Registration Dossier
Registration Dossier
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EC number: 468-670-0 | 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
- Principles of method if other than guideline:
- - EC Directive 96/54/EEC, B.7 Repeated Dose (28 days)
Toxicity (oral), 1996.
- OECD 407, Repeated Dose 28-day Oral Toxicity Study in
Rodents, 1995
- OPPTS 870.3050, Repeated dose 28-day oral toxicity study
in rodents. Office of Prevention, Pesticides and Toxic
Substances (7101), EPA 712-C-00-366, 2000. - GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: Rat, Wistar Crl:(WI) BR
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- propylene glycol
- Details on oral exposure:
- Method of administration:
Gavage - Duration of treatment / exposure:
- Test duration: 28 days
- 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 150 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 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 no changes in clinical appearance, performance of
functional observations, body weight and food consumption
measurements that were considered to be of toxicological
significance.
Laboratory findings:
There were no changes or alterations during haematological
investigations that were considered to be of toxicological
significance.
Effects in organs:
There were no changes in macroscopic examination that were
considered to be of toxicological significance.
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:
- < 50 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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