Artificial Saliva Solution - For chemical release and toxicological risk assessments.

Artificial Saliva Solution is a controlled test medium developed for chemical release, extraction, and toxicological risk assessment studies of medical and dental materials intended for intraoral use. The formulation has been specifically designed to comply with the requirements of TS EN ISO 10993-17 for chemical risk evaluation.

This product provides a representative and reproducible extraction matrix, enabling the transfer of chemical characterization data obtained under ISO 10993-18 into a toxicological risk assessment framework in accordance with ISO 10993-17.

Key Features

• Suitable for chemical release and exposure assessment under ISO 10993-17

• Protein-free and free of biological macromolecules for clean analytical performance

• Compatible with ICP-MS, GC-MS, and LC-MS analytical techniques

• Controlled ionic strength and buffered pH composition

• Reproducible and standardized extraction environment

Applications

• Dental restorative materials

• Orthodontic wires, brackets, and elastomers

• Intraoral polymeric and metallic medical devices

• Chemical characterization and extraction studies

• Biocompatibility assessments according to ISO 10993-17 and ISO 10993-18

Technical Overview

This artificial saliva solution provides a simplified and well-defined ionic environment designed to represent the chemical extraction capacity of human saliva. The absence of proteins and enzymes minimizes analytical interference, allowing accurate detection and quantification of low-level substances released from medical devices.

The pH is adjusted to reflect physiological oral conditions and is suitable for both short- and long-term contact scenarios. The formulation supports a risk-based regulatory approach, enabling clear scientific justification in compliance with regulatory expectations.

Advantages

• Regulation-friendly and transparent composition

• High analytical compatibility

• Inter-laboratory reproducibility

• Suitable for routine quality control and R&D studies

Storage and Handling

• Store at 2–8 °C in light-protected containers

• Allow to reach room temperature before use