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:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- N/A
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
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Weight at study initiation: 376-458 g
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.40-0.46 g test substance
1st: Induction 100 %
2nd: Induction 100 %
3rd: Challenge 100 %
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.40-0.46 g test substance
1st: Induction 100 %
2nd: Induction 100 %
3rd: Challenge 100 %
- No. of animals per dose:
- 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test group/control group
- Dose level:
- 2.5%,25%,50%,100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test group/control group. Dose level: 2.5%,25%,50%,100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: test group/control group
- Dose level:
- 2.5%,25%,50%,100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: test group/control group. Dose level: 2.5%,25%,50%,100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- other: test group/control group
- Dose level:
- 2.5%,25%,50%,100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: other: test group/control group. Dose level: 2.5%,25%,50%,100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Any other information on results incl. tables
no reaction observed in any of 10 animals
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
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