NOAEL Studies Cosmetic Ingredient

HC Blue No. 11 NOAEL Studies

INCI: HC BLUE NO. 11

CAS: 910463-51-3

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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SCCS_vision_codex 28 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =160 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 2 Comment It is not clear on which basis the study authors dismiss the statistically significant changes in kidney histology and kidney weight observed in the mid-dose animals","dose":"ntly increased (up to 26%) in a dose-related manner in all treated males and in high dose females at the end of the treatment period.","effect":"ntly increased (up to 26%) in a dose-related manner in all treated males and in high dose females at the end of the treatment period. Histological examination of the liver revealed statistically significant centrilobular hepatocytic hypertrophy in animals of the high-dose group. A generalised violet coloration on the skin of the animals from all treated groups, and of the stomach and content of the urinary bladder of some high dose animals were not regarded as adverse. Conclusion The study authors considered the NOAEL to be 160 mg/kg bw/day. Ref.: 2 Comment It is not clear on which basis the study authors dismiss the statistically significant changes in kidney histology and kidney weight observed in the mid-dose animals. In the females of the lowest dose group, also histological changes in the kidneys are observed (tubular cell vacuolisation), and kidney weight is slightly increased, but not statistically significant. This should be taken into consideration when calculating the Margin of Safety. On the basis of the histologic","page":14,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_001"}
SCCS_vision_codex NOAEL =80 mg/kg bw/day - - - NOAEL study {"dose":"y histology and kidney weight observed in the mid-dose animals.","effect":"y histology and kidney weight observed in the mid-dose animals. In the females of the lowest dose group, also histological changes in the kidneys are observed (tubular cell vacuolisation), and kidney weight is slightly increased, but not statistically significant. This should be taken into consideration when calculating the Margin of Safety. On the basis of the histological changes in the kidneys, in the mid and high dose animals, accompanied by increases in absolute and relative kidney weights, the SCCP sets the NOAEL at 80 mg/kg bw/day. 14","page":14,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_002"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day human - - developmental toxicity {"citation":"Ref.: 3 3","dose":"igh dose group when compared to controls on Day 9.","effect":"igh dose group when compared to controls on Day 9. A statistically significant reduction in mean foetal weight was also noted in this group. At skeletal examination, a general retardation in the ossification of several bones was observed in the mid- and/or high dose groups. These changes were considered to be a consequence of the presence of foetuses with a lower foetal weight and due to the signs of marginal maternal toxicity observed in the high dose groups. Based on the effect on body weight gain the maternal NOAEL is 200 mg/kg bw/day. The NOAEL for foetal toxicity was 100 mg/kg bw/day, on the basis of the retarded ossification. In this study the test chemical is not teratogenic. Ref.: 3 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 19","page":19,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_003"}
SCCS_vision_codex NOAEL =0.046 mg/kg bw rat oral 90day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...","effect":"SCCP/1079/07 Opinion on HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow canno","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_005"}
SCCS_vision_codex NOAEL =80 mg/kg bw rat oral 90day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...","effect":"SCCP/1079/07 Opinion on HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow cannot be a","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_006"}
SCCS_vision_codex NOAEL =1275 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.","effect":"he calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without justification, indicating that the reported value is realistic. HC Blue n° 11 is both a secondary and a tertiary amine. Its nitrosamine (N- Nitrosodiethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_008"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.","effect":"iethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a non-sensitizer when tested up to the highest achievable concentration of 25% (w/v) in ethanol:water (7:3 v/v) in a LLNA study. 20","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_010"}
SCCS_vision_codex NOAEL =160 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 2 Comment It is not clear on which basis the study authors dismiss the statistically significant changes in kidney histology and kidney weight observed in the mid-dose animals","dose":"ntly increased (up to 26%) in a dose-related manner in all treated males and in high dose females at the end of the treatment period.","effect":"ntly increased (up to 26%) in a dose-related manner in all treated males and in high dose females at the end of the treatment period. Histological examination of the liver revealed statistically significant centrilobular hepatocytic hypertrophy in animals of the high-dose group. A generalised violet coloration on the skin of the animals from all treated groups, and of the stomach and content of the urinary bladder of some high dose animals were not regarded as adverse. Conclusion The study authors considered the NOAEL to be 160 mg/kg bw/day. Ref.: 2 Comment It is not clear on which basis the study authors dismiss the statistically significant changes in kidney histology and kidney weight observed in the mid-dose animals. In the females of the lowest dose group, also histological changes in the kidneys are observed (tubular cell vacuolisation), and kidney weight is slightly increased, but not statistically significant. This should be taken into consideration when calculating the Margin of Safety. On the basis of the histologic","page":14,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_001"}
SCCS_vision_codex NOAEL =80 mg/kg bw/day - - - NOAEL study {"dose":"y histology and kidney weight observed in the mid-dose animals.","effect":"y histology and kidney weight observed in the mid-dose animals. In the females of the lowest dose group, also histological changes in the kidneys are observed (tubular cell vacuolisation), and kidney weight is slightly increased, but not statistically significant. This should be taken into consideration when calculating the Margin of Safety. On the basis of the histological changes in the kidneys, in the mid and high dose animals, accompanied by increases in absolute and relative kidney weights, the SCCP sets the NOAEL at 80 mg/kg bw/day. 14","page":14,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_002"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day human - - developmental toxicity {"citation":"Ref.: 3 3","dose":"igh dose group when compared to controls on Day 9.","effect":"igh dose group when compared to controls on Day 9. A statistically significant reduction in mean foetal weight was also noted in this group. At skeletal examination, a general retardation in the ossification of several bones was observed in the mid- and/or high dose groups. These changes were considered to be a consequence of the presence of foetuses with a lower foetal weight and due to the signs of marginal maternal toxicity observed in the high dose groups. Based on the effect on body weight gain the maternal NOAEL is 200 mg/kg bw/day. The NOAEL for foetal toxicity was 100 mg/kg bw/day, on the basis of the retarded ossification. In this study the test chemical is not teratogenic. Ref.: 3 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 19","page":19,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_003"}
SCCS_vision_codex NOAEL =0.046 mg/kg bw rat oral 90day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...","effect":"SCCP/1079/07 Opinion on HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow canno","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_005"}
SCCS_vision_codex NOAEL =80 mg/kg bw rat oral 90day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...","effect":"SCCP/1079/07 Opinion on HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow cannot be a","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_006"}
SCCS_vision_codex NOAEL =1275 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.","effect":"he calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without justification, indicating that the reported value is realistic. HC Blue n° 11 is both a secondary and a tertiary amine. Its nitrosamine (N- Nitrosodiethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_008"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.","effect":"iethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a non-sensitizer when tested up to the highest achievable concentration of 25% (w/v) in ethanol:water (7:3 v/v) in a LLNA study. 20","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_010"}
SCCS_vision_codex NOAEL =160 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 2 Comment It is not clear on which basis the study authors dismiss the statistically significant changes in kidney histology and kidney weight observed in the mid-dose animals","dose":"ntly increased (up to 26%) in a dose-related manner in all treated males and in high dose females at the end of the treatment period.","effect":"ntly increased (up to 26%) in a dose-related manner in all treated males and in high dose females at the end of the treatment period. Histological examination of the liver revealed statistically significant centrilobular hepatocytic hypertrophy in animals of the high-dose group. A generalised violet coloration on the skin of the animals from all treated groups, and of the stomach and content of the urinary bladder of some high dose animals were not regarded as adverse. Conclusion The study authors considered the NOAEL to be 160 mg/kg bw/day. Ref.: 2 Comment It is not clear on which basis the study authors dismiss the statistically significant changes in kidney histology and kidney weight observed in the mid-dose animals. In the females of the lowest dose group, also histological changes in the kidneys are observed (tubular cell vacuolisation), and kidney weight is slightly increased, but not statistically significant. This should be taken into consideration when calculating the Margin of Safety. On the basis of the histologic","page":14,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_001"}
SCCS_vision_codex NOAEL =80 mg/kg bw/day - - - NOAEL study {"dose":"y histology and kidney weight observed in the mid-dose animals.","effect":"y histology and kidney weight observed in the mid-dose animals. In the females of the lowest dose group, also histological changes in the kidneys are observed (tubular cell vacuolisation), and kidney weight is slightly increased, but not statistically significant. This should be taken into consideration when calculating the Margin of Safety. On the basis of the histological changes in the kidneys, in the mid and high dose animals, accompanied by increases in absolute and relative kidney weights, the SCCP sets the NOAEL at 80 mg/kg bw/day. 14","page":14,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_002"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day human - - developmental toxicity {"citation":"Ref.: 3 3","dose":"igh dose group when compared to controls on Day 9.","effect":"igh dose group when compared to controls on Day 9. A statistically significant reduction in mean foetal weight was also noted in this group. At skeletal examination, a general retardation in the ossification of several bones was observed in the mid- and/or high dose groups. These changes were considered to be a consequence of the presence of foetuses with a lower foetal weight and due to the signs of marginal maternal toxicity observed in the high dose groups. Based on the effect on body weight gain the maternal NOAEL is 200 mg/kg bw/day. The NOAEL for foetal toxicity was 100 mg/kg bw/day, on the basis of the retarded ossification. In this study the test chemical is not teratogenic. Ref.: 3 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 19","page":19,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_003"}
SCCS_vision_codex NOAEL =0.046 mg/kg bw rat oral 90day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...","effect":"SCCP/1079/07 Opinion on HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow canno","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_005"}
SCCS_vision_codex NOAEL =80 mg/kg bw rat oral 90day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...","effect":"SCCP/1079/07 Opinion on HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow cannot be a","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_006"}
SCCS_vision_codex NOAEL =1275 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.","effect":"he calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without justification, indicating that the reported value is realistic. HC Blue n° 11 is both a secondary and a tertiary amine. Its nitrosamine (N- Nitrosodiethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_008"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.","effect":"iethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a non-sensitizer when tested up to the highest achievable concentration of 25% (w/v) in ethanol:water (7:3 v/v) in a LLNA study. 20","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_010"}
SCCS_vision_codex NOAEL =160 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 2 Comment It is not clear on which basis the study authors dismiss the statistically significant changes in kidney histology and kidney weight observed in the mid-dose animals","dose":"ntly increased (up to 26%) in a dose-related manner in all treated males and in high dose females at the end of the treatment period.","effect":"ntly increased (up to 26%) in a dose-related manner in all treated males and in high dose females at the end of the treatment period. Histological examination of the liver revealed statistically significant centrilobular hepatocytic hypertrophy in animals of the high-dose group. A generalised violet coloration on the skin of the animals from all treated groups, and of the stomach and content of the urinary bladder of some high dose animals were not regarded as adverse. Conclusion The study authors considered the NOAEL to be 160 mg/kg bw/day. Ref.: 2 Comment It is not clear on which basis the study authors dismiss the statistically significant changes in kidney histology and kidney weight observed in the mid-dose animals. In the females of the lowest dose group, also histological changes in the kidneys are observed (tubular cell vacuolisation), and kidney weight is slightly increased, but not statistically significant. This should be taken into consideration when calculating the Margin of Safety. On the basis of the histologic","page":14,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_001"}
SCCS_vision_codex NOAEL =80 mg/kg bw/day - - - NOAEL study {"dose":"y histology and kidney weight observed in the mid-dose animals.","effect":"y histology and kidney weight observed in the mid-dose animals. In the females of the lowest dose group, also histological changes in the kidneys are observed (tubular cell vacuolisation), and kidney weight is slightly increased, but not statistically significant. This should be taken into consideration when calculating the Margin of Safety. On the basis of the histological changes in the kidneys, in the mid and high dose animals, accompanied by increases in absolute and relative kidney weights, the SCCP sets the NOAEL at 80 mg/kg bw/day. 14","page":14,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_002"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day human - - developmental toxicity {"citation":"Ref.: 3 3","dose":"igh dose group when compared to controls on Day 9.","effect":"igh dose group when compared to controls on Day 9. A statistically significant reduction in mean foetal weight was also noted in this group. At skeletal examination, a general retardation in the ossification of several bones was observed in the mid- and/or high dose groups. These changes were considered to be a consequence of the presence of foetuses with a lower foetal weight and due to the signs of marginal maternal toxicity observed in the high dose groups. Based on the effect on body weight gain the maternal NOAEL is 200 mg/kg bw/day. The NOAEL for foetal toxicity was 100 mg/kg bw/day, on the basis of the retarded ossification. In this study the test chemical is not teratogenic. Ref.: 3 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 19","page":19,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_003"}
SCCS_vision_codex NOAEL =0.046 mg/kg bw rat oral 90day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...","effect":"SCCP/1079/07 Opinion on HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow canno","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_005"}
SCCS_vision_codex NOAEL =80 mg/kg bw rat oral 90day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...","effect":"SCCP/1079/07 Opinion on HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow cannot be a","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_006"}
SCCS_vision_codex NOAEL =1275 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.","effect":"he calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without justification, indicating that the reported value is realistic. HC Blue n° 11 is both a secondary and a tertiary amine. Its nitrosamine (N- Nitrosodiethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_008"}
SCCS_vision_codex NOAEL =100 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.","effect":"iethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a non-sensitizer when tested up to the highest achievable concentration of 25% (w/v) in ethanol:water (7:3 v/v) in a LLNA study. 20","page":20,"pdf":"sccp_o_111.pdf","row_type":"noael_study","study_id":"sccp_o_111_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 11 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 160 mg/kg bw/day - - - - SOURCE_SUBDIR=sccp_o_111; REPORT_TITLE=OPINION ON HC Blue n° 11 COLIPA n° B77; OPINION_NUMBER=SCCP/1079/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=160; DOSE=ntly increased (up to 26%) in a dose-related manner in all treated males and in high dose females at the end of the treatment period.; EFFECT=ntly increased (up to 26%) in a dose-related manner in all treated males and in high dose females at the end of the treatment period. Histological examination of the liver revealed statistically significant centrilobular hepatocytic hypertrophy in animals of the high-dose group. A generalised violet coloration on the skin of the animals from all treated groups, and of the stomach and content of the urinary bladder of some high dose animals were not regarded as adverse. Conclusion The study authors considered the NOAEL to be 160 mg/kg bw/day. Ref.: 2 Comment It is not clear on which basis the study authors dismiss the statistically significant changes in kidney histology and kidney weight observed in the mid-dose animals. In the females of the lowest dose group, also histological changes in the kidneys are observed (tubular cell vacuolisation), and kidney weight is slightly increased, but not statistically significant. This should be taken into consideration when calculating the Margin of Safety. On the basis of the histologic; CITATION=Ref.: 2 Comment It is not clear on which basis the study authors dismiss the statistically significant changes in kidney histology and kidney weight observed in the mid-dose animals; CITATION_NUMBERS=[2]; REFERENCE=Ref.: 2 Comment It is not clear on which basis the study authors dismiss the statistically significant changes in kidney histology and kidney weight observed in the mid-dose animals; DETAILS_JSON={"cas_number":"23920-15-2","citation":"Ref.: 2 Comment It is not clear on which basis the study authors dismiss the statistically significant changes in kidney histology and kidney weight observed in the mid-dose animals","dose":"ntly increased (up to 26%) in a dose-related manner in all treated males and in high dose females at the end of the treatment period.","duration":"","effect":"ntly increased (up to 26%) in a dose-related manner in all treated males and in high dose females at the end of the treatment period. Histological examination of the liver revealed statistically significant centrilobular hepatocytic hypertrophy in animals of the high-dose group. A generalised violet coloration on the skin of the animals from all treated groups, and of the stomach and content of the urinary bladder of some high dose animals were not regarded as adverse. Conclusion The study authors considered the NOAEL to be 160 mg/kg bw/day. Ref.: 2 Comment It is not clear on which basis the study authors dismiss the statistically significant changes in kidney histology and kidney weight observed in the mid-dose animals. In the females of the lowest dose group, also histological changes in the kidneys are observed (tubular cell vacuolisation), and kidney weight is slightly increased, but not statistically significant. This should be taken into consideration when calculating the Margin of Safety. On the basis of the histologic","endpoint":"","ingredient":"HC Blue No. 11","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"160","page":14,"route":"","species":"","study_id":"sccp_o_111_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 80 mg/kg bw/day - - - - SOURCE_SUBDIR=sccp_o_111; REPORT_TITLE=OPINION ON HC Blue n° 11 COLIPA n° B77; OPINION_NUMBER=SCCP/1079/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=80; DOSE=y histology and kidney weight observed in the mid-dose animals.; EFFECT=y histology and kidney weight observed in the mid-dose animals. In the females of the lowest dose group, also histological changes in the kidneys are observed (tubular cell vacuolisation), and kidney weight is slightly increased, but not statistically significant. This should be taken into consideration when calculating the Margin of Safety. On the basis of the histological changes in the kidneys, in the mid and high dose animals, accompanied by increases in absolute and relative kidney weights, the SCCP sets the NOAEL at 80 mg/kg bw/day. 14; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"23920-15-2","citation":"","dose":"y histology and kidney weight observed in the mid-dose animals.","duration":"","effect":"y histology and kidney weight observed in the mid-dose animals. In the females of the lowest dose group, also histological changes in the kidneys are observed (tubular cell vacuolisation), and kidney weight is slightly increased, but not statistically significant. This should be taken into consideration when calculating the Margin of Safety. On the basis of the histological changes in the kidneys, in the mid and high dose animals, accompanied by increases in absolute and relative kidney weights, the SCCP sets the NOAEL at 80 mg/kg bw/day. 14","endpoint":"","ingredient":"HC Blue No. 11","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":14,"route":"","species":"","study_id":"sccp_o_111_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.046 mg/kg bw rat oral 90day dermal absorption SOURCE_SUBDIR=sccp_o_111; REPORT_TITLE=OPINION ON HC Blue n° 11 COLIPA n° B77; OPINION_NUMBER=SCCP/1079/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT== 0.046; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...; EFFECT=SCCP/1079/07 Opinion on HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow canno; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"23920-15-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...","duration":"90day","effect":"SCCP/1079/07 Opinion on HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow canno","endpoint":"dermal absorption","ingredient":"HC Blue No. 11","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.046","page":20,"route":"oral","species":"rat","study_id":"sccp_o_111_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =80 mg/kg bw rat oral 90day dermal absorption SOURCE_SUBDIR=sccp_o_111; REPORT_TITLE=OPINION ON HC Blue n° 11 COLIPA n° B77; OPINION_NUMBER=SCCP/1079/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT== 80; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...; EFFECT=SCCP/1079/07 Opinion on HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow cannot be a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"23920-15-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...","duration":"90day","effect":"SCCP/1079/07 Opinion on HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow cannot be a","endpoint":"dermal absorption","ingredient":"HC Blue No. 11","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 80","page":20,"route":"oral","species":"rat","study_id":"sccp_o_111_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =80 mg/kg bw rat oral 90day dermal absorption SOURCE_SUBDIR=sccp_o_111; REPORT_TITLE=OPINION ON HC Blue n° 11 COLIPA n° B77; OPINION_NUMBER=SCCP/1079/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT== 80; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...; EFFECT=HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without just; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"23920-15-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dos...","duration":"90day","effect":"HC Blue n° 11 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Blue n°11) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 3.993 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.795 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.046 mg/kg bw No observed adverse effect level NOAEL = 80 mg/kg bw (90day, rat, oral gavage) Margin of Safety NOAEL / SED = 1739 3.3.14. Discussion This risk assessment relates to the use of HC Blue n° 11 in non-oxidative hair dye formulations only. Physico-chemical properties HC Blue n° 11 is used as an ingredient in direct hair dye formulations in concentrations up to 2%. The solubility of HC Blue n° 11 in water is not determined according to the Official EC Method, and thus exact solubility in water is not known. The calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without just","endpoint":"dermal absorption","ingredient":"HC Blue No. 11","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 80","page":20,"route":"oral","species":"rat","study_id":"sccp_o_111_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 200 mg/kg bw/day human - - developmental toxicity SOURCE_SUBDIR=sccp_o_111; REPORT_TITLE=OPINION ON HC Blue n° 11 COLIPA n° B77; OPINION_NUMBER=SCCP/1079/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=200; DOSE=igh dose group when compared to controls on Day 9.; EFFECT=igh dose group when compared to controls on Day 9. A statistically significant reduction in mean foetal weight was also noted in this group. At skeletal examination, a general retardation in the ossification of several bones was observed in the mid- and/or high dose groups. These changes were considered to be a consequence of the presence of foetuses with a lower foetal weight and due to the signs of marginal maternal toxicity observed in the high dose groups. Based on the effect on body weight gain the maternal NOAEL is 200 mg/kg bw/day. The NOAEL for foetal toxicity was 100 mg/kg bw/day, on the basis of the retarded ossification. In this study the test chemical is not teratogenic. Ref.: 3 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 19; CITATION=Ref.: 3 3; CITATION_NUMBERS=[3]; REFERENCE=Ref.: 3 3; DETAILS_JSON={"cas_number":"23920-15-2","citation":"Ref.: 3 3","dose":"igh dose group when compared to controls on Day 9.","duration":"","effect":"igh dose group when compared to controls on Day 9. A statistically significant reduction in mean foetal weight was also noted in this group. At skeletal examination, a general retardation in the ossification of several bones was observed in the mid- and/or high dose groups. These changes were considered to be a consequence of the presence of foetuses with a lower foetal weight and due to the signs of marginal maternal toxicity observed in the high dose groups. Based on the effect on body weight gain the maternal NOAEL is 200 mg/kg bw/day. The NOAEL for foetal toxicity was 100 mg/kg bw/day, on the basis of the retarded ossification. In this study the test chemical is not teratogenic. Ref.: 3 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 19","endpoint":"developmental toxicity","ingredient":"HC Blue No. 11","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":19,"route":"","species":"human","study_id":"sccp_o_111_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 200 mg/kg bw/day human - - developmental toxicity SOURCE_SUBDIR=sccp_o_111; REPORT_TITLE=OPINION ON HC Blue n° 11 COLIPA n° B77; OPINION_NUMBER=SCCP/1079/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=200; DOSE=At skeletal examination, a general retardation in the ossification of several bones was observed in the mid- and/or high dose groups.; EFFECT=controls on Day 9. A statistically significant reduction in mean foetal weight was also noted in this group. At skeletal examination, a general retardation in the ossification of several bones was observed in the mid- and/or high dose groups. These changes were considered to be a consequence of the presence of foetuses with a lower foetal weight and due to the signs of marginal maternal toxicity observed in the high dose groups. Based on the effect on body weight gain the maternal NOAEL is 200 mg/kg bw/day. The NOAEL for foetal toxicity was 100 mg/kg bw/day, on the basis of the retarded ossification. In this study the test chemical is not teratogenic. Ref.: 3 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 19; CITATION=Ref.: 3 3; CITATION_NUMBERS=[3]; REFERENCE=Ref.: 3 3; DETAILS_JSON={"cas_number":"23920-15-2","citation":"Ref.: 3 3","dose":"At skeletal examination, a general retardation in the ossification of several bones was observed in the mid- and/or high dose groups.","duration":"","effect":"controls on Day 9. A statistically significant reduction in mean foetal weight was also noted in this group. At skeletal examination, a general retardation in the ossification of several bones was observed in the mid- and/or high dose groups. These changes were considered to be a consequence of the presence of foetuses with a lower foetal weight and due to the signs of marginal maternal toxicity observed in the high dose groups. Based on the effect on body weight gain the maternal NOAEL is 200 mg/kg bw/day. The NOAEL for foetal toxicity was 100 mg/kg bw/day, on the basis of the retarded ossification. In this study the test chemical is not teratogenic. Ref.: 3 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 19","endpoint":"developmental toxicity","ingredient":"HC Blue No. 11","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":19,"route":"","species":"human","study_id":"sccp_o_111_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1275 mg/kg bw rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_111; REPORT_TITLE=OPINION ON HC Blue n° 11 COLIPA n° B77; OPINION_NUMBER=SCCP/1079/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=1275; DOSE=General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.; EFFECT=he calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without justification, indicating that the reported value is realistic. HC Blue n° 11 is both a secondary and a tertiary amine. Its nitrosamine (N- Nitrosodiethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"23920-15-2","citation":"","dose":"General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.","duration":"subchronic","effect":"he calculated value of Log Pow cannot be accepted as an estimate of the true physical constant without justification, indicating that the reported value is realistic. HC Blue n° 11 is both a secondary and a tertiary amine. Its nitrosamine (N- Nitrosodiethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a","endpoint":"repeated dose toxicity","ingredient":"HC Blue No. 11","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1275","page":20,"route":"oral","species":"rat","study_id":"sccp_o_111_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 80 mg/kg bw/day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_111; REPORT_TITLE=OPINION ON HC Blue n° 11 COLIPA n° B77; OPINION_NUMBER=SCCP/1079/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=80; DOSE=General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.; EFFECT=not be accepted as an estimate of the true physical constant without justification, indicating that the reported value is realistic. HC Blue n° 11 is both a secondary and a tertiary amine. Its nitrosamine (N- Nitrosodiethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a non-se; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"23920-15-2","citation":"","dose":"General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.","duration":"subchronic","effect":"not be accepted as an estimate of the true physical constant without justification, indicating that the reported value is realistic. HC Blue n° 11 is both a secondary and a tertiary amine. Its nitrosamine (N- Nitrosodiethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a non-se","endpoint":"repeated dose toxicity","ingredient":"HC Blue No. 11","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":20,"route":"oral","species":"rat","study_id":"sccp_o_111_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 100 mg/kg bw rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_111; REPORT_TITLE=OPINION ON HC Blue n° 11 COLIPA n° B77; OPINION_NUMBER=SCCP/1079/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=100; DOSE=General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.; EFFECT=iethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a non-sensitizer when tested up to the highest achievable concentration of 25% (w/v) in ethanol:water (7:3 v/v) in a LLNA study. 20; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"23920-15-2","citation":"","dose":"General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.","duration":"subchronic","effect":"iethanol-amine) content in batch I-37979 is reported to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a non-sensitizer when tested up to the highest achievable concentration of 25% (w/v) in ethanol:water (7:3 v/v) in a LLNA study. 20","endpoint":"repeated dose toxicity","ingredient":"HC Blue No. 11","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":20,"route":"oral","species":"rat","study_id":"sccp_o_111_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 100 mg/kg bw rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_111; REPORT_TITLE=OPINION ON HC Blue n° 11 COLIPA n° B77; OPINION_NUMBER=SCCP/1079/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=100; DOSE=General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.; EFFECT=to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a non-sensitizer when tested up to the highest achievable concentration of 25% (w/v) in ethanol:water (7:3 v/v) in a LLNA study. 20; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"23920-15-2","citation":"","dose":"General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice.","duration":"subchronic","effect":"to be 1600 ppb. No data on the stability of HC Blue n° 11 in marketed products was provided. General toxicity The LD50 was calculated to be 1250 mg/kg bw in male and female rats and 1275 mg/kg bw in female mice. A No Observed Adverse Effect Level (NOAEL) for HC Blue n° 11 of 80 mg/kg bw/day was established in a subchronic oral toxicity study in rats, based on histological changes in the kidneys and increased kidney weight. In a teratogenicity study in rats the NOAEL for embryo/foetotoxicity was 100 mg/kg bw. The NOAEL of maternal toxicity was 200 mg/kg bw. Irritation / sensitisation Under the conditions of the study, HC Blue n° 11 was not irritant when applied to the intact rabbit skin. Undiluted, it was irritating to the rabbit eye. It was found to be a non-sensitizer when tested up to the highest achievable concentration of 25% (w/v) in ethanol:water (7:3 v/v) in a LLNA study. 20","endpoint":"repeated dose toxicity","ingredient":"HC Blue No. 11","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":20,"route":"oral","species":"rat","study_id":"sccp_o_111_noael_011"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 83ZYM95HPE UNII - - - chemical {"approval_status":null,"molecular_formula":"C13H21N3O5.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"83ZYM95HPE"}
openFDA substances FDA UNII substance identifier 83ZYM95HPE UNII - - - chemical {"approval_status":null,"molecular_formula":"C13H21N3O5.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"83ZYM95HPE"}
openFDA substances FDA UNII substance identifier 83ZYM95HPE UNII - - - chemical {"approval_status":null,"molecular_formula":"C13H21N3O5.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"83ZYM95HPE"}
openFDA substances FDA UNII substance identifier 83ZYM95HPE UNII - - - chemical {"approval_status":null,"molecular_formula":"C13H21N3O5.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"83ZYM95HPE"}