Health risk assessment of a nicotine salt

Background

Nicotine can be added to e-liquids either in its basic form or as a nicotine salt. Bibra was approached by a client interested in assessing the use of a particular salt as a source of nicotine in one of its e-liquid products.

Client

A manufacturer of vaping products.

Project goals

Bibra was asked to evaluate the potential health risks of inhaling the nicotine salt by considering data on the complete salt and on its negatively charged (anionic) non-nicotine moiety (assuming complete dissociation of the salt in the systemic circulation).

Approach

Bibra identified available toxicity data on both the salt and on its non-nicotine moiety through comprehensive literature searches of internal (TRACE) and external data sources. Limited data were available on the undissociated nicotine salt, but a range of primary research regarding the toxicological profile of the anion was identified and critically reviewed. Doses from the e-liquid device were estimated and compared to normal background exposures to the anion (e.g. through the diet), and to levels considered safe from the toxicological dataset. This information was used to conclude on the risks of local and systemic effects upon single and repeated exposure to the nicotine salt in the e-liquid.

Project outcome

Bibra concluded that the inhaled dose of the nicotine salt would not pose any significant systemic toxicity risks. On the other hand, respiratory irritation could not be confidently excluded due to the limited data available from relevant inhalation studies.

Bibra project team

Beth O’Connell
Pete Watts

 

E-cigarettes and other NTNDDs More recent work Info about us Meet our team