Registration Dossier
Registration Dossier
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EC number: 413-110-2 | CAS number: 135861-56-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Body responsible for the test
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD GUIDELINE 401 (1987) 21 CFR 58 (FDA) C(81)30(Final)(OECD)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- male/female
Administration / exposure
- Vehicle:
- corn oil
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
Any other information on results incl. tables
Mortality
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs
Signs of toxicity related to dose levels: Soft stools were noted in 2 females on the day of treatment only. This was not considered as remarkable.
Gross pathology
Effects on organs: No remarkable findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance showed no oral acute toxicity under the condition of the test.
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