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Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. However the reliability is estimated to be at level 1: Study conducted in accordance with generally accepted scientific principles. Possible deficiencies do not affect the quality of relevant results.
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no
Test material information:
Composition 1
Species:
other: Rat (Crj: CD(SD))
Route of administration:
oral: unspecified
Vehicle:
olive oil
Details on oral exposure:
Method of administration:
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: 6 animals at 0 mg/kg bw/day
Male: 6 animals at 8 mg/kg bw/day
Male: 6 animals at 40 mg/kg bw/day
Male: 6 animals at 200 mg/kg bw/day
Male: 6 animals at 1000 mg/kg bw/day
Female: 6 animals at 0 mg/kg bw/day
Female: 6 animals at 8 mg/kg bw/day
Female: 6 animals at 40 mg/kg bw/day
Female: 6 animals at 200 mg/kg bw/day
Female: 6 animals at 1000 mg/kg bw/day
Clinical signs:
no effects observed
Description (incidence and severity):
There were no deaths during the study period. No treatment-related observations.
Mortality:
no mortality observed
Description (incidence):
There were no deaths during the study period. No treatment-related observations.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No abnormalities were noted in the dosing period.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
No abnormalities were noted during the dosing period.
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Description (incidence and severity):
No abnormalities were noted at the end of the study period.
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
Increased absolute and relative liver weights were noted in males of the 1000 mg/kg/day dose group. No other related changes were noted.
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
No treatment-related effects were observed.
Histopathological findings: neoplastic:
no effects observed
Details on results:
Cyst formation in the kidney was noted in both sexes of the
1000 mg/kg/day dose groups. This was not considered due be
due to the test substance as this observation is common in
this strain of rat and was also noted in control group
animals.
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
200 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:
subacute
Species:
rat

Mode of Action Analysis / Human Relevance Framework

Additional information

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
In a 28-d repeated oral toxicity GLP study in CD(SD) rats, the NOAEL value was 1000 mg/kg bw/day.

Justification for classification or non-classification