Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The temp. and relative humidity were set to achieve limits of 17 to 23 deg. C and 30 to 70% respectively. The rate of air exchange was at least 15 changes per hour and lighting was controlled.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left untreated eye was used for control
Amount / concentration applied:
A volume of 0.1m of the test material was placed into the conjunctival sac of the right eye.
Duration of treatment / exposure:
1 hr, 24 hr, 48hr, 72hr
Observation period (in vivo):
Assessment of ocular damage/irritation was made appr. 1 hour and 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
Initially a single rabbit was treated. After consideration of the ocular responses, two additional animlas were treated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1hr, 24hr, 48 hr, 72hr
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1hr, 24hr, 48 hr, 72hr
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1hr, 24hr, 48 hr, 72hr
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1hr, 24hr, 48 hr, 72hr
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritant / corrosive response data:
No conrneal or iridial effects were noted during hte study.
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment.
All treated eye appeared normal at the 24-hour observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjuctival irritation. All treated eyes appeared normal at the 24-hour observation
Executive summary:

Introduction: The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbity. The method was designed to meet the requirenmnets of the following:


• OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye IrritationlCorrosion” (adopted 24 February 1987)
• Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)

Result. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 24-hour observation.




• OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye IrritationlCorrosion” (adopted 24 February 1987)


• Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)


Result. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 24-hour observation.


Conclusion. The test material produced a maximum group mean score of 6.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.


The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 93/21/EEC.



The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 93/21/EEC.