2-ethoxyethyl methacrylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-07-06 to 1993-07-20

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 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 24th February 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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:

rat

Strain:

other: Sprague-Dawley ICO: OFASD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: app. 8 weeks
- Weight at study initiation: 248 ± 8 g (males), 218 ± 7 g (females)
- Fasting period before study: no
- Housing: individually during treatment, polycarbonate cages covered with a stainless steel lid
- 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): 22±3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 5x6 cm (females), 5x7 cm (males)
- % coverage: 10% body surface area
- 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 (no residual test substance was observed after patch removal)

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: bodyweights were recorded on days 1 (=day of treatment), 5, 8, 15; clinical signs: several times following application; at least once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: necropsy of dead animals

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: 20% mortality at this dose level

Mortality:

2/5 females were found dead 24 hours after treatment without any preclinical signs.

Clinical signs:

No clinical signs and cutaneous reactions were observed during the study.

Body weight:

Between days 1 and 5, a decrease in body weight was noted for 1/5 males, the bodyweight gain was slightly reduced for 1/5 males and 2/5 females. The body
weight of these animals showed an improvement during the remainder of the observation period. This finding was probably due to the stress caused by the experimental conditions and was not attributed to treatment with the test substance
The body weight gain of the surviving animals was normal.

Gross pathology:

Macroscopic examination of the main organs of the animals found dead during the study or sacrificed at the end of the study revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 for ETMA in rats is >2000 mg/kg bw.

Executive summary:

In an acute dermal toxicity study according to OECD guideline 402, adopted 24 February 1987, 5 male and 5 female app. 8 weeks old Sprague-Dawley ICO: OFASD rats were dermally exposed to ETMA (99.94% a.i.) for 24 hours under a semiocclusive dressing to approx. 10% of body surface area at a single dose of 2000 mg/kg bw. Animals then were observed for 14 days.

2/5 females were found dead 24 h after treatment without any preclinical signs.

No clinical signs and cutaneous reactions were observed during the study.

Between days 1 and 5, a decrease in body weight was noted for 1/5 males, the bodyweight gain was slightly reduced for 1/5 males and 2/5 females. The body weight of these animals showed an improvement during the remainder of the observation period. This finding was probably due to the stress caused by the experimental conditions and was not attributed to treatment with the test substance. The body weight gain of the surviving animals was normal.

Macroscopic examination of the main organs of the animals found dead during the study or sacrificed at the end of the study revealed no apparent abnormalities.

 

Dermal LD50 (rat, male/female) > 2000 mg/kg bw