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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD GUIDELINE 405 (1987) EEC Directive 84/449 (1984) - Annex V - method B5 EPA n° 798.4500 (1990) MAFF n° 4200 (1985)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Score:
0.56
Max. score:
2
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0
Irritation parameter:
chemosis score
Basis:
mean
Score:
0.22
Max. score:
2
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
0.06
Max. score:
1
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0
Irritation parameter:
iris score
Basis:
mean
Score:
0.33
Max. score:
1
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0

Any other information on results incl. tables

Reversibility of any observed effect: Changes fully reversible within 7 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was found to be not irritating to eye under the condition of the test.