2-ethoxyethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: acceptable publication but no info about substance purity

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests.

Author:

Weil CS, Scala RA

Year:

1971

Bibliographic source:

Toxicol. Appl. Pharmacol. 19, 276-360

Reference 2

Reference Type:

publication

Title:

Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes.

Author:

Draize, J.H., Woodard, G., and Calvery, H.O.

Year:

1944

Bibliographic source:

J. Pharmacol. Exp. Ther. 82, 377-389

Materials and methods

Principles of method if other than guideline:

Method: Draize Test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethoxyethanol

EC Number:

203-804-1

EC Name:

2-ethoxyethanol

Cas Number:

110-80-5

Molecular formula:

C4H10O2

IUPAC Name:

2-ethoxyethan-1-ol

Details on test material:

substance identity as stated in publication: Ethylene glycol monoethyl ether
purity: no data

Test animals / tissue source

Species:

rabbit

Strain:

other: albino rabbits

Details on test animals or tissues and environmental conditions:

Animal weight: at least 2.0 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml

Duration of treatment / exposure:

1 h

Observation period (in vivo):

1, 24 and 72 hours and 7 days after application

Number of animals or in vitro replicates:

6 animals per laboratory (in total 24 laboratories -> 144 animals)

Details on study design:

Comment: no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

7.8

Max. score:

110

Reversibility:

not fully reversible within: 7 d

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

20.8

Max. score:

110

Reversibility:

not fully reversible within: 7 d

Any other information on results incl. tables

Summary of the obtained results:

	Individual scale range of all experiments	Median of 6 animals/laboratory	Median of 24 laboratory medians
after 24 h	0 -65	1 -60	20.8
after 72 h	0 -64	0 -35	7.8
after 7 days	0 -54	0 -20.5	0

The published results are summarizied results obtained from 24 different laboratories all testing the eye-irritation of 2 -Ethoxyethanol:

19 of 24 laboratories rated the test substance as "irritant", 3 of 24 as "nonirritant" and 2 of 24 as "questionable" (nonirritant: 0 or 1 rabbit eye with positive score; questionable: 2 or 3 rabbit eyes with positive score; irritant: 4, 5, or 6 rabbit eyes with positive score).

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information

Conclusions:

24 different laboratories evaluated the eye irritation potential of the test substance 2-ethoxyethanol. The test animals (6 per laboratory, 144 in total) were albino rabbits and the scoring occurred according to Draize et al. (1944). By summarizing all results after 24 hours a median score of all laboratories of 20.8/110 was determined. However, 19/24 laboratories evaluated the test substance as irritant, 2/24 as questionable, and 3/24 as nonirritant. According to these results the author of this IUCLID dossier interpreted the test substance to be slightly irritating. Therefore the results of this key study are conclusive but not sufficient for classification as eye irritant.