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Toxicological information

Eye irritation

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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

Referenceopen allclose all

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 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

Reference
Name:
Unnamed
Type:
Constituent
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

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.