Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
24 mg
Duration of treatment / exposure:
no data
Observation period (in vivo):
72 h (chemosis & iris score)
8 d (cornea & conjunctivae score)
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Reversibility:
fully reversible within: 15 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Reversibility:
fully reversible within: 15 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Reversibility:
fully reversible within: 15 d
Irritation parameter:
conjunctivae score
Basis:
mean
Max. score:
2
Remarks on result:
other: Max. duration: 8 d; Max. value at end of observation period: (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Reversibility:
fully reversible within: 15 d
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Reversibility:
fully reversible within: 15 d
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Reversibility:
fully reversible within: 15 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h
Max. score:
2
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Reversibility:
fully reversible within: 15 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Reversibility:
fully reversible within: 15 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Reversibility:
fully reversible within: 15 d
Irritation parameter:
cornea opacity score
Basis:
mean
Max. score:
1
Remarks on result:
other: Max. duration: 8 d; Max. value at end of observation period: (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Reversibility:
fully reversible within: 15 d
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Reversibility:
fully reversible within: 15 d
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Reversibility:
fully reversible within: 15 d
Irritation parameter:
iris score
Basis:
mean
Max. score:
1
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: (related to all animals)

Any other information on results incl. tables

Contracted pupil, marginal cornea vascularisation, bloody secretion, damage of cornea substance, ulceration.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
The test substance was found to be irritating to eye under the conditions of the test.