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In the Electronic Nicotine Delivery Systems (ENDS) sector, toxicology plays an important role in both new product development, ongoing product stewardship of commercial products and regulatory submissions to demonstrate the acceptability, safety and compliance of a particular product.

How Toxicology can help

Toxicological studies aid the design, development, modification, stewardship and authorization of ENDS products. Broughton Nicotine Services provide toxicological strategies and services to support ENDS manufacturers in the following key areas:

  • Assessing the level of toxicological concern associated with ENDS products and their ingredients, device materials, emissions and product as a whole.
  • Understanding possible biological responses to specific endpoints of ENDS products as a whole or on a single substance basis.
  • Storing chemical information and toxicological data associated with substances related to ENDS products such as their ingredients and emissions.
  • Providing expert toxicological advice on new ENDS products, or modifications to an existing product, on their appropriateness for the protection of public health.
  • Becoming a long-term strategic toxicological partner to clients providing consultancy services across the Product Stewardship lifecycle of ENDS products.

What do Toxicological Studies involve?

Toxicological studies involve a tiered approach of data gathering and risk assessment depending upon the ENDS product. The ultimate objective is to develop an informed and scientifically justified assessment of the risk to health presented by an ENDS product. This involves considering the nature of any hazard presented by an ingredient, exposure levels and the dose response, which collectively enable risk characterization.

Toxicology Services offered by Broughton Nicotine Services are broken into two core areas:

Toxicology Risk Assessments

Desk based toxicology services.

Evaluating the potential health risks associated with exposure to contaminants or other residues in an Electronic Nicotine Delivery Systems (ENDS).

Broughton Nicotine Services Risk Assessments include:

  • Literature reviews - review and assessment of published literature to support regulatory submission.
  • Product Hazard Screen - to assist with product development, acquired products or identify products as regulatory submission candidates.
  • Expert Review - expert scientific review provides critical evaluation of all available toxicological data (desk based, or lab based).
  • In Silico Risk Assessments - assessment of risk utilizing predictive tools include Derek Nexus, Leadscope, Model Applier, Toxtree and OECD Toolbox.
  • Quantitative Risk Assessments (QRA’s) - individual health risk of e-liquid ingredients, device materials and aerosol emissions when compared to other tobacco products.
  • QRA Narrative - comprehensive regulatory report writing characterizing the potential health risk of the product constituents and the product based on quantitative chemistry, toxicology and exposure scientific assessments.

In Vitro Toxicity Testing

Gathering regulatory in vitro toxicity data through designed experimental toxicology studies to determine the effect of a chemical substance or the whole aerosol is an important part of an ENDS scientific dossier.

Broughton Nicotine Services In vitro testing services include:

  • Custom ENDS aerosol collection and chemistry characterization.
  • Design of in vitro studies, identifying fit for purpose laboratory sites and interpretation of results.
  • Managing (or coordination of) regulatory in vitro toxicology testing for mutagenicity, genotoxicity and cytotoxicity including the Ames test, in vitro micronucleus assay, mouse lymphoma assay, and neutral red uptake assay.
  • Design, coordination and interpretation of other in vitro assays such as the comet assay, cell transformation assays, 3D tissue assays and screening assays.
  • Novel in vitro method development and validation specific for next generation nicotine products.

Our team of experienced toxicologists will design and manage your studies to comply with ENDS regulations including US PMTA and EU Medicinal Products. Broughton Nicotine Services is a Good Laboratory Practice (GLP) certified Contract Research Organization (CRO) facility for in vitro toxicity services.

Toxicological studies will often include a tailored mix of different types of studies according to regulatory and/or product development requirements.

Broughton Nicotine Services has developed a custom database, named ToxHQ, designed to store critical safety information on ENDS products and their ingredients.

A fully integrated approach to toxicological studies

Broughton Nicotine Services offer a wide range of toxicology services, combined with a network of internal experts and partners, exclusively dedicated to supporting companies operating in the ENDS sector. This full-service, when integrated with our other ENDS-focused analytical and scientific services provided, supports regulatory submissions and enables new product development to advance a smoke free future.

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Resources

Leaflet

Overview of our full-service PMTA compliance solution, from planning through to compilation and submission.

Guide

Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.

Leaflet

Download our leaflet for an overview of our comprehensive services to support the ENDS industry from regulatory submission to maintaining compliance.