Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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

Constituent 1
Chemical structure
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 methacrylate
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:
other: No clinical signs and cutaneous reactions were observed during the study.
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

Categories Display