Registration Dossier
Registration Dossier
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EC number: 480-430-7 | 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: 96/54/EG, B.7; OECD 407 (1995)
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Wistar Rj:WI (IOPS HAN)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: diet
- Details on oral exposure:
- Method of administration:
oral - 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 40.4 mg/kg bw/day
Male: 5 animals at 399 mg/kg bw/day
Male: 5 animals at 800 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 47.3 mg/kg bw/day
Female: 5 animals at 460 mg/kg bw/day
Female: 5 animals at 917 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
There were no mortalities and no test substance-related
clinical signs. Body weight and food consumption parameters
were unaffected by treatment in either sex at any dose level
during the course of the study.
No test substance-related effects were detected during 'open
field' observations, assessment of sensory function, and
forelimb and hindlimb grip strength as well as in overall
exploratory locomotor activity in males and females at any
dose level.
Laboratory findings:
No test substance-related differences in haematology,
clinical biochemistry and urinalysis parameters were noted
when compared with the control values.
Effects in organs:
There were no changes in organ weights, macroscopic and
microscopic examination that were considered to be an effect
of treatment with the test substance.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 800 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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