2-ethoxyethyl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-07-20 to 1993-07-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 12th May 1981

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethoxyethyl methacrylate

EC Number:

219-135-3

EC Name:

2-ethoxyethyl methacrylate

Cas Number:

2370-63-0

Molecular formula:

C8H14O3

IUPAC Name:

2-ethoxyethyl 2-methylprop-2-enoate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 2-ethoxyethyl methacrylate, MAEE

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.3 ± 0.1 kg
- Housing: individually in polystyrene cages
- Diet (e.g. ad libitum): pelleted diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated left flank served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

7 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: gauze patches were held in contact with the skin by means of adhesive hypoallergic aerated semi-occlusive dressing and restraining bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no (after removal of the patches, no residual test substance was observed)

SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 d

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 4 d

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 5 d

Results 4

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight to moderate cutaneous reactions (erythema grade 1 and 2) were observed for up to 72 h (2/3 animals) or 4 d (1/3 animals) after the removal of the dressing. From day 3 to 6, a dryness of the skin was observed at the treatment site in 1/3 animals. During the whole observation period, the animals were free of edema.
All effects were fully reversible within 4 or 5 days.

Other effects:

no other effects reported

Any other information on results incl. tables

 

Rabbit number	reaction	score after 1h/24h/48h/72h/4d/5d/6d/7d
1	erythema (max score 4)	0/1/1/1/0/-/-
	edema (max score 4)	0/0/0/0/0/-/-
2	erythema (max score 4)	1/2/2/1/0/-/-
	edema (max score 4)	0/0/0/0/0/-/-
3	erythema (max score 4)	1/2/2/2/1/0/0
	edema (max score 4)	0/0/0/0^S/0^S/0^S/0

- = no cutaneous examination performed; S = dryness of skin

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

ETMA is not irritating to rabbit skin

Executive summary:

In a primary dermal irritation study according to OECD guideline 404, adopted 12 May 1981, 3 male New Zealand white rabbits were dermally exposed to 0.5 mL of ETMA (99.94 % a.i.) for 4 h to ca. 6 cm² body surface area. Animals then were observed for 6 days. Irritation was scored by the method of Draize.

Very slight to moderate cutaneous reactions (erythema grade 1 and 2) were observed for up to 72 hours (2/3 animals) or 4 d (1/3 animals) after the removal of the dressing. From day 3 to 6, a dryness of the skin was observed at the treatment site in 1/3 animals. During the whole observation period, the animals were free of edema. All effects were fully reversible within 4 or 5 days.

In this study, ETMA is not a dermal irritant.