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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
In Vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP status unknown, near guideline study, available as unpublished report, restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Deviation did not impact the scientific validity of the study.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Not reported

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not reported

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
Not reported
Duration of treatment / exposure:
Not reported
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
cornea
Basis:
mean
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
overall irritation score
Remarks:
iris
Basis:
mean
Time point:
other: 1 h
Score:
0.8
Reversibility:
fully reversible within: 24 h
Irritation parameter:
overall irritation score
Remarks:
conjunctivae
Basis:
mean
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
overall irritation score
Basis:
other: total (cornea, iris and conjuctivae)
Time point:
other: 1 h
Score:
3.7
Reversibility:
fully reversible within: 24 h

Any other information on results incl. tables

The report states that corneal opacity (involving up to 25% of the cornea) was noted in one rabbit and iritis in another 1 hr post-instillation however the rapid reversibility of these responses (both fully resolved by 24 hr) suggests possible over-interpretation. Conjunctival redness was also noted in 5 rabbits with conjunctival chemosis in one, however responses again cleared within 24 hours.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Slight eye irritation effects were present 1 hour after instillation but had resolved within 24 hours.
Executive summary:

Slight eye irritation effects were present 1 hour after instillation but had resolved within 24 hours.