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Administrative data

Description of key information

Skin: The test material was not irritating to the rabbits' skin under the test conditions chosen.
Eye: The test material was irritating to the rabbits' eyes under test conditions chosen.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin 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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no 48-hour-observation; further time points necessary to evaluate fully reversibility
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kuiper's Rabbit Ranch, Gary, Indiana
- Weight at study initiation: 2295 to 2933 grams
- Housing: individually housed in hanging wire-mesh cages
- Diet: Purina® Rabbit Chow®, ad libitum
- Water: ad libitum
- Acclimation period: 14 days

Type of coverage:
occlusive
Preparation of test site:
other: clipped and abraded
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
3 males
3 females
Details on study design:
TEST SITE
- Area of exposure: back of each rabbit under a one inch square gauze patch
- % coverage: 20 -30% of the body surface
- Type of wrap: the application sites were covered with gauze bandaging and overwrapped with Saran Wrap. The entire application area was then wrapped with several layers of 75 mm Elastoplast tape. A collar was also applied.

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours

Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h/ 72 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: individual scores for intact skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h/ 72 h
Score:
0.25
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
other: individual scores for intact skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h/ 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: individual scores for intact skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h/72 h
Score:
0
Max. score:
4
Remarks on result:
other: individual score for intact skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h/ 72 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: individual score for intact skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h/ 72 h
Score:
0
Max. score:
4
Remarks on result:
other: individual score for intact skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h/ 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: individual score for abraded skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h/ 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: individual score for abraded skin; blanching after 24 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h/ 72 h
Score:
0
Max. score:
4
Remarks on result:
other: individual score for abraded skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h/ 72 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: individual score for abraded skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h/ 72 h
Score:
0
Max. score:
4
Remarks on result:
other: individual score for abraded skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h/ 72 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: individual score for abraded skin
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
not determinable
Interpretation of results:
not irritating
Conclusions:
The results obtained from the study show, that the mean values of the recordings 24 and 72 hours after treatment for both erythema and edema were in the range of 0 to 1 for all individual animals.
Executive summary:

In a primary dermal irritation study (International Research and Development Corporation, 1978), three male and three female New Zealand White rabbits were dermally exposed to 0.5 mL of tert-butyl peracetate (75% (w/w) in mineral spirit) for 24 hours. The skin of three of the rabbits was abraded with a scalpel blade. Animals then were observed 24 and 72 hours after test item application. Irritation was scored by a modified method of Skin Reaction Code (National Academy of Sciences, 1977). The mean erythema score (24/72h) was 0.6 for intact skin and 0.5 for abraded skin and the mean edema score (24/72h) was 0.25 for intact and 0.5 for abraded skin. Based on the results tert-butyl peracetate (75 % (w/w) in mineral spirit) is not considered a dermal irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
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

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
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

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

 

 

 

 

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In a primary dermal irritation study (International Research and Development Corporation, 1978), three male and three female New Zealand White rabbits were dermally exposed to 0.5 mL of tert-butyl peracetate (75% (w/w) in mineral spirit) for 24 hours. The skin of three of the rabbits was abraded with a scalpel blade. Animals then were observed 24 and 72 hours after test item application. Irritation was scored by a modified method of Skin Reaction Code (National Academy of Sciences, 1977). The mean erythema score (24/72h) was 0.6 for intact skin and 0.5 for abraded skin and the mean edema score (24/72h) was 0.25 for intact and 0.5 for abraded skin. Based on the results tert-butyl peracetate (75 % (w/w) in mineral spirit) is not considered a dermal irritant.

Eye irritation

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.


Justification for selection of skin irritation / corrosion endpoint:
one available study

Justification for selection of eye irritation endpoint:
one available study

Effects on eye irritation: irritating

Justification for classification or non-classification

Concerning the skin irritation study, the test material is not considered to be classified for skin irritation under Regulation (EC) No 1272/2008 and Directive 67/548/EEC..

Based on the data received from the eye irritation study, the test material is considered to be classified for eye irritation cat. 2, H319 under Regulation (EC) No 1272/2008.