NOAEL Studies Cosmetic Ingredient

Acid Blue 62 NOAEL Studies

INCI: CI 62045

CAS: 4368-56-3

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

Back to parent ingredient page
COSMOS_DB 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 100 mg/kg bw/day rat oral 90 day Subchronic SCCP; C. Fabreguettes. Thirteen-Week Toxicity Study by Oral Route (Gavage) in Rats. CITStudy No. 10604 TSR (CIES1 93045), October 17, 1994
COSMOS_DB LOAEL 300 mg/kg bw/day rat oral 6-15 Gestation day Developmental SCCP; M.H. Savary. Embryotoxicity/Teratogenicity Study by Oral Route in Rats. CIT Study No.10637 RSR (CIES1 94001), January 12, 1994
SCCNFP_vision_codex 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCNFP_vision_codex NOAEL =300 mg/kg bw/day rat - - developmental toxicity {"citation":"Ref.: 12","dose":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment.","effect":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment. Litter data and foetal examinations from treated foetuses did not differ from those for control foetuses. No anomalies or malformations of toxicological significance were observed. Conclusion Acid Blue 62 (53.4% pure) was noted to have maternotoxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus. Ref.: 12","page":14,"pdf":"out277_en.pdf","row_type":"noael_study","study_id":"out277_en_noael_001"}
SCCNFP_vision_codex NOAEL =53 % mouse oral developmental repeated dose toxicity {"dose":"The available studies (acute oral toxicity, repeated dose toxicity and developmental toxicity) have all been performed with a test substance of a rather low purity.","effect":"g under the conditions of the study. However, the test does not conform to guinea pig maximisation test guideline. Acid Blue 62 (98.4% pure) did not induce delayed contact hypersensitivity in the LLNA. The available studies (acute oral toxicity, repeated dose toxicity and developmental toxicity) have all been performed with a test substance of a rather low purity. Therefore, and especially since the composition of the tested batch is not known (purity is about 53%), it is not possible to give an indication of the NOAEL. The exact composition of the test substance must be provided. Acid Blue 62 has been tested in vitro on bacterial cells for the induction of gene mutations and on mammalian cells for the induction of chromosome aberrations. It was found non mutagenic, neither clastogenic. The test item is neither clastogenic nor aneugenic in vivo on mice treated orally.","page":18,"pdf":"out277_en.pdf","row_type":"noael_study","study_id":"out277_en_noael_002"}
SCCNFP_vision_codex NOAEL =300 mg/kg bw/day rat - - developmental toxicity {"citation":"Ref.: 12","dose":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment.","effect":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment. Litter data and foetal examinations from treated foetuses did not differ from those for control foetuses. No anomalies or malformations of toxicological significance were observed. Conclusion Acid Blue 62 (53.4% pure) was noted to have maternotoxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus. Ref.: 12","page":14,"pdf":"out277_en.pdf","row_type":"noael_study","study_id":"out277_en_noael_001"}
SCCNFP_vision_codex NOAEL =53 % mouse oral developmental repeated dose toxicity {"dose":"The available studies (acute oral toxicity, repeated dose toxicity and developmental toxicity) have all been performed with a test substance of a rather low purity.","effect":"g under the conditions of the study. However, the test does not conform to guinea pig maximisation test guideline. Acid Blue 62 (98.4% pure) did not induce delayed contact hypersensitivity in the LLNA. The available studies (acute oral toxicity, repeated dose toxicity and developmental toxicity) have all been performed with a test substance of a rather low purity. Therefore, and especially since the composition of the tested batch is not known (purity is about 53%), it is not possible to give an indication of the NOAEL. The exact composition of the test substance must be provided. Acid Blue 62 has been tested in vitro on bacterial cells for the induction of gene mutations and on mammalian cells for the induction of chromosome aberrations. It was found non mutagenic, neither clastogenic. The test item is neither clastogenic nor aneugenic in vivo on mice treated orally.","page":18,"pdf":"out277_en.pdf","row_type":"noael_study","study_id":"out277_en_noael_002"}
SCCNFP_vision_codex NOAEL =300 mg/kg bw/day rat - - developmental toxicity {"citation":"Ref.: 12","dose":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment.","effect":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment. Litter data and foetal examinations from treated foetuses did not differ from those for control foetuses. No anomalies or malformations of toxicological significance were observed. Conclusion Acid Blue 62 (53.4% pure) was noted to have maternotoxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus. Ref.: 12","page":14,"pdf":"out277_en.pdf","row_type":"noael_study","study_id":"out277_en_noael_001"}
SCCNFP_vision_codex NOAEL =53 % mouse oral developmental repeated dose toxicity {"dose":"The available studies (acute oral toxicity, repeated dose toxicity and developmental toxicity) have all been performed with a test substance of a rather low purity.","effect":"g under the conditions of the study. However, the test does not conform to guinea pig maximisation test guideline. Acid Blue 62 (98.4% pure) did not induce delayed contact hypersensitivity in the LLNA. The available studies (acute oral toxicity, repeated dose toxicity and developmental toxicity) have all been performed with a test substance of a rather low purity. Therefore, and especially since the composition of the tested batch is not known (purity is about 53%), it is not possible to give an indication of the NOAEL. The exact composition of the test substance must be provided. Acid Blue 62 has been tested in vitro on bacterial cells for the induction of gene mutations and on mammalian cells for the induction of chromosome aberrations. It was found non mutagenic, neither clastogenic. The test item is neither clastogenic nor aneugenic in vivo on mice treated orally.","page":18,"pdf":"out277_en.pdf","row_type":"noael_study","study_id":"out277_en_noael_002"}
SCCNFP_vision_codex NOAEL =300 mg/kg bw/day rat - - developmental toxicity {"citation":"Ref.: 12","dose":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment.","effect":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment. Litter data and foetal examinations from treated foetuses did not differ from those for control foetuses. No anomalies or malformations of toxicological significance were observed. Conclusion Acid Blue 62 (53.4% pure) was noted to have maternotoxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus. Ref.: 12","page":14,"pdf":"out277_en.pdf","row_type":"noael_study","study_id":"out277_en_noael_001"}
SCCNFP_vision_codex NOAEL =53 % mouse oral developmental repeated dose toxicity {"dose":"The available studies (acute oral toxicity, repeated dose toxicity and developmental toxicity) have all been performed with a test substance of a rather low purity.","effect":"g under the conditions of the study. However, the test does not conform to guinea pig maximisation test guideline. Acid Blue 62 (98.4% pure) did not induce delayed contact hypersensitivity in the LLNA. The available studies (acute oral toxicity, repeated dose toxicity and developmental toxicity) have all been performed with a test substance of a rather low purity. Therefore, and especially since the composition of the tested batch is not known (purity is about 53%), it is not possible to give an indication of the NOAEL. The exact composition of the test substance must be provided. Acid Blue 62 has been tested in vitro on bacterial cells for the induction of gene mutations and on mammalian cells for the induction of chromosome aberrations. It was found non mutagenic, neither clastogenic. The test item is neither clastogenic nor aneugenic in vivo on mice treated orally.","page":18,"pdf":"out277_en.pdf","row_type":"noael_study","study_id":"out277_en_noael_002"}
SCCS_vision_codex 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat - - developmental toxicity {"citation":"Ref.: 12 3","dose":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment.","effect":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment. Litter data and foetal examinations from treated foetuses did not differ from those for control foetuses. No anomalies or malformations of toxicological significance were observed. Conclusion Acid Blue 62 (53.4% pure) was noted to have maternotoxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus. Ref.: 12 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity /","page":21,"pdf":"sccp_o_010.pdf","row_type":"noael_study","study_id":"sccp_o_010_noael_001"}
SCCS_vision_codex NOAEL =160 mg/kg rat oral subchronic repeated dose toxicity {"dose":"Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg =...","effect":"identical independent of the mode of calculation (percentage versus µg/cm2). Only the calculation based on usage data is shown. Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg = 0.29 mg/kg No observed adverse effect level (mg/kg) NOAEL = 160 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 552 3.3.14. Discussion Acid Blue 62 is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye). Acid Blue 62 (53.4% pure) was noted to have materno-toxic effects at 1000 mg/kg bw/day, but","page":22,"pdf":"sccp_o_010.pdf","row_type":"noael_study","study_id":"sccp_o_010_noael_002"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat - - developmental toxicity {"citation":"Ref.: 12 3","dose":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment.","effect":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment. Litter data and foetal examinations from treated foetuses did not differ from those for control foetuses. No anomalies or malformations of toxicological significance were observed. Conclusion Acid Blue 62 (53.4% pure) was noted to have maternotoxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus. Ref.: 12 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity /","page":21,"pdf":"sccp_o_010.pdf","row_type":"noael_study","study_id":"sccp_o_010_noael_001"}
SCCS_vision_codex NOAEL =160 mg/kg rat oral subchronic repeated dose toxicity {"dose":"Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg =...","effect":"identical independent of the mode of calculation (percentage versus µg/cm2). Only the calculation based on usage data is shown. Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg = 0.29 mg/kg No observed adverse effect level (mg/kg) NOAEL = 160 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 552 3.3.14. Discussion Acid Blue 62 is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye). Acid Blue 62 (53.4% pure) was noted to have materno-toxic effects at 1000 mg/kg bw/day, but","page":22,"pdf":"sccp_o_010.pdf","row_type":"noael_study","study_id":"sccp_o_010_noael_002"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat - - developmental toxicity {"citation":"Ref.: 12 3","dose":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment.","effect":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment. Litter data and foetal examinations from treated foetuses did not differ from those for control foetuses. No anomalies or malformations of toxicological significance were observed. Conclusion Acid Blue 62 (53.4% pure) was noted to have maternotoxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus. Ref.: 12 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity /","page":21,"pdf":"sccp_o_010.pdf","row_type":"noael_study","study_id":"sccp_o_010_noael_001"}
SCCS_vision_codex NOAEL =160 mg/kg rat oral subchronic repeated dose toxicity {"dose":"Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg =...","effect":"identical independent of the mode of calculation (percentage versus µg/cm2). Only the calculation based on usage data is shown. Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg = 0.29 mg/kg No observed adverse effect level (mg/kg) NOAEL = 160 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 552 3.3.14. Discussion Acid Blue 62 is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye). Acid Blue 62 (53.4% pure) was noted to have materno-toxic effects at 1000 mg/kg bw/day, but","page":22,"pdf":"sccp_o_010.pdf","row_type":"noael_study","study_id":"sccp_o_010_noael_002"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat - - developmental toxicity {"citation":"Ref.: 12 3","dose":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment.","effect":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment. Litter data and foetal examinations from treated foetuses did not differ from those for control foetuses. No anomalies or malformations of toxicological significance were observed. Conclusion Acid Blue 62 (53.4% pure) was noted to have maternotoxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus. Ref.: 12 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity /","page":21,"pdf":"sccp_o_010.pdf","row_type":"noael_study","study_id":"sccp_o_010_noael_001"}
SCCS_vision_codex NOAEL =160 mg/kg rat oral subchronic repeated dose toxicity {"dose":"Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg =...","effect":"identical independent of the mode of calculation (percentage versus µg/cm2). Only the calculation based on usage data is shown. Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg = 0.29 mg/kg No observed adverse effect level (mg/kg) NOAEL = 160 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 552 3.3.14. Discussion Acid Blue 62 is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye). Acid Blue 62 (53.4% pure) was noted to have materno-toxic effects at 1000 mg/kg bw/day, but","page":22,"pdf":"sccp_o_010.pdf","row_type":"noael_study","study_id":"sccp_o_010_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCNFP:beta.noael_studies developmental toxicity 300 mg/kg bw/day rat - - developmental toxicity SOURCE_SUBDIR=out277_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 62 COLIPA n° C67; OPINION_NUMBER=SCCNFP/0782/04; COMMITTEE=SCCNFP; REPORT_DATE=25 May 2004; VALUE_TEXT=300; DOSE=1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment.; EFFECT=1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment. Litter data and foetal examinations from treated foetuses did not differ from those for control foetuses. No anomalies or malformations of toxicological significance were observed. Conclusion Acid Blue 62 (53.4% pure) was noted to have maternotoxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus. Ref.: 12; CITATION=Ref.: 12; CITATION_NUMBERS=[12]; REFERENCE=Ref.: 12; DETAILS_JSON={"cas_number":"4368-56-3","citation":"Ref.: 12","dose":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment.","duration":"","effect":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment. Litter data and foetal examinations from treated foetuses did not differ from those for control foetuses. No anomalies or malformations of toxicological significance were observed. Conclusion Acid Blue 62 (53.4% pure) was noted to have maternotoxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus. Ref.: 12","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":14,"route":"","species":"rat","study_id":"out277_en_noael_001"}
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 53 % mouse oral developmental repeated dose toxicity SOURCE_SUBDIR=out277_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 62 COLIPA n° C67; OPINION_NUMBER=SCCNFP/0782/04; COMMITTEE=SCCNFP; REPORT_DATE=25 May 2004; VALUE_TEXT=53; DOSE=The available studies (acute oral toxicity, repeated dose toxicity and developmental toxicity) have all been performed with a test substance of a rather low purity.; EFFECT=g under the conditions of the study. However, the test does not conform to guinea pig maximisation test guideline. Acid Blue 62 (98.4% pure) did not induce delayed contact hypersensitivity in the LLNA. The available studies (acute oral toxicity, repeated dose toxicity and developmental toxicity) have all been performed with a test substance of a rather low purity. Therefore, and especially since the composition of the tested batch is not known (purity is about 53%), it is not possible to give an indication of the NOAEL. The exact composition of the test substance must be provided. Acid Blue 62 has been tested in vitro on bacterial cells for the induction of gene mutations and on mammalian cells for the induction of chromosome aberrations. It was found non mutagenic, neither clastogenic. The test item is neither clastogenic nor aneugenic in vivo on mice treated orally.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4368-56-3","citation":"","dose":"The available studies (acute oral toxicity, repeated dose toxicity and developmental toxicity) have all been performed with a test substance of a rather low purity.","duration":"developmental","effect":"g under the conditions of the study. However, the test does not conform to guinea pig maximisation test guideline. Acid Blue 62 (98.4% pure) did not induce delayed contact hypersensitivity in the LLNA. The available studies (acute oral toxicity, repeated dose toxicity and developmental toxicity) have all been performed with a test substance of a rather low purity. Therefore, and especially since the composition of the tested batch is not known (purity is about 53%), it is not possible to give an indication of the NOAEL. The exact composition of the test substance must be provided. Acid Blue 62 has been tested in vitro on bacterial cells for the induction of gene mutations and on mammalian cells for the induction of chromosome aberrations. It was found non mutagenic, neither clastogenic. The test item is neither clastogenic nor aneugenic in vivo on mice treated orally.","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"53","page":18,"route":"oral","species":"mouse","study_id":"out277_en_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg bw/day rat - - developmental toxicity SOURCE_SUBDIR=sccp_o_010; REPORT_TITLE=Opinion on Acid Blue 62 COLIPA N° C 67; OPINION_NUMBER=SCCP/0878/05; COMMITTEE=SCCP; REPORT_DATE=21 June 2005; VALUE_TEXT=300; DOSE=1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment.; EFFECT=1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment. Litter data and foetal examinations from treated foetuses did not differ from those for control foetuses. No anomalies or malformations of toxicological significance were observed. Conclusion Acid Blue 62 (53.4% pure) was noted to have maternotoxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus. Ref.: 12 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity /; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"4368-56-3","citation":"Ref.: 12 3","dose":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment.","duration":"","effect":"1000 mg/kg bw/day, with statistically significant differences in body weight gain being recorded on the first three days of treatment. Litter data and foetal examinations from treated foetuses did not differ from those for control foetuses. No anomalies or malformations of toxicological significance were observed. Conclusion Acid Blue 62 (53.4% pure) was noted to have maternotoxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus. Ref.: 12 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity /","endpoint":"developmental toxicity","ingredient":"Acid Blue 62 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":21,"route":"","species":"rat","study_id":"sccp_o_010_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg bw/day rat - - developmental toxicity SOURCE_SUBDIR=sccp_o_010; REPORT_TITLE=Opinion on Acid Blue 62 COLIPA N° C 67; OPINION_NUMBER=SCCP/0878/05; COMMITTEE=SCCP; REPORT_DATE=21 June 2005; VALUE_TEXT=300; DOSE=The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye).; EFFECT=Discussion Acid Blue 62 is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye). Acid Blue 62 (53.4% pure) was noted to have materno-toxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4368-56-3","citation":"","dose":"The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye).","duration":"","effect":"Discussion Acid Blue 62 is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye). Acid Blue 62 (53.4% pure) was noted to have materno-toxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic at any dose level. The No Observed Adverse Effect level was considered to be 300 mg/kg bw/day (160 mg/kg bw/day active dye) for the pregnant female rat and 1000 mg/kg bw/day (534 mg/kg bw/day active dye) for the foetus.","endpoint":"developmental toxicity","ingredient":"Acid Blue 62 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":22,"route":"","species":"rat","study_id":"sccp_o_010_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =160 mg/kg rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_010; REPORT_TITLE=Opinion on Acid Blue 62 COLIPA N° C 67; OPINION_NUMBER=SCCP/0878/05; COMMITTEE=SCCP; REPORT_DATE=21 June 2005; VALUE_TEXT== 160; DOSE=Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg =...; EFFECT=identical independent of the mode of calculation (percentage versus µg/cm2). Only the calculation based on usage data is shown. Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg = 0.29 mg/kg No observed adverse effect level (mg/kg) NOAEL = 160 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 552 3.3.14. Discussion Acid Blue 62 is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye). Acid Blue 62 (53.4% pure) was noted to have materno-toxic effects at 1000 mg/kg bw/day, but; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4368-56-3","citation":"","dose":"Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg =...","duration":"subchronic","effect":"identical independent of the mode of calculation (percentage versus µg/cm2). Only the calculation based on usage data is shown. Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg = 0.29 mg/kg No observed adverse effect level (mg/kg) NOAEL = 160 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 552 3.3.14. Discussion Acid Blue 62 is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye). Acid Blue 62 (53.4% pure) was noted to have materno-toxic effects at 1000 mg/kg bw/day, but","endpoint":"repeated dose toxicity","ingredient":"Acid Blue 62 (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 160","page":22,"route":"oral","species":"rat","study_id":"sccp_o_010_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =160 mg/kg rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_010; REPORT_TITLE=Opinion on Acid Blue 62 COLIPA N° C 67; OPINION_NUMBER=SCCP/0878/05; COMMITTEE=SCCP; REPORT_DATE=21 June 2005; VALUE_TEXT== 160; DOSE=Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg =...; EFFECT=ulation (percentage versus µg/cm2). Only the calculation based on usage data is shown. Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg = 0.29 mg/kg No observed adverse effect level (mg/kg) NOAEL = 160 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 552 3.3.14. Discussion Acid Blue 62 is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye). Acid Blue 62 (53.4% pure) was noted to have materno-toxic effects at 1000 mg/kg bw/day, but was well toler; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4368-56-3","citation":"","dose":"Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg =...","duration":"subchronic","effect":"ulation (percentage versus µg/cm2). Only the calculation based on usage data is shown. Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg = 0.29 mg/kg No observed adverse effect level (mg/kg) NOAEL = 160 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 552 3.3.14. Discussion Acid Blue 62 is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye). Acid Blue 62 (53.4% pure) was noted to have materno-toxic effects at 1000 mg/kg bw/day, but was well toler","endpoint":"repeated dose toxicity","ingredient":"Acid Blue 62 (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 160","page":22,"route":"oral","species":"rat","study_id":"sccp_o_010_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =160 mg/kg rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_010; REPORT_TITLE=Opinion on Acid Blue 62 COLIPA N° C 67; OPINION_NUMBER=SCCP/0878/05; COMMITTEE=SCCP; REPORT_DATE=21 June 2005; VALUE_TEXT== 160; DOSE=Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg =...; EFFECT=on usage data is shown. Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg = 0.29 mg/kg No observed adverse effect level (mg/kg) NOAEL = 160 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 552 3.3.14. Discussion Acid Blue 62 is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye). Acid Blue 62 (53.4% pure) was noted to have materno-toxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4368-56-3","citation":"","dose":"Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg =...","duration":"subchronic","effect":"on usage data is shown. Based on the usage data Based on a usage volume of 35 ml, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 175 mg Typical body weight of human = 60 kg Maximum absorption through the skin A = 1.00 Retention factor R = 0.1 Dermal absorption per treatment I x A x R = 17.5 mg Systemic exposure dose (SED) I x A x R / 60 kg = 0.29 mg/kg No observed adverse effect level (mg/kg) NOAEL = 160 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 552 3.3.14. Discussion Acid Blue 62 is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content of the dye is not reported. The No Observable Adverse Effect Level for the study (conducted with 53.4% pure Acid Blue 62) was considered by the performing laboratory to be 300 mg/kg bw/day (160 mg/kg bw/day active dye). Acid Blue 62 (53.4% pure) was noted to have materno-toxic effects at 1000 mg/kg bw/day, but was well tolerated at 300 mg/kg bw/day. It was not embryotoxic or teratogenic","endpoint":"repeated dose toxicity","ingredient":"Acid Blue 62 (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 160","page":22,"route":"oral","species":"rat","study_id":"sccp_o_010_noael_004"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier DG356U29IU UNII - - - chemical {"approval_status":null,"molecular_formula":"C20H19N2O5S.Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"DG356U29IU"}
openFDA substances FDA UNII substance identifier DG356U29IU UNII - - - chemical {"approval_status":null,"molecular_formula":"C20H19N2O5S.Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"DG356U29IU"}
openFDA substances FDA UNII substance identifier DG356U29IU UNII - - - chemical {"approval_status":null,"molecular_formula":"C20H19N2O5S.Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"DG356U29IU"}
openFDA substances FDA UNII substance identifier DG356U29IU UNII - - - chemical {"approval_status":null,"molecular_formula":"C20H19N2O5S.Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"DG356U29IU"}