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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 for cross-reference:
reference to same study
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

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.