Registration Dossier
Registration Dossier
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EC number: 406-310-6 | CAS number: 82717-96-2
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: OECD 407 (1981)
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Wistar Hoe:WISKf (SPF 71)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Sesamöl "ENGLISH" sesame oil
- Details on oral exposure:
- Method of administration:
Magensonde (by 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 30 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 750 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 30 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 750 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
Es traten weder vorzeitige Todesfälle noch Anzeichen für
klinische Toxizität auf. Futter- und Wasseraufnahme sowie
Gewichtsentwicklung entsprachen den Kontrollwerten.
"ENGLISH"
Neither premature mortalities nor signs of clinical toxicity
occurred. The feed and water intake as well as the weight
development corresponded to that of the controls.
Laboratory findings:
Hämatologisch zeigten sich keine Veränderungen.
Klinisch-chemisch wurden Schwankungen einiger Meßparameter
beobachtet, die aber weder signifikant unterschiedlich noch
dosiswirkungsspezifisch waren und somit toxikologisch nicht
relevant bewertet wurden.
"ENGLISH"
Haematologically, there were no changes.
Clinico-chemically, there was some variance in a few
measurement parameters. However, this was neither
significantly different nor dose-specific. Consequently, it
was not regarded as toxicologically relevant.
Effects in organs:
Morphologisch ergaben sich keine substanzbedingten
pathologischen Befunde.
"ENGLISH"
Morphologically, there were no substance-related
pathological findings.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 750 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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