NOAEL Studies Cosmetic Ingredient

HC Red No. 17 NOAEL Studies

INCI: HC RED NO. 17

CAS: Not confirmed in search results (Colipa/Cosmetics Europe designation: B120)

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

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SCCS_vision_codex 20 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =1000 mg/kg bw rat oral 13 weeks NOAEL study {"dose":"no consistent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females.","effect":"no consistent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females. When compared to controls, significant lower food consumption associated with a decrease in mean bodyweights and bodyweight gains were observed at the dose of 1000 mg/kg/day in males. Conclusion The daily oral administration for 13 weeks of HC Red No. 17 to rats at dose levels of 100, 300 or 1000 mg/kg bw was well tolerated. Thus, under the conditions of the study, the NOAEL (No Observed Adverse Effect Level) of this 90-day oral toxicity study on HC Red No. 17 was 300 mg/kg bw/day in Wistar rats. Ref. 6","page":19,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_001"}
SCCS_vision_codex NOAEL =300 mg/kg/day human - developmental developmental toxicity {"dose":"urred only at the highest dose level of 1000 mg/kg/day such as lower mean body weight, body weight gain, corrected bodyweight gain and food intake when compared to controls.","effect":"urred only at the highest dose level of 1000 mg/kg/day such as lower mean body weight, body weight gain, corrected bodyweight gain and food intake when compared to controls. No changes in maternal and litter parameters were noted in any group. There were no foetal external, visceral and skeletal findings attributed to the administration of the test item. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal bodyweight, the No Observed Adverse Effect Levels (NOAEL) for maternal and developmental toxicity of HC Red No. 17 were respectively set at 300 mg/kg/day and 1000 mg/kg/day. HC Red No. 17 was considered to have no teratogenic potential. Ref. 10 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (in","page":24,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_003"}
SCCS_vision_codex NOAEL =0.0004 mg/kg bw rat oral 90-day dermal absorption {"dose":"agenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 58...","effect":"agenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.024 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00040 mg/kg bw No observed adverse effect level NOAEL = 300 mg/kg bw/d (90-day, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d","page":24,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_004"}
SCCS_vision_codex NOAEL =300 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per trea...","effect":"3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.024 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00040 mg/kg bw No observed adverse effect level NOAEL = 300 mg/kg bw/d (90-day, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d","page":24,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_005"}
SCCS_vision_codex NOAEL =10 % - - - NOAEL study {"effect":"SCCS/1558/15 Revision of the opinion on HC Red No. 17 (B120) ___________________________________________________________________________________________ 25 Margin of Safety adjusted NOAEL/SED = 75.000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered. 3.3.14 Discussion Physico-chemical properties HC Red No. 17 or Vibracolor Garnet Red is a dark red powder. The product is very slightly soluble in water and practically insoluble in corn oil and ethanol. HC Red No17 is intended to be used as a non-oxidative hair colouring product at concentrations up to 0.5% HC Red 17 is a tertiary amine and thus it is prone to nitrosation. It should not","page":25,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_006"}
SCCS_vision_codex NOAEL =1000 mg/kg bw rat oral 13 weeks NOAEL study {"dose":"no consistent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females.","effect":"no consistent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females. When compared to controls, significant lower food consumption associated with a decrease in mean bodyweights and bodyweight gains were observed at the dose of 1000 mg/kg/day in males. Conclusion The daily oral administration for 13 weeks of HC Red No. 17 to rats at dose levels of 100, 300 or 1000 mg/kg bw was well tolerated. Thus, under the conditions of the study, the NOAEL (No Observed Adverse Effect Level) of this 90-day oral toxicity study on HC Red No. 17 was 300 mg/kg bw/day in Wistar rats. Ref. 6","page":19,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_001"}
SCCS_vision_codex NOAEL =300 mg/kg/day human - developmental developmental toxicity {"dose":"urred only at the highest dose level of 1000 mg/kg/day such as lower mean body weight, body weight gain, corrected bodyweight gain and food intake when compared to controls.","effect":"urred only at the highest dose level of 1000 mg/kg/day such as lower mean body weight, body weight gain, corrected bodyweight gain and food intake when compared to controls. No changes in maternal and litter parameters were noted in any group. There were no foetal external, visceral and skeletal findings attributed to the administration of the test item. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal bodyweight, the No Observed Adverse Effect Levels (NOAEL) for maternal and developmental toxicity of HC Red No. 17 were respectively set at 300 mg/kg/day and 1000 mg/kg/day. HC Red No. 17 was considered to have no teratogenic potential. Ref. 10 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (in","page":24,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_003"}
SCCS_vision_codex NOAEL =0.0004 mg/kg bw rat oral 90-day dermal absorption {"dose":"agenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 58...","effect":"agenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.024 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00040 mg/kg bw No observed adverse effect level NOAEL = 300 mg/kg bw/d (90-day, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d","page":24,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_004"}
SCCS_vision_codex NOAEL =300 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per trea...","effect":"3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.024 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00040 mg/kg bw No observed adverse effect level NOAEL = 300 mg/kg bw/d (90-day, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d","page":24,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_005"}
SCCS_vision_codex NOAEL =10 % - - - NOAEL study {"effect":"SCCS/1558/15 Revision of the opinion on HC Red No. 17 (B120) ___________________________________________________________________________________________ 25 Margin of Safety adjusted NOAEL/SED = 75.000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered. 3.3.14 Discussion Physico-chemical properties HC Red No. 17 or Vibracolor Garnet Red is a dark red powder. The product is very slightly soluble in water and practically insoluble in corn oil and ethanol. HC Red No17 is intended to be used as a non-oxidative hair colouring product at concentrations up to 0.5% HC Red 17 is a tertiary amine and thus it is prone to nitrosation. It should not","page":25,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_006"}
SCCS_vision_codex NOAEL =1000 mg/kg bw rat oral 13 weeks NOAEL study {"dose":"no consistent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females.","effect":"no consistent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females. When compared to controls, significant lower food consumption associated with a decrease in mean bodyweights and bodyweight gains were observed at the dose of 1000 mg/kg/day in males. Conclusion The daily oral administration for 13 weeks of HC Red No. 17 to rats at dose levels of 100, 300 or 1000 mg/kg bw was well tolerated. Thus, under the conditions of the study, the NOAEL (No Observed Adverse Effect Level) of this 90-day oral toxicity study on HC Red No. 17 was 300 mg/kg bw/day in Wistar rats. Ref. 6","page":19,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_001"}
SCCS_vision_codex NOAEL =300 mg/kg/day human - developmental developmental toxicity {"dose":"urred only at the highest dose level of 1000 mg/kg/day such as lower mean body weight, body weight gain, corrected bodyweight gain and food intake when compared to controls.","effect":"urred only at the highest dose level of 1000 mg/kg/day such as lower mean body weight, body weight gain, corrected bodyweight gain and food intake when compared to controls. No changes in maternal and litter parameters were noted in any group. There were no foetal external, visceral and skeletal findings attributed to the administration of the test item. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal bodyweight, the No Observed Adverse Effect Levels (NOAEL) for maternal and developmental toxicity of HC Red No. 17 were respectively set at 300 mg/kg/day and 1000 mg/kg/day. HC Red No. 17 was considered to have no teratogenic potential. Ref. 10 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (in","page":24,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_003"}
SCCS_vision_codex NOAEL =0.0004 mg/kg bw rat oral 90-day dermal absorption {"dose":"agenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 58...","effect":"agenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.024 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00040 mg/kg bw No observed adverse effect level NOAEL = 300 mg/kg bw/d (90-day, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d","page":24,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_004"}
SCCS_vision_codex NOAEL =300 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per trea...","effect":"3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.024 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00040 mg/kg bw No observed adverse effect level NOAEL = 300 mg/kg bw/d (90-day, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d","page":24,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_005"}
SCCS_vision_codex NOAEL =10 % - - - NOAEL study {"effect":"SCCS/1558/15 Revision of the opinion on HC Red No. 17 (B120) ___________________________________________________________________________________________ 25 Margin of Safety adjusted NOAEL/SED = 75.000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered. 3.3.14 Discussion Physico-chemical properties HC Red No. 17 or Vibracolor Garnet Red is a dark red powder. The product is very slightly soluble in water and practically insoluble in corn oil and ethanol. HC Red No17 is intended to be used as a non-oxidative hair colouring product at concentrations up to 0.5% HC Red 17 is a tertiary amine and thus it is prone to nitrosation. It should not","page":25,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_006"}
SCCS_vision_codex NOAEL =1000 mg/kg bw rat oral 13 weeks NOAEL study {"dose":"no consistent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females.","effect":"no consistent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females. When compared to controls, significant lower food consumption associated with a decrease in mean bodyweights and bodyweight gains were observed at the dose of 1000 mg/kg/day in males. Conclusion The daily oral administration for 13 weeks of HC Red No. 17 to rats at dose levels of 100, 300 or 1000 mg/kg bw was well tolerated. Thus, under the conditions of the study, the NOAEL (No Observed Adverse Effect Level) of this 90-day oral toxicity study on HC Red No. 17 was 300 mg/kg bw/day in Wistar rats. Ref. 6","page":19,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_001"}
SCCS_vision_codex NOAEL =300 mg/kg/day human - developmental developmental toxicity {"dose":"urred only at the highest dose level of 1000 mg/kg/day such as lower mean body weight, body weight gain, corrected bodyweight gain and food intake when compared to controls.","effect":"urred only at the highest dose level of 1000 mg/kg/day such as lower mean body weight, body weight gain, corrected bodyweight gain and food intake when compared to controls. No changes in maternal and litter parameters were noted in any group. There were no foetal external, visceral and skeletal findings attributed to the administration of the test item. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal bodyweight, the No Observed Adverse Effect Levels (NOAEL) for maternal and developmental toxicity of HC Red No. 17 were respectively set at 300 mg/kg/day and 1000 mg/kg/day. HC Red No. 17 was considered to have no teratogenic potential. Ref. 10 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (in","page":24,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_003"}
SCCS_vision_codex NOAEL =0.0004 mg/kg bw rat oral 90-day dermal absorption {"dose":"agenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 58...","effect":"agenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.024 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00040 mg/kg bw No observed adverse effect level NOAEL = 300 mg/kg bw/d (90-day, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d","page":24,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_004"}
SCCS_vision_codex NOAEL =300 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per trea...","effect":"3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.024 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00040 mg/kg bw No observed adverse effect level NOAEL = 300 mg/kg bw/d (90-day, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d","page":24,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_005"}
SCCS_vision_codex NOAEL =10 % - - - NOAEL study {"effect":"SCCS/1558/15 Revision of the opinion on HC Red No. 17 (B120) ___________________________________________________________________________________________ 25 Margin of Safety adjusted NOAEL/SED = 75.000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered. 3.3.14 Discussion Physico-chemical properties HC Red No. 17 or Vibracolor Garnet Red is a dark red powder. The product is very slightly soluble in water and practically insoluble in corn oil and ethanol. HC Red No17 is intended to be used as a non-oxidative hair colouring product at concentrations up to 0.5% HC Red 17 is a tertiary amine and thus it is prone to nitrosation. It should not","page":25,"pdf":"sccs_o_182.pdf","row_type":"noael_study","study_id":"sccs_o_182_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw rat oral 13 weeks - SOURCE_SUBDIR=sccs_o_182; REPORT_TITLE=OPINION ON HC Red No. 17 (B120); OPINION_NUMBER=SCCS/1558/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1000; DOSE=no consistent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females.; EFFECT=no consistent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females. When compared to controls, significant lower food consumption associated with a decrease in mean bodyweights and bodyweight gains were observed at the dose of 1000 mg/kg/day in males. Conclusion The daily oral administration for 13 weeks of HC Red No. 17 to rats at dose levels of 100, 300 or 1000 mg/kg bw was well tolerated. Thus, under the conditions of the study, the NOAEL (No Observed Adverse Effect Level) of this 90-day oral toxicity study on HC Red No. 17 was 300 mg/kg bw/day in Wistar rats. Ref. 6; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449471-67-3","citation":"","dose":"no consistent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females.","duration":"13 weeks","effect":"no consistent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females. When compared to controls, significant lower food consumption associated with a decrease in mean bodyweights and bodyweight gains were observed at the dose of 1000 mg/kg/day in males. Conclusion The daily oral administration for 13 weeks of HC Red No. 17 to rats at dose levels of 100, 300 or 1000 mg/kg bw was well tolerated. Thus, under the conditions of the study, the NOAEL (No Observed Adverse Effect Level) of this 90-day oral toxicity study on HC Red No. 17 was 300 mg/kg bw/day in Wistar rats. Ref. 6","endpoint":"","ingredient":"HC Red No. 17","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":19,"route":"oral","species":"rat","study_id":"sccs_o_182_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw rat oral 13 weeks - SOURCE_SUBDIR=sccs_o_182; REPORT_TITLE=OPINION ON HC Red No. 17 (B120); OPINION_NUMBER=SCCS/1558/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1000; DOSE=istent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females.; EFFECT=istent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females. When compared to controls, significant lower food consumption associated with a decrease in mean bodyweights and bodyweight gains were observed at the dose of 1000 mg/kg/day in males. Conclusion The daily oral administration for 13 weeks of HC Red No. 17 to rats at dose levels of 100, 300 or 1000 mg/kg bw was well tolerated. Thus, under the conditions of the study, the NOAEL (No Observed Adverse Effect Level) of this 90-day oral toxicity study on HC Red No. 17 was 300 mg/kg bw/day in Wistar rats. Ref. 6; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449471-67-3","citation":"","dose":"istent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females.","duration":"13 weeks","effect":"istent changes in body weights and food consumption at the dose levels of 100 and 300 mg/kg/day in males and at all dose levels in females. When compared to controls, significant lower food consumption associated with a decrease in mean bodyweights and bodyweight gains were observed at the dose of 1000 mg/kg/day in males. Conclusion The daily oral administration for 13 weeks of HC Red No. 17 to rats at dose levels of 100, 300 or 1000 mg/kg bw was well tolerated. Thus, under the conditions of the study, the NOAEL (No Observed Adverse Effect Level) of this 90-day oral toxicity study on HC Red No. 17 was 300 mg/kg bw/day in Wistar rats. Ref. 6","endpoint":"","ingredient":"HC Red No. 17","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":19,"route":"oral","species":"rat","study_id":"sccs_o_182_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 10 % - - - - SOURCE_SUBDIR=sccs_o_182; REPORT_TITLE=OPINION ON HC Red No. 17 (B120); OPINION_NUMBER=SCCS/1558/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=10; EFFECT=SCCS/1558/15 Revision of the opinion on HC Red No. 17 (B120) ___________________________________________________________________________________________ 25 Margin of Safety adjusted NOAEL/SED = 75.000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered. 3.3.14 Discussion Physico-chemical properties HC Red No. 17 or Vibracolor Garnet Red is a dark red powder. The product is very slightly soluble in water and practically insoluble in corn oil and ethanol. HC Red No17 is intended to be used as a non-oxidative hair colouring product at concentrations up to 0.5% HC Red 17 is a tertiary amine and thus it is prone to nitrosation. It should not; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449471-67-3","citation":"","dose":"","duration":"","effect":"SCCS/1558/15 Revision of the opinion on HC Red No. 17 (B120) ___________________________________________________________________________________________ 25 Margin of Safety adjusted NOAEL/SED = 75.000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered. 3.3.14 Discussion Physico-chemical properties HC Red No. 17 or Vibracolor Garnet Red is a dark red powder. The product is very slightly soluble in water and practically insoluble in corn oil and ethanol. HC Red No17 is intended to be used as a non-oxidative hair colouring product at concentrations up to 0.5% HC Red 17 is a tertiary amine and thus it is prone to nitrosation. It should not","endpoint":"","ingredient":"HC Red No. 17","loael_value":"","noael_unit":"%","noael_value":"10","page":25,"route":"","species":"","study_id":"sccs_o_182_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg/day rat oral - - SOURCE_SUBDIR=sccs_o_182; REPORT_TITLE=OPINION ON HC Red No. 17 (B120); OPINION_NUMBER=SCCS/1558/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1000; DOSE=17 (pinkish urine and reddish brown faeces) observed at 300 and 1000 mg/kg/day.; EFFECT=adverse effects, with only signs related to the staining properties of HC Red No. 17 (pinkish urine and reddish brown faeces) observed at 300 and 1000 mg/kg/day. Coloured urine was indicative of renal excretion of the test material, thus showing systemic exposure of the animals following oral administration of HC Red No. 17. When compared to controls, significantly lower food consumption associated with lower mean bodyweights and bodyweight gains were observed at 1000 mg/kg/day in male rats only. Accordingly, the No Observed Adverse Effect Level (NOAEL) for this study was considered to be 300 mg/kg/day. The potential effects of HC Red No. 17 on embryo-foetal development were evaluated in a study performed by the oral route (gavage) in which pregnant rats were given HC Red No. 17 during the sensitive period of organogenesis. In this study performed at 100, 300 or 1000 mg/kg/day, maternal toxicity was observed at the highest dose level and consisted of lower mean bodyweight, bodyweight gain, corrected bodyweight gain and food intake when compared to contro; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449471-67-3","citation":"","dose":"17 (pinkish urine and reddish brown faeces) observed at 300 and 1000 mg/kg/day.","duration":"","effect":"adverse effects, with only signs related to the staining properties of HC Red No. 17 (pinkish urine and reddish brown faeces) observed at 300 and 1000 mg/kg/day. Coloured urine was indicative of renal excretion of the test material, thus showing systemic exposure of the animals following oral administration of HC Red No. 17. When compared to controls, significantly lower food consumption associated with lower mean bodyweights and bodyweight gains were observed at 1000 mg/kg/day in male rats only. Accordingly, the No Observed Adverse Effect Level (NOAEL) for this study was considered to be 300 mg/kg/day. The potential effects of HC Red No. 17 on embryo-foetal development were evaluated in a study performed by the oral route (gavage) in which pregnant rats were given HC Red No. 17 during the sensitive period of organogenesis. In this study performed at 100, 300 or 1000 mg/kg/day, maternal toxicity was observed at the highest dose level and consisted of lower mean bodyweight, bodyweight gain, corrected bodyweight gain and food intake when compared to contro","endpoint":"","ingredient":"HC Red No. 17","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":25,"route":"oral","species":"rat","study_id":"sccs_o_182_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 300 mg/kg/day rat oral - - SOURCE_SUBDIR=sccs_o_182; REPORT_TITLE=OPINION ON HC Red No. 17 (B120); OPINION_NUMBER=SCCS/1558/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=300; DOSE=17 (pinkish urine and reddish brown faeces) observed at 300 and 1000 mg/kg/day.; EFFECT=related to the staining properties of HC Red No. 17 (pinkish urine and reddish brown faeces) observed at 300 and 1000 mg/kg/day. Coloured urine was indicative of renal excretion of the test material, thus showing systemic exposure of the animals following oral administration of HC Red No. 17. When compared to controls, significantly lower food consumption associated with lower mean bodyweights and bodyweight gains were observed at 1000 mg/kg/day in male rats only. Accordingly, the No Observed Adverse Effect Level (NOAEL) for this study was considered to be 300 mg/kg/day. The potential effects of HC Red No. 17 on embryo-foetal development were evaluated in a study performed by the oral route (gavage) in which pregnant rats were given HC Red No. 17 during the sensitive period of organogenesis. In this study performed at 100, 300 or 1000 mg/kg/day, maternal toxicity was observed at the highest dose level and consisted of lower mean bodyweight, bodyweight gain, corrected bodyweight gain and food intake when compared to controls. The; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449471-67-3","citation":"","dose":"17 (pinkish urine and reddish brown faeces) observed at 300 and 1000 mg/kg/day.","duration":"","effect":"related to the staining properties of HC Red No. 17 (pinkish urine and reddish brown faeces) observed at 300 and 1000 mg/kg/day. Coloured urine was indicative of renal excretion of the test material, thus showing systemic exposure of the animals following oral administration of HC Red No. 17. When compared to controls, significantly lower food consumption associated with lower mean bodyweights and bodyweight gains were observed at 1000 mg/kg/day in male rats only. Accordingly, the No Observed Adverse Effect Level (NOAEL) for this study was considered to be 300 mg/kg/day. The potential effects of HC Red No. 17 on embryo-foetal development were evaluated in a study performed by the oral route (gavage) in which pregnant rats were given HC Red No. 17 during the sensitive period of organogenesis. In this study performed at 100, 300 or 1000 mg/kg/day, maternal toxicity was observed at the highest dose level and consisted of lower mean bodyweight, bodyweight gain, corrected bodyweight gain and food intake when compared to controls. The","endpoint":"","ingredient":"HC Red No. 17","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":25,"route":"oral","species":"rat","study_id":"sccs_o_182_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.0004 mg/kg bw rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_182; REPORT_TITLE=OPINION ON HC Red No. 17 (B120); OPINION_NUMBER=SCCS/1558/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT== 0.00040; DOSE=agenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 58...; EFFECT=agenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.024 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00040 mg/kg bw No observed adverse effect level NOAEL = 300 mg/kg bw/d (90-day, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449471-67-3","citation":"","dose":"agenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 58...","duration":"90-day","effect":"agenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.024 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00040 mg/kg bw No observed adverse effect level NOAEL = 300 mg/kg bw/d (90-day, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d","endpoint":"dermal absorption","ingredient":"HC Red No. 17","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.00040","page":24,"route":"oral","species":"rat","study_id":"sccs_o_182_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =300 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_182; REPORT_TITLE=OPINION ON HC Red No. 17 (B120); OPINION_NUMBER=SCCS/1558/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT== 300; DOSE=3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per trea...; EFFECT=3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.024 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00040 mg/kg bw No observed adverse effect level NOAEL = 300 mg/kg bw/d (90-day, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449471-67-3","citation":"","dose":"3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per trea...","duration":"90-day","effect":"3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (20mg/cm2 applied to the skin for 20 minutes) (0.5 % formulation, on-head concentration 100 µg/cm2) Absorption through the skin A = 0.041 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.024 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00040 mg/kg bw No observed adverse effect level NOAEL = 300 mg/kg bw/d (90-day, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d","endpoint":"dermal absorption","ingredient":"HC Red No. 17","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 300","page":24,"route":"oral","species":"rat","study_id":"sccs_o_182_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 300 mg/kg/day human - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_182; REPORT_TITLE=OPINION ON HC Red No. 17 (B120); OPINION_NUMBER=SCCS/1558/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=300; DOSE=urred only at the highest dose level of 1000 mg/kg/day such as lower mean body weight, body weight gain, corrected bodyweight gain and food intake when compared to controls.; EFFECT=urred only at the highest dose level of 1000 mg/kg/day such as lower mean body weight, body weight gain, corrected bodyweight gain and food intake when compared to controls. No changes in maternal and litter parameters were noted in any group. There were no foetal external, visceral and skeletal findings attributed to the administration of the test item. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal bodyweight, the No Observed Adverse Effect Levels (NOAEL) for maternal and developmental toxicity of HC Red No. 17 were respectively set at 300 mg/kg/day and 1000 mg/kg/day. HC Red No. 17 was considered to have no teratogenic potential. Ref. 10 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1449471-67-3","citation":"","dose":"urred only at the highest dose level of 1000 mg/kg/day such as lower mean body weight, body weight gain, corrected bodyweight gain and food intake when compared to controls.","duration":"developmental","effect":"urred only at the highest dose level of 1000 mg/kg/day such as lower mean body weight, body weight gain, corrected bodyweight gain and food intake when compared to controls. No changes in maternal and litter parameters were noted in any group. There were no foetal external, visceral and skeletal findings attributed to the administration of the test item. Conclusion On the basis of the results obtained in the present study, and specifically the effects on maternal bodyweight, the No Observed Adverse Effect Levels (NOAEL) for maternal and developmental toxicity of HC Red No. 17 were respectively set at 300 mg/kg/day and 1000 mg/kg/day. HC Red No. 17 was considered to have no teratogenic potential. Ref. 10 3.3.9 Toxicokinetics 3.3.9.1 Toxicokinetics in laboratory animals 3.3.9.2 Toxicokinetics in humans 3.3.10 Photo-induced toxicity 3.3.10.1 Phototoxicity / photo-irritation and photosensitisation 3.3.10.2 Photomutagenicity / photoclastogenicity 3.3.11 Human data 3.3.12 Special investigations 3.3.13 Safety evaluation (in","endpoint":"developmental toxicity","ingredient":"HC Red No. 17","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":24,"route":"","species":"human","study_id":"sccs_o_182_noael_003"}