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Toxicological information

Endpoint summary

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Description of key information

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Referenceopen allclose all

Endpoint:
short-term repeated dose toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: OECD 408 (1987)
GLP compliance:
yes
Limit test:
no
Species:
other: rat, Wistar
Route of administration:
oral: unspecified
Vehicle:
other: Keine
Details on oral exposure:
Method of administration:
Futter
Duration of treatment / exposure:
Test duration: 90 days
Frequency of treatment:
Dosing regime: 7 days/week
Details on results:
Clinical observations:
Es traten keine vorzeitigen Todesfälle auf.
Klinisch, labordiagnostisch und pathomorphologisch konnten
keine substanzbedingten pathologischen Veränderungen
beobachtet werden.
«ENGLISCH+
No premature mortalities occurred.
Clinically, laboratory-diagnostically and
pathomorphologically, no substance-related pathological
changes could be observed.
Laboratory findings:
Leichte Schwankungen der der hämatologischen und klinischchemischen Parameter entsprachen der biologischen
Variationsbreite der Spezies.
«ENGLISCH+
Slight variations in the haematological and clinico-chemical
parameters corresponded to the range of biological variation
in the species.
Effects in organs:
Lebergewichtserhöhungen ohne histologisches Korrelat bei
weiblichen behandelten Tieren konnten nicht als
Substanzwirkung aufgefaît werden.
«ENGLISCH+
Liver-weight increases without histological correlates among
treated female animals could not be interpreted as being
substance-related.
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Critical effects observed:
not specified
Conclusions:
Classified as: Not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

Justification for classification or non-classification