Subchronic toxicity combined with Implantation

START 5 Subchronic toxicity combined with Implantation

1. Biological Effect: Subacute Toxicity
2. Turnaround time: 20 weeks
3. Sample Requirements: ISO to be individually determined;

 

ISO 10993-11 (toxicity part)

These tests evaluate the potential sub-chronic negative systemic effects from a single or repeated exposure to extracts of a medical device.

ISO 10993-6 (implantation part)

The purpose of the study is to evaluate the medical device for local effects on living tissue when implanted subcutaneously in rats. The bioreactivity of a test item is determined through microscopic and macroscopic through a comparison of the tissue response caused by the medical device as compared to an appropriate control material. The area of the tissue surrounding the center position of each implant will be processed and a histopathologist will process the implanted sites for histopathological evaluation.

      Species

Norway Rat (Rattus norvegicus)

­Strain

Wistar Rat

Sex

20 & 20

Quantity

40

Duration

90 days

Dose Route

Implant

Dose volume & frequency

According to ISO & FDA guidelines

Clinical Observations

Daily

Body Weights

Daily before injections

Clinical Pathology

All groups terminal; urine tests (9 paramteters)

& biochemistry (17 parameters) & hematology (7 parameters)

Necropsy

Gross with tissue collections

Histopathology

According to ISO & FDA guidelines