Registration Dossier

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
Study period:
24 January 1983 to 10 March 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Section 1500.42 - Federal Hazardous Substances Act Regulations - 16 CFR.
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Specific details on test material used for the study:
Product as manufactured in White Oil.

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Specified only as young adults
- Weight at study initiation:
- Housing: Stainless steel with elevated wire mesh flooring 1 rabbit/cage
- Diet: Ad libitum
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60 to75 °F
- Humidity (%):40 to 45 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL of the test material was dosed as the test material was supplied (unchanged, no vehicle).
Duration of treatment / exposure:
21 days; the test material was not washed from the eyes.
Observation period (in vivo):
The treated eyes were examined at 1, 2, 3, 4, 7, 14 and 21 days following installation of the test material into the eyes.
Number of animals or in vitro replicates:
Six
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The test material was not washed from the eyes.
- Time after start of exposure: Not applicable

SCORING SYSTEM: The Draize scale

TOOL USED TO ASSESS SCORE: None specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritant / corrosive response data:
The test material was irritating, with some parameters not returning to normal within the 21 days observation period.

Any other information on results incl. tables

Individual Daily Scores

Rabbit no.

Tissue and item

Readings

Day

1

2

3

4

7

14

21

1

Corneal opacity

3

2M

2M

2

2P

2P

3P

Iris

2++

0

0

1

1

0

0

Conjunctival redness

3

3

3

3

2

1

0

Conjunctival chemosis

4

4

4

4

2

1

1

2

Corneal opacity

2

2M

2M

1

1

2

4

Iris

0

0

0

0

0

0

0

Conjunctival redness

3

3

2

2

2

1

1

Conjunctival chemosis

4

4

4

4

3

2

2

3

Corneal opacity

2M

1M

2M

2

1P

2

4P

Iris

0

1

0

0

1

0

0

Conjunctival redness

3

3

2

2

2

1

1

Conjunctival chemosis

4

4

4

4

2

2

3

4

Corneal opacity

2M

1M

1M

2

2P

1P

2

Iris

0

0

1

1

1

1

0

Conjunctival redness

3

3

3

2

1

1

0

Conjunctival chemosis

4

4

4

3

3

3

1

5

Corneal opacity

2M

1M

1M

2M

1

0P

0

Iris

0

0

0

1

1

1

0

Conjunctival redness

3

3

3

2

1

1

0

Conjunctival chemosis

4

4

4

4

1

1

1

6

Corneal opacity

1

1M

1M

1

1P

2P

2P

Iris

0

1

0

1

1

1

0

Conjunctival redness

3

3

3

3

2

1

0

Conjunctival chemosis

4

4

4

4

2

1

1

M = Mucous

P = Pannus

++ Maximum score assigned for iris since iris was not visible due to maximum corneal opacities.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of the study, the test substance was determined to be an eye irritant.
Executive summary:

A study was conducted to investigate the potential of the test material to cause irritation to the eye in albino rabbits.

The methods employed in the testing, evaluation and in the grading of the test material are similar to those described in Section 1500.42 - Federal Hazardous Substances Act Regulations - 16 CFR.

Six healthy young adult albino rabbits were used in this study. 0.1 mL of the test material was instilled into one eye of the test animals while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.

The treated eyes were examined at one, two, three, four, seven, fourteen and twenty-one days following instillation of the test material into the eyes. Interpretation of the results was made in accordance with the Draize Seale of Scoring Ocular Lesions.

Under the conditions of the study, the test material was shown to be an eye irritant (Category 1).