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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:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Referenced as Method B5 in Commision Directive 84/449/EEC
GLP compliance:
yes
Remarks:
Good Laboratory Practice, The United Kingdom Compliance Programme, Department of Health 1989

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Active su

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Amount / concentration applied:
A volume of 0.1 ml of the test material was instilled into the conjunctival sac of the right eye
Duration of treatment / exposure:
The upper and lower eyelids were held together for about one second immediately after instillation.
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48, 72 hours follwing treatment.
Number of animals or in vitro replicates:
3

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 1 h
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Remarks:
redness, chemosis and discharge
Basis:
mean
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material did not produce positive criteria in any rabbit according to the EEC labellng regulations and was classified as NON-IRRITANT to the rabbit eye. No symbol and risk phrase are therefore required