Reaction products of 2-(chloromethyl)oxirane and glycerol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well-documented publication, which meets basic scientific principles

Cross-reference

Reason / purpose:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

The Toxicology of Epoxy Resins

Author:

Hine, C.H., Kodama, J.K., Anderson, H.H., Simonson, D.W., Wellington, J.S.

Year:

1958

Bibliographic source:

AMA archive s of industrial health / American Medical Association, 17, p. 129-144

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The test material was applied on the clipped backs of Albino rabbits and held in contact under semiocclusive conditions during 24 hours. The readings were made directly and after 48 hours after the pathch removal.

GLP compliance:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): EPON 562

Test animals

Species:

rabbit

Strain:

other: Albino

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.0 - 3.2 kg

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped over the back and flanks, and four areas of the back designated for the test, two intact and two scarified with wire mesh

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

no details given

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

no data

Details on study design:

Albino rabbits were clipped over the back and flanks, and four areas of the back designated for the test, two intact and two scarified with wire mesh. The animals were immobilized in a multiple rabbit holder (Laug, 1944), and patches of gauze were secured over the areas with adhesive tape. The compounds were introduced under the patches, and the entire trunk of the rabbits enveloped in rubber dam. After 24 hours the rabbits were released, the resins removed, and a first reading made. After 72 hours a second reading was made.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

5

Reversibility:

no data

Remarks on result:

other: moderately irritating

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

This well-documented publication gives a detailed information about the experiments conducted and meets basic scientific principles. Therefore it is considered to be of the high quality (reliability Klimisch 2). The validity criteria of the test system are fulfilled. EPON 562 was moderately irritating, with a score of five.

Executive summary:

The skin irritation potential of Polyglycidyl Ether of Substituted Glycerin (EPON 562) was investigated by Hine et al.(1958). The test material was administered semiocclusively to rabbits (male Albino). The rabbits were clipped over the back and flanks, and four areas of the back designated for the test, two intact and two scarified with wire mesh. The animals were immobilized in a multiple rabbit holder, and patches of gauze were secured over the areas with adhesive tape. The compound was introduced under the patches, and the entire trunk of the rabbits enveloped in rubber dam. After 24 hours the rabbits were released, the resin removed, and a first reading made. After 72 hours a second reading was made. EPON 562 was moderately irritating, with a score of 5.