# A Regulatory-Compliant Genotoxicity Study of a Mixture of C60 and C70 Fullerenes Dissolved in Olive Oil Using the Mammalian Micronucleus Test

## TL;DR

This study shows that a fullerene mixture in olive oil is not genotoxic in mice, addressing safety concerns for potential medical use.

## Contribution

First regulatory-compliant in vivo genotoxicity study of C60/C70 fullerenes in olive oil using the Mammalian Micronucleus Test.

## Key findings

- Fullerene oily solutions showed no genotoxic activity in mice at high doses.
- The study was conducted in compliance with OECD and EPA guidelines in a GLP laboratory.
- Results support the safety of fullerene oily solutions for further regulatory evaluation.

## Abstract

Although they show great promise in the medical field, the safety of fullerenes—discovered forty years ago—is still uncertain, according to regulatory experts at the European Scientific Committee on Consumer Safety. This is a major obstacle to progress in the field. Meanwhile, oily solutions of fullerenes intended for human and pet consumption can be purchased online, without any marketing authorization. Therefore, to avoid any potential public health issues, regulatory-compliant preclinical studies on fullerene oily solutions are urgently needed. We present the first in vivo genotoxicity study of a C60/C70 fullerene mixture (4.1/1, w/w) dissolved in extra virgin olive oil (0.8 mg/mL). The study was conducted using the Mammalian Micronucleus Test (MMT) in an independent GLP-laboratory, in compliance with the OECD and EPA guidelines. The MMT was performed on NMRI mice following the oral administration of fullerenes at doses of up to 3.6 mg/kg. This dose is almost the maximum dose that can be administered to rodents. The data obtained clearly show that fullerene oily solutions have no genotoxic activity under these conditions. This should pave the way for further regulatory investigations of fullerene oily solutions.