NOAEL Studies Cosmetic Ingredient

HC Yellow No. 17 NOAEL Studies

INCI: HC YELLOW NO. 17

CAS: Not confirmed from retrieved sources — verify via CosIng

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 16 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat - - NOAEL study {"dose":"Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum.","effect":"minal fasting body and organ weights, gross and microscopic examination compared to the vehicle control group. Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum. Histopathological examination showed no relevant treatment-related lesions in males and females of the 1000 mg/kg bw/d group compared to the vehicle control group. Conclusion Under the conditions of this study, the “No Observed Adverse Effect Level (NOAEL)” of E212289 in Wistar rats is defined at 1000 mg/kg bw/d. Ref. 6","page":17,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_001"}
SCCS_vision_codex NOAEL =0.00045 mg/kg bw/d rat oral developmental developmental toxicity {"dose":"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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Der...","effect":"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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","page":23,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_003"}
SCCS_vision_codex NOAEL =300 mg/kg bw/d rat oral developmental developmental toxicity {"dose":"/ 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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS...","effect":"/ 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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","page":23,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_004"}
SCCS_vision_codex NOAEL =30 mg/kg bw/d rat oral developmental developmental toxicity {"dose":"investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg b...","effect":"investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","page":23,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat - - NOAEL study {"dose":"Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum.","effect":"minal fasting body and organ weights, gross and microscopic examination compared to the vehicle control group. Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum. Histopathological examination showed no relevant treatment-related lesions in males and females of the 1000 mg/kg bw/d group compared to the vehicle control group. Conclusion Under the conditions of this study, the “No Observed Adverse Effect Level (NOAEL)” of E212289 in Wistar rats is defined at 1000 mg/kg bw/d. Ref. 6","page":17,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_001"}
SCCS_vision_codex NOAEL =0.00045 mg/kg bw/d rat oral developmental developmental toxicity {"dose":"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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Der...","effect":"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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","page":23,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_003"}
SCCS_vision_codex NOAEL =300 mg/kg bw/d rat oral developmental developmental toxicity {"dose":"/ 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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS...","effect":"/ 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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","page":23,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_004"}
SCCS_vision_codex NOAEL =30 mg/kg bw/d rat oral developmental developmental toxicity {"dose":"investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg b...","effect":"investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","page":23,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat - - NOAEL study {"dose":"Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum.","effect":"minal fasting body and organ weights, gross and microscopic examination compared to the vehicle control group. Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum. Histopathological examination showed no relevant treatment-related lesions in males and females of the 1000 mg/kg bw/d group compared to the vehicle control group. Conclusion Under the conditions of this study, the “No Observed Adverse Effect Level (NOAEL)” of E212289 in Wistar rats is defined at 1000 mg/kg bw/d. Ref. 6","page":17,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_001"}
SCCS_vision_codex NOAEL =0.00045 mg/kg bw/d rat oral developmental developmental toxicity {"dose":"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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Der...","effect":"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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","page":23,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_003"}
SCCS_vision_codex NOAEL =300 mg/kg bw/d rat oral developmental developmental toxicity {"dose":"/ 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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS...","effect":"/ 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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","page":23,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_004"}
SCCS_vision_codex NOAEL =30 mg/kg bw/d rat oral developmental developmental toxicity {"dose":"investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg b...","effect":"investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","page":23,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_005"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat - - NOAEL study {"dose":"Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum.","effect":"minal fasting body and organ weights, gross and microscopic examination compared to the vehicle control group. Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum. Histopathological examination showed no relevant treatment-related lesions in males and females of the 1000 mg/kg bw/d group compared to the vehicle control group. Conclusion Under the conditions of this study, the “No Observed Adverse Effect Level (NOAEL)” of E212289 in Wistar rats is defined at 1000 mg/kg bw/d. Ref. 6","page":17,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_001"}
SCCS_vision_codex NOAEL =0.00045 mg/kg bw/d rat oral developmental developmental toxicity {"dose":"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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Der...","effect":"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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","page":23,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_003"}
SCCS_vision_codex NOAEL =300 mg/kg bw/d rat oral developmental developmental toxicity {"dose":"/ 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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS...","effect":"/ 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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","page":23,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_004"}
SCCS_vision_codex NOAEL =30 mg/kg bw/d rat oral developmental developmental toxicity {"dose":"investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg b...","effect":"investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","page":23,"pdf":"sccs_o_186.pdf","row_type":"noael_study","study_id":"sccs_o_186_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw/d rat - - - SOURCE_SUBDIR=sccs_o_186; REPORT_TITLE=OPINION ON HC Yellow No. 17 (B121); OPINION_NUMBER=SCCS/1559/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1000; DOSE=Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum.; EFFECT=minal fasting body and organ weights, gross and microscopic examination compared to the vehicle control group. Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum. Histopathological examination showed no relevant treatment-related lesions in males and females of the 1000 mg/kg bw/d group compared to the vehicle control group. Conclusion Under the conditions of this study, the “No Observed Adverse Effect Level (NOAEL)” of E212289 in Wistar rats is defined at 1000 mg/kg bw/d. Ref. 6; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1450801-55-4","citation":"","dose":"Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum.","duration":"","effect":"minal fasting body and organ weights, gross and microscopic examination compared to the vehicle control group. Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum. Histopathological examination showed no relevant treatment-related lesions in males and females of the 1000 mg/kg bw/d group compared to the vehicle control group. Conclusion Under the conditions of this study, the “No Observed Adverse Effect Level (NOAEL)” of E212289 in Wistar rats is defined at 1000 mg/kg bw/d. Ref. 6","endpoint":"","ingredient":"HC Yellow No. 17","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":17,"route":"","species":"rat","study_id":"sccs_o_186_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw/d rat - - - SOURCE_SUBDIR=sccs_o_186; REPORT_TITLE=OPINION ON HC Yellow No. 17 (B121); OPINION_NUMBER=SCCS/1559/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1000; DOSE=Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum.; EFFECT=ts, gross and microscopic examination compared to the vehicle control group. Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum. Histopathological examination showed no relevant treatment-related lesions in males and females of the 1000 mg/kg bw/d group compared to the vehicle control group. Conclusion Under the conditions of this study, the “No Observed Adverse Effect Level (NOAEL)” of E212289 in Wistar rats is defined at 1000 mg/kg bw/d. Ref. 6; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1450801-55-4","citation":"","dose":"Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum.","duration":"","effect":"ts, gross and microscopic examination compared to the vehicle control group. Gross pathological examination showed reddish brown contents in the caecum of all rats at 1000 mg/kg bw/d, which was considered to be due to the colour of the test item present in the caecum. Histopathological examination showed no relevant treatment-related lesions in males and females of the 1000 mg/kg bw/d group compared to the vehicle control group. Conclusion Under the conditions of this study, the “No Observed Adverse Effect Level (NOAEL)” of E212289 in Wistar rats is defined at 1000 mg/kg bw/d. Ref. 6","endpoint":"","ingredient":"HC Yellow No. 17","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":17,"route":"","species":"rat","study_id":"sccs_o_186_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =0.00045 mg/kg bw/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_186; REPORT_TITLE=OPINION ON HC Yellow No. 17 (B121); OPINION_NUMBER=SCCS/1559/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT== 0.00045; DOSE=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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Der...; EFFECT=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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1450801-55-4","citation":"","dose":"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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Der...","duration":"developmental","effect":"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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","endpoint":"developmental toxicity","ingredient":"HC Yellow No. 17","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.00045","page":23,"route":"oral","species":"rat","study_id":"sccs_o_186_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =300 mg/kg bw/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_186; REPORT_TITLE=OPINION ON HC Yellow No. 17 (B121); OPINION_NUMBER=SCCS/1559/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT== 300; DOSE=/ 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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS...; EFFECT=/ 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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1450801-55-4","citation":"","dose":"/ 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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS...","duration":"developmental","effect":"/ 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 (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","endpoint":"developmental toxicity","ingredient":"HC Yellow No. 17","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 300","page":23,"route":"oral","species":"rat","study_id":"sccs_o_186_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =30 mg/kg bw/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_186; REPORT_TITLE=OPINION ON HC Yellow No. 17 (B121); OPINION_NUMBER=SCCS/1559/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT== 30; DOSE=investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg b...; EFFECT=investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1450801-55-4","citation":"","dose":"investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg b...","duration":"developmental","effect":"investigations 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Absorption through the skin A = 0.047 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.027 mg Typical bodyweight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/… = 0.00045 mg/kg bw/d No observed adverse effect level NOAEL = 300 mg/kg bw/d (developmental toxicity study, oral, rat) Bioavailability 10%* = 30 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 66000 * Because of the large molecular weight and the ionic character of the dye, 10% bioavailability is considered.","endpoint":"developmental toxicity","ingredient":"HC Yellow No. 17","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 30","page":23,"route":"oral","species":"rat","study_id":"sccs_o_186_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_186; REPORT_TITLE=OPINION ON HC Yellow No. 17 (B121); OPINION_NUMBER=SCCS/1559/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=1000; DOSE=However, no deaths were observed in the subchronic (13-week) oral toxicity study performed in rats as well as in the developmental toxicity study in rats at dose levels of 100, 300 and 1000 mg/kg/day (Ref.; EFFECT=f HC Yellow No. 17 was provided except that it was considered to be 85.7% pure. EC Methods were not used for the determination of water solubility and Log Pow. General toxicity No acute oral toxicity studies were submitted with HC Yellow No. 17. However, no deaths were observed in the subchronic (13-week) oral toxicity study performed in rats as well as in the developmental toxicity study in rats at dose levels of 100, 300 and 1000 mg/kg/day (Ref. 6 and Ref. 10). In an oral subchronic toxicity study in rats the NOAEL of HC Yellow No. 17 is derived at 1000 mg/kg bw/d. In an oral developmental toxicity study in rats the NOAEL for maternal toxicity and foetal toxicity are 300 mg/kg bw/d and 1000 mg/kg bw/d, respectively. No study on reproductive toxicity was provided. Irritation/sensitisation Under the conditions of human Episkin test for skin irritation, it can be concluded that undiluted HC Yellow 17 is non-irritant after dermal application. On the basis of the results obtained in the BCOP study, it can be concluded that HC; CITATION=(Ref. 6 and Ref. 10); CITATION_NUMBERS=[6,10]; REFERENCE=(Ref. 6 and Ref. 10); DETAILS_JSON={"cas_number":"1450801-55-4","citation":"(Ref. 6 and Ref. 10)","dose":"However, no deaths were observed in the subchronic (13-week) oral toxicity study performed in rats as well as in the developmental toxicity study in rats at dose levels of 100, 300 and 1000 mg/kg/day (Ref.","duration":"subchronic","effect":"f HC Yellow No. 17 was provided except that it was considered to be 85.7% pure. EC Methods were not used for the determination of water solubility and Log Pow. General toxicity No acute oral toxicity studies were submitted with HC Yellow No. 17. However, no deaths were observed in the subchronic (13-week) oral toxicity study performed in rats as well as in the developmental toxicity study in rats at dose levels of 100, 300 and 1000 mg/kg/day (Ref. 6 and Ref. 10). In an oral subchronic toxicity study in rats the NOAEL of HC Yellow No. 17 is derived at 1000 mg/kg bw/d. In an oral developmental toxicity study in rats the NOAEL for maternal toxicity and foetal toxicity are 300 mg/kg bw/d and 1000 mg/kg bw/d, respectively. No study on reproductive toxicity was provided. Irritation/sensitisation Under the conditions of human Episkin test for skin irritation, it can be concluded that undiluted HC Yellow 17 is non-irritant after dermal application. On the basis of the results obtained in the BCOP study, it can be concluded that HC","endpoint":"repeated dose toxicity","ingredient":"HC Yellow No. 17","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":24,"route":"oral","species":"rat","study_id":"sccs_o_186_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 300 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_186; REPORT_TITLE=OPINION ON HC Yellow No. 17 (B121); OPINION_NUMBER=SCCS/1559/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=15 December 2015; VALUE_TEXT=300; DOSE=However, no deaths were observed in the subchronic (13-week) oral toxicity study performed in rats as well as in the developmental toxicity study in rats at dose levels of 100, 300 and 1000 mg/kg/day (Ref.; EFFECT=he determination of water solubility and Log Pow. General toxicity No acute oral toxicity studies were submitted with HC Yellow No. 17. However, no deaths were observed in the subchronic (13-week) oral toxicity study performed in rats as well as in the developmental toxicity study in rats at dose levels of 100, 300 and 1000 mg/kg/day (Ref. 6 and Ref. 10). In an oral subchronic toxicity study in rats the NOAEL of HC Yellow No. 17 is derived at 1000 mg/kg bw/d. In an oral developmental toxicity study in rats the NOAEL for maternal toxicity and foetal toxicity are 300 mg/kg bw/d and 1000 mg/kg bw/d, respectively. No study on reproductive toxicity was provided. Irritation/sensitisation Under the conditions of human Episkin test for skin irritation, it can be concluded that undiluted HC Yellow 17 is non-irritant after dermal application. On the basis of the results obtained in the BCOP study, it can be concluded that HC Yellow No. 17 at 20% (w/w) in physiological saline is not a strong eye irritant. This does, however, not exclu; CITATION=(Ref. 6 and Ref. 10); CITATION_NUMBERS=[6,10]; REFERENCE=(Ref. 6 and Ref. 10); DETAILS_JSON={"cas_number":"1450801-55-4","citation":"(Ref. 6 and Ref. 10)","dose":"However, no deaths were observed in the subchronic (13-week) oral toxicity study performed in rats as well as in the developmental toxicity study in rats at dose levels of 100, 300 and 1000 mg/kg/day (Ref.","duration":"subchronic","effect":"he determination of water solubility and Log Pow. General toxicity No acute oral toxicity studies were submitted with HC Yellow No. 17. However, no deaths were observed in the subchronic (13-week) oral toxicity study performed in rats as well as in the developmental toxicity study in rats at dose levels of 100, 300 and 1000 mg/kg/day (Ref. 6 and Ref. 10). In an oral subchronic toxicity study in rats the NOAEL of HC Yellow No. 17 is derived at 1000 mg/kg bw/d. In an oral developmental toxicity study in rats the NOAEL for maternal toxicity and foetal toxicity are 300 mg/kg bw/d and 1000 mg/kg bw/d, respectively. No study on reproductive toxicity was provided. Irritation/sensitisation Under the conditions of human Episkin test for skin irritation, it can be concluded that undiluted HC Yellow 17 is non-irritant after dermal application. On the basis of the results obtained in the BCOP study, it can be concluded that HC Yellow No. 17 at 20% (w/w) in physiological saline is not a strong eye irritant. This does, however, not exclu","endpoint":"repeated dose toxicity","ingredient":"HC Yellow No. 17","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":24,"route":"oral","species":"rat","study_id":"sccs_o_186_noael_007"}