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Toxicological information

Acute Toxicity: oral

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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:
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
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

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.