Registration Dossier

Toxicological information

Skin irritation / corrosion

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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.