Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: experimental study on similar substance
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, test procedure in accordance with OECD 406 methods, meets generally accepted scientific principles, acceptable for assessment. Not GLP compliant.

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 substance Labelling Act Sect. 191-12 (february 1965)
Deviations:
yes
Remarks:
slight modifications
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
Details on test animals or tissues and environmental conditions:
Healthy New Zealand White rabbits (Porton strain) aged 12-16 weeks with average body weights of 2.70 kgs. (males ) and 2.58 kgs (females) bred on the premises and maintained under a semi-barrier system. Six rabbits (3 males and 3 females) were acclimatised in the test area for one week prior to the start of the trial.The rabbits were caged singly in an experimental room maintained at a temperature of 20°C. (_+1°) and a relative humidityof 50-70%. Animals ware exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. A commercial irradiated diet(Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye served as control
Amount / concentration applied:
100 mg of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately200 ml. of warm water.
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
up to 16 days
Number of animals or in vitro replicates:
6 (3 males and 3 females)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: all animals
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
animal: 11,13
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: all animals
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 15 days
Irritation parameter:
chemosis score
Basis:
animal: 11,15,16
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
animal: 13,14
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
animal: 14
Time point:
other: 1 h
Score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal: all animals
Time point:
other: 1 h
Score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Time point:
24/48/72 h
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Time point:
24/48/72 h
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Time point:
24/48/72 h
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Time point:
24/48/72 h
Remarks on result:
positive indication of irritation

Any other information on results incl. tables

 

Time

Rabbit no.

11

13

15

12

14

16

1 h

Cornea Opacity

1

1

1

1

1

1

Iris

 

 

 

 

 

 

Conjunctivae

Redness

Chemosis

Discharge

 

2

1

3

 

2

2

3

 

2

1

3

 

2

3

3

 

2

2

3

 

2

1

3

 

Time

Rabbit no.

11

13

15

12

14

16

1 day

Cornea Opacity

1

1

 

1

1

1

Iris

1

1

 

 

 

 

Conjunctivae

Redness

Chemosis

Discharge

 

2

2

2

 

2

3

3

 

2

1

 

 

2

3

2

 

2

2

1

 

2

1

 

 

Time

Rabbit no.

11

13

15

12

14

16

3 days

Cornea Opacity

1

1

 

1

 

1

Iris

1

1

 

 

 

 

Conjunctivae

Redness

Chemosis

Discharge

 

3

2

1

 

3

2

2

 

1

 

 

 

3

2

2

 

2

1

 

 

3

 

 

 

Time

Rabbit no.

11

13

15

12

14

16

6 days

Cornea Opacity

1

 

 

 

 

 

Iris

1

1

 

 

 

 

Conjunctivae

Redness

Chemosis

Discharge

 

2

1

 

 

2

2

 

 

1

 

 

 

2

1

 

 

1

 

 

 

1

 

 

 

Time

Rabbit no.

11

13

15

12

14

16

10 days

Cornea Opacity

 

 

 

 

 

 

Iris

 

 

 

 

 

 

Conjunctivae

Redness

Chemosis

Discharge

 

 

1

 

 

1

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
irritant for the eye
Executive summary:

The ocular reactions were scored by the 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. (sea appendix I).The tested substance is considered to be irritant for the rabbits eyes.