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Registration Dossier
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EC number: 812-491-6 | CAS number: 1312943-23-9
Acute Toxicity: dermal
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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:
- guideline study without detailed documentation
- Remarks:
- This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- corn oil
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 5 male and 5 female per dose
- Control animals:
- not specified
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- not specified
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: No deaths or signs of toxicity were observed.
- Gross pathology:
- No treatment-related effects on organs were observed
- Other findings:
- Signs of toxicity (local): At the site of treatment, spots with crusts were noted in 2 females on day 8 and 1 female on day 15
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 for the acute dermal exposure of rats to the test item was determined to be > 2000 mg/kg b.w., the only concentration tested.
- Executive summary:
The acute dermal toxicity of the test item was determined in a guideline limit test with male and female wistar rats at a dose level of 2000 mg/kg b.w. The LD50 was determined to be > 2000 mg/kg b.w., the only concentration tested. No deaths or effects on organs were observed. At the site of treatment, spots with crusts were noted in 2 females on day 8 and 1 female on day 15. The test item does not meet the GHS criteria and is not classified.
The study is a GLP compliant, guideline study suitable for use for assessment of this endpoint, with restrictions.
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