Registration Dossier
Registration Dossier
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EC number: 255-982-5 | CAS number: 42872-30-0
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: Consistent test but without details of documents and no indication of GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Sentitizers induce primary proliferation of lymphocytes in the lymph node draining the applciation site. The Local Lymph Node Assay (LLNA) assesses this proliferation. The lymphocyte subpopulations of the draining lymph nodes are studies by flow cytometry.
Evaluation is based on the ratio of T cells to B cells (CD3:CD19). This ratio is an indicator of the B cell proliferation induced by the treatment of mice with contact allergens. If the ratio of T cells to B cells is below 4, the test article is considered as a sensitizer. - GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-(m-benzoylphenyl)propionitrile
- EC Number:
- 255-982-5
- EC Name:
- 2-(m-benzoylphenyl)propionitrile
- Cas Number:
- 42872-30-0
- Molecular formula:
- C16H13NO
- IUPAC Name:
- 2-(3-benzoylphenyl)propanenitrile
- Details on test material:
- Test article: BPPN, an intermediate product of Ketoprofen synthesis
Batch: BPPN-E630
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
Study design: in vivo (LLNA)
- Concentration:
- 25 µL to the dorsum of both ears on day 1, day 2 and day 3
- No. of animals per dose:
- 4
- Positive control substance(s):
- other: DNCB
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- other: Ratio of T cells to B cells
- Value:
- 9.5
- Remarks on result:
- other: Not sensitising when the ratio of T cells to B cells is larger than 4.
Any other information on results incl. tables
No data
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- With BPPN, the CD3:CD19 ratio was higher than 4. The test article had no sensitizing activity.
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