Registration Dossier
Registration Dossier
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EC number: 427-090-8 | CAS number: 116044-44-1
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- A mixture of: ethyl (2R,3R)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate; ethyl (2S,3S)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate
- EC Number:
- 427-090-8
- EC Name:
- A mixture of: ethyl (2R,3R)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate; ethyl (2S,3S)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate
- Cas Number:
- 116044-44-1
- IUPAC Name:
- bis(ethyl (2R,3R)-3-(propan-2-yl)bicyclo[2.2.1]hept-5-ene-2-carboxylate)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50, 150 and 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 150 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Biochemical and histopathological effects seen at top dose (1000 mg/kg)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on histopathological changes seen in the liver and biochemical changes at the top dose, a no effect level of 150mg/kg has been established in the rat.
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