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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Principles of method if other than guideline:
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. Usually 50 µL or mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The talcum-treated adjacent eye served as a control.
GLP compliance:
no

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.96 - 3.12 kg

ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: approx. 50 mg of talcum in the other eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
- Concentration (if solution): pure
Duration of treatment / exposure:
Treatment was once. The eye was left unwashed.
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not performed

SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Any other information on results incl. tables

Animal  Reading  Opacity Iritis Redness Chemosis Comment
1 1 h 0 0 1 0 substance residues
2 1 h 0 0 1 0 substance residues
1 3 h 0 0 1 0  
2 3 h 0 0 1 0  
1 24 h 0 0 1 0  
2 24 h 0 0 1 0  
1 48 h 0 0 1 0  
2 48 h 0 0 0 0  
1 72 h 0 0 1 0  
2 72 h 0 0 0 0  
1 4 d 0 0 0 0  
2 4 d 0 0 0 0  
1 7 d 0 0 1 0  
2 7 d 0 0 0 0  
1 8 d 0 0 0 0  
2 8 d 0 0 0 0  
1 24 - 72 h 0.00 0.00 1.00 0.00  
2 24 - 72 h 0.00 0.00 0.33 0.00  
mean 24 - 72 h 0.00 0.00 0.67 0.00  

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
In a study with rabbits according to an internal method, the test item was not irritant to skin.
Executive summary:

The skin irritation of the test item was assessed according to an internal standard method (BASF test). White Vienna rabbits (weight at study initiation: 2.96 - 3.12 kg) were used. 50 mg of the undiluted test item were applied to the conjunctival sac of one eye of 2 animals. The talcum-treated adjacent eye served as a control. Washing of the eyes after treatment was not performed. Effects were scored 24, 48 and 72 hours after treatment. In result, the cornea opacity score (mean), iris score (mean) and the chemosis score was 0. The conjunctivae score (mean) was 0.67. Effects were fully reversible within 8 days. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to eye.