Butyl 2,3-epoxypropyl ether

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1973

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Principles of method if other than guideline:

To test the eye irritating potential of the test substance two tests were performed by instilling 0.1 mL of undiluted test material into rabbit eyes without a rinse. Scoring of effects was according to the method of Draize.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butyl 2,3-epoxypropyl ether

EC Number:

219-376-4

EC Name:

Butyl 2,3-epoxypropyl ether

Cas Number:

2426-08-6

Molecular formula:

C7H14O2

IUPAC Name:

2-(butoxymethyl)oxirane

Test material form:

liquid

Specific details on test material used for the study:

Name as cited in report: Butyl glycidyl ether

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Eyes were not washed out.

Observation period (in vivo):

Until no gross evidence of irritation to the ocular tissue was observed.

Number of animals or in vitro replicates:

3

Details on study design:

Scoring was by the Draize method with a maximum score of 110 based on up to 80 points for irritation to the cornea, 10 for the iris, and 20 for the conjunctiva. The “maximum average score” is obtained by averaging the score of each rabbit at the time of maximum irritation. The descriptive rating is based on a combination of the Draize score and corneal involvement (i.e., degree and duration) as described by J.C. Calandra, Interpretation of Eye Irritation tests”, J. Soc. Cosmet. Chem., 13, 281-289, 1962.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Draize score (max. ave. score)

Basis:

mean

Time point:

other: time of maximum irritation

Score:

23.2

Max. score:

110

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Degree of Irritaion: moderate

Results 2

Irritation parameter:

other: Draize score (max. ave. score)

Basis:

mean

Time point:

other: time of maximum irritation

Score:

41.3

Max. score:

110

Reversibility:

not reversible

Remarks:

for 1/3 animals

Remarks on result:

other: Degree of Irritation: moderate to severe

Irritant / corrosive response data:

In the first test, the effects observed in the eye of one animal were fully reversed within three days and of the other two animals in seven days.
In the second test, the effects observed in the eye of 2 animals were fully reversed within 4 days. The third animal showed severe ocular damage. This was not cleared after 3 days and judged to be irreversible damage.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria