Registration Dossier
Registration Dossier
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EC number: 629-704-1 | CAS number: 226995-92-2
Endpoint summary
Administrative data
Description of key information
In a reliable acute toxicity study the substance was administered to Wistar rats (10 animals/dose) by oral gavage at a dose level of 5000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity during the 14 day observation period.The oral LD50 is >5000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 August 1997 - 10 September 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA, 16 CFR 1500.3(c)(2)(i)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals/dose
- Control animals:
- no
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived the 5000 mg/kg bw dose.
- Clinical signs:
- other: There were no abnormal systemic observations during the study.
- Gross pathology:
- Animals were not examined for gross pathology.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 is >5000 mg/kg bw.
- Executive summary:
In an acute toxicity study the substance was administered to Wistar rats (10 animals/dose) by oral gavage at a dose level of 5000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity during the 14 day observation period. The oral LD50 is >5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Sufficient to address requirements.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the findings of a reliable acute oral toxicity study conducted on the substance, classification of the substance is not justified.
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