Registration Dossier
Registration Dossier
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EC number: 460-450-2 | CAS number: 872728-82-0
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: 96/54/EG, B.7; OECD 407 (1995)
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Wistar CRL:(WI) BR
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: 1 % aqueous methylcellulose
- 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 0 mg/kg bw/day
Male: 5 animals at 50 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 0 mg/kg bw/day
Female: 5 animals at 50 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:
There were no treatment-related deaths or other differences
from control for other parameters measured, including
clinical appearance, body weight, food and water consumption
that were considered to be related to treatment.
There were no abnormalities noted in the functional
observation battery (in sensory reactivity to different
types of stimuli, in grip strength or motor activity).
Laboratory findings:
There were no test substance-related effects on hematology
and clinical biochemistry parameters at termination of the
treatment which could be considered of biological
significance.
Effects in organs:
There were no changes in organ weights, macroscopic and
microscopic examination that were considered to be an effect
of treatment.
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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