INITIAL IN VITRO SCREENING APPROACH TO INVESTIGATE THE POTENTIAL HEALTH AND ENVIRONMENTAL HAZARDS OF ENVIROX™ – A NANOPARTICULATE CERIUM OXIDE DIESEL FUEL ADDITIVE.

This study by scientists at Oxonica, Product Assessment & Regulatory Compliance, and SafePharm Laboratories Ltd. demonstrated that MatTek’s EpiDerm in vitro tissue model system can be used to determine the skin irritation potential of formulations containing nanoparticles. Nanotechnology is the new industrial revolution of the 21st Century as the various processes lead to radical improvements in medicine, manufacturing, energy production, land remediation, information technology and many other everyday products and applications. With this revolution however, there are undoubted concerns for health, safety and the environment which arise from the unique nature of materials and processes at the nanometre scale. The in vitro assays used in the screening strategy are all validated, internationally accepted protocols and provide a useful indication of potential toxicity of a chemical as a result of effects on various toxicological endpoints such as local site of contact (dermal) irritation, general cytotoxicity and mutagenicity. The initial in vitro screening strategy described in this paper and used by scientists at Oxonica, Product Assessment & Regulatory Compliance and SafePharm Laboratories Ltd. to investigate the potential health implications, if any, which may arise following exposure to one specific application of nanoparticulate cerium oxide used as a diesel fuel borne catalyst, reflects a precautionary approach and the results will inform judgement on how best to proceed to ensure safe use. The EpiDerm™ EPI-200 human epidermal model from MatTek Corporation (Ashland, MA, USA) was utilised in this preliminary screening approach for assessment of the safety of Envirox™ since the skin is a potential route of exposure during the formulation and use of the nanocerium oxide containing diesel fuel additive when accidental skin contamination might reasonably be expected to occur. The initial screening studies for human health which included local site of contact (dermal) irritation, general cytotoxicity and mutagenicity and environmental effects (acute Daphnia magna toxicity and activated sludge respiration inhibition) demonstrated no differences in biological effects potential between nano and non-nano cerium oxide. These data support the conclusion of a lack of any additional (eco)-toxicological effects potential for nanocerium oxide when compared to that of non-nano cerium oxide in a number of in vitro assays undertaken as a preliminary toxicity screen.

Cerium oxide, EpiDerm, Nanomaterials, Nanoparticles, SLS 20%, TX100 1%

Diesel fuel additive, EPI-200, EpiDerm, MTT, Nanoparticle, Nanoparticulate, Nanotechnology