Registration Dossier
Registration Dossier
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EC number: 811-752-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-(4-{1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl}phenyl)-2-methylpropanenitrile
- EC Number:
- 811-752-1
- Cas Number:
- 169032-19-3
- Molecular formula:
- C32 H38 N2 O2
- IUPAC Name:
- 2-(4-{1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl}phenyl)-2-methylpropanenitrile
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaCrl
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 10% w/v, 25% w/v, 50% w/v in dimethylformamide
- No. of animals per dose:
- 4
- Details on study design:
- Groups of 4 female mice were subjected to topical applications of vehicle control or of one of the test formulations to the outer aspect of the auditory pinnae once daily on Days 1, 2 and 3. On Day 6, a 20 µCi dose of tritiated 3H-methyl thymidine was injected intravenously into each mouse. Approximately five hours later, the auricular lymph nodes were recovered from each animal. The pairs of nodes from each animal were pooled and suspensions of the cellular components of the lymph nodes were prepared in 5% w/v trichloroacetic acid and processed through a scintillation counter.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- at 10%, 25% and 50% of test article diluted in vehicle
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LLNA demonstrated that 2-[4-[1-hydroxy-4-[4-[hydroxy(diphenyl)methyl]-1-piperidyl]butyl]phenyl]-2-methyl-propanenitrile does not have the potential to cause skin sensitisation.
The test article did not meet the criteria for classification as a sensitiser according to the GHS of Classification and Labelling of Chemicals.
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