| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5000 |
ppm |
rat |
- |
2-year |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=5000; DOSE=SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 22 11%) but all females receiving 20000 ppm or more had uterine atrophy.; EFFECT=SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 22 11%) but all females receiving 20000 ppm or more had uterine atrophy. Thus, doses of 5000 and 10000 ppm were selected for the female rats in the 2-year study. The NOAEL was determined as 5000 ppm for male rats (equivalent to 250 mg/kg/d) and 10000 ppm for female rats (equivalent to 500 mg/kg/d). Mice: A combination of deaths and decreased mean body weights relative to controls precluded the selection of doses above 10000 ppm. Therefore, doses of 5000 and 10000 ppm were selected for mice in the 2-year studies. The NOAEL was determined as 5000 ppm for mice (equivalent to 750 mg/kg/d body weight). Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight); CITATION=Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight); CITATION_NUMBERS=[14,5000,250]; REFERENCE=Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight); DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight)","dose":"SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 22 11%) but all females receiving 20000 ppm or more had uterine atrophy.","duration":"2-year","effect":"SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 22 11%) but all females receiving 20000 ppm or more had uterine atrophy. Thus, doses of 5000 and 10000 ppm were selected for the female rats in the 2-year study. The NOAEL was determined as 5000 ppm for male rats (equivalent to 250 mg/kg/d) and 10000 ppm for female rats (equivalent to 500 mg/kg/d). Mice: A combination of deaths and decreased mean body weights relative to controls precluded the selection of doses above 10000 ppm. Therefore, doses of 5000 and 10000 ppm were selected for mice in the 2-year studies. The NOAEL was determined as 5000 ppm for mice (equivalent to 750 mg/kg/d body weight). Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight)","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"ppm","noael_value":"5000","page":22,"route":"","species":"rat","study_id":"sccs_o_008_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5000 |
ppm |
rat |
dermal |
2-year |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=5000; DOSE=11%) but all females receiving 20000 ppm or more had uterine atrophy.; EFFECT=11%) but all females receiving 20000 ppm or more had uterine atrophy. Thus, doses of 5000 and 10000 ppm were selected for the female rats in the 2-year study. The NOAEL was determined as 5000 ppm for male rats (equivalent to 250 mg/kg/d) and 10000 ppm for female rats (equivalent to 500 mg/kg/d). Mice: A combination of deaths and decreased mean body weights relative to controls precluded the selection of doses above 10000 ppm. Therefore, doses of 5000 and 10000 ppm were selected for mice in the 2-year studies. The NOAEL was determined as 5000 ppm for mice (equivalent to 750 mg/kg/d body weight). Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from this study. Mice: A NOAEL of 5000 ppm (equivalent to 750 mg/kg/d body weight) for male and female mice may be derived from this study. 13 Week dermal toxicity Guideline: / Species/strain: New Zealand White rabbit Group size: 12 (6 males and 6 females); CITATION=Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from; CITATION_NUMBERS=[14,5000,250,1000,500]; REFERENCE=Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from; DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from","dose":"11%) but all females receiving 20000 ppm or more had uterine atrophy.","duration":"2-year","effect":"11%) but all females receiving 20000 ppm or more had uterine atrophy. Thus, doses of 5000 and 10000 ppm were selected for the female rats in the 2-year study. The NOAEL was determined as 5000 ppm for male rats (equivalent to 250 mg/kg/d) and 10000 ppm for female rats (equivalent to 500 mg/kg/d). Mice: A combination of deaths and decreased mean body weights relative to controls precluded the selection of doses above 10000 ppm. Therefore, doses of 5000 and 10000 ppm were selected for mice in the 2-year studies. The NOAEL was determined as 5000 ppm for mice (equivalent to 750 mg/kg/d body weight). Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from this study. Mice: A NOAEL of 5000 ppm (equivalent to 750 mg/kg/d body weight) for male and female mice may be derived from this study. 13 Week dermal toxicity Guideline: / Species/strain: New Zealand White rabbit Group size: 12 (6 males and 6 females)","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"ppm","noael_value":"5000","page":22,"route":"dermal","species":"rat","study_id":"sccs_o_008_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5000 |
ppm |
rat |
dermal |
2-year |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=5000; DOSE=The NOAEL was determined as 5000 ppm for male rats (equivalent to 250 mg/kg/d) and 10000 ppm for female rats (equivalent to 500 mg/kg/d).; EFFECT=elected for the female rats in the 2-year study. The NOAEL was determined as 5000 ppm for male rats (equivalent to 250 mg/kg/d) and 10000 ppm for female rats (equivalent to 500 mg/kg/d). Mice: A combination of deaths and decreased mean body weights relative to controls precluded the selection of doses above 10000 ppm. Therefore, doses of 5000 and 10000 ppm were selected for mice in the 2-year studies. The NOAEL was determined as 5000 ppm for mice (equivalent to 750 mg/kg/d body weight). Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from this study. Mice: A NOAEL of 5000 ppm (equivalent to 750 mg/kg/d body weight) for male and female mice may be derived from this study. 13 Week dermal toxicity Guideline: / Species/strain: New Zealand White rabbit Group size: 12 (6 males and 6 females) Test substance: HC Yellow n° 4, 0.4% in hair dye formulation (unknown purity and specifications) Batch: / Pur; CITATION=Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from; CITATION_NUMBERS=[14,5000,250,1000,500]; REFERENCE=Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from; DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from","dose":"The NOAEL was determined as 5000 ppm for male rats (equivalent to 250 mg/kg/d) and 10000 ppm for female rats (equivalent to 500 mg/kg/d).","duration":"2-year","effect":"elected for the female rats in the 2-year study. The NOAEL was determined as 5000 ppm for male rats (equivalent to 250 mg/kg/d) and 10000 ppm for female rats (equivalent to 500 mg/kg/d). Mice: A combination of deaths and decreased mean body weights relative to controls precluded the selection of doses above 10000 ppm. Therefore, doses of 5000 and 10000 ppm were selected for mice in the 2-year studies. The NOAEL was determined as 5000 ppm for mice (equivalent to 750 mg/kg/d body weight). Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from this study. Mice: A NOAEL of 5000 ppm (equivalent to 750 mg/kg/d body weight) for male and female mice may be derived from this study. 13 Week dermal toxicity Guideline: / Species/strain: New Zealand White rabbit Group size: 12 (6 males and 6 females) Test substance: HC Yellow n° 4, 0.4% in hair dye formulation (unknown purity and specifications) Batch: / Pur","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"ppm","noael_value":"5000","page":22,"route":"dermal","species":"rat","study_id":"sccs_o_008_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5000 |
ppm |
rat |
dermal |
2-year |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=5000; DOSE=A combination of deaths and decreased mean body weights relative to controls precluded the selection of doses above 10000 ppm.; EFFECT=g/d). Mice: A combination of deaths and decreased mean body weights relative to controls precluded the selection of doses above 10000 ppm. Therefore, doses of 5000 and 10000 ppm were selected for mice in the 2-year studies. The NOAEL was determined as 5000 ppm for mice (equivalent to 750 mg/kg/d body weight). Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from this study. Mice: A NOAEL of 5000 ppm (equivalent to 750 mg/kg/d body weight) for male and female mice may be derived from this study. 13 Week dermal toxicity Guideline: / Species/strain: New Zealand White rabbit Group size: 12 (6 males and 6 females) Test substance: HC Yellow n° 4, 0.4% in hair dye formulation (unknown purity and specifications) Batch: / Purity: / Vehicle: / Dose levels: / Dose volume: 1 ml/kg bw Administration: topical application, twice weekly for 13 weeks GLP: / Study period: 1976 Hair dye formulation containing 0.; CITATION=Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from; CITATION_NUMBERS=[14,5000,250,1000,500]; REFERENCE=Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from; DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from","dose":"A combination of deaths and decreased mean body weights relative to controls precluded the selection of doses above 10000 ppm.","duration":"2-year","effect":"g/d). Mice: A combination of deaths and decreased mean body weights relative to controls precluded the selection of doses above 10000 ppm. Therefore, doses of 5000 and 10000 ppm were selected for mice in the 2-year studies. The NOAEL was determined as 5000 ppm for mice (equivalent to 750 mg/kg/d body weight). Ref.: 14 Comments Rats: A NOAEL of 5000 ppm (equivalent to 250 mg/kg/d body weight) for male rats and of 10000 ppm (equivalent to 500 mg/kg/d body weight) for female may be derived from this study. Mice: A NOAEL of 5000 ppm (equivalent to 750 mg/kg/d body weight) for male and female mice may be derived from this study. 13 Week dermal toxicity Guideline: / Species/strain: New Zealand White rabbit Group size: 12 (6 males and 6 females) Test substance: HC Yellow n° 4, 0.4% in hair dye formulation (unknown purity and specifications) Batch: / Purity: / Vehicle: / Dose levels: / Dose volume: 1 ml/kg bw Administration: topical application, twice weekly for 13 weeks GLP: / Study period: 1976 Hair dye formulation containing 0.","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"ppm","noael_value":"5000","page":22,"route":"dermal","species":"rat","study_id":"sccs_o_008_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
0.1 |
% |
rat |
oral |
10 weeks |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=0.1; DOSE=The low dose level of 0.1% of HC Yellow n°4 in the diet was not an unequivocal NOAEL in the dominant lethal phase.; EFFECT=SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 30 The experiment did not conform to a guideline and was not performed according to GLP. The low dose level of 0.1% of HC Yellow n°4 in the diet was not an unequivocal NOAEL in the dominant lethal phase. Dominant Lethal study (combined teratology and dominant lethal study) Guideline: / Species/strain: rat, Sprague-Dawley (TAC:N(SD)fBR) Group size: 60 (20 males per group) Test substance: HC Yellow n° 4 Batch: 22900186 Purity: / Dose levels: 0, 0.03 and 0.1% HC Yellow n° 4 in diet (for 10 weeks until mating) basal laboratory chow during mating GLP: / Study period: 1988 - 1989 The 60 male Sprague-Dawley rats received their appropriate test diets for a period of ten weeks prior to th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"The low dose level of 0.1% of HC Yellow n°4 in the diet was not an unequivocal NOAEL in the dominant lethal phase.","duration":"10 weeks","effect":"SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 30 The experiment did not conform to a guideline and was not performed according to GLP. The low dose level of 0.1% of HC Yellow n°4 in the diet was not an unequivocal NOAEL in the dominant lethal phase. Dominant Lethal study (combined teratology and dominant lethal study) Guideline: / Species/strain: rat, Sprague-Dawley (TAC:N(SD)fBR) Group size: 60 (20 males per group) Test substance: HC Yellow n° 4 Batch: 22900186 Purity: / Dose levels: 0, 0.03 and 0.1% HC Yellow n° 4 in diet (for 10 weeks until mating) basal laboratory chow during mating GLP: / Study period: 1988 - 1989 The 60 male Sprague-Dawley rats received their appropriate test diets for a period of ten weeks prior to th","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"%","noael_value":"0.1","page":30,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
50 |
mg/kg bw/d |
rat |
oral |
3 days |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=50; DOSE=ogy Rat, Sprague- Dawley m and f oral 0.3%: retardation in foetal development 1%: severely foetotoxic 17 (I) teratology Rat, Sprague- Dawley f oral 0.03 and 0.1%: no effect 22 (I) teratology rat crl-CD f (G6- G20) oral 200 mg/kg bw/d and above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in la...; EFFECT=ogy Rat, Sprague- Dawley m and f oral 0.3%: retardation in foetal development 1%: severely foetotoxic 17 (I) teratology Rat, Sprague- Dawley f oral 0.03 and 0.1%: no effect 22 (I) teratology rat crl-CD f (G6- G20) oral 200 mg/kg bw/d and above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes and number of live foetuses NOAEL maternal: 50 mg/kg bw/d developm: 500 mg/kg bw/d 19 teratology Rat, crl-CD f (G6- G20) oral 50 mg/kg bw/d and above: coloration 150 mg/kg bw/d and above: ↓ in body weight and food consumption 300 mg/kg bw/d: ↑ in foetal body weight NOAEL maternal: 50 mg/kg bw/d developm: 300 mg/kg bw/d 20 teratology Rat, crl-CD f (G1- G19) every 3 days topical formulation applied no NOAEL can be derived 21 3.3.9. Toxicokinetics No data submitted; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"ogy Rat, Sprague- Dawley m and f oral 0.3%: retardation in foetal development 1%: severely foetotoxic 17 (I) teratology Rat, Sprague- Dawley f oral 0.03 and 0.1%: no effect 22 (I) teratology rat crl-CD f (G6- G20) oral 200 mg/kg bw/d and above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in la...","duration":"3 days","effect":"ogy Rat, Sprague- Dawley m and f oral 0.3%: retardation in foetal development 1%: severely foetotoxic 17 (I) teratology Rat, Sprague- Dawley f oral 0.03 and 0.1%: no effect 22 (I) teratology rat crl-CD f (G6- G20) oral 200 mg/kg bw/d and above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes and number of live foetuses NOAEL maternal: 50 mg/kg bw/d developm: 500 mg/kg bw/d 19 teratology Rat, crl-CD f (G6- G20) oral 50 mg/kg bw/d and above: coloration 150 mg/kg bw/d and above: ↓ in body weight and food consumption 300 mg/kg bw/d: ↑ in foetal body weight NOAEL maternal: 50 mg/kg bw/d developm: 300 mg/kg bw/d 20 teratology Rat, crl-CD f (G1- G19) every 3 days topical formulation applied no NOAEL can be derived 21 3.3.9. Toxicokinetics No data submitted","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":43,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
50 |
mg/kg bw/d |
rat |
oral |
3 days |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=50; DOSE=d above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes and number of live foetuses NOAEL maternal:; EFFECT=d above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes and number of live foetuses NOAEL maternal: 50 mg/kg bw/d developm: 500 mg/kg bw/d 19 teratology Rat, crl-CD f (G6- G20) oral 50 mg/kg bw/d and above: coloration 150 mg/kg bw/d and above: ↓ in body weight and food consumption 300 mg/kg bw/d: ↑ in foetal body weight NOAEL maternal: 50 mg/kg bw/d developm: 300 mg/kg bw/d 20 teratology Rat, crl-CD f (G1- G19) every 3 days topical formulation applied no NOAEL can be derived 21 3.3.9. Toxicokinetics No data submitted; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"d above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes and number of live foetuses NOAEL maternal:","duration":"3 days","effect":"d above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes and number of live foetuses NOAEL maternal: 50 mg/kg bw/d developm: 500 mg/kg bw/d 19 teratology Rat, crl-CD f (G6- G20) oral 50 mg/kg bw/d and above: coloration 150 mg/kg bw/d and above: ↓ in body weight and food consumption 300 mg/kg bw/d: ↑ in foetal body weight NOAEL maternal: 50 mg/kg bw/d developm: 300 mg/kg bw/d 20 teratology Rat, crl-CD f (G1- G19) every 3 days topical formulation applied no NOAEL can be derived 21 3.3.9. Toxicokinetics No data submitted","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":43,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
300 |
mg/kg bw/d |
rat |
oral |
3 days |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=300; DOSE=50 mg/kg bw/d developm:; EFFECT=/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes and number of live foetuses NOAEL maternal: 50 mg/kg bw/d developm: 500 mg/kg bw/d 19 teratology Rat, crl-CD f (G6- G20) oral 50 mg/kg bw/d and above: coloration 150 mg/kg bw/d and above: ↓ in body weight and food consumption 300 mg/kg bw/d: ↑ in foetal body weight NOAEL maternal: 50 mg/kg bw/d developm: 300 mg/kg bw/d 20 teratology Rat, crl-CD f (G1- G19) every 3 days topical formulation applied no NOAEL can be derived 21 3.3.9. Toxicokinetics No data submitted; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"50 mg/kg bw/d developm:","duration":"3 days","effect":"/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes and number of live foetuses NOAEL maternal: 50 mg/kg bw/d developm: 500 mg/kg bw/d 19 teratology Rat, crl-CD f (G6- G20) oral 50 mg/kg bw/d and above: coloration 150 mg/kg bw/d and above: ↓ in body weight and food consumption 300 mg/kg bw/d: ↑ in foetal body weight NOAEL maternal: 50 mg/kg bw/d developm: 300 mg/kg bw/d 20 teratology Rat, crl-CD f (G1- G19) every 3 days topical formulation applied no NOAEL can be derived 21 3.3.9. Toxicokinetics No data submitted","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":43,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
43 |
- |
rabbit |
dermal |
13-week |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=unclear:Unlabeled table on page 43: 13-week | New Zealand White rabbit | m and f | dermal | formulation applied no NOAEL can be derived | 21; EFFECT=Unlabeled table on page 43: 13-week | New Zealand White rabbit | m and f | dermal | formulation applied no NOAEL can be derived | 21; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"","duration":"13-week","effect":"Unlabeled table on page 43: 13-week | New Zealand White rabbit | m and f | dermal | formulation applied no NOAEL can be derived | 21","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 43: 13-week | New Zealand White rabbit | m and f | dermal | formulation applied no NOAEL can be derived | 21","page":43,"route":"dermal","species":"rabbit","study_id":"sccs_o_008_noael_027"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
200 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=200; DOSE=Unlabeled table on page 43: teratology | rat crl-CD | f (G6- G20) | oral | 200 mg/kg bw/d and above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes a...; EFFECT=Unlabeled table on page 43: teratology | rat crl-CD | f (G6- G20) | oral | 200 mg/kg bw/d and above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes and number of live foetuses | NOAEL maternal: 50 mg/kg bw/d developm: 500 mg/kg bw/d | 19; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"Unlabeled table on page 43: teratology | rat crl-CD | f (G6- G20) | oral | 200 mg/kg bw/d and above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes a...","duration":"","effect":"Unlabeled table on page 43: teratology | rat crl-CD | f (G6- G20) | oral | 200 mg/kg bw/d and above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes and number of live foetuses | NOAEL maternal: 50 mg/kg bw/d developm: 500 mg/kg bw/d | 19","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":43,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_028"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
50 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=50; DOSE=Unlabeled table on page 43: teratology | Rat, crl-CD | f (G6- G20) | oral | 50 mg/kg bw/d and above: coloration 150 mg/kg bw/d and above: ↓ in body weight and food consumption 300 mg/kg bw/d: ↑ in foetal body weight | NOAEL maternal:; EFFECT=Unlabeled table on page 43: teratology | Rat, crl-CD | f (G6- G20) | oral | 50 mg/kg bw/d and above: coloration 150 mg/kg bw/d and above: ↓ in body weight and food consumption 300 mg/kg bw/d: ↑ in foetal body weight | NOAEL maternal: 50 mg/kg bw/d developm: 300 mg/kg bw/d | 20; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"Unlabeled table on page 43: teratology | Rat, crl-CD | f (G6- G20) | oral | 50 mg/kg bw/d and above: coloration 150 mg/kg bw/d and above: ↓ in body weight and food consumption 300 mg/kg bw/d: ↑ in foetal body weight | NOAEL maternal:","duration":"","effect":"Unlabeled table on page 43: teratology | Rat, crl-CD | f (G6- G20) | oral | 50 mg/kg bw/d and above: coloration 150 mg/kg bw/d and above: ↓ in body weight and food consumption 300 mg/kg bw/d: ↑ in foetal body weight | NOAEL maternal: 50 mg/kg bw/d developm: 300 mg/kg bw/d | 20","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":43,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_029"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
43 |
- |
rat |
dermal |
3 days |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=unclear:Unlabeled table on page 43: teratology | Rat, crl-CD | f (G1- G19) every 3 days | topical | formulation applied no NOAEL can be derived | 21; EFFECT=Unlabeled table on page 43: teratology | Rat, crl-CD | f (G1- G19) every 3 days | topical | formulation applied no NOAEL can be derived | 21; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"","duration":"3 days","effect":"Unlabeled table on page 43: teratology | Rat, crl-CD | f (G1- G19) every 3 days | topical | formulation applied no NOAEL can be derived | 21","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 43: teratology | Rat, crl-CD | f (G1- G19) every 3 days | topical | formulation applied no NOAEL can be derived | 21","page":43,"route":"dermal","species":"rat","study_id":"sccs_o_008_noael_030"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5000 |
ppm |
rat |
oral |
13-week |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=5000; DOSE=13-week | Rat, F344 mice, B6C3F1 | m and f | oral | Rat 10000 ppm (m) and 20000 ppm (f) and above: ↓ bw;; EFFECT=Unlabeled table on page 43: 13-week | Rat, F344 mice, B6C3F1 | m and f | oral | Rat 10000 ppm (m) and 20000 ppm (f) and above: ↓ bw; 20000 ppm (f) uterine atrophy; 40000 ppm (m): renal mineralization and thyroid pigmentation Mice 80000 ppm: 15 † (m and f) 40000 ppm: 1† (m) 10000 ppm: ↓ bw | Rat m: 5000 ppm (250 mg/kg bw/d) f: 10000 ppm (500 mg/kg bw/d) Mice m and f: 5000 ppm (750 mg/kg bw/d) | 14; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"13-week | Rat, F344 mice, B6C3F1 | m and f | oral | Rat 10000 ppm (m) and 20000 ppm (f) and above: ↓ bw;","duration":"13-week","effect":"Unlabeled table on page 43: 13-week | Rat, F344 mice, B6C3F1 | m and f | oral | Rat 10000 ppm (m) and 20000 ppm (f) and above: ↓ bw; 20000 ppm (f) uterine atrophy; 40000 ppm (m): renal mineralization and thyroid pigmentation Mice 80000 ppm: 15 † (m and f) 40000 ppm: 1† (m) 10000 ppm: ↓ bw | Rat m: 5000 ppm (250 mg/kg bw/d) f: 10000 ppm (500 mg/kg bw/d) Mice m and f: 5000 ppm (750 mg/kg bw/d) | 14","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"ppm","noael_value":"5000","page":43,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_031"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
50 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=50; DOSE=Unlabeled table on page 43: teratology | rat crl-CD | f (G6- G20) | oral | 200 mg/kg bw/d and above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes a...; EFFECT=Unlabeled table on page 43: teratology | rat crl-CD | f (G6- G20) | oral | 200 mg/kg bw/d and above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes and number of live foetuses | NOAEL maternal: 50 mg/kg bw/d developm: 500 mg/kg bw/d | 19; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"Unlabeled table on page 43: teratology | rat crl-CD | f (G6- G20) | oral | 200 mg/kg bw/d and above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes a...","duration":"","effect":"Unlabeled table on page 43: teratology | rat crl-CD | f (G6- G20) | oral | 200 mg/kg bw/d and above: coloration and ↓ in mean body weight gains 500 mg/kg bw/d and above: ↓ in feed consumption and ↑ in late resorption 1000 mg/kg bw/d: ↓ in mean body weight and ↑ resorptions; ↓ in foetal body weight; oedema in foetuses and ↓ in mean litter sizes and number of live foetuses | NOAEL maternal: 50 mg/kg bw/d developm: 500 mg/kg bw/d | 19","endpoint":"","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":43,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_032"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=0.001 |
mg/kg bw |
rat |
oral |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT== 0.001; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 4) (non-oxidative) Absorption through the skin A = 0.152 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.088 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0....; EFFECT=SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 45 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 4) (non-oxidative) Absorption through the skin A = 0.152 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.088 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.001 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw (maternal, oral, rat) Margin of Safety NOAEL / SED = 50000 3.3.14. Discussion Physico-chemical properties HC Yellow n° 4 is used in non-oxidative hair dye formulations with a maximum on-head concentration of 1.5%. Only for one batch, data on identity and purity was provided. For other batches used, the stated purity was between >93 to 99.9%. For many batches used no information on purity was available. Impurities were not quantified by appropriate standards but relative to absolute resultin; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 4) (non-oxidative) Absorption through the skin A = 0.152 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.088 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0....","duration":"","effect":"SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 45 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 4) (non-oxidative) Absorption through the skin A = 0.152 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.088 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.001 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw (maternal, oral, rat) Margin of Safety NOAEL / SED = 50000 3.3.14. Discussion Physico-chemical properties HC Yellow n° 4 is used in non-oxidative hair dye formulations with a maximum on-head concentration of 1.5%. Only for one batch, data on identity and purity was provided. For other batches used, the stated purity was between >93 to 99.9%. For many batches used no information on purity was available. Impurities were not quantified by appropriate standards but relative to absolute resultin","endpoint":"dermal absorption","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.001","page":45,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=50 |
mg/kg bw |
rat |
oral |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT== 50; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 4) (non-oxidative) Absorption through the skin A = 0.152 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.088 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0....; EFFECT=pinion on HC Yellow n° 4 __________________________________________________________________________________ 45 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 4) (non-oxidative) Absorption through the skin A = 0.152 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.088 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.001 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw (maternal, oral, rat) Margin of Safety NOAEL / SED = 50000 3.3.14. Discussion Physico-chemical properties HC Yellow n° 4 is used in non-oxidative hair dye formulations with a maximum on-head concentration of 1.5%. Only for one batch, data on identity and purity was provided. For other batches used, the stated purity was between >93 to 99.9%. For many batches used no information on purity was available. Impurities were not quantified by appropriate standards but relative to absolute resulting HPLC; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 4) (non-oxidative) Absorption through the skin A = 0.152 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.088 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0....","duration":"","effect":"pinion on HC Yellow n° 4 __________________________________________________________________________________ 45 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 4) (non-oxidative) Absorption through the skin A = 0.152 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.088 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.001 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw (maternal, oral, rat) Margin of Safety NOAEL / SED = 50000 3.3.14. Discussion Physico-chemical properties HC Yellow n° 4 is used in non-oxidative hair dye formulations with a maximum on-head concentration of 1.5%. Only for one batch, data on identity and purity was provided. For other batches used, the stated purity was between >93 to 99.9%. For many batches used no information on purity was available. Impurities were not quantified by appropriate standards but relative to absolute resulting HPLC","endpoint":"dermal absorption","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 50","page":45,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=50 |
mg/kg bw |
rat |
oral |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT== 50; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 4) (non-oxidative) Absorption through the skin A = 0.152 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.088 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0....; EFFECT=_______________________________________________ 45 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 4) (non-oxidative) Absorption through the skin A = 0.152 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.088 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.001 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw (maternal, oral, rat) Margin of Safety NOAEL / SED = 50000 3.3.14. Discussion Physico-chemical properties HC Yellow n° 4 is used in non-oxidative hair dye formulations with a maximum on-head concentration of 1.5%. Only for one batch, data on identity and purity was provided. For other batches used, the stated purity was between >93 to 99.9%. For many batches used no information on purity was available. Impurities were not quantified by appropriate standards but relative to absolute resulting HPLC area. Only UV-active impurities were identified, because of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 4) (non-oxidative) Absorption through the skin A = 0.152 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.088 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0....","duration":"","effect":"_______________________________________________ 45 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Yellow n° 4) (non-oxidative) Absorption through the skin A = 0.152 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.088 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.001 mg/kg bw No observed adverse effect level NOAEL = 50 mg/kg bw (maternal, oral, rat) Margin of Safety NOAEL / SED = 50000 3.3.14. Discussion Physico-chemical properties HC Yellow n° 4 is used in non-oxidative hair dye formulations with a maximum on-head concentration of 1.5%. Only for one batch, data on identity and purity was provided. For other batches used, the stated purity was between >93 to 99.9%. For many batches used no information on purity was available. Impurities were not quantified by appropriate standards but relative to absolute resulting HPLC area. Only UV-active impurities were identified, because of","endpoint":"dermal absorption","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 50","page":45,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
99.2 |
% |
rat |
oral |
Prenatal |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=99.2; DOSE=The dose applied to the F0 rats was increasing weekly during the study form 0.2 ml to 0.5 ml.; EFFECT=SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 37 The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known and assumed to be commercial raw materials. Different hair dye formulations were tested in this study. The dose applied to the F0 rats was increasing weekly during the study form 0.2 ml to 0.5 ml. No NOAEL can be derived from this study. 3.3.8.2. Teratogenicity Prenatal developmental study, range finding study Guideline: OECD 414 (2001) Species/strain: rat, Crl:CD® (SD)IGS BR VAF/Plus® Group size: 40 (8 presumed-pregnant females per group) Test substance: HC Yellow n° 4 (GTS 03976)- purity 99.2 % Batch: 17 Purity: 99.2% Vehicle: 100% polyethylene glycol 400 Dose levels: 0, 50, 200, 500 and 1000 mg/kg bw Dose volume: 5 ml/kg bw Route: oral, gavage Administration: once daily on Day 6 through Day 20 GLP statement: i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"The dose applied to the F0 rats was increasing weekly during the study form 0.2 ml to 0.5 ml.","duration":"Prenatal","effect":"SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 37 The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known and assumed to be commercial raw materials. Different hair dye formulations were tested in this study. The dose applied to the F0 rats was increasing weekly during the study form 0.2 ml to 0.5 ml. No NOAEL can be derived from this study. 3.3.8.2. Teratogenicity Prenatal developmental study, range finding study Guideline: OECD 414 (2001) Species/strain: rat, Crl:CD® (SD)IGS BR VAF/Plus® Group size: 40 (8 presumed-pregnant females per group) Test substance: HC Yellow n° 4 (GTS 03976)- purity 99.2 % Batch: 17 Purity: 99.2% Vehicle: 100% polyethylene glycol 400 Dose levels: 0, 50, 200, 500 and 1000 mg/kg bw Dose volume: 5 ml/kg bw Route: oral, gavage Administration: once daily on Day 6 through Day 20 GLP statement: i","endpoint":"developmental toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"%","noael_value":"99.2","page":37,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
50 |
mg/kg/d |
rat |
oral |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=50; DOSE=se of 500 mg/kg bw/d.; EFFECT=se of 500 mg/kg bw/d. Foetal parameters: Body weight were reduced in the foetus of rats treated at the dose of 1000 mg/kg bw/d. Thirteen foetuses from five litters in the 1000 mg/kg bw/d dosage group were observed with whole body oedema (anasarca). Mean litter sizes and number of live foetuses were decreased in 1000 mg/kg dose group. Conclusion: Based on the results of this study, the doses of 0, 50, 150 and 300 mg/kg bw/d were selected for the developmental toxicity study in rats. Ref.: 19 Comments: A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 500 mg/kg/d may be derived from this study. Prenatal developmental, main study Guideline: OECD 414 (2001) Species/strain: rat, Crl:CD® (SD)IGS BR VAF/Plus® Group size: 100 (25 presumed-pregnant females per group) Test substance: HC Yellow n° 4 (GTS 03976) Batch: 17 Purity: 99.2% Vehicle: 100% polyethylene glycol 400 Dose levels: 0, 50, 150 and 300 mg/kg bw Dose volume: 5 ml/kg bw Route: oral, gavage Administration: once daily on Day 6 through Day 20 GLP statement: in c; CITATION=Ref.: 19 Comments: A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 500 mg/kg/d may be derived from this study; CITATION_NUMBERS=[19,50,500]; REFERENCE=Ref.: 19 Comments: A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 500 mg/kg/d may be derived from this study; DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 19 Comments: A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 500 mg/kg/d may be derived from this study","dose":"se of 500 mg/kg bw/d.","duration":"developmental","effect":"se of 500 mg/kg bw/d. Foetal parameters: Body weight were reduced in the foetus of rats treated at the dose of 1000 mg/kg bw/d. Thirteen foetuses from five litters in the 1000 mg/kg bw/d dosage group were observed with whole body oedema (anasarca). Mean litter sizes and number of live foetuses were decreased in 1000 mg/kg dose group. Conclusion: Based on the results of this study, the doses of 0, 50, 150 and 300 mg/kg bw/d were selected for the developmental toxicity study in rats. Ref.: 19 Comments: A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 500 mg/kg/d may be derived from this study. Prenatal developmental, main study Guideline: OECD 414 (2001) Species/strain: rat, Crl:CD® (SD)IGS BR VAF/Plus® Group size: 100 (25 presumed-pregnant females per group) Test substance: HC Yellow n° 4 (GTS 03976) Batch: 17 Purity: 99.2% Vehicle: 100% polyethylene glycol 400 Dose levels: 0, 50, 150 and 300 mg/kg bw Dose volume: 5 ml/kg bw Route: oral, gavage Administration: once daily on Day 6 through Day 20 GLP statement: in c","endpoint":"developmental toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg/d","noael_value":"50","page":38,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
500 |
mg/kg/d |
rat |
oral |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=500; DOSE=Body weight were reduced in the foetus of rats treated at the dose of 1000 mg/kg bw/d.; EFFECT=: Body weight were reduced in the foetus of rats treated at the dose of 1000 mg/kg bw/d. Thirteen foetuses from five litters in the 1000 mg/kg bw/d dosage group were observed with whole body oedema (anasarca). Mean litter sizes and number of live foetuses were decreased in 1000 mg/kg dose group. Conclusion: Based on the results of this study, the doses of 0, 50, 150 and 300 mg/kg bw/d were selected for the developmental toxicity study in rats. Ref.: 19 Comments: A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 500 mg/kg/d may be derived from this study. Prenatal developmental, main study Guideline: OECD 414 (2001) Species/strain: rat, Crl:CD® (SD)IGS BR VAF/Plus® Group size: 100 (25 presumed-pregnant females per group) Test substance: HC Yellow n° 4 (GTS 03976) Batch: 17 Purity: 99.2% Vehicle: 100% polyethylene glycol 400 Dose levels: 0, 50, 150 and 300 mg/kg bw Dose volume: 5 ml/kg bw Route: oral, gavage Administration: once daily on Day 6 through Day 20 GLP statement: in compliance Study period: 17 October – 4 N; CITATION=Ref.: 19 Comments: A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 500 mg/kg/d may be derived from this study; CITATION_NUMBERS=[19,50,500]; REFERENCE=Ref.: 19 Comments: A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 500 mg/kg/d may be derived from this study; DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 19 Comments: A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 500 mg/kg/d may be derived from this study","dose":"Body weight were reduced in the foetus of rats treated at the dose of 1000 mg/kg bw/d.","duration":"developmental","effect":": Body weight were reduced in the foetus of rats treated at the dose of 1000 mg/kg bw/d. Thirteen foetuses from five litters in the 1000 mg/kg bw/d dosage group were observed with whole body oedema (anasarca). Mean litter sizes and number of live foetuses were decreased in 1000 mg/kg dose group. Conclusion: Based on the results of this study, the doses of 0, 50, 150 and 300 mg/kg bw/d were selected for the developmental toxicity study in rats. Ref.: 19 Comments: A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 500 mg/kg/d may be derived from this study. Prenatal developmental, main study Guideline: OECD 414 (2001) Species/strain: rat, Crl:CD® (SD)IGS BR VAF/Plus® Group size: 100 (25 presumed-pregnant females per group) Test substance: HC Yellow n° 4 (GTS 03976) Batch: 17 Purity: 99.2% Vehicle: 100% polyethylene glycol 400 Dose levels: 0, 50, 150 and 300 mg/kg bw Dose volume: 5 ml/kg bw Route: oral, gavage Administration: once daily on Day 6 through Day 20 GLP statement: in compliance Study period: 17 October – 4 N","endpoint":"developmental toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg/d","noael_value":"500","page":38,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
50 |
mg/kg bw/d |
rat |
dermal |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=50; DOSE=of 150 and 300 mg/kg bw/d on days 15 to 18.; EFFECT=of 150 and 300 mg/kg bw/d on days 15 to 18. No significant differences were observed in the number of corpora lutea, implantations or resorptions in all treated rats when comparing with the control rats. Foetal parameters: No significant differences were observed in the number of either live foetuses, dead or resorbed foetuses or foetal abnormalities in all treated rats when compared with the control rats. A significant increase in the foetal body weight was observed the high dose group. Conclusion A maternal NOAEL of 50 mg/kg bw/d and a developmental NOAEL of 300 mg/kg bw/d were determined from this study since the increase in foetal body weight was not considered as an adverse effect. Ref.: 20 Teratogenicity study, topical application Guideline: / Species/strain: Charles River CD rats Group size: 100, 20 mated females per group (3 neg. control, 1 pos. control, 1 test) Test substance: HC Yellow n° 4, 0.4% in hair dye formulation Batch: / Purity: / unknown purity and specifications assume commercial raw material Vehicle:; CITATION=Ref.: 20 Teratogenicity study, topical application Guideline: / Species/strain: Charles River CD rats Group size: 100, 20 mated females per group (3 neg; CITATION_NUMBERS=[20,100,3]; REFERENCE=Ref.: 20 Teratogenicity study, topical application Guideline: / Species/strain: Charles River CD rats Group size: 100, 20 mated females per group (3 neg; DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 20 Teratogenicity study, topical application Guideline: / Species/strain: Charles River CD rats Group size: 100, 20 mated females per group (3 neg","dose":"of 150 and 300 mg/kg bw/d on days 15 to 18.","duration":"developmental","effect":"of 150 and 300 mg/kg bw/d on days 15 to 18. No significant differences were observed in the number of corpora lutea, implantations or resorptions in all treated rats when comparing with the control rats. Foetal parameters: No significant differences were observed in the number of either live foetuses, dead or resorbed foetuses or foetal abnormalities in all treated rats when compared with the control rats. A significant increase in the foetal body weight was observed the high dose group. Conclusion A maternal NOAEL of 50 mg/kg bw/d and a developmental NOAEL of 300 mg/kg bw/d were determined from this study since the increase in foetal body weight was not considered as an adverse effect. Ref.: 20 Teratogenicity study, topical application Guideline: / Species/strain: Charles River CD rats Group size: 100, 20 mated females per group (3 neg. control, 1 pos. control, 1 test) Test substance: HC Yellow n° 4, 0.4% in hair dye formulation Batch: / Purity: / unknown purity and specifications assume commercial raw material Vehicle:","endpoint":"developmental toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":39,"route":"dermal","species":"rat","study_id":"sccs_o_008_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
300 |
mg/kg bw/d |
rat |
dermal |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=300; DOSE=No significant differences were observed in the number of corpora lutea, implantations or resorptions in all treated rats when comparing with the control rats.; EFFECT=. No significant differences were observed in the number of corpora lutea, implantations or resorptions in all treated rats when comparing with the control rats. Foetal parameters: No significant differences were observed in the number of either live foetuses, dead or resorbed foetuses or foetal abnormalities in all treated rats when compared with the control rats. A significant increase in the foetal body weight was observed the high dose group. Conclusion A maternal NOAEL of 50 mg/kg bw/d and a developmental NOAEL of 300 mg/kg bw/d were determined from this study since the increase in foetal body weight was not considered as an adverse effect. Ref.: 20 Teratogenicity study, topical application Guideline: / Species/strain: Charles River CD rats Group size: 100, 20 mated females per group (3 neg. control, 1 pos. control, 1 test) Test substance: HC Yellow n° 4, 0.4% in hair dye formulation Batch: / Purity: / unknown purity and specifications assume commercial raw material Vehicle: / Dose levels: / Dose volume: 2 ml/kg bw Ro; CITATION=Ref.: 20 Teratogenicity study, topical application Guideline: / Species/strain: Charles River CD rats Group size: 100, 20 mated females per group (3 neg; CITATION_NUMBERS=[20,100,3]; REFERENCE=Ref.: 20 Teratogenicity study, topical application Guideline: / Species/strain: Charles River CD rats Group size: 100, 20 mated females per group (3 neg; DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 20 Teratogenicity study, topical application Guideline: / Species/strain: Charles River CD rats Group size: 100, 20 mated females per group (3 neg","dose":"No significant differences were observed in the number of corpora lutea, implantations or resorptions in all treated rats when comparing with the control rats.","duration":"developmental","effect":". No significant differences were observed in the number of corpora lutea, implantations or resorptions in all treated rats when comparing with the control rats. Foetal parameters: No significant differences were observed in the number of either live foetuses, dead or resorbed foetuses or foetal abnormalities in all treated rats when compared with the control rats. A significant increase in the foetal body weight was observed the high dose group. Conclusion A maternal NOAEL of 50 mg/kg bw/d and a developmental NOAEL of 300 mg/kg bw/d were determined from this study since the increase in foetal body weight was not considered as an adverse effect. Ref.: 20 Teratogenicity study, topical application Guideline: / Species/strain: Charles River CD rats Group size: 100, 20 mated females per group (3 neg. control, 1 pos. control, 1 test) Test substance: HC Yellow n° 4, 0.4% in hair dye formulation Batch: / Purity: / unknown purity and specifications assume commercial raw material Vehicle: / Dose levels: / Dose volume: 2 ml/kg bw Ro","endpoint":"developmental toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":39,"route":"dermal","species":"rat","study_id":"sccs_o_008_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
0.4 |
% |
- |
- |
- |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=0.4; EFFECT=consumption between test and control groups was observed. No significant difference in number of corpora lutea, implantations, resorptions, abortions and sex ratio between test and control groups was observed. Foetal parameters: No differences in the number of live, dead or resorbed foetuses and number of foetal abnormalities were observed. Conclusion The administration of formulation P-24 containing 0.4% of HC Yellow n°4 every third day of the gestation period produces no embryotoxic or teratogenic effects. A NOAEL of 0.4% HC Yellow n°4 in the hair dye formulation was determined. Ref.: 21 Comment The experiment did not conform to a guideline and was not performed according to GLP. The study is reported only as an article in J. Toxicol. Env. Health but not provided as a full report. HC Yellow n° 4 was applied every three days. The purity and specifications of test article is not known and assumed to be commercial raw materials. The test concentration of HC Yellow n°4 was lower than the use concentration in non-oxidative hair; CITATION=Ref.: 21 Comment The experiment did not conform to a guideline and was not performed according to GLP; CITATION_NUMBERS=[21]; REFERENCE=Ref.: 21 Comment The experiment did not conform to a guideline and was not performed according to GLP; DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 21 Comment The experiment did not conform to a guideline and was not performed according to GLP","dose":"","duration":"","effect":"consumption between test and control groups was observed. No significant difference in number of corpora lutea, implantations, resorptions, abortions and sex ratio between test and control groups was observed. Foetal parameters: No differences in the number of live, dead or resorbed foetuses and number of foetal abnormalities were observed. Conclusion The administration of formulation P-24 containing 0.4% of HC Yellow n°4 every third day of the gestation period produces no embryotoxic or teratogenic effects. A NOAEL of 0.4% HC Yellow n°4 in the hair dye formulation was determined. Ref.: 21 Comment The experiment did not conform to a guideline and was not performed according to GLP. The study is reported only as an article in J. Toxicol. Env. Health but not provided as a full report. HC Yellow n° 4 was applied every three days. The purity and specifications of test article is not known and assumed to be commercial raw materials. The test concentration of HC Yellow n°4 was lower than the use concentration in non-oxidative hair","endpoint":"developmental toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"%","noael_value":"0.4","page":40,"route":"","species":"","study_id":"sccs_o_008_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
0.1 |
% |
rat |
oral |
6 weeks |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=0.1; DOSE=A dose level of 1% was severely foetotoxic.; EFFECT=nclusions Administration of HC Yellow n°4 in the diet at a level of 1% affected intrauterine survival severely. A dose level of 1% was severely foetotoxic. A possible indication of foetal toxicity was noted in the 0.3% group but at a dose level of 0.1%; HC Yellow n°4 did not produce any observable foetal toxicity. HC Yellow n°4 was however not teratogenic at any of the dose levels in this study. Ref.: 17, submission I Comment The experiment did not conform to a guideline and was not performed according to GLP. No NOAEL can be derived from this study. Teratology study (Combined teratology and dominant lethal study) Guideline: / Species/strain: rat, Sprague-Dawley (TAC:N(SD)fBR) Group size: 75 (25 females per group) Test substance: HC Yellow n° 4 Batch: 22900186 Purity: / Dose levels: 0, 0.03 and 0.1% HC Yellow n° 4 in diet (for 6 weeks until mating) basal laboratory chow during mating 0, 0.03 and 0.1% HC Yellow n° 4 in diet (from Day 0 through Day 20) GLP: / Study period: 1988 - 1989 75 females received their appropriate te; CITATION=Ref.: 17, submission I Comment The experiment did not conform to a guideline and was not performed according to GLP; CITATION_NUMBERS=[17]; REFERENCE=Ref.: 17, submission I Comment The experiment did not conform to a guideline and was not performed according to GLP; DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 17, submission I Comment The experiment did not conform to a guideline and was not performed according to GLP","dose":"A dose level of 1% was severely foetotoxic.","duration":"6 weeks","effect":"nclusions Administration of HC Yellow n°4 in the diet at a level of 1% affected intrauterine survival severely. A dose level of 1% was severely foetotoxic. A possible indication of foetal toxicity was noted in the 0.3% group but at a dose level of 0.1%; HC Yellow n°4 did not produce any observable foetal toxicity. HC Yellow n°4 was however not teratogenic at any of the dose levels in this study. Ref.: 17, submission I Comment The experiment did not conform to a guideline and was not performed according to GLP. No NOAEL can be derived from this study. Teratology study (Combined teratology and dominant lethal study) Guideline: / Species/strain: rat, Sprague-Dawley (TAC:N(SD)fBR) Group size: 75 (25 females per group) Test substance: HC Yellow n° 4 Batch: 22900186 Purity: / Dose levels: 0, 0.03 and 0.1% HC Yellow n° 4 in diet (for 6 weeks until mating) basal laboratory chow during mating 0, 0.03 and 0.1% HC Yellow n° 4 in diet (from Day 0 through Day 20) GLP: / Study period: 1988 - 1989 75 females received their appropriate te","endpoint":"developmental toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"%","noael_value":"0.1","page":41,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
0.1 |
% |
rat |
oral |
sub-chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=0.1; DOSE=ight gain for day 17 was noted for rats treated at the dose of 0.03% and 0.1% during the second mating.; EFFECT=ight gain for day 17 was noted for rats treated at the dose of 0.03% and 0.1% during the second mating. The number of pregnancies, pre-implantation and post-implantation loss and the number of live pups was comparable among all groups. Conclusion HC Yellow n°4 did not produce a dominant lethal effect or cause infertility of male Sprague- Dawley rats when fed in the diet for ten weeks prior to mating at dose levels of 0.03% and 0.1%. Ref.: 22, submission I Comment As in the previous study (ref 17) an unequivocal NOEL was not determined in the teratology and dominant lethal phases, this study was done to serve as a repeat of the reproductive phases using a control level and two dose levels. An examination of testis should have been done as an atrophy was observed at the dose of 0.3% in the combined sub-chronic feeding, teratology and dominant lethal study (ref 17). 3.3.7. Carcinogenicity Oral administration Rats Guideline: / Species/strain: F344/N rats Group size: 70 animals per sex and dose; CITATION=Ref.: 22, submission I Comment As in the previous study (ref 17) an unequivocal NOEL was not determined in the teratology and dominant lethal phases, this study was done to serve as a re; CITATION_NUMBERS=[22,17]; REFERENCE=Ref.: 22, submission I Comment As in the previous study (ref 17) an unequivocal NOEL was not determined in the teratology and dominant lethal phases, this study was done to serve as a re; DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 22, submission I Comment As in the previous study (ref 17) an unequivocal NOEL was not determined in the teratology and dominant lethal phases, this study was done to serve as a re","dose":"ight gain for day 17 was noted for rats treated at the dose of 0.03% and 0.1% during the second mating.","duration":"sub-chronic","effect":"ight gain for day 17 was noted for rats treated at the dose of 0.03% and 0.1% during the second mating. The number of pregnancies, pre-implantation and post-implantation loss and the number of live pups was comparable among all groups. Conclusion HC Yellow n°4 did not produce a dominant lethal effect or cause infertility of male Sprague- Dawley rats when fed in the diet for ten weeks prior to mating at dose levels of 0.03% and 0.1%. Ref.: 22, submission I Comment As in the previous study (ref 17) an unequivocal NOEL was not determined in the teratology and dominant lethal phases, this study was done to serve as a repeat of the reproductive phases using a control level and two dose levels. An examination of testis should have been done as an atrophy was observed at the dose of 0.3% in the combined sub-chronic feeding, teratology and dominant lethal study (ref 17). 3.3.7. Carcinogenicity Oral administration Rats Guideline: / Species/strain: F344/N rats Group size: 70 animals per sex and dose","endpoint":"repeated dose toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"%","noael_value":"0.1","page":30,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1.5 |
% |
rat |
oral |
Sub-chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=1.5; DOSE=98.9% (approximately) Dose levels:; EFFECT=ow n°4 in the hair dye formulation was determined. Ref.: 21 Comment The experiment did not conform to a guideline and was not performed according to GLP. The study is reported only as an article in J. Toxicol. Env. Health but not provided as a full report. HC Yellow n° 4 was applied every three days. The purity and specifications of test article is not known and assumed to be commercial raw materials. The test concentration of HC Yellow n°4 was lower than the use concentration in non-oxidative hair dye (1.5%). No NOAEL can be derived from this study. Teratology study (Combined Sub-chronic feeding, teratology and Dominant Lethal study) Guideline: / Species/strain: rat, Sprague-Dawley (TAC:N(SD)fBR) Group size: 100 (25 females per group) Test substance: HC Yellow n° 4 Batch: 22900186 Purity: 98.9% (approximately) Dose levels: 0, 0.1, 0.3 and 1.0% HC Yellow n° 4 in diet (until mating (2 weeks)) basal laboratory chow during mating 0, 0.1, 0.3 and 1.0% HC Yellow n° 4 in diet (from Day 0 through Day 20) GLP: / Study period: 1987; CITATION=Ref.: 21 Comment The experiment did not conform to a guideline and was not performed according to GLP; CITATION_NUMBERS=[21]; REFERENCE=Ref.: 21 Comment The experiment did not conform to a guideline and was not performed according to GLP; DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 21 Comment The experiment did not conform to a guideline and was not performed according to GLP","dose":"98.9% (approximately) Dose levels:","duration":"Sub-chronic","effect":"ow n°4 in the hair dye formulation was determined. Ref.: 21 Comment The experiment did not conform to a guideline and was not performed according to GLP. The study is reported only as an article in J. Toxicol. Env. Health but not provided as a full report. HC Yellow n° 4 was applied every three days. The purity and specifications of test article is not known and assumed to be commercial raw materials. The test concentration of HC Yellow n°4 was lower than the use concentration in non-oxidative hair dye (1.5%). No NOAEL can be derived from this study. Teratology study (Combined Sub-chronic feeding, teratology and Dominant Lethal study) Guideline: / Species/strain: rat, Sprague-Dawley (TAC:N(SD)fBR) Group size: 100 (25 females per group) Test substance: HC Yellow n° 4 Batch: 22900186 Purity: 98.9% (approximately) Dose levels: 0, 0.1, 0.3 and 1.0% HC Yellow n° 4 in diet (until mating (2 weeks)) basal laboratory chow during mating 0, 0.1, 0.3 and 1.0% HC Yellow n° 4 in diet (from Day 0 through Day 20) GLP: / Study period: 1987","endpoint":"repeated dose toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"%","noael_value":"1.5","page":40,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
0.4 |
% |
rat |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=0.4; EFFECT=l groups in fertility, gestation and live indices. The F2 parents had markedly reduced fertility indices for three separate matings to produce the F3 litters. There were no significant differences between control groups and the test group with regard to fertility. Therefore it was concluded that the tested formulation did not cause the reduction in fertility. Offspring: No significant differences between body weights, litter size and survival rats between the test and control groups were observed. Conclusion A NOAEL of 0.4% HC Yellow n°4 in the hair dye formulation was determined. Ref.: 24 Comments; CITATION=Ref.: 24 Comments; CITATION_NUMBERS=[24]; REFERENCE=Ref.: 24 Comments; DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 24 Comments","dose":"","duration":"","effect":"l groups in fertility, gestation and live indices. The F2 parents had markedly reduced fertility indices for three separate matings to produce the F3 litters. There were no significant differences between control groups and the test group with regard to fertility. Therefore it was concluded that the tested formulation did not cause the reduction in fertility. Offspring: No significant differences between body weights, litter size and survival rats between the test and control groups were observed. Conclusion A NOAEL of 0.4% HC Yellow n°4 in the hair dye formulation was determined. Ref.: 24 Comments","endpoint":"reproductive toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"%","noael_value":"0.4","page":36,"route":"","species":"rat","study_id":"sccs_o_008_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
0.1 |
% |
rat |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=0.1; DOSE=SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 42 HC Yellow n°4 does not appear to produce a teratogenic effect or any observable evidence of foetal toxicity when fed in the diet for six weeks prior to mating and during gestation to female Sprague-Dawley rats at dose leve...; EFFECT=SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 42 HC Yellow n°4 does not appear to produce a teratogenic effect or any observable evidence of foetal toxicity when fed in the diet for six weeks prior to mating and during gestation to female Sprague-Dawley rats at dose levels of 0.03% and 0.1%. Ref.: 22, submission I Comment No NOAEL can be derived from this study. This study was done to serve as a repeat of the reproductive phases using a control level and two dose levels. Teratology study Guideline: / Species/strain: rat, Sprague-Dawley (TAC:N(SD)fBR) Group size: 40 (20 females per group) Test substance: HC Yellow n° 4 Batch: 22900186 Purity: 99.65% Dose levels: 0 and 1.0% HC Yellow n° 4 in diet GLP: / Study period: 1988 Evidence of foetotoxic effect of HC Yellow n°4 was found in this study. 47 foetuses were dead in the treated group (0; CITATION=Ref.: 22, submission I Comment No NOAEL can be derived from this study; CITATION_NUMBERS=[22]; REFERENCE=Ref.: 22, submission I Comment No NOAEL can be derived from this study; DETAILS_JSON={"cas_number":"59820-43-8","citation":"Ref.: 22, submission I Comment No NOAEL can be derived from this study","dose":"SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 42 HC Yellow n°4 does not appear to produce a teratogenic effect or any observable evidence of foetal toxicity when fed in the diet for six weeks prior to mating and during gestation to female Sprague-Dawley rats at dose leve...","duration":"","effect":"SCCS/1230/09 Opinion on HC Yellow n° 4 __________________________________________________________________________________ 42 HC Yellow n°4 does not appear to produce a teratogenic effect or any observable evidence of foetal toxicity when fed in the diet for six weeks prior to mating and during gestation to female Sprague-Dawley rats at dose levels of 0.03% and 0.1%. Ref.: 22, submission I Comment No NOAEL can be derived from this study. This study was done to serve as a repeat of the reproductive phases using a control level and two dose levels. Teratology study Guideline: / Species/strain: rat, Sprague-Dawley (TAC:N(SD)fBR) Group size: 40 (20 females per group) Test substance: HC Yellow n° 4 Batch: 22900186 Purity: 99.65% Dose levels: 0 and 1.0% HC Yellow n° 4 in diet GLP: / Study period: 1988 Evidence of foetotoxic effect of HC Yellow n°4 was found in this study. 47 foetuses were dead in the treated group (0","endpoint":"reproductive toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"%","noael_value":"0.1","page":42,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
0.1 |
% |
rat |
oral |
13-week |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=0.1; DOSE=_______________________________ 43 Study Species Sex Route Effects Critical dose Ref 13-week Rat, F344 mice, B6C3F1 m and f oral Rat 10000 ppm (m) and 20000 ppm (f) and above: ↓ bw;; EFFECT=_______________________________ 43 Study Species Sex Route Effects Critical dose Ref 13-week Rat, F344 mice, B6C3F1 m and f oral Rat 10000 ppm (m) and 20000 ppm (f) and above: ↓ bw; 20000 ppm (f) uterine atrophy; 40000 ppm (m): renal mineralization and thyroid pigmentation Mice 80000 ppm: 15 † (m and f) 40000 ppm: 1† (m) 10000 ppm: ↓ bw Rat m: 5000 ppm (250 mg/kg bw/d) f: 10000 ppm (500 mg/kg bw/d) Mice m and f: 5000 ppm (750 mg/kg bw/d) 14 13-week New Zealand White rabbit m and f dermal formulation applied no NOAEL can be derived 21 90-day Rat, Sprague- Dawley m and f oral 0, 0.1%, 0.3% and 1%: no specific related effect 17 (I) 6 months Rat, Sprague- Dawley m and f oral 0.1% and above: ↑ in liver weight 1%: ↓ in body weights (m and f) and in testes weight 17 (I) dominant lethal study Rat, Sprague- Dawley m oral No dominant lethal effect but at 0.1% and above: ↓ in fertility (↓ in nb of pregnant females) 17 (I) dominant lethal study Rat, Sprague- Dawley m oral 0.03 and 0.1%: no effect 22 (I) teratology Rat, Sprague- Dawle; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"_______________________________ 43 Study Species Sex Route Effects Critical dose Ref 13-week Rat, F344 mice, B6C3F1 m and f oral Rat 10000 ppm (m) and 20000 ppm (f) and above: ↓ bw;","duration":"13-week","effect":"_______________________________ 43 Study Species Sex Route Effects Critical dose Ref 13-week Rat, F344 mice, B6C3F1 m and f oral Rat 10000 ppm (m) and 20000 ppm (f) and above: ↓ bw; 20000 ppm (f) uterine atrophy; 40000 ppm (m): renal mineralization and thyroid pigmentation Mice 80000 ppm: 15 † (m and f) 40000 ppm: 1† (m) 10000 ppm: ↓ bw Rat m: 5000 ppm (250 mg/kg bw/d) f: 10000 ppm (500 mg/kg bw/d) Mice m and f: 5000 ppm (750 mg/kg bw/d) 14 13-week New Zealand White rabbit m and f dermal formulation applied no NOAEL can be derived 21 90-day Rat, Sprague- Dawley m and f oral 0, 0.1%, 0.3% and 1%: no specific related effect 17 (I) 6 months Rat, Sprague- Dawley m and f oral 0.1% and above: ↑ in liver weight 1%: ↓ in body weights (m and f) and in testes weight 17 (I) dominant lethal study Rat, Sprague- Dawley m oral No dominant lethal effect but at 0.1% and above: ↓ in fertility (↓ in nb of pregnant females) 17 (I) dominant lethal study Rat, Sprague- Dawley m oral 0.03 and 0.1%: no effect 22 (I) teratology Rat, Sprague- Dawle","endpoint":"reproductive toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"%","noael_value":"0.1","page":43,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
50 |
mg/kg/d |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=50; DOSE=bsolute and relative testes weight was observed in rats at the dose of 1% in food.; EFFECT=bsolute and relative testes weight was observed in rats at the dose of 1% in food. This decrease is probably related to the severe diffuse testes atrophy seen at high dose in the dominant lethal study. No appropriate two generation reproduction toxicity study was submitted. However, because of the low exposure and the magnitude of MOS no additional reproductive toxicity study seems to be necessary. In the teratogenicity studies performed in rats by oral route, foetotoxicity was observed at high doses. A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 300 mg/kg/d were determined. The maternal NOAEL of 50 mg/kg/d was used to calculate the margin of safety. Skin/eye irritation and sensitisation HC Yellow n° 4 was not irritant to rabbit skin. HC Yellow n° 4 was considered to be an eye irritant in rabbits. HC Yellow n° 4 was not a contact allergen in a LLNA. It was not a photo- allergen. None of the submitted studies on sensitisation were conform to guidelines. Although there is no evidence from the available data that HC; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"bsolute and relative testes weight was observed in rats at the dose of 1% in food.","duration":"developmental","effect":"bsolute and relative testes weight was observed in rats at the dose of 1% in food. This decrease is probably related to the severe diffuse testes atrophy seen at high dose in the dominant lethal study. No appropriate two generation reproduction toxicity study was submitted. However, because of the low exposure and the magnitude of MOS no additional reproductive toxicity study seems to be necessary. In the teratogenicity studies performed in rats by oral route, foetotoxicity was observed at high doses. A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 300 mg/kg/d were determined. The maternal NOAEL of 50 mg/kg/d was used to calculate the margin of safety. Skin/eye irritation and sensitisation HC Yellow n° 4 was not irritant to rabbit skin. HC Yellow n° 4 was considered to be an eye irritant in rabbits. HC Yellow n° 4 was not a contact allergen in a LLNA. It was not a photo- allergen. None of the submitted studies on sensitisation were conform to guidelines. Although there is no evidence from the available data that HC","endpoint":"reproductive toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg/d","noael_value":"50","page":46,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
300 |
mg/kg/d |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=300; DOSE=bserved in rats at the dose of 1% in food.; EFFECT=bserved in rats at the dose of 1% in food. This decrease is probably related to the severe diffuse testes atrophy seen at high dose in the dominant lethal study. No appropriate two generation reproduction toxicity study was submitted. However, because of the low exposure and the magnitude of MOS no additional reproductive toxicity study seems to be necessary. In the teratogenicity studies performed in rats by oral route, foetotoxicity was observed at high doses. A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 300 mg/kg/d were determined. The maternal NOAEL of 50 mg/kg/d was used to calculate the margin of safety. Skin/eye irritation and sensitisation HC Yellow n° 4 was not irritant to rabbit skin. HC Yellow n° 4 was considered to be an eye irritant in rabbits. HC Yellow n° 4 was not a contact allergen in a LLNA. It was not a photo- allergen. None of the submitted studies on sensitisation were conform to guidelines. Although there is no evidence from the available data that HC Yellow n° 4 is a sensitiser, this canno; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"bserved in rats at the dose of 1% in food.","duration":"developmental","effect":"bserved in rats at the dose of 1% in food. This decrease is probably related to the severe diffuse testes atrophy seen at high dose in the dominant lethal study. No appropriate two generation reproduction toxicity study was submitted. However, because of the low exposure and the magnitude of MOS no additional reproductive toxicity study seems to be necessary. In the teratogenicity studies performed in rats by oral route, foetotoxicity was observed at high doses. A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 300 mg/kg/d were determined. The maternal NOAEL of 50 mg/kg/d was used to calculate the margin of safety. Skin/eye irritation and sensitisation HC Yellow n° 4 was not irritant to rabbit skin. HC Yellow n° 4 was considered to be an eye irritant in rabbits. HC Yellow n° 4 was not a contact allergen in a LLNA. It was not a photo- allergen. None of the submitted studies on sensitisation were conform to guidelines. Although there is no evidence from the available data that HC Yellow n° 4 is a sensitiser, this canno","endpoint":"reproductive toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg/d","noael_value":"300","page":46,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
50 |
mg/kg/d |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_008; REPORT_TITLE=OPINION ON HC Yellow n° 4 COLIPA n° B38; OPINION_NUMBER=SCCS/1230/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=50; DOSE=rease is probably related to the severe diffuse testes atrophy seen at high dose in the dominant lethal study.; EFFECT=rease is probably related to the severe diffuse testes atrophy seen at high dose in the dominant lethal study. No appropriate two generation reproduction toxicity study was submitted. However, because of the low exposure and the magnitude of MOS no additional reproductive toxicity study seems to be necessary. In the teratogenicity studies performed in rats by oral route, foetotoxicity was observed at high doses. A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 300 mg/kg/d were determined. The maternal NOAEL of 50 mg/kg/d was used to calculate the margin of safety. Skin/eye irritation and sensitisation HC Yellow n° 4 was not irritant to rabbit skin. HC Yellow n° 4 was considered to be an eye irritant in rabbits. HC Yellow n° 4 was not a contact allergen in a LLNA. It was not a photo- allergen. None of the submitted studies on sensitisation were conform to guidelines. Although there is no evidence from the available data that HC Yellow n° 4 is a sensitiser, this cannot be excluded. Percutaneous absorption Under the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"59820-43-8","citation":"","dose":"rease is probably related to the severe diffuse testes atrophy seen at high dose in the dominant lethal study.","duration":"developmental","effect":"rease is probably related to the severe diffuse testes atrophy seen at high dose in the dominant lethal study. No appropriate two generation reproduction toxicity study was submitted. However, because of the low exposure and the magnitude of MOS no additional reproductive toxicity study seems to be necessary. In the teratogenicity studies performed in rats by oral route, foetotoxicity was observed at high doses. A maternal NOAEL of 50 mg/kg/d and a developmental NOAEL of 300 mg/kg/d were determined. The maternal NOAEL of 50 mg/kg/d was used to calculate the margin of safety. Skin/eye irritation and sensitisation HC Yellow n° 4 was not irritant to rabbit skin. HC Yellow n° 4 was considered to be an eye irritant in rabbits. HC Yellow n° 4 was not a contact allergen in a LLNA. It was not a photo- allergen. None of the submitted studies on sensitisation were conform to guidelines. Although there is no evidence from the available data that HC Yellow n° 4 is a sensitiser, this cannot be excluded. Percutaneous absorption Under the","endpoint":"reproductive toxicity","ingredient":"1-Nitro-3-(2-hydroxyethyl)-oxy-4","loael_value":"","noael_unit":"mg/kg/d","noael_value":"50","page":46,"route":"oral","species":"rat","study_id":"sccs_o_008_noael_026"} |