Subacute Toxicity Test
1. Biological Effect: Subacute Systemic Toxicity
2. Turnaround time: 12 weeks
3. Sample Requirements: ISO to be individualy determined;
ISO 10993-11
These tests evaluate the potential sub-acute negative systemic effects from a single or repeated exposure to extracts of a medical device.
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| NORWAY RAT | |
|---|---|
| Species | Norway Rat (Rattus norvegicus) |
| Strain | Wistar Rat |
| Sex | 20 & 20 or 12 & 12 (specified with Sponsor) |
| Quantity | 40 or 24 (specified with Sponsor) |
| Dose volume | 40 mL/kg (intravenous – polar) & 20 mL/kg (intraperitoneal – nonpolar) or 10 mL/kg (intravenous – polar) & 5 mL/kg (intraperitoneal – nonpolar) |
| Dose frequency | Daily or 5 days per week |
| Clinical observations | Daily |
| Body Weights | Daily before injections |
| Clinical Pathology | All groups terminal: urine tests (9 paremeters) & biochemistry (17 paremeters) & hematology (6 paremeters) |
| Necropsy | Gross with tissue collection |
| Histopathology | 40 tissues processed and evaluated by a histopathologist (collected from 1 rat from 1 group) |