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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study according OECD 405

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
100 µl test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits. the lids were then gently held together for about one second. the other eye remained untreated and served as control. the treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test compound
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
puritý: 99.8 %

Test animals / tissue source

Species:
rabbit
Strain:
other: HC:NZW

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
Comment: rinsed after (see exposure time)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
ca. 0.4
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Other effects:
no data

Any other information on results incl. tables

this study reveals that the test substance does not have a significant irritant potential on the eye

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

method: 100 µl test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits. the lids were then gently held together for about one second. the other eye remained untreated and served as control. the treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test compound

result: not irritating to the eye