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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
no observation on day 21 after start was done; observations were done up to 72 h after start.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
3 rabbits; rinsed eye; 3-day observation for signs on conjunctiva, cornea and iris.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
not specified
Observation period (in vivo):
Up to 72 h.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: #1, #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

animal finding 24 h 48 h 72 h
1 conj. chemosis 1 0 0
conj. redness 1 0 1
corneal opacity 0 0 0

iritis

0 0 0
2

conj. chemosis

0 0 0
conj. redness 1 0 1
corneal opacity 0 0 0

iritis

0 0 0
3 conj. chemosis 1 0 0
conj. redness 2 1 1
corneal opacity 0 0 0
iritis 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not irritant according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to the rabbit eye.
Executive summary:

Method

Test substance was applied to the eye of 3 rabbits; treated eye were rinsed. Effects on conjunctivae, cornea and iris were scored 24, 48 and 72 h after start.

Results

No signs of irritation were noted on cornea and iris; conjunctivae chemosis was noted in 2/3 rabbits at 24 h and it was completely reversible within 48 h. Conjunctivae redness was noted in all rabbits; it was not fully reversible within the 72 h observation period, however such signs were slight, i.e. score 1 after 72 h.