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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. However the reliability is estimated to be at level 1: Study conducted in accordance with generally accepted scientific principles. Possible deficiencies do not affect the quality of relevant results.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 401 (1987), 21 CFR 58 (FDA) C(81)30 (final) (OECD)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Albino rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Doses:
Male: 5000 mg/kg bw
Female: 5000 mg/kg bw
No. of animals per sex per dose:
Male: number of animals 5
Female: number of animals 5

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
not specified
Mortality:
Male: number of deaths: 0
Female: 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 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