Registration Dossier
Registration Dossier
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EC number: 457-750-0 | CAS number: -
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: Method B.7 Including functional observation battery for neurological signs.
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: Rat, Crl:HanWist(Glx/BRL) BR
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Suspension in corn oil
- 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 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
There were very few clinical signs observed, all of which
were within the normal range of observations seen in control
animals. No clinical signs considered to be treatment
related.
Laboratory findings:
No significant findings
Effects in organs:
No significant effect
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:
- > 1 000 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
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