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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993-07-08 to 1993-07-22
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:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 24th February 1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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: OFA-SD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: app. 6 weeks
- Weight at study initiation: 189 ± 2 g (males), 158 ± 8 g (females)
- Fasting period before study: app. 18 h before and 4 h after dosing
- Housing: in groups of 5 by sex 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
- Air changes (per hr): app. 13
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
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

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: mortality: 0/10
Mortality:
No deaths occurred during the observation period.
Clinical signs:
No clinical signs were observed during the study period.
Body weight:
The body weight gain of the animals had slowed down slightly between days 1 and 5. Thereafter, between days 5 and 8, an increase of the body weight gain was noted. During the second week of the observation period, the body weight gain of the animals was normal.
Gross pathology:
Macroscopic examination of the main organs of the animals 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 oral LD50 for ETMA in rats is > 2000 mg/kg bw.
Executive summary:

In an acute oral toxicity study according to OECD guideline 401, adopted 24 February 1987, groups of fasted app. 6 week old Sprague-Dawley ICO: OFA-SD rats (5/sex) were given a single oral dose of ETMA (99.94% a.i.) by gavage at a dose level of 2000 mg/kg bw and observed for 14 days.

No deaths occurred during the observation period.

No clinical signs were observed during the study period.

The body weight gain of the animals had slowed down slightly between days 1 and 5. Thereafter, between days 5 and 8, an increase of the body weight gain was noted. During the second week of the observation period, the body weight gain of the animals was normal. 

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

 

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