Toxicology Services

What do Toxicological Studies involve?

Toxicological studies involve a tiered approach of data gathering and risk assessment depending upon the product. The ultimate objective is to develop an informed and scientiﬁcally justiﬁed assessment of the risk to health presented by a 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 are represented by two core areas:

Toxicology Risk Assessments

Desk based toxicology services.

Evaluating the potential health risks associated with exposure to contaminants or other residues in a product.

Literature reviews - review and assessment of published literature to support regulatory submissions.
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 including Derek Nexus, Leadscope, Model Applier, Toxtree and OECD Toolbox.
Quantitative Risk Assessments (QRA’s) - individual health risk of ingredients used in the medium of nicotine delivery, device and packaging 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.

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

Broughton in-vitro testing services include:

For inhalable NGPs, custom ENDS aerosol collection and chemistry characterization.
For Modern Oral Pouches, extraction of the liquid from the pouch.
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, 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 delivery products (NGPs).

Our team of experienced toxicologists will design and manage your studies to comply with regulations including US PMTA and Medicinal Products. Broughton is a Good Laboratory Practice certiﬁed Contract Research Organization (CRO) facility.

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

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

A fully integrated approach to toxicological studies

Broughton offers a wide range of toxicology services, combined with a network of internal experts and partners, supporting companies operating in the NGP sector. This full-service supports regulatory submissions and enables new product development to create a smoke-free future.