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EC number: 233-477-0 | CAS number: 10193-36-9
Toxicological information
Endpoint summary
Administrative data
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
- 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
Reference
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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