Registration Dossier
Registration Dossier
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EC number: 617-180-7 | CAS number: 80875-98-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Test performed accoding to OECD Guideline of 12/05/1981
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD of 12/05/1981
- Principles of method if other than guideline:
- Substance administrated to a group of 10 animals (5 males/5 females) : dose = 5000mg/kg in aqueous solution (20ml/kg).
Mortality, general behaviour and weight evolution of animals have been controlled during a 14 days period after single administration.
Anatomopathologic examination was performed on each animal at the end of the study. - GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- (2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid
- EC Number:
- 617-180-7
- Cas Number:
- 80875-98-5
- Molecular formula:
- C9 H15 N O2
- IUPAC Name:
- (2S,3aS,7aS)-Octahydro-1H-indole-2-carboxylic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- Cream to white powder
Constituent 1
- Specific details on test material used for the study:
- OP 1/87 SI
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Doses:
- Single dose = 5000mg/kg in aqueous solution (20ml/kg).
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat. (total fraction)
- Mortality:
- No mortality
- Clinical signs:
- other: No significant clinical signs
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD 50 oral/rat > 5000mg/kg
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