Dimethyl malonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 SIDS

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 402 (Acute Dermal Toxicity)

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
- Weight at study initiation: 200-300 g

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

AREA: intact shorn backside skin (10% of body surface)
REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 1.74 cm3/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:

Observation time: 14 days
Clinical symptoms were recorded 0.5, 1, 2, 3, 4, 5, and 6 h after application of the test substance and once daily in the following two weeks.
The application area was examined for substance related local effects. Body weights were recorded at days 0 (day of application of the test substance), 7 and 14.
After the 14 day observation period all animals were killed by inhalation of CO2, sectioned and investigated for substance related 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: No substance related clinical signs were observed. No local effects were observed at the application site.

Gross pathology:

No indications for any substance related organ effects were observed. No changes of the skin at the application site were found.