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: The study was performed according to OECD Guideline n° 405 and in compliance with UK GLP standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.1 ml of the test material
Duration of treatment / exposure:
the test material was not removed
Observation period (in vivo):
1, 24, 48, 72 hours and after 7 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
16.3
Max. score:
17
Reversibility:
fully reversible
Remarks:
All treated eyes appeared normal at the 7-day observation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
15.7
Max. score:
29
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
9.7
Max. score:
15
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
7.7
Max. score:
15
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Irritant / corrosive response data:
The test material produced a maximum group mean score of 16.3 and was classified as a moderate irritant (class 5 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 Commission Directive 93/21/EEC.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a maximum group mean score of 16.3 and was classified as a moderate irritant (class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The substance should not be classified for eye irritation/corrosion using the criteria of Directive 67/548/EEC (DSD) or the criteria of Regulation No 1272/2008 (CLP).