Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
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:
study report
Title:
Unnamed
Year:
1992
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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
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:
rabbit
Strain:
other: Small white russian, Chbb: HM, SPF
Details on test animals and environmental conditions:
Source: Fa. Dr. Karl Thomae GmbH, Biberach
Weight at study initiation: 2 - 3 kg
Sex: 1 male, 2 females

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shearing
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 cm3 (0.5 mL)
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: shorn skin of the dorsal area of the body, 6 cm2


REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scheme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no findings observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no findings observed
Irritant / corrosive response data:
Slight erythema (grade 1) was observed in all 3 animals 30 to 60 min after removal of the patch.
Other effects:
No substance related clinical signs or macroscopic organ findings at necropsy were reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information