Reaction products of 2-(chloromethyl)oxirane and glycerol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

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 for cross-reference:

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 irritating effect of the test material was tested on normal rabbit eyes by dropping 0.1 mL of a 20% suspension in propylene glycol on the center of the cornea. Readings were made at 1, 24 and 48 hours, with the cornea unstained and then stained with a 2% solution of fluorescein sodium. Injury was scored according to the method of Draize.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Polyglycidyl Ether of Substituted Glycerin (EPON 562)

IUPAC Name:

Polyglycidyl Ether of Substituted Glycerin (EPON 562)

Details on test material:

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

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino

Details on test animals or tissues and environmental conditions:

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

Test system

Vehicle:

other: propylene glycol

Controls:

other: yes the other eye served as control

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

not specified

Observation period (in vivo):

48 hours

Number of animals or in vitro replicates:

no details given

Details on study design:

Dropping 0.1 mL of a 20 % suspension in propylene glycol on the centre of the cornea

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24 and 48 hours

Score:

82

Max. score:

120

Reversibility:

not specified

Remarks on result:

other: severely 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 severely irritating to rabbit eyes (score 82 of 120).

Executive summary:

The eye irritation potential of EPON 562 was investigated by Hine et al.(Hine, 1958). The irritating effect was tested on normal rabbit (male Albino) eyes by dropping 0.1 mL of a 20% suspension in propylene glycol on the center of the cornea. Readings were made at 1, 24, and 48 hours, with the corneas unstained and then stained with a 2% solution of fluorescein sodium. Injury was scored according to the method of Draize. EPON 562 was severely irritating to rabbit eyes (score 82 of maximum 120).