Registration Dossier
Registration Dossier
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EC number: 200-960-2 | CAS number: 76-42-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- 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)
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
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oxycodone base is non irritant to the eye.
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