Registration Dossier
Registration Dossier
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EC number: 201-983-0 | CAS number: 90-30-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
Materials and methods
- Principles of method if other than guideline:
- The experiments reported herein were conducted according to the "Guide for the Care and Use of Laboratory Animals", DHEW 78-23. Toxicity screening designed to evaluate the acute toxicity of N-phenyl-α-naphthylamine by use of the following test: Single Dose Oral LD50 in Rats
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N-1-naphthylaniline
- EC Number:
- 201-983-0
- EC Name:
- N-1-naphthylaniline
- Cas Number:
- 90-30-2
- Molecular formula:
- C16H13N
- IUPAC Name:
- N-phenylnaphthalen-1-amine
- Details on test material:
- - Name of test material (as cited in study report): N-phenyl-α-naphthylamine
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: for at least 16 hours prior to administration
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- DOSAGE PREPARATION: Solutions of the test material were prepared such that precalculated doses could be given using dose volumes of 0.01 ml per gram of body weight.
- Doses:
- 500, 1000, 2000, 4000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
Rats were weighed individually at the time of testing to determine the proper injection volume. Any deaths occuring during this observation period were included in the final mortality figures. - Statistics:
- Mortality data was treated statistically using the moving average interpolation method of Weil (1952) for LD50 and 95 % confidence limits determinations.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 625 mg/kg bw
- 95% CL:
- ca. 1 201 - 2 197
- Mortality:
- 500 mg/kg: 0 dead/5 alive
1000 mg/kg: 0/5
2000 mg/kg: 4/5
4000 mg/kg: 5/5 - Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 4
- Remarks:
- EU GHS criteria
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