NOAEL Studies Cosmetic Ingredient

HC RED NO. 1 NOAEL Studies

CAS: 2784-89-6

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 2 mg/kg bw/day rat oral 91 day Subchronic SCCP; A 91-Day Oral Gavage Toxicity Study With GTS03974 In Rats With A 28-Day RecoveryPhase, P&G study # 2746-53896, July 2005
SCCS_vision_codex 28 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral 91-day repeated dose toxicity {"citation":"Ref.: 11 91-day oral subchronic toxicity study in rats","dose":"150, 300 and 600 mg/kg/day females.","effect":"150, 300 and 600 mg/kg/day females. Conclusion Based on the results of this study, oral administration of HC Red n° 1 in the rat for 14 consecutive days at up to 600 mg/kg/day did not produce treatment-related mortality. However, notable treatment-related changes were observed in the 150, 300 and 600 mg/kg/day dose groups. These generally consisted of clinical abnormalities, decreased weight gain/food consumption, abnormal clinical pathology, gross necropsy observations and increased liver and spleen weights. The no-observed-adverse-effect level (NOAEL) in this study is 50 mg/kg bw/d. Ref.: 11 91-day oral subchronic toxicity study in rats","page":14,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_001"}
SCCS_vision_codex NOAEL =20 mg/kg bw/d rabbit oral - NOAEL study {"citation":"Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d","dose":"Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.","effect":"es (20 mg/kg bw/d). There were no test article-related microscopic findings in this study: Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 m","page":16,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_003"}
SCCS_vision_codex NOAEL =5 mg/kg bw/d rabbit oral 13 weeks NOAEL study {"citation":"Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d","dose":"with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.","effect":"with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 ml per kg of a solution containing 0.15% HC Red n° 1 Treatment: Topical administration twice weekly for 13 weeks GLP: not in compliance The exp","page":16,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_005"}
SCCS_vision_codex NOAEL =25 mg/kg/day - oral developmental developmental toxicity {"citation":"Ref.: 18","dose":"Absolute feed consumption values were significantly reduced in the 25 mg/kg/day dosage group on days 6 to 9, and absolute and relative feed consumption values were also significantly reduced in the 125 mg/kg/day dosage group on days 18 to 21.","effect":"as well as for the entire dosage and gestation periods. Absolute feed consumption values were significantly reduced in the 25 mg/kg/day dosage group on days 6 to 9, and absolute and relative feed consumption values were also significantly reduced in the 125 mg/kg/day dosage group on days 18 to 21. Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related. The maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Ref.: 18","page":31,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_006"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d - - developmental developmental toxicity {"citation":"Ref.: 18","dose":"Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related.","effect":"g/day dosage group on days 18 to 21. Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related. The maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Ref.: 18","page":31,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_007"}
SCCS_vision_codex NOAEL =0.0294 mg/kg rat oral subchronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...","effect":"981/06 Opinion on HC Red n° 1 ____________________________________________________________________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (fe","page":33,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_008"}
SCCS_vision_codex NOAEL =5 mg/kg rat oral subchronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...","effect":"__________________________________________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females). In a subchronic toxici","page":33,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_009"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral 91-day repeated dose toxicity {"citation":"Ref.: 11 91-day oral subchronic toxicity study in rats","dose":"150, 300 and 600 mg/kg/day females.","effect":"150, 300 and 600 mg/kg/day females. Conclusion Based on the results of this study, oral administration of HC Red n° 1 in the rat for 14 consecutive days at up to 600 mg/kg/day did not produce treatment-related mortality. However, notable treatment-related changes were observed in the 150, 300 and 600 mg/kg/day dose groups. These generally consisted of clinical abnormalities, decreased weight gain/food consumption, abnormal clinical pathology, gross necropsy observations and increased liver and spleen weights. The no-observed-adverse-effect level (NOAEL) in this study is 50 mg/kg bw/d. Ref.: 11 91-day oral subchronic toxicity study in rats","page":14,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_001"}
SCCS_vision_codex NOAEL =20 mg/kg bw/d rabbit oral - NOAEL study {"citation":"Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d","dose":"Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.","effect":"es (20 mg/kg bw/d). There were no test article-related microscopic findings in this study: Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 m","page":16,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_003"}
SCCS_vision_codex NOAEL =5 mg/kg bw/d rabbit oral 13 weeks NOAEL study {"citation":"Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d","dose":"with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.","effect":"with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 ml per kg of a solution containing 0.15% HC Red n° 1 Treatment: Topical administration twice weekly for 13 weeks GLP: not in compliance The exp","page":16,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_005"}
SCCS_vision_codex NOAEL =25 mg/kg/day - oral developmental developmental toxicity {"citation":"Ref.: 18","dose":"Absolute feed consumption values were significantly reduced in the 25 mg/kg/day dosage group on days 6 to 9, and absolute and relative feed consumption values were also significantly reduced in the 125 mg/kg/day dosage group on days 18 to 21.","effect":"as well as for the entire dosage and gestation periods. Absolute feed consumption values were significantly reduced in the 25 mg/kg/day dosage group on days 6 to 9, and absolute and relative feed consumption values were also significantly reduced in the 125 mg/kg/day dosage group on days 18 to 21. Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related. The maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Ref.: 18","page":31,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_006"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d - - developmental developmental toxicity {"citation":"Ref.: 18","dose":"Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related.","effect":"g/day dosage group on days 18 to 21. Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related. The maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Ref.: 18","page":31,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_007"}
SCCS_vision_codex NOAEL =0.0294 mg/kg rat oral subchronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...","effect":"981/06 Opinion on HC Red n° 1 ____________________________________________________________________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (fe","page":33,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_008"}
SCCS_vision_codex NOAEL =5 mg/kg rat oral subchronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...","effect":"__________________________________________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females). In a subchronic toxici","page":33,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_009"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral 91-day repeated dose toxicity {"citation":"Ref.: 11 91-day oral subchronic toxicity study in rats","dose":"150, 300 and 600 mg/kg/day females.","effect":"150, 300 and 600 mg/kg/day females. Conclusion Based on the results of this study, oral administration of HC Red n° 1 in the rat for 14 consecutive days at up to 600 mg/kg/day did not produce treatment-related mortality. However, notable treatment-related changes were observed in the 150, 300 and 600 mg/kg/day dose groups. These generally consisted of clinical abnormalities, decreased weight gain/food consumption, abnormal clinical pathology, gross necropsy observations and increased liver and spleen weights. The no-observed-adverse-effect level (NOAEL) in this study is 50 mg/kg bw/d. Ref.: 11 91-day oral subchronic toxicity study in rats","page":14,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_001"}
SCCS_vision_codex NOAEL =20 mg/kg bw/d rabbit oral - NOAEL study {"citation":"Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d","dose":"Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.","effect":"es (20 mg/kg bw/d). There were no test article-related microscopic findings in this study: Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 m","page":16,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_003"}
SCCS_vision_codex NOAEL =5 mg/kg bw/d rabbit oral 13 weeks NOAEL study {"citation":"Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d","dose":"with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.","effect":"with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 ml per kg of a solution containing 0.15% HC Red n° 1 Treatment: Topical administration twice weekly for 13 weeks GLP: not in compliance The exp","page":16,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_005"}
SCCS_vision_codex NOAEL =25 mg/kg/day - oral developmental developmental toxicity {"citation":"Ref.: 18","dose":"Absolute feed consumption values were significantly reduced in the 25 mg/kg/day dosage group on days 6 to 9, and absolute and relative feed consumption values were also significantly reduced in the 125 mg/kg/day dosage group on days 18 to 21.","effect":"as well as for the entire dosage and gestation periods. Absolute feed consumption values were significantly reduced in the 25 mg/kg/day dosage group on days 6 to 9, and absolute and relative feed consumption values were also significantly reduced in the 125 mg/kg/day dosage group on days 18 to 21. Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related. The maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Ref.: 18","page":31,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_006"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d - - developmental developmental toxicity {"citation":"Ref.: 18","dose":"Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related.","effect":"g/day dosage group on days 18 to 21. Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related. The maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Ref.: 18","page":31,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_007"}
SCCS_vision_codex NOAEL =0.0294 mg/kg rat oral subchronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...","effect":"981/06 Opinion on HC Red n° 1 ____________________________________________________________________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (fe","page":33,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_008"}
SCCS_vision_codex NOAEL =5 mg/kg rat oral subchronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...","effect":"__________________________________________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females). In a subchronic toxici","page":33,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_009"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral 91-day repeated dose toxicity {"citation":"Ref.: 11 91-day oral subchronic toxicity study in rats","dose":"150, 300 and 600 mg/kg/day females.","effect":"150, 300 and 600 mg/kg/day females. Conclusion Based on the results of this study, oral administration of HC Red n° 1 in the rat for 14 consecutive days at up to 600 mg/kg/day did not produce treatment-related mortality. However, notable treatment-related changes were observed in the 150, 300 and 600 mg/kg/day dose groups. These generally consisted of clinical abnormalities, decreased weight gain/food consumption, abnormal clinical pathology, gross necropsy observations and increased liver and spleen weights. The no-observed-adverse-effect level (NOAEL) in this study is 50 mg/kg bw/d. Ref.: 11 91-day oral subchronic toxicity study in rats","page":14,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_001"}
SCCS_vision_codex NOAEL =20 mg/kg bw/d rabbit oral - NOAEL study {"citation":"Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d","dose":"Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.","effect":"es (20 mg/kg bw/d). There were no test article-related microscopic findings in this study: Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 m","page":16,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_003"}
SCCS_vision_codex NOAEL =5 mg/kg bw/d rabbit oral 13 weeks NOAEL study {"citation":"Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d","dose":"with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.","effect":"with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 ml per kg of a solution containing 0.15% HC Red n° 1 Treatment: Topical administration twice weekly for 13 weeks GLP: not in compliance The exp","page":16,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_005"}
SCCS_vision_codex NOAEL =25 mg/kg/day - oral developmental developmental toxicity {"citation":"Ref.: 18","dose":"Absolute feed consumption values were significantly reduced in the 25 mg/kg/day dosage group on days 6 to 9, and absolute and relative feed consumption values were also significantly reduced in the 125 mg/kg/day dosage group on days 18 to 21.","effect":"as well as for the entire dosage and gestation periods. Absolute feed consumption values were significantly reduced in the 25 mg/kg/day dosage group on days 6 to 9, and absolute and relative feed consumption values were also significantly reduced in the 125 mg/kg/day dosage group on days 18 to 21. Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related. The maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Ref.: 18","page":31,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_006"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d - - developmental developmental toxicity {"citation":"Ref.: 18","dose":"Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related.","effect":"g/day dosage group on days 18 to 21. Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related. The maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Ref.: 18","page":31,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_007"}
SCCS_vision_codex NOAEL =0.0294 mg/kg rat oral subchronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...","effect":"981/06 Opinion on HC Red n° 1 ____________________________________________________________________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (fe","page":33,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_008"}
SCCS_vision_codex NOAEL =5 mg/kg rat oral subchronic repeated dose toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...","effect":"__________________________________________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females). In a subchronic toxici","page":33,"pdf":"sccp_o_072.pdf","row_type":"noael_study","study_id":"sccp_o_072_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 13 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 20 mg/kg bw/d rabbit oral - - SOURCE_SUBDIR=sccp_o_072; REPORT_TITLE=Opinion on HC Red n° 1 COLIPA N° B48; OPINION_NUMBER=SCCP/0981/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=20; DOSE=Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.; EFFECT=es (20 mg/kg bw/d). There were no test article-related microscopic findings in this study: Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 m; CITATION=Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d; CITATION_NUMBERS=[12,20,5]; REFERENCE=Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d; DETAILS_JSON={"cas_number":"2784-89-6","citation":"Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d","dose":"Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.","duration":"","effect":"es (20 mg/kg bw/d). There were no test article-related microscopic findings in this study: Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 m","endpoint":"","ingredient":"HC Red n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"20","page":16,"route":"oral","species":"rabbit","study_id":"sccp_o_072_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 20 mg/kg bw/d rabbit oral - - SOURCE_SUBDIR=sccp_o_072; REPORT_TITLE=Opinion on HC Red n° 1 COLIPA N° B48; OPINION_NUMBER=SCCP/0981/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=20; DOSE=Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.; EFFECT=test article-related microscopic findings in this study: Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 ml per k; CITATION=Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d; CITATION_NUMBERS=[12,20,5]; REFERENCE=Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d; DETAILS_JSON={"cas_number":"2784-89-6","citation":"Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d","dose":"Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.","duration":"","effect":"test article-related microscopic findings in this study: Gross necropsy observations at the end of the treatment period were consistent with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 ml per k","endpoint":"","ingredient":"HC Red n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"20","page":16,"route":"oral","species":"rabbit","study_id":"sccp_o_072_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 5 mg/kg bw/d rabbit oral 13 weeks - SOURCE_SUBDIR=sccp_o_072; REPORT_TITLE=Opinion on HC Red n° 1 COLIPA N° B48; OPINION_NUMBER=SCCP/0981/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=5; DOSE=with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.; EFFECT=with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 ml per kg of a solution containing 0.15% HC Red n° 1 Treatment: Topical administration twice weekly for 13 weeks GLP: not in compliance The exp; CITATION=Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d; CITATION_NUMBERS=[12,20,5]; REFERENCE=Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d; DETAILS_JSON={"cas_number":"2784-89-6","citation":"Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d","dose":"with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day.","duration":"13 weeks","effect":"with oral administration of a chemical dye and included abnormal contents in the large intestine in females and stained tail and hair coat in both males and females treated with 20 mg/kg/day. There were no notable gross necropsy observations observed at the end of the recovery period for males or females. Conclusion According to the applicant the no-observed-adverse-effect level (NOAEL) in this study is 20 mg/kg bw/d. Ref.: 12 Comment Due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. Dermal toxicity in rabbits following topical administration of a hair dye formulation containing 0.15 % HC Red n° 1 Guideline: / Species/strain: New Zealand White Rabbits Group size: 6 males and females per group Test substance: A semi-permanent hair dye formulation (P24) containing 0.15% HC Red n° 1 (see Table below) Batch: / Purity: not given Dose: 1 ml per kg of a solution containing 0.15% HC Red n° 1 Treatment: Topical administration twice weekly for 13 weeks GLP: not in compliance The exp","endpoint":"","ingredient":"HC Red n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"5","page":16,"route":"oral","species":"rabbit","study_id":"sccp_o_072_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 25 mg/kg/day - oral developmental developmental toxicity SOURCE_SUBDIR=sccp_o_072; REPORT_TITLE=Opinion on HC Red n° 1 COLIPA N° B48; OPINION_NUMBER=SCCP/0981/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=25; DOSE=Absolute feed consumption values were significantly reduced in the 25 mg/kg/day dosage group on days 6 to 9, and absolute and relative feed consumption values were also significantly reduced in the 125 mg/kg/day dosage group on days 18 to 21.; EFFECT=as well as for the entire dosage and gestation periods. Absolute feed consumption values were significantly reduced in the 25 mg/kg/day dosage group on days 6 to 9, and absolute and relative feed consumption values were also significantly reduced in the 125 mg/kg/day dosage group on days 18 to 21. Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related. The maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Ref.: 18; CITATION=Ref.: 18; CITATION_NUMBERS=[18]; REFERENCE=Ref.: 18; DETAILS_JSON={"cas_number":"2784-89-6","citation":"Ref.: 18","dose":"Absolute feed consumption values were significantly reduced in the 25 mg/kg/day dosage group on days 6 to 9, and absolute and relative feed consumption values were also significantly reduced in the 125 mg/kg/day dosage group on days 18 to 21.","duration":"developmental","effect":"as well as for the entire dosage and gestation periods. Absolute feed consumption values were significantly reduced in the 25 mg/kg/day dosage group on days 6 to 9, and absolute and relative feed consumption values were also significantly reduced in the 125 mg/kg/day dosage group on days 18 to 21. Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related. The maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Ref.: 18","endpoint":"developmental toxicity","ingredient":"HC Red n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"25","page":31,"route":"oral","species":"","study_id":"sccp_o_072_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 125 mg/kg bw/d - - developmental developmental toxicity SOURCE_SUBDIR=sccp_o_072; REPORT_TITLE=Opinion on HC Red n° 1 COLIPA N° B48; OPINION_NUMBER=SCCP/0981/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=125; DOSE=Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related.; EFFECT=g/day dosage group on days 18 to 21. Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related. The maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Ref.: 18; CITATION=Ref.: 18; CITATION_NUMBERS=[18]; REFERENCE=Ref.: 18; DETAILS_JSON={"cas_number":"2784-89-6","citation":"Ref.: 18","dose":"Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related.","duration":"developmental","effect":"g/day dosage group on days 18 to 21. Caesarean- sectioning and litter parameters were unaffected by substance treatment as high as 125 mg/kg/day, and no foetal alterations were considered treatment related. The maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Ref.: 18","endpoint":"developmental toxicity","ingredient":"HC Red n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"125","page":31,"route":"","species":"","study_id":"sccp_o_072_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 50 mg/kg bw/d rat oral 91-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_072; REPORT_TITLE=Opinion on HC Red n° 1 COLIPA N° B48; OPINION_NUMBER=SCCP/0981/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=50; DOSE=150, 300 and 600 mg/kg/day females.; EFFECT=150, 300 and 600 mg/kg/day females. Conclusion Based on the results of this study, oral administration of HC Red n° 1 in the rat for 14 consecutive days at up to 600 mg/kg/day did not produce treatment-related mortality. However, notable treatment-related changes were observed in the 150, 300 and 600 mg/kg/day dose groups. These generally consisted of clinical abnormalities, decreased weight gain/food consumption, abnormal clinical pathology, gross necropsy observations and increased liver and spleen weights. The no-observed-adverse-effect level (NOAEL) in this study is 50 mg/kg bw/d. Ref.: 11 91-day oral subchronic toxicity study in rats; CITATION=Ref.: 11 91-day oral subchronic toxicity study in rats; CITATION_NUMBERS=[11,91]; REFERENCE=Ref.: 11 91-day oral subchronic toxicity study in rats; DETAILS_JSON={"cas_number":"2784-89-6","citation":"Ref.: 11 91-day oral subchronic toxicity study in rats","dose":"150, 300 and 600 mg/kg/day females.","duration":"91-day","effect":"150, 300 and 600 mg/kg/day females. Conclusion Based on the results of this study, oral administration of HC Red n° 1 in the rat for 14 consecutive days at up to 600 mg/kg/day did not produce treatment-related mortality. However, notable treatment-related changes were observed in the 150, 300 and 600 mg/kg/day dose groups. These generally consisted of clinical abnormalities, decreased weight gain/food consumption, abnormal clinical pathology, gross necropsy observations and increased liver and spleen weights. The no-observed-adverse-effect level (NOAEL) in this study is 50 mg/kg bw/d. Ref.: 11 91-day oral subchronic toxicity study in rats","endpoint":"repeated dose toxicity","ingredient":"HC Red n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":14,"route":"oral","species":"rat","study_id":"sccp_o_072_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 50 mg/kg bw/d rat oral 91-day repeated dose toxicity SOURCE_SUBDIR=sccp_o_072; REPORT_TITLE=Opinion on HC Red n° 1 COLIPA N° B48; OPINION_NUMBER=SCCP/0981/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=50; DOSE=Conclusion Based on the results of this study, oral administration of HC Red n° 1 in the rat for 14 consecutive days at up to 600 mg/kg/day did not produce treatment-related mortality.; EFFECT=. Conclusion Based on the results of this study, oral administration of HC Red n° 1 in the rat for 14 consecutive days at up to 600 mg/kg/day did not produce treatment-related mortality. However, notable treatment-related changes were observed in the 150, 300 and 600 mg/kg/day dose groups. These generally consisted of clinical abnormalities, decreased weight gain/food consumption, abnormal clinical pathology, gross necropsy observations and increased liver and spleen weights. The no-observed-adverse-effect level (NOAEL) in this study is 50 mg/kg bw/d. Ref.: 11 91-day oral subchronic toxicity study in rats; CITATION=Ref.: 11 91-day oral subchronic toxicity study in rats; CITATION_NUMBERS=[11,91]; REFERENCE=Ref.: 11 91-day oral subchronic toxicity study in rats; DETAILS_JSON={"cas_number":"2784-89-6","citation":"Ref.: 11 91-day oral subchronic toxicity study in rats","dose":"Conclusion Based on the results of this study, oral administration of HC Red n° 1 in the rat for 14 consecutive days at up to 600 mg/kg/day did not produce treatment-related mortality.","duration":"91-day","effect":". Conclusion Based on the results of this study, oral administration of HC Red n° 1 in the rat for 14 consecutive days at up to 600 mg/kg/day did not produce treatment-related mortality. However, notable treatment-related changes were observed in the 150, 300 and 600 mg/kg/day dose groups. These generally consisted of clinical abnormalities, decreased weight gain/food consumption, abnormal clinical pathology, gross necropsy observations and increased liver and spleen weights. The no-observed-adverse-effect level (NOAEL) in this study is 50 mg/kg bw/d. Ref.: 11 91-day oral subchronic toxicity study in rats","endpoint":"repeated dose toxicity","ingredient":"HC Red n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":14,"route":"oral","species":"rat","study_id":"sccp_o_072_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =0.0294 mg/kg rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_072; REPORT_TITLE=Opinion on HC Red n° 1 COLIPA N° B48; OPINION_NUMBER=SCCP/0981/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT== 0.0294; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...; EFFECT=981/06 Opinion on HC Red n° 1 ____________________________________________________________________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (fe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2784-89-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...","duration":"subchronic","effect":"981/06 Opinion on HC Red n° 1 ____________________________________________________________________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (fe","endpoint":"repeated dose toxicity","ingredient":"HC Red n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.0294","page":33,"route":"oral","species":"rat","study_id":"sccp_o_072_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =5 mg/kg rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_072; REPORT_TITLE=Opinion on HC Red n° 1 COLIPA N° B48; OPINION_NUMBER=SCCP/0981/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT== 5; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...; EFFECT=__________________________________________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females). In a subchronic toxici; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2784-89-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...","duration":"subchronic","effect":"__________________________________________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females). In a subchronic toxici","endpoint":"repeated dose toxicity","ingredient":"HC Red n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 5","page":33,"route":"oral","species":"rat","study_id":"sccp_o_072_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =5 mg/kg rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_072; REPORT_TITLE=Opinion on HC Red n° 1 COLIPA N° B48; OPINION_NUMBER=SCCP/0981/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT== 5; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...; EFFECT=________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females). In a subchronic toxicity study due to the decreased rela; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2784-89-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg...","duration":"subchronic","effect":"________________________________ 33 3.3.12. Special investigations / 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.52 µg/cm2 Typical body weight of human = 60 kg Skin area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.764 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0294 mg/kg No observed adverse effect level (rat, subchronic, oral) NOAEL = 5 mg/kg Margin of Safety NOAEL/SED = 170 3.3.14. Discussion Physico-chemical specifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females). In a subchronic toxicity study due to the decreased rela","endpoint":"repeated dose toxicity","ingredient":"HC Red n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 5","page":33,"route":"oral","species":"rat","study_id":"sccp_o_072_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 5 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_072; REPORT_TITLE=Opinion on HC Red n° 1 COLIPA N° B48; OPINION_NUMBER=SCCP/0981/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=5; DOSE=General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females).; EFFECT=ifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females). In a subchronic toxicity study due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. In a teratogenicity study, the maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Several toxicological studies including teratogenicity, subchronic toxicity and reproductive toxicity were performed using topical adminis; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2784-89-6","citation":"","dose":"General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females).","duration":"subchronic","effect":"ifications Stability of the test material in marketed products is not reported. Calculated values of Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females). In a subchronic toxicity study due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. In a teratogenicity study, the maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Several toxicological studies including teratogenicity, subchronic toxicity and reproductive toxicity were performed using topical adminis","endpoint":"repeated dose toxicity","ingredient":"HC Red n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"5","page":33,"route":"oral","species":"rat","study_id":"sccp_o_072_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 25 mg/kg/day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_072; REPORT_TITLE=Opinion on HC Red n° 1 COLIPA N° B48; OPINION_NUMBER=SCCP/0981/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=25; DOSE=General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females).; EFFECT=f Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females). In a subchronic toxicity study due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. In a teratogenicity study, the maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Several toxicological studies including teratogenicity, subchronic toxicity and reproductive toxicity were performed using topical administration of a hair dye formulation containing inter alia 0.15% HC Red n° 1. These studies are of lim; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2784-89-6","citation":"","dose":"General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females).","duration":"subchronic","effect":"f Log Pow can not be accepted as estimates of the true physical constants without justification, indicating that the reported values are realistic. General toxicity The acute oral LD50 in the Sprague-Dawley strain of rats was between 2500 and 5000 mg/kg bw (males) and between 625 and 1250 mg/kg bw (females). In a subchronic toxicity study due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. In a teratogenicity study, the maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Several toxicological studies including teratogenicity, subchronic toxicity and reproductive toxicity were performed using topical administration of a hair dye formulation containing inter alia 0.15% HC Red n° 1. These studies are of lim","endpoint":"repeated dose toxicity","ingredient":"HC Red n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"25","page":33,"route":"oral","species":"rat","study_id":"sccp_o_072_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 125 mg/kg bw/d mouse dermal subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_072; REPORT_TITLE=Opinion on HC Red n° 1 COLIPA N° B48; OPINION_NUMBER=SCCP/0981/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=10 October 2006; VALUE_TEXT=125; DOSE=s) and between 625 and 1250 mg/kg bw (females).; EFFECT=s) and between 625 and 1250 mg/kg bw (females). In a subchronic toxicity study due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. In a teratogenicity study, the maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Several toxicological studies including teratogenicity, subchronic toxicity and reproductive toxicity were performed using topical administration of a hair dye formulation containing inter alia 0.15% HC Red n° 1. These studies are of limited value. Irritation/sensitisation HC Red n° 1 was shown to be a skin sensitiser in guinea pigs (by Guinea pig maximation test and an open epicutaneous test), in mice (by LLNA) and in humans (by Repeated insult patch test). According to the Guinea pig maximisa; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2784-89-6","citation":"","dose":"s) and between 625 and 1250 mg/kg bw (females).","duration":"subchronic","effect":"s) and between 625 and 1250 mg/kg bw (females). In a subchronic toxicity study due to the decreased relative thymic weight at 20 mg/kg bw/d the SCCP sets the NOAEL at 5 mg/kg bw/d. In a teratogenicity study, the maternal no-observable-adverse-effect-level (NOAEL) for HC Red n° 1 was 25 mg/kg/day; at doses above this level, there were significant effects on maternal weight gain during the dosage period. There were no adverse effects observed on developmental parameter. Based on these observations, the developmental NOAEL is 125 mg/kg bw/d. Several toxicological studies including teratogenicity, subchronic toxicity and reproductive toxicity were performed using topical administration of a hair dye formulation containing inter alia 0.15% HC Red n° 1. These studies are of limited value. Irritation/sensitisation HC Red n° 1 was shown to be a skin sensitiser in guinea pigs (by Guinea pig maximation test and an open epicutaneous test), in mice (by LLNA) and in humans (by Repeated insult patch test). According to the Guinea pig maximisa","endpoint":"repeated dose toxicity","ingredient":"HC Red n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"125","page":33,"route":"dermal","species":"mouse","study_id":"sccp_o_072_noael_013"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 1FZM1701IS UNII - - - chemical {"approval_status":null,"molecular_formula":"C12H11N3O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1FZM1701IS"}
openFDA substances FDA UNII substance identifier 1FZM1701IS UNII - - - chemical {"approval_status":null,"molecular_formula":"C12H11N3O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1FZM1701IS"}
openFDA substances FDA UNII substance identifier 1FZM1701IS UNII - - - chemical {"approval_status":null,"molecular_formula":"C12H11N3O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1FZM1701IS"}
openFDA substances FDA UNII substance identifier 1FZM1701IS UNII - - - chemical {"approval_status":null,"molecular_formula":"C12H11N3O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1FZM1701IS"}