Registration Dossier
Registration Dossier
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EC number: 428-410-9 | CAS number: 67014-36-2
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: 28 days repeated dose toxicity study (oral)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- other: not verifiable
- Rationale for reliability incl. deficiencies:
- other: no information given in SNIF-file
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 998
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 material
- Reference substance name:
- -
- EC Number:
- 428-410-9
- EC Name:
- -
- Cas Number:
- 67014-36-2
- Molecular formula:
- C8H9N3O
- IUPAC Name:
- 5-amino-6-methyl-2,3-dihydro-1H-1,3-benzodiazol-2-one
Constituent 1
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: Magensonde
- 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 3 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 75 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 3 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 75 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
Es traten keine Verhaltensstörungen auf. Bei den Weibchen der hohen Dosisgruppe wurde ab dem 22. Tag eine signifikante Verminderung des Körpergewichts im Vergleich zu den Kontrollen beobachtet. In der Tendenz (nicht signifikant) wurden auch leicht niedrigere Körpergewichte bei den Weibchen der mittleren Dosisgruppe festgestellt.
Laboratory findings:
Es traten keine toxikologisch relevanten Veränderungen auf.
Effects in organs:
Makroskopisch und mikroskopisch wurden keine substanzbedingten toxikologisch relevanten Veränderungen gefunden.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 15 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 5 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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