Registration Dossier
Registration Dossier
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EC number: 255-980-4 | CAS number: 42872-29-7
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: Study according to international guideline but not 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:
- 3-(1-cyanoethyl)benzoyl chloride
- EC Number:
- 255-980-4
- EC Name:
- 3-(1-cyanoethyl)benzoyl chloride
- Cas Number:
- 42872-29-7
- Molecular formula:
- C10H8ClNO
- IUPAC Name:
- 3-(1-cyanoethyl)benzoyl chloride
- Details on test material:
- Batch: CFPPN-2C4.4
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
Study design: in vivo (LLNA)
- Concentration:
- 25µL to the dorsum of both ears on day 1, day 2 and day 3.
- No. of animals per dose:
- Number of animals/group: 4
- Positive control substance(s):
- other: DNCB
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: WithCFPPN, the CD3:CD19 ratio was lower than 4 (R = CD3:CD19 = 2.2). Thus the test article had sensitizing activity.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CFPPN (batch CFPPN 2C4.4), an intermediate product of Ketoprofen synthesis, is a skin sensitizer. It does require labeling with classification R43/H317.
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