Subacute Toxicity Test

START 5 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.

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)