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Silicones are among the world’s most important and adaptable materials, used in thousands of products and applications – from health care and personal care to electronics, transportation, construction and energy. The backbone of silicon and oxygen atoms is the foundation of silicone chemistry and allows for the formation of siloxanes. Siloxanes are raw materials based on silicon, oxygen, hydrogen and carbon and are the critical building blocks used to make silicone products. 

Siloxanes, including the cyclic siloxanes octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclohexasiloxane (D6) are among the most extensively studied materials used in consumer and industrial applications today. More than 1,000 studies over many decades have been conducted to assess the safety of siloxanes for workers, consumers, the environment, and manufacturing processes. Results of this continuous research and testing demonstrate the safety of siloxanes in their diverse and important applications. A host of independent scientists and expert scientific panels have confirmed siloxanes safety both for human health and the environment.

As part of the Silicones Industry’s commitment to the safety of its products and its sound product stewardship practices, the Industry has proactively conducted several siloxane modelling and monitoring initiatives. Computer models that can estimate a chemical’s physical-chemical properties and potential environmental fate and concentration are important tools for academics, industry, and regulators. Each of the siloxane materials have unique physical-chemical properties that differ significantly from the traditional organic chemicals for which most computer modelling programs have been developed. Thus, the Silicones Industry has collaborated with modelling experts around the world to customize the input parameters of these models based on the properties of the chemical being modelled.

In addition, the Silicones Industry has committed to several environmental monitoring programs aimed at measuring concentrations of siloxanes around the world to customize and validate these models.

The results of this continuous research and testing demonstrate the safety of silicones in their diverse and important applications.

Regulatory Information

GSC advocates that countries use a risk-based weight-of-evidence (WoE) approach which considers exposure to evaluate the safety of silicone materials.

GSC also advocates that countries and regulatory authorities avoid adopting assessment conclusions or risk-management approaches from countries or regions that do not utilize risk-based WoE approaches.

A fundamental underpinning of the silicones industry’s commitment to product stewardship is the belief that comprehensive, robust, risk-based assessments utilizing a WoE approach should be the primary driver for development of chemical regulatory policy. A core requirement for the development of scientific assessments is the availability of high-quality data. The silicones industry’s willingness to develop those data is an illustration of the industry’s commitment to the generation of sound science to support chemical regulatory decision-making.

 

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