Oxycodone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

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 type:

standard acute method

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:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Remarks:

0.6% aqueous solution

Doses:

0, 300 and 2000 mg/kg

No. of animals per sex per dose:

3 to 6

Control animals:

yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Mortality:

Incidence and day of death:
300: 0/3
2000: 3/3 (D1, D2, D3)

Clinical signs:

300: Decreased activity (D1: 6/6), Soiled urogenital area (D2: 2/6)
2000: Weakness (D1: 3/3; D2: 1/1), Decubitus (D1: 3/3), Blood on the muzzle (D2: 1/1)

Body weight:

300: Lower body weight gain in all animals on D3 with total or partial
recovery on D15.

Gross pathology:

Animals found dead:
2000: Lungs: dark red or dark red area (3/3), Dried blood on the muzzle (3/3), Stomach: meteorism (1/3), Soiled urogenital area (1/3)
Animals sacrificed (D15):
300: No treatment-related changes

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The maximal non-lethal dose determined experimentally was 300 mg/kg in female rats (with 300 < LD50 < 2000 mg/kg). This dose induced decreased activity and soiled urogenital area as well as lower body weight gain at the beginning of the study.