Registration Dossier

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: Test was conducted according to OECD 405, Directive 84/449/EEC, B.5 and compliant with GLP.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
100 MG
Duration of treatment / exposure:
72 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48, 72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72h
Score:
0
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24,48 and 72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall 24, 48 and 72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
not specified

Any other information on results incl. tables

conjunctivae score (redness): Max. duration: h; Max. value at end of observation period: 0 (related to all animals);

chemosis score: Max duration: h; Max.value at end of observation period: 0 (related to all animals);

cornea score: Max.duration: h; Max.value at end of observation period: 0 (related to all animals);

iris score: Max. duration: h; Max. value at end of observation period: 0 (related to all animals).

All Draize scores were zero. No signs of systemic toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not classified as irritating to the eye.