tert-butyl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference 1

Reference Type:

other: Amendment to study report

Title:

Unnamed

Year:

1995

Report date:

1995

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl methacrylate

EC Number:

209-548-7

EC Name:

tert-butyl methacrylate

Cas Number:

585-07-9

Molecular formula:

C8H14O2

IUPAC Name:

tert-butyl 2-methylprop-2-enoate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (supplier): BASF AG
- Lot number of test material: LAB.J.NO. 387
- Purity: not specifed

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator, exclusion of light
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions and during storage: The stability of the test substance over the study period was proved by reanalysis. The result was reported in the form of an amendment (12 January 1995). According to the analytical determination, dated December 07, the test substance was stable over the study period. The sample appeared to be homogeneous.

FORM AS APPLIED IN THE TEST
- The test substance was applied in a single dose to the tact untreated skin. The test patch was secured in position with a semiocclusive dressing.

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Age at study initiation: young adult, not further specified
- Weight at study initiation: 3.35 - 3.82 kg
- Housing: single
- Diet: Kliba Labordiaet 341, Klingenthalmuehle AG, Kauseraugst, Switzerland, about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 h/12 h (6.00 a.m.- 6.00 p.m./6.00 p.m.- 6.00 a.m.)

IN-LIFE DATES: not specified

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: Yes, untreated skin sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test patch (2.5 cm x 2.5 cm) was moistened with a dose of 0.5 ml of the unchanged liquid test substance.

Duration of treatment / exposure:

4 h

Observation period:

15 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: upper third of the back or flanks
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: Idealbinde, Pfaelzische Verbandsstoff-Fabrik, Kaiserslautern, Germany and Fixomull stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance wa sremoved at the end of the exposure period with Lutrol (=Polyethylenglykol) pure and Lutrol/water 1:1
- Time after start of exposure: 4 h

SCORING SYSTEM: OECD Draize
- for detailed information please refer to section "Any other information on materials and methods incl. tables"

OBSERVATION TIME POINTS: 1 h, 24 h, 48 h, 72 h, 8 d and 15 d after removal of the patch

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24, 48, 72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 15 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24, 48, 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 15 d

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24, 48, 72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 15 d

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

2.43

Max. score:

4

Reversibility:

fully reversible within: 15 d

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The numerical scores awarded to the dermal reactions of each animal elicited by the test substance are given in Table 1 in section "Any other information on results incl. tables".

Any other information on results incl. tables

Table 1: Dermal reactions elicited by the test substance.

Exposition:	4 h
Animal	Reading	Erythema	Edema	Symptoms
1	1 h	2	1
2	1 h	1	0
3	1 h	2	1
1	24 h	3	1
2	24 h	2	0
3	24 h	2	0
1	48 h	3	1
2	48 h	2	0
3	48 h	2	0
1	72 h	3	1
2	72 h	2	0
3	72 h	3	0
1	8 d	1	0	Scaling
2	8 d	1	0	Scaling
3	8 d	1	0	Scaling
1	15 d	0	0
2	15 d	0	0	Scaling
3	15 d	0	0
mean	24 - 72 h	2.44	0.33

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the test conditions chosen and considering the described findings the test substance gives indication of an irritant property to the skin.

Executive summary:

Acute dermal irritation or corrosion to skin was evaluated in a GLP compliant study according to the OECD TG 404. Thereby, test patches containing 0.5 ml of the test substance were applied by a single topical application to the intact skin of three white Vienna rabbits for 4 hours under semiocclusive dressing. The skin sites were evaluated for erythema/eschar and edema formation 1 h, 24 h, 48 h, 72 h, 8 d and 15 d following removal of the patches. The average score (24 to 72 hours) for irritation was calculated to be 2.4 for erythema and 0.3 for edema. Signs of skin irritation such as erythema and edema were reversible within 15 days after removal of the patches, while scaling was still present in one animal at study termination. Under the test conditions chosen and considering the described findings the test substance gives indication of an irritant property to the skin.