The user safety assessment of a selenized yeast feed additive.

Of the several selenized yeasts authorised for use as feed additives in the EU, CNCM I-3060 inactivated' (Sel-Plex), was the first to be approved for use, in 2006. The additive has a concentration of selenium between 2000 and 2400 mg/kg and a selenomethionine content greater than 63%. Previous toxicological and safety studies have shown Sel-Plex to be safe for use for target animal species, consumers, users and the environment. A new formulation of Sel-Plex was recently developed however, with a minimum selenium content of 3000 mg/kg. The increase in selenium in this product, Sel-Plex 3000, presented the need to assess the risk for workers and users and to establish if there would be any eye and/or skin irritancy and skin sensitisation effects associated with the product. The purpose of this paper is to present the methodology and results of the user safety skin and eye studies performed on Sel-Plex 3000. In vitro skin and eye models were used to assess skin and eye irritancy, while skin sensitisation was examined using an in vivo method. The acute eye irritation was evaluated using a Reconstructed human Cornea-like Epithelium (RhCE) model, which followed the OECD guideline 492. The skin irritation was assessed based on its ability to induce cell death in a commercial reconstructed human epidermis (RhE) model (EPISKIN™) according to the OECD Guideline No. 439. The skin sensitising potential was evaluated in the Guinea pig in line with OECD Guideline 406, and measured the extent and degree of skin reaction to a challenge exposure following previous topical exposure of a substance on the skin. The skin and eye irritation test results showed that Sel-Plex 3000 was a non-irritant in both cases. The skin sensitisation study showed that the additive did not generate a sensitisation response in the guinea pig and should not be considered a skin sensitiser. These results indicate that Sel-Plex 3000 is safe to use for workers in an industrial setting when handling the product and the studies may be further used to support regulatory compliance in respective markets.