NOAEL Studies Colorant

D&C Yellow No. 10 (Quinoline Yellow) NOAEL Studies

INCI: CI 47005

CAS: 8004-92-0

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

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EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =50 mg/kg bw/day Rat oral: feed - chronic/long term toxicity EFSA ANS - 2009 - OutputID 393 - neurology - neurotoxicity - Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive - doi:10.2903/j.efsa.2009.1329
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI =0.5 mg/kg bw/day Consumers - - ADI EFSA ANS - 2009 - OutputID 393 - Consumers - Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive - doi:10.2903/j.efsa.2009.1329
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI =0.5 mg/kg bw/day Consumers - - ADI EFSA ANS - 2009 - OutputID 393 - Consumers - Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive - doi:10.2903/j.efsa.2009.1329
NTP_ICE_endocrine 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_endocrine Model Score 0 unitless - - - ARPathway2016; AR Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=6074; RecordID=ARPathway2016_1595; DatasetName=ARPathway2016; DTXSID=DTXSID0041721; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0041721
SCCS_vision_codex 40 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =1000 mg/kg bw/day rat oral subacute repeated dose toxicity {"dose":"3.3.4 Repeated dose toxicity From SCCNFP/0789/04 Summary of toxicological studies At present, no studies on acute, subacute, subchronic, chronic, reproductive and developmental toxicity and carcinogenicity are available to the SCCNFP for evaluation.","effect":"d. 3.3.4 Repeated dose toxicity From SCCNFP/0789/04 Summary of toxicological studies At present, no studies on acute, subacute, subchronic, chronic, reproductive and developmental toxicity and carcinogenicity are available to the SCCNFP for evaluation. From the documents supplied by the applicant, it can be derived that many of such studies were performed between 1960 and 1980. The studies are summarized in Table 4. The Scientific Committee on Food (SCF) established an ADI value of 0-10 mg/kg bw/day, based on a NOEL of 1000 mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG de","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_001"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral chronic reproductive toxicity {"dose":"mg/kg bw/day in a long-term mice study (table 4, study n° 11).","effect":"mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluatio","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_003"}
SCCS_vision_codex NOAEL =50 mg/kg bw/day rat oral Subacute repeated dose toxicity {"dose":"Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet.","effect":"feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluation Parameters / effects NOEL 1 Subacute / cat / number unknown Po / 7 d / 100 mg/kg bw Oettel et al. 1965 / DFG + BIBRA Red blood cells / no effect / 2 Subchronic / rat / 5m + 5 f diet / 90 d / 0, 0.25, 0.5, 1.0, 2.0, 5.0 % Hansen et al. 1960 / DFG + BIBRA Body weight, food consumption, haematology, organ weight / No adverse e","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_004"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat oral Subacute repeated dose toxicity {"dose":"From these findings, a NOAEL of 50 mg/kg bw/day could be deduced.","effect":"orresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluation Parameters / effects NOEL 1 Subacute / cat / number unknown Po / 7 d / 100 mg/kg bw Oettel et al. 1965 / DFG + BIBRA Red blood cells / no effect / 2 Subchronic / rat / 5m + 5 f diet / 90 d / 0, 0.25, 0.5, 1.0, 2.0, 5.0 % Hansen et al. 1960 / DFG + BIBRA Body weight, food consumption, haematology, organ weight / No adverse effects 2500 mg/kg bw/d 3 Subchronic / dog / number unknown diet / 90 d / 3 % Hazleton 1962 / DFG Parameters not given/ Body weight reduction / 4 Subchronic / rat / 20 m + 20 f diet / 90 d / 3 % Hazleton 1965 / BIBRA Body","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_005"}
SCCS_vision_codex NOAEL =0.0783 mg/kg bw rat oral chronic reproductive toxicity {"dose":"CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw...","effect":"owed a low penetration into the viable skin layers and into the receptor fluid (5.35 + 2.76). The SCCS has used the dermal absorption value of 8.11 µg/cm² (Mean + 1x SD) in Margin of Safety (MoS) calculations as below: CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw/d (oral chronic toxicity and carcinogenicity study in the rat with a reproductive toxicity phase, rat) Bioavailability 50%* NOAELsys = 25 mg/kg bw/d Margin of Safety: adjusted NOAELsys/SED = 25 mg/kg bw /d / 0.0783 mg /kg bw/ d -> MoS: 319 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","page":28,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_013"}
SCCS_vision_codex NOAEL =4 - - - - NOAEL study {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: No. | study type / | Application | Source / evaluation | Parameters / effects | NOEL","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_016"}
SCCS_vision_codex NOAEL =2500 - rat - Subchronic repeated dose toxicity {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 2 | Subchronic / rat / | Hansen et al. 1960 / | Body weight, food | 2500","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_017"}
SCCS_vision_codex NOAEL =1500 - rat oral Subchronic repeated dose toxicity {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 4 | Subchronic / rat / | diet / | Hazleton 1965 / | Body weight, clinical | 1500","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_018"}
SCCS_vision_codex NOAEL =3 % - - 90 d NOAEL study {"dose":"20 m + 20 f | 90 d / 3 % | BIBRA | signs, haematology, | mg/kg","effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 20 m + 20 f | 90 d / 3 % | BIBRA | signs, haematology, | mg/kg","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_019"}
SCCS_vision_codex NOAEL >50 - rat - Chronic NOAEL study {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 5 | Chronic / rat / 10 | Sc / 7 m / 50 | Oettel et al. 1965 / | Parameters not given / no | > 50","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_020"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day rat oral subacute repeated dose toxicity {"dose":"3.3.4 Repeated dose toxicity From SCCNFP/0789/04 Summary of toxicological studies At present, no studies on acute, subacute, subchronic, chronic, reproductive and developmental toxicity and carcinogenicity are available to the SCCNFP for evaluation.","effect":"d. 3.3.4 Repeated dose toxicity From SCCNFP/0789/04 Summary of toxicological studies At present, no studies on acute, subacute, subchronic, chronic, reproductive and developmental toxicity and carcinogenicity are available to the SCCNFP for evaluation. From the documents supplied by the applicant, it can be derived that many of such studies were performed between 1960 and 1980. The studies are summarized in Table 4. The Scientific Committee on Food (SCF) established an ADI value of 0-10 mg/kg bw/day, based on a NOEL of 1000 mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG de","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_001"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral chronic reproductive toxicity {"dose":"mg/kg bw/day in a long-term mice study (table 4, study n° 11).","effect":"mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluatio","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_003"}
SCCS_vision_codex NOAEL =50 mg/kg bw/day rat oral Subacute repeated dose toxicity {"dose":"Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet.","effect":"feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluation Parameters / effects NOEL 1 Subacute / cat / number unknown Po / 7 d / 100 mg/kg bw Oettel et al. 1965 / DFG + BIBRA Red blood cells / no effect / 2 Subchronic / rat / 5m + 5 f diet / 90 d / 0, 0.25, 0.5, 1.0, 2.0, 5.0 % Hansen et al. 1960 / DFG + BIBRA Body weight, food consumption, haematology, organ weight / No adverse e","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_004"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat oral Subacute repeated dose toxicity {"dose":"From these findings, a NOAEL of 50 mg/kg bw/day could be deduced.","effect":"orresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluation Parameters / effects NOEL 1 Subacute / cat / number unknown Po / 7 d / 100 mg/kg bw Oettel et al. 1965 / DFG + BIBRA Red blood cells / no effect / 2 Subchronic / rat / 5m + 5 f diet / 90 d / 0, 0.25, 0.5, 1.0, 2.0, 5.0 % Hansen et al. 1960 / DFG + BIBRA Body weight, food consumption, haematology, organ weight / No adverse effects 2500 mg/kg bw/d 3 Subchronic / dog / number unknown diet / 90 d / 3 % Hazleton 1962 / DFG Parameters not given/ Body weight reduction / 4 Subchronic / rat / 20 m + 20 f diet / 90 d / 3 % Hazleton 1965 / BIBRA Body","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_005"}
SCCS_vision_codex NOAEL =0.0783 mg/kg bw rat oral chronic reproductive toxicity {"dose":"CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw...","effect":"owed a low penetration into the viable skin layers and into the receptor fluid (5.35 + 2.76). The SCCS has used the dermal absorption value of 8.11 µg/cm² (Mean + 1x SD) in Margin of Safety (MoS) calculations as below: CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw/d (oral chronic toxicity and carcinogenicity study in the rat with a reproductive toxicity phase, rat) Bioavailability 50%* NOAELsys = 25 mg/kg bw/d Margin of Safety: adjusted NOAELsys/SED = 25 mg/kg bw /d / 0.0783 mg /kg bw/ d -> MoS: 319 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","page":28,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_013"}
SCCS_vision_codex NOAEL =4 - - - - NOAEL study {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: No. | study type / | Application | Source / evaluation | Parameters / effects | NOEL","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_016"}
SCCS_vision_codex NOAEL =2500 - rat - Subchronic repeated dose toxicity {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 2 | Subchronic / rat / | Hansen et al. 1960 / | Body weight, food | 2500","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_017"}
SCCS_vision_codex NOAEL =1500 - rat oral Subchronic repeated dose toxicity {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 4 | Subchronic / rat / | diet / | Hazleton 1965 / | Body weight, clinical | 1500","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_018"}
SCCS_vision_codex NOAEL =3 % - - 90 d NOAEL study {"dose":"20 m + 20 f | 90 d / 3 % | BIBRA | signs, haematology, | mg/kg","effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 20 m + 20 f | 90 d / 3 % | BIBRA | signs, haematology, | mg/kg","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_019"}
SCCS_vision_codex NOAEL >50 - rat - Chronic NOAEL study {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 5 | Chronic / rat / 10 | Sc / 7 m / 50 | Oettel et al. 1965 / | Parameters not given / no | > 50","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_020"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day rat oral subacute repeated dose toxicity {"dose":"3.3.4 Repeated dose toxicity From SCCNFP/0789/04 Summary of toxicological studies At present, no studies on acute, subacute, subchronic, chronic, reproductive and developmental toxicity and carcinogenicity are available to the SCCNFP for evaluation.","effect":"d. 3.3.4 Repeated dose toxicity From SCCNFP/0789/04 Summary of toxicological studies At present, no studies on acute, subacute, subchronic, chronic, reproductive and developmental toxicity and carcinogenicity are available to the SCCNFP for evaluation. From the documents supplied by the applicant, it can be derived that many of such studies were performed between 1960 and 1980. The studies are summarized in Table 4. The Scientific Committee on Food (SCF) established an ADI value of 0-10 mg/kg bw/day, based on a NOEL of 1000 mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG de","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_001"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral chronic reproductive toxicity {"dose":"mg/kg bw/day in a long-term mice study (table 4, study n° 11).","effect":"mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluatio","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_003"}
SCCS_vision_codex NOAEL =50 mg/kg bw/day rat oral Subacute repeated dose toxicity {"dose":"Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet.","effect":"feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluation Parameters / effects NOEL 1 Subacute / cat / number unknown Po / 7 d / 100 mg/kg bw Oettel et al. 1965 / DFG + BIBRA Red blood cells / no effect / 2 Subchronic / rat / 5m + 5 f diet / 90 d / 0, 0.25, 0.5, 1.0, 2.0, 5.0 % Hansen et al. 1960 / DFG + BIBRA Body weight, food consumption, haematology, organ weight / No adverse e","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_004"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat oral Subacute repeated dose toxicity {"dose":"From these findings, a NOAEL of 50 mg/kg bw/day could be deduced.","effect":"orresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluation Parameters / effects NOEL 1 Subacute / cat / number unknown Po / 7 d / 100 mg/kg bw Oettel et al. 1965 / DFG + BIBRA Red blood cells / no effect / 2 Subchronic / rat / 5m + 5 f diet / 90 d / 0, 0.25, 0.5, 1.0, 2.0, 5.0 % Hansen et al. 1960 / DFG + BIBRA Body weight, food consumption, haematology, organ weight / No adverse effects 2500 mg/kg bw/d 3 Subchronic / dog / number unknown diet / 90 d / 3 % Hazleton 1962 / DFG Parameters not given/ Body weight reduction / 4 Subchronic / rat / 20 m + 20 f diet / 90 d / 3 % Hazleton 1965 / BIBRA Body","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_005"}
SCCS_vision_codex NOAEL =0.0783 mg/kg bw rat oral chronic reproductive toxicity {"dose":"CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw...","effect":"owed a low penetration into the viable skin layers and into the receptor fluid (5.35 + 2.76). The SCCS has used the dermal absorption value of 8.11 µg/cm² (Mean + 1x SD) in Margin of Safety (MoS) calculations as below: CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw/d (oral chronic toxicity and carcinogenicity study in the rat with a reproductive toxicity phase, rat) Bioavailability 50%* NOAELsys = 25 mg/kg bw/d Margin of Safety: adjusted NOAELsys/SED = 25 mg/kg bw /d / 0.0783 mg /kg bw/ d -> MoS: 319 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","page":28,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_013"}
SCCS_vision_codex NOAEL =4 - - - - NOAEL study {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: No. | study type / | Application | Source / evaluation | Parameters / effects | NOEL","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_016"}
SCCS_vision_codex NOAEL =2500 - rat - Subchronic repeated dose toxicity {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 2 | Subchronic / rat / | Hansen et al. 1960 / | Body weight, food | 2500","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_017"}
SCCS_vision_codex NOAEL =1500 - rat oral Subchronic repeated dose toxicity {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 4 | Subchronic / rat / | diet / | Hazleton 1965 / | Body weight, clinical | 1500","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_018"}
SCCS_vision_codex NOAEL =3 % - - 90 d NOAEL study {"dose":"20 m + 20 f | 90 d / 3 % | BIBRA | signs, haematology, | mg/kg","effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 20 m + 20 f | 90 d / 3 % | BIBRA | signs, haematology, | mg/kg","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_019"}
SCCS_vision_codex NOAEL >50 - rat - Chronic NOAEL study {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 5 | Chronic / rat / 10 | Sc / 7 m / 50 | Oettel et al. 1965 / | Parameters not given / no | > 50","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_020"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day rat oral subacute repeated dose toxicity {"dose":"3.3.4 Repeated dose toxicity From SCCNFP/0789/04 Summary of toxicological studies At present, no studies on acute, subacute, subchronic, chronic, reproductive and developmental toxicity and carcinogenicity are available to the SCCNFP for evaluation.","effect":"d. 3.3.4 Repeated dose toxicity From SCCNFP/0789/04 Summary of toxicological studies At present, no studies on acute, subacute, subchronic, chronic, reproductive and developmental toxicity and carcinogenicity are available to the SCCNFP for evaluation. From the documents supplied by the applicant, it can be derived that many of such studies were performed between 1960 and 1980. The studies are summarized in Table 4. The Scientific Committee on Food (SCF) established an ADI value of 0-10 mg/kg bw/day, based on a NOEL of 1000 mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG de","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_001"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral chronic reproductive toxicity {"dose":"mg/kg bw/day in a long-term mice study (table 4, study n° 11).","effect":"mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluatio","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_003"}
SCCS_vision_codex NOAEL =50 mg/kg bw/day rat oral Subacute repeated dose toxicity {"dose":"Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet.","effect":"feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluation Parameters / effects NOEL 1 Subacute / cat / number unknown Po / 7 d / 100 mg/kg bw Oettel et al. 1965 / DFG + BIBRA Red blood cells / no effect / 2 Subchronic / rat / 5m + 5 f diet / 90 d / 0, 0.25, 0.5, 1.0, 2.0, 5.0 % Hansen et al. 1960 / DFG + BIBRA Body weight, food consumption, haematology, organ weight / No adverse e","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_004"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat oral Subacute repeated dose toxicity {"dose":"From these findings, a NOAEL of 50 mg/kg bw/day could be deduced.","effect":"orresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluation Parameters / effects NOEL 1 Subacute / cat / number unknown Po / 7 d / 100 mg/kg bw Oettel et al. 1965 / DFG + BIBRA Red blood cells / no effect / 2 Subchronic / rat / 5m + 5 f diet / 90 d / 0, 0.25, 0.5, 1.0, 2.0, 5.0 % Hansen et al. 1960 / DFG + BIBRA Body weight, food consumption, haematology, organ weight / No adverse effects 2500 mg/kg bw/d 3 Subchronic / dog / number unknown diet / 90 d / 3 % Hazleton 1962 / DFG Parameters not given/ Body weight reduction / 4 Subchronic / rat / 20 m + 20 f diet / 90 d / 3 % Hazleton 1965 / BIBRA Body","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_005"}
SCCS_vision_codex NOAEL =0.0783 mg/kg bw rat oral chronic reproductive toxicity {"dose":"CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw...","effect":"owed a low penetration into the viable skin layers and into the receptor fluid (5.35 + 2.76). The SCCS has used the dermal absorption value of 8.11 µg/cm² (Mean + 1x SD) in Margin of Safety (MoS) calculations as below: CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw/d (oral chronic toxicity and carcinogenicity study in the rat with a reproductive toxicity phase, rat) Bioavailability 50%* NOAELsys = 25 mg/kg bw/d Margin of Safety: adjusted NOAELsys/SED = 25 mg/kg bw /d / 0.0783 mg /kg bw/ d -> MoS: 319 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","page":28,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_013"}
SCCS_vision_codex NOAEL =4 - - - - NOAEL study {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: No. | study type / | Application | Source / evaluation | Parameters / effects | NOEL","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_016"}
SCCS_vision_codex NOAEL =2500 - rat - Subchronic repeated dose toxicity {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 2 | Subchronic / rat / | Hansen et al. 1960 / | Body weight, food | 2500","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_017"}
SCCS_vision_codex NOAEL =1500 - rat oral Subchronic repeated dose toxicity {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 4 | Subchronic / rat / | diet / | Hazleton 1965 / | Body weight, clinical | 1500","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_018"}
SCCS_vision_codex NOAEL =3 % - - 90 d NOAEL study {"dose":"20 m + 20 f | 90 d / 3 % | BIBRA | signs, haematology, | mg/kg","effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 20 m + 20 f | 90 d / 3 % | BIBRA | signs, haematology, | mg/kg","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_019"}
SCCS_vision_codex NOAEL >50 - rat - Chronic NOAEL study {"effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 5 | Chronic / rat / 10 | Sc / 7 m / 50 | Oettel et al. 1965 / | Parameters not given / no | > 50","page":19,"pdf":"sccs_o_253.pdf","row_type":"noael_study","study_id":"sccs_o_253_noael_020"}
ToxValDB_EFSA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOAEL =50 mg/kg bw/day Rat oral - chronic LONG_REF=EFSA ANS (2009). Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive. doi:10.2903/j.efsa.2009.1329.; TITLE=Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2009.1329; 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=neurology; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=EFSA_dup_-_15614322_15614323_15614324: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_2f4657c6f0b614cd2678a4c47599c430
ToxValDB_WHO_JECFA_ADI 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_WHO_JECFA_ADI ADI <=3 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afc40e4b0d99f5a87c094; 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/871; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=WHO JECFA ADI:15715379:-:--; 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_f770ec99db86ee002f4a13ff0abd72a8
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 20 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 4 - - - - - SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=unclear:Table 4: an overview of the toxicity studies reviewed in submission I.: No. | study type / | Application | Source / evaluation | Parameters / effects | NOEL; EFFECT=Table 4: an overview of the toxicity studies reviewed in submission I.: No. | study type / | Application | Source / evaluation | Parameters / effects | NOEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"","duration":"","effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: No. | study type / | Application | Source / evaluation | Parameters / effects | NOEL","endpoint":"","ingredient":"in representative batches and results","loael_value":"","noael_unit":"","noael_value":"unclear:Table 4: an overview of the toxicity studies reviewed in submission I.: No. | study type / | Application | Source / evaluation | Parameters / effects | NOEL","page":19,"route":"","species":"","study_id":"sccs_o_253_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 3 % - - 90 d - SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=3; DOSE=20 m + 20 f | 90 d / 3 % | BIBRA | signs, haematology, | mg/kg; EFFECT=Table 4: an overview of the toxicity studies reviewed in submission I.: 20 m + 20 f | 90 d / 3 % | BIBRA | signs, haematology, | mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"20 m + 20 f | 90 d / 3 % | BIBRA | signs, haematology, | mg/kg","duration":"90 d","effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 20 m + 20 f | 90 d / 3 % | BIBRA | signs, haematology, | mg/kg","endpoint":"","ingredient":"in representative batches and results","loael_value":"","noael_unit":"%","noael_value":"3","page":19,"route":"","species":"","study_id":"sccs_o_253_noael_019"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - >50 - rat - Chronic - SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=> 50; EFFECT=Table 4: an overview of the toxicity studies reviewed in submission I.: 5 | Chronic / rat / 10 | Sc / 7 m / 50 | Oettel et al. 1965 / | Parameters not given / no | > 50; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"","duration":"Chronic","effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 5 | Chronic / rat / 10 | Sc / 7 m / 50 | Oettel et al. 1965 / | Parameters not given / no | > 50","endpoint":"","ingredient":"in representative batches and results","loael_value":"","noael_unit":"","noael_value":"> 50","page":19,"route":"","species":"rat","study_id":"sccs_o_253_noael_020"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg bw/day rat oral subacute repeated dose toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=1000; DOSE=3.3.4 Repeated dose toxicity From SCCNFP/0789/04 Summary of toxicological studies At present, no studies on acute, subacute, subchronic, chronic, reproductive and developmental toxicity and carcinogenicity are available to the SCCNFP for evaluation.; EFFECT=d. 3.3.4 Repeated dose toxicity From SCCNFP/0789/04 Summary of toxicological studies At present, no studies on acute, subacute, subchronic, chronic, reproductive and developmental toxicity and carcinogenicity are available to the SCCNFP for evaluation. From the documents supplied by the applicant, it can be derived that many of such studies were performed between 1960 and 1980. The studies are summarized in Table 4. The Scientific Committee on Food (SCF) established an ADI value of 0-10 mg/kg bw/day, based on a NOEL of 1000 mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG de; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"3.3.4 Repeated dose toxicity From SCCNFP/0789/04 Summary of toxicological studies At present, no studies on acute, subacute, subchronic, chronic, reproductive and developmental toxicity and carcinogenicity are available to the SCCNFP for evaluation.","duration":"subacute","effect":"d. 3.3.4 Repeated dose toxicity From SCCNFP/0789/04 Summary of toxicological studies At present, no studies on acute, subacute, subchronic, chronic, reproductive and developmental toxicity and carcinogenicity are available to the SCCNFP for evaluation. From the documents supplied by the applicant, it can be derived that many of such studies were performed between 1960 and 1980. The studies are summarized in Table 4. The Scientific Committee on Food (SCF) established an ADI value of 0-10 mg/kg bw/day, based on a NOEL of 1000 mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG de","endpoint":"repeated dose toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":19,"route":"oral","species":"rat","study_id":"sccs_o_253_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 50 mg/kg bw/day rat oral Subacute repeated dose toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=50; DOSE=Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet.; EFFECT=feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluation Parameters / effects NOEL 1 Subacute / cat / number unknown Po / 7 d / 100 mg/kg bw Oettel et al. 1965 / DFG + BIBRA Red blood cells / no effect / 2 Subchronic / rat / 5m + 5 f diet / 90 d / 0, 0.25, 0.5, 1.0, 2.0, 5.0 % Hansen et al. 1960 / DFG + BIBRA Body weight, food consumption, haematology, organ weight / No adverse e; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet.","duration":"Subacute","effect":"feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluation Parameters / effects NOEL 1 Subacute / cat / number unknown Po / 7 d / 100 mg/kg bw Oettel et al. 1965 / DFG + BIBRA Red blood cells / no effect / 2 Subchronic / rat / 5m + 5 f diet / 90 d / 0, 0.25, 0.5, 1.0, 2.0, 5.0 % Hansen et al. 1960 / DFG + BIBRA Body weight, food consumption, haematology, organ weight / No adverse e","endpoint":"repeated dose toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":19,"route":"oral","species":"rat","study_id":"sccs_o_253_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 100 mg/kg bw rat oral Subacute repeated dose toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=100; DOSE=From these findings, a NOAEL of 50 mg/kg bw/day could be deduced.; EFFECT=orresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluation Parameters / effects NOEL 1 Subacute / cat / number unknown Po / 7 d / 100 mg/kg bw Oettel et al. 1965 / DFG + BIBRA Red blood cells / no effect / 2 Subchronic / rat / 5m + 5 f diet / 90 d / 0, 0.25, 0.5, 1.0, 2.0, 5.0 % Hansen et al. 1960 / DFG + BIBRA Body weight, food consumption, haematology, organ weight / No adverse effects 2500 mg/kg bw/d 3 Subchronic / dog / number unknown diet / 90 d / 3 % Hazleton 1962 / DFG Parameters not given/ Body weight reduction / 4 Subchronic / rat / 20 m + 20 f diet / 90 d / 3 % Hazleton 1965 / BIBRA Body; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"From these findings, a NOAEL of 50 mg/kg bw/day could be deduced.","duration":"Subacute","effect":"orresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluation Parameters / effects NOEL 1 Subacute / cat / number unknown Po / 7 d / 100 mg/kg bw Oettel et al. 1965 / DFG + BIBRA Red blood cells / no effect / 2 Subchronic / rat / 5m + 5 f diet / 90 d / 0, 0.25, 0.5, 1.0, 2.0, 5.0 % Hansen et al. 1960 / DFG + BIBRA Body weight, food consumption, haematology, organ weight / No adverse effects 2500 mg/kg bw/d 3 Subchronic / dog / number unknown diet / 90 d / 3 % Hazleton 1962 / DFG Parameters not given/ Body weight reduction / 4 Subchronic / rat / 20 m + 20 f diet / 90 d / 3 % Hazleton 1965 / BIBRA Body","endpoint":"repeated dose toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":19,"route":"oral","species":"rat","study_id":"sccs_o_253_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 50 mg/kg bw/day rat oral 18 day repeated dose toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=50; DOSE=city rabbit / 15 Po / 6-18 day of gestation / max. dose 150 mg/kg bw Biodynamics 1972 / BIBRA Parameters not given / no effect > 150 mg/kg bw/d Ref.; EFFECT=city rabbit / 15 Po / 6-18 day of gestation / max. dose 150 mg/kg bw Biodynamics 1972 / BIBRA Parameters not given / no effect > 150 mg/kg bw/d Ref. 6 Submission II dossier No new repeated dose toxicity data provided in submission II (Ref 7). SCCS comments The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by the WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day. This was based on the NOAEL of 50 mg/kg bw/day, derived from the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats, and applying an uncertainty factor of 100 to this NOAEL. 3.3.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity See 3.3.4.3 3.3.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity See 3.3.4.3 3.3.4.3 Chronic (> 12 months) toxicity Chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats (study 12 in the table 4) Guidelines/Guidanc; CITATION=(Ref 7); CITATION_NUMBERS=[7]; REFERENCE=(Ref 7); DETAILS_JSON={"cas_number":"8004-92-0","citation":"(Ref 7)","dose":"city rabbit / 15 Po / 6-18 day of gestation / max. dose 150 mg/kg bw Biodynamics 1972 / BIBRA Parameters not given / no effect > 150 mg/kg bw/d Ref.","duration":"18 day","effect":"city rabbit / 15 Po / 6-18 day of gestation / max. dose 150 mg/kg bw Biodynamics 1972 / BIBRA Parameters not given / no effect > 150 mg/kg bw/d Ref. 6 Submission II dossier No new repeated dose toxicity data provided in submission II (Ref 7). SCCS comments The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by the WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day. This was based on the NOAEL of 50 mg/kg bw/day, derived from the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats, and applying an uncertainty factor of 100 to this NOAEL. 3.3.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity See 3.3.4.3 3.3.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity See 3.3.4.3 3.3.4.3 Chronic (> 12 months) toxicity Chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats (study 12 in the table 4) Guidelines/Guidanc","endpoint":"repeated dose toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":21,"route":"oral","species":"rat","study_id":"sccs_o_253_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 50 mg/kg bw/day rat oral chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=50; DOSE=ew repeated dose toxicity data provided in submission II (Ref 7).; EFFECT=ew repeated dose toxicity data provided in submission II (Ref 7). SCCS comments The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by the WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day. This was based on the NOAEL of 50 mg/kg bw/day, derived from the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats, and applying an uncertainty factor of 100 to this NOAEL. 3.3.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity See 3.3.4.3 3.3.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity See 3.3.4.3 3.3.4.3 Chronic (> 12 months) toxicity Chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats (study 12 in the table 4) Guidelines/Guidances: No information available GLP: No information available Test item: D&C Yellow10 Vehicle: Diet Experimental animals Species: Rat Strain: Albino Sex: Males and fe; CITATION=(Ref 7); CITATION_NUMBERS=[7]; REFERENCE=(Ref 7); DETAILS_JSON={"cas_number":"8004-92-0","citation":"(Ref 7)","dose":"ew repeated dose toxicity data provided in submission II (Ref 7).","duration":"chronic","effect":"ew repeated dose toxicity data provided in submission II (Ref 7). SCCS comments The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by the WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day. This was based on the NOAEL of 50 mg/kg bw/day, derived from the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats, and applying an uncertainty factor of 100 to this NOAEL. 3.3.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity See 3.3.4.3 3.3.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity See 3.3.4.3 3.3.4.3 Chronic (> 12 months) toxicity Chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats (study 12 in the table 4) Guidelines/Guidances: No information available GLP: No information available Test item: D&C Yellow10 Vehicle: Diet Experimental animals Species: Rat Strain: Albino Sex: Males and fe","endpoint":"repeated dose toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":21,"route":"oral","species":"rat","study_id":"sccs_o_253_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 50 mg/kg bw/day rat oral chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=50; DOSE=t and >1000 mg/kg bw in dog.; EFFECT=t and >1000 mg/kg bw in dog. Repeated dose toxicity A long-term chronic chronic/carcinogenicity study with a reproductive toxicity phase was conducted in albino rats with Acid Yellow 3 at 0, 2.0 and 5.0 % (equivalent to 0, 1000 and 2500 mg/kg bw/day) for 24 months. No adverse effects were noted in the F0 generation. Reduced viability and lower weight gains during lactation had been registered at 0.5 % in the diet (equivalent to 250 mg/kg bw/day) and above. Since no other treatment-related effects were noted, a NOAEL of 50 mg/kg bw/day was derived from this study.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"t and >1000 mg/kg bw in dog.","duration":"chronic","effect":"t and >1000 mg/kg bw in dog. Repeated dose toxicity A long-term chronic chronic/carcinogenicity study with a reproductive toxicity phase was conducted in albino rats with Acid Yellow 3 at 0, 2.0 and 5.0 % (equivalent to 0, 1000 and 2500 mg/kg bw/day) for 24 months. No adverse effects were noted in the F0 generation. Reduced viability and lower weight gains during lactation had been registered at 0.5 % in the diet (equivalent to 250 mg/kg bw/day) and above. Since no other treatment-related effects were noted, a NOAEL of 50 mg/kg bw/day was derived from this study.","endpoint":"repeated dose toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":29,"route":"oral","species":"rat","study_id":"sccs_o_253_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 2500 - rat - Subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=2500; EFFECT=Table 4: an overview of the toxicity studies reviewed in submission I.: 2 | Subchronic / rat / | Hansen et al. 1960 / | Body weight, food | 2500; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"","duration":"Subchronic","effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 2 | Subchronic / rat / | Hansen et al. 1960 / | Body weight, food | 2500","endpoint":"repeated dose toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"","noael_value":"2500","page":19,"route":"","species":"rat","study_id":"sccs_o_253_noael_017"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1500 - rat oral Subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=1500; EFFECT=Table 4: an overview of the toxicity studies reviewed in submission I.: 4 | Subchronic / rat / | diet / | Hazleton 1965 / | Body weight, clinical | 1500; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"","duration":"Subchronic","effect":"Table 4: an overview of the toxicity studies reviewed in submission I.: 4 | Subchronic / rat / | diet / | Hazleton 1965 / | Body weight, clinical | 1500","endpoint":"repeated dose toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"","noael_value":"1500","page":19,"route":"oral","species":"rat","study_id":"sccs_o_253_noael_018"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 1000 mg/kg bw/day rat oral chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=1000; DOSE=The Scientific Committee on Food (SCF) established an ADI value of 0-10 mg/kg bw/day, based on a NOEL of 1000 mg/kg bw/day in a long-term mice study (table 4, study n° 11).; EFFECT=ble to the SCCNFP for evaluation. From the documents supplied by the applicant, it can be derived that many of such studies were performed between 1960 and 1980. The studies are summarized in Table 4. The Scientific Committee on Food (SCF) established an ADI value of 0-10 mg/kg bw/day, based on a NOEL of 1000 mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"The Scientific Committee on Food (SCF) established an ADI value of 0-10 mg/kg bw/day, based on a NOEL of 1000 mg/kg bw/day in a long-term mice study (table 4, study n° 11).","duration":"chronic","effect":"ble to the SCCNFP for evaluation. From the documents supplied by the applicant, it can be derived that many of such studies were performed between 1960 and 1980. The studies are summarized in Table 4. The Scientific Committee on Food (SCF) established an ADI value of 0-10 mg/kg bw/day, based on a NOEL of 1000 mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in","endpoint":"reproductive toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":19,"route":"oral","species":"rat","study_id":"sccs_o_253_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 250 mg/kg bw/day rat oral chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=250; DOSE=mg/kg bw/day in a long-term mice study (table 4, study n° 11).; EFFECT=mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluatio; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"mg/kg bw/day in a long-term mice study (table 4, study n° 11).","duration":"chronic","effect":"mg/kg bw/day in a long-term mice study (table 4, study n° 11). The same study was evaluated by JECFA and the same ADI value was estimated. FDA derived an acceptable daily intake of 10 mg/kg bw/day, based on a NOAEL of 1000 mg/kg bw/day, corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice (Table 4, studies n° 8 and 9). These studies were additionally evaluated by BIBRA and the DFG. Based on body and organ weight changes, BIBRA and DFG deduced a NOAEL of 250 mg/kg bw/day, corresponding to 0.5% in the diet. Furthermore, it has to be mentioned that the evaluation of a reproductive toxicity study by BIBRA (study 12 in the Table 4) concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day could be deduced. Table 4: an overview of the toxicity studies reviewed in submission I. No. study type / Species / No. Application route / time / doses Source / evaluatio","endpoint":"reproductive toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":19,"route":"oral","species":"rat","study_id":"sccs_o_253_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 50 mg/kg bw/day rat oral chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=50; DOSE=Conclusion In the long-term chronic toxicity/carcinogenicity study with a reproductive toxicity phase in male and female albino rats receiving 0, 0.03, 0.1, 0.5, 2, or 5 % D&C Yellow10 in the diet (equivalent to 0, 15, 50, 250, 1000 or 2500 mg/kg bw/day), reduced viability and lower weight gains in pups derived from F0 dams during lactation at d...; EFFECT=ve parameters were noted. Conclusion In the long-term chronic toxicity/carcinogenicity study with a reproductive toxicity phase in male and female albino rats receiving 0, 0.03, 0.1, 0.5, 2, or 5 % D&C Yellow10 in the diet (equivalent to 0, 15, 50, 250, 1000 or 2500 mg/kg bw/day), reduced viability and lower weight gains in pups derived from F0 dams during lactation at dose levels of 250, 1000 and 2500 mg/kg bw/day were observed. These effects were considered as indicative of a treatment-related effect. Thus, the NOAEL under the conditions of this study was 50 mg/kg bw/day. Ref. 7 SCCS comments The SCCS agrees with the former evaluations performed which defined a NOAEL of 50 mg/kg bw / day obtained in the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats. 3.3.5 Reproductive toxicity 3.3.5.1 Fertility and reproduction toxicity See 3.3.4.3 3.3.5.2 Developmental Toxicity See 3.3.4.3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"Conclusion In the long-term chronic toxicity/carcinogenicity study with a reproductive toxicity phase in male and female albino rats receiving 0, 0.03, 0.1, 0.5, 2, or 5 % D&C Yellow10 in the diet (equivalent to 0, 15, 50, 250, 1000 or 2500 mg/kg bw/day), reduced viability and lower weight gains in pups derived from F0 dams during lactation at d...","duration":"chronic","effect":"ve parameters were noted. Conclusion In the long-term chronic toxicity/carcinogenicity study with a reproductive toxicity phase in male and female albino rats receiving 0, 0.03, 0.1, 0.5, 2, or 5 % D&C Yellow10 in the diet (equivalent to 0, 15, 50, 250, 1000 or 2500 mg/kg bw/day), reduced viability and lower weight gains in pups derived from F0 dams during lactation at dose levels of 250, 1000 and 2500 mg/kg bw/day were observed. These effects were considered as indicative of a treatment-related effect. Thus, the NOAEL under the conditions of this study was 50 mg/kg bw/day. Ref. 7 SCCS comments The SCCS agrees with the former evaluations performed which defined a NOAEL of 50 mg/kg bw / day obtained in the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats. 3.3.5 Reproductive toxicity 3.3.5.1 Fertility and reproduction toxicity See 3.3.4.3 3.3.5.2 Developmental Toxicity See 3.3.4.3","endpoint":"reproductive toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":22,"route":"oral","species":"rat","study_id":"sccs_o_253_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 50 mg/kg bw / day rat oral chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=50; DOSE=rats receiving 0, 0.03, 0.1, 0.5, 2, or 5 % D&C Yellow10 in the diet (equivalent to 0, 15, 50, 250, 1000 or 2500 mg/kg bw/day), reduced viability and lower weight gains in pups derived from F0 dams during lactation at dose levels of 250, 1000 and 2500 mg/kg bw/day were observed.; EFFECT=rats receiving 0, 0.03, 0.1, 0.5, 2, or 5 % D&C Yellow10 in the diet (equivalent to 0, 15, 50, 250, 1000 or 2500 mg/kg bw/day), reduced viability and lower weight gains in pups derived from F0 dams during lactation at dose levels of 250, 1000 and 2500 mg/kg bw/day were observed. These effects were considered as indicative of a treatment-related effect. Thus, the NOAEL under the conditions of this study was 50 mg/kg bw/day. Ref. 7 SCCS comments The SCCS agrees with the former evaluations performed which defined a NOAEL of 50 mg/kg bw / day obtained in the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats. 3.3.5 Reproductive toxicity 3.3.5.1 Fertility and reproduction toxicity See 3.3.4.3 3.3.5.2 Developmental Toxicity See 3.3.4.3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"rats receiving 0, 0.03, 0.1, 0.5, 2, or 5 % D&C Yellow10 in the diet (equivalent to 0, 15, 50, 250, 1000 or 2500 mg/kg bw/day), reduced viability and lower weight gains in pups derived from F0 dams during lactation at dose levels of 250, 1000 and 2500 mg/kg bw/day were observed.","duration":"chronic","effect":"rats receiving 0, 0.03, 0.1, 0.5, 2, or 5 % D&C Yellow10 in the diet (equivalent to 0, 15, 50, 250, 1000 or 2500 mg/kg bw/day), reduced viability and lower weight gains in pups derived from F0 dams during lactation at dose levels of 250, 1000 and 2500 mg/kg bw/day were observed. These effects were considered as indicative of a treatment-related effect. Thus, the NOAEL under the conditions of this study was 50 mg/kg bw/day. Ref. 7 SCCS comments The SCCS agrees with the former evaluations performed which defined a NOAEL of 50 mg/kg bw / day obtained in the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats. 3.3.5 Reproductive toxicity 3.3.5.1 Fertility and reproduction toxicity See 3.3.4.3 3.3.5.2 Developmental Toxicity See 3.3.4.3","endpoint":"reproductive toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw / day","noael_value":"50","page":22,"route":"oral","species":"rat","study_id":"sccs_o_253_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 50 mg/kg bw/day rat dermal chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=50; DOSE=5) - Submission II ___________________________________________________________________________________________ ___________________________________________________________________________________________ 28 3.4 SAFETY EVALUATION (including calculation of the MoS) The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the...; EFFECT=5) - Submission II ___________________________________________________________________________________________ ___________________________________________________________________________________________ 28 3.4 SAFETY EVALUATION (including calculation of the MoS) The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day. This was based on the NOAEL of 50 mg/kg bw/day obtained in the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats and applying an uncertainty factor of 100 to the NOAEL. Based on this NOAEL as the Point of Departure (POD), the SCCS has revised the exposure calculation for non-oxidative conditions in accordance with the changed procedure for SED calculations (SCCS/1628/21). The dermal absorption data from studies carried out according to most recent guidelines and guidance requirements under non-oxidative co; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"5) - Submission II ___________________________________________________________________________________________ ___________________________________________________________________________________________ 28 3.4 SAFETY EVALUATION (including calculation of the MoS) The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the...","duration":"chronic","effect":"5) - Submission II ___________________________________________________________________________________________ ___________________________________________________________________________________________ 28 3.4 SAFETY EVALUATION (including calculation of the MoS) The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day. This was based on the NOAEL of 50 mg/kg bw/day obtained in the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats and applying an uncertainty factor of 100 to the NOAEL. Based on this NOAEL as the Point of Departure (POD), the SCCS has revised the exposure calculation for non-oxidative conditions in accordance with the changed procedure for SED calculations (SCCS/1628/21). The dermal absorption data from studies carried out according to most recent guidelines and guidance requirements under non-oxidative co","endpoint":"reproductive toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":28,"route":"dermal","species":"rat","study_id":"sccs_o_253_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 50 mg/kg bw/day rat dermal chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=50; DOSE=__________________________ 28 3.4 SAFETY EVALUATION (including calculation of the MoS) The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day.; EFFECT=__________________________ 28 3.4 SAFETY EVALUATION (including calculation of the MoS) The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day. This was based on the NOAEL of 50 mg/kg bw/day obtained in the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats and applying an uncertainty factor of 100 to the NOAEL. Based on this NOAEL as the Point of Departure (POD), the SCCS has revised the exposure calculation for non-oxidative conditions in accordance with the changed procedure for SED calculations (SCCS/1628/21). The dermal absorption data from studies carried out according to most recent guidelines and guidance requirements under non-oxidative conditions, showed a low penetration into the viable skin layers and into the receptor fluid (5.35 + 2.76). The SCCS has used the dermal absorption value of 8.11 µg/cm² (Mean + 1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"__________________________ 28 3.4 SAFETY EVALUATION (including calculation of the MoS) The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day.","duration":"chronic","effect":"__________________________ 28 3.4 SAFETY EVALUATION (including calculation of the MoS) The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day. This was based on the NOAEL of 50 mg/kg bw/day obtained in the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats and applying an uncertainty factor of 100 to the NOAEL. Based on this NOAEL as the Point of Departure (POD), the SCCS has revised the exposure calculation for non-oxidative conditions in accordance with the changed procedure for SED calculations (SCCS/1628/21). The dermal absorption data from studies carried out according to most recent guidelines and guidance requirements under non-oxidative conditions, showed a low penetration into the viable skin layers and into the receptor fluid (5.35 + 2.76). The SCCS has used the dermal absorption value of 8.11 µg/cm² (Mean + 1","endpoint":"reproductive toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":28,"route":"dermal","species":"rat","study_id":"sccs_o_253_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 50 mg/kg bw/day rat dermal chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT=50; DOSE=_____ 28 3.4 SAFETY EVALUATION (including calculation of the MoS) The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day.; EFFECT=_____ 28 3.4 SAFETY EVALUATION (including calculation of the MoS) The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day. This was based on the NOAEL of 50 mg/kg bw/day obtained in the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats and applying an uncertainty factor of 100 to the NOAEL. Based on this NOAEL as the Point of Departure (POD), the SCCS has revised the exposure calculation for non-oxidative conditions in accordance with the changed procedure for SED calculations (SCCS/1628/21). The dermal absorption data from studies carried out according to most recent guidelines and guidance requirements under non-oxidative conditions, showed a low penetration into the viable skin layers and into the receptor fluid (5.35 + 2.76). The SCCS has used the dermal absorption value of 8.11 µg/cm² (Mean + 1x SD) in Margin of Sa; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"_____ 28 3.4 SAFETY EVALUATION (including calculation of the MoS) The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day.","duration":"chronic","effect":"_____ 28 3.4 SAFETY EVALUATION (including calculation of the MoS) The previously established Acceptable Daily Intake (ADI) of 0-10 mg/kg bw/day by the FAO (1974) was revised following evaluation by WHO (1975, 1978 and 1984) and the EU Scientific Committee for Food (SCF) (1984) to 0.5 mg/kg bw/day. This was based on the NOAEL of 50 mg/kg bw/day obtained in the chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats and applying an uncertainty factor of 100 to the NOAEL. Based on this NOAEL as the Point of Departure (POD), the SCCS has revised the exposure calculation for non-oxidative conditions in accordance with the changed procedure for SED calculations (SCCS/1628/21). The dermal absorption data from studies carried out according to most recent guidelines and guidance requirements under non-oxidative conditions, showed a low penetration into the viable skin layers and into the receptor fluid (5.35 + 2.76). The SCCS has used the dermal absorption value of 8.11 µg/cm² (Mean + 1x SD) in Margin of Sa","endpoint":"reproductive toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":28,"route":"dermal","species":"rat","study_id":"sccs_o_253_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity =0.0783 mg/kg bw rat oral chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT== 0.0783; DOSE=CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw...; EFFECT=owed a low penetration into the viable skin layers and into the receptor fluid (5.35 + 2.76). The SCCS has used the dermal absorption value of 8.11 µg/cm² (Mean + 1x SD) in Margin of Safety (MoS) calculations as below: CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw/d (oral chronic toxicity and carcinogenicity study in the rat with a reproductive toxicity phase, rat) Bioavailability 50%* NOAELsys = 25 mg/kg bw/d Margin of Safety: adjusted NOAELsys/SED = 25 mg/kg bw /d / 0.0783 mg /kg bw/ d -> MoS: 319 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw...","duration":"chronic","effect":"owed a low penetration into the viable skin layers and into the receptor fluid (5.35 + 2.76). The SCCS has used the dermal absorption value of 8.11 µg/cm² (Mean + 1x SD) in Margin of Safety (MoS) calculations as below: CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw/d (oral chronic toxicity and carcinogenicity study in the rat with a reproductive toxicity phase, rat) Bioavailability 50%* NOAELsys = 25 mg/kg bw/d Margin of Safety: adjusted NOAELsys/SED = 25 mg/kg bw /d / 0.0783 mg /kg bw/ d -> MoS: 319 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","endpoint":"reproductive toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.0783","page":28,"route":"oral","species":"rat","study_id":"sccs_o_253_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity =50 mg/kg bw/d rat oral chronic reproductive toxicity SOURCE_SUBDIR=sccs_o_253; REPORT_TITLE=OPINION on Acid Yellow 3 – C054 (CAS No. 8004-92-0, EC. No 305-897-5); OPINION_NUMBER=SCCS/1631/21; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 23 July 2021; VALUE_TEXT== 50; DOSE=CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw...; EFFECT=iable skin layers and into the receptor fluid (5.35 + 2.76). The SCCS has used the dermal absorption value of 8.11 µg/cm² (Mean + 1x SD) in Margin of Safety (MoS) calculations as below: CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw/d (oral chronic toxicity and carcinogenicity study in the rat with a reproductive toxicity phase, rat) Bioavailability 50%* NOAELsys = 25 mg/kg bw/d Margin of Safety: adjusted NOAELsys/SED = 25 mg/kg bw /d / 0.0783 mg /kg bw/ d -> MoS: 319 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"8004-92-0","citation":"","dose":"CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw...","duration":"chronic","effect":"iable skin layers and into the receptor fluid (5.35 + 2.76). The SCCS has used the dermal absorption value of 8.11 µg/cm² (Mean + 1x SD) in Margin of Safety (MoS) calculations as below: CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin DAa = 8.11 µg/cm² Skin Surface area of scalp exposed SSA = 580 cm2 Dermal Absorption per treatment SSA x DAa x 0.001 = 4.7 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SSA x DAa x 0.001/bw = 0.0783 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw/d (oral chronic toxicity and carcinogenicity study in the rat with a reproductive toxicity phase, rat) Bioavailability 50%* NOAELsys = 25 mg/kg bw/d Margin of Safety: adjusted NOAELsys/SED = 25 mg/kg bw /d / 0.0783 mg /kg bw/ d -> MoS: 319 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","endpoint":"reproductive toxicity","ingredient":"in representative batches and results","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":28,"route":"oral","species":"rat","study_id":"sccs_o_253_noael_014"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 35SW5USQ3G UNII - - - mixture {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"35SW5USQ3G"}
openFDA substances FDA UNII substance identifier 35SW5USQ3G UNII - - - mixture {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"35SW5USQ3G"}
openFDA substances FDA UNII substance identifier 35SW5USQ3G UNII - - - mixture {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"35SW5USQ3G"}
openFDA substances FDA UNII substance identifier 35SW5USQ3G UNII - - - mixture {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"35SW5USQ3G"}