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: Study according to OECD test guideline 405 under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C-SAT 100018
- Physical state: slightly yellowish solid
- Analytical purity: 100%
- Lot/batch No.: CF00460029
- Expiration date of the lot/batch:26.02.2011
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian Rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
1h
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of 24, 48 and 72h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24, 48 and 72h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Redness of score 1 (all three rabbits) and chemosis of score 1 (one rabbit) was observed after 1 hour.
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a study according to OECD test guideline 405 under GLP, the test substance was not irrritating to the eye.
Executive summary:

The eye irritation potential of the test substance was investigated in a study according to OECD test guideline 405.

The amount of 0.1g was applied to eyes of three Russian rabbits and washed out after 1 hour. After 1 hour, redness (score 1) was observed in all rabbits and chemosis of score 1 in one rabbit. No irritant reaction was present after 24, 48 and 72 hours in all rabbits. Therefore, the test substance is considered to be not irritating to the eye.