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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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, no separate chemosis scores given.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Storage condition of test material: 25 °C in a glass container sealed inside a polyethylene bag

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Keen Ridge Rabbit Ranch, Edgewood, New Mexico
- Weight at study initiation: 2.7 - 2.9 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
Duration of treatment / exposure:
Single application
Observation period (in vivo):
72 h (1h, 4h, 24h, 48h and 72 h)
Number of animals or in vitro replicates:
6 (2 per wash condition)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 4 animals out of 6
- Time after start of exposure: 30 s and 5 min

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1h, 4h, 24h,48h and 72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1h, 4h, 24h,48h and 72h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h and 4h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Values for animals with the unwashed eyes. Animals with washed eyes had lower scores.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Irritation was observed only in conjunctival tissue. Conjunctival responses were observed at all treatment levels at 1 h and generally consisted of mild redness. All treatment groups were judged normal at 48 h. The eye irritation caused by the test article was mild and transitory.

Any other information on results incl. tables

Table 1. Eye irritation response in rabbits treated with test materiala

Tissue graded Average Irritationb
hours days
1 4 1 2 3
Wash at 30 s




Cornea 0 0 0 0 0
Iris 0 0 0 0 0
Conjunctive 1 2 0 0 0
Wash at 5 m




Cornea 0 0 0 0 0
Iris 0 0 0 0 0
Conjunctive 1 1 1 0 0
No wash




Cornea 0 0 0 0 0
Iris 0 0 0 0 0
Conjunctive 3 3 0 0 0

a) Two rabbits per wash condition.

b) Maximum cornea response = 80; maximum iris response = 10; maximum conjunctivae response = 20.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Irritation was observed only in conjunctival tissue during the first day after application.