Registration Dossier
Registration Dossier
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EC number: 203-921-8 | CAS number: 111-92-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data only given as summary tables but acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 954
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- according to Draize et al. (1944): J. Pharmacol. & Exper. Therap. 82, 377
Penetration of rabbit skin is estimated by a technique closely skin to the one-day cuff method of Draize and associates, using groups of four male albinorabbits weighing 2.5 to 3.5 kg. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film.The animals are immobilized during the 24 hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14 day observation period. - GLP compliance:
- no
Test material
- Reference substance name:
- Dibutylamine
- EC Number:
- 203-921-8
- EC Name:
- Dibutylamine
- Cas Number:
- 111-92-2
- Molecular formula:
- C8H19N
- IUPAC Name:
- N-butylbutan-1-amine
- Details on test material:
- Di-n-butylamine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- Method according to Draize (Draize et al., 1944, Methods for study of irritation an toxicity of substances applied topically to the skin
and mucous membranes; J. Pharmacol. Exper. Therap. 82:377, 1944) - Duration of exposure:
- 24 h
- Doses:
- no data
- No. of animals per sex per dose:
- 4 (males only)
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 768 mg/kg bw
- 95% CL:
- 620 - 1 130
- Remarks on result:
- other: original value: 1.01 ml/kg bw
- Mortality:
- no data
- Clinical signs:
- no data
- Body weight:
- no data
- Gross pathology:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The LD50 value of the test substance was found to be 768 mg/kg bw after a contact period of 24 hours.
- Executive summary:
Penetration of New Zealand White rabbit skin is estimated by a technique closely skin to the one-day cuff method of Draize and associates, using groups of four male rabbits weighing 2.5 to 3.5 kg. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film.The animals are immobilized during the 24 hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14 day observation period. The LD50 value of the test substance was found to be 768 mg/kg bw.
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