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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:
1978-08-23 and 1978-12-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
tert-butyl peracetate
EC Number:
203-514-5
EC Name:
tert-butyl peracetate
Cas Number:
107-71-1
Molecular formula:
C6H12O3
IUPAC Name:
tert-butyl peracetate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: The Charles River Breeding Laboratories, Inc., N. Wilmington, Massachusetts
- Weight at study initiation: 2317 to 2681 grams
- Housing: individually housed in hanging wire-mesh cages
- Diet: Purina® Rabbit Chow®, ad libitum
- Water: ad libitum
- Acclimation period: 36 days

Test system

Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
the eyelids were gently held together for 1 second, single treatment
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days after installation of the test material
Number of animals or in vitro replicates:
3 males
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

TOOL USED TO ASSESS SCORE: 2% sodium fluorescein solution

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours or 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.77
Max. score:
2
Reversibility:
fully reversible within: 48 hours or 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h/ 48 h/ 72 h
Score:
2.24
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1.88
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.16
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
1.83
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.83
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.17
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.83
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.5
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.83
Max. score:
4
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

The following table shows the irritation parameter of each individual animal.

Basis

Irritation parameter

Time point

Score

Max. score

Reversibility

Animal 1

Cornea score

24 h/ 48 h/ 72 h

1.66

4

Fully reversible within 7 d

Iris score

1.0

2

Fully reversible within 7 d

Conjunctivae score

2.16

3

Fully reversible within 7 d

Chemosis score

1.66

4

Fully reversible within 7 d

Animal 2

Cornea score

24 h/ 48 h/ 72 h

0

4

 

Iris score

0.33

2

Fully reversible within 48 h

Conjunctivae score

2.0

3

Fully reversible within 7 d

Chemosis score

1.66

4

Fully reversible within 7 d

Animal 3

Cornea score

24 h/ 48 h/ 72 h

1.66

4

Fully reversible within 7 d

Iris score

1.0

2

Fully reversible within 7 d

Conjunctivae score

2.5

3

Fully reversible within 7 d

Chemosis score

2.66

4

Fully reversible within 7 d

Animal 4

Cornea score

24 h/ 48 h/ 72 h

1.66

4

Fully reversible within 7 d

Iris score

0.33

2

Fully reversible within 48 h

Conjunctivae score

2.16

3

Fully reversible within 7 d

Chemosis score

1.33

4

Fully reversible within 7 d

Animal 5

Cornea score

24 h/ 48 h/ 72 h

1.0

4

Fully reversible within 72 h

Iris score

1.0

2

Fully reversible within 7 d

Conjunctivae score

2.16

3

Fully reversible within 7 d

Chemosis score

1.16

4

Fully reversible within 7 d

Animal 6

Cornea score

24 h/ 48 h/ 72 h

1.83

4

Fully reversible within 7 d

Iris score

1.0

2

Fully reversible within 7 d

Conjunctivae score

2.5

3

Fully reversible within 7 d

Chemosis score

2.83

4

Fully reversible within 7 d

The following table presents the grade of effect with time.

Observations

Examination Interval (No. Positive/ No. Dosed)

Hours

1

24

48

72

7 days

Corneal epithelial damage, peeling

3/6

3/6

4/6

3/6

0/6

Blanching conjunctivae

6/6

0/6

2/6

0/6

0/6

Clear discharge

6/6

3/6

1/6

0/6

0/6

Purulent discharge

0/6

3/6

1/6

2/6

0/6

Vocalization immediately following dosing

3/6

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
Category II
Conclusions:
The cornea score from 5 of 6 animals was greater or equal 1. The iris score was greater or equal 1 at 4 of 6 animals. The redness score was greater or equal 2 at all animals. Based of these results, the test material is considered to be classified for eye irritation.
Executive summary:

In a primary eye irritation study (International Research and Development Corporation, 1978), 0.1 mL of tert-butyl peracetate (75 % (w/w) in mineral spirit) without a vehicle was instilled into the conjunctival sac of the right eye of three male and three female New Zealand White rabbits.The left eye served as the untreated control for each rabbit. None of the rabbits received a washout.Animals then were observed at the following time points: 1, 24, 48 and 72 hours following instillation and after 7 days. Irritation was scored by the method of Draize. The mean cornea score (24/48/72h) was 1.3, the mean iris score (24/48/72h) was 0.77 and the mean chemosis score (24/48/72h) was 1.88. Effects were fully reversible after 7 days. Based on the results, tert-butyl peracetate (75 % (w/w) in mineral spirit) is considered an eye irritant.

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