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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an accepted protocol. No data on GLP compliance.
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Not applicable.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cutina hr solution, also known as castor oil, hydrogenated

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 155 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Doses:
10,000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
Not reported
Statistics:
Not reported

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: None
Mortality:
No mortality occurred
Clinical signs:
No signs of toxicity observed
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the acute toxicity of castor oil, hydrogenated to rat was determined to be >10,000 mg/kg bw.
Executive summary:

A study was conducted to assess the acute toxicity of the test substance to rat according to a method similar/equivalent to OECD Guideline 401.

A group of 10 male Wistar rats were treated with the test substance prepared as a 25% solution in olive oil. The solution was administered by means of a stomach tube at a dosage of 10,000 mg/kg bw.

Under the conditions of the study, the acute toxicity of the test substance to rat was determined to be >10,000 mg/kg bw.