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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Study predates GLP and OECD guidelines, minor restrictions in reporting, but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
0.1 mg of the test substance was allowed to fall on the lower everted lid of one eye of each out of six rabbits, then upper and lower lids were carefully closed and held together for at least one second. Untreated eye served as a control. Eyes were not rinsed and examined 24, 48, 72 hours and 7 days after the instillation.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
WTR 38, Vulkacit LDA, white coloured-powder, stored at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.72
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.72
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.83
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Other effects:
24 hours after WTR 38 has been brought into the eyes, slight corneal damage and slight iritis were observed in 4 out of 6 rabbits. Moderate or severe conjunctivae damage was observed in all rabbits. In the course of the 7 days observation period these eye lesions recoverd partly.

Applicant's summary and conclusion