NOAEL Studies Cosmetic Ingredient

Basic Brown 17 NOAEL Studies

INCI: BASIC BROWN 17

CAS: 16581-71-8

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 36 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =60 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3","dose":"Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.","effect":"bw/day at the end of the recovery period; in the same animals the relative liver weights were higher than controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the pre","page":18,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_001"}
SCCS_vision_codex NOAEL =77.4 % - - Chronic genotoxicity {"citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3","dose":"Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.","effect":"period; in the same animals the relative liver weights were higher than controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the presence a","page":18,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_002"}
SCCS_vision_codex NOAEL =120 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","effect":"s, and percent live male foetuses were similar to the controls. No dams had litters of only resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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","page":23,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_004"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","effect":"ere no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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 sub","page":23,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_007"}
SCCS_vision_codex NOAEL =46 mg/kg bw/day rabbit dermal 14 days dermal absorption {"dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","effect":"ent of Basic Red 118 impurity in Basic Brown 17. Water solubility is not determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low). Dermal absorption 0.48% of the applied dose corresponds","page":24,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_011"}
SCCS_vision_codex NOAEL =93 mg/kg bw/day rabbit dermal 14 days dermal absorption {"dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","effect":"ot determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low). Dermal absorption 0.48% of the applied dose corresponds to 1.62 μg/cm². The mean + 1SD (1.62 + 0.75) = 2.37 μg/cm2 should be u","page":24,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_012"}
SCCS_vision_codex NOAEL =0.023 mg/kg bw rat oral 90-day dermal absorption {"dose":"__________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS =...","effect":"__________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. T","page":30,"pdf":"sccs_o_152.pdf","row_type":"noael_study","study_id":"sccs_o_152_noael_008"}
SCCS_vision_codex NOAEL =46 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"_________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per tre...","effect":"_________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. The bat","page":30,"pdf":"sccs_o_152.pdf","row_type":"noael_study","study_id":"sccs_o_152_noael_009"}
SCCS_vision_codex NOAEL =23 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"on of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"on of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. The batches have varying dye contents due to the addition of an extender. The results from the toxicity tests shou","page":30,"pdf":"sccs_o_152.pdf","row_type":"noael_study","study_id":"sccs_o_152_noael_010"}
SCCS_vision_codex NOAEL =60 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3","dose":"Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.","effect":"bw/day at the end of the recovery period; in the same animals the relative liver weights were higher than controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the pre","page":18,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_001"}
SCCS_vision_codex NOAEL =77.4 % - - Chronic genotoxicity {"citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3","dose":"Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.","effect":"period; in the same animals the relative liver weights were higher than controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the presence a","page":18,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_002"}
SCCS_vision_codex NOAEL =120 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","effect":"s, and percent live male foetuses were similar to the controls. No dams had litters of only resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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","page":23,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_004"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","effect":"ere no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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 sub","page":23,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_007"}
SCCS_vision_codex NOAEL =46 mg/kg bw/day rabbit dermal 14 days dermal absorption {"dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","effect":"ent of Basic Red 118 impurity in Basic Brown 17. Water solubility is not determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low). Dermal absorption 0.48% of the applied dose corresponds","page":24,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_011"}
SCCS_vision_codex NOAEL =93 mg/kg bw/day rabbit dermal 14 days dermal absorption {"dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","effect":"ot determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low). Dermal absorption 0.48% of the applied dose corresponds to 1.62 μg/cm². The mean + 1SD (1.62 + 0.75) = 2.37 μg/cm2 should be u","page":24,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_012"}
SCCS_vision_codex NOAEL =60 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3","dose":"Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.","effect":"bw/day at the end of the recovery period; in the same animals the relative liver weights were higher than controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the pre","page":18,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_001"}
SCCS_vision_codex NOAEL =77.4 % - - Chronic genotoxicity {"citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3","dose":"Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.","effect":"period; in the same animals the relative liver weights were higher than controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the presence a","page":18,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_002"}
SCCS_vision_codex NOAEL =120 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","effect":"s, and percent live male foetuses were similar to the controls. No dams had litters of only resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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","page":23,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_004"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","effect":"ere no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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 sub","page":23,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_007"}
SCCS_vision_codex NOAEL =46 mg/kg bw/day rabbit dermal 14 days dermal absorption {"dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","effect":"ent of Basic Red 118 impurity in Basic Brown 17. Water solubility is not determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low). Dermal absorption 0.48% of the applied dose corresponds","page":24,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_011"}
SCCS_vision_codex NOAEL =93 mg/kg bw/day rabbit dermal 14 days dermal absorption {"dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","effect":"ot determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low). Dermal absorption 0.48% of the applied dose corresponds to 1.62 μg/cm². The mean + 1SD (1.62 + 0.75) = 2.37 μg/cm2 should be u","page":24,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_012"}
SCCS_vision_codex NOAEL =0.023 mg/kg bw rat oral 90-day dermal absorption {"dose":"__________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS =...","effect":"__________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. T","page":30,"pdf":"sccs_o_152.pdf","row_type":"noael_study","study_id":"sccs_o_152_noael_008"}
SCCS_vision_codex NOAEL =46 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"_________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per tre...","effect":"_________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. The bat","page":30,"pdf":"sccs_o_152.pdf","row_type":"noael_study","study_id":"sccs_o_152_noael_009"}
SCCS_vision_codex NOAEL =23 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"on of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"on of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. The batches have varying dye contents due to the addition of an extender. The results from the toxicity tests shou","page":30,"pdf":"sccs_o_152.pdf","row_type":"noael_study","study_id":"sccs_o_152_noael_010"}
SCCS_vision_codex NOAEL =0.023 mg/kg bw rat oral 90-day dermal absorption {"dose":"__________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS =...","effect":"__________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. T","page":30,"pdf":"sccs_o_152.pdf","row_type":"noael_study","study_id":"sccs_o_152_noael_008"}
SCCS_vision_codex NOAEL =46 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"_________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per tre...","effect":"_________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. The bat","page":30,"pdf":"sccs_o_152.pdf","row_type":"noael_study","study_id":"sccs_o_152_noael_009"}
SCCS_vision_codex NOAEL =23 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"on of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"on of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. The batches have varying dye contents due to the addition of an extender. The results from the toxicity tests shou","page":30,"pdf":"sccs_o_152.pdf","row_type":"noael_study","study_id":"sccs_o_152_noael_010"}
SCCS_vision_codex NOAEL =60 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3","dose":"Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.","effect":"bw/day at the end of the recovery period; in the same animals the relative liver weights were higher than controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the pre","page":18,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_001"}
SCCS_vision_codex NOAEL =77.4 % - - Chronic genotoxicity {"citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3","dose":"Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.","effect":"period; in the same animals the relative liver weights were higher than controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the presence a","page":18,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_002"}
SCCS_vision_codex NOAEL =120 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","effect":"s, and percent live male foetuses were similar to the controls. No dams had litters of only resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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","page":23,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_004"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","effect":"ere no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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 sub","page":23,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_007"}
SCCS_vision_codex NOAEL =46 mg/kg bw/day rabbit dermal 14 days dermal absorption {"dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","effect":"ent of Basic Red 118 impurity in Basic Brown 17. Water solubility is not determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low). Dermal absorption 0.48% of the applied dose corresponds","page":24,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_011"}
SCCS_vision_codex NOAEL =93 mg/kg bw/day rabbit dermal 14 days dermal absorption {"dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","effect":"ot determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low). Dermal absorption 0.48% of the applied dose corresponds to 1.62 μg/cm². The mean + 1SD (1.62 + 0.75) = 2.37 μg/cm2 should be u","page":24,"pdf":"sccs_o_086.pdf","row_type":"noael_study","study_id":"sccs_o_086_noael_012"}
SCCS_vision_codex NOAEL =0.023 mg/kg bw rat oral 90-day dermal absorption {"dose":"__________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS =...","effect":"__________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. T","page":30,"pdf":"sccs_o_152.pdf","row_type":"noael_study","study_id":"sccs_o_152_noael_008"}
SCCS_vision_codex NOAEL =46 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"_________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per tre...","effect":"_________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. The bat","page":30,"pdf":"sccs_o_152.pdf","row_type":"noael_study","study_id":"sccs_o_152_noael_009"}
SCCS_vision_codex NOAEL =23 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"on of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"on of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. The batches have varying dye contents due to the addition of an extender. The results from the toxicity tests shou","page":30,"pdf":"sccs_o_152.pdf","row_type":"noael_study","study_id":"sccs_o_152_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 28 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 120 mg/kg bw/day - - - - SOURCE_SUBDIR=sccs_o_086; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B7; OPINION_NUMBER=SCCS/1448/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=120; DOSE=In one mid-dose foetus, brain ventricles were enlarged.; EFFECT=s, and percent live male foetuses were similar to the controls. No dams had litters of only resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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; CITATION=Ref.: 13 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref.: 13 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","duration":"","effect":"s, and percent live male foetuses were similar to the controls. No dams had litters of only resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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","endpoint":"","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"120","page":23,"route":"","species":"","study_id":"sccs_o_086_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 120 mg/kg bw/day - - - - SOURCE_SUBDIR=sccs_o_086; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B7; OPINION_NUMBER=SCCS/1448/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=120; DOSE=In one mid-dose foetus, brain ventricles were enlarged.; EFFECT=were similar to the controls. No dams had litters of only resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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 su; CITATION=Ref.: 13 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref.: 13 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","duration":"","effect":"were similar to the controls. No dams had litters of only resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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 su","endpoint":"","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"120","page":23,"route":"","species":"","study_id":"sccs_o_086_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 120 mg/kg bw/day human - - - SOURCE_SUBDIR=sccs_o_086; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B7; OPINION_NUMBER=SCCS/1448/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=120; DOSE=In one mid-dose foetus, brain ventricles were enlarged.; EFFECT=resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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 d; CITATION=Ref.: 13 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref.: 13 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","duration":"","effect":"resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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 d","endpoint":"","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"120","page":23,"route":"","species":"human","study_id":"sccs_o_086_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 240 mg/kg bw/day human - - - SOURCE_SUBDIR=sccs_o_086; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B7; OPINION_NUMBER=SCCS/1448/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=240; DOSE=In one mid-dose foetus, brain ventricles were enlarged.; EFFECT=ere no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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 sub; CITATION=Ref.: 13 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref.: 13 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","duration":"","effect":"ere no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 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 sub","endpoint":"","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"240","page":23,"route":"","species":"human","study_id":"sccs_o_086_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 46 mg/kg bw/day rabbit dermal 14 days dermal absorption SOURCE_SUBDIR=sccs_o_086; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B7; OPINION_NUMBER=SCCS/1448/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=46; DOSE=On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.; EFFECT=ent of Basic Red 118 impurity in Basic Brown 17. Water solubility is not determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low). Dermal absorption 0.48% of the applied dose corresponds; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","duration":"14 days","effect":"ent of Basic Red 118 impurity in Basic Brown 17. Water solubility is not determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low). Dermal absorption 0.48% of the applied dose corresponds","endpoint":"dermal absorption","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"46","page":24,"route":"dermal","species":"rabbit","study_id":"sccs_o_086_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 93 mg/kg bw/day rabbit dermal 14 days dermal absorption SOURCE_SUBDIR=sccs_o_086; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B7; OPINION_NUMBER=SCCS/1448/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=93; DOSE=On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.; EFFECT=ot determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low). Dermal absorption 0.48% of the applied dose corresponds to 1.62 μg/cm². The mean + 1SD (1.62 + 0.75) = 2.37 μg/cm2 should be u; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","duration":"14 days","effect":"ot determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low). Dermal absorption 0.48% of the applied dose corresponds to 1.62 μg/cm². The mean + 1SD (1.62 + 0.75) = 2.37 μg/cm2 should be u","endpoint":"dermal absorption","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"93","page":24,"route":"dermal","species":"rabbit","study_id":"sccs_o_086_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.023 mg/kg bw rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT== 0.023; DOSE=__________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS =...; EFFECT=__________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. T; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"__________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS =...","duration":"90-day","effect":"__________________________________________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. T","endpoint":"dermal absorption","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.023","page":30,"route":"oral","species":"rat","study_id":"sccs_o_152_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =46 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT== 46; DOSE=_________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per tre...; EFFECT=_________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. The bat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"_________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per tre...","duration":"90-day","effect":"_________________________________________________________ 30 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. The bat","endpoint":"dermal absorption","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 46","page":30,"route":"oral","species":"rat","study_id":"sccs_o_152_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =23 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT== 23; DOSE=on of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...; EFFECT=on of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. The batches have varying dye contents due to the addition of an extender. The results from the toxicity tests shou; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"on of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","duration":"90-day","effect":"on of the MoS) CALCULATION OF THE MARGIN OF SAFETY Basic Brown 17 (Non-oxidative conditions) (2.0% formulation, on head concentration 2,0%) Absorption through the skin A = 2.37 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.38 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.023 mg/kg bw No observed adverse effect level NOAEL = 46 mg/kg bw/d (90-day, oral, rat) Bioavailability 50%* = 23 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 1000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physico-chemical properties Basic Brown 17 is used as a direct dye for hair colouring products. It is used without mixing with an oxidising agent (e.g. hydrogen peroxide). The final on head concentration of Basic Brown 17 can be up to 2.0%. The batches have varying dye contents due to the addition of an extender. The results from the toxicity tests shou","endpoint":"dermal absorption","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 23","page":30,"route":"oral","species":"rat","study_id":"sccs_o_152_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 60 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_086; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B7; OPINION_NUMBER=SCCS/1448/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=60; DOSE=Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.; EFFECT=bw/day at the end of the recovery period; in the same animals the relative liver weights were higher than controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the pre; CITATION=Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3; CITATION_NUMBERS=[12,2005,14,2010,3]; REFERENCE=Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3","dose":"Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.","duration":"Chronic","effect":"bw/day at the end of the recovery period; in the same animals the relative liver weights were higher than controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the pre","endpoint":"genotoxicity","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":18,"route":"","species":"","study_id":"sccs_o_086_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 77.4 % - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_086; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B7; OPINION_NUMBER=SCCS/1448/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=77.4; DOSE=Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.; EFFECT=period; in the same animals the relative liver weights were higher than controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the presence a; CITATION=Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3; CITATION_NUMBERS=[12,2005,14,2010,3]; REFERENCE=Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3","dose":"Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.","duration":"Chronic","effect":"period; in the same animals the relative liver weights were higher than controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the presence a","endpoint":"genotoxicity","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"%","noael_value":"77.4","page":18,"route":"","species":"","study_id":"sccs_o_086_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 77.4 % - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_086; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B7; OPINION_NUMBER=SCCS/1448/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=77.4; DOSE=Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.; EFFECT=han controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the presence and absence of S9- mix. Test substance: B 007 Solvent: deionised water; CITATION=Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3; CITATION_NUMBERS=[12,2005,14,2010,3]; REFERENCE=Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3","dose":"Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.","duration":"Chronic","effect":"han controls. Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission IV) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the presence and absence of S9- mix. Test substance: B 007 Solvent: deionised water","endpoint":"genotoxicity","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"%","noael_value":"77.4","page":18,"route":"","species":"","study_id":"sccs_o_086_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 60 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=60; DOSE=asic Brown 17 (B007) ___________________________________________________________________________________________ 22 Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animal...; EFFECT=asic Brown 17 (B007) ___________________________________________________________________________________________ 22 Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the pres; CITATION=Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3; CITATION_NUMBERS=[12,2005,14,2010,3]; REFERENCE=Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3","dose":"asic Brown 17 (B007) ___________________________________________________________________________________________ 22 Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animal...","duration":"Chronic","effect":"asic Brown 17 (B007) ___________________________________________________________________________________________ 22 Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the pres","endpoint":"genotoxicity","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":22,"route":"","species":"","study_id":"sccs_o_152_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 77.4 % - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=77.4; DOSE=______________________________________________________________________________ 22 Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/da...; EFFECT=______________________________________________________________________________ 22 Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the presence an; CITATION=Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3; CITATION_NUMBERS=[12,2005,14,2010,3]; REFERENCE=Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3","dose":"______________________________________________________________________________ 22 Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/da...","duration":"Chronic","effect":"______________________________________________________________________________ 22 Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the presence an","endpoint":"genotoxicity","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"%","noael_value":"77.4","page":22,"route":"","species":"","study_id":"sccs_o_152_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 77.4 % - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=77.4; DOSE=_________ 22 Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.; EFFECT=_________ 22 Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the presence and absence of S9- mix. Test substance: B 007 Solvent: deionised water; CITATION=Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3; CITATION_NUMBERS=[12,2005,14,2010,3]; REFERENCE=Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3","dose":"_________ 22 Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period.","duration":"Chronic","effect":"_________ 22 Changes in clinical chemistry parameters that could be correlated with the histopathological changes detected in the heart and skeletal muscle were a moderate to marked increase in aspartate aminotransferase detected in some animals dosed at 120 and 180 mg/kg bw/day at the end of the treatment period. Conclusion On the basis of this study, the low dose level of 60 mg/kg bw/day may be considered the No Observed Adverse Effect Level (NOAEL). As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). Ref.: 12 (2005 submission)/ 14 (2010 submission VI) 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537. Replicates: triplicates in only one experiment both in the presence and absence of S9- mix. Test substance: B 007 Solvent: deionised water","endpoint":"genotoxicity","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"%","noael_value":"77.4","page":22,"route":"","species":"","study_id":"sccs_o_152_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 60 mg/kg bw/day rabbit - 14 days irritation SOURCE_SUBDIR=sccs_o_086; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B7; OPINION_NUMBER=SCCS/1448/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=60; DOSE=On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.; EFFECT=e Cosmetic Directive, Basic Red 118 is not permitted for use in cosmetics except as an impurity in Basic Brown 17. However, the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Water solubility is not determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","duration":"14 days","effect":"e Cosmetic Directive, Basic Red 118 is not permitted for use in cosmetics except as an impurity in Basic Brown 17. However, the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Water solubility is not determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn","endpoint":"irritation","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":24,"route":"","species":"rabbit","study_id":"sccs_o_086_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 60 mg/kg bw/day rabbit - 14 days irritation SOURCE_SUBDIR=sccs_o_086; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B7; OPINION_NUMBER=SCCS/1448/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=60; DOSE=On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.; EFFECT=8 is not permitted for use in cosmetics except as an impurity in Basic Brown 17. However, the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Water solubility is not determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicl; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","duration":"14 days","effect":"8 is not permitted for use in cosmetics except as an impurity in Basic Brown 17. However, the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Water solubility is not determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicl","endpoint":"irritation","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":24,"route":"","species":"rabbit","study_id":"sccs_o_086_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 77.4 % rabbit - 14 days irritation SOURCE_SUBDIR=sccs_o_086; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B7; OPINION_NUMBER=SCCS/1448/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=77.4; DOSE=On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.; EFFECT=the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Water solubility is not determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","duration":"14 days","effect":"the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Water solubility is not determined by EU Method A.6 Stability of Basic Brown 17 in test solutions and in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). Irritation / sensitisation Under the conditions of the study, the test substance showed some irritant potential to the rabbit skin and rabbit eye. A conclusion on sensitisation cannot be drawn (vehicle used is not a recommended vehicle for LLNA; the maximum test concentration is too low).","endpoint":"irritation","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"%","noael_value":"77.4","page":24,"route":"","species":"rabbit","study_id":"sccs_o_086_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 120 mg/kg bw/day - - - irritation SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=120; DOSE=In one mid-dose foetus, brain ventricles were enlarged.; EFFECT=s, and percent live male foetuses were similar to the controls. No dams had litters of only resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 3.3.9 Toxicokinetics No data submitted. 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.3.10.2 Photomutagenicity / photoclastogenicity No data submitted; CITATION=Ref.: 13 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref.: 13 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","duration":"","effect":"s, and percent live male foetuses were similar to the controls. No dams had litters of only resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 3.3.9 Toxicokinetics No data submitted. 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.3.10.2 Photomutagenicity / photoclastogenicity No data submitted","endpoint":"irritation","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"120","page":29,"route":"","species":"","study_id":"sccs_o_152_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 120 mg/kg bw/day - - - irritation SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=120; DOSE=In one mid-dose foetus, brain ventricles were enlarged.; EFFECT=were similar to the controls. No dams had litters of only resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 3.3.9 Toxicokinetics No data submitted. 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.3.10.2 Photomutagenicity / photoclastogenicity No data submitted. 3.3.; CITATION=Ref.: 13 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref.: 13 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","duration":"","effect":"were similar to the controls. No dams had litters of only resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 3.3.9 Toxicokinetics No data submitted. 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.3.10.2 Photomutagenicity / photoclastogenicity No data submitted. 3.3.","endpoint":"irritation","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"120","page":29,"route":"","species":"","study_id":"sccs_o_152_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 120 mg/kg bw/day human - - irritation SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=120; DOSE=In one mid-dose foetus, brain ventricles were enlarged.; EFFECT=resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 3.3.9 Toxicokinetics No data submitted. 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.3.10.2 Photomutagenicity / photoclastogenicity No data submitted. 3.3.11 Human data No data submitted. 3.3.12 Special investigations No data submitted.; CITATION=Ref.: 13 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref.: 13 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","duration":"","effect":"resorbed conceptuses, and there were no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 3.3.9 Toxicokinetics No data submitted. 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.3.10.2 Photomutagenicity / photoclastogenicity No data submitted. 3.3.11 Human data No data submitted. 3.3.12 Special investigations No data submitted.","endpoint":"irritation","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"120","page":29,"route":"","species":"human","study_id":"sccs_o_152_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 240 mg/kg bw/day human - - irritation SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=240; DOSE=In one mid-dose foetus, brain ventricles were enlarged.; EFFECT=ere no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 3.3.9 Toxicokinetics No data submitted. 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.3.10.2 Photomutagenicity / photoclastogenicity No data submitted. 3.3.11 Human data No data submitted. 3.3.12 Special investigations No data submitted.; CITATION=Ref.: 13 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref.: 13 3; DETAILS_JSON={"cas_number":"68391-32-2","citation":"Ref.: 13 3","dose":"In one mid-dose foetus, brain ventricles were enlarged.","duration":"","effect":"ere no dead foetuses. Foetal parameters 13 small foetuses were found (control: 4, low dose: 3, mid-dose: 5 and high dose: 1). In one mid-dose foetus, brain ventricles were enlarged. This was considered incidental. There were no other dose-dependent, significant differences in the litter or foetal incidences of any gross external, soft tissue or skeletal alterations. Conclusion The maternal No Observed Adverse Effect Level (NOAEL) was considered to be 120 mg/kg bw/day. The foetal No Observed Adverse Effect Level (NOAEL) was higher than 240 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAELs were recalculated to 93 mg/kg bw/day (maternal) and 186 mg/kg bw/day (foetal). Ref.: 13 3.3.9 Toxicokinetics No data submitted. 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation No data submitted. 3.3.10.2 Photomutagenicity / photoclastogenicity No data submitted. 3.3.11 Human data No data submitted. 3.3.12 Special investigations No data submitted.","endpoint":"irritation","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"240","page":29,"route":"","species":"human","study_id":"sccs_o_152_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 60 mg/kg bw/day - - 14 days reproductive toxicity SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=60; DOSE=On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.; EFFECT=sic Brown 17 was 4.5 % (w/w) and 2.3% (HPLC peak area). According to the Cosmetic Directive, Basic Red 118 is not permitted for use in cosmetics except as an impurity in Basic Brown 17. However, the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Stability of Basic Brown 17 in in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). This NOAEL should be used for the calculation of MoS. The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). No study on reproductive toxicity was provided.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","duration":"14 days","effect":"sic Brown 17 was 4.5 % (w/w) and 2.3% (HPLC peak area). According to the Cosmetic Directive, Basic Red 118 is not permitted for use in cosmetics except as an impurity in Basic Brown 17. However, the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Stability of Basic Brown 17 in in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). This NOAEL should be used for the calculation of MoS. The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). No study on reproductive toxicity was provided.","endpoint":"reproductive toxicity","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":30,"route":"","species":"","study_id":"sccs_o_152_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 60 mg/kg bw/day - - 14 days reproductive toxicity SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=60; DOSE=On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.; EFFECT=.3% (HPLC peak area). According to the Cosmetic Directive, Basic Red 118 is not permitted for use in cosmetics except as an impurity in Basic Brown 17. However, the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Stability of Basic Brown 17 in in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). This NOAEL should be used for the calculation of MoS. The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). No study on reproductive toxicity was provided.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","duration":"14 days","effect":".3% (HPLC peak area). According to the Cosmetic Directive, Basic Red 118 is not permitted for use in cosmetics except as an impurity in Basic Brown 17. However, the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Stability of Basic Brown 17 in in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). This NOAEL should be used for the calculation of MoS. The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). No study on reproductive toxicity was provided.","endpoint":"reproductive toxicity","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":30,"route":"","species":"","study_id":"sccs_o_152_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 77.4 % - - 14 days reproductive toxicity SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=77.4; DOSE=On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.; EFFECT=for use in cosmetics except as an impurity in Basic Brown 17. However, the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Stability of Basic Brown 17 in in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). This NOAEL should be used for the calculation of MoS. The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). No study on reproductive toxicity was provided.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","duration":"14 days","effect":"for use in cosmetics except as an impurity in Basic Brown 17. However, the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Stability of Basic Brown 17 in in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). This NOAEL should be used for the calculation of MoS. The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). No study on reproductive toxicity was provided.","endpoint":"reproductive toxicity","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"%","noael_value":"77.4","page":30,"route":"","species":"","study_id":"sccs_o_152_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 46 mg/kg bw/day - - 14 days reproductive toxicity SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=46; DOSE=On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.; EFFECT=7. However, the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Stability of Basic Brown 17 in in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). This NOAEL should be used for the calculation of MoS. The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). No study on reproductive toxicity was provided.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","duration":"14 days","effect":"7. However, the Cosmetic Directive does not mention the permitted content of Basic Red 118 impurity in Basic Brown 17. Stability of Basic Brown 17 in in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). This NOAEL should be used for the calculation of MoS. The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). No study on reproductive toxicity was provided.","endpoint":"reproductive toxicity","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"46","page":30,"route":"","species":"","study_id":"sccs_o_152_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 93 mg/kg bw/day - - 14 days reproductive toxicity SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=93; DOSE=On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.; EFFECT=he permitted content of Basic Red 118 impurity in Basic Brown 17. Stability of Basic Brown 17 in in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). This NOAEL should be used for the calculation of MoS. The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). No study on reproductive toxicity was provided.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","duration":"14 days","effect":"he permitted content of Basic Red 118 impurity in Basic Brown 17. Stability of Basic Brown 17 in in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). This NOAEL should be used for the calculation of MoS. The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). No study on reproductive toxicity was provided.","endpoint":"reproductive toxicity","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"93","page":30,"route":"","species":"","study_id":"sccs_o_152_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 93 mg/kg bw/day - - 14 days reproductive toxicity SOURCE_SUBDIR=sccs_o_152; REPORT_TITLE=OPINION ON Basic Brown 17 COLIPA n° B007; OPINION_NUMBER=SCCS/1531/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 30 September 2008; VALUE_TEXT=93; DOSE=On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.; EFFECT=ility of Basic Brown 17 in in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). This NOAEL should be used for the calculation of MoS. The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). No study on reproductive toxicity was provided.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-32-2","citation":"","dose":"On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day.","duration":"14 days","effect":"ility of Basic Brown 17 in in typical hair dye formulations was not reported. General toxicity After 14 days observation, the LD50 was reported to be between 8 and 16 g/kg bw. On the basis of a 90-day study, the No Observed Adverse Effect Level (NOAEL) was 60 mg/kg bw/day. As the dye content of the test substance was only 77.4%, the NOAEL is recalculated to 46 mg/kg bw/day (60 x 0.774). This NOAEL should be used for the calculation of MoS. The NOAEL for maternal toxicity was considered to be 93 mg/kg bw/day. The NOAEL for foetal toxicity was higher than 186 mg/kg bw/day (both values also corrected for dye content). No study on reproductive toxicity was provided.","endpoint":"reproductive toxicity","ingredient":"Basic Brown 17","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"93","page":30,"route":"","species":"","study_id":"sccs_o_152_noael_016"}