Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study with acceptable restrictions (report not available for the submitter, no further details available). Presumably rapid evaporation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
methyl vinyl ether (MVE)
no further details

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals were kept in rooms designed to maintain adequate environmental conditions, and were given a commercial diet and municipal water ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: unexposed eyes
Amount / concentration applied:
undiluted
Amount applied: 0.1 mL
Duration of treatment / exposure:
unwashed
Observation period (in vivo):
scoring days 1, 2, 3, 7, 14, and 21
Number of animals or in vitro replicates:
6 male and female New Zealand White Rabbits were used for the study
Details on study design:
The dose (0.1 mL of undiluted, cold test material) was instilled into the conjunctival sac of one eye per animal, and eyelids were held together for one second. The eyes were scored based on a defined scale (evaluating the cornea, iris, and conjunctivae) at days 1, 2, 3, 7, 14, and 21. Fluorescein staining was used to determine corneal injury before dosing and at day 1 readings.

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: No corneal injury or iritis; minor transient conjunctival irritation in 5/6 rabbits
Irritant / corrosive response data:
No corneal injury or iritis in any of 6 eyes was noted. Minor transient conjunctival irritation in 5/6 rabbits from 0.1 mL undiluted liquid was observed, but resolved within 24 hours. No further details available.
One animal was sacrificed at 4 days after it developed moribund appearance, which was probably not related to treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The instillation of 0.1 mL undiluted, cold liquid resulted only in minor transient conjunctival irritation in 5/6 New Zealand White rabbits; the effects were fully reversible within 24 h.