Registration Dossier
Registration Dossier
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EC number: 210-478-4 | CAS number: 616-38-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The results of the evaluation report published in this document have been peer-reviewed.
Data source
Reference
- Reference Type:
- publication
- Title:
- ICCVAM TEST METHOD EVALUATION REPORT. The Reduced Murine Local Lymph Node Assay: An Alternative Test Method Using Fewer Animals to Assess the Allergic Contact Dermatitis Potential of Chemicals and Products
- Author:
- Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)
- Year:
- 2 009
- Bibliographic source:
- NIH Publication Number 09-6439. Research Triangle Park, NC: National Institute of Environmental Health Sciences; online available at http://iccvam.niehs.nih.gov/docs/immunotox_docs/LLNA-LD/TMER.pdf
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Dimethyl carbonate
- EC Number:
- 210-478-4
- EC Name:
- Dimethyl carbonate
- Cas Number:
- 616-38-6
- Molecular formula:
- C3H6O3
- IUPAC Name:
- dimethyl carbonate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca or CBA/J
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- - 0.5%
- 5%
- 50% - No. of animals per dose:
- minimum of four animals per dose
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: - Conc.(0.5%): SI = 0.64 - Conc.(5%): SI = 0.69 - Conc.(50%): SI = 1.71
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: no data
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance 'dimethyl carbonate' is not expected to cause skin sensitisation (= result of traditional LLNA).
Moreover a “reduced LLNA” (rLLNA), also referred to as the “cut-down” or “limit dose” LLNA was performed. The result of the rLLNA was in line with the result of the traditional LLNA: not sensitising.
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