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Toxicological information

Skin sensitisation

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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:
2006
Bibliographic source:
Directorate C - Public Health and Risk Assessment C7 - Risk assessment

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

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