tert-butyl acrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1964

Report date:

1964

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid test substance.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl acrylate

EC Number:

216-768-7

EC Name:

tert-butyl acrylate

Cas Number:

1663-39-4

Molecular formula:

C7H12O2

IUPAC Name:

tert-butyl acrylate

Specific details on test material used for the study:

tert. Butylacrylate, stabilized with 0.02 % hydroquinone

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 2.04 - 2.97 kg


ENVIRONMENTAL CONDITIONS
not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

ca. 1 mL

Duration of treatment / exposure:

20 h and 1, 5, 15 min

Observation period:

7/8 days

Number of animals:

4 (in two trials)

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: The skin area exposed for 20 h was not washed, while the shorter treated areas were washed twice, with Lutrol and Lutrol : water 1:1 solution

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

20 h exposure

Basis:

animal #1

Time point:

24/48 h

Score:

2.5

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Remarks:

20 h exposure

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Remarks on result:

other: animal died before 48h reading

Results 3

Irritation parameter:

erythema score

Remarks:

20 h exposure

Basis:

animal: animal #3, #4

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 or 8 days (animal #4 or #3, respectively)

Results 4

Irritation parameter:

edema score

Remarks:

20 h exposure

Basis:

animal #1

Time point:

24/48 h

Score:

2.5

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

edema score

Remarks:

20 h exposure

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Remarks on result:

other: animal died before 48h reading

Results 6

Irritation parameter:

edema score

Remarks:

20 h exposure

Basis:

animal: #3, #4

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

erythema score

Remarks:

15 min exposure

Basis:

animal #1

Time point:

24/48 h

Score:

2.5

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 8

Irritation parameter:

erythema score

Remarks:

15 min exposure

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Remarks on result:

other: animal died before 48h reading

Results 9

Irritation parameter:

erythema score

Remarks:

15 min exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

erythema score

Remarks:

15 min exposure

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

edema score

Remarks:

15 min exposure

Basis:

animal #1

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

edema score

Remarks:

15 min exposure

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

other: animal died before 48h reading

Results 13

Irritation parameter:

edema score

Remarks:

15 min exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 14

Irritation parameter:

edema score

Remarks:

15 min exposure

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

See comments in table below.

Other effects:

Reversible clinical signs (apathy and abdominal position with stretched extremities) were seen directly after the 20 h exposure.

Any other information on results incl. tables

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h and the 15 min exposition will serve as approximation.

Exposure:	20 h
Animal	Reading	Erythema	Edema	Comment
1	24 h	2	2	largely extending beyond the area of exposure; reversible apathy
2	24 h	2	2	largely extending beyond the area of exposure; apathy, followed by abdominal position and convulsions of the extremities before exitus
3	24 h	2	2	abdominal position with stretched extremities for one hour after exposure was finished
4	24 h	2	2	abdominal position with stretched extremities for one hour after exposure was finished
1	48 h	3	2	largely extending beyond the area of exposure
2	48 h	animal died
3	48 h	3	2
4	48 h	3	2
3	72 h	1	0	fine scaling
4	72 h	1	0	fine scaling
3	4 d	1	0	fine scaling
4	4 d	1	0
1	5 d	1	0	largely extending beyond the area of exposure
2	5 d	animal died
1	7 d	0	0	scaling
2	7 d	animal died
3	7 d	1	0	fine scaling
4	7 d	0	0	fine scaling
1	8 d	0	0	scaling
2	8 d	animal died
3	8 d	0	0	fine scaling
4	8 d	0	0	fine scaling
mean	24 - 48 h	2.11	1.56
Exposure:	15 min
Animal	Reading	Erythema	Edema	Comment
1	24 h	2	0	largely extending beyond the area of exposure
2	24 h	2	0	largely extending beyond the area of exposure
3	24 h	2	0
4	24 h	2	2
1	48 h	3	2	largely extending beyond the area of exposure
2	48 h	animal died
3	48 h	2	0
4	48 h	2	0
3	72 h	1	0
4	72 h	0	0
3	4 d	0	0
4	4 d	0	0
1	5 d	2	2	parchment-like
2	5 d	animal died
1	7 d	1	0	rough scaling
2	7 d	animal died
3	7 d	0	0
4	7 d	0	0	fine scaling
1	8 d	0	0	scaling
2	8 d	animal died
mean	24 - 48 h	1.78	0.44

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria