NOAEL Studies Cosmetic Ingredient

CI 20470 NOAEL Studies

CAS: 1064-48-8

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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COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 0.300000011921 mg/kg bw/day rat oral 90 day Subchronic SCCS; Braun W.H., Damme B., Flade D., Konrad D. 13-Week Oral Toxicity (Gavage) Study inthe Rat. RCC Ltd, Study nr 851932, 29 September 2004
SCCS_vision_codex 20 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =1 - rat - - NOAEL study {"citation":"Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group","dose":"e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed.","effect":"e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed. In the liver, increased incidence and/or severity of haemosiderin deposits mainly stored in macrophages was observed. In addition haemopoietic cell foci increased in incidence of the high dose females; this was considered by the study authors to be adaptive in nature. Conclusion Due to the changes in haematological parameters and the correlated histological findings in the spleen, the NOEL of Acid Black 1 could not be established. Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group. The SCCS agrees with the conclusion of the study authors Study 2 Guideline: OECD 408 (1998) Species/strain: rat, HanBrl:WIST (SPF) Group size: 100 (group 1 and 4: 15 per sex and per dose; group 2 and 3: 10 per sex and per dose) Recovery group: 5 per sex and per dose (control and high dose group) Test","page":18,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_001"}
SCCS_vision_codex NOAEL =5 mg/kg/day - - 90-day NOAEL study {"citation":"Ref.: 7 SCCS comments to the two 90-day studies: The SCCS has revealed some inconsistencies between the results of various haematological parameters in male animals in the low-dose (stud","dose":"Alpha-1-globulin levels were also significantly reduced at the high dose.","effect":"riglycerides were significantly lower and outside the lower historic control range. The levels rose during the recovery phase but not to levels comparable to the controls. The study authors suggested that this was due to metabolic changes in the liver. Alpha-1-globulin levels were also significantly reduced at the high dose. Absolute or relative organ weights were comparable with the controls. No substance related macroscopic or adverse microscopic findings were noted. Conclusion The study authors considered the NOAEL for Acid Black 1 to be 5 mg/kg/day (4.7 mg active dye/kg bw/day) on the basis of the minimal reduction of haemoglobin accompanied by “left- shifting” of reticulocyte maturity indices without compensatory reticulocytosis. Ref.: 7 SCCS comments to the two 90-day studies: The SCCS has revealed some inconsistencies between the results of various haematological parameters in male animals in the low-dose (study 2) and high-dose (study 1) 90-day studies in general, e.g. RBC decreased in high-dose study, but increased or","page":19,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_002"}
SCCS_vision_codex NOAEL =40 mg/kg bw/day human - - developmental toxicity {"citation":"Ref.: 9 3","dose":"ndings At the high dose, reduced foetal body weight (13%) was noted.","effect":"ndings At the high dose, reduced foetal body weight (13%) was noted. Consequently, though statistically significant differences in skeletal ossification were seen, these were considered to be due to delayed maturation and not evidence of a teratogenic potential. The frequency of other foetal abnormalities noted during external examination, visceral examination or skeletal examination were comparable with the controls at all doses. Conclusion Based on this study, the maternal and foetal No-Observable-Effect-Level (NOEL) of Acid Black 1 was considered to be 40 mg/kg bw/day (38 mg active dye/kg bw/day). Ref.: 9 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 40 hairdressers with a known relevant allergy to 4-phenylenediamine (PPD) and or 2,5- diaminotoluene sulphate (DTS) and/or 2-nitro-4-phenylenediamine (ONPPD) and a hi","page":27,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_003"}
SCCS_vision_codex NOAEL =0.78 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"e MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Black 1) (non-oxidative conditions) Absorption through the skin A = 0.16 µg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.09 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0015 mg/kg bw Lowest observed adverse e...","effect":"e MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Black 1) (non-oxidative conditions) Absorption through the skin A = 0.16 µg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.09 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0015 mg/kg bw Lowest observed adverse effect level LOAEL = 4.7 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 2.35 mg/kg bw/d Uncertainty factor for LOAEL (3) = 0.78 mg/kg bw/d Margin of Safety NOAEL / SED = 522 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Acid Black 1 is used as a direct hair colouring agent up to an on-head concentration of 0.5% in non-oxidative hair dye formulations. Acid Black 1 is also listed in Annex IV – List of colouring agents allowed for use in cosmetic products – to Directive 76/768/EEC on cosmetic products, column 4: colouring agents","page":28,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_004"}
SCCS_vision_codex NOAEL =0.5 % mouse oral 90-day dermal absorption {"effect":"CC-CCR, Roßdorf, Study nr 665302, 11 August 2000 19. Honarvar N. LLNA in mice with Acid Black 1. RCC-CCR, Roßdorf, Study nr 870100, 21 February 2005 20. Contact Sensitisation: Classification according to Potency. ECETOX, Technical Report No. 87, April 2003 21. Hair dye sensitized hairdressers: the cross reaction pattern with new generation hair dyes. Fautz R, Fuchs A, van der Walle H, Contact Dermatitis, 46, 2002: 319-324 Submission III, 2012 • Wolfgang Dekant, Professor of Toxicology; Würzburg: Derivation of a NOAEL for Acid Black 1 from the results of the two available 90-day oral toxicity studies; October 2010 • Charles River Report No. 32319; Craig Blackstock, January 2012; the in vitro percutaneous absorption of radiolabelled Acid Black 1 (B015) at two concentrations (0.5%, w/w and 0.2% w/w) in a Non-Oxidative Hair Dye Formulation Through Human Skin • Fautz R., Fuchs A., van der Walle H., Hair dye sensitized hairdressers; cross reaction pattern with new generation of hair dyes; Contact Dermatitis, 46, 2002: 319-324 Addi","page":32,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_006"}
SCCS_vision_codex NOAEL =1 - rat - - NOAEL study {"citation":"Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group","dose":"e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed.","effect":"e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed. In the liver, increased incidence and/or severity of haemosiderin deposits mainly stored in macrophages was observed. In addition haemopoietic cell foci increased in incidence of the high dose females; this was considered by the study authors to be adaptive in nature. Conclusion Due to the changes in haematological parameters and the correlated histological findings in the spleen, the NOEL of Acid Black 1 could not be established. Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group. The SCCS agrees with the conclusion of the study authors Study 2 Guideline: OECD 408 (1998) Species/strain: rat, HanBrl:WIST (SPF) Group size: 100 (group 1 and 4: 15 per sex and per dose; group 2 and 3: 10 per sex and per dose) Recovery group: 5 per sex and per dose (control and high dose group) Test","page":18,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_001"}
SCCS_vision_codex NOAEL =5 mg/kg/day - - 90-day NOAEL study {"citation":"Ref.: 7 SCCS comments to the two 90-day studies: The SCCS has revealed some inconsistencies between the results of various haematological parameters in male animals in the low-dose (stud","dose":"Alpha-1-globulin levels were also significantly reduced at the high dose.","effect":"riglycerides were significantly lower and outside the lower historic control range. The levels rose during the recovery phase but not to levels comparable to the controls. The study authors suggested that this was due to metabolic changes in the liver. Alpha-1-globulin levels were also significantly reduced at the high dose. Absolute or relative organ weights were comparable with the controls. No substance related macroscopic or adverse microscopic findings were noted. Conclusion The study authors considered the NOAEL for Acid Black 1 to be 5 mg/kg/day (4.7 mg active dye/kg bw/day) on the basis of the minimal reduction of haemoglobin accompanied by “left- shifting” of reticulocyte maturity indices without compensatory reticulocytosis. Ref.: 7 SCCS comments to the two 90-day studies: The SCCS has revealed some inconsistencies between the results of various haematological parameters in male animals in the low-dose (study 2) and high-dose (study 1) 90-day studies in general, e.g. RBC decreased in high-dose study, but increased or","page":19,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_002"}
SCCS_vision_codex NOAEL =40 mg/kg bw/day human - - developmental toxicity {"citation":"Ref.: 9 3","dose":"ndings At the high dose, reduced foetal body weight (13%) was noted.","effect":"ndings At the high dose, reduced foetal body weight (13%) was noted. Consequently, though statistically significant differences in skeletal ossification were seen, these were considered to be due to delayed maturation and not evidence of a teratogenic potential. The frequency of other foetal abnormalities noted during external examination, visceral examination or skeletal examination were comparable with the controls at all doses. Conclusion Based on this study, the maternal and foetal No-Observable-Effect-Level (NOEL) of Acid Black 1 was considered to be 40 mg/kg bw/day (38 mg active dye/kg bw/day). Ref.: 9 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 40 hairdressers with a known relevant allergy to 4-phenylenediamine (PPD) and or 2,5- diaminotoluene sulphate (DTS) and/or 2-nitro-4-phenylenediamine (ONPPD) and a hi","page":27,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_003"}
SCCS_vision_codex NOAEL =0.78 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"e MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Black 1) (non-oxidative conditions) Absorption through the skin A = 0.16 µg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.09 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0015 mg/kg bw Lowest observed adverse e...","effect":"e MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Black 1) (non-oxidative conditions) Absorption through the skin A = 0.16 µg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.09 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0015 mg/kg bw Lowest observed adverse effect level LOAEL = 4.7 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 2.35 mg/kg bw/d Uncertainty factor for LOAEL (3) = 0.78 mg/kg bw/d Margin of Safety NOAEL / SED = 522 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Acid Black 1 is used as a direct hair colouring agent up to an on-head concentration of 0.5% in non-oxidative hair dye formulations. Acid Black 1 is also listed in Annex IV – List of colouring agents allowed for use in cosmetic products – to Directive 76/768/EEC on cosmetic products, column 4: colouring agents","page":28,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_004"}
SCCS_vision_codex NOAEL =0.5 % mouse oral 90-day dermal absorption {"effect":"CC-CCR, Roßdorf, Study nr 665302, 11 August 2000 19. Honarvar N. LLNA in mice with Acid Black 1. RCC-CCR, Roßdorf, Study nr 870100, 21 February 2005 20. Contact Sensitisation: Classification according to Potency. ECETOX, Technical Report No. 87, April 2003 21. Hair dye sensitized hairdressers: the cross reaction pattern with new generation hair dyes. Fautz R, Fuchs A, van der Walle H, Contact Dermatitis, 46, 2002: 319-324 Submission III, 2012 • Wolfgang Dekant, Professor of Toxicology; Würzburg: Derivation of a NOAEL for Acid Black 1 from the results of the two available 90-day oral toxicity studies; October 2010 • Charles River Report No. 32319; Craig Blackstock, January 2012; the in vitro percutaneous absorption of radiolabelled Acid Black 1 (B015) at two concentrations (0.5%, w/w and 0.2% w/w) in a Non-Oxidative Hair Dye Formulation Through Human Skin • Fautz R., Fuchs A., van der Walle H., Hair dye sensitized hairdressers; cross reaction pattern with new generation of hair dyes; Contact Dermatitis, 46, 2002: 319-324 Addi","page":32,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_006"}
SCCS_vision_codex NOAEL =1 - rat - - NOAEL study {"citation":"Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group","dose":"e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed.","effect":"e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed. In the liver, increased incidence and/or severity of haemosiderin deposits mainly stored in macrophages was observed. In addition haemopoietic cell foci increased in incidence of the high dose females; this was considered by the study authors to be adaptive in nature. Conclusion Due to the changes in haematological parameters and the correlated histological findings in the spleen, the NOEL of Acid Black 1 could not be established. Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group. The SCCS agrees with the conclusion of the study authors Study 2 Guideline: OECD 408 (1998) Species/strain: rat, HanBrl:WIST (SPF) Group size: 100 (group 1 and 4: 15 per sex and per dose; group 2 and 3: 10 per sex and per dose) Recovery group: 5 per sex and per dose (control and high dose group) Test","page":18,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_001"}
SCCS_vision_codex NOAEL =5 mg/kg/day - - 90-day NOAEL study {"citation":"Ref.: 7 SCCS comments to the two 90-day studies: The SCCS has revealed some inconsistencies between the results of various haematological parameters in male animals in the low-dose (stud","dose":"Alpha-1-globulin levels were also significantly reduced at the high dose.","effect":"riglycerides were significantly lower and outside the lower historic control range. The levels rose during the recovery phase but not to levels comparable to the controls. The study authors suggested that this was due to metabolic changes in the liver. Alpha-1-globulin levels were also significantly reduced at the high dose. Absolute or relative organ weights were comparable with the controls. No substance related macroscopic or adverse microscopic findings were noted. Conclusion The study authors considered the NOAEL for Acid Black 1 to be 5 mg/kg/day (4.7 mg active dye/kg bw/day) on the basis of the minimal reduction of haemoglobin accompanied by “left- shifting” of reticulocyte maturity indices without compensatory reticulocytosis. Ref.: 7 SCCS comments to the two 90-day studies: The SCCS has revealed some inconsistencies between the results of various haematological parameters in male animals in the low-dose (study 2) and high-dose (study 1) 90-day studies in general, e.g. RBC decreased in high-dose study, but increased or","page":19,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_002"}
SCCS_vision_codex NOAEL =40 mg/kg bw/day human - - developmental toxicity {"citation":"Ref.: 9 3","dose":"ndings At the high dose, reduced foetal body weight (13%) was noted.","effect":"ndings At the high dose, reduced foetal body weight (13%) was noted. Consequently, though statistically significant differences in skeletal ossification were seen, these were considered to be due to delayed maturation and not evidence of a teratogenic potential. The frequency of other foetal abnormalities noted during external examination, visceral examination or skeletal examination were comparable with the controls at all doses. Conclusion Based on this study, the maternal and foetal No-Observable-Effect-Level (NOEL) of Acid Black 1 was considered to be 40 mg/kg bw/day (38 mg active dye/kg bw/day). Ref.: 9 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 40 hairdressers with a known relevant allergy to 4-phenylenediamine (PPD) and or 2,5- diaminotoluene sulphate (DTS) and/or 2-nitro-4-phenylenediamine (ONPPD) and a hi","page":27,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_003"}
SCCS_vision_codex NOAEL =0.78 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"e MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Black 1) (non-oxidative conditions) Absorption through the skin A = 0.16 µg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.09 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0015 mg/kg bw Lowest observed adverse e...","effect":"e MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Black 1) (non-oxidative conditions) Absorption through the skin A = 0.16 µg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.09 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0015 mg/kg bw Lowest observed adverse effect level LOAEL = 4.7 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 2.35 mg/kg bw/d Uncertainty factor for LOAEL (3) = 0.78 mg/kg bw/d Margin of Safety NOAEL / SED = 522 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Acid Black 1 is used as a direct hair colouring agent up to an on-head concentration of 0.5% in non-oxidative hair dye formulations. Acid Black 1 is also listed in Annex IV – List of colouring agents allowed for use in cosmetic products – to Directive 76/768/EEC on cosmetic products, column 4: colouring agents","page":28,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_004"}
SCCS_vision_codex NOAEL =0.5 % mouse oral 90-day dermal absorption {"effect":"CC-CCR, Roßdorf, Study nr 665302, 11 August 2000 19. Honarvar N. LLNA in mice with Acid Black 1. RCC-CCR, Roßdorf, Study nr 870100, 21 February 2005 20. Contact Sensitisation: Classification according to Potency. ECETOX, Technical Report No. 87, April 2003 21. Hair dye sensitized hairdressers: the cross reaction pattern with new generation hair dyes. Fautz R, Fuchs A, van der Walle H, Contact Dermatitis, 46, 2002: 319-324 Submission III, 2012 • Wolfgang Dekant, Professor of Toxicology; Würzburg: Derivation of a NOAEL for Acid Black 1 from the results of the two available 90-day oral toxicity studies; October 2010 • Charles River Report No. 32319; Craig Blackstock, January 2012; the in vitro percutaneous absorption of radiolabelled Acid Black 1 (B015) at two concentrations (0.5%, w/w and 0.2% w/w) in a Non-Oxidative Hair Dye Formulation Through Human Skin • Fautz R., Fuchs A., van der Walle H., Hair dye sensitized hairdressers; cross reaction pattern with new generation of hair dyes; Contact Dermatitis, 46, 2002: 319-324 Addi","page":32,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_006"}
SCCS_vision_codex NOAEL =1 - rat - - NOAEL study {"citation":"Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group","dose":"e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed.","effect":"e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed. In the liver, increased incidence and/or severity of haemosiderin deposits mainly stored in macrophages was observed. In addition haemopoietic cell foci increased in incidence of the high dose females; this was considered by the study authors to be adaptive in nature. Conclusion Due to the changes in haematological parameters and the correlated histological findings in the spleen, the NOEL of Acid Black 1 could not be established. Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group. The SCCS agrees with the conclusion of the study authors Study 2 Guideline: OECD 408 (1998) Species/strain: rat, HanBrl:WIST (SPF) Group size: 100 (group 1 and 4: 15 per sex and per dose; group 2 and 3: 10 per sex and per dose) Recovery group: 5 per sex and per dose (control and high dose group) Test","page":18,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_001"}
SCCS_vision_codex NOAEL =5 mg/kg/day - - 90-day NOAEL study {"citation":"Ref.: 7 SCCS comments to the two 90-day studies: The SCCS has revealed some inconsistencies between the results of various haematological parameters in male animals in the low-dose (stud","dose":"Alpha-1-globulin levels were also significantly reduced at the high dose.","effect":"riglycerides were significantly lower and outside the lower historic control range. The levels rose during the recovery phase but not to levels comparable to the controls. The study authors suggested that this was due to metabolic changes in the liver. Alpha-1-globulin levels were also significantly reduced at the high dose. Absolute or relative organ weights were comparable with the controls. No substance related macroscopic or adverse microscopic findings were noted. Conclusion The study authors considered the NOAEL for Acid Black 1 to be 5 mg/kg/day (4.7 mg active dye/kg bw/day) on the basis of the minimal reduction of haemoglobin accompanied by “left- shifting” of reticulocyte maturity indices without compensatory reticulocytosis. Ref.: 7 SCCS comments to the two 90-day studies: The SCCS has revealed some inconsistencies between the results of various haematological parameters in male animals in the low-dose (study 2) and high-dose (study 1) 90-day studies in general, e.g. RBC decreased in high-dose study, but increased or","page":19,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_002"}
SCCS_vision_codex NOAEL =40 mg/kg bw/day human - - developmental toxicity {"citation":"Ref.: 9 3","dose":"ndings At the high dose, reduced foetal body weight (13%) was noted.","effect":"ndings At the high dose, reduced foetal body weight (13%) was noted. Consequently, though statistically significant differences in skeletal ossification were seen, these were considered to be due to delayed maturation and not evidence of a teratogenic potential. The frequency of other foetal abnormalities noted during external examination, visceral examination or skeletal examination were comparable with the controls at all doses. Conclusion Based on this study, the maternal and foetal No-Observable-Effect-Level (NOEL) of Acid Black 1 was considered to be 40 mg/kg bw/day (38 mg active dye/kg bw/day). Ref.: 9 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 40 hairdressers with a known relevant allergy to 4-phenylenediamine (PPD) and or 2,5- diaminotoluene sulphate (DTS) and/or 2-nitro-4-phenylenediamine (ONPPD) and a hi","page":27,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_003"}
SCCS_vision_codex NOAEL =0.78 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"e MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Black 1) (non-oxidative conditions) Absorption through the skin A = 0.16 µg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.09 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0015 mg/kg bw Lowest observed adverse e...","effect":"e MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Black 1) (non-oxidative conditions) Absorption through the skin A = 0.16 µg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.09 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0015 mg/kg bw Lowest observed adverse effect level LOAEL = 4.7 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 2.35 mg/kg bw/d Uncertainty factor for LOAEL (3) = 0.78 mg/kg bw/d Margin of Safety NOAEL / SED = 522 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Acid Black 1 is used as a direct hair colouring agent up to an on-head concentration of 0.5% in non-oxidative hair dye formulations. Acid Black 1 is also listed in Annex IV – List of colouring agents allowed for use in cosmetic products – to Directive 76/768/EEC on cosmetic products, column 4: colouring agents","page":28,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_004"}
SCCS_vision_codex NOAEL =0.5 % mouse oral 90-day dermal absorption {"effect":"CC-CCR, Roßdorf, Study nr 665302, 11 August 2000 19. Honarvar N. LLNA in mice with Acid Black 1. RCC-CCR, Roßdorf, Study nr 870100, 21 February 2005 20. Contact Sensitisation: Classification according to Potency. ECETOX, Technical Report No. 87, April 2003 21. Hair dye sensitized hairdressers: the cross reaction pattern with new generation hair dyes. Fautz R, Fuchs A, van der Walle H, Contact Dermatitis, 46, 2002: 319-324 Submission III, 2012 • Wolfgang Dekant, Professor of Toxicology; Würzburg: Derivation of a NOAEL for Acid Black 1 from the results of the two available 90-day oral toxicity studies; October 2010 • Charles River Report No. 32319; Craig Blackstock, January 2012; the in vitro percutaneous absorption of radiolabelled Acid Black 1 (B015) at two concentrations (0.5%, w/w and 0.2% w/w) in a Non-Oxidative Hair Dye Formulation Through Human Skin • Fautz R., Fuchs A., van der Walle H., Hair dye sensitized hairdressers; cross reaction pattern with new generation of hair dyes; Contact Dermatitis, 46, 2002: 319-324 Addi","page":32,"pdf":"sccs_o_148.pdf","row_type":"noael_study","study_id":"sccs_o_148_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1 - rat - - - SOURCE_SUBDIR=sccs_o_148; REPORT_TITLE=OPINION ON Acid Black 1 COLIPA n° B15; OPINION_NUMBER=SCCS/1492/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=unclear:e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed. In the liver, increased incidence and/or severity of haemosiderin deposits mainly stored in macrophages was observed. In addition haemopoietic cell foci increased in incidence of the high dose females; this was considered by the study authors to be adaptive in nature. Conclusion Due to the changes in haematological parameters and the correlated histological findings in the spleen, the NOEL of Acid Black 1 could not be established. Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group. The SCCS agrees with the conclusion of the study authors Study 2 Guideline: OECD 408 (1998) Species/strain: rat, HanBrl:WIST (SPF) Group size: 100 (group 1 and 4: 15 per sex and per dose; group 2 and 3: 10 per sex and per dose) Recovery group: 5 per sex and per dose (control and high dose group) Test; DOSE=e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed.; EFFECT=e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed. In the liver, increased incidence and/or severity of haemosiderin deposits mainly stored in macrophages was observed. In addition haemopoietic cell foci increased in incidence of the high dose females; this was considered by the study authors to be adaptive in nature. Conclusion Due to the changes in haematological parameters and the correlated histological findings in the spleen, the NOEL of Acid Black 1 could not be established. Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group. The SCCS agrees with the conclusion of the study authors Study 2 Guideline: OECD 408 (1998) Species/strain: rat, HanBrl:WIST (SPF) Group size: 100 (group 1 and 4: 15 per sex and per dose; group 2 and 3: 10 per sex and per dose) Recovery group: 5 per sex and per dose (control and high dose group) Test; CITATION=Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group; CITATION_NUMBERS=[6]; REFERENCE=Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group; DETAILS_JSON={"cas_number":"1064-48-8","citation":"Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group","dose":"e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed.","duration":"","effect":"e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed. In the liver, increased incidence and/or severity of haemosiderin deposits mainly stored in macrophages was observed. In addition haemopoietic cell foci increased in incidence of the high dose females; this was considered by the study authors to be adaptive in nature. Conclusion Due to the changes in haematological parameters and the correlated histological findings in the spleen, the NOEL of Acid Black 1 could not be established. Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group. The SCCS agrees with the conclusion of the study authors Study 2 Guideline: OECD 408 (1998) Species/strain: rat, HanBrl:WIST (SPF) Group size: 100 (group 1 and 4: 15 per sex and per dose; group 2 and 3: 10 per sex and per dose) Recovery group: 5 per sex and per dose (control and high dose group) Test","endpoint":"","ingredient":"Acid Black 1","loael_value":"","noael_unit":"","noael_value":"unclear:e of lymphoid foci and tubular mineralization in high dose males, and of pelvic mineralization in high dose females were observed. In the liver, increased incidence and/or severity of haemosiderin deposits mainly stored in macrophages was observed. In addition haemopoietic cell foci increased in incidence of the high dose females; this was considered by the study authors to be adaptive in nature. Conclusion Due to the changes in haematological parameters and the correlated histological findings in the spleen, the NOEL of Acid Black 1 could not be established. Ref.: 6 Comment Regarding the changes in haematological parameters, the SCCS noted that only reticulocytosis was statistically significantly changed in the low dose group. The SCCS agrees with the conclusion of the study authors Study 2 Guideline: OECD 408 (1998) Species/strain: rat, HanBrl:WIST (SPF) Group size: 100 (group 1 and 4: 15 per sex and per dose; group 2 and 3: 10 per sex and per dose) Recovery group: 5 per sex and per dose (control and high dose group) Test","page":18,"route":"","species":"rat","study_id":"sccs_o_148_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 5 mg/kg/day - - 90-day - SOURCE_SUBDIR=sccs_o_148; REPORT_TITLE=OPINION ON Acid Black 1 COLIPA n° B15; OPINION_NUMBER=SCCS/1492/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=5; DOSE=Alpha-1-globulin levels were also significantly reduced at the high dose.; EFFECT=riglycerides were significantly lower and outside the lower historic control range. The levels rose during the recovery phase but not to levels comparable to the controls. The study authors suggested that this was due to metabolic changes in the liver. Alpha-1-globulin levels were also significantly reduced at the high dose. Absolute or relative organ weights were comparable with the controls. No substance related macroscopic or adverse microscopic findings were noted. Conclusion The study authors considered the NOAEL for Acid Black 1 to be 5 mg/kg/day (4.7 mg active dye/kg bw/day) on the basis of the minimal reduction of haemoglobin accompanied by “left- shifting” of reticulocyte maturity indices without compensatory reticulocytosis. Ref.: 7 SCCS comments to the two 90-day studies: The SCCS has revealed some inconsistencies between the results of various haematological parameters in male animals in the low-dose (study 2) and high-dose (study 1) 90-day studies in general, e.g. RBC decreased in high-dose study, but increased or; CITATION=Ref.: 7 SCCS comments to the two 90-day studies: The SCCS has revealed some inconsistencies between the results of various haematological parameters in male animals in the low-dose (stud; CITATION_NUMBERS=[7,90]; REFERENCE=Ref.: 7 SCCS comments to the two 90-day studies: The SCCS has revealed some inconsistencies between the results of various haematological parameters in male animals in the low-dose (stud; DETAILS_JSON={"cas_number":"1064-48-8","citation":"Ref.: 7 SCCS comments to the two 90-day studies: The SCCS has revealed some inconsistencies between the results of various haematological parameters in male animals in the low-dose (stud","dose":"Alpha-1-globulin levels were also significantly reduced at the high dose.","duration":"90-day","effect":"riglycerides were significantly lower and outside the lower historic control range. The levels rose during the recovery phase but not to levels comparable to the controls. The study authors suggested that this was due to metabolic changes in the liver. Alpha-1-globulin levels were also significantly reduced at the high dose. Absolute or relative organ weights were comparable with the controls. No substance related macroscopic or adverse microscopic findings were noted. Conclusion The study authors considered the NOAEL for Acid Black 1 to be 5 mg/kg/day (4.7 mg active dye/kg bw/day) on the basis of the minimal reduction of haemoglobin accompanied by “left- shifting” of reticulocyte maturity indices without compensatory reticulocytosis. Ref.: 7 SCCS comments to the two 90-day studies: The SCCS has revealed some inconsistencies between the results of various haematological parameters in male animals in the low-dose (study 2) and high-dose (study 1) 90-day studies in general, e.g. RBC decreased in high-dose study, but increased or","endpoint":"","ingredient":"Acid Black 1","loael_value":"","noael_unit":"mg/kg/day","noael_value":"5","page":19,"route":"","species":"","study_id":"sccs_o_148_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.78 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_148; REPORT_TITLE=OPINION ON Acid Black 1 COLIPA n° B15; OPINION_NUMBER=SCCS/1492/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT== 0.78; DOSE=e MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Black 1) (non-oxidative conditions) Absorption through the skin A = 0.16 µg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.09 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0015 mg/kg bw Lowest observed adverse e...; LOAEL_VALUE=4.7 mg/kg bw/d; EFFECT=e MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Black 1) (non-oxidative conditions) Absorption through the skin A = 0.16 µg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.09 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0015 mg/kg bw Lowest observed adverse effect level LOAEL = 4.7 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 2.35 mg/kg bw/d Uncertainty factor for LOAEL (3) = 0.78 mg/kg bw/d Margin of Safety NOAEL / SED = 522 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Acid Black 1 is used as a direct hair colouring agent up to an on-head concentration of 0.5% in non-oxidative hair dye formulations. Acid Black 1 is also listed in Annex IV – List of colouring agents allowed for use in cosmetic products – to Directive 76/768/EEC on cosmetic products, column 4: colouring agents; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1064-48-8","citation":"","dose":"e MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Black 1) (non-oxidative conditions) Absorption through the skin A = 0.16 µg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.09 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0015 mg/kg bw Lowest observed adverse e...","duration":"90-day","effect":"e MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Black 1) (non-oxidative conditions) Absorption through the skin A = 0.16 µg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.09 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0015 mg/kg bw Lowest observed adverse effect level LOAEL = 4.7 mg/kg bw/d (90-day, oral, rat) 50% bioavailability * = 2.35 mg/kg bw/d Uncertainty factor for LOAEL (3) = 0.78 mg/kg bw/d Margin of Safety NOAEL / SED = 522 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Acid Black 1 is used as a direct hair colouring agent up to an on-head concentration of 0.5% in non-oxidative hair dye formulations. Acid Black 1 is also listed in Annex IV – List of colouring agents allowed for use in cosmetic products – to Directive 76/768/EEC on cosmetic products, column 4: colouring agents","endpoint":"dermal absorption","ingredient":"Acid Black 1","loael_value":"4.7 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"= 0.78","page":28,"route":"oral","species":"rat","study_id":"sccs_o_148_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 0.5 % mouse oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_148; REPORT_TITLE=OPINION ON Acid Black 1 COLIPA n° B15; OPINION_NUMBER=SCCS/1492/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=0.5; EFFECT=CC-CCR, Roßdorf, Study nr 665302, 11 August 2000 19. Honarvar N. LLNA in mice with Acid Black 1. RCC-CCR, Roßdorf, Study nr 870100, 21 February 2005 20. Contact Sensitisation: Classification according to Potency. ECETOX, Technical Report No. 87, April 2003 21. Hair dye sensitized hairdressers: the cross reaction pattern with new generation hair dyes. Fautz R, Fuchs A, van der Walle H, Contact Dermatitis, 46, 2002: 319-324 Submission III, 2012 • Wolfgang Dekant, Professor of Toxicology; Würzburg: Derivation of a NOAEL for Acid Black 1 from the results of the two available 90-day oral toxicity studies; October 2010 • Charles River Report No. 32319; Craig Blackstock, January 2012; the in vitro percutaneous absorption of radiolabelled Acid Black 1 (B015) at two concentrations (0.5%, w/w and 0.2% w/w) in a Non-Oxidative Hair Dye Formulation Through Human Skin • Fautz R., Fuchs A., van der Walle H., Hair dye sensitized hairdressers; cross reaction pattern with new generation of hair dyes; Contact Dermatitis, 46, 2002: 319-324 Addi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1064-48-8","citation":"","dose":"","duration":"90-day","effect":"CC-CCR, Roßdorf, Study nr 665302, 11 August 2000 19. Honarvar N. LLNA in mice with Acid Black 1. RCC-CCR, Roßdorf, Study nr 870100, 21 February 2005 20. Contact Sensitisation: Classification according to Potency. ECETOX, Technical Report No. 87, April 2003 21. Hair dye sensitized hairdressers: the cross reaction pattern with new generation hair dyes. Fautz R, Fuchs A, van der Walle H, Contact Dermatitis, 46, 2002: 319-324 Submission III, 2012 • Wolfgang Dekant, Professor of Toxicology; Würzburg: Derivation of a NOAEL for Acid Black 1 from the results of the two available 90-day oral toxicity studies; October 2010 • Charles River Report No. 32319; Craig Blackstock, January 2012; the in vitro percutaneous absorption of radiolabelled Acid Black 1 (B015) at two concentrations (0.5%, w/w and 0.2% w/w) in a Non-Oxidative Hair Dye Formulation Through Human Skin • Fautz R., Fuchs A., van der Walle H., Hair dye sensitized hairdressers; cross reaction pattern with new generation of hair dyes; Contact Dermatitis, 46, 2002: 319-324 Addi","endpoint":"dermal absorption","ingredient":"Acid Black 1","loael_value":"","noael_unit":"%","noael_value":"0.5","page":32,"route":"oral","species":"mouse","study_id":"sccs_o_148_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 40 mg/kg bw/day human - - developmental toxicity SOURCE_SUBDIR=sccs_o_148; REPORT_TITLE=OPINION ON Acid Black 1 COLIPA n° B15; OPINION_NUMBER=SCCS/1492/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=40; DOSE=ndings At the high dose, reduced foetal body weight (13%) was noted.; EFFECT=ndings At the high dose, reduced foetal body weight (13%) was noted. Consequently, though statistically significant differences in skeletal ossification were seen, these were considered to be due to delayed maturation and not evidence of a teratogenic potential. The frequency of other foetal abnormalities noted during external examination, visceral examination or skeletal examination were comparable with the controls at all doses. Conclusion Based on this study, the maternal and foetal No-Observable-Effect-Level (NOEL) of Acid Black 1 was considered to be 40 mg/kg bw/day (38 mg active dye/kg bw/day). Ref.: 9 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 40 hairdressers with a known relevant allergy to 4-phenylenediamine (PPD) and or 2,5- diaminotoluene sulphate (DTS) and/or 2-nitro-4-phenylenediamine (ONPPD) and a hi; CITATION=Ref.: 9 3; CITATION_NUMBERS=[9,3]; REFERENCE=Ref.: 9 3; DETAILS_JSON={"cas_number":"1064-48-8","citation":"Ref.: 9 3","dose":"ndings At the high dose, reduced foetal body weight (13%) was noted.","duration":"","effect":"ndings At the high dose, reduced foetal body weight (13%) was noted. Consequently, though statistically significant differences in skeletal ossification were seen, these were considered to be due to delayed maturation and not evidence of a teratogenic potential. The frequency of other foetal abnormalities noted during external examination, visceral examination or skeletal examination were comparable with the controls at all doses. Conclusion Based on this study, the maternal and foetal No-Observable-Effect-Level (NOEL) of Acid Black 1 was considered to be 40 mg/kg bw/day (38 mg active dye/kg bw/day). Ref.: 9 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 40 hairdressers with a known relevant allergy to 4-phenylenediamine (PPD) and or 2,5- diaminotoluene sulphate (DTS) and/or 2-nitro-4-phenylenediamine (ONPPD) and a hi","endpoint":"developmental toxicity","ingredient":"Acid Black 1","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":27,"route":"","species":"human","study_id":"sccs_o_148_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 40 mg/kg bw/day rat dermal sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_148; REPORT_TITLE=OPINION ON Acid Black 1 COLIPA n° B15; OPINION_NUMBER=SCCS/1492/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 December 2013; VALUE_TEXT=40; DOSE=The results of the haematological parameters in the low-dose study are presumably not fully reliable although supporting some of the findings in the high-dose study.; LOAEL_VALUE=40 mg/kg bw/day; EFFECT=hropoietic effects of Acid Black 1 suggesting the development of haemolytic anaemia were seen in both sub-chronic toxicity studies in rats. Males seem to be more susceptible. The results of the haematological parameters in the low-dose study are presumably not fully reliable although supporting some of the findings in the high-dose study. Therefore, the safety assessment will be based on the high-dose study with the lowest dose level of 5 mg/kg bw/day as a LOAEL. The maternal and foetal No Observable Effect Level (NOEL) of Acid Black 1 was considered to be 40 mg/kg bw/day (38 mg active dye/kg bw/day) in a developmental toxicity study in rats. No two generation reproduction study was submitted. Skin/eye irritation and sensitisation 10% (w/v) Acid Black 1 in tap water was shown to be non-irritant to rabbit skin. Acid Black 1 at 5% (w/v) concentration was not irritating to eye. In a LLNA study, Acid Black 1 was found to be a moderate skin sensitiser. Percutaneous absorption The dermal absorption of B15 at 1% final concentration; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1064-48-8","citation":"","dose":"The results of the haematological parameters in the low-dose study are presumably not fully reliable although supporting some of the findings in the high-dose study.","duration":"sub-chronic","effect":"hropoietic effects of Acid Black 1 suggesting the development of haemolytic anaemia were seen in both sub-chronic toxicity studies in rats. Males seem to be more susceptible. The results of the haematological parameters in the low-dose study are presumably not fully reliable although supporting some of the findings in the high-dose study. Therefore, the safety assessment will be based on the high-dose study with the lowest dose level of 5 mg/kg bw/day as a LOAEL. The maternal and foetal No Observable Effect Level (NOEL) of Acid Black 1 was considered to be 40 mg/kg bw/day (38 mg active dye/kg bw/day) in a developmental toxicity study in rats. No two generation reproduction study was submitted. Skin/eye irritation and sensitisation 10% (w/v) Acid Black 1 in tap water was shown to be non-irritant to rabbit skin. Acid Black 1 at 5% (w/v) concentration was not irritating to eye. In a LLNA study, Acid Black 1 was found to be a moderate skin sensitiser. Percutaneous absorption The dermal absorption of B15 at 1% final concentration","endpoint":"repeated dose toxicity","ingredient":"Acid Black 1","loael_value":"40 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"40","page":29,"route":"dermal","species":"rat","study_id":"sccs_o_148_noael_005"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier SZT789770M UNII - - - chemical {"approval_status":null,"molecular_formula":"C22H14N6O9S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SZT789770M"}
openFDA substances FDA UNII substance identifier SZT789770M UNII - - - chemical {"approval_status":null,"molecular_formula":"C22H14N6O9S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SZT789770M"}
openFDA substances FDA UNII substance identifier SZT789770M UNII - - - chemical {"approval_status":null,"molecular_formula":"C22H14N6O9S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SZT789770M"}
openFDA substances FDA UNII substance identifier SZT789770M UNII - - - chemical {"approval_status":null,"molecular_formula":"C22H14N6O9S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SZT789770M"}