Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study using standard protocols.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye served as control for each rabbit
Amount / concentration applied:
0.1 gram applied in left eye of each rabbit
Duration of treatment / exposure:
4 days
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
6 rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1-4 days
Remarks on result:
other: no responses
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1-4 days
Remarks on result:
other: no responses
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1-4 days
Remarks on result:
other: no responses
Irritant / corrosive response data:
No responses/effects observed in any of the rabbits.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No irritation effects observed. The substance is not irritating to eyes.
Executive summary:

No irritation effects observed. The substance is not irritating to eyes.