Registration Dossier
Registration Dossier
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EC number: 200-960-2 | CAS number: 76-42-6
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:
- 2 002
- 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
- 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
- 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.
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