NOAEL Studies Cosmetic Ingredient

HC Yellow No. 2 NOAEL Studies

INCI: HC YELLOW NO. 2

CAS: 4926-55-0

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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COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 5 mg/kg bw/day rat oral 91 day Subchronic SCCS; A 91-Day Oral Gavage Toxicity Study With GTS03975 in Rats with a 28-Day RecoveryPhase, P&G study # 2747-53907, July 12, 2005
SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral Chronic NOAEL study {"citation":"Ref.: 12 Comment According to OECD guideline 408 the highest dose level should be chosen with the aim to induce toxicity","dose":"al administration of HC Yellow n° 2 up to 50 mg/kg bw/d in the rat for 91 consecutive days produced no mortality or notable signs of systemic toxicity.","effect":"al administration of HC Yellow n° 2 up to 50 mg/kg bw/d in the rat for 91 consecutive days produced no mortality or notable signs of systemic toxicity. In addition, there were no significant microscopic lesions observed following histopathological evaluation of selected organs/tissues. A variety of statistically significant changes were observed in the 5, 20 and 50 mg/kg bw/d animals, but these were deemed of no toxicological significance. Based on the findings in this study, the no-observed-adverse- effect level (NOAEL) for oral administration of HC Yellow n° 2 to rats for at least 91 consecutive days is 50 mg/kg bw/d. Ref.: 12 Comment According to OECD guideline 408 the highest dose level should be chosen with the aim to induce toxicity. 3.3.5.3. Chronic (> 12 months) toxicity 20 month study in mice, topical application of a hair dye formulation 0.05 ml per cm2 of a hair dye formulation containing 0.5% HC Yellow n° 2 was applied without occlusion three times weekly for twenty months to 60 male and 60 female Eppley Swiss mic","page":19,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat oral developmental developmental toxicity {"citation":"Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats","dose":"e 50, 200 or 500 mg/kg bw/d dosages of HC Yellow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range.","effect":"e 50, 200 or 500 mg/kg bw/d dosages of HC Yellow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range. Administration of dosages of HC Yellow n° 2 up to and including 500 mg/kg bw/d did not affect any other Caesarean-sectioning, litter observations or cause any gross external, soft tissue or skeletal alterations. Conclusion On the basis of these data, the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The small reduction in foetal body weights and reduced ossification site averages for phalanges were not considered adverse. Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats. Levels of 0, 0.195 and 0.78% of a hair dye composite material containing 15 hair dye substances were incorporated in the diet and provided ad libitum from GD 6 to GD 15 to 3 groups of each 20 pregnant a","page":30,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_002"}
SCCS_vision_codex NOAEL =0.05 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose S...","effect":"Opinion on HC Yellow n° 2 ___________________________________________________________________________________________ 32 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_004"}
SCCS_vision_codex NOAEL =0.08 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"r treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SA...","effect":"r treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typica","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_007"}
SCCS_vision_codex NOAEL =99.88 % rat oral 90-day repeated dose toxicity {"dose":"S x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14.","effect":"S x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic tox","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_010"}
SCCS_vision_codex NOAEL =625 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw.","effect":"day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic toxicity study in rats the no-observed-adverse-effect level (NOAEL) for oral administration of HC Yellow n° 2 is 50 mg/kg bw/d (the highest dose tested). In a developmental toxicity study in rats the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The study on reproductive toxicity was performed only with a formulation containing HC Yellow n° 2 which corresponds to a dose of 0.98 mg/kg bw/d.","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_011"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral Chronic NOAEL study {"citation":"Ref.: 12 Comment According to OECD guideline 408 the highest dose level should be chosen with the aim to induce toxicity","dose":"al administration of HC Yellow n° 2 up to 50 mg/kg bw/d in the rat for 91 consecutive days produced no mortality or notable signs of systemic toxicity.","effect":"al administration of HC Yellow n° 2 up to 50 mg/kg bw/d in the rat for 91 consecutive days produced no mortality or notable signs of systemic toxicity. In addition, there were no significant microscopic lesions observed following histopathological evaluation of selected organs/tissues. A variety of statistically significant changes were observed in the 5, 20 and 50 mg/kg bw/d animals, but these were deemed of no toxicological significance. Based on the findings in this study, the no-observed-adverse- effect level (NOAEL) for oral administration of HC Yellow n° 2 to rats for at least 91 consecutive days is 50 mg/kg bw/d. Ref.: 12 Comment According to OECD guideline 408 the highest dose level should be chosen with the aim to induce toxicity. 3.3.5.3. Chronic (> 12 months) toxicity 20 month study in mice, topical application of a hair dye formulation 0.05 ml per cm2 of a hair dye formulation containing 0.5% HC Yellow n° 2 was applied without occlusion three times weekly for twenty months to 60 male and 60 female Eppley Swiss mic","page":19,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat oral developmental developmental toxicity {"citation":"Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats","dose":"e 50, 200 or 500 mg/kg bw/d dosages of HC Yellow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range.","effect":"e 50, 200 or 500 mg/kg bw/d dosages of HC Yellow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range. Administration of dosages of HC Yellow n° 2 up to and including 500 mg/kg bw/d did not affect any other Caesarean-sectioning, litter observations or cause any gross external, soft tissue or skeletal alterations. Conclusion On the basis of these data, the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The small reduction in foetal body weights and reduced ossification site averages for phalanges were not considered adverse. Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats. Levels of 0, 0.195 and 0.78% of a hair dye composite material containing 15 hair dye substances were incorporated in the diet and provided ad libitum from GD 6 to GD 15 to 3 groups of each 20 pregnant a","page":30,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_002"}
SCCS_vision_codex NOAEL =0.05 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose S...","effect":"Opinion on HC Yellow n° 2 ___________________________________________________________________________________________ 32 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_004"}
SCCS_vision_codex NOAEL =0.08 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"r treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SA...","effect":"r treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typica","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_007"}
SCCS_vision_codex NOAEL =99.88 % rat oral 90-day repeated dose toxicity {"dose":"S x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14.","effect":"S x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic tox","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_010"}
SCCS_vision_codex NOAEL =625 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw.","effect":"day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic toxicity study in rats the no-observed-adverse-effect level (NOAEL) for oral administration of HC Yellow n° 2 is 50 mg/kg bw/d (the highest dose tested). In a developmental toxicity study in rats the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The study on reproductive toxicity was performed only with a formulation containing HC Yellow n° 2 which corresponds to a dose of 0.98 mg/kg bw/d.","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_011"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral Chronic NOAEL study {"citation":"Ref.: 12 Comment According to OECD guideline 408 the highest dose level should be chosen with the aim to induce toxicity","dose":"al administration of HC Yellow n° 2 up to 50 mg/kg bw/d in the rat for 91 consecutive days produced no mortality or notable signs of systemic toxicity.","effect":"al administration of HC Yellow n° 2 up to 50 mg/kg bw/d in the rat for 91 consecutive days produced no mortality or notable signs of systemic toxicity. In addition, there were no significant microscopic lesions observed following histopathological evaluation of selected organs/tissues. A variety of statistically significant changes were observed in the 5, 20 and 50 mg/kg bw/d animals, but these were deemed of no toxicological significance. Based on the findings in this study, the no-observed-adverse- effect level (NOAEL) for oral administration of HC Yellow n° 2 to rats for at least 91 consecutive days is 50 mg/kg bw/d. Ref.: 12 Comment According to OECD guideline 408 the highest dose level should be chosen with the aim to induce toxicity. 3.3.5.3. Chronic (> 12 months) toxicity 20 month study in mice, topical application of a hair dye formulation 0.05 ml per cm2 of a hair dye formulation containing 0.5% HC Yellow n° 2 was applied without occlusion three times weekly for twenty months to 60 male and 60 female Eppley Swiss mic","page":19,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat oral developmental developmental toxicity {"citation":"Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats","dose":"e 50, 200 or 500 mg/kg bw/d dosages of HC Yellow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range.","effect":"e 50, 200 or 500 mg/kg bw/d dosages of HC Yellow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range. Administration of dosages of HC Yellow n° 2 up to and including 500 mg/kg bw/d did not affect any other Caesarean-sectioning, litter observations or cause any gross external, soft tissue or skeletal alterations. Conclusion On the basis of these data, the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The small reduction in foetal body weights and reduced ossification site averages for phalanges were not considered adverse. Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats. Levels of 0, 0.195 and 0.78% of a hair dye composite material containing 15 hair dye substances were incorporated in the diet and provided ad libitum from GD 6 to GD 15 to 3 groups of each 20 pregnant a","page":30,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_002"}
SCCS_vision_codex NOAEL =0.05 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose S...","effect":"Opinion on HC Yellow n° 2 ___________________________________________________________________________________________ 32 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_004"}
SCCS_vision_codex NOAEL =0.08 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"r treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SA...","effect":"r treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typica","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_007"}
SCCS_vision_codex NOAEL =99.88 % rat oral 90-day repeated dose toxicity {"dose":"S x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14.","effect":"S x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic tox","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_010"}
SCCS_vision_codex NOAEL =625 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw.","effect":"day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic toxicity study in rats the no-observed-adverse-effect level (NOAEL) for oral administration of HC Yellow n° 2 is 50 mg/kg bw/d (the highest dose tested). In a developmental toxicity study in rats the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The study on reproductive toxicity was performed only with a formulation containing HC Yellow n° 2 which corresponds to a dose of 0.98 mg/kg bw/d.","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_011"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral Chronic NOAEL study {"citation":"Ref.: 12 Comment According to OECD guideline 408 the highest dose level should be chosen with the aim to induce toxicity","dose":"al administration of HC Yellow n° 2 up to 50 mg/kg bw/d in the rat for 91 consecutive days produced no mortality or notable signs of systemic toxicity.","effect":"al administration of HC Yellow n° 2 up to 50 mg/kg bw/d in the rat for 91 consecutive days produced no mortality or notable signs of systemic toxicity. In addition, there were no significant microscopic lesions observed following histopathological evaluation of selected organs/tissues. A variety of statistically significant changes were observed in the 5, 20 and 50 mg/kg bw/d animals, but these were deemed of no toxicological significance. Based on the findings in this study, the no-observed-adverse- effect level (NOAEL) for oral administration of HC Yellow n° 2 to rats for at least 91 consecutive days is 50 mg/kg bw/d. Ref.: 12 Comment According to OECD guideline 408 the highest dose level should be chosen with the aim to induce toxicity. 3.3.5.3. Chronic (> 12 months) toxicity 20 month study in mice, topical application of a hair dye formulation 0.05 ml per cm2 of a hair dye formulation containing 0.5% HC Yellow n° 2 was applied without occlusion three times weekly for twenty months to 60 male and 60 female Eppley Swiss mic","page":19,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat oral developmental developmental toxicity {"citation":"Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats","dose":"e 50, 200 or 500 mg/kg bw/d dosages of HC Yellow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range.","effect":"e 50, 200 or 500 mg/kg bw/d dosages of HC Yellow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range. Administration of dosages of HC Yellow n° 2 up to and including 500 mg/kg bw/d did not affect any other Caesarean-sectioning, litter observations or cause any gross external, soft tissue or skeletal alterations. Conclusion On the basis of these data, the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The small reduction in foetal body weights and reduced ossification site averages for phalanges were not considered adverse. Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats. Levels of 0, 0.195 and 0.78% of a hair dye composite material containing 15 hair dye substances were incorporated in the diet and provided ad libitum from GD 6 to GD 15 to 3 groups of each 20 pregnant a","page":30,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_002"}
SCCS_vision_codex NOAEL =0.05 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose S...","effect":"Opinion on HC Yellow n° 2 ___________________________________________________________________________________________ 32 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_004"}
SCCS_vision_codex NOAEL =0.08 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"r treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SA...","effect":"r treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typica","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_007"}
SCCS_vision_codex NOAEL =99.88 % rat oral 90-day repeated dose toxicity {"dose":"S x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14.","effect":"S x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic tox","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_010"}
SCCS_vision_codex NOAEL =625 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw.","effect":"day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic toxicity study in rats the no-observed-adverse-effect level (NOAEL) for oral administration of HC Yellow n° 2 is 50 mg/kg bw/d (the highest dose tested). In a developmental toxicity study in rats the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The study on reproductive toxicity was performed only with a formulation containing HC Yellow n° 2 which corresponds to a dose of 0.98 mg/kg bw/d.","page":32,"pdf":"sccs_o_038.pdf","row_type":"noael_study","study_id":"sccs_o_038_noael_011"}
ToxValDB_ECHA_IUCLID 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =500 mg/kg bw/day Rat oral - developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac32e4b0a7c65d1bdd22; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22290/7/9/3?documentUUID=bcef1609-8ff5-4d14-9e28-d41fbd397ab5; YEAR=2005; ORIGINAL_YEAR=2005; TOXICOLOGICAL_EFFECT=fetus: external malformations|fetus: skeletal malformations|fetus: visceral malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15821118_15821587:M/F:-fetal; 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_efeef4b12553154675219fdd327f69b3
ToxValDB_ECHA_IUCLID NOAEL =600 mg/kg bw/day Rat oral short-term; 14 days short-term QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb41e4b0a7c65d225626; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22290/7/6/2?documentUUID=bcef1609-8ff5-4d14-9e28-d41fbd397ab5; YEAR=2005; ORIGINAL_YEAR=2005; TOXICOLOGICAL_EFFECT=clinical signs|gross pathology|mortality; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|gross pathology|mortality/survival; STUDY_GROUP=ECHA IUCLID:15838937: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_7bb079c306344839b727921091bd276c
ToxValDB_ECHA_IUCLID NOAEL ~50 mg/kg bw/day Rat oral chronic; 91 days chronic QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae4ee4b0a7c65d1c885c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22290/7/6/2?documentUUID=bcef1609-8ff5-4d14-9e28-d41fbd397ab5; YEAR=2005; ORIGINAL_YEAR=2005; TOXICOLOGICAL_EFFECT=clinical signs|gross pathology|haematology|histopathology: non-neoplastic|mortality|ophthalmological examination; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|gross pathology|hematology|mortality/survival|nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID:15846343: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_ba88ca44aea8183b00ae9996d2f70bf3
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 14 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 50 mg/kg bw/d rat oral Chronic - SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=50; DOSE=al administration of HC Yellow n° 2 up to 50 mg/kg bw/d in the rat for 91 consecutive days produced no mortality or notable signs of systemic toxicity.; EFFECT=al administration of HC Yellow n° 2 up to 50 mg/kg bw/d in the rat for 91 consecutive days produced no mortality or notable signs of systemic toxicity. In addition, there were no significant microscopic lesions observed following histopathological evaluation of selected organs/tissues. A variety of statistically significant changes were observed in the 5, 20 and 50 mg/kg bw/d animals, but these were deemed of no toxicological significance. Based on the findings in this study, the no-observed-adverse- effect level (NOAEL) for oral administration of HC Yellow n° 2 to rats for at least 91 consecutive days is 50 mg/kg bw/d. Ref.: 12 Comment According to OECD guideline 408 the highest dose level should be chosen with the aim to induce toxicity. 3.3.5.3. Chronic (> 12 months) toxicity 20 month study in mice, topical application of a hair dye formulation 0.05 ml per cm2 of a hair dye formulation containing 0.5% HC Yellow n° 2 was applied without occlusion three times weekly for twenty months to 60 male and 60 female Eppley Swiss mic; CITATION=Ref.: 12 Comment According to OECD guideline 408 the highest dose level should be chosen with the aim to induce toxicity; CITATION_NUMBERS=[12,408]; REFERENCE=Ref.: 12 Comment According to OECD guideline 408 the highest dose level should be chosen with the aim to induce toxicity; DETAILS_JSON={"cas_number":"4926-55-0","citation":"Ref.: 12 Comment According to OECD guideline 408 the highest dose level should be chosen with the aim to induce toxicity","dose":"al administration of HC Yellow n° 2 up to 50 mg/kg bw/d in the rat for 91 consecutive days produced no mortality or notable signs of systemic toxicity.","duration":"Chronic","effect":"al administration of HC Yellow n° 2 up to 50 mg/kg bw/d in the rat for 91 consecutive days produced no mortality or notable signs of systemic toxicity. In addition, there were no significant microscopic lesions observed following histopathological evaluation of selected organs/tissues. A variety of statistically significant changes were observed in the 5, 20 and 50 mg/kg bw/d animals, but these were deemed of no toxicological significance. Based on the findings in this study, the no-observed-adverse- effect level (NOAEL) for oral administration of HC Yellow n° 2 to rats for at least 91 consecutive days is 50 mg/kg bw/d. Ref.: 12 Comment According to OECD guideline 408 the highest dose level should be chosen with the aim to induce toxicity. 3.3.5.3. Chronic (> 12 months) toxicity 20 month study in mice, topical application of a hair dye formulation 0.05 ml per cm2 of a hair dye formulation containing 0.5% HC Yellow n° 2 was applied without occlusion three times weekly for twenty months to 60 male and 60 female Eppley Swiss mic","endpoint":"","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":19,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.05 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 0.05; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose S...; EFFECT=Opinion on HC Yellow n° 2 ___________________________________________________________________________________________ 32 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4926-55-0","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose S...","duration":"90-day","effect":"Opinion on HC Yellow n° 2 ___________________________________________________________________________________________ 32 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only","endpoint":"dermal absorption","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.05","page":32,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =50 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 50; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose S...; EFFECT=______________________________________________________________________________________ 32 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% o; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4926-55-0","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose S...","duration":"90-day","effect":"______________________________________________________________________________________ 32 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% o","endpoint":"dermal absorption","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":32,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =50 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 50; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose S...; EFFECT=__________________________ 32 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have b; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4926-55-0","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose S...","duration":"90-day","effect":"__________________________ 32 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Yellow n° 2 (Non-oxidative formulation) Absorption through the skin A (mean + 1 SD) = 5.31 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have b","endpoint":"dermal absorption","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":32,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.08 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 0.08; DOSE=r treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SA...; EFFECT=r treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typica; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4926-55-0","citation":"","dose":"r treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SA...","duration":"90-day","effect":"r treatment SAS x A x 0.001 = 3.08 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typica","endpoint":"dermal absorption","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.08","page":32,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =50 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 50; DOSE=8 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per...; EFFECT=8 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4926-55-0","citation":"","dose":"8 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per...","duration":"90-day","effect":"8 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair","endpoint":"dermal absorption","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":32,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =50 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT== 50; DOSE=dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of...; EFFECT=dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secon; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4926-55-0","citation":"","dose":"dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of...","duration":"90-day","effect":"dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 974 (Oxidative formulation) Absorption through the skin A (mean + 1 SD) = 8.27 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secon","endpoint":"dermal absorption","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":32,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 500 mg/kg bw/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=500; DOSE=e 50, 200 or 500 mg/kg bw/d dosages of HC Yellow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range.; EFFECT=e 50, 200 or 500 mg/kg bw/d dosages of HC Yellow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range. Administration of dosages of HC Yellow n° 2 up to and including 500 mg/kg bw/d did not affect any other Caesarean-sectioning, litter observations or cause any gross external, soft tissue or skeletal alterations. Conclusion On the basis of these data, the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The small reduction in foetal body weights and reduced ossification site averages for phalanges were not considered adverse. Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats. Levels of 0, 0.195 and 0.78% of a hair dye composite material containing 15 hair dye substances were incorporated in the diet and provided ad libitum from GD 6 to GD 15 to 3 groups of each 20 pregnant a; CITATION=Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats; CITATION_NUMBERS=[19]; REFERENCE=Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats; DETAILS_JSON={"cas_number":"4926-55-0","citation":"Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats","dose":"e 50, 200 or 500 mg/kg bw/d dosages of HC Yellow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range.","duration":"developmental","effect":"e 50, 200 or 500 mg/kg bw/d dosages of HC Yellow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range. Administration of dosages of HC Yellow n° 2 up to and including 500 mg/kg bw/d did not affect any other Caesarean-sectioning, litter observations or cause any gross external, soft tissue or skeletal alterations. Conclusion On the basis of these data, the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The small reduction in foetal body weights and reduced ossification site averages for phalanges were not considered adverse. Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats. Levels of 0, 0.195 and 0.78% of a hair dye composite material containing 15 hair dye substances were incorporated in the diet and provided ad libitum from GD 6 to GD 15 to 3 groups of each 20 pregnant a","endpoint":"developmental toxicity","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":30,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 500 mg/kg bw/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=500; DOSE=Administration of dosages of HC Yellow n° 2 up to and including 500 mg/kg bw/d did not affect any other Caesarean-sectioning, litter observations or cause any gross external, soft tissue or skeletal alterations.; EFFECT=llow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range. Administration of dosages of HC Yellow n° 2 up to and including 500 mg/kg bw/d did not affect any other Caesarean-sectioning, litter observations or cause any gross external, soft tissue or skeletal alterations. Conclusion On the basis of these data, the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The small reduction in foetal body weights and reduced ossification site averages for phalanges were not considered adverse. Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats. Levels of 0, 0.195 and 0.78% of a hair dye composite material containing 15 hair dye substances were incorporated in the diet and provided ad libitum from GD 6 to GD 15 to 3 groups of each 20 pregnant animals. The concentration of HC Yellow n° 2; CITATION=Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats; CITATION_NUMBERS=[19]; REFERENCE=Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats; DETAILS_JSON={"cas_number":"4926-55-0","citation":"Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats","dose":"Administration of dosages of HC Yellow n° 2 up to and including 500 mg/kg bw/d did not affect any other Caesarean-sectioning, litter observations or cause any gross external, soft tissue or skeletal alterations.","duration":"developmental","effect":"llow n° 2 were associated with significant reductions in the average number of ossified fore- and/or hind- limb phalanges that were also all within historical control range. Administration of dosages of HC Yellow n° 2 up to and including 500 mg/kg bw/d did not affect any other Caesarean-sectioning, litter observations or cause any gross external, soft tissue or skeletal alterations. Conclusion On the basis of these data, the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The small reduction in foetal body weights and reduced ossification site averages for phalanges were not considered adverse. Ref.: 19 Developmental toxicity study in rats using a formulation A teratology study was performed on Virgin CFE-S rats. Levels of 0, 0.195 and 0.78% of a hair dye composite material containing 15 hair dye substances were incorporated in the diet and provided ad libitum from GD 6 to GD 15 to 3 groups of each 20 pregnant animals. The concentration of HC Yellow n° 2","endpoint":"developmental toxicity","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":30,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 99.88 % rat oral 90-day repeated dose toxicity SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=99.88; DOSE=S x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14.; EFFECT=S x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic tox; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4926-55-0","citation":"","dose":"S x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14.","duration":"90-day","effect":"S x A x 0.001 = 4.80 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.08 mg/kg bw/d No observed adverse effect level NOAEL = 50 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 625 3.3.14. Discussion Physico-chemical properties In only 50% of the toxicological studies batches of HC Yellow n° 2 have been used which had been characterized according to identity, purity, stability and homogeneity. The chemical identity of HC Yellow n° 2 which has been used for the NOAEL setting sub chronic 91 day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic tox","endpoint":"repeated dose toxicity","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"%","noael_value":"99.88","page":32,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 625 mg/kg bw rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=625; DOSE=Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw.; EFFECT=day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic toxicity study in rats the no-observed-adverse-effect level (NOAEL) for oral administration of HC Yellow n° 2 is 50 mg/kg bw/d (the highest dose tested). In a developmental toxicity study in rats the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The study on reproductive toxicity was performed only with a formulation containing HC Yellow n° 2 which corresponds to a dose of 0.98 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4926-55-0","citation":"","dose":"Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw.","duration":"subchronic","effect":"day study, is well documented with respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic toxicity study in rats the no-observed-adverse-effect level (NOAEL) for oral administration of HC Yellow n° 2 is 50 mg/kg bw/d (the highest dose tested). In a developmental toxicity study in rats the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The study on reproductive toxicity was performed only with a formulation containing HC Yellow n° 2 which corresponds to a dose of 0.98 mg/kg bw/d.","endpoint":"repeated dose toxicity","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"mg/kg bw","noael_value":"625","page":32,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 50 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=50; DOSE=Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw.; EFFECT=respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic toxicity study in rats the no-observed-adverse-effect level (NOAEL) for oral administration of HC Yellow n° 2 is 50 mg/kg bw/d (the highest dose tested). In a developmental toxicity study in rats the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The study on reproductive toxicity was performed only with a formulation containing HC Yellow n° 2 which corresponds to a dose of 0.98 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4926-55-0","citation":"","dose":"Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw.","duration":"subchronic","effect":"respect to identity, purity (99.88%), stability and homogeneity. The stability in a typical hair dye formulation was not reported. HC Yellow n° 2 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic toxicity study in rats the no-observed-adverse-effect level (NOAEL) for oral administration of HC Yellow n° 2 is 50 mg/kg bw/d (the highest dose tested). In a developmental toxicity study in rats the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The study on reproductive toxicity was performed only with a formulation containing HC Yellow n° 2 which corresponds to a dose of 0.98 mg/kg bw/d.","endpoint":"repeated dose toxicity","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":32,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 500 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=500; DOSE=Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw.; EFFECT=e to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic toxicity study in rats the no-observed-adverse-effect level (NOAEL) for oral administration of HC Yellow n° 2 is 50 mg/kg bw/d (the highest dose tested). In a developmental toxicity study in rats the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The study on reproductive toxicity was performed only with a formulation containing HC Yellow n° 2 which corresponds to a dose of 0.98 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4926-55-0","citation":"","dose":"Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw.","duration":"subchronic","effect":"e to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic toxicity study in rats the no-observed-adverse-effect level (NOAEL) for oral administration of HC Yellow n° 2 is 50 mg/kg bw/d (the highest dose tested). In a developmental toxicity study in rats the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The study on reproductive toxicity was performed only with a formulation containing HC Yellow n° 2 which corresponds to a dose of 0.98 mg/kg bw/d.","endpoint":"repeated dose toxicity","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":32,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 500 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_038; REPORT_TITLE=OPINION ON HC Yellow n° 2 COLIPA n° B41; OPINION_NUMBER=SCCS/1309/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 September 2010; VALUE_TEXT=500; DOSE=Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw.; EFFECT=es. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic toxicity study in rats the no-observed-adverse-effect level (NOAEL) for oral administration of HC Yellow n° 2 is 50 mg/kg bw/d (the highest dose tested). In a developmental toxicity study in rats the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The study on reproductive toxicity was performed only with a formulation containing HC Yellow n° 2 which corresponds to a dose of 0.98 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4926-55-0","citation":"","dose":"Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw.","duration":"subchronic","effect":"es. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Toxicity HC Yellow n° 2 was toxic after oral gavage dosing of 1250 mg/kg bw, not at 625 mg/kg bw. In a subchronic toxicity study in rats the no-observed-adverse-effect level (NOAEL) for oral administration of HC Yellow n° 2 is 50 mg/kg bw/d (the highest dose tested). In a developmental toxicity study in rats the maternal no-observable-adverse-effect- level (NOAEL) is 500 mg/kg bw/d. The developmental NOAEL is also 500 mg/kg bw/d. The study on reproductive toxicity was performed only with a formulation containing HC Yellow n° 2 which corresponds to a dose of 0.98 mg/kg bw/d.","endpoint":"repeated dose toxicity","ingredient":"2-Nitro-N-(2-hydroxyethyl)aniline","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":32,"route":"oral","species":"rat","study_id":"sccs_o_038_noael_014"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 9FVT2KMV9O UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H10N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9FVT2KMV9O"}
openFDA substances FDA UNII substance identifier 9FVT2KMV9O UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H10N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9FVT2KMV9O"}
openFDA substances FDA UNII substance identifier 9FVT2KMV9O UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H10N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9FVT2KMV9O"}
openFDA substances FDA UNII substance identifier 9FVT2KMV9O UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H10N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9FVT2KMV9O"}