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: guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
other: Kn 172
Batch No.: Kn-Gi 8634/1

Batch No.: Kn-Gi-8634/1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
undiluted
Amount applied: 0.1 g
Duration of treatment / exposure:
24 hour(s)
Number of animals or in vitro replicates:
1
Details on study design:
Comment: rinsed after (see exposure time),
one animal test due to severe eye irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: hours
Score:
24 - 72
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: hours
Score:
24 - 72
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 1 and 2
Time point:
other: hours
Score:
24 - 72
Max. score:
0.33
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: hours
Score:
24 - 72
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: hours
Score:
24 - 72
Max. score:
0

Any other information on results incl. tables

A severe reaction was observed following ocular administration of KN 172  to a single rabbit.
The severity of the observed chemosis did not permit the evaluation of  the Cornea and iris at the 24 and 48 hour examinations. The reaction  observedup to the 7 day examination appeared to be completely reversible  at the end of the observation period but of such severity to require  classification of the test item as severely irritant for the eye. 
European Directives concerning the classification, packaging and  labelling of dangerous substances (671548EEC and subsequent revisions)  wouldindicate the following:
Classification : Xi / R41- Risk of serious damage to eyes

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information
Conclusions:
Classification: risk of serious damage to eyes
Executive summary:

The acute eye irritation of KN 172 was investigated in the rabbit.

A severe reaction was observed following ocular administration of KN 172 to a single rabbit.

The severity of the observed chemosis did not permit the evaluation of the Cornea and iris at

the 24 and 48 hour examinations. The reaction observed up to the 7 day examination appeared

to be completely reversible at the end of the observation period but of such severity to require

classification of the test item as severely irritant for the eye.

European Directives concerning the classification, packaging and labelling of dangerous

substances (671548EEC and subsequent revisions) would indicate the following:

Classification: Required

Symbol: Xi

R Phrase: R41- Risk of serious damage to eyes