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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: experimnental result on similar substance
Adequacy of study:
key study
Study period:
December 11 to 19, 1978
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:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
GLP compliance:
no
Remarks:
Study conducted before 1981

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany
- Weight at study initiation: 1.5 to 2 kg
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period: for a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g of test substance applied as such
- Application: The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds.
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 male and 3 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: flushed with 10 ml of physiological saline
- Time after start of exposure: approximately 30 seconds after treatment

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal: 268
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: washed eyes
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal: 269
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: washed eyes
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal: 270
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: washed eyes
Irritation parameter:
iris score
Basis:
animal: 268
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 1
Max. score:
1
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: washed eyes
Irritation parameter:
iris score
Basis:
animal: 269, 270
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no signs of irritation
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 268
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 269
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 270
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 1.66
Max. score:
2
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: washed eyes
Irritation parameter:
chemosis score
Basis:
animal: 268, 269
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: washed eyes
Irritation parameter:
chemosis score
Basis:
animal: 290
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 1.66
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: washed eyes

Applicant's summary and conclusion

Interpretation of results:
other: Category 1 (irreversible effects on the eye) based on CLP criteria
Conclusions:
Irreversible effects on the eye
Executive summary:

Method

The eye irritation was determined in an irritation test according to the Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959), the US Association of Food and Drug Officials (AFDO), similar to OECD guideline 405. During the test 3 male and 3 female of Hymalaian rabbit were exposed to the substance as such (3 animals rinsed; 3 animals not rinsed). Approximately 30 seconds after treatment the test item was flushed with 10 ml of physiological saline. The irritation scores were registered after 24, 48, 72 hours, 4 and 7 days and the evaluation of the eye irritatation potential of the test item was conducted considering the mean score following grading at 24, 48 and 72 h for each animal.

Observations

After 7 days the irritation effects were reversible only in one animal (rinsed).

Result

Irreversible effects on the eye.