Registration Dossier
Registration Dossier
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EC number: 423-930-2 | CAS number: 1184-85-6
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: 92/69/EWG, B.7; OECD 407
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Wistar Hoe: WISKf (SPF71)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: deionisiertes Wasser (deion. water)
- Details on oral exposure:
- Method of administration:
Schlundsonde (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 62.5 mg/kg bw/day
Male: 5 animals at 250 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 62.5 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
Keine behandlungsbedingten Effekte
Laboratory findings:
Die hämatologischen Untersuchungen ergaben erhöhte Werte für
Erythrozytenzahl, Hämoglobin, Hämatokrit und nicht
signifikant erhöhte Werte für MCH und MCHC bei beiden
Geschlechtern der hohen Dosierung, die Weibchen zeigten
ebenfalls erhöhte MCV-Werte. Klinisch-chemisch ergaben sich
erhöhte Harnstoff- und Triglyzeridkonzentrationen bei den
Hochdosismännchen, die Weibchen dieser Dosisgruppe hatten
erniedrigte Triglyzerinwerte. Das Urinvolumen war bei den
Männchen der hohen Dosierung und bei den Weibchen aller
Dosisgruppen erhöht. Bei beiden Geschlechtern waren in der
mittleren und hohen Dosierung die Ketonkörper und
Ascorbinsäure im Harn erhöht (Ausnahme: Männchen der
mittleren Dosierung wiesen keine Ketonkörper auf). Im Urin
der Männchen der hohen Dosierung wurden vermehrt granulierte
Epithelzellen nachgewiesen.
Effects in organs:
Die Organgewichte der Nieren (relativ) und der Nebennieren
(relativ) waren bei den Männchen der hohen Dosierung erhöht.
Mikroskopisch wurden keine behandlungsbedingten Effekte in
den Organen festgestellt.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 250 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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