Registration Dossier
Registration Dossier
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EC number: 203-656-8 | CAS number: 109-21-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
- Principles of method if other than guideline:
- There are no details on the study protocol. The test material was applied to the skin of 10 rabbits. Mortality and/or systemic effects were observed over a 14 day period. Gross necropsy was conducted on all animals.
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Butyl butyrate
- EC Number:
- 203-656-8
- EC Name:
- Butyl butyrate
- Cas Number:
- 109-21-7
- Molecular formula:
- C8H16O2
- IUPAC Name:
- butyl butanoate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No information given
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- Not specified.
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 (sex not specified)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died.
- Clinical signs:
- other: There were no effects observed
- Gross pathology:
- Necropsy findings were routine and not compound-related.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not acute dermal toxic. The LD50 is > 5000 mg/kg bw.
- Executive summary:
In the current study the acute dermal toxicity of the test item was assessed in rabbits. The study was not according to OECD and GLP was not specified.
The test material was applied to the skin of 10 rabbits. Mortality and systemic effects were observed over a period of 14 days. Gross necropsy was conducted on all animals. The dose used was 5000 mg/kg bw.
No animals died during the course of the study and no specific compound-related effects were observed. Therefore, the dermal acute LD50 is > 5000 mg/kg bw.
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