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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:
weight of evidence
Study period:
March 12, 1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
The reliability assigned to this study is 4 as the composition of the active ingredient in the test item is low.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965),
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
Porton strain
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12-16 weeks
- Weight at study initiation: average body weights of 2.61 and 2.70
- Housing: rabbits were caged singly in an experimental room
- Diet (e.g. ad libitum): commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week prior to the start of the trial

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 50 - 70 %
- Photoperiod (hrs dark / hrs light): artificial light for 10 hours daily from 08.00 - 18.00 hours

Test system

Vehicle:
not specified
Controls:
yes, concurrent negative control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
30 sec
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed out of the eyes of three of the rabbits with approximately
200 ml. of warm water.
- Time after start of exposure: 30 sec

SCORING SYSTEM: method described in "Appraisal of the Safety of Chemicals in
Food Drugs and Cosmetics" page 51, published by the Association of
Food and Drug Officials of the U.S.A.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 15, 16
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: washed eyes
Irritation parameter:
cornea opacity score
Basis:
animal: 14
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: washed eyes
Irritation parameter:
iris score
Basis:
animal: 14, 15, 16
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 15
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 14, 16
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: washed eyes
Irritation parameter:
chemosis score
Basis:
animal: 14, 15, 16
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: washed eyes

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not eye irritant
Executive summary:

Method

The test was carried out in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), on six healthy Neu Zealand White rabbits.

100 mg of the test compound were instilled into the conjunctival sac of the left eye. The rabbits were examined 1, 24, 48 and 72 hours after application.

Results

Under test conditions the substance result to be not eye irritant