Registration Dossier
Registration Dossier
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EC number: 620-448-6 | CAS number: 566200-79-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study followed a guideline similar to OECD 401
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- Preliminary study: 125, 250, 500, 1000 and 2000 mg/kg
Definitive study: 2000 mg/kg - No. of animals per sex per dose:
- Number of animals used in preliminary study: 2
Number of animals used in definitive study: 5 - Control animals:
- no
- Details on study design:
- A preliminary study was conducted to determine the dose range for the definitive test. As the preliminary study reported no abnormalities in rats up to a dose of 2000 mg/kg, a limit test was carried out for the definitive test. Treated rats were observed for a period of 14 days and clinical observations (e.g. mortality, body weight) were recorded.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed
- Clinical signs:
- other: No abnormal clinical signs were observed
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study the oral LD50 to female rats (Sprague-Dawley) was >2000 mg/kg
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