(10R)-10-hydroxyoctadecanoic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Hydroxystearic acid deposition and metabolism in rats fed hydrogenated castor oil

Author:

Binder, R.G. et al.

Year:

1970

Bibliographic source:

Lipids 5(10):832-837

Materials and methods

Principles of method if other than guideline:

- Principle of test: In a 90-days oral repeated dose toxicity study female rats were given feed mixed with hydrogenated castor oil. The castor oil contained 86.5% 12-hydroxystearic acid.
- Parameters analysed / observed: Mortality, body weight, organ weights, histopathology, hematological parameters

GLP compliance:

no

Test type:

other: 90-days oral repeated dose toxicity

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rat

Strain:

not specified

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: After weaning
- Diet: Commercial rat diet

Administration / exposure

Route of administration:

oral: feed

Vehicle:

other: first feeding trial: unchanged (no vehicle); second feeding trial: corn oil

Details on oral exposure:

Second feeding trial: The test substance was dissolved in corn oil before being added to the diet. The diet contained 1% test substance and 19% corn oil, 5% test substance and 5% corn oil or 10% test substance and 10% corn oil, respectively. respectively.

Doses:

First feeding trial: 5, 10 and 20%
Second feeding trial: 1, 5 and 10%
Assuming a food consumption of 20 grams per animal and day, and an average weight of 250 grams, the dose levels 1, 5, 10 and 20% of the test substance were equivalent to 692, 3460, 6920, and 13840 mg/kg bw/day.

No. of animals per sex per dose:

3

Control animals:

yes

Remarks:

Commercial rat diet was chosen for the control animals of the first feeding trial. The control diet of the second feedring trail contained 20% corn oil.

Details on study design:

- Necropsy of survivors performed: Yes, numerous tissues (organs not specified) were preserved in 10% formaldehyde for microscopic pathological examination.
- Other examinations performed: Prior to autopsy, blood samples were taken for hematological study (hematological parameters not specified). Body weights (determination of body weights not specified) and organ weights (organs weighed not specified) were recorded.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 13 840 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study periods of both feeding trials.

Clinical signs:

No clinical signs of toxicity were described after the 90-day treatment period of both feeding trials.

Body weight:

10 and 20%: Reduction of growth rate was noted in the first feeding trial.
In the second feeding trial, no effect on body weight was noted.

Gross pathology:

Necropsy and histopathological examination revealed no substance-related findings in the control or treatment groups of both feeding trials.

Other findings:

- Organ weights: No substance-related findings were observed in the animals of all treatment groups.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008

Conclusions:

CLP: not classified