NOAEL Studies Cosmetic Ingredient

HC Blue No. 17 NOAEL Studies

INCI: HC BLUE NO. 17

CAS: 16517-75-2

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

Back to parent ingredient page
SCCS_vision_codex 28 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =0.04 mg/kg bw/d rat oral developmental repeated dose toxicity {"dose":"onic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","effect":"onic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat) (Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2500 * 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 HC Blue 17 is used as a hair colouring agent up to 2% on-head concentration of in non- oxidative as well as in oxidative hair dye formulations. Characterisation of HC Blue 17","page":26,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_015"}
SCCS_vision_codex NOAEL =0.04 mg/kg bw/d rat oral developmental repeated dose toxicity {"dose":"onic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","effect":"onic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat) (Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2500 * 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 HC Blue 17 is used as a hair colouring agent up to 2% on-head concentration of in non- oxidative as well as in oxidative hair dye formulations. Characterisation of HC Blue 17","page":26,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_015"}
SCCS_vision_codex NOAEL =0.04 mg/kg bw/d rat oral developmental repeated dose toxicity {"dose":"onic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","effect":"onic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat) (Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2500 * 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 HC Blue 17 is used as a hair colouring agent up to 2% on-head concentration of in non- oxidative as well as in oxidative hair dye formulations. Characterisation of HC Blue 17","page":26,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_015"}
SCCS_vision_codex NOAEL =0.04 mg/kg bw/d rat oral developmental repeated dose toxicity {"dose":"onic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","effect":"onic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat) (Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2500 * 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 HC Blue 17 is used as a hair colouring agent up to 2% on-head concentration of in non- oxidative as well as in oxidative hair dye formulations. Characterisation of HC Blue 17","page":26,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_015"}
SCCS_vision_codex NOAEL =0.05 mg/kg bw/d rat oral subchronic repeated dose toxicity {"dose":"SCCS/1471/12 Opinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal ab...","effect":"SCCS/1471/12 Opinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.74 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x","page":26,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_013"}
SCCS_vision_codex NOAEL =0.05 mg/kg bw/d rat oral subchronic repeated dose toxicity {"dose":"SCCS/1471/12 Opinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal ab...","effect":"SCCS/1471/12 Opinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.74 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x","page":26,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_013"}
SCCS_vision_codex NOAEL =0.05 mg/kg bw/d rat oral subchronic repeated dose toxicity {"dose":"SCCS/1471/12 Opinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal ab...","effect":"SCCS/1471/12 Opinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.74 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x","page":26,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_013"}
SCCS_vision_codex NOAEL =0.05 mg/kg bw/d rat oral subchronic repeated dose toxicity {"dose":"SCCS/1471/12 Opinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal ab...","effect":"SCCS/1471/12 Opinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.74 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x","page":26,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_013"}
SCCS_vision_codex NOAEL =40 mg/kg bw/d rabbit oral Chronic genotoxicity {"citation":"Ref.: 1)","dose":"The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d.","effect":"SCCS-rejected applicant NOAEL: , 23 Comment of the SCCS The reported irritant effects in the nasal cavity are quite unusual in an oral gavage study and may be due to technical problems during administration of the test substance. HC Blue 17 is not considered a strong mucosal irritant: no signs of stomach irritation were observed and the substance was considered only slightly irritant to the rabbit eyes (see Ref.: 1). The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvrA Repli","page":17,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_003"}
SCCS_vision_codex NOAEL =40 mg/kg bw/d rabbit oral Chronic genotoxicity {"citation":"Ref.: 1)","dose":"The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d.","effect":"SCCS-rejected applicant NOAEL: , 23 Comment of the SCCS The reported irritant effects in the nasal cavity are quite unusual in an oral gavage study and may be due to technical problems during administration of the test substance. HC Blue 17 is not considered a strong mucosal irritant: no signs of stomach irritation were observed and the substance was considered only slightly irritant to the rabbit eyes (see Ref.: 1). The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvrA Repli","page":17,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_003"}
SCCS_vision_codex NOAEL =40 mg/kg bw/d rabbit oral Chronic genotoxicity {"citation":"Ref.: 1)","dose":"The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d.","effect":"SCCS-rejected applicant NOAEL: , 23 Comment of the SCCS The reported irritant effects in the nasal cavity are quite unusual in an oral gavage study and may be due to technical problems during administration of the test substance. HC Blue 17 is not considered a strong mucosal irritant: no signs of stomach irritation were observed and the substance was considered only slightly irritant to the rabbit eyes (see Ref.: 1). The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvrA Repli","page":17,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_003"}
SCCS_vision_codex NOAEL =40 mg/kg bw/d rabbit oral Chronic genotoxicity {"citation":"Ref.: 1)","dose":"The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d.","effect":"SCCS-rejected applicant NOAEL: , 23 Comment of the SCCS The reported irritant effects in the nasal cavity are quite unusual in an oral gavage study and may be due to technical problems during administration of the test substance. HC Blue 17 is not considered a strong mucosal irritant: no signs of stomach irritation were observed and the substance was considered only slightly irritant to the rabbit eyes (see Ref.: 1). The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvrA Repli","page":17,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_003"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral - NOAEL study {"citation":"Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehic","dose":"t 1000 mg/kg bw/d also the mean absolute body weights were reduced.","effect":"t 1000 mg/kg bw/d also the mean absolute body weights were reduced. Post-implantation losses and the mean number of foetuses per dam were not affected by treatment with the test item at any dose level. During necropsy of the females, no macroscopical findings were noted. During the external examination of the foetuses, no external findings were noted. No test item-related effects on foetal sex ratios were noted. No test item-related effects on foetal body weights were noted. Conclusion Based on these results, the NOAEL (No Observed Adverse Effect Level) for maternal and foetal organisms was considered to be 100 mg/kg bw/d. Based on these data the following dose levels are considered appropriate for the main study: 40, 200 and 1000 mg/kg bw/d. Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehicle: Milli-Q-water Dose levels: 0, 40, 200, 1000 mg/kg bw/d Dose volume: 10 mL/kg bw Route: oral (gavag","page":23,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral - NOAEL study {"citation":"Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehic","dose":"t 1000 mg/kg bw/d also the mean absolute body weights were reduced.","effect":"t 1000 mg/kg bw/d also the mean absolute body weights were reduced. Post-implantation losses and the mean number of foetuses per dam were not affected by treatment with the test item at any dose level. During necropsy of the females, no macroscopical findings were noted. During the external examination of the foetuses, no external findings were noted. No test item-related effects on foetal sex ratios were noted. No test item-related effects on foetal body weights were noted. Conclusion Based on these results, the NOAEL (No Observed Adverse Effect Level) for maternal and foetal organisms was considered to be 100 mg/kg bw/d. Based on these data the following dose levels are considered appropriate for the main study: 40, 200 and 1000 mg/kg bw/d. Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehicle: Milli-Q-water Dose levels: 0, 40, 200, 1000 mg/kg bw/d Dose volume: 10 mL/kg bw Route: oral (gavag","page":23,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral - NOAEL study {"citation":"Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehic","dose":"t 1000 mg/kg bw/d also the mean absolute body weights were reduced.","effect":"t 1000 mg/kg bw/d also the mean absolute body weights were reduced. Post-implantation losses and the mean number of foetuses per dam were not affected by treatment with the test item at any dose level. During necropsy of the females, no macroscopical findings were noted. During the external examination of the foetuses, no external findings were noted. No test item-related effects on foetal sex ratios were noted. No test item-related effects on foetal body weights were noted. Conclusion Based on these results, the NOAEL (No Observed Adverse Effect Level) for maternal and foetal organisms was considered to be 100 mg/kg bw/d. Based on these data the following dose levels are considered appropriate for the main study: 40, 200 and 1000 mg/kg bw/d. Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehicle: Milli-Q-water Dose levels: 0, 40, 200, 1000 mg/kg bw/d Dose volume: 10 mL/kg bw Route: oral (gavag","page":23,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral - NOAEL study {"citation":"Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehic","dose":"t 1000 mg/kg bw/d also the mean absolute body weights were reduced.","effect":"t 1000 mg/kg bw/d also the mean absolute body weights were reduced. Post-implantation losses and the mean number of foetuses per dam were not affected by treatment with the test item at any dose level. During necropsy of the females, no macroscopical findings were noted. During the external examination of the foetuses, no external findings were noted. No test item-related effects on foetal sex ratios were noted. No test item-related effects on foetal body weights were noted. Conclusion Based on these results, the NOAEL (No Observed Adverse Effect Level) for maternal and foetal organisms was considered to be 100 mg/kg bw/d. Based on these data the following dose levels are considered appropriate for the main study: 40, 200 and 1000 mg/kg bw/d. Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehicle: Milli-Q-water Dose levels: 0, 40, 200, 1000 mg/kg bw/d Dose volume: 10 mL/kg bw Route: oral (gavag","page":23,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_005"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - - developmental toxicity {"citation":"Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an","dose":"Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development.","effect":"st item. Mean food consumption was statistically significantly reduced from days 6 to 12 post coitum, resulting in a slightly reduced mean body weight gain from day 13 post coitum onwards. Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development. Based on the above mentioned results, for maternal organisms the NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg bw/d and the NOEL (No Observed Effect Level) was considered to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the reduction of the corrected body weight gain as not being test item related. The SCCS sets the NOAEL of maternal toxicity at","page":25,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_010"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - - developmental toxicity {"citation":"Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an","dose":"Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development.","effect":"st item. Mean food consumption was statistically significantly reduced from days 6 to 12 post coitum, resulting in a slightly reduced mean body weight gain from day 13 post coitum onwards. Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development. Based on the above mentioned results, for maternal organisms the NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg bw/d and the NOEL (No Observed Effect Level) was considered to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the reduction of the corrected body weight gain as not being test item related. The SCCS sets the NOAEL of maternal toxicity at","page":25,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_010"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - - developmental toxicity {"citation":"Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an","dose":"Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development.","effect":"st item. Mean food consumption was statistically significantly reduced from days 6 to 12 post coitum, resulting in a slightly reduced mean body weight gain from day 13 post coitum onwards. Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development. Based on the above mentioned results, for maternal organisms the NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg bw/d and the NOEL (No Observed Effect Level) was considered to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the reduction of the corrected body weight gain as not being test item related. The SCCS sets the NOAEL of maternal toxicity at","page":25,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_010"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - - developmental toxicity {"citation":"Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an","dose":"Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development.","effect":"st item. Mean food consumption was statistically significantly reduced from days 6 to 12 post coitum, resulting in a slightly reduced mean body weight gain from day 13 post coitum onwards. Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development. Based on the above mentioned results, for maternal organisms the NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg bw/d and the NOEL (No Observed Effect Level) was considered to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the reduction of the corrected body weight gain as not being test item related. The SCCS sets the NOAEL of maternal toxicity at","page":25,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_010"}
SCCS_vision_codex NOAEL =1000 mg/kg/day human oral - irritation {"dose":"ared to 40 mg/kg bw/day could be related to increased struggling by the dosed animals that made dosing more difficult.","effect":"ared to 40 mg/kg bw/day could be related to increased struggling by the dosed animals that made dosing more difficult. This increased struggling could be due to the higher concentration of a test article that may have had bad taste and/or was more irritant to the respiratory tract at higher concentrations. The consulting pathologist is in agreement with the interpretation of the study authors that there was no evidence of any adverse test article-related effect on mortality and/or respiratory tract pathology: The No-Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day based on the absence of any adverse test article-related findings. The 5 unscheduled deaths that occurred during the course of the study were not test article related and were either related to gavage error or an undetermined cause. The various degenerative changes noted in the nasal cavity (levels III and IV) were considered secondary to the local deposition of the test article during the dosing procedure and are not relevant to any risk assessment for human use of the test article. Ref","page":17,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_001"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rabbit - Chronic genotoxicity {"citation":"Ref.: 1)","dose":"The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d.","effect":"ubstance. HC Blue 17 is not considered a strong mucosal irritant: no signs of stomach irritation were observed and the substance was considered only slightly irritant to the rabbit eyes (see Ref.: 1). The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvrA Replicates: triplicate cultures in 2 independent experiments","page":17,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_004"}
SCCS_vision_codex NOAEL =1000 mg/kg/day human oral - irritation {"dose":"ared to 40 mg/kg bw/day could be related to increased struggling by the dosed animals that made dosing more difficult.","effect":"ared to 40 mg/kg bw/day could be related to increased struggling by the dosed animals that made dosing more difficult. This increased struggling could be due to the higher concentration of a test article that may have had bad taste and/or was more irritant to the respiratory tract at higher concentrations. The consulting pathologist is in agreement with the interpretation of the study authors that there was no evidence of any adverse test article-related effect on mortality and/or respiratory tract pathology: The No-Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day based on the absence of any adverse test article-related findings. The 5 unscheduled deaths that occurred during the course of the study were not test article related and were either related to gavage error or an undetermined cause. The various degenerative changes noted in the nasal cavity (levels III and IV) were considered secondary to the local deposition of the test article during the dosing procedure and are not relevant to any risk assessment for human use of the test article. Ref","page":17,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_001"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rabbit - Chronic genotoxicity {"citation":"Ref.: 1)","dose":"The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d.","effect":"ubstance. HC Blue 17 is not considered a strong mucosal irritant: no signs of stomach irritation were observed and the substance was considered only slightly irritant to the rabbit eyes (see Ref.: 1). The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvrA Replicates: triplicate cultures in 2 independent experiments","page":17,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_004"}
SCCS_vision_codex NOAEL =1000 mg/kg/day human oral - irritation {"dose":"ared to 40 mg/kg bw/day could be related to increased struggling by the dosed animals that made dosing more difficult.","effect":"ared to 40 mg/kg bw/day could be related to increased struggling by the dosed animals that made dosing more difficult. This increased struggling could be due to the higher concentration of a test article that may have had bad taste and/or was more irritant to the respiratory tract at higher concentrations. The consulting pathologist is in agreement with the interpretation of the study authors that there was no evidence of any adverse test article-related effect on mortality and/or respiratory tract pathology: The No-Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day based on the absence of any adverse test article-related findings. The 5 unscheduled deaths that occurred during the course of the study were not test article related and were either related to gavage error or an undetermined cause. The various degenerative changes noted in the nasal cavity (levels III and IV) were considered secondary to the local deposition of the test article during the dosing procedure and are not relevant to any risk assessment for human use of the test article. Ref","page":17,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_001"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rabbit - Chronic genotoxicity {"citation":"Ref.: 1)","dose":"The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d.","effect":"ubstance. HC Blue 17 is not considered a strong mucosal irritant: no signs of stomach irritation were observed and the substance was considered only slightly irritant to the rabbit eyes (see Ref.: 1). The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvrA Replicates: triplicate cultures in 2 independent experiments","page":17,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_004"}
SCCS_vision_codex NOAEL =1000 mg/kg/day human oral - irritation {"dose":"ared to 40 mg/kg bw/day could be related to increased struggling by the dosed animals that made dosing more difficult.","effect":"ared to 40 mg/kg bw/day could be related to increased struggling by the dosed animals that made dosing more difficult. This increased struggling could be due to the higher concentration of a test article that may have had bad taste and/or was more irritant to the respiratory tract at higher concentrations. The consulting pathologist is in agreement with the interpretation of the study authors that there was no evidence of any adverse test article-related effect on mortality and/or respiratory tract pathology: The No-Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day based on the absence of any adverse test article-related findings. The 5 unscheduled deaths that occurred during the course of the study were not test article related and were either related to gavage error or an undetermined cause. The various degenerative changes noted in the nasal cavity (levels III and IV) were considered secondary to the local deposition of the test article during the dosing procedure and are not relevant to any risk assessment for human use of the test article. Ref","page":17,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_001"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rabbit - Chronic genotoxicity {"citation":"Ref.: 1)","dose":"The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d.","effect":"ubstance. HC Blue 17 is not considered a strong mucosal irritant: no signs of stomach irritation were observed and the substance was considered only slightly irritant to the rabbit eyes (see Ref.: 1). The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvrA Replicates: triplicate cultures in 2 independent experiments","page":17,"pdf":"sccs_o_128.pdf","row_type":"noael_study","study_id":"sccs_o_128_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 20 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/d rat oral - - SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=100; DOSE=t 1000 mg/kg bw/d also the mean absolute body weights were reduced.; EFFECT=t 1000 mg/kg bw/d also the mean absolute body weights were reduced. Post-implantation losses and the mean number of foetuses per dam were not affected by treatment with the test item at any dose level. During necropsy of the females, no macroscopical findings were noted. During the external examination of the foetuses, no external findings were noted. No test item-related effects on foetal sex ratios were noted. No test item-related effects on foetal body weights were noted. Conclusion Based on these results, the NOAEL (No Observed Adverse Effect Level) for maternal and foetal organisms was considered to be 100 mg/kg bw/d. Based on these data the following dose levels are considered appropriate for the main study: 40, 200 and 1000 mg/kg bw/d. Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehicle: Milli-Q-water Dose levels: 0, 40, 200, 1000 mg/kg bw/d Dose volume: 10 mL/kg bw Route: oral (gavag; CITATION=Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehic; CITATION_NUMBERS=[12,414,2001,22,347,2017,8,97]; REFERENCE=Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehic; DETAILS_JSON={"cas_number":"16517-75-2","citation":"Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehic","dose":"t 1000 mg/kg bw/d also the mean absolute body weights were reduced.","duration":"","effect":"t 1000 mg/kg bw/d also the mean absolute body weights were reduced. Post-implantation losses and the mean number of foetuses per dam were not affected by treatment with the test item at any dose level. During necropsy of the females, no macroscopical findings were noted. During the external examination of the foetuses, no external findings were noted. No test item-related effects on foetal sex ratios were noted. No test item-related effects on foetal body weights were noted. Conclusion Based on these results, the NOAEL (No Observed Adverse Effect Level) for maternal and foetal organisms was considered to be 100 mg/kg bw/d. Based on these data the following dose levels are considered appropriate for the main study: 40, 200 and 1000 mg/kg bw/d. Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehicle: Milli-Q-water Dose levels: 0, 40, 200, 1000 mg/kg bw/d Dose volume: 10 mL/kg bw Route: oral (gavag","endpoint":"","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":23,"route":"oral","species":"rat","study_id":"sccs_o_128_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw/d rat oral - - SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=100; DOSE=mg/kg bw/d also the mean absolute body weights were reduced.; EFFECT=mg/kg bw/d also the mean absolute body weights were reduced. Post-implantation losses and the mean number of foetuses per dam were not affected by treatment with the test item at any dose level. During necropsy of the females, no macroscopical findings were noted. During the external examination of the foetuses, no external findings were noted. No test item-related effects on foetal sex ratios were noted. No test item-related effects on foetal body weights were noted. Conclusion Based on these results, the NOAEL (No Observed Adverse Effect Level) for maternal and foetal organisms was considered to be 100 mg/kg bw/d. Based on these data the following dose levels are considered appropriate for the main study: 40, 200 and 1000 mg/kg bw/d. Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehicle: Milli-Q-water Dose levels: 0, 40, 200, 1000 mg/kg bw/d Dose volume: 10 mL/kg bw Route: oral (gavage) Administration: daily from day; CITATION=Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehic; CITATION_NUMBERS=[12,414,2001,22,347,2017,8,97]; REFERENCE=Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehic; DETAILS_JSON={"cas_number":"16517-75-2","citation":"Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehic","dose":"mg/kg bw/d also the mean absolute body weights were reduced.","duration":"","effect":"mg/kg bw/d also the mean absolute body weights were reduced. Post-implantation losses and the mean number of foetuses per dam were not affected by treatment with the test item at any dose level. During necropsy of the females, no macroscopical findings were noted. During the external examination of the foetuses, no external findings were noted. No test item-related effects on foetal sex ratios were noted. No test item-related effects on foetal body weights were noted. Conclusion Based on these results, the NOAEL (No Observed Adverse Effect Level) for maternal and foetal organisms was considered to be 100 mg/kg bw/d. Based on these data the following dose levels are considered appropriate for the main study: 40, 200 and 1000 mg/kg bw/d. Ref.: 12 Main study Guideline: OECD 414 (2001) Species/strain: rat, HanRcc:WIST(SPF) Group size: 22 mated females per test group Test substance: Blue 347 Batch: XB20178 Purity: 97% Vehicle: Milli-Q-water Dose levels: 0, 40, 200, 1000 mg/kg bw/d Dose volume: 10 mL/kg bw Route: oral (gavage) Administration: daily from day","endpoint":"","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":23,"route":"oral","species":"rat","study_id":"sccs_o_128_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 200 mg/kg bw/d - - - developmental toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=200; DOSE=Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development.; EFFECT=st item. Mean food consumption was statistically significantly reduced from days 6 to 12 post coitum, resulting in a slightly reduced mean body weight gain from day 13 post coitum onwards. Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development. Based on the above mentioned results, for maternal organisms the NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg bw/d and the NOEL (No Observed Effect Level) was considered to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the reduction of the corrected body weight gain as not being test item related. The SCCS sets the NOAEL of maternal toxicity at; CITATION=Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an; CITATION_NUMBERS=[13,1000]; REFERENCE=Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an; DETAILS_JSON={"cas_number":"16517-75-2","citation":"Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an","dose":"Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development.","duration":"","effect":"st item. Mean food consumption was statistically significantly reduced from days 6 to 12 post coitum, resulting in a slightly reduced mean body weight gain from day 13 post coitum onwards. Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development. Based on the above mentioned results, for maternal organisms the NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg bw/d and the NOEL (No Observed Effect Level) was considered to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the reduction of the corrected body weight gain as not being test item related. The SCCS sets the NOAEL of maternal toxicity at","endpoint":"developmental toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":25,"route":"","species":"","study_id":"sccs_o_128_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 200 mg/kg bw/d human - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=200; DOSE=to be 200 mg/kg bw/d.; EFFECT=to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the reduction of the corrected body weight gain as not being test item related. The SCCS sets the NOAEL of maternal toxicity at 200 mg/kg bw/d, the NOAEL of developmental toxicity including teratogenicity is 1000 mg/kg bw/d. 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data submitted; CITATION=Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an; CITATION_NUMBERS=[13,1000]; REFERENCE=Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an; DETAILS_JSON={"cas_number":"16517-75-2","citation":"Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an","dose":"to be 200 mg/kg bw/d.","duration":"developmental","effect":"to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the reduction of the corrected body weight gain as not being test item related. The SCCS sets the NOAEL of maternal toxicity at 200 mg/kg bw/d, the NOAEL of developmental toxicity including teratogenicity is 1000 mg/kg bw/d. 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data submitted","endpoint":"developmental toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":25,"route":"","species":"human","study_id":"sccs_o_128_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 200 mg/kg bw/d human - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=200; DOSE=s was considered to be 1000 mg/kg bw/d.; EFFECT=s was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the reduction of the corrected body weight gain as not being test item related. The SCCS sets the NOAEL of maternal toxicity at 200 mg/kg bw/d, the NOAEL of developmental toxicity including teratogenicity is 1000 mg/kg bw/d. 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data submitted; CITATION=Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an; CITATION_NUMBERS=[13,1000]; REFERENCE=Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an; DETAILS_JSON={"cas_number":"16517-75-2","citation":"Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an","dose":"s was considered to be 1000 mg/kg bw/d.","duration":"developmental","effect":"s was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the reduction of the corrected body weight gain as not being test item related. The SCCS sets the NOAEL of maternal toxicity at 200 mg/kg bw/d, the NOAEL of developmental toxicity including teratogenicity is 1000 mg/kg bw/d. 3.3.9 Toxicokinetics No data submitted 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2 Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11 Human data No data submitted 3.3.12 Special investigations No data submitted","endpoint":"developmental toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":25,"route":"","species":"human","study_id":"sccs_o_128_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg bw/d - - - developmental toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=1000; DOSE=usion At 1000 mg/kg bw/d, blue discoloured faeces were observed in all females, which were considered to be a consequence of the colouring properties of the test item.; EFFECT=usion At 1000 mg/kg bw/d, blue discoloured faeces were observed in all females, which were considered to be a consequence of the colouring properties of the test item. Mean food consumption was statistically significantly reduced from days 6 to 12 post coitum, resulting in a slightly reduced mean body weight gain from day 13 post coitum onwards. Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development. Based on the above mentioned results, for maternal organisms the NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg bw/d and the NOEL (No Observed Effect Level) was considered to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test i; CITATION=Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test i; CITATION_NUMBERS=[13,1000]; REFERENCE=Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test i; DETAILS_JSON={"cas_number":"16517-75-2","citation":"Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test i","dose":"usion At 1000 mg/kg bw/d, blue discoloured faeces were observed in all females, which were considered to be a consequence of the colouring properties of the test item.","duration":"","effect":"usion At 1000 mg/kg bw/d, blue discoloured faeces were observed in all females, which were considered to be a consequence of the colouring properties of the test item. Mean food consumption was statistically significantly reduced from days 6 to 12 post coitum, resulting in a slightly reduced mean body weight gain from day 13 post coitum onwards. Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development. Based on the above mentioned results, for maternal organisms the NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg bw/d and the NOEL (No Observed Effect Level) was considered to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test i","endpoint":"developmental toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":25,"route":"","species":"","study_id":"sccs_o_128_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg bw/d - - - developmental toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=1000; DOSE=t 1000 mg/kg bw/d, blue discoloured faeces were observed in all females, which were considered to be a consequence of the colouring properties of the test item.; EFFECT=t 1000 mg/kg bw/d, blue discoloured faeces were observed in all females, which were considered to be a consequence of the colouring properties of the test item. Mean food consumption was statistically significantly reduced from days 6 to 12 post coitum, resulting in a slightly reduced mean body weight gain from day 13 post coitum onwards. Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development. Based on the above mentioned results, for maternal organisms the NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg bw/d and the NOEL (No Observed Effect Level) was considered to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the; CITATION=Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an; CITATION_NUMBERS=[13,1000]; REFERENCE=Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an; DETAILS_JSON={"cas_number":"16517-75-2","citation":"Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an","dose":"t 1000 mg/kg bw/d, blue discoloured faeces were observed in all females, which were considered to be a consequence of the colouring properties of the test item.","duration":"","effect":"t 1000 mg/kg bw/d, blue discoloured faeces were observed in all females, which were considered to be a consequence of the colouring properties of the test item. Mean food consumption was statistically significantly reduced from days 6 to 12 post coitum, resulting in a slightly reduced mean body weight gain from day 13 post coitum onwards. Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development. Based on the above mentioned results, for maternal organisms the NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg bw/d and the NOEL (No Observed Effect Level) was considered to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the","endpoint":"developmental toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":25,"route":"","species":"","study_id":"sccs_o_128_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg bw/d - - - developmental toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=1000; DOSE=Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development.; EFFECT=were considered to be a consequence of the colouring properties of the test item. Mean food consumption was statistically significantly reduced from days 6 to 12 post coitum, resulting in a slightly reduced mean body weight gain from day 13 post coitum onwards. Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development. Based on the above mentioned results, for maternal organisms the NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg bw/d and the NOEL (No Observed Effect Level) was considered to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the reduction of the corrected body weight gain as not; CITATION=Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an; CITATION_NUMBERS=[13,1000]; REFERENCE=Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an; DETAILS_JSON={"cas_number":"16517-75-2","citation":"Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related an","dose":"Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development.","duration":"","effect":"were considered to be a consequence of the colouring properties of the test item. Mean food consumption was statistically significantly reduced from days 6 to 12 post coitum, resulting in a slightly reduced mean body weight gain from day 13 post coitum onwards. Treatment with the test item up to and including 1000 mg/kg bw/d did not affect embryo-foetal development. Based on the above mentioned results, for maternal organisms the NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg bw/d and the NOEL (No Observed Effect Level) was considered to be 200 mg/kg bw/d. The NOEL for foetal organisms was considered to be 1000 mg/kg bw/d. Under the conditions described for this study, Blue 347 did not reveal teratogenic potential up to and including 1000 mg/kg bw/d. Ref.: 13 Comment It is not clear why the study authors considered the reduction of both the mean food consumption and the mean body weight gain at 1000 mg/kg bw/d as test item related and, in contrast, the reduction of the corrected body weight gain as not","endpoint":"developmental toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":25,"route":"","species":"","study_id":"sccs_o_128_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 40 mg/kg bw/d rabbit oral Chronic genotoxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=40; DOSE=The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d.; EFFECT=SCCS-rejected applicant NOAEL: , 23 Comment of the SCCS The reported irritant effects in the nasal cavity are quite unusual in an oral gavage study and may be due to technical problems during administration of the test substance. HC Blue 17 is not considered a strong mucosal irritant: no signs of stomach irritation were observed and the substance was considered only slightly irritant to the rabbit eyes (see Ref.: 1). The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvrA Repli; CITATION=Ref.: 1); CITATION_NUMBERS=[1]; REFERENCE=Ref.: 1); DETAILS_JSON={"cas_number":"16517-75-2","citation":"Ref.: 1)","dose":"The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d.","duration":"Chronic","effect":"SCCS-rejected applicant NOAEL: , 23 Comment of the SCCS The reported irritant effects in the nasal cavity are quite unusual in an oral gavage study and may be due to technical problems during administration of the test substance. HC Blue 17 is not considered a strong mucosal irritant: no signs of stomach irritation were observed and the substance was considered only slightly irritant to the rabbit eyes (see Ref.: 1). The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvrA Repli","endpoint":"genotoxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"40","page":17,"route":"oral","species":"rabbit","study_id":"sccs_o_128_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 1000 mg/kg bw/d rabbit - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=1000; DOSE=The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d.; EFFECT=ubstance. HC Blue 17 is not considered a strong mucosal irritant: no signs of stomach irritation were observed and the substance was considered only slightly irritant to the rabbit eyes (see Ref.: 1). The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvrA Replicates: triplicate cultures in 2 independent experiments; CITATION=Ref.: 1); CITATION_NUMBERS=[1]; REFERENCE=Ref.: 1); DETAILS_JSON={"cas_number":"16517-75-2","citation":"Ref.: 1)","dose":"The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d.","duration":"Chronic","effect":"ubstance. HC Blue 17 is not considered a strong mucosal irritant: no signs of stomach irritation were observed and the substance was considered only slightly irritant to the rabbit eyes (see Ref.: 1). The local irritant effects in the nasal cavity were concentration-related and also observed at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium TA98, TA100, TA1535, TA1537, and E. coli WP2 uvrA Replicates: triplicate cultures in 2 independent experiments","endpoint":"genotoxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":17,"route":"","species":"rabbit","study_id":"sccs_o_128_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 1000 mg/kg/day human oral - irritation SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=1000; DOSE=ared to 40 mg/kg bw/day could be related to increased struggling by the dosed animals that made dosing more difficult.; EFFECT=ared to 40 mg/kg bw/day could be related to increased struggling by the dosed animals that made dosing more difficult. This increased struggling could be due to the higher concentration of a test article that may have had bad taste and/or was more irritant to the respiratory tract at higher concentrations. The consulting pathologist is in agreement with the interpretation of the study authors that there was no evidence of any adverse test article-related effect on mortality and/or respiratory tract pathology: The No-Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day based on the absence of any adverse test article-related findings. The 5 unscheduled deaths that occurred during the course of the study were not test article related and were either related to gavage error or an undetermined cause. The various degenerative changes noted in the nasal cavity (levels III and IV) were considered secondary to the local deposition of the test article during the dosing procedure and are not relevant to any risk assessment for human use of the test article. Ref; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"16517-75-2","citation":"","dose":"ared to 40 mg/kg bw/day could be related to increased struggling by the dosed animals that made dosing more difficult.","duration":"","effect":"ared to 40 mg/kg bw/day could be related to increased struggling by the dosed animals that made dosing more difficult. This increased struggling could be due to the higher concentration of a test article that may have had bad taste and/or was more irritant to the respiratory tract at higher concentrations. The consulting pathologist is in agreement with the interpretation of the study authors that there was no evidence of any adverse test article-related effect on mortality and/or respiratory tract pathology: The No-Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day based on the absence of any adverse test article-related findings. The 5 unscheduled deaths that occurred during the course of the study were not test article related and were either related to gavage error or an undetermined cause. The various degenerative changes noted in the nasal cavity (levels III and IV) were considered secondary to the local deposition of the test article during the dosing procedure and are not relevant to any risk assessment for human use of the test article. Ref","endpoint":"irritation","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":17,"route":"oral","species":"human","study_id":"sccs_o_128_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 1000 mg/kg/day human oral - irritation SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=1000; DOSE=The No-Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day based on the absence of any adverse test article-related findings.; EFFECT=elated to increased struggling by the dosed animals that made dosing more difficult. This increased struggling could be due to the higher concentration of a test article that may have had bad taste and/or was more irritant to the respiratory tract at higher concentrations. The consulting pathologist is in agreement with the interpretation of the study authors that there was no evidence of any adverse test article-related effect on mortality and/or respiratory tract pathology: The No-Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day based on the absence of any adverse test article-related findings. The 5 unscheduled deaths that occurred during the course of the study were not test article related and were either related to gavage error or an undetermined cause. The various degenerative changes noted in the nasal cavity (levels III and IV) were considered secondary to the local deposition of the test article during the dosing procedure and are not relevant to any risk assessment for human use of the test article. Ref.: 22,; CITATION=Ref.: 22,; CITATION_NUMBERS=[22]; REFERENCE=Ref.: 22,; DETAILS_JSON={"cas_number":"16517-75-2","citation":"Ref.: 22,","dose":"The No-Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day based on the absence of any adverse test article-related findings.","duration":"","effect":"elated to increased struggling by the dosed animals that made dosing more difficult. This increased struggling could be due to the higher concentration of a test article that may have had bad taste and/or was more irritant to the respiratory tract at higher concentrations. The consulting pathologist is in agreement with the interpretation of the study authors that there was no evidence of any adverse test article-related effect on mortality and/or respiratory tract pathology: The No-Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day based on the absence of any adverse test article-related findings. The 5 unscheduled deaths that occurred during the course of the study were not test article related and were either related to gavage error or an undetermined cause. The various degenerative changes noted in the nasal cavity (levels III and IV) were considered secondary to the local deposition of the test article during the dosing procedure and are not relevant to any risk assessment for human use of the test article. Ref.: 22,","endpoint":"irritation","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":17,"route":"oral","species":"human","study_id":"sccs_o_128_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =0.04 mg/kg bw/d rat oral developmental repeated dose toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT== 0.04; DOSE=onic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.; EFFECT=onic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat) (Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2500 * 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 HC Blue 17 is used as a hair colouring agent up to 2% on-head concentration of in non- oxidative as well as in oxidative hair dye formulations. Characterisation of HC Blue 17; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"16517-75-2","citation":"","dose":"onic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","duration":"developmental","effect":"onic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat) (Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2500 * 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 HC Blue 17 is used as a hair colouring agent up to 2% on-head concentration of in non- oxidative as well as in oxidative hair dye formulations. Characterisation of HC Blue 17","endpoint":"repeated dose toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.04","page":26,"route":"oral","species":"rat","study_id":"sccs_o_128_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =0.05 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT== 0.05; DOSE=SCCS/1471/12 Opinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal ab...; EFFECT=SCCS/1471/12 Opinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.74 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"16517-75-2","citation":"","dose":"SCCS/1471/12 Opinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal ab...","duration":"subchronic","effect":"SCCS/1471/12 Opinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.74 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x","endpoint":"repeated dose toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.05","page":26,"route":"oral","species":"rat","study_id":"sccs_o_128_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 40 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=40; DOSE=In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d.; EFFECT=SCCS-rejected applicant NOAEL: Dermal absorption The dermal absorption figure to be taken into consideration for the calculation of the margin of safety is the Mean + SD or 1.76 + 2.96 = 4,72 μg /cm2 for non-oxidative conditions and (2.18 + 2.05 = 4.23 µg/cm²) for oxidative condition, respectively. General toxicity No data on acute toxicity were submitted. In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. The SCCS sets the NOAEL of maternal toxicity at 200 mg/kg bw/d, the NOAEL of developmental toxicity including teratogenicity is 1000 mg/kg bw/d. No study on reproductive toxicity was provided. Mutagenicity Overall, the genotoxicity of HC Blue 17 is sufficiently investigated in valid g; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"16517-75-2","citation":"","dose":"In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d.","duration":"subchronic","effect":"SCCS-rejected applicant NOAEL: Dermal absorption The dermal absorption figure to be taken into consideration for the calculation of the margin of safety is the Mean + SD or 1.76 + 2.96 = 4,72 μg /cm2 for non-oxidative conditions and (2.18 + 2.05 = 4.23 µg/cm²) for oxidative condition, respectively. General toxicity No data on acute toxicity were submitted. In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. The SCCS sets the NOAEL of maternal toxicity at 200 mg/kg bw/d, the NOAEL of developmental toxicity including teratogenicity is 1000 mg/kg bw/d. No study on reproductive toxicity was provided. Mutagenicity Overall, the genotoxicity of HC Blue 17 is sufficiently investigated in valid g","endpoint":"repeated dose toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"40","page":27,"route":"oral","species":"rat","study_id":"sccs_o_128_noael_017"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =200 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT== 200; DOSE=pinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per t...; EFFECT=pinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.74 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"16517-75-2","citation":"","dose":"pinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per t...","duration":"subchronic","effect":"pinion on HC Blue 17 ___________________________________________________________________________________________ 26 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Blue 17 Non oxidative conditions Absorption through the skin A = 4.72 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.74 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.","endpoint":"repeated dose toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 200","page":26,"route":"oral","species":"rat","study_id":"sccs_o_128_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity =200 mg/kg bw/d rat oral developmental repeated dose toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT== 200; DOSE=ternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.; EFFECT=ternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat) (Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2500 * 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 HC Blue 17 is used as a hair colouring agent up to 2% on-head concentration of in non- oxidative as well as in oxidative hair dye formulations. Characterisation of HC Blue 17 in tw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"16517-75-2","citation":"","dose":"ternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation.","duration":"developmental","effect":"ternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. Oxidative conditions Absorption through the skin A = 4.23 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.45 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 200 mg/kg bw/d (subchronic toxicity study, oral, rat) (Maternal toxicity in developmental toxicity study) 50% bioavailable * = 100 mg/kg bw/d MOS = 2500 * 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 HC Blue 17 is used as a hair colouring agent up to 2% on-head concentration of in non- oxidative as well as in oxidative hair dye formulations. Characterisation of HC Blue 17 in tw","endpoint":"repeated dose toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 200","page":26,"route":"oral","species":"rat","study_id":"sccs_o_128_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 200 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=200; DOSE=In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d.; EFFECT=SCCS-rejected applicant NOAEL: n, respectively. General toxicity No data on acute toxicity were submitted. In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. The SCCS sets the NOAEL of maternal toxicity at 200 mg/kg bw/d, the NOAEL of developmental toxicity including teratogenicity is 1000 mg/kg bw/d. No study on reproductive toxicity was provided. Mutagenicity Overall, the genotoxicity of HC Blue 17 is sufficiently investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. HC Blue 17 did not induce gene mutations in a gene mutation test in bacteria nor in a gene mutation tests using the hprt-locus of mammalian cells.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"16517-75-2","citation":"","dose":"In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d.","duration":"subchronic","effect":"SCCS-rejected applicant NOAEL: n, respectively. General toxicity No data on acute toxicity were submitted. In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. The SCCS sets the NOAEL of maternal toxicity at 200 mg/kg bw/d, the NOAEL of developmental toxicity including teratogenicity is 1000 mg/kg bw/d. No study on reproductive toxicity was provided. Mutagenicity Overall, the genotoxicity of HC Blue 17 is sufficiently investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. HC Blue 17 did not induce gene mutations in a gene mutation test in bacteria nor in a gene mutation tests using the hprt-locus of mammalian cells.","endpoint":"repeated dose toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":27,"route":"oral","species":"rat","study_id":"sccs_o_128_noael_019"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 200 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=200; DOSE=In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d.; EFFECT=SCCS-rejected applicant NOAEL: te toxicity were submitted. In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. The SCCS sets the NOAEL of maternal toxicity at 200 mg/kg bw/d, the NOAEL of developmental toxicity including teratogenicity is 1000 mg/kg bw/d. No study on reproductive toxicity was provided. Mutagenicity Overall, the genotoxicity of HC Blue 17 is sufficiently investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. HC Blue 17 did not induce gene mutations in a gene mutation test in bacteria nor in a gene mutation tests using the hprt-locus of mammalian cells. An in vitro gene mutation test using the tk-locus; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"16517-75-2","citation":"","dose":"In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d.","duration":"subchronic","effect":"SCCS-rejected applicant NOAEL: te toxicity were submitted. In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. The SCCS sets the NOAEL of maternal toxicity at 200 mg/kg bw/d, the NOAEL of developmental toxicity including teratogenicity is 1000 mg/kg bw/d. No study on reproductive toxicity was provided. Mutagenicity Overall, the genotoxicity of HC Blue 17 is sufficiently investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. HC Blue 17 did not induce gene mutations in a gene mutation test in bacteria nor in a gene mutation tests using the hprt-locus of mammalian cells. An in vitro gene mutation test using the tk-locus","endpoint":"repeated dose toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":27,"route":"oral","species":"rat","study_id":"sccs_o_128_noael_020"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_128; REPORT_TITLE=OPINION ON HC Blue 17 COLIPA n° C184; OPINION_NUMBER=SCCS/1471/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=26 February 2013; VALUE_TEXT=1000; DOSE=In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d.; EFFECT=SCCS-rejected applicant NOAEL: conditions and (2.18 + 2.05 = 4.23 µg/cm²) for oxidative condition, respectively. General toxicity No data on acute toxicity were submitted. In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. The SCCS sets the NOAEL of maternal toxicity at 200 mg/kg bw/d, the NOAEL of developmental toxicity including teratogenicity is 1000 mg/kg bw/d. No study on reproductive toxicity was provided. Mutagenicity Overall, the genotoxicity of HC Blue 17 is sufficiently investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. HC Blue 17 did not induce gene mutations in a gene mutation test in bacteria nor; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"16517-75-2","citation":"","dose":"In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d.","duration":"subchronic","effect":"SCCS-rejected applicant NOAEL: conditions and (2.18 + 2.05 = 4.23 µg/cm²) for oxidative condition, respectively. General toxicity No data on acute toxicity were submitted. In the oral subchronic toxicity study in rats in the nasal cavity local irritant effects were observed which were concentration-related and also seen at the lowest dose 40 mg/kg bw/d. No NOEL was derived in this study. However, for the foreseen use as hair dye ingredient these effects are not considered relevant. Due to the intestinal lesions observed at 1000 mg/kg bw/d the NOAEL of systemic toxicity is 200 mg/kg bw/d. The SCCS sets the NOAEL of maternal toxicity at 200 mg/kg bw/d, the NOAEL of developmental toxicity including teratogenicity is 1000 mg/kg bw/d. No study on reproductive toxicity was provided. Mutagenicity Overall, the genotoxicity of HC Blue 17 is sufficiently investigated in valid genotoxicity tests for the 3 endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. HC Blue 17 did not induce gene mutations in a gene mutation test in bacteria nor","endpoint":"repeated dose toxicity","ingredient":"HC Blue 17 (INCI-name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":27,"route":"oral","species":"rat","study_id":"sccs_o_128_noael_018"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 8432OLU48W UNII - - - chemical {"approval_status":null,"molecular_formula":"C21H26N3O2.CH3O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8432OLU48W"}
openFDA substances FDA UNII substance identifier 8432OLU48W UNII - - - chemical {"approval_status":null,"molecular_formula":"C21H26N3O2.CH3O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8432OLU48W"}
openFDA substances FDA UNII substance identifier 8432OLU48W UNII - - - chemical {"approval_status":null,"molecular_formula":"C21H26N3O2.CH3O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8432OLU48W"}
openFDA substances FDA UNII substance identifier 8432OLU48W UNII - - - chemical {"approval_status":null,"molecular_formula":"C21H26N3O2.CH3O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8432OLU48W"}