tert-butyl peracetate

Endpoint summary

Description of key information

Skin (equivalent to OECD 404): The test material was not irritating to the rabbits' skin under the test conditions chosen.
Eye (equivalent to OECD 405): 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:

GHS criteria not met

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:

yes, concurrent no treatment

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:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 72 hours or 7 days

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.77

Max. score:

2

Reversibility:

fully reversible within: 48 hours or 7 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2.24

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 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

Irritant / corrosive response data:

Refer to Table 1 and Table 2 ("Any other information on results incl. tables")

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

Table 1: Individual observations of irritation parameters

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.

Table 2: Grading of observed irritation symptoms

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 2 (irritating to eyes) based on GHS criteria

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 classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.

 

Eye irritation:

Based on available data, the test item is classified and labelled for eye irritation cat. 2 (H319) according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.

 

Skin irritation:

Classification regarding skin irritation is not warranted according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.