NOAEL Studies Cosmetic Ingredient

HC Orange No. 6 NOAEL Studies

INCI: HC ORANGE NO. 6

CAS: 1449653-83-1

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

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SCCS_vision_codex 32 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 7 3","dose":"A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment.","effect":"kidneys weights in females displayed consistent changes, but they were of small magnitude and were considered to be of no toxicological significance. A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment. Scattered microscopic lesions were seen in control and treated rats at very low incidence, but none of the findings was considered related to the administration of the test item. Conclusion According to the applicant, the NOAEL was considered to be 300 mg/kg bw/day for both males and females. SCCS comment The SCCS agrees with the NOAEL of 300 mg/kg bw/day. Ref.: 7 3.3.5.3 Chronic (> 12 months) toxicity 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD TG 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA 102 Replicates: triplicates plates in two separate experiments Test substance: R0068893B (hair-dye B125 - HC Orange N","page":18,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg/day - - developmental developmental toxicity {"citation":"Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20","dose":"of sacral vertebrae were noted, whereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group.","effect":"of sacral vertebrae were noted, whereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group. These changes reached statistical significance but were considered by the authors of the report to be unrelated to treatment in the absence of dose-related relationship, specifically in the absence of similar changes at the highest dose level of 1000 mg/kg/day. Conclusion Based on the above results, the authors of the study report established the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of R0068893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day. Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SCCS agrees that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show a","page":25,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_003"}
SCCS_vision_codex NOAEL =300 mg/kg/day - - developmental developmental toxicity {"dose":"variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range.","effect":"variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range. Moreover, they were associated with other foetus developmental disturbances (e.g. decreased body weight). Some foetal skeletal variations which were observed at 100 and 300 mg/kg were most likely caused by retarded ossification due to slight maternal toxicity at these doses. Therefore, they should not be treated as toxicologically relevant, even if they were statistically significant. The SCCS agrees that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals","page":25,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_007"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat oral prenatal developmental toxicity {"dose":"tisation / 3.3.10.2 Photomutagenicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Der...","effect":"tisation / 3.3.10.2 Photomutagenicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate imp","page":26,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_008"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral prenatal developmental toxicity {"dose":"nicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SA...","effect":"nicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate impuritie","page":26,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_009"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral prenatal developmental toxicity {"dose":"alculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3...","effect":"alculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate impurities such as ethyl methanesulfonate (which may be formed in the presence of ethanol) should be reported and quantified.","page":26,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_010"}
SCCS_vision_codex NOAEL =19 % rat oral 90 days repeated dose toxicity {"dose":"_______________________________________ 27 General toxicity No acute oral toxicity study with R0068893B was submitted but repeated dose studies did not show the potential for acute toxicity.","effect":"_______________________________________ 27 General toxicity No acute oral toxicity study with R0068893B was submitted but repeated dose studies did not show the potential for acute toxicity. Daily administration of 100, 300 and 1000 mg/kg bw/day R0068893B by oral gavage to male and female Wistar Hannover rats for 90 days resulted in a treatment-related decrease in body weight and body weight gain at 1000 mg/kg bw/day when compared to controls (body weight gain: -18% in males and -19 % in females). Therefore the NOAEL for this study can be established at 300 mg/kg. Developmental toxicity Some foetal skeletal variations which were observed at 100 and 300 mg/kg/day were most likely caused by retarded ossification due to slight maternal toxicity at these doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the","page":27,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_011"}
SCCS_vision_codex NOAEL =100 mg/kg - dermal developmental developmental toxicity {"dose":"The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day.","effect":"se doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SSCS agree that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose-related trend. Therefore the NOAEL for maternal toxicity can be established at 100 mg/kg. Irritation/sensitisation The in vitro tests did not indicate skin irritancy. While an eye irritation potential at 20% cannot be excluded, it can be assumed that this will be of no concern in view of the 0.5% intended use concentration. The in vivo tests did not indicate a skin-sensitising potential. Dermal absorption The submitted documents indicate a very low rate of dermal penetration. Because of the relatively short exposure time in the test system, the","page":27,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_013"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 7 3","dose":"A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment.","effect":"kidneys weights in females displayed consistent changes, but they were of small magnitude and were considered to be of no toxicological significance. A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment. Scattered microscopic lesions were seen in control and treated rats at very low incidence, but none of the findings was considered related to the administration of the test item. Conclusion According to the applicant, the NOAEL was considered to be 300 mg/kg bw/day for both males and females. SCCS comment The SCCS agrees with the NOAEL of 300 mg/kg bw/day. Ref.: 7 3.3.5.3 Chronic (> 12 months) toxicity 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD TG 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA 102 Replicates: triplicates plates in two separate experiments Test substance: R0068893B (hair-dye B125 - HC Orange N","page":18,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg/day - - developmental developmental toxicity {"citation":"Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20","dose":"of sacral vertebrae were noted, whereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group.","effect":"of sacral vertebrae were noted, whereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group. These changes reached statistical significance but were considered by the authors of the report to be unrelated to treatment in the absence of dose-related relationship, specifically in the absence of similar changes at the highest dose level of 1000 mg/kg/day. Conclusion Based on the above results, the authors of the study report established the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of R0068893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day. Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SCCS agrees that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show a","page":25,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_003"}
SCCS_vision_codex NOAEL =300 mg/kg/day - - developmental developmental toxicity {"dose":"variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range.","effect":"variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range. Moreover, they were associated with other foetus developmental disturbances (e.g. decreased body weight). Some foetal skeletal variations which were observed at 100 and 300 mg/kg were most likely caused by retarded ossification due to slight maternal toxicity at these doses. Therefore, they should not be treated as toxicologically relevant, even if they were statistically significant. The SCCS agrees that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals","page":25,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_007"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat oral prenatal developmental toxicity {"dose":"tisation / 3.3.10.2 Photomutagenicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Der...","effect":"tisation / 3.3.10.2 Photomutagenicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate imp","page":26,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_008"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral prenatal developmental toxicity {"dose":"nicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SA...","effect":"nicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate impuritie","page":26,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_009"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral prenatal developmental toxicity {"dose":"alculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3...","effect":"alculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate impurities such as ethyl methanesulfonate (which may be formed in the presence of ethanol) should be reported and quantified.","page":26,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_010"}
SCCS_vision_codex NOAEL =19 % rat oral 90 days repeated dose toxicity {"dose":"_______________________________________ 27 General toxicity No acute oral toxicity study with R0068893B was submitted but repeated dose studies did not show the potential for acute toxicity.","effect":"_______________________________________ 27 General toxicity No acute oral toxicity study with R0068893B was submitted but repeated dose studies did not show the potential for acute toxicity. Daily administration of 100, 300 and 1000 mg/kg bw/day R0068893B by oral gavage to male and female Wistar Hannover rats for 90 days resulted in a treatment-related decrease in body weight and body weight gain at 1000 mg/kg bw/day when compared to controls (body weight gain: -18% in males and -19 % in females). Therefore the NOAEL for this study can be established at 300 mg/kg. Developmental toxicity Some foetal skeletal variations which were observed at 100 and 300 mg/kg/day were most likely caused by retarded ossification due to slight maternal toxicity at these doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the","page":27,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_011"}
SCCS_vision_codex NOAEL =100 mg/kg - dermal developmental developmental toxicity {"dose":"The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day.","effect":"se doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SSCS agree that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose-related trend. Therefore the NOAEL for maternal toxicity can be established at 100 mg/kg. Irritation/sensitisation The in vitro tests did not indicate skin irritancy. While an eye irritation potential at 20% cannot be excluded, it can be assumed that this will be of no concern in view of the 0.5% intended use concentration. The in vivo tests did not indicate a skin-sensitising potential. Dermal absorption The submitted documents indicate a very low rate of dermal penetration. Because of the relatively short exposure time in the test system, the","page":27,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_013"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 7 3","dose":"A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment.","effect":"kidneys weights in females displayed consistent changes, but they were of small magnitude and were considered to be of no toxicological significance. A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment. Scattered microscopic lesions were seen in control and treated rats at very low incidence, but none of the findings was considered related to the administration of the test item. Conclusion According to the applicant, the NOAEL was considered to be 300 mg/kg bw/day for both males and females. SCCS comment The SCCS agrees with the NOAEL of 300 mg/kg bw/day. Ref.: 7 3.3.5.3 Chronic (> 12 months) toxicity 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD TG 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA 102 Replicates: triplicates plates in two separate experiments Test substance: R0068893B (hair-dye B125 - HC Orange N","page":18,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg/day - - developmental developmental toxicity {"citation":"Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20","dose":"of sacral vertebrae were noted, whereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group.","effect":"of sacral vertebrae were noted, whereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group. These changes reached statistical significance but were considered by the authors of the report to be unrelated to treatment in the absence of dose-related relationship, specifically in the absence of similar changes at the highest dose level of 1000 mg/kg/day. Conclusion Based on the above results, the authors of the study report established the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of R0068893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day. Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SCCS agrees that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show a","page":25,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_003"}
SCCS_vision_codex NOAEL =300 mg/kg/day - - developmental developmental toxicity {"dose":"variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range.","effect":"variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range. Moreover, they were associated with other foetus developmental disturbances (e.g. decreased body weight). Some foetal skeletal variations which were observed at 100 and 300 mg/kg were most likely caused by retarded ossification due to slight maternal toxicity at these doses. Therefore, they should not be treated as toxicologically relevant, even if they were statistically significant. The SCCS agrees that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals","page":25,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_007"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat oral prenatal developmental toxicity {"dose":"tisation / 3.3.10.2 Photomutagenicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Der...","effect":"tisation / 3.3.10.2 Photomutagenicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate imp","page":26,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_008"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral prenatal developmental toxicity {"dose":"nicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SA...","effect":"nicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate impuritie","page":26,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_009"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral prenatal developmental toxicity {"dose":"alculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3...","effect":"alculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate impurities such as ethyl methanesulfonate (which may be formed in the presence of ethanol) should be reported and quantified.","page":26,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_010"}
SCCS_vision_codex NOAEL =19 % rat oral 90 days repeated dose toxicity {"dose":"_______________________________________ 27 General toxicity No acute oral toxicity study with R0068893B was submitted but repeated dose studies did not show the potential for acute toxicity.","effect":"_______________________________________ 27 General toxicity No acute oral toxicity study with R0068893B was submitted but repeated dose studies did not show the potential for acute toxicity. Daily administration of 100, 300 and 1000 mg/kg bw/day R0068893B by oral gavage to male and female Wistar Hannover rats for 90 days resulted in a treatment-related decrease in body weight and body weight gain at 1000 mg/kg bw/day when compared to controls (body weight gain: -18% in males and -19 % in females). Therefore the NOAEL for this study can be established at 300 mg/kg. Developmental toxicity Some foetal skeletal variations which were observed at 100 and 300 mg/kg/day were most likely caused by retarded ossification due to slight maternal toxicity at these doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the","page":27,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_011"}
SCCS_vision_codex NOAEL =100 mg/kg - dermal developmental developmental toxicity {"dose":"The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day.","effect":"se doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SSCS agree that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose-related trend. Therefore the NOAEL for maternal toxicity can be established at 100 mg/kg. Irritation/sensitisation The in vitro tests did not indicate skin irritancy. While an eye irritation potential at 20% cannot be excluded, it can be assumed that this will be of no concern in view of the 0.5% intended use concentration. The in vivo tests did not indicate a skin-sensitising potential. Dermal absorption The submitted documents indicate a very low rate of dermal penetration. Because of the relatively short exposure time in the test system, the","page":27,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_013"}
SCCS_vision_codex NOAEL =300 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 7 3","dose":"A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment.","effect":"kidneys weights in females displayed consistent changes, but they were of small magnitude and were considered to be of no toxicological significance. A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment. Scattered microscopic lesions were seen in control and treated rats at very low incidence, but none of the findings was considered related to the administration of the test item. Conclusion According to the applicant, the NOAEL was considered to be 300 mg/kg bw/day for both males and females. SCCS comment The SCCS agrees with the NOAEL of 300 mg/kg bw/day. Ref.: 7 3.3.5.3 Chronic (> 12 months) toxicity 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD TG 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA 102 Replicates: triplicates plates in two separate experiments Test substance: R0068893B (hair-dye B125 - HC Orange N","page":18,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg/day - - developmental developmental toxicity {"citation":"Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20","dose":"of sacral vertebrae were noted, whereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group.","effect":"of sacral vertebrae were noted, whereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group. These changes reached statistical significance but were considered by the authors of the report to be unrelated to treatment in the absence of dose-related relationship, specifically in the absence of similar changes at the highest dose level of 1000 mg/kg/day. Conclusion Based on the above results, the authors of the study report established the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of R0068893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day. Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SCCS agrees that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show a","page":25,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_003"}
SCCS_vision_codex NOAEL =300 mg/kg/day - - developmental developmental toxicity {"dose":"variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range.","effect":"variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range. Moreover, they were associated with other foetus developmental disturbances (e.g. decreased body weight). Some foetal skeletal variations which were observed at 100 and 300 mg/kg were most likely caused by retarded ossification due to slight maternal toxicity at these doses. Therefore, they should not be treated as toxicologically relevant, even if they were statistically significant. The SCCS agrees that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals","page":25,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_007"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat oral prenatal developmental toxicity {"dose":"tisation / 3.3.10.2 Photomutagenicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Der...","effect":"tisation / 3.3.10.2 Photomutagenicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate imp","page":26,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_008"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral prenatal developmental toxicity {"dose":"nicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SA...","effect":"nicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate impuritie","page":26,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_009"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral prenatal developmental toxicity {"dose":"alculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3...","effect":"alculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate impurities such as ethyl methanesulfonate (which may be formed in the presence of ethanol) should be reported and quantified.","page":26,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_010"}
SCCS_vision_codex NOAEL =19 % rat oral 90 days repeated dose toxicity {"dose":"_______________________________________ 27 General toxicity No acute oral toxicity study with R0068893B was submitted but repeated dose studies did not show the potential for acute toxicity.","effect":"_______________________________________ 27 General toxicity No acute oral toxicity study with R0068893B was submitted but repeated dose studies did not show the potential for acute toxicity. Daily administration of 100, 300 and 1000 mg/kg bw/day R0068893B by oral gavage to male and female Wistar Hannover rats for 90 days resulted in a treatment-related decrease in body weight and body weight gain at 1000 mg/kg bw/day when compared to controls (body weight gain: -18% in males and -19 % in females). Therefore the NOAEL for this study can be established at 300 mg/kg. Developmental toxicity Some foetal skeletal variations which were observed at 100 and 300 mg/kg/day were most likely caused by retarded ossification due to slight maternal toxicity at these doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the","page":27,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_011"}
SCCS_vision_codex NOAEL =100 mg/kg - dermal developmental developmental toxicity {"dose":"The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day.","effect":"se doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SSCS agree that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose-related trend. Therefore the NOAEL for maternal toxicity can be established at 100 mg/kg. Irritation/sensitisation The in vitro tests did not indicate skin irritancy. While an eye irritation potential at 20% cannot be excluded, it can be assumed that this will be of no concern in view of the 0.5% intended use concentration. The in vivo tests did not indicate a skin-sensitising potential. Dermal absorption The submitted documents indicate a very low rate of dermal penetration. Because of the relatively short exposure time in the test system, the","page":27,"pdf":"sccs_o_201.pdf","row_type":"noael_study","study_id":"sccs_o_201_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 13 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg/day - - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_201; REPORT_TITLE=OPINION ON HC Orange No. 6 (B125); OPINION_NUMBER=SCCS/1579/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 November 2016; VALUE_TEXT=100; DOSE=of sacral vertebrae were noted, whereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group.; EFFECT=of sacral vertebrae were noted, whereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group. These changes reached statistical significance but were considered by the authors of the report to be unrelated to treatment in the absence of dose-related relationship, specifically in the absence of similar changes at the highest dose level of 1000 mg/kg/day. Conclusion Based on the above results, the authors of the study report established the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of R0068893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day. Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SCCS agrees that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show a; CITATION=Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20; CITATION_NUMBERS=[2,300,1000,20]; REFERENCE=Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20; DETAILS_JSON={"cas_number":"1449653-83-1","citation":"Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20","dose":"of sacral vertebrae were noted, whereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group.","duration":"developmental","effect":"of sacral vertebrae were noted, whereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group. These changes reached statistical significance but were considered by the authors of the report to be unrelated to treatment in the absence of dose-related relationship, specifically in the absence of similar changes at the highest dose level of 1000 mg/kg/day. Conclusion Based on the above results, the authors of the study report established the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of R0068893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day. Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SCCS agrees that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show a","endpoint":"developmental toxicity","ingredient":"HC Orange No. 6","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":25,"route":"","species":"","study_id":"sccs_o_201_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg/day - - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_201; REPORT_TITLE=OPINION ON HC Orange No. 6 (B125); OPINION_NUMBER=SCCS/1579/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 November 2016; VALUE_TEXT=100; DOSE=hereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group.; EFFECT=hereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group. These changes reached statistical significance but were considered by the authors of the report to be unrelated to treatment in the absence of dose-related relationship, specifically in the absence of similar changes at the highest dose level of 1000 mg/kg/day. Conclusion Based on the above results, the authors of the study report established the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of R0068893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day. Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SCCS agrees that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose; CITATION=Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20; CITATION_NUMBERS=[2,300,1000,20]; REFERENCE=Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20; DETAILS_JSON={"cas_number":"1449653-83-1","citation":"Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20","dose":"hereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group.","duration":"developmental","effect":"hereas the incidence of incomplete supraoccipital bone ossification was higher at 100 and 300 mg/kg/day, compared to the control group. These changes reached statistical significance but were considered by the authors of the report to be unrelated to treatment in the absence of dose-related relationship, specifically in the absence of similar changes at the highest dose level of 1000 mg/kg/day. Conclusion Based on the above results, the authors of the study report established the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of R0068893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day. Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SCCS agrees that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose","endpoint":"developmental toxicity","ingredient":"HC Orange No. 6","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":25,"route":"","species":"","study_id":"sccs_o_201_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg/day - - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_201; REPORT_TITLE=OPINION ON HC Orange No. 6 (B125); OPINION_NUMBER=SCCS/1579/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 November 2016; VALUE_TEXT=100; DOSE=was higher at 100 and 300 mg/kg/day, compared to the control group.; EFFECT=was higher at 100 and 300 mg/kg/day, compared to the control group. These changes reached statistical significance but were considered by the authors of the report to be unrelated to treatment in the absence of dose-related relationship, specifically in the absence of similar changes at the highest dose level of 1000 mg/kg/day. Conclusion Based on the above results, the authors of the study report established the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of R0068893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day. Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SCCS agrees that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose-related trend. Therefore the NOAEL for maternal toxicity can be es; CITATION=Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20; CITATION_NUMBERS=[2,300,1000,20]; REFERENCE=Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20; DETAILS_JSON={"cas_number":"1449653-83-1","citation":"Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20","dose":"was higher at 100 and 300 mg/kg/day, compared to the control group.","duration":"developmental","effect":"was higher at 100 and 300 mg/kg/day, compared to the control group. These changes reached statistical significance but were considered by the authors of the report to be unrelated to treatment in the absence of dose-related relationship, specifically in the absence of similar changes at the highest dose level of 1000 mg/kg/day. Conclusion Based on the above results, the authors of the study report established the No Observed Adverse Effect Level (NOAEL) for maternal toxicity of R0068893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day. Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SCCS agrees that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose-related trend. Therefore the NOAEL for maternal toxicity can be es","endpoint":"developmental toxicity","ingredient":"HC Orange No. 6","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":25,"route":"","species":"","study_id":"sccs_o_201_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg - - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_201; REPORT_TITLE=OPINION ON HC Orange No. 6 (B125); OPINION_NUMBER=SCCS/1579/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 November 2016; VALUE_TEXT=100; DOSE=68893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day.; EFFECT=68893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day. Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SCCS agrees that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose-related trend. Therefore the NOAEL for maternal toxicity can be established at 100 mg/kg. The SCCS agrees that the test item R00688938 did not show any teratogenic potential. Most foetal skeletal variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range. Moreover, they were associated with other foetus developmental disturbances (e.g. decreased body weight). Some foetal skeletal variations which were observed at 100 and 300 mg/kg were most likely caused by retarded ossification due to slight maternal t; CITATION=Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20; CITATION_NUMBERS=[2,300,1000,20]; REFERENCE=Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20; DETAILS_JSON={"cas_number":"1449653-83-1","citation":"Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20","dose":"68893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day.","duration":"developmental","effect":"68893B at 100 mg/kg/day and the NOAEL for foetal developmental toxicity at 300 mg/kg/day. Ref.: 2 SCCS comment The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SCCS agrees that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose-related trend. Therefore the NOAEL for maternal toxicity can be established at 100 mg/kg. The SCCS agrees that the test item R00688938 did not show any teratogenic potential. Most foetal skeletal variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range. Moreover, they were associated with other foetus developmental disturbances (e.g. decreased body weight). Some foetal skeletal variations which were observed at 100 and 300 mg/kg were most likely caused by retarded ossification due to slight maternal t","endpoint":"developmental toxicity","ingredient":"HC Orange No. 6","loael_value":"","noael_unit":"mg/kg","noael_value":"100","page":25,"route":"","species":"","study_id":"sccs_o_201_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg/day - - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_201; REPORT_TITLE=OPINION ON HC Orange No. 6 (B125); OPINION_NUMBER=SCCS/1579/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 November 2016; VALUE_TEXT=300; DOSE=variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range.; EFFECT=variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range. Moreover, they were associated with other foetus developmental disturbances (e.g. decreased body weight). Some foetal skeletal variations which were observed at 100 and 300 mg/kg were most likely caused by retarded ossification due to slight maternal toxicity at these doses. Therefore, they should not be treated as toxicologically relevant, even if they were statistically significant. The SCCS agrees that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449653-83-1","citation":"","dose":"variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range.","duration":"developmental","effect":"variations were observed at 1000 mg/kg/day and their incidences were outside of historical control range. Moreover, they were associated with other foetus developmental disturbances (e.g. decreased body weight). Some foetal skeletal variations which were observed at 100 and 300 mg/kg were most likely caused by retarded ossification due to slight maternal toxicity at these doses. Therefore, they should not be treated as toxicologically relevant, even if they were statistically significant. The SCCS agrees that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. 3.3.9 Toxicokinetics No data 3.3.9.1 Toxicokinetics in laboratory animals","endpoint":"developmental toxicity","ingredient":"HC Orange No. 6","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":25,"route":"","species":"","study_id":"sccs_o_201_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 10 mg/kg bw rat oral prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_201; REPORT_TITLE=OPINION ON HC Orange No. 6 (B125); OPINION_NUMBER=SCCS/1579/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 November 2016; VALUE_TEXT=10-3; DOSE=tisation / 3.3.10.2 Photomutagenicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Der...; EFFECT=tisation / 3.3.10.2 Photomutagenicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate imp; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449653-83-1","citation":"","dose":"tisation / 3.3.10.2 Photomutagenicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Der...","duration":"prenatal","effect":"tisation / 3.3.10.2 Photomutagenicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate imp","endpoint":"developmental toxicity","ingredient":"HC Orange No. 6","loael_value":"","noael_unit":"mg/kg bw","noael_value":"10-3","page":26,"route":"oral","species":"rat","study_id":"sccs_o_201_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =100 mg/kg bw/d rat oral prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_201; REPORT_TITLE=OPINION ON HC Orange No. 6 (B125); OPINION_NUMBER=SCCS/1579/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 November 2016; VALUE_TEXT== 100; DOSE=nicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SA...; EFFECT=nicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate impuritie; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449653-83-1","citation":"","dose":"nicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SA...","duration":"prenatal","effect":"nicity / photoclastogenicity / 3.3.11 Human data / 3.3.12 Special investigations / 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate impuritie","endpoint":"developmental toxicity","ingredient":"HC Orange No. 6","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 100","page":26,"route":"oral","species":"rat","study_id":"sccs_o_201_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =50 mg/kg bw/d rat oral prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_201; REPORT_TITLE=OPINION ON HC Orange No. 6 (B125); OPINION_NUMBER=SCCS/1579/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 November 2016; VALUE_TEXT== 50; DOSE=alculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3...; EFFECT=alculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate impurities such as ethyl methanesulfonate (which may be formed in the presence of ethanol) should be reported and quantified.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449653-83-1","citation":"","dose":"alculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3...","duration":"prenatal","effect":"alculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (non-oxidative conditions) (on-head concentration 0,5 %) Absorption through the skin A = 0.201 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.12 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 1.94x10-3 mg/kg bw No observed adverse effect level NOAEL = 100 mg/kg bw/d (prenatal, developmental, oral, rat) Bioavailability 50%* = 50 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 25773 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion Physicochemical properties The SCCS notes the presence of ethanol in the batches used for the chemical analysis. Since Vibracolor Copper Orange is in the form of a methanesulfonate salt, any potential methane sulfonate impurities such as ethyl methanesulfonate (which may be formed in the presence of ethanol) should be reported and quantified.","endpoint":"developmental toxicity","ingredient":"HC Orange No. 6","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 50","page":26,"route":"oral","species":"rat","study_id":"sccs_o_201_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg/day rat - 90 days developmental toxicity SOURCE_SUBDIR=sccs_o_201; REPORT_TITLE=OPINION ON HC Orange No. 6 (B125); OPINION_NUMBER=SCCS/1579/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 November 2016; VALUE_TEXT=300; DOSE=and female Wistar Hannover rats for 90 days resulted in a treatment-related decrease in body weight and body weight gain at 1000 mg/kg bw/day when compared to controls (body weight gain: -18% in males and -19 % in females).; EFFECT=and female Wistar Hannover rats for 90 days resulted in a treatment-related decrease in body weight and body weight gain at 1000 mg/kg bw/day when compared to controls (body weight gain: -18% in males and -19 % in females). Therefore the NOAEL for this study can be established at 300 mg/kg. Developmental toxicity Some foetal skeletal variations which were observed at 100 and 300 mg/kg/day were most likely caused by retarded ossification due to slight maternal toxicity at these doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SSCS agree that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose-related trend. Therefore the NOAEL for maternal toxicity can be establis; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449653-83-1","citation":"","dose":"and female Wistar Hannover rats for 90 days resulted in a treatment-related decrease in body weight and body weight gain at 1000 mg/kg bw/day when compared to controls (body weight gain: -18% in males and -19 % in females).","duration":"90 days","effect":"and female Wistar Hannover rats for 90 days resulted in a treatment-related decrease in body weight and body weight gain at 1000 mg/kg bw/day when compared to controls (body weight gain: -18% in males and -19 % in females). Therefore the NOAEL for this study can be established at 300 mg/kg. Developmental toxicity Some foetal skeletal variations which were observed at 100 and 300 mg/kg/day were most likely caused by retarded ossification due to slight maternal toxicity at these doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SSCS agree that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose-related trend. Therefore the NOAEL for maternal toxicity can be establis","endpoint":"developmental toxicity","ingredient":"HC Orange No. 6","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":27,"route":"","species":"rat","study_id":"sccs_o_201_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg - dermal developmental developmental toxicity SOURCE_SUBDIR=sccs_o_201; REPORT_TITLE=OPINION ON HC Orange No. 6 (B125); OPINION_NUMBER=SCCS/1579/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 November 2016; VALUE_TEXT=100; DOSE=The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day.; EFFECT=se doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SSCS agree that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose-related trend. Therefore the NOAEL for maternal toxicity can be established at 100 mg/kg. Irritation/sensitisation The in vitro tests did not indicate skin irritancy. While an eye irritation potential at 20% cannot be excluded, it can be assumed that this will be of no concern in view of the 0.5% intended use concentration. The in vivo tests did not indicate a skin-sensitising potential. Dermal absorption The submitted documents indicate a very low rate of dermal penetration. Because of the relatively short exposure time in the test system, the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449653-83-1","citation":"","dose":"The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day.","duration":"developmental","effect":"se doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the controls). SSCS agree that the changes could be treatment related and should be considered to be of toxicological significance, despite the fact they did not achieve statistical significance or show any dose-related trend. Therefore the NOAEL for maternal toxicity can be established at 100 mg/kg. Irritation/sensitisation The in vitro tests did not indicate skin irritancy. While an eye irritation potential at 20% cannot be excluded, it can be assumed that this will be of no concern in view of the 0.5% intended use concentration. The in vivo tests did not indicate a skin-sensitising potential. Dermal absorption The submitted documents indicate a very low rate of dermal penetration. Because of the relatively short exposure time in the test system, the","endpoint":"developmental toxicity","ingredient":"HC Orange No. 6","loael_value":"","noael_unit":"mg/kg","noael_value":"100","page":27,"route":"dermal","species":"","study_id":"sccs_o_201_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 300 mg/kg bw/day rat - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_201; REPORT_TITLE=OPINION ON HC Orange No. 6 (B125); OPINION_NUMBER=SCCS/1579/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 November 2016; VALUE_TEXT=300; DOSE=A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment.; EFFECT=kidneys weights in females displayed consistent changes, but they were of small magnitude and were considered to be of no toxicological significance. A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment. Scattered microscopic lesions were seen in control and treated rats at very low incidence, but none of the findings was considered related to the administration of the test item. Conclusion According to the applicant, the NOAEL was considered to be 300 mg/kg bw/day for both males and females. SCCS comment The SCCS agrees with the NOAEL of 300 mg/kg bw/day. Ref.: 7 3.3.5.3 Chronic (> 12 months) toxicity 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD TG 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA 102 Replicates: triplicates plates in two separate experiments Test substance: R0068893B (hair-dye B125 - HC Orange N; CITATION=Ref.: 7 3; CITATION_NUMBERS=[7,3]; REFERENCE=Ref.: 7 3; DETAILS_JSON={"cas_number":"1449653-83-1","citation":"Ref.: 7 3","dose":"A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment.","duration":"Chronic","effect":"kidneys weights in females displayed consistent changes, but they were of small magnitude and were considered to be of no toxicological significance. A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment. Scattered microscopic lesions were seen in control and treated rats at very low incidence, but none of the findings was considered related to the administration of the test item. Conclusion According to the applicant, the NOAEL was considered to be 300 mg/kg bw/day for both males and females. SCCS comment The SCCS agrees with the NOAEL of 300 mg/kg bw/day. Ref.: 7 3.3.5.3 Chronic (> 12 months) toxicity 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD TG 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA 102 Replicates: triplicates plates in two separate experiments Test substance: R0068893B (hair-dye B125 - HC Orange N","endpoint":"genotoxicity","ingredient":"HC Orange No. 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":18,"route":"","species":"rat","study_id":"sccs_o_201_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 300 mg/kg bw/day rat - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_201; REPORT_TITLE=OPINION ON HC Orange No. 6 (B125); OPINION_NUMBER=SCCS/1579/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 November 2016; VALUE_TEXT=300; DOSE=A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment.; EFFECT=o be of no toxicological significance. A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment. Scattered microscopic lesions were seen in control and treated rats at very low incidence, but none of the findings was considered related to the administration of the test item. Conclusion According to the applicant, the NOAEL was considered to be 300 mg/kg bw/day for both males and females. SCCS comment The SCCS agrees with the NOAEL of 300 mg/kg bw/day. Ref.: 7 3.3.5.3 Chronic (> 12 months) toxicity 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD TG 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA 102 Replicates: triplicates plates in two separate experiments Test substance: R0068893B (hair-dye B125 - HC Orange No 6) Batch: R0068893B 014 L 001 (red powder) Purity: 98.4% (UV detector) Solvent: water (at concentrations up t; CITATION=Ref.: 7 3; CITATION_NUMBERS=[7,3]; REFERENCE=Ref.: 7 3; DETAILS_JSON={"cas_number":"1449653-83-1","citation":"Ref.: 7 3","dose":"A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment.","duration":"Chronic","effect":"o be of no toxicological significance. A few macroscopic lesions were observed, involving both the control and the 300 mg/kg bw/day group that were considered unrelated to treatment. Scattered microscopic lesions were seen in control and treated rats at very low incidence, but none of the findings was considered related to the administration of the test item. Conclusion According to the applicant, the NOAEL was considered to be 300 mg/kg bw/day for both males and females. SCCS comment The SCCS agrees with the NOAEL of 300 mg/kg bw/day. Ref.: 7 3.3.5.3 Chronic (> 12 months) toxicity 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD TG 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA 102 Replicates: triplicates plates in two separate experiments Test substance: R0068893B (hair-dye B125 - HC Orange No 6) Batch: R0068893B 014 L 001 (red powder) Purity: 98.4% (UV detector) Solvent: water (at concentrations up t","endpoint":"genotoxicity","ingredient":"HC Orange No. 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":18,"route":"","species":"rat","study_id":"sccs_o_201_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 19 % rat oral 90 days repeated dose toxicity SOURCE_SUBDIR=sccs_o_201; REPORT_TITLE=OPINION ON HC Orange No. 6 (B125); OPINION_NUMBER=SCCS/1579/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 November 2016; VALUE_TEXT=19; DOSE=_______________________________________ 27 General toxicity No acute oral toxicity study with R0068893B was submitted but repeated dose studies did not show the potential for acute toxicity.; EFFECT=_______________________________________ 27 General toxicity No acute oral toxicity study with R0068893B was submitted but repeated dose studies did not show the potential for acute toxicity. Daily administration of 100, 300 and 1000 mg/kg bw/day R0068893B by oral gavage to male and female Wistar Hannover rats for 90 days resulted in a treatment-related decrease in body weight and body weight gain at 1000 mg/kg bw/day when compared to controls (body weight gain: -18% in males and -19 % in females). Therefore the NOAEL for this study can be established at 300 mg/kg. Developmental toxicity Some foetal skeletal variations which were observed at 100 and 300 mg/kg/day were most likely caused by retarded ossification due to slight maternal toxicity at these doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449653-83-1","citation":"","dose":"_______________________________________ 27 General toxicity No acute oral toxicity study with R0068893B was submitted but repeated dose studies did not show the potential for acute toxicity.","duration":"90 days","effect":"_______________________________________ 27 General toxicity No acute oral toxicity study with R0068893B was submitted but repeated dose studies did not show the potential for acute toxicity. Daily administration of 100, 300 and 1000 mg/kg bw/day R0068893B by oral gavage to male and female Wistar Hannover rats for 90 days resulted in a treatment-related decrease in body weight and body weight gain at 1000 mg/kg bw/day when compared to controls (body weight gain: -18% in males and -19 % in females). Therefore the NOAEL for this study can be established at 300 mg/kg. Developmental toxicity Some foetal skeletal variations which were observed at 100 and 300 mg/kg/day were most likely caused by retarded ossification due to slight maternal toxicity at these doses. The SCCS concluded that the NOAEL value for developmental toxicity can be established at 300 mg/kg/day. The study showed that the corrected maternal body weight gain was lower in dams exposed to 300 and 1000 mg/kg/day (-20.9% mid and -18.8% high dose, when compared to the","endpoint":"repeated dose toxicity","ingredient":"HC Orange No. 6","loael_value":"","noael_unit":"%","noael_value":"19","page":27,"route":"oral","species":"rat","study_id":"sccs_o_201_noael_011"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier PKS7O14JK4 UNII - - - chemical {"approval_status":null,"molecular_formula":"C38H48N4O4S2.2CH3O3S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PKS7O14JK4"}
openFDA substances FDA UNII substance identifier PKS7O14JK4 UNII - - - chemical {"approval_status":null,"molecular_formula":"C38H48N4O4S2.2CH3O3S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PKS7O14JK4"}
openFDA substances FDA UNII substance identifier PKS7O14JK4 UNII - - - chemical {"approval_status":null,"molecular_formula":"C38H48N4O4S2.2CH3O3S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PKS7O14JK4"}
openFDA substances FDA UNII substance identifier PKS7O14JK4 UNII - - - chemical {"approval_status":null,"molecular_formula":"C38H48N4O4S2.2CH3O3S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PKS7O14JK4"}