Registration Dossier

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:
2011
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 lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch: CFPPN-2C4.4

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.