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Registration Dossier
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EC number: 454-140-6 | CAS number: 376608-71-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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 420 (Acute Oral Toxicity - Fixed Dose Method)
- 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, 113-116, 1992.
(B.1 bis Acute Toxicity (Oral) Fixed Dose Method). - GLP compliance:
- yes
- Test type:
- fixed dose procedure
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:
- female
- Details on test animals or test system and environmental conditions:
- Rat - Wistar (Alpk:APfSD)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% w/v aqueous carboxymethylcellulose
- Doses:
- Dose 300mg/kg 50 mg/kg
Number animals 1 5 - No. of animals per sex per dose:
- Preliminary sighting study: 0 (male)
Preliminary sighting study: 1 (female)
Main study: 0 (male)
Main study: 5 (female) - Details on study design:
- Main study:
50 mg/kg
Results and discussion
- Preliminary study:
- Species/strain: Rat - Wistar (Alpk:APfSD)
300 mg/kg bw: Evident toxicity: Y; Mortality: Y
Effect levels
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 50 mg/kg bw
- Remarks on result:
- other: No. with evident toxicity: 5; No. of deaths: 0; No. of animals used: 5
- Clinical signs:
- other: Signs of toxicity: No deaths. Signs of toxicity on day 1 only.
- Gross pathology:
- Effects on organs:
None - Other findings:
- Dose 300mg/kg 50 mg/kg
Number animals 1 5
sex female female
mortality 1 0
Clinical signs :
prostration splayed gait
tremors Piloerection, lacrymation
cyanosis Salivation, stained nose,
reduced splay reflex
Gross necropsy :
no macroscopic no macroscopic
effects effects
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information
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