NOAEL Studies
Cosmetic Ingredient
PEG-3 2,2'-DI-P-PHENYLENEDIAMINE NOAEL Studies
CAS: 144644-13-3
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
SCCNFP_vision_codex 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg bw | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 13 2","dose":"In the high dose group all animals and some animals of the 25 mg/kg bw group showed mainly intracellular brownish pigmentation of the kidney tubules.","effect":"ood. These changes were reversible as seen in the recovery group. In the high dose group all animals and some animals of the 25 mg/kg bw group showed mainly intracellular brownish pigmentation of the kidney tubules. Furthermore, pigmentation was observed in the thyroid epithelium and in the stroma of the villi of the anterior part of the duodenum. No pigmentation was seen in the target organs of the group 10 mg/kg bw. Only in the high dose group an inflammatory change of the forestomach was observed in males. The NOAEL in this study is 10 mg/kg bw. Ref.: 13 2.3.8. Sub-chronic dermal toxicity No data","page":6,"pdf":"out235_en.pdf","row_type":"noael_study","study_id":"out235_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg bw | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 13 2","dose":"In the high dose group all animals and some animals of the 25 mg/kg bw group showed mainly intracellular brownish pigmentation of the kidney tubules.","effect":"ood. These changes were reversible as seen in the recovery group. In the high dose group all animals and some animals of the 25 mg/kg bw group showed mainly intracellular brownish pigmentation of the kidney tubules. Furthermore, pigmentation was observed in the thyroid epithelium and in the stroma of the villi of the anterior part of the duodenum. No pigmentation was seen in the target organs of the group 10 mg/kg bw. Only in the high dose group an inflammatory change of the forestomach was observed in males. The NOAEL in this study is 10 mg/kg bw. Ref.: 13 2.3.8. Sub-chronic dermal toxicity No data","page":6,"pdf":"out235_en.pdf","row_type":"noael_study","study_id":"out235_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg bw | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 13 2","dose":"In the high dose group all animals and some animals of the 25 mg/kg bw group showed mainly intracellular brownish pigmentation of the kidney tubules.","effect":"ood. These changes were reversible as seen in the recovery group. In the high dose group all animals and some animals of the 25 mg/kg bw group showed mainly intracellular brownish pigmentation of the kidney tubules. Furthermore, pigmentation was observed in the thyroid epithelium and in the stroma of the villi of the anterior part of the duodenum. No pigmentation was seen in the target organs of the group 10 mg/kg bw. Only in the high dose group an inflammatory change of the forestomach was observed in males. The NOAEL in this study is 10 mg/kg bw. Ref.: 13 2.3.8. Sub-chronic dermal toxicity No data","page":6,"pdf":"out235_en.pdf","row_type":"noael_study","study_id":"out235_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg bw | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 13 2","dose":"In the high dose group all animals and some animals of the 25 mg/kg bw group showed mainly intracellular brownish pigmentation of the kidney tubules.","effect":"ood. These changes were reversible as seen in the recovery group. In the high dose group all animals and some animals of the 25 mg/kg bw group showed mainly intracellular brownish pigmentation of the kidney tubules. Furthermore, pigmentation was observed in the thyroid epithelium and in the stroma of the villi of the anterior part of the duodenum. No pigmentation was seen in the target organs of the group 10 mg/kg bw. Only in the high dose group an inflammatory change of the forestomach was observed in males. The NOAEL in this study is 10 mg/kg bw. Ref.: 13 2.3.8. Sub-chronic dermal toxicity No data","page":6,"pdf":"out235_en.pdf","row_type":"noael_study","study_id":"out235_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =45 | mg/kg bw | rat | - | - | dermal absorption | {"citation":"Ref.: 14 2","dose":"The majority of the females in this dose group had dark kidneys and/or black points on the kidneys.","effect":"weight gain were reduced. The majority of the females in this dose group had dark kidneys and/or black points on the kidneys. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) were noted. No substance-related changes in the incidence of visceral and skeletal abnormalities were found, but the reporting of skeletal abnormalities does not allow an evaluation in detail. The NOAEL of embryo/foetotoxicity was 200 mg/kg bw, the NOAEL of maternal toxicity was 45 mg/kg bw in this study. Ref.: 14 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Tissue : Rat clipped dorsal skin (female rats Sprague Dawley strain) Method : in vivo measurement of the absorption from the urinary and faecal excretion, and from the skin residue, carcass and excreta analysis after sacrifice of the animal Test substance : 1,10-bis-(2,5-diaminophenyl)-1,4,7,10-tetraoxadecane (x4 HCl) at the concentration of 4 % in a commercial type for","page":11,"pdf":"out235_en.pdf","row_type":"noael_study","study_id":"out235_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =45 | mg/kg bw | rat | - | - | dermal absorption | {"citation":"Ref.: 14 2","dose":"The majority of the females in this dose group had dark kidneys and/or black points on the kidneys.","effect":"weight gain were reduced. The majority of the females in this dose group had dark kidneys and/or black points on the kidneys. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) were noted. No substance-related changes in the incidence of visceral and skeletal abnormalities were found, but the reporting of skeletal abnormalities does not allow an evaluation in detail. The NOAEL of embryo/foetotoxicity was 200 mg/kg bw, the NOAEL of maternal toxicity was 45 mg/kg bw in this study. Ref.: 14 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Tissue : Rat clipped dorsal skin (female rats Sprague Dawley strain) Method : in vivo measurement of the absorption from the urinary and faecal excretion, and from the skin residue, carcass and excreta analysis after sacrifice of the animal Test substance : 1,10-bis-(2,5-diaminophenyl)-1,4,7,10-tetraoxadecane (x4 HCl) at the concentration of 4 % in a commercial type for","page":11,"pdf":"out235_en.pdf","row_type":"noael_study","study_id":"out235_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =45 | mg/kg bw | rat | - | - | dermal absorption | {"citation":"Ref.: 14 2","dose":"The majority of the females in this dose group had dark kidneys and/or black points on the kidneys.","effect":"weight gain were reduced. The majority of the females in this dose group had dark kidneys and/or black points on the kidneys. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) were noted. No substance-related changes in the incidence of visceral and skeletal abnormalities were found, but the reporting of skeletal abnormalities does not allow an evaluation in detail. The NOAEL of embryo/foetotoxicity was 200 mg/kg bw, the NOAEL of maternal toxicity was 45 mg/kg bw in this study. Ref.: 14 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Tissue : Rat clipped dorsal skin (female rats Sprague Dawley strain) Method : in vivo measurement of the absorption from the urinary and faecal excretion, and from the skin residue, carcass and excreta analysis after sacrifice of the animal Test substance : 1,10-bis-(2,5-diaminophenyl)-1,4,7,10-tetraoxadecane (x4 HCl) at the concentration of 4 % in a commercial type for","page":11,"pdf":"out235_en.pdf","row_type":"noael_study","study_id":"out235_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =45 | mg/kg bw | rat | - | - | dermal absorption | {"citation":"Ref.: 14 2","dose":"The majority of the females in this dose group had dark kidneys and/or black points on the kidneys.","effect":"weight gain were reduced. The majority of the females in this dose group had dark kidneys and/or black points on the kidneys. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) were noted. No substance-related changes in the incidence of visceral and skeletal abnormalities were found, but the reporting of skeletal abnormalities does not allow an evaluation in detail. The NOAEL of embryo/foetotoxicity was 200 mg/kg bw, the NOAEL of maternal toxicity was 45 mg/kg bw in this study. Ref.: 14 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Tissue : Rat clipped dorsal skin (female rats Sprague Dawley strain) Method : in vivo measurement of the absorption from the urinary and faecal excretion, and from the skin residue, carcass and excreta analysis after sacrifice of the animal Test substance : 1,10-bis-(2,5-diaminophenyl)-1,4,7,10-tetraoxadecane (x4 HCl) at the concentration of 4 % in a commercial type for","page":11,"pdf":"out235_en.pdf","row_type":"noael_study","study_id":"out235_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg bw | rat | - | - | dermal absorption | {"citation":"Ref.: 14 2","dose":"p (200 mg/kg bw) maternal food consumption and body weight gain were reduced.","effect":"p (200 mg/kg bw) maternal food consumption and body weight gain were reduced. The majority of the females in this dose group had dark kidneys and/or black points on the kidneys. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) were noted. No substance-related changes in the incidence of visceral and skeletal abnormalities were found, but the reporting of skeletal abnormalities does not allow an evaluation in detail. The NOAEL of embryo/foetotoxicity was 200 mg/kg bw, the NOAEL of maternal toxicity was 45 mg/kg bw in this study. Ref.: 14 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Tissue : Rat clipped dorsal skin (female rats Sprague Dawley strain) Method : in vivo measurement of the absorption from the urinary and faecal excretion, and from the skin residue, carcass and excreta analysis after sacrifice of the animal Test substance : 1,10-bis-(2,5-diaminophenyl)-1,4,7,10-tetraoxadecane (x4 HCl) at t","page":11,"pdf":"out235_en.pdf","row_type":"noael_study","study_id":"out235_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg bw | rat | - | - | dermal absorption | {"citation":"Ref.: 14 2","dose":"p (200 mg/kg bw) maternal food consumption and body weight gain were reduced.","effect":"p (200 mg/kg bw) maternal food consumption and body weight gain were reduced. The majority of the females in this dose group had dark kidneys and/or black points on the kidneys. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) were noted. No substance-related changes in the incidence of visceral and skeletal abnormalities were found, but the reporting of skeletal abnormalities does not allow an evaluation in detail. The NOAEL of embryo/foetotoxicity was 200 mg/kg bw, the NOAEL of maternal toxicity was 45 mg/kg bw in this study. Ref.: 14 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Tissue : Rat clipped dorsal skin (female rats Sprague Dawley strain) Method : in vivo measurement of the absorption from the urinary and faecal excretion, and from the skin residue, carcass and excreta analysis after sacrifice of the animal Test substance : 1,10-bis-(2,5-diaminophenyl)-1,4,7,10-tetraoxadecane (x4 HCl) at t","page":11,"pdf":"out235_en.pdf","row_type":"noael_study","study_id":"out235_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg bw | rat | - | - | dermal absorption | {"citation":"Ref.: 14 2","dose":"p (200 mg/kg bw) maternal food consumption and body weight gain were reduced.","effect":"p (200 mg/kg bw) maternal food consumption and body weight gain were reduced. The majority of the females in this dose group had dark kidneys and/or black points on the kidneys. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) were noted. No substance-related changes in the incidence of visceral and skeletal abnormalities were found, but the reporting of skeletal abnormalities does not allow an evaluation in detail. The NOAEL of embryo/foetotoxicity was 200 mg/kg bw, the NOAEL of maternal toxicity was 45 mg/kg bw in this study. Ref.: 14 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Tissue : Rat clipped dorsal skin (female rats Sprague Dawley strain) Method : in vivo measurement of the absorption from the urinary and faecal excretion, and from the skin residue, carcass and excreta analysis after sacrifice of the animal Test substance : 1,10-bis-(2,5-diaminophenyl)-1,4,7,10-tetraoxadecane (x4 HCl) at t","page":11,"pdf":"out235_en.pdf","row_type":"noael_study","study_id":"out235_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg bw | rat | - | - | dermal absorption | {"citation":"Ref.: 14 2","dose":"p (200 mg/kg bw) maternal food consumption and body weight gain were reduced.","effect":"p (200 mg/kg bw) maternal food consumption and body weight gain were reduced. The majority of the females in this dose group had dark kidneys and/or black points on the kidneys. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) were noted. No substance-related changes in the incidence of visceral and skeletal abnormalities were found, but the reporting of skeletal abnormalities does not allow an evaluation in detail. The NOAEL of embryo/foetotoxicity was 200 mg/kg bw, the NOAEL of maternal toxicity was 45 mg/kg bw in this study. Ref.: 14 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Tissue : Rat clipped dorsal skin (female rats Sprague Dawley strain) Method : in vivo measurement of the absorption from the urinary and faecal excretion, and from the skin residue, carcass and excreta analysis after sacrifice of the animal Test substance : 1,10-bis-(2,5-diaminophenyl)-1,4,7,10-tetraoxadecane (x4 HCl) at t","page":11,"pdf":"out235_en.pdf","row_type":"noael_study","study_id":"out235_en_noael_002"} |
UnifiedCodex:SCCNFP:beta.noael_studies 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 45 | mg/kg bw | rat | - | - | dermal absorption | SOURCE_SUBDIR=out235_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING PEG-3,2’,2’-DI-P-PHENYLENEDIAMINE COLIPA n° A146; OPINION_NUMBER=SCCNFP/0733/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=45; DOSE=The majority of the females in this dose group had dark kidneys and/or black points on the kidneys.; EFFECT=weight gain were reduced. The majority of the females in this dose group had dark kidneys and/or black points on the kidneys. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) were noted. No substance-related changes in the incidence of visceral and skeletal abnormalities were found, but the reporting of skeletal abnormalities does not allow an evaluation in detail. The NOAEL of embryo/foetotoxicity was 200 mg/kg bw, the NOAEL of maternal toxicity was 45 mg/kg bw in this study. Ref.: 14 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Tissue : Rat clipped dorsal skin (female rats Sprague Dawley strain) Method : in vivo measurement of the absorption from the urinary and faecal excretion, and from the skin residue, carcass and excreta analysis after sacrifice of the animal Test substance : 1,10-bis-(2,5-diaminophenyl)-1,4,7,10-tetraoxadecane (x4 HCl) at the concentration of 4 % in a commercial type for; CITATION=Ref.: 14 2; CITATION_NUMBERS=[14,2]; REFERENCE=Ref.: 14 2; DETAILS_JSON={"cas_number":"144644-13-3","citation":"Ref.: 14 2","dose":"The majority of the females in this dose group had dark kidneys and/or black points on the kidneys.","duration":"","effect":"weight gain were reduced. The majority of the females in this dose group had dark kidneys and/or black points on the kidneys. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) were noted. No substance-related changes in the incidence of visceral and skeletal abnormalities were found, but the reporting of skeletal abnormalities does not allow an evaluation in detail. The NOAEL of embryo/foetotoxicity was 200 mg/kg bw, the NOAEL of maternal toxicity was 45 mg/kg bw in this study. Ref.: 14 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Tissue : Rat clipped dorsal skin (female rats Sprague Dawley strain) Method : in vivo measurement of the absorption from the urinary and faecal excretion, and from the skin residue, carcass and excreta analysis after sacrifice of the animal Test substance : 1,10-bis-(2,5-diaminophenyl)-1,4,7,10-tetraoxadecane (x4 HCl) at the concentration of 4 % in a commercial type for","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"45","page":11,"route":"","species":"rat","study_id":"out235_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 200 | mg/kg bw | rat | - | - | dermal absorption | SOURCE_SUBDIR=out235_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING PEG-3,2’,2’-DI-P-PHENYLENEDIAMINE COLIPA n° A146; OPINION_NUMBER=SCCNFP/0733/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=200; DOSE=p (200 mg/kg bw) maternal food consumption and body weight gain were reduced.; EFFECT=p (200 mg/kg bw) maternal food consumption and body weight gain were reduced. The majority of the females in this dose group had dark kidneys and/or black points on the kidneys. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) were noted. No substance-related changes in the incidence of visceral and skeletal abnormalities were found, but the reporting of skeletal abnormalities does not allow an evaluation in detail. The NOAEL of embryo/foetotoxicity was 200 mg/kg bw, the NOAEL of maternal toxicity was 45 mg/kg bw in this study. Ref.: 14 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Tissue : Rat clipped dorsal skin (female rats Sprague Dawley strain) Method : in vivo measurement of the absorption from the urinary and faecal excretion, and from the skin residue, carcass and excreta analysis after sacrifice of the animal Test substance : 1,10-bis-(2,5-diaminophenyl)-1,4,7,10-tetraoxadecane (x4 HCl) at t; CITATION=Ref.: 14 2; CITATION_NUMBERS=[14,2]; REFERENCE=Ref.: 14 2; DETAILS_JSON={"cas_number":"144644-13-3","citation":"Ref.: 14 2","dose":"p (200 mg/kg bw) maternal food consumption and body weight gain were reduced.","duration":"","effect":"p (200 mg/kg bw) maternal food consumption and body weight gain were reduced. The majority of the females in this dose group had dark kidneys and/or black points on the kidneys. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) were noted. No substance-related changes in the incidence of visceral and skeletal abnormalities were found, but the reporting of skeletal abnormalities does not allow an evaluation in detail. The NOAEL of embryo/foetotoxicity was 200 mg/kg bw, the NOAEL of maternal toxicity was 45 mg/kg bw in this study. Ref.: 14 2.7. Toxicokinetics (including Percutaneous Absorption) Guideline : / Tissue : Rat clipped dorsal skin (female rats Sprague Dawley strain) Method : in vivo measurement of the absorption from the urinary and faecal excretion, and from the skin residue, carcass and excreta analysis after sacrifice of the animal Test substance : 1,10-bis-(2,5-diaminophenyl)-1,4,7,10-tetraoxadecane (x4 HCl) at t","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"200","page":11,"route":"","species":"rat","study_id":"out235_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 10 | mg/kg bw | rat | oral | 13 weeks | irritation | SOURCE_SUBDIR=out235_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING PEG-3,2’,2’-DI-P-PHENYLENEDIAMINE COLIPA n° A146; OPINION_NUMBER=SCCNFP/0733/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=10; DOSE=The oral LD50 of A 146 in rats is between 1000 and 2000 mg/kg bw.; EFFECT=2.11. Safety evaluation Not applicable 2.12. Conclusions The absolute content of the test substance in all batches and the impurities in the test material are not described. Log Pow of the test material is not reported, and the information provided on solubility and stability of the test substance is insufficient. The oral LD50 of A 146 in rats is between 1000 and 2000 mg/kg bw. The target organ in the 13 weeks oral toxicity study in rats was mainly the kidney showing brownish pigmentation in the tubuli. The NOAEL was 10 mg/kg bw. The NOAEL of embryo/foetotoxicity in a rat study was 200 mg/kg bw. The substance was classified non-irritant to the skin and slightly irritant to the eye. It was classified as an extreme sensitiser under the conditions of the test in the guinea pig.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"144644-13-3","citation":"","dose":"The oral LD50 of A 146 in rats is between 1000 and 2000 mg/kg bw.","duration":"13 weeks","effect":"2.11. Safety evaluation Not applicable 2.12. Conclusions The absolute content of the test substance in all batches and the impurities in the test material are not described. Log Pow of the test material is not reported, and the information provided on solubility and stability of the test substance is insufficient. The oral LD50 of A 146 in rats is between 1000 and 2000 mg/kg bw. The target organ in the 13 weeks oral toxicity study in rats was mainly the kidney showing brownish pigmentation in the tubuli. The NOAEL was 10 mg/kg bw. The NOAEL of embryo/foetotoxicity in a rat study was 200 mg/kg bw. The substance was classified non-irritant to the skin and slightly irritant to the eye. It was classified as an extreme sensitiser under the conditions of the test in the guinea pig.","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"10","page":15,"route":"oral","species":"rat","study_id":"out235_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 200 | mg/kg bw | rat | oral | 13 weeks | irritation | SOURCE_SUBDIR=out235_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING PEG-3,2’,2’-DI-P-PHENYLENEDIAMINE COLIPA n° A146; OPINION_NUMBER=SCCNFP/0733/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=200; DOSE=The oral LD50 of A 146 in rats is between 1000 and 2000 mg/kg bw.; EFFECT=Not applicable 2.12. Conclusions The absolute content of the test substance in all batches and the impurities in the test material are not described. Log Pow of the test material is not reported, and the information provided on solubility and stability of the test substance is insufficient. The oral LD50 of A 146 in rats is between 1000 and 2000 mg/kg bw. The target organ in the 13 weeks oral toxicity study in rats was mainly the kidney showing brownish pigmentation in the tubuli. The NOAEL was 10 mg/kg bw. The NOAEL of embryo/foetotoxicity in a rat study was 200 mg/kg bw. The substance was classified non-irritant to the skin and slightly irritant to the eye. It was classified as an extreme sensitiser under the conditions of the test in the guinea pig.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"144644-13-3","citation":"","dose":"The oral LD50 of A 146 in rats is between 1000 and 2000 mg/kg bw.","duration":"13 weeks","effect":"Not applicable 2.12. Conclusions The absolute content of the test substance in all batches and the impurities in the test material are not described. Log Pow of the test material is not reported, and the information provided on solubility and stability of the test substance is insufficient. The oral LD50 of A 146 in rats is between 1000 and 2000 mg/kg bw. The target organ in the 13 weeks oral toxicity study in rats was mainly the kidney showing brownish pigmentation in the tubuli. The NOAEL was 10 mg/kg bw. The NOAEL of embryo/foetotoxicity in a rat study was 200 mg/kg bw. The substance was classified non-irritant to the skin and slightly irritant to the eye. It was classified as an extreme sensitiser under the conditions of the test in the guinea pig.","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"200","page":15,"route":"oral","species":"rat","study_id":"out235_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 10 | mg/kg bw | - | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out235_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING PEG-3,2’,2’-DI-P-PHENYLENEDIAMINE COLIPA n° A146; OPINION_NUMBER=SCCNFP/0733/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=10; DOSE=In the high dose group all animals and some animals of the 25 mg/kg bw group showed mainly intracellular brownish pigmentation of the kidney tubules.; EFFECT=ood. These changes were reversible as seen in the recovery group. In the high dose group all animals and some animals of the 25 mg/kg bw group showed mainly intracellular brownish pigmentation of the kidney tubules. Furthermore, pigmentation was observed in the thyroid epithelium and in the stroma of the villi of the anterior part of the duodenum. No pigmentation was seen in the target organs of the group 10 mg/kg bw. Only in the high dose group an inflammatory change of the forestomach was observed in males. The NOAEL in this study is 10 mg/kg bw. Ref.: 13 2.3.8. Sub-chronic dermal toxicity No data; CITATION=Ref.: 13 2; CITATION_NUMBERS=[13,2]; REFERENCE=Ref.: 13 2; DETAILS_JSON={"cas_number":"144644-13-3","citation":"Ref.: 13 2","dose":"In the high dose group all animals and some animals of the 25 mg/kg bw group showed mainly intracellular brownish pigmentation of the kidney tubules.","duration":"Sub-chronic","effect":"ood. These changes were reversible as seen in the recovery group. In the high dose group all animals and some animals of the 25 mg/kg bw group showed mainly intracellular brownish pigmentation of the kidney tubules. Furthermore, pigmentation was observed in the thyroid epithelium and in the stroma of the villi of the anterior part of the duodenum. No pigmentation was seen in the target organs of the group 10 mg/kg bw. Only in the high dose group an inflammatory change of the forestomach was observed in males. The NOAEL in this study is 10 mg/kg bw. Ref.: 13 2.3.8. Sub-chronic dermal toxicity No data","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"10","page":6,"route":"dermal","species":"","study_id":"out235_en_noael_001"} |