Registration Dossier
Registration Dossier
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EC number: 812-243-7 | CAS number: 1189352-83-7
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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- no
- Remarks:
- (study performed according to SOP in a laboratory that conforms to GLP but report not audited by the QAU)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1-chloro-3-iodo-5-(trifluoromethyl)benzene
- EC Number:
- 812-243-7
- Cas Number:
- 1189352-83-7
- Molecular formula:
- C7 H3 Cl F3 I
- IUPAC Name:
- 1-chloro-3-iodo-5-(trifluoromethyl)benzene
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25%
- No. of animals per dose:
- 4
- Details on study design:
- Sensitizers induce primary proliferation of lymphocytes in the lymph node draining the application site. The LLNA assesses this proliferation. The lymphocyte subpopulations of the draining lymph nodes are studied 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.
- Positive control substance(s):
- other: DNCB
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- other: CD3:CD19 ratio
- Value:
- ca. 5.1
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions; MR-008-2 (Q6F62), an intermediate product of ML925 synthesis, is not a sensitizer as the CD3:CD19 ratio was higher than 4. It does not require labeling with any classification.
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