NOAEL Studies
Cosmetic Ingredient
2-Amino-6-Chloro-4-Nitrophenol NOAEL Studies
INCI: 2-AMINO-6-CHLORO-4-NITROPHENOL
CAS: 6358-09-4
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR_vision_codex 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR_vision_codex | NOAEL | =30 | mg / kg / day | rat | oral | subchronic | repeated dose toxicity | {"citation":"2; 6; 4","dose":"In subchronic oral studies in rats, a no observable adverse effect level of 30 mg / kg / day for 2-Amino-6-Chloro-4-Nitrophenol was determined; at higher doses, increased organ weights were seen.","effect":"shington, DC 20036, USA. 2-Amino-6-Chloro-4-Nitrophenol and its hydrochloride salt are substituted aromatic compounds that function as colorants in hair dyes. Only the hydrochloride salt is currently reported to be used. 2-Amino-6-Chloro-4- Nitrophenol is poorly absorbed through the skin. Less than 0.25% of 2-Amino- 6-Chloro-4-Nitrophenol found in a nonoxidative hair dye was absorbed. Less than 0.2% of 2-Amino-6-Chloro-4-Nitrophenol found in an oxidative hair dye was absorbed. In subchronic oral studies in rats, a no observable adverse effect level of 30 mg / kg / day for 2-Amino-6-Chloro-4-Nitrophenol was determined; at higher doses, increased organ weights were seen. A 2% solution of 2-Amino-6- Chloro-4-Nitrophenol applied under occlusive conditions was found to be non- irritating to rabbits. At 0.1%, 2-Amino-6-Chloro-4-Nitrophenol was nonsensi- tizing; at 2%, there was sufficient skin coloration from the dye that assessment of sensitization was difficult; but no obviously sensitized areas were reported. An oral teratogenicity study in rats showed no birth defects. In one Ames t...","page":1,"pdf":"PRS59.pdf","row_type":"noael_study","study_id":"PRS59_noael_001"} |
| CIR_vision_codex | NOAEL | =30 | mg / kg / day | rat | oral | subchronic | repeated dose toxicity | {"citation":"2; 6; 4","dose":"In subchronic oral studies in rats, a no observable adverse effect level of 30 mg / kg / day for 2-Amino-6-Chloro-4-Nitrophenol was determined; at higher doses, increased organ weights were seen.","effect":"shington, DC 20036, USA. 2-Amino-6-Chloro-4-Nitrophenol and its hydrochloride salt are substituted aromatic compounds that function as colorants in hair dyes. Only the hydrochloride salt is currently reported to be used. 2-Amino-6-Chloro-4- Nitrophenol is poorly absorbed through the skin. Less than 0.25% of 2-Amino- 6-Chloro-4-Nitrophenol found in a nonoxidative hair dye was absorbed. Less than 0.2% of 2-Amino-6-Chloro-4-Nitrophenol found in an oxidative hair dye was absorbed. In subchronic oral studies in rats, a no observable adverse effect level of 30 mg / kg / day for 2-Amino-6-Chloro-4-Nitrophenol was determined; at higher doses, increased organ weights were seen. A 2% solution of 2-Amino-6- Chloro-4-Nitrophenol applied under occlusive conditions was found to be non- irritating to rabbits. At 0.1%, 2-Amino-6-Chloro-4-Nitrophenol was nonsensi- tizing; at 2%, there was sufficient skin coloration from the dye that assessment of sensitization was difficult; but no obviously sensitized areas were reported. An oral teratogenicity study in rats showed no birth defects. In one Ames t...","page":1,"pdf":"PRS59.pdf","row_type":"noael_study","study_id":"PRS59_noael_001"} |
| CIR_vision_codex | NOAEL | =30 | mg / kg / day | rat | oral | subchronic | repeated dose toxicity | {"citation":"2; 6; 4","dose":"In subchronic oral studies in rats, a no observable adverse effect level of 30 mg / kg / day for 2-Amino-6-Chloro-4-Nitrophenol was determined; at higher doses, increased organ weights were seen.","effect":"shington, DC 20036, USA. 2-Amino-6-Chloro-4-Nitrophenol and its hydrochloride salt are substituted aromatic compounds that function as colorants in hair dyes. Only the hydrochloride salt is currently reported to be used. 2-Amino-6-Chloro-4- Nitrophenol is poorly absorbed through the skin. Less than 0.25% of 2-Amino- 6-Chloro-4-Nitrophenol found in a nonoxidative hair dye was absorbed. Less than 0.2% of 2-Amino-6-Chloro-4-Nitrophenol found in an oxidative hair dye was absorbed. In subchronic oral studies in rats, a no observable adverse effect level of 30 mg / kg / day for 2-Amino-6-Chloro-4-Nitrophenol was determined; at higher doses, increased organ weights were seen. A 2% solution of 2-Amino-6- Chloro-4-Nitrophenol applied under occlusive conditions was found to be non- irritating to rabbits. At 0.1%, 2-Amino-6-Chloro-4-Nitrophenol was nonsensi- tizing; at 2%, there was sufficient skin coloration from the dye that assessment of sensitization was difficult; but no obviously sensitized areas were reported. An oral teratogenicity study in rats showed no birth defects. In one Ames t...","page":1,"pdf":"PRS59.pdf","row_type":"noael_study","study_id":"PRS59_noael_001"} |
| CIR_vision_codex | NOAEL | =30 | mg / kg / day | rat | oral | subchronic | repeated dose toxicity | {"citation":"2; 6; 4","dose":"In subchronic oral studies in rats, a no observable adverse effect level of 30 mg / kg / day for 2-Amino-6-Chloro-4-Nitrophenol was determined; at higher doses, increased organ weights were seen.","effect":"shington, DC 20036, USA. 2-Amino-6-Chloro-4-Nitrophenol and its hydrochloride salt are substituted aromatic compounds that function as colorants in hair dyes. Only the hydrochloride salt is currently reported to be used. 2-Amino-6-Chloro-4- Nitrophenol is poorly absorbed through the skin. Less than 0.25% of 2-Amino- 6-Chloro-4-Nitrophenol found in a nonoxidative hair dye was absorbed. Less than 0.2% of 2-Amino-6-Chloro-4-Nitrophenol found in an oxidative hair dye was absorbed. In subchronic oral studies in rats, a no observable adverse effect level of 30 mg / kg / day for 2-Amino-6-Chloro-4-Nitrophenol was determined; at higher doses, increased organ weights were seen. A 2% solution of 2-Amino-6- Chloro-4-Nitrophenol applied under occlusive conditions was found to be non- irritating to rabbits. At 0.1%, 2-Amino-6-Chloro-4-Nitrophenol was nonsensi- tizing; at 2%, there was sufficient skin coloration from the dye that assessment of sensitization was difficult; but no obviously sensitized areas were reported. An oral teratogenicity study in rats showed no birth defects. In one Ames t...","page":1,"pdf":"PRS59.pdf","row_type":"noael_study","study_id":"PRS59_noael_001"} |
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 10 | mg/kg bw/day | rat | oral | 6-15 Gestation day | Developmental | SCCP; Korn W.D. Teratogenicity study with “Chlororange (Cos 198)” in Wistar rats; |
NTP_ICE_skin_sensitization 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_sensitization | EC3 | 2.2 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13037; Record_ID=skin_sensitization_invivo_3007; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID9043855; Assay=LLNA; Endpoint=EC3; Response=2.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9043855 |
| NTP_ICE_skin_sensitization | EC3 | 6.85 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13059; Record_ID=skin_sensitization_invivo_3035; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID9043855; Assay=LLNA; Endpoint=EC3; Response=6.85; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9043855 |
SCCS_vision_codex 20 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | human | - | developmental | developmental toxicity | {"citation":"Ref.: 27 3","dose":"Body weight gain and food consumption were reduced in the high dose group.","effect":"bservations and post- mortem findings but the urine was discoloured. Body weight gain and food consumption were reduced in the high dose group. Gross necropsy revealed no treatment related effects. There were no treatment related effects with regard to reproduction e.g. uterus and placenta weights, the number of corpora lutea, litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the foetuses revealed no treatment related findings. Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw. No teratogenic and foetotoxic effects were observed even at the highest dose 90 mg/kg bw which is the NOAEL of developmental toxicity. Ref.: 27 3.3.9. Toxicokinetics Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: 2-amino-6-chloro-4-nitrophenol Batch: GST009-01/30-07 Purity: 99.9% (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Inc","page":20,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_001"} |
| SCCS_vision_codex | NOAEL | =90 | mg/kg bw | human | - | developmental | developmental toxicity | {"citation":"Ref.: 27 3","dose":"Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw.","effect":"ross necropsy revealed no treatment related effects. There were no treatment related effects with regard to reproduction e.g. uterus and placenta weights, the number of corpora lutea, litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the foetuses revealed no treatment related findings. Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw. No teratogenic and foetotoxic effects were observed even at the highest dose 90 mg/kg bw which is the NOAEL of developmental toxicity. Ref.: 27 3.3.9. Toxicokinetics Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: 2-amino-6-chloro-4-nitrophenol Batch: GST009-01/30-07 Purity: 99.9% (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubation time 60 min Number of experience: Two independent experiments GLP: not in compliance The bioavailability of 2-amino-6-chloro-4-nitrophen","page":20,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.065 | mg/kg | human | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","effect":"on 2-amino-6-chloro-4-nitrophenol ____________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) compone","page":25,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_003"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg | human | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","effect":"_____________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a","page":25,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_004"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"dose":"General toxicity The LD50 was considered to be ≥ 2000 mg/kg bw.","effect":"SCCS-rejected applicant NOAEL: Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a ratio between 1:1 and 1:3. General toxicity The LD50 was considered to be ≥ 2000 mg/kg bw. The NOAEL was set at 30 mg/kg bw/day in a subchronic oral toxicity study in rats and for maternal toxicity. It was set at 90 mg/kg bw/day for developmental toxicity. Irritation/sensitisation Chororange was not photo-toxic or photo-allergenic under the conditions of the experiments. It showed to be a skin sensitiser. Dermal absorption According to the SCCP Notes of Guidance, skin samples of more than 1 donor should have been used. Therefore, the study cannot be used for a safety assessment. The figures of experiment A (in","page":25,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_006"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | human | - | developmental | developmental toxicity | {"citation":"Ref.: 27 3","dose":"Body weight gain and food consumption were reduced in the high dose group.","effect":"bservations and post- mortem findings but the urine was discoloured. Body weight gain and food consumption were reduced in the high dose group. Gross necropsy revealed no treatment related effects. There were no treatment related effects with regard to reproduction e.g. uterus and placenta weights, the number of corpora lutea, litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the foetuses revealed no treatment related findings. Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw. No teratogenic and foetotoxic effects were observed even at the highest dose 90 mg/kg bw which is the NOAEL of developmental toxicity. Ref.: 27 3.3.9. Toxicokinetics Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: 2-amino-6-chloro-4-nitrophenol Batch: GST009-01/30-07 Purity: 99.9% (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Inc","page":20,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_001"} |
| SCCS_vision_codex | NOAEL | =90 | mg/kg bw | human | - | developmental | developmental toxicity | {"citation":"Ref.: 27 3","dose":"Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw.","effect":"ross necropsy revealed no treatment related effects. There were no treatment related effects with regard to reproduction e.g. uterus and placenta weights, the number of corpora lutea, litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the foetuses revealed no treatment related findings. Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw. No teratogenic and foetotoxic effects were observed even at the highest dose 90 mg/kg bw which is the NOAEL of developmental toxicity. Ref.: 27 3.3.9. Toxicokinetics Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: 2-amino-6-chloro-4-nitrophenol Batch: GST009-01/30-07 Purity: 99.9% (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubation time 60 min Number of experience: Two independent experiments GLP: not in compliance The bioavailability of 2-amino-6-chloro-4-nitrophen","page":20,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.065 | mg/kg | human | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","effect":"on 2-amino-6-chloro-4-nitrophenol ____________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) compone","page":25,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_003"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg | human | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","effect":"_____________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a","page":25,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_004"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"dose":"General toxicity The LD50 was considered to be ≥ 2000 mg/kg bw.","effect":"SCCS-rejected applicant NOAEL: Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a ratio between 1:1 and 1:3. General toxicity The LD50 was considered to be ≥ 2000 mg/kg bw. The NOAEL was set at 30 mg/kg bw/day in a subchronic oral toxicity study in rats and for maternal toxicity. It was set at 90 mg/kg bw/day for developmental toxicity. Irritation/sensitisation Chororange was not photo-toxic or photo-allergenic under the conditions of the experiments. It showed to be a skin sensitiser. Dermal absorption According to the SCCP Notes of Guidance, skin samples of more than 1 donor should have been used. Therefore, the study cannot be used for a safety assessment. The figures of experiment A (in","page":25,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_006"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | human | - | developmental | developmental toxicity | {"citation":"Ref.: 27 3","dose":"Body weight gain and food consumption were reduced in the high dose group.","effect":"bservations and post- mortem findings but the urine was discoloured. Body weight gain and food consumption were reduced in the high dose group. Gross necropsy revealed no treatment related effects. There were no treatment related effects with regard to reproduction e.g. uterus and placenta weights, the number of corpora lutea, litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the foetuses revealed no treatment related findings. Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw. No teratogenic and foetotoxic effects were observed even at the highest dose 90 mg/kg bw which is the NOAEL of developmental toxicity. Ref.: 27 3.3.9. Toxicokinetics Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: 2-amino-6-chloro-4-nitrophenol Batch: GST009-01/30-07 Purity: 99.9% (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Inc","page":20,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_001"} |
| SCCS_vision_codex | NOAEL | =90 | mg/kg bw | human | - | developmental | developmental toxicity | {"citation":"Ref.: 27 3","dose":"Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw.","effect":"ross necropsy revealed no treatment related effects. There were no treatment related effects with regard to reproduction e.g. uterus and placenta weights, the number of corpora lutea, litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the foetuses revealed no treatment related findings. Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw. No teratogenic and foetotoxic effects were observed even at the highest dose 90 mg/kg bw which is the NOAEL of developmental toxicity. Ref.: 27 3.3.9. Toxicokinetics Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: 2-amino-6-chloro-4-nitrophenol Batch: GST009-01/30-07 Purity: 99.9% (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubation time 60 min Number of experience: Two independent experiments GLP: not in compliance The bioavailability of 2-amino-6-chloro-4-nitrophen","page":20,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.065 | mg/kg | human | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","effect":"on 2-amino-6-chloro-4-nitrophenol ____________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) compone","page":25,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_003"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg | human | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","effect":"_____________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a","page":25,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_004"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"dose":"General toxicity The LD50 was considered to be ≥ 2000 mg/kg bw.","effect":"SCCS-rejected applicant NOAEL: Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a ratio between 1:1 and 1:3. General toxicity The LD50 was considered to be ≥ 2000 mg/kg bw. The NOAEL was set at 30 mg/kg bw/day in a subchronic oral toxicity study in rats and for maternal toxicity. It was set at 90 mg/kg bw/day for developmental toxicity. Irritation/sensitisation Chororange was not photo-toxic or photo-allergenic under the conditions of the experiments. It showed to be a skin sensitiser. Dermal absorption According to the SCCP Notes of Guidance, skin samples of more than 1 donor should have been used. Therefore, the study cannot be used for a safety assessment. The figures of experiment A (in","page":25,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_006"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | human | - | developmental | developmental toxicity | {"citation":"Ref.: 27 3","dose":"Body weight gain and food consumption were reduced in the high dose group.","effect":"bservations and post- mortem findings but the urine was discoloured. Body weight gain and food consumption were reduced in the high dose group. Gross necropsy revealed no treatment related effects. There were no treatment related effects with regard to reproduction e.g. uterus and placenta weights, the number of corpora lutea, litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the foetuses revealed no treatment related findings. Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw. No teratogenic and foetotoxic effects were observed even at the highest dose 90 mg/kg bw which is the NOAEL of developmental toxicity. Ref.: 27 3.3.9. Toxicokinetics Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: 2-amino-6-chloro-4-nitrophenol Batch: GST009-01/30-07 Purity: 99.9% (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Inc","page":20,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_001"} |
| SCCS_vision_codex | NOAEL | =90 | mg/kg bw | human | - | developmental | developmental toxicity | {"citation":"Ref.: 27 3","dose":"Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw.","effect":"ross necropsy revealed no treatment related effects. There were no treatment related effects with regard to reproduction e.g. uterus and placenta weights, the number of corpora lutea, litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the foetuses revealed no treatment related findings. Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw. No teratogenic and foetotoxic effects were observed even at the highest dose 90 mg/kg bw which is the NOAEL of developmental toxicity. Ref.: 27 3.3.9. Toxicokinetics Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: 2-amino-6-chloro-4-nitrophenol Batch: GST009-01/30-07 Purity: 99.9% (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubation time 60 min Number of experience: Two independent experiments GLP: not in compliance The bioavailability of 2-amino-6-chloro-4-nitrophen","page":20,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.065 | mg/kg | human | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","effect":"on 2-amino-6-chloro-4-nitrophenol ____________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) compone","page":25,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_003"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg | human | dermal | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","effect":"_____________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a","page":25,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_004"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"dose":"General toxicity The LD50 was considered to be ≥ 2000 mg/kg bw.","effect":"SCCS-rejected applicant NOAEL: Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a ratio between 1:1 and 1:3. General toxicity The LD50 was considered to be ≥ 2000 mg/kg bw. The NOAEL was set at 30 mg/kg bw/day in a subchronic oral toxicity study in rats and for maternal toxicity. It was set at 90 mg/kg bw/day for developmental toxicity. Irritation/sensitisation Chororange was not photo-toxic or photo-allergenic under the conditions of the experiments. It showed to be a skin sensitiser. Dermal absorption According to the SCCP Notes of Guidance, skin samples of more than 1 donor should have been used. Therefore, the study cannot be used for a safety assessment. The figures of experiment A (in","page":25,"pdf":"sccp_o_047.pdf","row_type":"noael_study","study_id":"sccp_o_047_noael_006"} |
ToxValDB_ECHA_IUCLID 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LOAEL | ~90 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae97e4b0a7c65d1c9ec0; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22556/7/6/2?documentUUID=c3491fb5-58f5-4f28-8f0a-c136ac0622c4; YEAR=2004; ORIGINAL_YEAR=2004; TOXICOLOGICAL_EFFECT=kidney: body weight and weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15837562_15837563:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2ec83e5b774d3b21d2640d9d55fe27d8 |
| ToxValDB_ECHA_IUCLID | NOAEL | =90 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac4ae4b0a7c65d1be54b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22556/7/9/3?documentUUID=c3491fb5-58f5-4f28-8f0a-c136ac0622c4; YEAR=2004; ORIGINAL_YEAR=2004; STUDY_GROUP=ECHA IUCLID:15821786:F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_635c61606142e62a0451be8ad69a191d |
| ToxValDB_ECHA_IUCLID | NOAEL | ~30 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae97e4b0a7c65d1c9ec0; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22556/7/6/2?documentUUID=c3491fb5-58f5-4f28-8f0a-c136ac0622c4; YEAR=2004; ORIGINAL_YEAR=2004; TOXICOLOGICAL_EFFECT=kidney; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15837562_15837563:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_dacf51949b92f396fc1fced55e1799f9 |
UnifiedCodex:CIR:beta.noael_studies 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 30 | mg / kg / day | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=PRS59; REPORT_TITLE=FINAL REPORT ON THE SAFETY ASSESSMENT OF 2-AMINO-6-CHLORO-4-NITROPHENOL AND 2-AMINO-6-CHLORO-4-NITROPHENOL HYDROCHLORIDE; OPINION_NUMBER=PRS59; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=1101; VALUE_TEXT=30; DOSE=In subchronic oral studies in rats, a no observable adverse effect level of 30 mg / kg / day for 2-Amino-6-Chloro-4-Nitrophenol was determined; at higher doses, increased organ weights were seen.; EFFECT=shington, DC 20036, USA. 2-Amino-6-Chloro-4-Nitrophenol and its hydrochloride salt are substituted aromatic compounds that function as colorants in hair dyes. Only the hydrochloride salt is currently reported to be used. 2-Amino-6-Chloro-4- Nitrophenol is poorly absorbed through the skin. Less than 0.25% of 2-Amino- 6-Chloro-4-Nitrophenol found in a nonoxidative hair dye was absorbed. Less than 0.2% of 2-Amino-6-Chloro-4-Nitrophenol found in an oxidative hair dye was absorbed. In subchronic oral studies in rats, a no observable adverse effect level of 30 mg / kg / day for 2-Amino-6-Chloro-4-Nitrophenol was determined; at higher doses, increased organ weights were seen. A 2% solution of 2-Amino-6- Chloro-4-Nitrophenol applied under occlusive conditions was found to be non- irritating to rabbits. At 0.1%, 2-Amino-6-Chloro-4-Nitrophenol was nonsensi- tizing; at 2%, there was sufficient skin coloration from the dye that assessment of sensitization was difficult; but no obviously sensitized areas were reported. An oral teratogenicity study in rats showed no birth defects. In one Ames t...; CITATION=2; 6; 4; CITATION_NUMBERS=[2,6,4]; REFERENCE=2; 6; 4; DETAILS_JSON={"cas_number":"6358-09-4","citation":"2; 6; 4","dose":"In subchronic oral studies in rats, a no observable adverse effect level of 30 mg / kg / day for 2-Amino-6-Chloro-4-Nitrophenol was determined; at higher doses, increased organ weights were seen.","duration":"subchronic","effect":"shington, DC 20036, USA. 2-Amino-6-Chloro-4-Nitrophenol and its hydrochloride salt are substituted aromatic compounds that function as colorants in hair dyes. Only the hydrochloride salt is currently reported to be used. 2-Amino-6-Chloro-4- Nitrophenol is poorly absorbed through the skin. Less than 0.25% of 2-Amino- 6-Chloro-4-Nitrophenol found in a nonoxidative hair dye was absorbed. Less than 0.2% of 2-Amino-6-Chloro-4-Nitrophenol found in an oxidative hair dye was absorbed. In subchronic oral studies in rats, a no observable adverse effect level of 30 mg / kg / day for 2-Amino-6-Chloro-4-Nitrophenol was determined; at higher doses, increased organ weights were seen. A 2% solution of 2-Amino-6- Chloro-4-Nitrophenol applied under occlusive conditions was found to be non- irritating to rabbits. At 0.1%, 2-Amino-6-Chloro-4-Nitrophenol was nonsensi- tizing; at 2%, there was sufficient skin coloration from the dye that assessment of sensitization was difficult; but no obviously sensitized areas were reported. An oral teratogenicity study in rats showed no birth defects. In one Ames t...","endpoint":"repeated dose toxicity","ingredient":"THE SAFETY ASSESSMENT OF 2-AMINO-6-CHLORO-4-NITROPHENOL AND 2-AMINO-6-CHLORO-4-NITROPHENOL HYDROCHLORIDE","loael_value":"","noael_unit":"mg / kg / day","noael_value":"30","page":1,"route":"oral","species":"rat","study_id":"PRS59_noael_001"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.065 | mg/kg | human | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_047; REPORT_TITLE=Opinion on 2-Amino-6-chloro-4-nitrophenol COLIPA N° B99; OPINION_NUMBER=SCCP/0948/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT== 0.065; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...; EFFECT=on 2-amino-6-chloro-4-nitrophenol ____________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a "direct dye", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) compone; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6358-09-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","duration":"","effect":"on 2-amino-6-chloro-4-nitrophenol ____________________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) compone","endpoint":"dermal absorption","ingredient":"2-amino-6-chloro-4-nitrophenol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.065","page":25,"route":"dermal","species":"human","study_id":"sccp_o_047_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =30 | mg/kg | human | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_047; REPORT_TITLE=Opinion on 2-Amino-6-chloro-4-nitrophenol COLIPA N° B99; OPINION_NUMBER=SCCP/0948/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT== 30; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...; EFFECT=_____________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a "direct dye", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6358-09-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","duration":"","effect":"_____________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a","endpoint":"dermal absorption","ingredient":"2-amino-6-chloro-4-nitrophenol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 30","page":25,"route":"dermal","species":"human","study_id":"sccp_o_047_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =30 | mg/kg | human | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_047; REPORT_TITLE=Opinion on 2-Amino-6-chloro-4-nitrophenol COLIPA N° B99; OPINION_NUMBER=SCCP/0948/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT== 30; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...; EFFECT=_____________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a "direct dye", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a ratio between 1:1 and 1:3. General toxicity The LD50 was consi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6358-09-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS...","duration":"","effect":"_____________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-6-chloro-4-nitrophenol) Maximum absorption through the skin A (µg/cm2) = 5.6 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.065 mg/kg No observed adverse effect level (mg/kg) NOAEL = 30 mg/kg (Embryo-foetal development) Margin of Safety NOAEL / SED = 462 3.3.14. Discussion Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a ratio between 1:1 and 1:3. General toxicity The LD50 was consi","endpoint":"dermal absorption","ingredient":"2-amino-6-chloro-4-nitrophenol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 30","page":25,"route":"dermal","species":"human","study_id":"sccp_o_047_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 30 | mg/kg bw | human | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_047; REPORT_TITLE=Opinion on 2-Amino-6-chloro-4-nitrophenol COLIPA N° B99; OPINION_NUMBER=SCCP/0948/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT=30; DOSE=Body weight gain and food consumption were reduced in the high dose group.; EFFECT=bservations and post- mortem findings but the urine was discoloured. Body weight gain and food consumption were reduced in the high dose group. Gross necropsy revealed no treatment related effects. There were no treatment related effects with regard to reproduction e.g. uterus and placenta weights, the number of corpora lutea, litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the foetuses revealed no treatment related findings. Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw. No teratogenic and foetotoxic effects were observed even at the highest dose 90 mg/kg bw which is the NOAEL of developmental toxicity. Ref.: 27 3.3.9. Toxicokinetics Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: 2-amino-6-chloro-4-nitrophenol Batch: GST009-01/30-07 Purity: 99.9% (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Inc; CITATION=Ref.: 27 3; CITATION_NUMBERS=[27,3]; REFERENCE=Ref.: 27 3; DETAILS_JSON={"cas_number":"6358-09-4","citation":"Ref.: 27 3","dose":"Body weight gain and food consumption were reduced in the high dose group.","duration":"developmental","effect":"bservations and post- mortem findings but the urine was discoloured. Body weight gain and food consumption were reduced in the high dose group. Gross necropsy revealed no treatment related effects. There were no treatment related effects with regard to reproduction e.g. uterus and placenta weights, the number of corpora lutea, litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the foetuses revealed no treatment related findings. Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw. No teratogenic and foetotoxic effects were observed even at the highest dose 90 mg/kg bw which is the NOAEL of developmental toxicity. Ref.: 27 3.3.9. Toxicokinetics Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: 2-amino-6-chloro-4-nitrophenol Batch: GST009-01/30-07 Purity: 99.9% (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Inc","endpoint":"developmental toxicity","ingredient":"2-amino-6-chloro-4-nitrophenol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"30","page":20,"route":"","species":"human","study_id":"sccp_o_047_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 90 | mg/kg bw | human | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_047; REPORT_TITLE=Opinion on 2-Amino-6-chloro-4-nitrophenol COLIPA N° B99; OPINION_NUMBER=SCCP/0948/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT=90; DOSE=Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw.; EFFECT=ross necropsy revealed no treatment related effects. There were no treatment related effects with regard to reproduction e.g. uterus and placenta weights, the number of corpora lutea, litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the foetuses revealed no treatment related findings. Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw. No teratogenic and foetotoxic effects were observed even at the highest dose 90 mg/kg bw which is the NOAEL of developmental toxicity. Ref.: 27 3.3.9. Toxicokinetics Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: 2-amino-6-chloro-4-nitrophenol Batch: GST009-01/30-07 Purity: 99.9% (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubation time 60 min Number of experience: Two independent experiments GLP: not in compliance The bioavailability of 2-amino-6-chloro-4-nitrophen; CITATION=Ref.: 27 3; CITATION_NUMBERS=[27,3]; REFERENCE=Ref.: 27 3; DETAILS_JSON={"cas_number":"6358-09-4","citation":"Ref.: 27 3","dose":"Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw.","duration":"developmental","effect":"ross necropsy revealed no treatment related effects. There were no treatment related effects with regard to reproduction e.g. uterus and placenta weights, the number of corpora lutea, litter size, foetal mortality, foetal body weight, birth position and sex ratio. The skeletal and visceral examination of the foetuses revealed no treatment related findings. Conclusion The NOAEL of maternal toxicity is 30 mg/kg bw. No teratogenic and foetotoxic effects were observed even at the highest dose 90 mg/kg bw which is the NOAEL of developmental toxicity. Ref.: 27 3.3.9. Toxicokinetics Biovailability across intestinal barrier in TC-7 (human intestinal epithelial) cells Guideline: / Cells: Human intestinal epithelial cell line TC-7 Test substance: 2-amino-6-chloro-4-nitrophenol Batch: GST009-01/30-07 Purity: 99.9% (HPLC at 254 nm) Test concentration: 50 µM in HBSS buffer containing 1 % DMSO Incubation time 60 min Number of experience: Two independent experiments GLP: not in compliance The bioavailability of 2-amino-6-chloro-4-nitrophen","endpoint":"developmental toxicity","ingredient":"2-amino-6-chloro-4-nitrophenol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"90","page":20,"route":"","species":"human","study_id":"sccp_o_047_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 2000 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_047; REPORT_TITLE=Opinion on 2-Amino-6-chloro-4-nitrophenol COLIPA N° B99; OPINION_NUMBER=SCCP/0948/05; COMMITTEE=SCCP; REPORT_DATE=28 March 2006; VALUE_TEXT=2000; DOSE=General toxicity The LD50 was considered to be ≥ 2000 mg/kg bw.; EFFECT=SCCS-rejected applicant NOAEL: Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a "direct dye", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a ratio between 1:1 and 1:3. General toxicity The LD50 was considered to be ≥ 2000 mg/kg bw. The NOAEL was set at 30 mg/kg bw/day in a subchronic oral toxicity study in rats and for maternal toxicity. It was set at 90 mg/kg bw/day for developmental toxicity. Irritation/sensitisation Chororange was not photo-toxic or photo-allergenic under the conditions of the experiments. It showed to be a skin sensitiser. Dermal absorption According to the SCCP Notes of Guidance, skin samples of more than 1 donor should have been used. Therefore, the study cannot be used for a safety assessment. The figures of experiment A (in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6358-09-4","citation":"","dose":"General toxicity The LD50 was considered to be ≥ 2000 mg/kg bw.","duration":"subchronic","effect":"SCCS-rejected applicant NOAEL: Physico-chemical specifications 2-Amino-6-chloro-4-nitrophenol is intended for use at a maximum on-head concentration of 2% in semi-permanent hair dyes formulations as a \"direct dye\", or as a non-reactive colorant in oxidative hair-dyes formulations. In the latter case, it has been found to be stable under the conditions during oxidative hair-dyeing, with the dye and developer (hydrogen peroxide) components mixed at a ratio between 1:1 and 1:3. General toxicity The LD50 was considered to be ≥ 2000 mg/kg bw. The NOAEL was set at 30 mg/kg bw/day in a subchronic oral toxicity study in rats and for maternal toxicity. It was set at 90 mg/kg bw/day for developmental toxicity. Irritation/sensitisation Chororange was not photo-toxic or photo-allergenic under the conditions of the experiments. It showed to be a skin sensitiser. Dermal absorption According to the SCCP Notes of Guidance, skin samples of more than 1 donor should have been used. Therefore, the study cannot be used for a safety assessment. The figures of experiment A (in","endpoint":"repeated dose toxicity","ingredient":"2-amino-6-chloro-4-nitrophenol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":25,"route":"oral","species":"rat","study_id":"sccp_o_047_noael_006"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 0ZLP5I1TMC | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H5ClN2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0ZLP5I1TMC"} |
| openFDA substances | FDA UNII substance identifier | 0ZLP5I1TMC | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H5ClN2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0ZLP5I1TMC"} |
| openFDA substances | FDA UNII substance identifier | 0ZLP5I1TMC | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H5ClN2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0ZLP5I1TMC"} |
| openFDA substances | FDA UNII substance identifier | 0ZLP5I1TMC | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H5ClN2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0ZLP5I1TMC"} |