Registration Dossier
Registration Dossier
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EC number: 203-597-8 | CAS number: 108-59-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 406 (Skin Sensitisation)
- Version / remarks:
- (adopted 1981)
- Deviations:
- yes
- Remarks:
- The guideline (OECD TG 406, adopted 1992) recommends the use of 20 test animals if there is no clear evidence, that the test substance is a sensitizer.
- GLP compliance:
- yes
- Type of study:
- Buehler test
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Dunkin Hartley, Pirbright White Bar:DHPW (SPF)
- Sex:
- female
- Details on test animals and environmental conditions:
- Source: Winkelmann, Barchen
Age: juvenile adult rats
Weight at study initiation: 376-458 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted test substance
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- undiluted test substance
- No. of animals per dose:
- Control group: 20 animals
Test group: 10 animals - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: undiluted test substance
- Control group: undiluted test substance
- Site: no data
- Frequency of applications: once per week, for 3 weeks (day 0, day 7, and day 14)
- Duration: 0-14 days
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 28
- Exposure period: 6 h
- Test groups: undiluted test substance
- Control group: undiluted test substance
- Site: no data
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48 , and 72 h
OTHER:
Observation of skin irritation 6, 24, and 48 h after application.
Observation of body weight development during the study.
Observation of clinical signs. - Challenge controls:
- Regular assessment of the reliability and sensitivity of the test system with standard allergens.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no findings.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no findings.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no findings.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no findings.
Any other information on results incl. tables
Results of the pilot study: No skin irritation was observed at any of the tested concentrations after 6, 24, and 48 h after treatment.
Clinical signs: None observed.
Body weight development during the study was normal.
Applicant's summary and conclusion
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