Dimethyl malonate

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:

other: Adopted according to OECD SIDS (publicly available peer reviewed source). Original document not available.

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

SIDS Initial Assessment Report For SIAM 20 (Malonic Acid Diesters: Dimethylmalonate, 108-59-8; Diethylmalonate, 105-53-3), April 19-22, 2005 Paris.

Author:

OECD

Year:

2005

Bibliographic source:

UNEP Publications

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(adopted 1987)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl malonate

EC Number:

203-597-8

EC Name:

Dimethyl malonate

Cas Number:

108-59-8

Molecular formula:

C5H8O4

IUPAC Name:

dimethyl malonate

Details on test material:

Purity: ca. 99 %
Impurities from the production process: methanol (ca. 0.3 %) and dimethyl-methylmalonate (ca. 0.2%)
Physical state: liquid, colorless

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPF Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Fa. Winkelmann, Borchen
- Age: 6 - 8 weeks
- Weight at study initiation: 128.6 g +/- 20 %

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- Doses per time period: once
- Volume administered or concentration: 1.74 cm3 /kg bw
- Post dose observation period: 2 weeks

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
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical symptoms were recorded 0.5, 1, 2, 3, 4, 5, and 6 hours after administration of the test substance and once daily for the following two weeks. Body weight was determined at the day of administration of the test substance, on days 7 and 14. After 14 days the animals were killed by CO2 inhalation, sectioned and investigated for any macroscopic organ changes.

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:

other: No mortality occurred.

Mortality:

No mortality occurred.

Clinical signs:

other: None

Gross pathology:

No indications of substance related organ changes were observed.