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Toxicological information

Eye irritation

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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:
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. certificate)
Remarks:
UK Department of Health, 29 January 2009

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
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
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
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.