NOAEL Studies
Cosmetic Ingredient
HC Yellow No. 10 NOAEL Studies
INCI: HC YELLOW NO. 10
CAS: 109023-83-8
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 25 | mg/kg bw/day | rat | oral | 93 day | Subchronic | SCCP; C.Mc Alinden. Imexine FAH: 13-week Oral (Gavage) Toxicity Study in the Rat. ToxicolLaboratories, Report N°LRL/79/94, 1995 |
SCCS_vision_codex 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw | rat | oral | 28-day | dermal absorption | {"dose":"“HC yellow n°10 has an acute oral toxicity of >5000 mg/kg bw in the rat.","effect":"“HC yellow n°10 has an acute oral toxicity of >5000 mg/kg bw in the rat. The substance can be classified as very slightly irritating to the eyes and slightly irritating to the skin. Percutaneous absorption of a formulation was 0.024 % in absence and 0.025 % in presence of hair. In a 28-day study with rats, 125 mg/kg/day is considered to be the No Toxic Effect Level. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 500 mg/kg bw. It should be noted that the NOEL stems from an daily exposure for 28 days, whereas human exposure to semi-permanent hair dye is unlikely to be more frequent than twice a month. The compound was found to be not mutagenic.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 24 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II of HC Yellow No. 10 was submitted by COLIPA in July 2005","page":5,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_001"} |
| SCCS_vision_codex | NOAEL | =125 | mg/kg/day | - | oral | 93 days | NOAEL study | {"dose":"Imexine FAH Batch: op T 10 Purity: not specified in study report, > 99% Dose:","effect":"rl CD (VAF plus) Group size: 10/sex/group Test substance: Imexine FAH Batch: op T 10 Purity: not specified in study report, > 99% Dose: 0, 25, 100, 500 mg/kg Vehicle: 0.5% methylcellulose Route: Gavage, 10 ml/kg/day. Exposure: 92/93 days GLP: in compliance These dose levels were selected on the basis of the results of 4-week preliminary study performed at 125, 500 and 2000 mg/kg/day, where significant changes in bodyweight and/or blood chemistry parameters at 2000 and/or 500 mg/kg/day were observed, and where the NOAEL was 125 mg/kg/day [17]. In the 13 week study, the dose was prepared daily. Animals were observed once daily for clinical signs and twice daily for mortality/morbidity. Body weight and food consumption were recorded weekly. Ophthalmologic evaluations on control and high-dose animals were performed before the treatment period and during week 13. Haematology, clinical chemistry and urinalysis evaluations were performed once during week 13. At the end of the treatment period, all animals were killed and grossly examin","page":13,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_002"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg/day | - | - | - | NOAEL study | {"dose":"Absolute and relative liver weights were significantly increased for both sexes at 500 mg/kg/day (+18% to +27% bw-related).","effect":"or parameters determined using a clinistix®, but no abnormalities were found for those parameters that could be measured. Absolute and relative liver weights were significantly increased for both sexes at 500 mg/kg/day (+18% to +27% bw-related). In males, absolute spleen weights were increased at 100 and 500 mg/kg/day. Relative spleen weight increase was only seen at 500 mg/kg/day (+19%), but was not significant. There were no histopathological findings to correspond with these macroscopic changes. Conclusion The NOAEL for HC Yellow 10 in this study was considered to be 100 mg/kg/day. Ref.: 5","page":13,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.0016 | mg/kg | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"icity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General to","page":19,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_006"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity","page":19,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_007"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg | rat | oral | 90-day | developmental toxicity | {"dose":"General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg.","effect":"roperties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg. The NOAEL for HC Yellow 10 in a 90-day study was considered to be 100 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for HC Yellow 10 for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic.","page":19,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_009"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw | rat | oral | 28-day | dermal absorption | {"dose":"“HC yellow n°10 has an acute oral toxicity of >5000 mg/kg bw in the rat.","effect":"“HC yellow n°10 has an acute oral toxicity of >5000 mg/kg bw in the rat. The substance can be classified as very slightly irritating to the eyes and slightly irritating to the skin. Percutaneous absorption of a formulation was 0.024 % in absence and 0.025 % in presence of hair. In a 28-day study with rats, 125 mg/kg/day is considered to be the No Toxic Effect Level. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 500 mg/kg bw. It should be noted that the NOEL stems from an daily exposure for 28 days, whereas human exposure to semi-permanent hair dye is unlikely to be more frequent than twice a month. The compound was found to be not mutagenic.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 24 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II of HC Yellow No. 10 was submitted by COLIPA in July 2005","page":5,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_001"} |
| SCCS_vision_codex | NOAEL | =125 | mg/kg/day | - | oral | 93 days | NOAEL study | {"dose":"Imexine FAH Batch: op T 10 Purity: not specified in study report, > 99% Dose:","effect":"rl CD (VAF plus) Group size: 10/sex/group Test substance: Imexine FAH Batch: op T 10 Purity: not specified in study report, > 99% Dose: 0, 25, 100, 500 mg/kg Vehicle: 0.5% methylcellulose Route: Gavage, 10 ml/kg/day. Exposure: 92/93 days GLP: in compliance These dose levels were selected on the basis of the results of 4-week preliminary study performed at 125, 500 and 2000 mg/kg/day, where significant changes in bodyweight and/or blood chemistry parameters at 2000 and/or 500 mg/kg/day were observed, and where the NOAEL was 125 mg/kg/day [17]. In the 13 week study, the dose was prepared daily. Animals were observed once daily for clinical signs and twice daily for mortality/morbidity. Body weight and food consumption were recorded weekly. Ophthalmologic evaluations on control and high-dose animals were performed before the treatment period and during week 13. Haematology, clinical chemistry and urinalysis evaluations were performed once during week 13. At the end of the treatment period, all animals were killed and grossly examin","page":13,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_002"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg/day | - | - | - | NOAEL study | {"dose":"Absolute and relative liver weights were significantly increased for both sexes at 500 mg/kg/day (+18% to +27% bw-related).","effect":"or parameters determined using a clinistix®, but no abnormalities were found for those parameters that could be measured. Absolute and relative liver weights were significantly increased for both sexes at 500 mg/kg/day (+18% to +27% bw-related). In males, absolute spleen weights were increased at 100 and 500 mg/kg/day. Relative spleen weight increase was only seen at 500 mg/kg/day (+19%), but was not significant. There were no histopathological findings to correspond with these macroscopic changes. Conclusion The NOAEL for HC Yellow 10 in this study was considered to be 100 mg/kg/day. Ref.: 5","page":13,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.0016 | mg/kg | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"icity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General to","page":19,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_006"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity","page":19,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_007"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg | rat | oral | 90-day | developmental toxicity | {"dose":"General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg.","effect":"roperties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg. The NOAEL for HC Yellow 10 in a 90-day study was considered to be 100 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for HC Yellow 10 for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic.","page":19,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_009"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw | rat | oral | 28-day | dermal absorption | {"dose":"“HC yellow n°10 has an acute oral toxicity of >5000 mg/kg bw in the rat.","effect":"“HC yellow n°10 has an acute oral toxicity of >5000 mg/kg bw in the rat. The substance can be classified as very slightly irritating to the eyes and slightly irritating to the skin. Percutaneous absorption of a formulation was 0.024 % in absence and 0.025 % in presence of hair. In a 28-day study with rats, 125 mg/kg/day is considered to be the No Toxic Effect Level. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 500 mg/kg bw. It should be noted that the NOEL stems from an daily exposure for 28 days, whereas human exposure to semi-permanent hair dye is unlikely to be more frequent than twice a month. The compound was found to be not mutagenic.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 24 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II of HC Yellow No. 10 was submitted by COLIPA in July 2005","page":5,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_001"} |
| SCCS_vision_codex | NOAEL | =125 | mg/kg/day | - | oral | 93 days | NOAEL study | {"dose":"Imexine FAH Batch: op T 10 Purity: not specified in study report, > 99% Dose:","effect":"rl CD (VAF plus) Group size: 10/sex/group Test substance: Imexine FAH Batch: op T 10 Purity: not specified in study report, > 99% Dose: 0, 25, 100, 500 mg/kg Vehicle: 0.5% methylcellulose Route: Gavage, 10 ml/kg/day. Exposure: 92/93 days GLP: in compliance These dose levels were selected on the basis of the results of 4-week preliminary study performed at 125, 500 and 2000 mg/kg/day, where significant changes in bodyweight and/or blood chemistry parameters at 2000 and/or 500 mg/kg/day were observed, and where the NOAEL was 125 mg/kg/day [17]. In the 13 week study, the dose was prepared daily. Animals were observed once daily for clinical signs and twice daily for mortality/morbidity. Body weight and food consumption were recorded weekly. Ophthalmologic evaluations on control and high-dose animals were performed before the treatment period and during week 13. Haematology, clinical chemistry and urinalysis evaluations were performed once during week 13. At the end of the treatment period, all animals were killed and grossly examin","page":13,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_002"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg/day | - | - | - | NOAEL study | {"dose":"Absolute and relative liver weights were significantly increased for both sexes at 500 mg/kg/day (+18% to +27% bw-related).","effect":"or parameters determined using a clinistix®, but no abnormalities were found for those parameters that could be measured. Absolute and relative liver weights were significantly increased for both sexes at 500 mg/kg/day (+18% to +27% bw-related). In males, absolute spleen weights were increased at 100 and 500 mg/kg/day. Relative spleen weight increase was only seen at 500 mg/kg/day (+19%), but was not significant. There were no histopathological findings to correspond with these macroscopic changes. Conclusion The NOAEL for HC Yellow 10 in this study was considered to be 100 mg/kg/day. Ref.: 5","page":13,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.0016 | mg/kg | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"icity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General to","page":19,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_006"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity","page":19,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_007"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg | rat | oral | 90-day | developmental toxicity | {"dose":"General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg.","effect":"roperties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg. The NOAEL for HC Yellow 10 in a 90-day study was considered to be 100 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for HC Yellow 10 for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic.","page":19,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_009"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw | rat | oral | 28-day | dermal absorption | {"dose":"“HC yellow n°10 has an acute oral toxicity of >5000 mg/kg bw in the rat.","effect":"“HC yellow n°10 has an acute oral toxicity of >5000 mg/kg bw in the rat. The substance can be classified as very slightly irritating to the eyes and slightly irritating to the skin. Percutaneous absorption of a formulation was 0.024 % in absence and 0.025 % in presence of hair. In a 28-day study with rats, 125 mg/kg/day is considered to be the No Toxic Effect Level. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 500 mg/kg bw. It should be noted that the NOEL stems from an daily exposure for 28 days, whereas human exposure to semi-permanent hair dye is unlikely to be more frequent than twice a month. The compound was found to be not mutagenic.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 24 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II of HC Yellow No. 10 was submitted by COLIPA in July 2005","page":5,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_001"} |
| SCCS_vision_codex | NOAEL | =125 | mg/kg/day | - | oral | 93 days | NOAEL study | {"dose":"Imexine FAH Batch: op T 10 Purity: not specified in study report, > 99% Dose:","effect":"rl CD (VAF plus) Group size: 10/sex/group Test substance: Imexine FAH Batch: op T 10 Purity: not specified in study report, > 99% Dose: 0, 25, 100, 500 mg/kg Vehicle: 0.5% methylcellulose Route: Gavage, 10 ml/kg/day. Exposure: 92/93 days GLP: in compliance These dose levels were selected on the basis of the results of 4-week preliminary study performed at 125, 500 and 2000 mg/kg/day, where significant changes in bodyweight and/or blood chemistry parameters at 2000 and/or 500 mg/kg/day were observed, and where the NOAEL was 125 mg/kg/day [17]. In the 13 week study, the dose was prepared daily. Animals were observed once daily for clinical signs and twice daily for mortality/morbidity. Body weight and food consumption were recorded weekly. Ophthalmologic evaluations on control and high-dose animals were performed before the treatment period and during week 13. Haematology, clinical chemistry and urinalysis evaluations were performed once during week 13. At the end of the treatment period, all animals were killed and grossly examin","page":13,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_002"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg/day | - | - | - | NOAEL study | {"dose":"Absolute and relative liver weights were significantly increased for both sexes at 500 mg/kg/day (+18% to +27% bw-related).","effect":"or parameters determined using a clinistix®, but no abnormalities were found for those parameters that could be measured. Absolute and relative liver weights were significantly increased for both sexes at 500 mg/kg/day (+18% to +27% bw-related). In males, absolute spleen weights were increased at 100 and 500 mg/kg/day. Relative spleen weight increase was only seen at 500 mg/kg/day (+19%), but was not significant. There were no histopathological findings to correspond with these macroscopic changes. Conclusion The NOAEL for HC Yellow 10 in this study was considered to be 100 mg/kg/day. Ref.: 5","page":13,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.0016 | mg/kg | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"icity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General to","page":19,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_006"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity","page":19,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_007"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg | rat | oral | 90-day | developmental toxicity | {"dose":"General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg.","effect":"roperties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg. The NOAEL for HC Yellow 10 in a 90-day study was considered to be 100 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for HC Yellow 10 for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic.","page":19,"pdf":"sccp_o_101.pdf","row_type":"noael_study","study_id":"sccp_o_101_noael_009"} |
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 | - | 125 | mg/kg/day | - | oral | 93 days | - | SOURCE_SUBDIR=sccp_o_101; REPORT_TITLE=OPINION ON HC Yellow n° 10 COLIPA n° B81; OPINION_NUMBER=SCCP/1080/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=125; DOSE=Imexine FAH Batch: op T 10 Purity: not specified in study report, > 99% Dose:; EFFECT=rl CD (VAF plus) Group size: 10/sex/group Test substance: Imexine FAH Batch: op T 10 Purity: not specified in study report, > 99% Dose: 0, 25, 100, 500 mg/kg Vehicle: 0.5% methylcellulose Route: Gavage, 10 ml/kg/day. Exposure: 92/93 days GLP: in compliance These dose levels were selected on the basis of the results of 4-week preliminary study performed at 125, 500 and 2000 mg/kg/day, where significant changes in bodyweight and/or blood chemistry parameters at 2000 and/or 500 mg/kg/day were observed, and where the NOAEL was 125 mg/kg/day [17]. In the 13 week study, the dose was prepared daily. Animals were observed once daily for clinical signs and twice daily for mortality/morbidity. Body weight and food consumption were recorded weekly. Ophthalmologic evaluations on control and high-dose animals were performed before the treatment period and during week 13. Haematology, clinical chemistry and urinalysis evaluations were performed once during week 13. At the end of the treatment period, all animals were killed and grossly examin; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"109023-83-8","citation":"","dose":"Imexine FAH Batch: op T 10 Purity: not specified in study report, > 99% Dose:","duration":"93 days","effect":"rl CD (VAF plus) Group size: 10/sex/group Test substance: Imexine FAH Batch: op T 10 Purity: not specified in study report, > 99% Dose: 0, 25, 100, 500 mg/kg Vehicle: 0.5% methylcellulose Route: Gavage, 10 ml/kg/day. Exposure: 92/93 days GLP: in compliance These dose levels were selected on the basis of the results of 4-week preliminary study performed at 125, 500 and 2000 mg/kg/day, where significant changes in bodyweight and/or blood chemistry parameters at 2000 and/or 500 mg/kg/day were observed, and where the NOAEL was 125 mg/kg/day [17]. In the 13 week study, the dose was prepared daily. Animals were observed once daily for clinical signs and twice daily for mortality/morbidity. Body weight and food consumption were recorded weekly. Ophthalmologic evaluations on control and high-dose animals were performed before the treatment period and during week 13. Haematology, clinical chemistry and urinalysis evaluations were performed once during week 13. At the end of the treatment period, all animals were killed and grossly examin","endpoint":"","ingredient":"HC Yellow No. 10","loael_value":"","noael_unit":"mg/kg/day","noael_value":"125","page":13,"route":"oral","species":"","study_id":"sccp_o_101_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 100 | mg/kg/day | - | - | - | - | SOURCE_SUBDIR=sccp_o_101; REPORT_TITLE=OPINION ON HC Yellow n° 10 COLIPA n° B81; OPINION_NUMBER=SCCP/1080/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=100; DOSE=Absolute and relative liver weights were significantly increased for both sexes at 500 mg/kg/day (+18% to +27% bw-related).; EFFECT=or parameters determined using a clinistix®, but no abnormalities were found for those parameters that could be measured. Absolute and relative liver weights were significantly increased for both sexes at 500 mg/kg/day (+18% to +27% bw-related). In males, absolute spleen weights were increased at 100 and 500 mg/kg/day. Relative spleen weight increase was only seen at 500 mg/kg/day (+19%), but was not significant. There were no histopathological findings to correspond with these macroscopic changes. Conclusion The NOAEL for HC Yellow 10 in this study was considered to be 100 mg/kg/day. Ref.: 5; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"109023-83-8","citation":"","dose":"Absolute and relative liver weights were significantly increased for both sexes at 500 mg/kg/day (+18% to +27% bw-related).","duration":"","effect":"or parameters determined using a clinistix®, but no abnormalities were found for those parameters that could be measured. Absolute and relative liver weights were significantly increased for both sexes at 500 mg/kg/day (+18% to +27% bw-related). In males, absolute spleen weights were increased at 100 and 500 mg/kg/day. Relative spleen weight increase was only seen at 500 mg/kg/day (+19%), but was not significant. There were no histopathological findings to correspond with these macroscopic changes. Conclusion The NOAEL for HC Yellow 10 in this study was considered to be 100 mg/kg/day. Ref.: 5","endpoint":"","ingredient":"HC Yellow No. 10","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":13,"route":"","species":"","study_id":"sccp_o_101_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 500 | mg/kg bw | rat | oral | 28-day | dermal absorption | SOURCE_SUBDIR=sccp_o_101; REPORT_TITLE=OPINION ON HC Yellow n° 10 COLIPA n° B81; OPINION_NUMBER=SCCP/1080/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=500; DOSE=“HC yellow n°10 has an acute oral toxicity of >5000 mg/kg bw in the rat.; EFFECT=“HC yellow n°10 has an acute oral toxicity of >5000 mg/kg bw in the rat. The substance can be classified as very slightly irritating to the eyes and slightly irritating to the skin. Percutaneous absorption of a formulation was 0.024 % in absence and 0.025 % in presence of hair. In a 28-day study with rats, 125 mg/kg/day is considered to be the No Toxic Effect Level. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 500 mg/kg bw. It should be noted that the NOEL stems from an daily exposure for 28 days, whereas human exposure to semi-permanent hair dye is unlikely to be more frequent than twice a month. The compound was found to be not mutagenic.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 24 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II of HC Yellow No. 10 was submitted by COLIPA in July 2005; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"109023-83-8","citation":"","dose":"“HC yellow n°10 has an acute oral toxicity of >5000 mg/kg bw in the rat.","duration":"28-day","effect":"“HC yellow n°10 has an acute oral toxicity of >5000 mg/kg bw in the rat. The substance can be classified as very slightly irritating to the eyes and slightly irritating to the skin. Percutaneous absorption of a formulation was 0.024 % in absence and 0.025 % in presence of hair. In a 28-day study with rats, 125 mg/kg/day is considered to be the No Toxic Effect Level. In the teratogenicity study, no signs of maternal or foetal toxicity were observed after administration of 500 mg/kg bw. It should be noted that the NOEL stems from an daily exposure for 28 days, whereas human exposure to semi-permanent hair dye is unlikely to be more frequent than twice a month. The compound was found to be not mutagenic.” The substance is currently regulated by the Cosmetics Directive (76/768/EC), Annex III, Part 2 under entry 24 on the List of substances, provisionally allowed, which cosmetic products must not contain except subject to restrictions and conditions laid down. Submission II of HC Yellow No. 10 was submitted by COLIPA in July 2005","endpoint":"dermal absorption","ingredient":"HC Yellow No. 10","loael_value":"","noael_unit":"mg/kg bw","noael_value":"500","page":5,"route":"oral","species":"rat","study_id":"sccp_o_101_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.0016 | mg/kg | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_101; REPORT_TITLE=OPINION ON HC Yellow n° 10 COLIPA n° B81; OPINION_NUMBER=SCCP/1080/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT== 0.0016; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...; EFFECT=icity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"109023-83-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...","duration":"90-day","effect":"icity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General to","endpoint":"dermal absorption","ingredient":"HC Yellow No. 10","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.0016","page":19,"route":"oral","species":"rat","study_id":"sccp_o_101_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =100 | mg/kg | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_101; REPORT_TITLE=OPINION ON HC Yellow n° 10 COLIPA n° B81; OPINION_NUMBER=SCCP/1080/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT== 100; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...; EFFECT=Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"109023-83-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...","duration":"90-day","effect":"Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity","endpoint":"dermal absorption","ingredient":"HC Yellow No. 10","loael_value":"","noael_unit":"mg/kg","noael_value":"= 100","page":19,"route":"oral","species":"rat","study_id":"sccp_o_101_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =100 | mg/kg | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_101; REPORT_TITLE=OPINION ON HC Yellow n° 10 COLIPA n° B81; OPINION_NUMBER=SCCP/1080/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT== 100; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...; EFFECT=ations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity The maximum non-lethal dose of HC Yellow N°10 following; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"109023-83-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure...","duration":"90-day","effect":"ations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 11) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 0.134 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.094 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0016 mg/kg No observed adverse effect level NOAEL = 100 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 62500 3.3.14. Discussion Physico-chemical properties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity The maximum non-lethal dose of HC Yellow N°10 following","endpoint":"dermal absorption","ingredient":"HC Yellow No. 10","loael_value":"","noael_unit":"mg/kg","noael_value":"= 100","page":19,"route":"oral","species":"rat","study_id":"sccp_o_101_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 100 | mg/kg/day | rat | - | - | developmental toxicity | SOURCE_SUBDIR=sccp_o_101; REPORT_TITLE=OPINION ON HC Yellow n° 10 COLIPA n° B81; OPINION_NUMBER=SCCP/1080/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=100; DOSE=Occasional foetuses from the 300 mg/kg/day group were similarly affected, but the differences with respect to the control group were minimal.; EFFECT=day, as indicated in the incidences of foetuses with generalised reduced ossification or localised incomplete ossification of the skull, vertebrae, sternum, paws and/or pelvis. Occasional foetuses from the 300 mg/kg/day group were similarly affected, but the differences with respect to the control group were minimal. The low dose group was unaffected. The incidences of skeletal or soft tissue foetal abnormalities did not show any treatment-related trends and were considered unlikely to cause permanent defects. The No Observed Adverse Effect Level (NOAEL) for HC Yellow n° 10 in this study for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic. Ref.: 9 3.3.9. Toxicokinetics No data submitted; CITATION=Ref.: 9 3; CITATION_NUMBERS=[9,3]; REFERENCE=Ref.: 9 3; DETAILS_JSON={"cas_number":"109023-83-8","citation":"Ref.: 9 3","dose":"Occasional foetuses from the 300 mg/kg/day group were similarly affected, but the differences with respect to the control group were minimal.","duration":"","effect":"day, as indicated in the incidences of foetuses with generalised reduced ossification or localised incomplete ossification of the skull, vertebrae, sternum, paws and/or pelvis. Occasional foetuses from the 300 mg/kg/day group were similarly affected, but the differences with respect to the control group were minimal. The low dose group was unaffected. The incidences of skeletal or soft tissue foetal abnormalities did not show any treatment-related trends and were considered unlikely to cause permanent defects. The No Observed Adverse Effect Level (NOAEL) for HC Yellow n° 10 in this study for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic. Ref.: 9 3.3.9. Toxicokinetics No data submitted","endpoint":"developmental toxicity","ingredient":"HC Yellow No. 10","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":18,"route":"","species":"rat","study_id":"sccp_o_101_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 100 | mg/kg/day | rat | - | - | developmental toxicity | SOURCE_SUBDIR=sccp_o_101; REPORT_TITLE=OPINION ON HC Yellow n° 10 COLIPA n° B81; OPINION_NUMBER=SCCP/1080/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=100; DOSE=Occasional foetuses from the 300 mg/kg/day group were similarly affected, but the differences with respect to the control group were minimal.; EFFECT=s of foetuses with generalised reduced ossification or localised incomplete ossification of the skull, vertebrae, sternum, paws and/or pelvis. Occasional foetuses from the 300 mg/kg/day group were similarly affected, but the differences with respect to the control group were minimal. The low dose group was unaffected. The incidences of skeletal or soft tissue foetal abnormalities did not show any treatment-related trends and were considered unlikely to cause permanent defects. The No Observed Adverse Effect Level (NOAEL) for HC Yellow n° 10 in this study for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic. Ref.: 9 3.3.9. Toxicokinetics No data submitted; CITATION=Ref.: 9 3; CITATION_NUMBERS=[9,3]; REFERENCE=Ref.: 9 3; DETAILS_JSON={"cas_number":"109023-83-8","citation":"Ref.: 9 3","dose":"Occasional foetuses from the 300 mg/kg/day group were similarly affected, but the differences with respect to the control group were minimal.","duration":"","effect":"s of foetuses with generalised reduced ossification or localised incomplete ossification of the skull, vertebrae, sternum, paws and/or pelvis. Occasional foetuses from the 300 mg/kg/day group were similarly affected, but the differences with respect to the control group were minimal. The low dose group was unaffected. The incidences of skeletal or soft tissue foetal abnormalities did not show any treatment-related trends and were considered unlikely to cause permanent defects. The No Observed Adverse Effect Level (NOAEL) for HC Yellow n° 10 in this study for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic. Ref.: 9 3.3.9. Toxicokinetics No data submitted","endpoint":"developmental toxicity","ingredient":"HC Yellow No. 10","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":18,"route":"","species":"rat","study_id":"sccp_o_101_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 2000 | mg/kg | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_101; REPORT_TITLE=OPINION ON HC Yellow n° 10 COLIPA n° B81; OPINION_NUMBER=SCCP/1080/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=2000; DOSE=General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg.; EFFECT=roperties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg. The NOAEL for HC Yellow 10 in a 90-day study was considered to be 100 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for HC Yellow 10 for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"109023-83-8","citation":"","dose":"General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg.","duration":"90-day","effect":"roperties HC Yellow n° 10 is used in semi-permanent (direct) hair colouring products at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg. The NOAEL for HC Yellow 10 in a 90-day study was considered to be 100 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for HC Yellow 10 for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic.","endpoint":"developmental toxicity","ingredient":"HC Yellow No. 10","loael_value":"","noael_unit":"mg/kg","noael_value":"2000","page":19,"route":"oral","species":"rat","study_id":"sccp_o_101_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 100 | mg/kg/day | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_101; REPORT_TITLE=OPINION ON HC Yellow n° 10 COLIPA n° B81; OPINION_NUMBER=SCCP/1080/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=100; DOSE=General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg.; EFFECT=cts at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg. The NOAEL for HC Yellow 10 in a 90-day study was considered to be 100 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for HC Yellow 10 for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"109023-83-8","citation":"","dose":"General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg.","duration":"90-day","effect":"cts at a general on- head concentration of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg. The NOAEL for HC Yellow 10 in a 90-day study was considered to be 100 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for HC Yellow 10 for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic.","endpoint":"developmental toxicity","ingredient":"HC Yellow No. 10","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":19,"route":"oral","species":"rat","study_id":"sccp_o_101_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 100 | mg/kg/day | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_101; REPORT_TITLE=OPINION ON HC Yellow n° 10 COLIPA n° B81; OPINION_NUMBER=SCCP/1080/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=100; DOSE=General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg.; EFFECT=ation of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg. The NOAEL for HC Yellow 10 in a 90-day study was considered to be 100 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for HC Yellow 10 for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"109023-83-8","citation":"","dose":"General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg.","duration":"90-day","effect":"ation of 0.1%. HC Yellow n° 10 is a secondary amine, and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. No data was provided on the stability of HC Yellow n° 10 in marketed products. General toxicity The maximum non-lethal dose of HC Yellow N°10 following single oral gavage to fasted rats was 2000 mg/kg. The NOAEL for HC Yellow 10 in a 90-day study was considered to be 100 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for HC Yellow 10 for maternal toxicity and embryo-foetal development was 100 mg/kg/day. Doses up to 1000 mg/kg/day to pregnant Sprague-Dawley rats were not teratogenic.","endpoint":"developmental toxicity","ingredient":"HC Yellow No. 10","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":19,"route":"oral","species":"rat","study_id":"sccp_o_101_noael_011"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | VQY3VF9106 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H14ClN3O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"VQY3VF9106"} |
| openFDA substances | FDA UNII substance identifier | VQY3VF9106 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H14ClN3O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"VQY3VF9106"} |
| openFDA substances | FDA UNII substance identifier | VQY3VF9106 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H14ClN3O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"VQY3VF9106"} |
| openFDA substances | FDA UNII substance identifier | VQY3VF9106 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H14ClN3O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"VQY3VF9106"} |