Provision of hazard and risk assessments for several flavourings in electronic cigarettes

Client

ECITA, the Electronic Cigarette Industry Trade Association [written with permission from ECITA]

Background

A wide array of flavouring substances are added to electronic cigarette formulations and these might be inhaled (along with nicotine and other excipients) by the consumer. The toxicological acceptability of such substances has historically been assessed for food and cosmetics applications, and their safety for use in electronic cigarettes (as inhaled flavourings) now needs to be substantiated.

Project goals

To provide the client with a high-quality hazard (toxicity) assessment (focusing on the inhalation route of exposure), from which to base a robust health risk assessment for each flavouring (or groups of flavourings) when included in an electronic cigarette formulation.

Approach

To search for and review the key available physico-chemical and toxicological data on each flavouring. The data included would cover all key toxicity endpoints (including acute and repeated systemic toxicity, irritation/cytotoxicity, skin and respiratory sensitisation, genotoxicity, reproductive and developmental toxicity, and carcinogenicity) and also critical ADME data that may help guide any oral to inhalation extrapolation in a subsequent risk assessment. Where data gaps are identified, the use of alternative information (e.g. read-across, (Q)SAR, Threshold of Toxicological Concern) is discussed in order to avoid (potentially costly) laboratory tests.

Project leader

Richard Young

With thanks to ECITA for allowing us to share this piece of project work in a public domain.

 

E-cigarettes

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