12-hydroxystearic acid

Acute Toxicity: oral

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

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

Test material information

Constituent 1

Reference substance name:

Castor oil, hydrogenated

EC Number:

232-292-2

EC Name:

Castor oil, hydrogenated

Cas Number:

8001-78-3

IUPAC Name:

8001-78-3

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 or test system 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:

other: 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.