Registration Dossier
Registration Dossier
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EC number: 248-196-9 | CAS number: 27059-08-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Monographs on Fragrance Raw Materials: Diethyl malonate
- Author:
- D. L. J. Opdyke
- Year:
- 1 976
- Bibliographic source:
- Food and Cosmetics Toxicology, Volume 14, Supplement, 1976, Pages 745-746
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the skin irritation potential of diethyl malonate in humans
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Diethyl malonate
- EC Number:
- 203-305-9
- EC Name:
- Diethyl malonate
- Cas Number:
- 105-53-3
- Molecular formula:
- C7H12O4
- IUPAC Name:
- 1,3-diethyl propanedioate
- Test material form:
- liquid
- Details on test material:
- Name of the test chemical: 1,3-diethyl propanedioate
Common Name: diethyl malonate
Molecular Fiormula:C7H12O4
Molecular Weight:160.1678 g/mol
InChI : 1S/C7H12O4/c1-3-10-6(8)5-7(9)11-4-2/h3-5H2,1-2H3
Substance Type: Organic
Physical State: Liquid
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical: 1,3-diethyl propanedioate
Common Name: diethyl malonate
Molecular Fiormula:C7H12O4
Molecular Weight:160.1678 g/mol
InChI : 1S/C7H12O4/c1-3-10-6(8)5-7(9)11-4-2/h3-5H2,1-2H3
Substance Type: Organic
Physical State: Liquid
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data available
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: petrolatum
- Controls:
- not specified
- Amount / concentration applied:
- 4% in petrolatum
- Duration of treatment / exposure:
- 48 hours
- Observation period:
- 48 hours
- Number of animals:
- no data available
- Details on study design:
- no data available
Results and discussion
In vitro
- Other effects / acceptance of results:
- no data available
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation observed
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
Diethyl malonate was not irritating to human skin after 48 hours exposure.- Executive summary:
A skin irritation study was performed in humans to assess the irritation potential of Diethyl malonate. Diethyl malonate was tested 4% in petrolatum in 48 hours closed patch test on human volunteers.Diethyl malonate was not irritating to human skin after 48 hours exposure.
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