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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:
other: Non-guideline study, limitations in reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Primary eye irritation study
GLP compliance:
no

Test material

Constituent 1
Details on test material:
Kryocide Insecticide: NB 84-146-2B

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Young adult rabbits (approximately 14 weeks of age) of the New Zealand White strain were maintained individually in screen bottom cages in temperature and humidity controlled quarters, provided continuous access to commercial laboratory feed and water, and held for acclimation period of at least 7 days.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the contra-lateral eye serving as the untreated control
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
The treated eyes of group II animals (n=3) were flushed for one minute with lukewarm water, starting 30 seconds after test material administration.
The eyes of group I rabbits remained unflushed.
Observation period (in vivo):
24, 48, 72 and 96 hours and 7 days after treatment
Number of animals or in vitro replicates:
9
Details on study design:
Nine acclimated animals were chosen at random for the test. The animals' eyes were examined using fluorescein dy procedures at least 24 hours before compound administration. Only those animals with no sign of corneal injury were used. Animals were divided into two groups: group I with six rabbits and group II with three rabbits.

Each animal received 0.1 g of the finely ground solid sample placed on the everted lower lid of one eye, with the contra-lateral eye serving as the untreated control. The upper and lower lids were gently held together for one second to prevent loss of material and then released, the treated eyes of group II animals were flushed for one minute with lukewarm water, starting 30 seconds after test material administration. The eyes of group I rabbits remained unflushed.

The treated eyes of both groups were observed for ocular lesions at 24, 48, 72 and 96 hours and at 7 days after treatment. At the 72 hour and 7 day readings, sodium fluorescein and ultraviolet light were used to aid in revealing possible corneal injury. Irritation was graded and scored according to the Draize technique.

Animals were weighed before compound administration and at weekly intervals during the study. At study termination all animals were euthanatized and discarded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 24
Score:
5.3
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 48
Score:
2.7
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 72
Score:
0.7
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 96
Score:
0.5
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 7 days
Score:
0
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.06
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.94
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.36
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Group I (unflushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 24
Score:
3.7
Remarks on result:
other: Group II (flushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 48
Score:
2
Remarks on result:
other: Group II (flushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 72
Score:
1.3
Remarks on result:
other: Group II (flushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 96
Score:
0
Remarks on result:
other: Group II (flushed)
Irritation parameter:
other: primary eye irritation scores (Draize)
Basis:
mean
Time point:
other: 7 days
Score:
0
Remarks on result:
other: Group II (flushed)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Group II (flushed)
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Group II (flushed)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.94
Max. score:
3
Reversibility:
fully reversible within: 96 hours
Remarks on result:
other: Group II (flushed)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Group II (flushed)
Irritant / corrosive response data:
The data do not indicate that the substance is an eye irritating substance. Moreover, 0.1 g was administered which is an excess compared to the prescribed amount in current guidelines (0.1 ml).

Applicant's summary and conclusion