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Report

A Guide To Toxicology Risk Assessments


June 11, 2020

Published by Fiona Brook

ENDS, PMTA, Toxicology, Science, EU MAA, EU TPD

Broughton  has produced an infographic to explain the process for toxicology risk assessments for Electronic Nicotine Delivery Systems (ENDS) products. 

Toxicology Infographic

This handy top level guide illustrates Broughton approach to demonstrating the safety of a product to support regulatory compliance through your chosen pathway.

The infographic covers the distinct areas associated with desk based and laboratory based risk assessment for ingredients, materials, and aerosols.

These include: 

  • Databases, literature, authoritative review searches, and in silico modeling to identify reference guidance values and known or potential hazards
  • Regulatory in vitro Toxicology and Novel in vitro Toxicology assays to assess the effects of aerosols and aerosols-derived matrices in live cells

The outcome of the desk base search and in vitro assays are then contextualised with puffing topography and human consumption data to determine the appropriate safety positioning of a product.  

This useful illustration is ideal for those seeking to learn more about toxicology risk assessments or looking to embark on a study placement,  download your copy today:

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A team of toxicologists dedicated to ENDS

Our new toxicology services division offers an experienced team for delivering Quantitative Risk Assessments, and also regulatory in vitro Toxicity Testing. This includes investment into Customised-Off-The-Shelf (COTS) in silico (Q)SAR software aligned with the company’s in-house developed toxicology software application designed for toxicology data management compliant with data integrity regulations.

To discuss how our Toxicology Services team can help you understand and reduce the health risks of your ENDS products for a regulatory submission and advance a smoke free future, contact us to arrange a meeting.

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From basic questions to complex compliance inquiries, we're here to help! Contact us today.