Registration Dossier
Registration Dossier
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EC number: 203-597-8 | CAS number: 108-59-8
Skin irritation / corrosion
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:
- 1 992
- 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:
- 2 005
- Bibliographic source:
- UNEP Publications
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- 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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Small white russian, Chbb: HM, SPF
- Details on test animals or test system 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
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