Registration Dossier
Registration Dossier
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EC number: 200-960-2 | CAS number: 76-42-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Enhanced method in relation to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- 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:
- Oxycodone
- EC Number:
- 200-960-2
- EC Name:
- Oxycodone
- Cas Number:
- 76-42-6
- Molecular formula:
- C18H21NO4
- IUPAC Name:
- (1S,5R,13R,17S)-17-hydroxy-10-methoxy-4-methyl-12-oxa-4-azapentacyclo[9.6.1.0^{1,13}.0^{5,17}.0^{7,18}]octadeca-7(18),8,10-trien-14-one
- Reference substance name:
- Unknown impurity
- IUPAC Name:
- Unknown impurity
- Test material form:
- solid
Constituent 1
impurity 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: 1,2 propanediol
- No. of animals per dose:
- 4
- Details on study design:
- 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 T cells to B cells ratio is below 4, the tested compound is considered as a sensitizer.
- Positive control substance(s):
- other: DNCB
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- other: Ratio CD3/CD19
- Value:
- 5.6
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oxycodone is not a sensitizer based on the described test.
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