Registration Dossier
Registration Dossier
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EC number: 454-140-6 | CAS number: 376608-71-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Annex V to Council Directive 67/548/EEC on the approximation
of laws, regulations and administrative provisions relating
to the classification, packaging and labelling of dangerous
substances, published in the Seventeenth Adaptation,
Commission Directive 92/69/EEC, OJEC L383A, 121-123, 1992.
(B.3 : Acute Toxicity (Dermal)). - GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 454-140-6
- EC Name:
- -
- Cas Number:
- 376608-71-8
- Molecular formula:
- C9H9F2N*C8H8O3
- IUPAC Name:
- (1R)-2-(3,4-difluorophenyl)cyclopropan-1-aminium (2R)-2-hydroxy-2-phenylacetate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: N/A
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Male: 2000 mg/kg bw; Number of animals: 5
Female: 2000 mg/kg bw; Number of animals: 5
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:
- other: Signs of toxicity related to dose levels: None
- Gross pathology:
- Effects on organs:
No treatment-related abnormalities. - Other findings:
- Signs of toxicity (local):
Signs of skin irritation were seen in all animals but, with
the exception of desquamation in one female, had completely
resolved by the end of the study.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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