Registration Dossier

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

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 SIDS
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 402 (Acute Dermal Toxicity)
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
- 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:
No substance related clinical signs were observed. No local effects were observed at the application site.
Body weight:
No substance related effects on body weight or body weight gain were reported.
Gross pathology:
No indications for any substance related organ effects were observed. No changes of the skin at the application site were found.

Applicant's summary and conclusion