Registration Dossier
Registration Dossier
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EC number: 212-344-0 | CAS number: 793-24-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study; original reference in Japanese, compilation of data from English summary and tables
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
- EC Number:
- 212-344-0
- EC Name:
- N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
- Cas Number:
- 793-24-8
- Molecular formula:
- C18H24N2
- IUPAC Name:
- N1-(4-methylpentan-2-yl)-N4-phenylbenzene-1,4-diamine
- Details on test material:
- IUCLID4 Test substance: other TS: purity 99 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Doses:
- 0, 250, 500, 1000, 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 per sex and dose
- Control animals:
- yes
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 005 mg/kg bw
- 95% CL:
- 711 - 1 604
- Remarks on result:
- other: clinical signs, pathological lesions in digestive organs and respiratory
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 893 mg/kg bw
- 95% CL:
- 634 - 1 346
- Remarks on result:
- other: clinical signs, pathological lesions in digestive organs and respiratory
Any other information on results incl. tables
RS-Freetext:
LD50: 1005 mg/kg (95% confidence limit: 711-1604 mg/kg)
MORTALITY:
-Time of death: day 2-4 p.a.
-Number of deaths at each dose males : 0/5, 0/5, 0/5, 2/5, 5/5
-Number of deaths at each dose females: 0/5, 0/5, 0/5, 3/5, 5/5
CLINICAL SIGNS:
from 500 mg/kg males and females: reduced volume of feces;
from 1000 mg/kg: hypoactivity, diarrhea, bradypnea,
hypothermia, prone position;
2000 mg/kg males: abnormal gait
2000 mg/kg: lacrimation, weakness of limbs
NECROPSY FINDINGS:
pathological lesions in digestive organs and respiratory
system
POTENTIAL TARGET ORGANS:
not reported
SEX-SPECIFIC DIFFERENCES:
male rats were less sensitive than female rats
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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