Registration Dossier
Registration Dossier
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EC number: 204-354-9 | CAS number: 119-84-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Remarks:
- other: review report
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Opinion on Coumarin (sensitisation only)
- Author:
- COMMITTEE ON CONSUMER PRODUCTS(SCCP)
- Year:
- 2 006
- Bibliographic source:
- Directorate C - Public Health and Risk Assessment C7 - Risk assessment
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- There's no guideline for Patch testing, humans.
For LLNA, OECD 429 or B.6 was adopt - GLP compliance:
- not specified
- Type of study:
- other: including LLNA and patch testing
Test material
- Reference substance name:
- Coumarin
- EC Number:
- 202-086-7
- EC Name:
- Coumarin
- Cas Number:
- 91-64-5
- Molecular formula:
- C9H6O2
- IUPAC Name:
- 2H-chromen-2-one
- Test material form:
- solid: crystalline
Constituent 1
Results and discussion
In vivo (LLNA)
Results
- Key result
- Remarks on result:
- other: See below "Any other information on results incl. tables“
Any other information on results incl. tables
The SI was 2.72 at 5% concentration, 2.92 at 10%, and 2.31 at 25%. The sensitivity of the test
system was shown by the positive control, HCA at 25%, for which the SI was 6.38.
Coumarin with the purity of 99.9% has been shown to be able to elicit allergic contact reactions
in individuals patch tested to a 2% dilution.
The test substance has not been identified by batch number with an associated chemical analysis.
The data submitted does not cause the SCCP to change the Opinion “Fragrance allergy in
consumers doc n°SCCNFP/0017/98.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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