Registration Dossier
Registration Dossier
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EC number: 202-870-9 | CAS number: 100-61-8
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- other: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2002
- 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:
- publication
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- The experiments were aimed at comparing exposure of dogs via the oral route and inhalation to analyze the magnitude of error involved with route-to-route extrapolation.
- GLP compliance:
- yes
- Test type:
- other: Exposing of dogs to a sub-lethal concentration.
- Limit test:
- no
Test material
- Reference substance name:
- Aniline
- EC Number:
- 200-539-3
- EC Name:
- Aniline
- Cas Number:
- 62-53-3
- Molecular formula:
- C6H7N
- IUPAC Name:
- aniline
Constituent 1
Test animals
- Species:
- dog
- Strain:
- other: Beagle: Hsd Cpb: DOBE
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- head only
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gas chromatography
- Duration of exposure:
- 4 h
- Remarks on duration:
- A first group was exposed for 4 h continously whereas a second group was exposed 4 periods of 1 h, with a 10-minute break. Twelve days after inhalation, the dogs from the first group were exposed to aniline by oral route (gavage).
- Concentrations:
- Group I: 174 mg/m³; Group II: 155 mg/m³.
- No. of animals per sex per dose:
- 4 dogs per group, not specified per sex.
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: Induction of 5% MetHb formation.
- Effect level:
- 165 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: Analytical results showed that Group I was exposed to 174 ± 8.3 mg/m³ and Group II to 155 ± 8.1 mg/m³, delivered doses are 15 and 13 mg/kg bw, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- other: toxic
- Remarks:
- Through inhalation aniline appeared to be signficantly less toxic than by oral route. Criteria used for interpretation of results: expert judgment
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