Registration Dossier
Registration Dossier
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EC number: 408-050-9 | CAS number: 76855-69-1 4-AA; AOSA; AZETIDONE-KANEKA; GR91990X
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V, B7
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- (2R,3R)-3-((R)-1-(tert-butyldimethylsiloxy)ethyl)-4-oxoazetidin-2-yl acetate
- EC Number:
- 408-050-9
- EC Name:
- (2R,3R)-3-((R)-1-(tert-butyldimethylsiloxy)ethyl)-4-oxoazetidin-2-yl acetate
- Cas Number:
- 76855-69-1
- Molecular formula:
- C13H25NO4Si
- IUPAC Name:
- (2R,3R)-3-[(1R)-1-[(tert-butyldimethylsilyl)oxy]ethyl]-4-oxoazetidin-2-yl acetate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
15, 150, 500 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 5 animals (Male or female) for each dose
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
500 mg/kg/day: salivation and urine staining. Decreased bodyweights and slightly decreased food consumption for males only. Slightly long tail flick response time and slightly reduced forelimb grip strenght.
150 mg/kg/day: salivation and urine staining. Decreased bodyweights for males only. Slightly long tail flick response time and slightly reduced forelimb grip strength for males.
Laboratory findings:
500 mg/kg/day: increased white blood cell counts and components of the count. Increased alanine aminotransferase and alkaline phosphatase (male only).
Effects in organs:
500 mg/kg/day: alightly increased liver weight. No histopathological changes.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Dose descriptor:
- NOEL
- Effect level:
- 15 mg/kg bw/day (nominal)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Not classified.
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