Toxicology

 

Toxicological Evaluation: Derivation of TI & EEDmax (Per Constituent)

Full toxicological evaluation, per constituent, of compounds found above the toxicological screening limit: estimated exposure dose (EEDmax), tolerable intake (TI) and margin of safety (MOS) derived under ISO 10993-17:2023 by a board-certified toxicologist.

GRK-2004

Toxicological Evaluation: Gas Pathway Risk Assessment and Report

A toxicological risk assessment for a gas pathway device to ISO 18562-1:2024: emission data from ISO 18562-2 and -3 testing interpreted into inhaled dose, with dose-based thresholds derived for up to 25 compounds or compound groups above the analytical evaluation threshold.

GRK-2003

Toxicological Evaluation: Risk Assessment & Report - ISO 10993-17:2023

A toxicological risk assessment to ISO 10993-17:2023 of your chemical characterisation data: constituents identified and grouped, screened against US and EU restricted-substance lists, and assessed against the toxicological screening limit — with TI and margin-of-safety derivation for anything above it quoted per constituent.

GRK-2001

Toxicological Evaluation: Risk Assessment & Report for Devices without E&L Test Data

A toxicological risk assessment to ISO 10993-17:2023 for a device with no extractables and leachables data, built from material formulations, safety data sheets and the substances that touch the device in manufacturing — theoretical worst-case exposure compared with the toxicological screening limit.

GRK-2006
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