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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:
09 - 16 Apr 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, UK
- Age at study initiation: 12 - 16 wks
- Weight at study initiation: 2.57 - 2.62 kg
- Housing: metal cages, single
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 5 d min.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 45 - 55 rh
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
60 mg
Duration of treatment / exposure:
1 treatment at 0 h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize scoring

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
probability of moderate irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.43
Max. score:
2
Reversibility:
fully reversible within: 7 d
Remarks on result:
probability of mild irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 d
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.56
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
probability of moderate irritation
Irritant / corrosive response data:
Considerable ocular irritation in 2/3 rabbits, slight irritation in 1/3 rabbits
Dulling of cornea in 2/3 rabbits
Iritis in 2/3 rabbits
Fully reversibly within 7 d in 3/3 rabbits

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The substance caused moderate signs of irritation in 2/3 rabbits. The cornea opacity score was >1 in 2/3 animals, all signs of irritation were fully reversible within 7 days. Therefore, the substance is classified as Category 2 for eye irritation.