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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Annex V
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Amount / concentration applied:
0.1 ml
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
ca. 0.5
Max. score:
0.6
Reversibility:
fully reversible within: 3d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
ca. 0.3
Max. score:
0.3
Reversibility:
fully reversible within: 3d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
Grade 1 conjunctival redness and chemosis was observed in
all three rabbits at 1 and 24 hours post-application.
Slight
discharge was also noted in all three rabbits at one hour.
Grade 1 conjunctival redness was also observed in 2 rabbits
at 48 hours. No reactions were seen at 72 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Slight effects observed, but not sufficiently severe for classification