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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study which meets basic scientific principles and contains sufficient detail to be able to judge the results reliable as a contribution to the understanding of the toxicity of this substance.

Data source

Reference
Reference Type:
publication
Title:
Development of a fixed-dose approach for the fluorescein leakage test.
Author:
Clothier RH, Morgan SJ, Atkinson KA, Garle MJ and Balls M
Year:
1994
Bibliographic source:
Toxicol. In vitro, 8(4), 883-884

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Study based on the fluorescein leakage test. A confluent layer of Madin-Darby canine kidney cells grown on a porous filer insert are exposed to a test substance. If the cells are damaged, the tight junctions between them cease to provide a barrier to the passage of fluorescein.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test system

Amount / concentration applied:
Tested at 50mg/l (single concentration)
Duration of treatment / exposure:
1 minute

Results and discussion

In vivo

Results
Irritation parameter:
other: fluoroscein leakage, expressed as a pecentage
Basis:
mean
Time point:
other: 1 minute
Score:
< 20
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Fluorescein leakage 11% (+/-6) after 1 minute exposure. After 72 hours leakage reduced to 2% (+/-0.3)

Any other information on results incl. tables

A fluorescein leakage of 20% or more was taken as an indication of toxicity to the monolayer of cells. For 2 -butoxyethyl acetate, there was signs of slight toxicity (irritation by proxy) but that this was reversible. The level of response was below that regarded as warranting classification as an eye irritant by the criteria of the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: internal criteria of this in vitro study
Executive summary:

2 -butoxyethyl acetate, along with a further 20 other substances, were tested in a fluorescein leakage test. A dose of 50 mg/ml was applied on a confluent layer of Madin-Darby canine kidney cells. Exposure time was 1 minute. The percentages of fluorescein leakage following and 72 h after one minute of exposure to 2 -butoxyethyl acetate were 11 ±6 % and 2 ±0.3 % respectively. According to this criteria of the study authors which was based on previous work, a result of <20% implied that the level of irritation was insufficient to warrant classification for eye irritancy. This data can be regarded as supportive of the in vivo data but it should however be borne in mind that the method has not been validated as an alternative for classification when used alone.