2-allyloxymethyl-2-ethylpropanediol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April - May 1961

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No indication of guideline followed of GLP compliance.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1961

Report date:

1961

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test material was applied to a clipped area on rabbits for a 24 hour exposure period and was observed for 14 days to determine the toxicity of the test substance when applied dermally.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trimethylolpropane Monoallyl Ether

IUPAC Name:

Trimethylolpropane Monoallyl Ether

Details on test material:

Trimethylolpropane Monoallyl Ether was a viscous, clear, colourless liquid.

Test animals

Species:

rabbit

Strain:

other:

Sex:

male

Details on test animals or test system and environmental conditions:

Groups of 4 male albino rabbits were used. The rabbits weighed 2 - 3 kgs.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The fur of the rabbits was clipped over the entire trunk, which equated to approximately 10% of the body surface and this area was coverd by an impervious plastic film. The calculated dose of the undiluted chemical was introduced through a cathether once the plastic cover was in place. The maximum dose applied to the rabbits was 20 milliliters/kg bw.
Following application of the test material, the rabbits were confined in stocks for 24 hours, after which the cover and the chemical were removed and the skin examined for gross changes.

Duration of exposure:

24 hours.

Doses:

3.95, 7.5 and 15.8 g/kg.

No. of animals per sex per dose:

4 male rabbits per dose group.

Control animals:

not specified

Details on study design:

Male albino rabbits (4 per dose group) were exposed to Trimethylolpropane Monoallyl Ether via dermal penetration. The degree of penetration through the intact skin was estimated employing the one-day cuff method used by Draize and associates as modified by Smyth and associates. The fur was clipped from the entire trunk of each animal and the test material was held in contact with the skin for 24 hours by an occlusive dressing. Following this exposure period, the dressing and test material were removed and the skin examined for any signs of gross changes. Mortality due to the effect of the chemical was considered complete after 14 days. All fatalities were subjected to autopsies to exclude extraneous causes of death while some survivors were sacrificed and examined for the existence of gross lesions.

Statistics:

No information provided.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 15.8 other: g/kg.

Based on:

test mat.

Mortality:

There were no mortalities observed in this study.

Clinical signs:

other: When dosed at 15.8 g/kg, necrosis of the skin was observed.

Gross pathology:

No information provided.

Other findings:

No additional information.

Any other information on results incl. tables

Skin penetration Toxicity for Rabbits of Trimethylolpropane Monoallyl Ether.

Average Weight (kg)
Dosage g/kg	Initial	Change 14 days	Number Died / Number Dosed	Days after dosing on which death occurred.
3.98	2.26	+0.33	0/4	-
7.95	2.04	+0.51	0/4	-
15.8	2.04	+0.07	0/4	-

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of Trimethylolpropane Monoallyl Ether by skin penetration for male albino rabbits is greater than 15.8 g/kg.

Executive summary:

The acute dermal toxicity of Trimethylolpropane Monoallyl Ether was determined in a study conducted on groups of 4 male albino rabbits administered the test material via dermal application. The fur was clipped from the entire trunk of each test animal and Trimethylolpropane Monoallyl Ether was applied by a cathether at concentrations of 3.98, 7.95 and 15.8 g/kg to the clipped area and was held in place using an impervious plastic cover. The test material remained in place for 24 hours. Any signs of toxicity were observed on removal of the test material and further observations were made over a 14 day observation period.

No mortalities were observed at any concentration over the course of the study. When dosed at 15.8 g/kg, some skin necrosis was observed. The LD₅₀of Trimethylolpropane Monoallyl Ether by skin penetration for male albino rabbits is greater than 15.8 g/kg.