Safety assessment of Weissella confusa - A direct-fed microbial candidate.

Weissella confusa is part of the lactic acid bacteria genera and a member of an autochthonous microbiota of humans and livestock. W. confusa has been proposed to have potential as a direct-fed microbial product, however, there is a lack of studies assessing its safety. A toxicological safety assessment of W. confusa was performed using a battery of in vitro, ex vivo and in vivo studies, testing for genotoxicity, skin and eye irritation and general toxicity. The bacterial reverse mutation (Ames) study did not reveal any genotoxicity in the presence and absence of metabolic activation (S9) at concentrations up to 5000 µg/mL. Moreover, an in vivo mammalian erythrocyte micronucleus study did not reveal any biologically relevant or statistically significant increases in the frequency of micronucleated polychromatic erythrocytes in mice, when tested at concentrations up to 2000 mg/kg body weight. W. confusa did not exert any skin irritation potential when tested in reconstructed skin membranes. When tested for eye irritation using an ex vivo model of isolated chicken eyes, mild irritation was observed. The 90-day sub-chronic oral toxicity (gavage) study was performed using Sprague Dawley rats at concentrations up to 92 × 108 cfu/kg body weight/day (nominal). The results showed that W. confusa were well tolerated, and no signs of toxicity were seen. The No Observed Adverse Effect Level (NOAEL) for both female and male animals was the highest concentration administered, 92 × 108 cfu/kg body weight/day (nominal). In conclusion, the toxicological studies performed confirmed W. confusa to be safe, making it a good candidate as a direct-fed microbial product.

Regulatory ecotoxicity testing of nanomaterials - proposed modifications of OECD test guidelines based on laboratory experience with silver and titanium dioxide nanoparticles.

Regulatory ecotoxicity testing of chemicals is of societal importance and a large effort is undertaken at the OECD to ensure that OECD test guidelines (TGs) for nanomaterials (NMs) are available. Significant progress to support the adaptation of selected TGs to NMs was achieved in the context of the project MARINA ( http://www.marina-fp7.eu/ ) funded within the 7th European Framework Program. Eight OECD TGs were adapted based on the testing of at least one ion-releasing NM (Ag) and two inert NMs (TiO2). With the materials applied, two main variants of NMs (ion releasing vs. inert NMs) were addressed. As the modifications of the test guidelines refer to general test topics (e.g. test duration or measuring principle), we assume that the described approaches and modifications will be suitable for the testing of further NMs with other chemical compositions. Firm proposals for modification of protocols with scientific justification(s) are presented for the following tests: growth inhibition using the green algae Raphidocelis subcapitata (formerly: Pseudokirchneriella subcapitata; TG 201), acute toxicity with the crustacean Daphnia magna (TG 202), development toxicity with the fish Danio rerio (TG 210), reproduction of the sediment-living worm Lumbriculus variegatus (TG 225), activity of soil microflora (TGs 216, 217), and reproduction of the invertebrates (Enchytraeus crypticus, Eisenia fetida, TGs 220, 222). Additionally, test descriptions for two further test systems (root elongation of plants in hydroponic culture; test on fish cells) are presented. Ecotoxicological data obtained with the modified test guidelines for TiO2 NMs and Ag NM and detailed method descriptions are available.