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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Study period:
10 April 2007 to 07 May 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well documented, test procedure in accordance with OECD 405 methods, meets generally accepted scientific principles, acceptable for assessment. GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
three male rabbits

Test system

Amount / concentration applied:
0.1 ml (95 mg) of the test material
Observation period (in vivo):
up to 21 days after administration
Number of animals or in vitro replicates:
three rabbits
Details on study design:
A single application of 0.1 ml (95 mg) of the test material was administered to the non irrigated eye of three rabbits. Ocular reactions were recorded 1, 24, 48, 72-hours, 7, 14 and 21 days after administration.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
ca. 0.7
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritant / corrosive response data:
not irritant
Other effects:
The test material produced moderate conjunctival irritation. Black staining of the lower half of the cornea was noted in one treated eye throughout thestudy. Anyway, the staining did not affect evaluation of ocular effects.

Any other information on results incl. tables

Table 1: Individual and Mean Scores for Cornea, Iris and conjunctivae

 Rabbit Number  Time After Treatment  Corneal Opacity  Iridial Inflammation  Conjunctival Redness Conjunctival Chemosis 
Rabbit 1 24 hours48 hours72 hours 000  000  10 0  000
Total  0  0    0
Mean     0.0 0.0  0.3   0.0
Rabbit 2 24 hours48 hours72 hours 000  000  11 0  11 0 
Total   0
Mean   0.0 0.0  0.7  0.7 
Rabbit 3 24 hours48 hours72 hours 000  000  110  110 
Total  
Mean   0.0  0.0  0.7  0.7 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Analogue substance 4 is considered as non-irritant to the eye of rabbits.
Executive summary:

The irritation index for analogue substance 4 was found to be 0 for the cornea, 0 for the iris and 0.7 for the conjunctivae.

The result show minimal irritation on rabbit eye following the indicated guideline but the tested item is to be considered as non-irritant to eye based on CLP criteria, table 3.2.2.7.1.