When this applies
When a toxicological risk assessment (GRK-2001) or assessment without E&L data (GRK-2006) finds constituents above the ISO 10993-17 toxicological screening limit, each one needs a compound-specific evaluation before the endpoint can be concluded. It also applies to constituents a reviewer has questioned, and to compounds flagged on a restricted-substance list.
When to commission it
Immediately after the screening-level assessment identifies the constituents, so the submission is not held by an open compound. Allow one week for a typical set; the time depends on the number of compounds and how much published toxicology exists for each.
What you receive
For each constituent: the maximum estimated exposure dose from the device's extractables data and intended use; a tolerable intake derived from the published toxicological data with documented point of departure and uncertainty factors; the resulting margin of safety; and a conclusion for each relevant endpoint. Written into the assessment and signed by a DABT board-certified toxicologist.
What it does not cover
The screening-level assessment itself, which is GRK-2001 or GRK-2006, and any further testing — such as a targeted leachables study — that a low margin of safety may call for. Where the published toxicology for a compound is genuinely absent, the evaluation says so and recommends the route forward rather than inventing a threshold.
Method
Compound-specific evaluation of constituents found above the toxicological screening limit: estimated exposure dose, tolerable intake and margin of safety under ISO 10993-17:2023. A Groenakker toxicologist reviews the chemical characterisation data for each constituent, calculates EEDmax from concentration and the device's exposure scenario, searches the toxicological literature and regulatory sources for a point of departure, derives the TI with justified uncertainty factors, and calculates the MOS. Each evaluation is reviewed and signed by a DABT board-certified toxicologist. Priced per set of five constituents.
Who does the work
In-house at Groenakker. The assessment is prepared under Groenakker’s ISO 13485:2016 certified quality system and signed by a DABT board-certified toxicologist, and issued in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
The ISO 10993-17 risk assessment (GRK-2001) or assessment without E&L data (GRK-2006) it completes, and the Biological Evaluation Report (GRK-1002) that carries the conclusion.
