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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
Study period:
1987
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:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 mg
Duration of treatment / exposure:
Single application
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects at any time poiint
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects at any time point
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
4 animals
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
2 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects at any time point
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
1 animals
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
5 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects at any time point
Irritant / corrosive response data:
No adverse effects were observed for the iris or corneal damage at any time point in any animal.
Minor conjuncitval irritation (redness) was observed in 4 animals and resolved within 1 day.
Minor chemosis was observed in 1 animals and resolved within 1 day.

Any other information on results incl. tables

Endpoint

Mean score

Maximum value

Maximum duration of any effect

Maximum value at the end of observation period

Conjunctivae / redness

1 in 4 animals

0 in 2 animals

1 in 4 animals

1 day

0

Chemosis

1 in 1 animal

0 in 5 animals

1 in 1 animal

1 day

0

Cornea

0

0

-

0

Iris

0

0

-

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No adverse effects were observed for the iris or corneal damage at any time point in any animal.
Minor conjuncitval irritation (redness) was observed in 4 animals and minor chemosis was observed in 1 animal. All eyes were normal after 1 day.
A single application of test material into the rabbit eye did not produce a positive response according to CLP criteria.