Oxycodone

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal 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

Test material information

Constituent 1

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

impurity 1

Reference substance name:

Unknown impurity

IUPAC Name:

Unknown impurity

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

< 2

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

< 2

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on this in vivo study, the substance is not irritant for the skin