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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

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

Test material

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Treated eyes were not washed with water after instillation
Observation period (in vivo):
Four days
Number of animals or in vitro replicates:
Three

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Not irritating
Other effects:
No to practically no initial pain reaction

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The neat substance is not irritating to the rabbit eye.
Executive summary:

The eye irritation potential of the substance was tested under GLP in vivo to principles equivalent to those of the relevant OECD TG 405. An aliquot of 0.1 mL of the neat liquid test substance was instilled into the left eye of three healthy rabbits. The right eye remained untreated and served as the control. The treated eyes were not washed after instillation. Animals were observed for a period of up to four days after treatment. There was practically no initial pain reaction after instillation. No corneal opacity or iritis was observed in any of the three test animals. Conjuctival redness occurred in all three animals, rated with scores of up to 2 in all animals. The average scores for conjuctival redness over a period of 72 hours were 1.3, 0.7 and 0.7 in individual test animals. Conjuctival redness was fully reversible within a period of four days in all animals. Chemosis was observed only in one treated animal and was rated with a maximum score of 1. The average chemosis score over a period of three days was 0.3 in this animal.