NOAEL Studies Cosmetic Ingredient

HC Blue No. 15 NOAEL Studies

INCI: HC BLUE NO. 15

CAS: 74578-10-2

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

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COSMOS_DB 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 4 mg/kg bw/day rat oral 90 day Subchronic SCCS; scientific report
COSMOS_DB NOAEL 1 mg/kg bw/day rat oral 90 day Subchronic SCCS; scientific report
SCCS_vision_codex 28 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =4 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 17 3","dose":"Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical bio...","effect":"the liver), increased urinary leukocytes, increased urinary erythrocytes in females, elevated liver weights, coinciding with minimal hypertrophy of centrilobular hepatocytes, elevated kidney weights; a marginally greater incidence and severity of focal myocarditis was observed, but this was found to be more likely fortuitously than substance-related (statistically non-significant). Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical biochemistry, urinalyses and higher kidney weights at 15 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","page":16,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_001"}
SCCS_vision_codex NOAEL =3 mg/kg bw/day rat - - dermal absorption {"citation":"Ref.: 23 3","dose":"Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses.","effect":"ects on reproduction data or foetal data were observed. Mean number of implantation sites, pre- and post-implantation losses and mean number of viable foetuses per litter and group were not affected by treatment. There were no dead or aborted foetuses. Mean sex ratios and mean foetal body weights were not affected by treatment. There were no treatment-related foetal external, visceral or skeletal (bones and cartilage) findings. Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses. Ref.: 23 3.3.9. Toxicokinetics Guidelines: OECD 417 (1984) Toxicokinetics and 427 (2004) percutaneous absorption Species/Strain: Rats, female, Wistar Crl: (WI) BR (outbred) Group Sizes: 4 in ADME studies (groups 1,2, 3, 4) 6 in toxicokinetics studies (5, 6, 7, 8) Test substance: 14C-labelled HC Blue No 15 (WR18403) HC Blue No 15 (WR18403) Batches: Labelled CFQ13944 batch 1 (Purity: 98%) BB77-020420 (38.5% w/w","page":22,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_003"}
SCCS_vision_codex NOAEL =4 mg/kg bw - oral 28 d NOAEL study {"dose":"2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy.","effect":"SCCS/1440/11 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 23 GLP: in compliance Date: 2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy. The selected dermal application level was higher than that for normal usage, but was chosen for comparison of the bioavailability with the other administration routes. Exposure was for 30 min. For the ADME study, in the oral and intravenous groups, urine and faeces were collected over 0-8, 8-24, 24-48. 48-72 and 72· 96 h and the animals were killed 96 hours post- dosing. In the dermal group, urine and faec","page":23,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_004"}
SCCS_vision_codex NOAEL =0.02 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/...","effect":"SCCS/1440/11 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability = 1.4 MOS = 82 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been supplied. Irritation, sensitisation Neat HC Blue n° 15 is irritant to mucous membranes. However, at a concentration of 2% (in water) slight i","page":25,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_005"}
SCCS_vision_codex NOAEL =4 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/...","effect":"ion on HC Blue n° 15 ___________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability = 1.4 MOS = 82 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been supplied. Irritation, sensitisation Neat HC Blue n° 15 is irritant to mucous membranes. However, at a concentration of 2% (in water) slight irritat","page":25,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_006"}
SCCS_vision_codex NOAEL =1.76 μg/cm - oral sub-chronic repeated dose toxicity {"dose":"15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity;","effect":"d. Dermal absorption The single experiment available did not conform to guidelines. 100mg/cm² of formulation was applied. Too few chambers were used (5) and the number of donors is not stated. The purity of HC Blue n° 15 is not given. The membrane thickness was inappropriate. In view of the above, and as penetration of HC Blue n° 15 is low, the amount considered as being absorbed from an oxidative hair dye formulation containing 1.67% HC Blue n° 15 is considered as (mean +2SD) 1.76 μg/cm². General toxicity The no observed adverse effect level (NOAEL) for HC Blue No. 15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity; 3 mg/kg bw/day for the dams and 30 mg/kg bw/day for foetuses in the prenatal development toxicity study. The toxicokinetic/ADME study suggested moderate oral absorption and low dermal penetration of 14C_HC Blue No. 15. After being metabolized, excretion was mainly faecal.","page":25,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_007"}
SCCS_vision_codex NOAEL =0.0003 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0...","effect":"504/13 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0003 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability * = 1.4 mg/kg bw/d MOS = 4800 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not be","page":29,"pdf":"sccs_o_127.pdf","row_type":"noael_study","study_id":"sccs_o_127_noael_005"}
SCCS_vision_codex NOAEL =4 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 17 3","dose":"Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical bio...","effect":"the liver), increased urinary leukocytes, increased urinary erythrocytes in females, elevated liver weights, coinciding with minimal hypertrophy of centrilobular hepatocytes, elevated kidney weights; a marginally greater incidence and severity of focal myocarditis was observed, but this was found to be more likely fortuitously than substance-related (statistically non-significant). Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical biochemistry, urinalyses and higher kidney weights at 15 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","page":16,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_001"}
SCCS_vision_codex NOAEL =3 mg/kg bw/day rat - - dermal absorption {"citation":"Ref.: 23 3","dose":"Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses.","effect":"ects on reproduction data or foetal data were observed. Mean number of implantation sites, pre- and post-implantation losses and mean number of viable foetuses per litter and group were not affected by treatment. There were no dead or aborted foetuses. Mean sex ratios and mean foetal body weights were not affected by treatment. There were no treatment-related foetal external, visceral or skeletal (bones and cartilage) findings. Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses. Ref.: 23 3.3.9. Toxicokinetics Guidelines: OECD 417 (1984) Toxicokinetics and 427 (2004) percutaneous absorption Species/Strain: Rats, female, Wistar Crl: (WI) BR (outbred) Group Sizes: 4 in ADME studies (groups 1,2, 3, 4) 6 in toxicokinetics studies (5, 6, 7, 8) Test substance: 14C-labelled HC Blue No 15 (WR18403) HC Blue No 15 (WR18403) Batches: Labelled CFQ13944 batch 1 (Purity: 98%) BB77-020420 (38.5% w/w","page":22,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_003"}
SCCS_vision_codex NOAEL =4 mg/kg bw - oral 28 d NOAEL study {"dose":"2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy.","effect":"SCCS/1440/11 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 23 GLP: in compliance Date: 2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy. The selected dermal application level was higher than that for normal usage, but was chosen for comparison of the bioavailability with the other administration routes. Exposure was for 30 min. For the ADME study, in the oral and intravenous groups, urine and faeces were collected over 0-8, 8-24, 24-48. 48-72 and 72· 96 h and the animals were killed 96 hours post- dosing. In the dermal group, urine and faec","page":23,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_004"}
SCCS_vision_codex NOAEL =0.02 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/...","effect":"SCCS/1440/11 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability = 1.4 MOS = 82 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been supplied. Irritation, sensitisation Neat HC Blue n° 15 is irritant to mucous membranes. However, at a concentration of 2% (in water) slight i","page":25,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_005"}
SCCS_vision_codex NOAEL =4 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/...","effect":"ion on HC Blue n° 15 ___________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability = 1.4 MOS = 82 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been supplied. Irritation, sensitisation Neat HC Blue n° 15 is irritant to mucous membranes. However, at a concentration of 2% (in water) slight irritat","page":25,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_006"}
SCCS_vision_codex NOAEL =1.76 μg/cm - oral sub-chronic repeated dose toxicity {"dose":"15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity;","effect":"d. Dermal absorption The single experiment available did not conform to guidelines. 100mg/cm² of formulation was applied. Too few chambers were used (5) and the number of donors is not stated. The purity of HC Blue n° 15 is not given. The membrane thickness was inappropriate. In view of the above, and as penetration of HC Blue n° 15 is low, the amount considered as being absorbed from an oxidative hair dye formulation containing 1.67% HC Blue n° 15 is considered as (mean +2SD) 1.76 μg/cm². General toxicity The no observed adverse effect level (NOAEL) for HC Blue No. 15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity; 3 mg/kg bw/day for the dams and 30 mg/kg bw/day for foetuses in the prenatal development toxicity study. The toxicokinetic/ADME study suggested moderate oral absorption and low dermal penetration of 14C_HC Blue No. 15. After being metabolized, excretion was mainly faecal.","page":25,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_007"}
SCCS_vision_codex NOAEL =4 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 17 3","dose":"Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical bio...","effect":"the liver), increased urinary leukocytes, increased urinary erythrocytes in females, elevated liver weights, coinciding with minimal hypertrophy of centrilobular hepatocytes, elevated kidney weights; a marginally greater incidence and severity of focal myocarditis was observed, but this was found to be more likely fortuitously than substance-related (statistically non-significant). Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical biochemistry, urinalyses and higher kidney weights at 15 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","page":16,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_001"}
SCCS_vision_codex NOAEL =3 mg/kg bw/day rat - - dermal absorption {"citation":"Ref.: 23 3","dose":"Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses.","effect":"ects on reproduction data or foetal data were observed. Mean number of implantation sites, pre- and post-implantation losses and mean number of viable foetuses per litter and group were not affected by treatment. There were no dead or aborted foetuses. Mean sex ratios and mean foetal body weights were not affected by treatment. There were no treatment-related foetal external, visceral or skeletal (bones and cartilage) findings. Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses. Ref.: 23 3.3.9. Toxicokinetics Guidelines: OECD 417 (1984) Toxicokinetics and 427 (2004) percutaneous absorption Species/Strain: Rats, female, Wistar Crl: (WI) BR (outbred) Group Sizes: 4 in ADME studies (groups 1,2, 3, 4) 6 in toxicokinetics studies (5, 6, 7, 8) Test substance: 14C-labelled HC Blue No 15 (WR18403) HC Blue No 15 (WR18403) Batches: Labelled CFQ13944 batch 1 (Purity: 98%) BB77-020420 (38.5% w/w","page":22,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_003"}
SCCS_vision_codex NOAEL =4 mg/kg bw - oral 28 d NOAEL study {"dose":"2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy.","effect":"SCCS/1440/11 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 23 GLP: in compliance Date: 2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy. The selected dermal application level was higher than that for normal usage, but was chosen for comparison of the bioavailability with the other administration routes. Exposure was for 30 min. For the ADME study, in the oral and intravenous groups, urine and faeces were collected over 0-8, 8-24, 24-48. 48-72 and 72· 96 h and the animals were killed 96 hours post- dosing. In the dermal group, urine and faec","page":23,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_004"}
SCCS_vision_codex NOAEL =0.02 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/...","effect":"SCCS/1440/11 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability = 1.4 MOS = 82 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been supplied. Irritation, sensitisation Neat HC Blue n° 15 is irritant to mucous membranes. However, at a concentration of 2% (in water) slight i","page":25,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_005"}
SCCS_vision_codex NOAEL =4 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/...","effect":"ion on HC Blue n° 15 ___________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability = 1.4 MOS = 82 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been supplied. Irritation, sensitisation Neat HC Blue n° 15 is irritant to mucous membranes. However, at a concentration of 2% (in water) slight irritat","page":25,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_006"}
SCCS_vision_codex NOAEL =1.76 μg/cm - oral sub-chronic repeated dose toxicity {"dose":"15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity;","effect":"d. Dermal absorption The single experiment available did not conform to guidelines. 100mg/cm² of formulation was applied. Too few chambers were used (5) and the number of donors is not stated. The purity of HC Blue n° 15 is not given. The membrane thickness was inappropriate. In view of the above, and as penetration of HC Blue n° 15 is low, the amount considered as being absorbed from an oxidative hair dye formulation containing 1.67% HC Blue n° 15 is considered as (mean +2SD) 1.76 μg/cm². General toxicity The no observed adverse effect level (NOAEL) for HC Blue No. 15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity; 3 mg/kg bw/day for the dams and 30 mg/kg bw/day for foetuses in the prenatal development toxicity study. The toxicokinetic/ADME study suggested moderate oral absorption and low dermal penetration of 14C_HC Blue No. 15. After being metabolized, excretion was mainly faecal.","page":25,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_007"}
SCCS_vision_codex NOAEL =0.0003 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0...","effect":"504/13 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0003 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability * = 1.4 mg/kg bw/d MOS = 4800 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not be","page":29,"pdf":"sccs_o_127.pdf","row_type":"noael_study","study_id":"sccs_o_127_noael_005"}
SCCS_vision_codex NOAEL =0.0003 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0...","effect":"504/13 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0003 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability * = 1.4 mg/kg bw/d MOS = 4800 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not be","page":29,"pdf":"sccs_o_127.pdf","row_type":"noael_study","study_id":"sccs_o_127_noael_005"}
SCCS_vision_codex NOAEL =4 mg/kg bw/day - - Chronic genotoxicity {"citation":"Ref.: 17 3","dose":"Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical bio...","effect":"the liver), increased urinary leukocytes, increased urinary erythrocytes in females, elevated liver weights, coinciding with minimal hypertrophy of centrilobular hepatocytes, elevated kidney weights; a marginally greater incidence and severity of focal myocarditis was observed, but this was found to be more likely fortuitously than substance-related (statistically non-significant). Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical biochemistry, urinalyses and higher kidney weights at 15 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","page":16,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_001"}
SCCS_vision_codex NOAEL =3 mg/kg bw/day rat - - dermal absorption {"citation":"Ref.: 23 3","dose":"Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses.","effect":"ects on reproduction data or foetal data were observed. Mean number of implantation sites, pre- and post-implantation losses and mean number of viable foetuses per litter and group were not affected by treatment. There were no dead or aborted foetuses. Mean sex ratios and mean foetal body weights were not affected by treatment. There were no treatment-related foetal external, visceral or skeletal (bones and cartilage) findings. Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses. Ref.: 23 3.3.9. Toxicokinetics Guidelines: OECD 417 (1984) Toxicokinetics and 427 (2004) percutaneous absorption Species/Strain: Rats, female, Wistar Crl: (WI) BR (outbred) Group Sizes: 4 in ADME studies (groups 1,2, 3, 4) 6 in toxicokinetics studies (5, 6, 7, 8) Test substance: 14C-labelled HC Blue No 15 (WR18403) HC Blue No 15 (WR18403) Batches: Labelled CFQ13944 batch 1 (Purity: 98%) BB77-020420 (38.5% w/w","page":22,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_003"}
SCCS_vision_codex NOAEL =4 mg/kg bw - oral 28 d NOAEL study {"dose":"2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy.","effect":"SCCS/1440/11 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 23 GLP: in compliance Date: 2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy. The selected dermal application level was higher than that for normal usage, but was chosen for comparison of the bioavailability with the other administration routes. Exposure was for 30 min. For the ADME study, in the oral and intravenous groups, urine and faeces were collected over 0-8, 8-24, 24-48. 48-72 and 72· 96 h and the animals were killed 96 hours post- dosing. In the dermal group, urine and faec","page":23,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_004"}
SCCS_vision_codex NOAEL =0.02 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/...","effect":"SCCS/1440/11 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability = 1.4 MOS = 82 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been supplied. Irritation, sensitisation Neat HC Blue n° 15 is irritant to mucous membranes. However, at a concentration of 2% (in water) slight i","page":25,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_005"}
SCCS_vision_codex NOAEL =4 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/...","effect":"ion on HC Blue n° 15 ___________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability = 1.4 MOS = 82 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been supplied. Irritation, sensitisation Neat HC Blue n° 15 is irritant to mucous membranes. However, at a concentration of 2% (in water) slight irritat","page":25,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_006"}
SCCS_vision_codex NOAEL =1.76 μg/cm - oral sub-chronic repeated dose toxicity {"dose":"15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity;","effect":"d. Dermal absorption The single experiment available did not conform to guidelines. 100mg/cm² of formulation was applied. Too few chambers were used (5) and the number of donors is not stated. The purity of HC Blue n° 15 is not given. The membrane thickness was inappropriate. In view of the above, and as penetration of HC Blue n° 15 is low, the amount considered as being absorbed from an oxidative hair dye formulation containing 1.67% HC Blue n° 15 is considered as (mean +2SD) 1.76 μg/cm². General toxicity The no observed adverse effect level (NOAEL) for HC Blue No. 15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity; 3 mg/kg bw/day for the dams and 30 mg/kg bw/day for foetuses in the prenatal development toxicity study. The toxicokinetic/ADME study suggested moderate oral absorption and low dermal penetration of 14C_HC Blue No. 15. After being metabolized, excretion was mainly faecal.","page":25,"pdf":"sccs_o_089.pdf","row_type":"noael_study","study_id":"sccs_o_089_noael_007"}
SCCS_vision_codex NOAEL =0.0003 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0...","effect":"504/13 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0003 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability * = 1.4 mg/kg bw/d MOS = 4800 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not be","page":29,"pdf":"sccs_o_127.pdf","row_type":"noael_study","study_id":"sccs_o_127_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 16 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 4 mg/kg bw - oral 28 d - SOURCE_SUBDIR=sccs_o_089; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1440/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT=4; DOSE=2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy.; EFFECT=SCCS/1440/11 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 23 GLP: in compliance Date: 2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy. The selected dermal application level was higher than that for normal usage, but was chosen for comparison of the bioavailability with the other administration routes. Exposure was for 30 min. For the ADME study, in the oral and intravenous groups, urine and faeces were collected over 0-8, 8-24, 24-48. 48-72 and 72· 96 h and the animals were killed 96 hours post- dosing. In the dermal group, urine and faec; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"74578-10-2","citation":"","dose":"2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy.","duration":"28 d","effect":"SCCS/1440/11 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 23 GLP: in compliance Date: 2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy. The selected dermal application level was higher than that for normal usage, but was chosen for comparison of the bioavailability with the other administration routes. Exposure was for 30 min. For the ADME study, in the oral and intravenous groups, urine and faeces were collected over 0-8, 8-24, 24-48. 48-72 and 72· 96 h and the animals were killed 96 hours post- dosing. In the dermal group, urine and faec","endpoint":"","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw","noael_value":"4","page":23,"route":"oral","species":"","study_id":"sccs_o_089_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 4 mg/kg bw - oral 28 d - SOURCE_SUBDIR=sccs_o_127; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1504/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT=4; DOSE=2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy.; EFFECT=SCCS/1504/13 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 27 GLP: in compliance Date: 2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy. The selected dermal application level was higher than that for normal usage, but was chosen for comparison of the bioavailability with the other administration routes. Exposure was for 30 min. For the ADME study, in the oral and intravenous groups, urine and faeces were collected over 0-8, 8-24, 24-48. 48-72 and 72· 96 h and the animals were killed 96 hours post- dosing. In the dermal group, urine and faec; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"74578-10-2","citation":"","dose":"2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy.","duration":"28 d","effect":"SCCS/1504/13 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 27 GLP: in compliance Date: 2005 Based on an oral 28 d study, the intravenous dose and low oral dose were selected on the NOAEL of 4 mg/kg bw and the 10-fold higher oral dose based on increased liver weight and centrilobular hypertrophy. The selected dermal application level was higher than that for normal usage, but was chosen for comparison of the bioavailability with the other administration routes. Exposure was for 30 min. For the ADME study, in the oral and intravenous groups, urine and faeces were collected over 0-8, 8-24, 24-48. 48-72 and 72· 96 h and the animals were killed 96 hours post- dosing. In the dermal group, urine and faec","endpoint":"","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw","noael_value":"4","page":27,"route":"oral","species":"","study_id":"sccs_o_127_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 3 mg/kg bw/day rat - - dermal absorption SOURCE_SUBDIR=sccs_o_089; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1440/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT=3; DOSE=Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses.; EFFECT=ects on reproduction data or foetal data were observed. Mean number of implantation sites, pre- and post-implantation losses and mean number of viable foetuses per litter and group were not affected by treatment. There were no dead or aborted foetuses. Mean sex ratios and mean foetal body weights were not affected by treatment. There were no treatment-related foetal external, visceral or skeletal (bones and cartilage) findings. Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses. Ref.: 23 3.3.9. Toxicokinetics Guidelines: OECD 417 (1984) Toxicokinetics and 427 (2004) percutaneous absorption Species/Strain: Rats, female, Wistar Crl: (WI) BR (outbred) Group Sizes: 4 in ADME studies (groups 1,2, 3, 4) 6 in toxicokinetics studies (5, 6, 7, 8) Test substance: 14C-labelled HC Blue No 15 (WR18403) HC Blue No 15 (WR18403) Batches: Labelled CFQ13944 batch 1 (Purity: 98%) BB77-020420 (38.5% w/w; CITATION=Ref.: 23 3; CITATION_NUMBERS=[23,3]; REFERENCE=Ref.: 23 3; DETAILS_JSON={"cas_number":"74578-10-2","citation":"Ref.: 23 3","dose":"Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses.","duration":"","effect":"ects on reproduction data or foetal data were observed. Mean number of implantation sites, pre- and post-implantation losses and mean number of viable foetuses per litter and group were not affected by treatment. There were no dead or aborted foetuses. Mean sex ratios and mean foetal body weights were not affected by treatment. There were no treatment-related foetal external, visceral or skeletal (bones and cartilage) findings. Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses. Ref.: 23 3.3.9. Toxicokinetics Guidelines: OECD 417 (1984) Toxicokinetics and 427 (2004) percutaneous absorption Species/Strain: Rats, female, Wistar Crl: (WI) BR (outbred) Group Sizes: 4 in ADME studies (groups 1,2, 3, 4) 6 in toxicokinetics studies (5, 6, 7, 8) Test substance: 14C-labelled HC Blue No 15 (WR18403) HC Blue No 15 (WR18403) Batches: Labelled CFQ13944 batch 1 (Purity: 98%) BB77-020420 (38.5% w/w","endpoint":"dermal absorption","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3","page":22,"route":"","species":"rat","study_id":"sccs_o_089_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.02 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_089; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1440/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT== 0.02; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/...; EFFECT=SCCS/1440/11 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability = 1.4 MOS = 82 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been supplied. Irritation, sensitisation Neat HC Blue n° 15 is irritant to mucous membranes. However, at a concentration of 2% (in water) slight i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"74578-10-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/...","duration":"90 day","effect":"SCCS/1440/11 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability = 1.4 MOS = 82 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been supplied. Irritation, sensitisation Neat HC Blue n° 15 is irritant to mucous membranes. However, at a concentration of 2% (in water) slight i","endpoint":"dermal absorption","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.02","page":25,"route":"oral","species":"rat","study_id":"sccs_o_089_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =4 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_089; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1440/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT== 4; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/...; EFFECT=ion on HC Blue n° 15 ___________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability = 1.4 MOS = 82 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been supplied. Irritation, sensitisation Neat HC Blue n° 15 is irritant to mucous membranes. However, at a concentration of 2% (in water) slight irritat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"74578-10-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/...","duration":"90 day","effect":"ion on HC Blue n° 15 ___________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 oxidative conditions Absorption through the skin A = 1.76 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.02 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability = 1.4 MOS = 82 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been supplied. Irritation, sensitisation Neat HC Blue n° 15 is irritant to mucous membranes. However, at a concentration of 2% (in water) slight irritat","endpoint":"dermal absorption","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 4","page":25,"route":"oral","species":"rat","study_id":"sccs_o_089_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 3 mg/kg bw/day rat - - dermal absorption SOURCE_SUBDIR=sccs_o_127; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1504/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT=3; DOSE=Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses.; EFFECT=ects on reproduction data or foetal data were observed. Mean number of implantation sites, pre- and post-implantation losses and mean number of viable foetuses per litter and group were not affected by treatment. There were no dead or aborted foetuses. Mean sex ratios and mean foetal body weights were not affected by treatment. There were no treatment-related foetal external, visceral or skeletal (bones and cartilage) findings. Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses. Ref.: 23 3.3.9. Toxicokinetics Guidelines: OECD 417 (1984) Toxicokinetics and 427 (2004) percutaneous absorption Species/Strain: Rats, female, Wistar Crl: (WI) BR (outbred) Group Sizes: 4 in ADME studies (groups 1,2, 3, 4) 6 in toxicokinetics studies (5, 6, 7, 8) Test substance: 14C-labelled HC Blue No 15 (WR18403) HC Blue No 15 (WR18403) Batches: Labelled CFQ13944 batch 1 (Purity: 98%) BB77-020420 (38.5% w/w; CITATION=Ref.: 23 3; CITATION_NUMBERS=[23,3]; REFERENCE=Ref.: 23 3; DETAILS_JSON={"cas_number":"74578-10-2","citation":"Ref.: 23 3","dose":"Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses.","duration":"","effect":"ects on reproduction data or foetal data were observed. Mean number of implantation sites, pre- and post-implantation losses and mean number of viable foetuses per litter and group were not affected by treatment. There were no dead or aborted foetuses. Mean sex ratios and mean foetal body weights were not affected by treatment. There were no treatment-related foetal external, visceral or skeletal (bones and cartilage) findings. Conclusion Based on the results of this study, the no observable adverse effect level (NOAEL) for Basic Blue 77 was considered to be 3 mg/kg bw/day for females and 30 mg/kg bw/day for foetuses. Ref.: 23 3.3.9. Toxicokinetics Guidelines: OECD 417 (1984) Toxicokinetics and 427 (2004) percutaneous absorption Species/Strain: Rats, female, Wistar Crl: (WI) BR (outbred) Group Sizes: 4 in ADME studies (groups 1,2, 3, 4) 6 in toxicokinetics studies (5, 6, 7, 8) Test substance: 14C-labelled HC Blue No 15 (WR18403) HC Blue No 15 (WR18403) Batches: Labelled CFQ13944 batch 1 (Purity: 98%) BB77-020420 (38.5% w/w","endpoint":"dermal absorption","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"3","page":26,"route":"","species":"rat","study_id":"sccs_o_127_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.0003 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_127; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1504/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT== 0.0003; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0...; EFFECT=504/13 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0003 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability * = 1.4 mg/kg bw/d MOS = 4800 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not be; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"74578-10-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0...","duration":"90 day","effect":"504/13 Opinion on HC Blue n° 15 ___________________________________________________________________________________________ 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0003 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability * = 1.4 mg/kg bw/d MOS = 4800 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not be","endpoint":"dermal absorption","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.0003","page":29,"route":"oral","species":"rat","study_id":"sccs_o_127_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =4 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_127; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1504/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT== 4; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0...; EFFECT=___________________________________________________________________________________________ 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0003 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability * = 1.4 mg/kg bw/d MOS = 4800 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been sup; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"74578-10-2","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0...","duration":"90 day","effect":"___________________________________________________________________________________________ 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue n° 15 Non oxidative and oxidative conditions Absorption through the skin A = 0.03 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.02 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0003 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 4 mg/kg bw/d (90 day study, oral route, rat) 35% bioavailability * = 1.4 mg/kg bw/d MOS = 4800 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14. Discussion Physico-chemical properties For the toxicological tests, a batch of the test substance had been used that is sufficiently characterized with respect to identity, purity and stability. Data about homogeneity of the test substance or its formulations have not been sup","endpoint":"dermal absorption","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 4","page":29,"route":"oral","species":"rat","study_id":"sccs_o_127_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 4 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_089; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1440/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT=4; DOSE=Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical bio...; EFFECT=the liver), increased urinary leukocytes, increased urinary erythrocytes in females, elevated liver weights, coinciding with minimal hypertrophy of centrilobular hepatocytes, elevated kidney weights; a marginally greater incidence and severity of focal myocarditis was observed, but this was found to be more likely fortuitously than substance-related (statistically non-significant). Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical biochemistry, urinalyses and higher kidney weights at 15 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"74578-10-2","citation":"Ref.: 17 3","dose":"Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical bio...","duration":"Chronic","effect":"the liver), increased urinary leukocytes, increased urinary erythrocytes in females, elevated liver weights, coinciding with minimal hypertrophy of centrilobular hepatocytes, elevated kidney weights; a marginally greater incidence and severity of focal myocarditis was observed, but this was found to be more likely fortuitously than substance-related (statistically non-significant). Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical biochemistry, urinalyses and higher kidney weights at 15 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","endpoint":"genotoxicity","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"4","page":16,"route":"","species":"","study_id":"sccs_o_089_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 4 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_089; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1440/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT=4; DOSE=Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical bio...; EFFECT=patocytes, elevated kidney weights; a marginally greater incidence and severity of focal myocarditis was observed, but this was found to be more likely fortuitously than substance-related (statistically non-significant). Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical biochemistry, urinalyses and higher kidney weights at 15 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"74578-10-2","citation":"Ref.: 17 3","dose":"Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical bio...","duration":"Chronic","effect":"patocytes, elevated kidney weights; a marginally greater incidence and severity of focal myocarditis was observed, but this was found to be more likely fortuitously than substance-related (statistically non-significant). Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical biochemistry, urinalyses and higher kidney weights at 15 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","endpoint":"genotoxicity","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"4","page":16,"route":"","species":"","study_id":"sccs_o_089_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 4 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_127; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1504/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT=4; DOSE=Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical bio...; EFFECT=the liver), increased urinary leukocytes, increased urinary erythrocytes in females, elevated liver weights, coinciding with minimal hypertrophy of centrilobular hepatocytes, elevated kidney weights; a marginally greater incidence and severity of focal myocarditis was observed, but this was found to be more likely fortuitously than substance-related (statistically non-significant). Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical biochemistry, urinalyses and higher kidney weights at 15 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"74578-10-2","citation":"Ref.: 17 3","dose":"Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical bio...","duration":"Chronic","effect":"the liver), increased urinary leukocytes, increased urinary erythrocytes in females, elevated liver weights, coinciding with minimal hypertrophy of centrilobular hepatocytes, elevated kidney weights; a marginally greater incidence and severity of focal myocarditis was observed, but this was found to be more likely fortuitously than substance-related (statistically non-significant). Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical biochemistry, urinalyses and higher kidney weights at 15 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","endpoint":"genotoxicity","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"4","page":20,"route":"","species":"","study_id":"sccs_o_127_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 4 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_127; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1504/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT=4; DOSE=Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical bio...; EFFECT=patocytes, elevated kidney weights; a marginally greater incidence and severity of focal myocarditis was observed, but this was found to be more likely fortuitously than substance-related (statistically non-significant). Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical biochemistry, urinalyses and higher kidney weights at 15 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"74578-10-2","citation":"Ref.: 17 3","dose":"Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical bio...","duration":"Chronic","effect":"patocytes, elevated kidney weights; a marginally greater incidence and severity of focal myocarditis was observed, but this was found to be more likely fortuitously than substance-related (statistically non-significant). Conclusion The results of this study indicate that 1 mg/kg bw/day of Basic Blue 77 was established as the no-observed-effect-level (NOEL), based upon passive effects at 4 mg/kg bw/day such as faecal discoloration, whereas 4 mg/kg bw/day was considered to be the no-observed- adverse-effect level (NOAEL), based upon various changes in clinical biochemistry, urinalyses and higher kidney weights at 15 mg/kg bw/day. Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro","endpoint":"genotoxicity","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"4","page":20,"route":"","species":"","study_id":"sccs_o_127_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1.76 μg/cm - oral sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_089; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1440/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT=1.76; DOSE=15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity;; EFFECT=d. Dermal absorption The single experiment available did not conform to guidelines. 100mg/cm² of formulation was applied. Too few chambers were used (5) and the number of donors is not stated. The purity of HC Blue n° 15 is not given. The membrane thickness was inappropriate. In view of the above, and as penetration of HC Blue n° 15 is low, the amount considered as being absorbed from an oxidative hair dye formulation containing 1.67% HC Blue n° 15 is considered as (mean +2SD) 1.76 μg/cm². General toxicity The no observed adverse effect level (NOAEL) for HC Blue No. 15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity; 3 mg/kg bw/day for the dams and 30 mg/kg bw/day for foetuses in the prenatal development toxicity study. The toxicokinetic/ADME study suggested moderate oral absorption and low dermal penetration of 14C_HC Blue No. 15. After being metabolized, excretion was mainly faecal.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"74578-10-2","citation":"","dose":"15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity;","duration":"sub-chronic","effect":"d. Dermal absorption The single experiment available did not conform to guidelines. 100mg/cm² of formulation was applied. Too few chambers were used (5) and the number of donors is not stated. The purity of HC Blue n° 15 is not given. The membrane thickness was inappropriate. In view of the above, and as penetration of HC Blue n° 15 is low, the amount considered as being absorbed from an oxidative hair dye formulation containing 1.67% HC Blue n° 15 is considered as (mean +2SD) 1.76 μg/cm². General toxicity The no observed adverse effect level (NOAEL) for HC Blue No. 15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity; 3 mg/kg bw/day for the dams and 30 mg/kg bw/day for foetuses in the prenatal development toxicity study. The toxicokinetic/ADME study suggested moderate oral absorption and low dermal penetration of 14C_HC Blue No. 15. After being metabolized, excretion was mainly faecal.","endpoint":"repeated dose toxicity","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"μg/cm","noael_value":"1.76","page":25,"route":"oral","species":"","study_id":"sccs_o_089_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 4 mg/kg bw/day - oral sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_089; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1440/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT=4; DOSE=15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity;; EFFECT=experiment available did not conform to guidelines. 100mg/cm² of formulation was applied. Too few chambers were used (5) and the number of donors is not stated. The purity of HC Blue n° 15 is not given. The membrane thickness was inappropriate. In view of the above, and as penetration of HC Blue n° 15 is low, the amount considered as being absorbed from an oxidative hair dye formulation containing 1.67% HC Blue n° 15 is considered as (mean +2SD) 1.76 μg/cm². General toxicity The no observed adverse effect level (NOAEL) for HC Blue No. 15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity; 3 mg/kg bw/day for the dams and 30 mg/kg bw/day for foetuses in the prenatal development toxicity study. The toxicokinetic/ADME study suggested moderate oral absorption and low dermal penetration of 14C_HC Blue No. 15. After being metabolized, excretion was mainly faecal.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"74578-10-2","citation":"","dose":"15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity;","duration":"sub-chronic","effect":"experiment available did not conform to guidelines. 100mg/cm² of formulation was applied. Too few chambers were used (5) and the number of donors is not stated. The purity of HC Blue n° 15 is not given. The membrane thickness was inappropriate. In view of the above, and as penetration of HC Blue n° 15 is low, the amount considered as being absorbed from an oxidative hair dye formulation containing 1.67% HC Blue n° 15 is considered as (mean +2SD) 1.76 μg/cm². General toxicity The no observed adverse effect level (NOAEL) for HC Blue No. 15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity; 3 mg/kg bw/day for the dams and 30 mg/kg bw/day for foetuses in the prenatal development toxicity study. The toxicokinetic/ADME study suggested moderate oral absorption and low dermal penetration of 14C_HC Blue No. 15. After being metabolized, excretion was mainly faecal.","endpoint":"repeated dose toxicity","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"4","page":25,"route":"oral","species":"","study_id":"sccs_o_089_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 4 mg/kg bw/day - oral sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_127; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1504/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT=4; DOSE=Dermal absorption The total absorbed dose of HC Blue No.; EFFECT=kin sensitizer under the defined experimental conditions. However, the highest test concentration was too low. Therefore, sensitising potential has not been excluded. Dermal absorption The total absorbed dose of HC Blue No. 15 at 72 h was 0.02 ± 0.01 μg equiv./cm2 and 0.01 ± 0.02 μg equiv./cm2 under non oxidative and oxidative conditions, respectively. The mean + 1SD is used to calculate MoS: 0.03 μg equiv./cm². The results are in line with the findings of the in vivo toxicokinetics study. General toxicity The no observed adverse effect level (NOAEL) for HC Blue No. 15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity; 3 mg/kg bw/day for the dams and 30 mg/kg bw/day for foetuses in the prenatal development toxicity study. The toxicokinetic/ADME study suggested moderate oral absorption and low dermal penetration of 14C-HC Blue No. 15. After being metabolized, excretion was mainly faecal. No; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"74578-10-2","citation":"","dose":"Dermal absorption The total absorbed dose of HC Blue No.","duration":"sub-chronic","effect":"kin sensitizer under the defined experimental conditions. However, the highest test concentration was too low. Therefore, sensitising potential has not been excluded. Dermal absorption The total absorbed dose of HC Blue No. 15 at 72 h was 0.02 ± 0.01 μg equiv./cm2 and 0.01 ± 0.02 μg equiv./cm2 under non oxidative and oxidative conditions, respectively. The mean + 1SD is used to calculate MoS: 0.03 μg equiv./cm². The results are in line with the findings of the in vivo toxicokinetics study. General toxicity The no observed adverse effect level (NOAEL) for HC Blue No. 15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity; 3 mg/kg bw/day for the dams and 30 mg/kg bw/day for foetuses in the prenatal development toxicity study. The toxicokinetic/ADME study suggested moderate oral absorption and low dermal penetration of 14C-HC Blue No. 15. After being metabolized, excretion was mainly faecal. No","endpoint":"repeated dose toxicity","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"4","page":29,"route":"oral","species":"","study_id":"sccs_o_127_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 4 mg/kg bw/day - oral sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_127; REPORT_TITLE=OPINION ON HC Blue n° 15 COLIPA n° C182; OPINION_NUMBER=SCCS/1504/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 April 2004; VALUE_TEXT=4; DOSE=Dermal absorption The total absorbed dose of HC Blue No.; EFFECT=xperimental conditions. However, the highest test concentration was too low. Therefore, sensitising potential has not been excluded. Dermal absorption The total absorbed dose of HC Blue No. 15 at 72 h was 0.02 ± 0.01 μg equiv./cm2 and 0.01 ± 0.02 μg equiv./cm2 under non oxidative and oxidative conditions, respectively. The mean + 1SD is used to calculate MoS: 0.03 μg equiv./cm². The results are in line with the findings of the in vivo toxicokinetics study. General toxicity The no observed adverse effect level (NOAEL) for HC Blue No. 15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity; 3 mg/kg bw/day for the dams and 30 mg/kg bw/day for foetuses in the prenatal development toxicity study. The toxicokinetic/ADME study suggested moderate oral absorption and low dermal penetration of 14C-HC Blue No. 15. After being metabolized, excretion was mainly faecal. No; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"74578-10-2","citation":"","dose":"Dermal absorption The total absorbed dose of HC Blue No.","duration":"sub-chronic","effect":"xperimental conditions. However, the highest test concentration was too low. Therefore, sensitising potential has not been excluded. Dermal absorption The total absorbed dose of HC Blue No. 15 at 72 h was 0.02 ± 0.01 μg equiv./cm2 and 0.01 ± 0.02 μg equiv./cm2 under non oxidative and oxidative conditions, respectively. The mean + 1SD is used to calculate MoS: 0.03 μg equiv./cm². The results are in line with the findings of the in vivo toxicokinetics study. General toxicity The no observed adverse effect level (NOAEL) for HC Blue No. 15 was considered to be 4 mg/kg bw/day in the sub-chronic (90 days) toxicity; 3 mg/kg bw/day for the dams and 30 mg/kg bw/day for foetuses in the prenatal development toxicity study. The toxicokinetic/ADME study suggested moderate oral absorption and low dermal penetration of 14C-HC Blue No. 15. After being metabolized, excretion was mainly faecal. No","endpoint":"repeated dose toxicity","ingredient":"HC Blue No. 15","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"4","page":29,"route":"oral","species":"","study_id":"sccs_o_127_noael_008"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 62LA9436UJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C23H22Cl2N2.H3O4P","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"62LA9436UJ"}
openFDA substances FDA UNII substance identifier 62LA9436UJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C23H22Cl2N2.H3O4P","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"62LA9436UJ"}
openFDA substances FDA UNII substance identifier 62LA9436UJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C23H22Cl2N2.H3O4P","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"62LA9436UJ"}
openFDA substances FDA UNII substance identifier 62LA9436UJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C23H22Cl2N2.H3O4P","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"62LA9436UJ"}