Registration Dossier
Registration Dossier
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EC number: 424-380-6 | CAS number: 43057-68-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- other: Rat (Sprague Dawley (CD))
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- corn oil
- Duration of exposure:
- 24 h
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- 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:
- Signs of toxicity related to dose levels:
There were no mortalities and no evidence of a systemic
response in any animal throughout the syudy. A slight
bodyweight loss and/or a slight reduction in bodyweight gain
was seen in 3 females. All other animals showed normal
bodyweight gains. - Gross pathology:
- Effects on organs:
No macroscopic abnormalities were observed. - Other findings:
- Signs of toxicity (local):
Transient slight to well defined erythema with or without
well defined oedema was seen in all animals resolving
completely by Day 7. Desquamation of the treatment site was
noted for one female on Day 3 only. In addition, residual
test substance staining of the treatment site was observed
in all rats, resolving by Day 8.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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