2-butoxyethyl acetate

Eye irritation

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

Test material information

Constituent 1

Reference substance name:

2-butoxyethyl acetate

EC Number:

203-933-3

EC Name:

2-butoxyethyl acetate

Cas Number:

112-07-2

Molecular formula:

C8H16O3

IUPAC Name:

2-butoxyethyl acetate

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.