indicated) were treated with Curry Red at an oral dose of 1000 mg/kg bw/day for 21 days followed by a dose of 1500 mg/kg bw/day until necropsy at day 76 (11 w). No effects were noted with regard to organ weights of liver, kidney and spleen. Haematology, clinical chemistry and histology did not reveal any substance related effects. For the described exposure scenario a NOAEL in pigs of 1500 mg/kg bw/day can be assumed. 2.3.5 Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity See 2.3.4 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity See also point 2.9. (combination studies chronic toxicity/carcinogenicity)","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1500","page":7,"route":"oral","species":"pig","study_id":"out264_en_noael_005"}

openFDA substances 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
openFDA substances	FDA UNII substance identifier	WZB9127XOA	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C18H14N2O8S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"WZB9127XOA"}
openFDA substances	FDA UNII substance identifier	WZB9127XOA	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C18H14N2O8S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"WZB9127XOA"}
openFDA substances	FDA UNII substance identifier	WZB9127XOA	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C18H14N2O8S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"WZB9127XOA"}
openFDA substances	FDA UNII substance identifier	WZB9127XOA	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C18H14N2O8S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"WZB9127XOA"}