Registration Dossier

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

Referenceopen allclose all

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 Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
None
Body weight:
No influence on body weight gain.
Gross pathology:
No indications of substance related organ changes were observed.

Applicant's summary and conclusion