Butane, 2-ethoxy-2-methyl-

Eye irritation

Administrative data

Endpoint:

eye irritation

Remarks:

other: in vitro

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant study using ECVAM-validated in vitro test system, no restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The method assesses the ocular irritancy potential of the test substance toward the cornea of the rabbit enucleated eye. The test material was applied undiluted for 10 s, then washed with saline solution. The cornea was assessed for opacity, fluorescein uptake and swelling for up to 4 hr post-treatment. The assay has undergone inter-laboratory validation and shown to detect test materials that are negligible or moderate to severe ocular irritants.

GLP compliance:

yes (incl. QA statement)

Remarks:

UK Department of Health, 29 January 2009

Test material

Test material information

Constituent 1

Reference substance name:

2-ethoxy-2-methylbutane

EC Number:

618-804-0

Cas Number:

919-94-8

Molecular formula:

C7H16O

IUPAC Name:

2-ethoxy-2-methylbutane

Details on test material:

- Name of test material (as cited in study report): TAEE, tert-amyl ethyl ether, CAS No. 919-94-8
- Lot/batch No.: 00931302
- Description: colourless liquid
- Purity: 99.4%
- Date received: 26 September 2008

Test animals / tissue source

Species:

other: rabbit eye, in vitro

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Not applicable

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

10 s

Observation period (in vivo):

60, 120 and 240 min post-treatment

Number of animals or in vitro replicates:

3 test eyes
2 control eyes

Details on study design:

The test material was applied undiluted for 10 s, then washed with saline solution. The cornea was assessed for opacity, fluorescein uptake and swelling for up to 4 hr post-treatment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: corneal opacity

Basis:

mean

Time point:

other: 60, 120 and 240 min

Score:

0

Max. score:

0

Remarks on result:

other: no corneal opacity present

Results 2

Irritation parameter:

other: fluorescein uptake

Basis:

mean

Time point:

other: 60, 120 and 240 min

Score:

0

Max. score:

0

Remarks on result:

other: no fluorescein uptake

Results 3

Irritation parameter:

other: corneal swelling

Basis:

mean

Remarks:

(percentage)

Time point:

other: 60, 120 and 240 min

Score:

8 - 9.5

Max. score:

100

Remarks on result:

other: negligible corneal swelling

Other effects:

The condition of the corneal epithelium was normal at 60, 120 and 240 min.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Not irritating to eye.

Executive summary:

The eye irritation potential of TAEE was assessed using a GLP-compliant rabbit enucleated eye test. The test material was applied undiluted for 10 s, rinsed with saline solution and the corneal surface assessed for opacity, fluorescein uptake and swelling for up to 4 hr post-treatment. The assay has undergone inter-laboratory validation and shown to detect test materials that are negligible or moderate to severe ocular irritants. The results indicated that TAEE was not an eye irritant under the conditions of the test.