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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
observation period of 8 days, limited data to test substance, source/breeder not mentioned, ages of animals not documented, read across substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Fed. Reg. 38, No. 187, § 1500.42, p. 27019, Sept. 27, 1973
Principles of method if other than guideline:
Draize Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
No. of animais per cage: 1
Room temperature: 20 - 26°C
Humidity: Conventional (about 30 - 70%)
Day/night rhythm: 12 h/12 h (6.00 - 18.00 hours/18.00 - 6.00 hours)
Diet: Ovator Solikanin 4 mm; Muskator-Werke, Düsseldorf, FRG (about 130 g per animal per day)
Drinking water: About 250 ml per animal per day: demineralized water (Monday - Friday), tap water (Saturday/Sunday).
Acclimatization period: About 8 days before the beginning of the study in the skin laboratory; same housing conditions as during the study.
Mean weight (kg) males 2.99, females 2.57

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml bulk volume (about 31 mg of the comminuted test substance)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6
Details on study design:
Appl. site: Conjunctival sac of the right eyelid
Assessment: Based on J. H. Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health.
Readings: 1 h, 24 h, 48 h, 72 h, 8 d after application
Single application to the conjunctival sac of the eyelid; the substance is not washed out

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 h
Score:
1.17
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 8d
Score:
0.3
Max. score:
3
Reversibility:
not fully reversible within: 8d
Remarks on result:
other: shows tendency to nomalize within 21d
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Other effects:
Discharge was observed in three animals at reading 24 h (score 1), in two animals at reading 48 h (score 1) and in one animal at reading 72h (score 1). This was reversible within 8 days.

Any other information on results incl. tables

Table 1: Irritation results

Animal

Reading

Cornea

Opacity

Iris

Conjunctiva

Additional findings

Redness

Chemosis

1

24 h

0

0

1

0

-

2

24 h

0

0

2

1

-

3

24 h

0

0

1

0

-

4

24 h

0

0

2

1

-

5

24 h

0

0

1

0

-

6

24 h

0

0

2

1

-

1

48 h

0

0

1

0

-

2

48 h

0

0

1

1

-

3

48 h

0

0

1

0

-

4

48 h

0

0

1

0

-

5

48 h

0

0

1

0

-

6

48 h

0

0

2

1

-

1

72 h

0

0

1

0

-

2

72 h

0

0

0

0

-

3

72 h

0

0

0

0

-

4

72 h

0

0

1

0

-

5

72 h

0

0

1

0

-

6

72 h

0

0

2

1

-

1

8 d

0

0

0

0

-

2

8 d

0

0

0

0

-

3

8 d

0

0

0

0

-

4

8 d

0

0

1

0

-

5

8 d

0

0

0

0

-

6

8 d

0

0

1

0

-

mean animal 1

24 - 72 h

0.00

0.00

1.00

0.00

 

mean animal 2

24 - 72 h

0.00

0.00

1.00

0.67

 

mean animal 3

24 - 72 h

0.00

0.00

0.67

0.00

 

mean animal 4

24 - 72 h

0.00

0.00

1.33

0.33

 

mean animal 5

24 - 72 h

0.00

0.00

1.00

0.00

 

mean animal 6

24 - 72 h

0.00

0.00

2.00

1.00

 

mean

24 - 72 h total

0.00

0.00

1.17

0.33

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met