Registration Dossier
Registration Dossier
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EC number: 807-880-2 | CAS number: 1125812-54-5
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 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:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-[(4-acetylnaphthalen-1-yl)formamido]-N-(2,2,2-trifluoroethyl)acetamide
- EC Number:
- 807-880-2
- Cas Number:
- 1125812-54-5
- Molecular formula:
- C17H15F3N2O3
- IUPAC Name:
- 2-[(4-acetylnaphthalen-1-yl)formamido]-N-(2,2,2-trifluoroethyl)acetamide
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 50%
- No. of animals per dose:
- 4
- Details on study design:
- 25 µL to the dorsum of both ears on day 1, 2 and 3
- Positive control substance(s):
- other: DNCB
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- other: Ratio CD3/CD19
- Value:
- 6.8
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The CD3/CD19 is higher than 4. The MR-008-4 intermediate has no sensitizing activity
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