Can local CROs help improve the safety of tattoos?

Can local CROs help improve the safety of tattoos?

Much of the public is aware of the risks that having a tattoo applied can pose, but how many are aware of the ink risks? The subject has been a hot topic of discussion in the last few years among not only regulators but also tattoo artists. Adverse reactions to tattoos in the US are tracked by the FDA, but tattoo ink manufacturing and formulation excipients are not. A number of common tattoo inks have been found to contain harmful metal impurities, unhealthy levels of preservatives such as formaldehyde and benzoisothiazolinone, or other chemicals labeled as carcinogenic by the International Agency for Research on Cancer (“IARC”) including aromatic hydrocarbons.  The loose regulatory situation has caught the attention from European Commission regulators, who have noted (in a 118-page Joint Research Centre (“JRC”) Report) that of all the tattoo-related alerts within the EU nearly two-thirds are due to ink imported from the US.

Much remains to be learnt, not only about the constituents commonly found in tattoo inks but also about processes for tattoo removal. Researchers have not yet been able to detail the effects of laser tattoo removal on the skin or on the body as a whole. It is thought that bright colors such as yellow are more likely to degrade into harmful chemicals when exposed to prolonged UV light or laser tattoo treatments. The effects that the ink reservoir has on the dermal tissue with which it is in contact remains unclear and chemical toxicity and carcinogenicity assessments are limited.

According to, San Diego is listed amongst “15 Most Tattoo-Friendly Cities in the U.S.”.  Aside from government-issued regulations, academic researchers and local CROs within the San Diego CRO community can help further our understanding of the effects of tattoo inks on the body. The advanced analytical techniques employed by local CROs (such as Tioga Research) might allow tattoo ink constituents to be assayed. Broad spectrum comparative studies might be conducted using proprietary high throughput experimentation (“HTE”) techniques.  Just recently, a two-year-old New York University startup has announced development of a tattoo ink intended to degrade after one year, with an option for faster removal upon application of a proprietary solution. With nearly 20% of the US population now sporting tattoos, there is a greater emphasis on raising awareness of the physiological impacts of chemicals residing in our skin.





About the Author and BIOCOM CRO Board Member