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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Fed. Reg. 28 (119): 5582, 1963
Deviations:
not specified
Principles of method if other than guideline:
Draize Test: In general, the techniques of tests as published by the FDA of the United States (Fed. Reg. 28 (119): 5582, 1963) and Draize and Kelley (Drug Cosmet. Industr. 71: 36, 1952) were followed. Only an observation period of up to 7 days was examined.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-hydroxybutyl acrylate
EC Number:
219-606-3
EC Name:
4-hydroxybutyl acrylate
Cas Number:
2478-10-6
Molecular formula:
C7H12O3
IUPAC Name:
4-hydroxybutyl acrylate
Specific details on test material used for the study:
- Name of test material: Butanediolmonoacrylate
- Chemical name: 2-Propenoic acid, 4-hydroxy ester
- Analytical purity: >= 94 %
- Substance No.: 77/759

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: no data
- Weight at study initiation: no data
- Housing: one animal/cage
- Diet (ad libitum): They received no hay or other extraneous material that might have entered the eyes.
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
no details given


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye remaining untreated, served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
once
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
- According to Draize and Kelly (Drug . Cosmet . Industr . 71 (1952) 36)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
other: animal died after 7 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: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Ulcus corneae was found after 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
other: animal died after 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Ulcus corneae was found after 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
other: animal died after 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Ulcus corneae was found after 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
other: animal died after 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Ulcus corneae was found after 7 days
Irritant / corrosive response data:
The test substance caused moderate to severe corneal damage, slight iritis and severe lesions of the conjunctivae. One rabbit died in the course of the observation period; the death occurred between the 72-hour reading and the 7-day reading; however, the cause of death was not considered to be substance-related. Another rabbit showed an ulcer of the cornea at the 7th day; according to the authors, this may be treatment-related.
 
According to the authors, the test substance was severely irritating to the eyes. Eye irritation score was 69 (maximum eye irritation index = 110).
Other effects:
One rabbit died in the course of the observation period; the death occurred between the 72-hour reading and the 7-day reading; however, the cause of death was not considered to be substance-related.

Any other information on results incl. tables

Individual eye irritation scores:

Time

Rabbit no.

Cornea

Iris

Conjunctivae

Total score

 

 

Opacity

Area

 

Redness

Chemosis

Discharge

 

1 hr

1

0

0

0

2

4

2

16

2

1

4

1

2

4

2

41

3

1

4

1

2

3

2

39

24 hr

1

2

4

1

2

3

3

61

2

2

4

1

2

4

3

63

3

3

4

1

2

4

3

83

48 hr

1

2

4

1

2

3

2

59

2

2

4

1

2

3

3

61

3

3

4

1

2

3

3

81

72 hr

1

3

4

1

2

3

2

79

2

2

4

1

2

2

2

57

3

3

4

1

2

3

2

79

7 d

1*

-

-

-

-

-

-

-

2

3

4

1

2

2

0

71

3**

4

3

1

2

2

3

79

* dead

** Rabbit no. 3 showed an ulcus corneae

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria