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Subacute/Subchronic Toxicity Testing

Subacute toxicity is assessed after single or multiple exposures to extracts of device materials. The exposure period is longer than typical acute toxicity tests, but not to exceed 10% of the animal’s lifespan. Subchronic toxicity is assessed after repeated intravenous injections of the device materials extract. These studies involve expanded evaluations and can include systemic changes, local irritation, body weight, blood values and tissue changes as part of the protocol. The length of time for the test and the parameters evaluated will depend on the end use of the device.

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Multiple extracts of a device and controls are prepared and injected over a time period for signs of toxicity through gross observation at the end of the study.
The subchronic toxicity is assessed after repeated intravenous injections of a device material extract.
The subchronic toxicity is assessed after repeated intravenous and intraperitoneal injections of a device material extract.

MHLW Testing

MHLW Subacute (28 Day) Intravenous Toxicity Study
This assay is used to verify that there are no substances with subacute toxicity in the extracts taken from test articles.