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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
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
other: Read Across Source
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
Principles of method if other than guideline:
METHOD FOLLOWED: Similar to OECD 408; the study
was performed before OECD 408 came into force, but conforms
to a number of the conditions.
GLP: No, study executed before existence of GLP.
STATISTICAL METHODS:Not reported.
METHOD OF CALCULATION:Not reported.
ANALYTICAL METHOD: Not reported.
GLP compliance:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: drinking water
Vehicle:
water
Duration of treatment / exposure:
3 months
Frequency of treatment:
Daily
Dose / conc.:
0 ppm
Dose / conc.:
1 800 ppm
Dose / conc.:
600 ppm
Dose / conc.:
200 ppm
No. of animals per sex per dose:
5/sex/dose (40 animals total)
Control animals:
not specified
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Endocrine findings:
not specified
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
Except for the kidneys, no morphological
changes have been observed in the organs examined. The
observed histological changes in the kidneys (tubule wall
calcinosis, glomerular swelling, tubule swelling, weakening of
the renal tubule cell walls and dilation of the tubule lumen)
were not dose-related and occurred also in the controls.
Cylindrical inclusions in the renal tubular cells were only
observed in the medium dosage group.
Histopathological findings: neoplastic:
no effects observed
Description (incidence and severity):
Except for the kidneys, no morphological
changes have been observed in the organs examined. The
observed histological changes in the kidneys (tubule wall
calcinosis, glomerular swelling, tubule swelling, weakening of
the renal tubule cell walls and dilation of the tubule lumen)
were not dose-related and occurred also in the controls.
Cylindrical inclusions in the renal tubular cells were only
observed in the medium dosage group.
Other effects:
not specified
Key result
Dose descriptor:
NOAEL
Effect level:
> 237 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
body weight and weight gain
clinical biochemistry
clinical signs
food consumption and compound intake
gross pathology
haematology
histopathology: neoplastic
histopathology: non-neoplastic
mortality
organ weights and organ / body weight ratios
urinalysis
water consumption and compound intake
Key result
Dose descriptor:
NOAEL
Effect level:
> 227 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
body weight and weight gain
clinical biochemistry
clinical signs
food consumption and compound intake
gross pathology
haematology
histopathology: neoplastic
histopathology: non-neoplastic
mortality
organ weights and organ / body weight ratios
urinalysis
water consumption and compound intake
Key result
Critical effects observed:
no
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
227 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

Justification for classification or non-classification

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