2-dimethylaminoethyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference 1

Reference Type:

other: summary report

Title:

Unnamed

Year:

1998

Reference 2

Reference Type:

publication

Title:

Toxicity Testing Reports of Envirmnmental Chemicals vol. 6, p. 539-568

Author:

Ministry of Health and Welfare, Japan

Year:

2003

Bibliographic source:

cited in: OECD SIDS, 2-Dimethylaminoethylmethacrylate, CAS No: 2867-47-2, 07/2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

2-dimethylaminoethyl methacrylate

EC Number:

220-688-8

EC Name:

2-dimethylaminoethyl methacrylate

Cas Number:

2867-47-2

Molecular formula:

C8H15NO2

IUPAC Name:

2-(dimethylamino)ethyl methacrylate

Test material form:

liquid

Specific details on test material used for the study:

TEST MATERIAL:
Name of test material: 2-(dimethylamino)ethyl methacrylate

Test animals

Species:

rat

Strain:

other: Crj:CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Japan Charles River Co., Ltd.
- Age at study initiation:
- Weight at study initiation: 134-152 g (males); 108-125 g (females)
- Fasting period before study: not specified
- Housing: polycarbonate cage (265W x 426D x 200H mm, Tokiwa Scientific Instruments Co., Ltd.) for lab animal bedding (Beta Chip, Nippon Charles River Co., Ltd.)
- Historical data: not specified
- Diet (e.g. ad libitum): autoclave-sterilized lab animal solid feed (MF, Oriental Yeast Co., Ltd.), ad libitum
- Water (e.g. ad libitum): Uv-irraditated tap water filtered through 5 µm filter,ad libitum
- Acclimation period: 7 days
- Microbiological status when known: SPF animals
- Method of randomisation in assigning animals to test and control groups

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2°C
- Humidity (%): 55+/-15%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

0 (Vehicle), 500, 1000, 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Statistics:

The weight measurements were tested for homoscedasticity through the Bartlett method, one-way ANOVA for equal variances, and Kruskal-Wallis for unequal variances. If there was a significant difference between the groups, the Dunnet method or Dunnet-type multiple comparison test was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths occurred in any of the treated groups.

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

Both males and females showed similar transitions compared to the control group.

Gross pathology:

Two males in the 2000 mg / kg group had a raised lesion in the anterior stomach. No other abnormalities were found.

Other findings:

Examination of the stomachs of two males in the 2000 mg / kg group, which were abnormal at autopsy, revealed mild papillary hyperplasia in the anterior gastric mucosa in one case. No other abnormalities were found.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

2- (Dimethylamino) ethyl methacrylate was orally administered to rats at a dose of 500, 1000 and 2000 mg / kg.

No deaths were observed in any of the groups, and no abnormalities were observed in the general condition or in body weight. Necropsy revealed a raised lesion in the anterior gastric region in males in the 2000 mg / kg group, and histopathologically papillary hyperplasia of the anterior gastric mucosa was observed as a related change. Acrylic acid esters containing this test substance are known to cause acute irritation to mucosa, and it has been reported that oral administration of ethyl acrylate causes hyperplasia of the anterior gastric mucosa in rats ²⁾. Since this change is considered to be the result of a local inflammatory response to the stimulant ²⁾, the change in the anterior stomach observed with this test substance is also considered to be the convergent with the inflammatory response to the stimulus.

The median lethal dose (LD₅₀ value) of a single oral dose of 2- (dimethylamino) ethyl methacrylate to rats was 2000 mg / kg or more for both males and females.