Registration Dossier
Registration Dossier
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EC number: 203-305-9 | CAS number: 105-53-3
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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Sensitization
- Author:
- Opdyke DLJ
- Year:
- 1 976
- Bibliographic source:
- Fd. cosmet. Toxicol., 14, 745-746.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- other: human maximisation test
- Justification for non-LLNA method:
- not available
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:
- diethyl malonate
Constituent 1
In vivo test system
Test animals
- Species:
- human
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- 4%
Challenge
- Concentration / amount:
- 4%
- No. of animals per dose:
- 23
Results and discussion
- Positive control results:
- A maximisation test according to Kligman, 1966 and Kligman and Eppstein, 1975 was reported in 23 volunteers. 4% of the test substance in petrolatum produced no sensitization reactions.
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 4%
- No. with + reactions:
- 0
- Total no. in group:
- 23
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 4%. No with. + reactions: 0.0. Total no. in groups: 23.0.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A human maximisation test was conducted with 23 volunteers. 4% of the test substance in petrolatum produced no sensitization reactions.
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