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Registration Dossier
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EC number: 416-600-4 | CAS number: -
Repeated dose toxicity: oral
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Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Repeated dose oral toxicity in rodent 28 day study. OECD method no 407, May 12 1981, and Annex to 92/69/EEC 31/7 92 part B.7.
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- other: SPF rat 20 males and 20 females of stock MOL: WIST
- Strain:
- other: SPF rat stock MOL: WIST
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Results of examinations
- Details on results:
- Clinical observations: There were no clinical signs caused by the treatment.
No deaths occured. Laboratory findings: The precentage of gamma globulins in the male rats group 4 was lower than that in the male rats in the control group. No difference was seen in the female rats and the difference was considered incidental. No other differences between groups were seen for the clinical chemical parameters. Effects in organs: None
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- ca. 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
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