Registration Dossier
Registration Dossier
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EC number: 438-020-0 | CAS number: 3159-07-7
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V, B7
- GLP compliance:
- yes
- Limit test:
- yes
Test animals
- Species:
- other: Rat (Wistar)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: 1% aqueous caboxymethyl cellulose
- Details on oral exposure:
- Method of administration:
Gavage - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 25 mg/kg bw/day
Male: 5 animals at 250 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 25 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
At a dose level of 1000mg Lactam 204,636/kg/day there were
no compound-related clinical changes and no effects on
bodyweight or food consumption.
Laboratory findings:
At a dose level of 1000mg Lactam 204,636/kg/day there were
minimal changes in some clinical chemistry parameters,
namely an increase in creatinine and plasma glucose.
At a dose level of 250mg Lactam 204,636/kg/day there was a
minimal reduction in plasma cholesterol.
Effects in organs:
At a dose level of 1000mg Lactam 204,636/kg/day there was a
slight reduction in brain and spleen weights (of
approximately 15 and 5% respectively). There were no
compound-related changes in macroscopic or microscopic
histopathology.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 25 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
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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