Registration Dossier
Registration Dossier
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EC number: 931-195-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
A 28 day oral toxicity study is available. The top dose level of 1000 mg/kg resulted in slight changes in body weight and liver weight in males.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 days
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Vehicle:
- other: none
- Details on oral exposure:
- Method of administration: gavage
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Test Duration: 28 days
- Frequency of treatment:
- Dosing regime : 7 days/week
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 600 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg/day lower body weight oin day 27 and at the end of the study in males only. Lower dosage no signs of toxicity
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- neutrophils were increased in top dose males
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- decreases in alkaline phosphatase and AST were seen in top dose males and mid and top dose females respectively. All were normal after 2 weeks recovery
- 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):
- 1000 mg/kg/day: relative increase of liver weight in males.
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 600 mg/kg bw/day (nominal)
- Basis for effect level:
- gross pathology
- Critical effects observed:
- not specified
- Conclusions:
- Classified as: Not Classified
- Executive summary:
Limited data provided by ECHA. Not possible to make further conclusions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 600 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study is considered as reliable.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available data, no classification for the repeated toxicity is required fo the substance according to the Regulation EC 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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