Advisory Committee on Pesticides Annual Report 2001

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Section B: Applications for provisional approvals for products containing new active substances The ACP considered that zoxamide and the formulated products were of low toxicity but could cause sensitisation by skin contact. Therefore, both the active substance and the formulated products were classified as “Irritant”. Metabolism in the rat was moderately rapid and distribution to organs and tissues was extensive. However, elimination was also rapid and almost complete. In toxicology studies, the dog was found to be the most sensitive species tested. An ADI of 2.6 mg/kg bw/day, a short term AOEL of 1.7 mg/kg bw/day and long-term AOEL of 1.5 mg/kg bw/day were agreed. The ADI and long-term AOEL were derived from the NOAEL from a one-year dog study where liver effects were seen at higher doses. The short-term AOEL was derived from the NOAEL from a 90-day dog study where reduced bodyweight gain and changes in red blood cell parameters were seen at higher doses. In all cases, a standard assessment factor of 100 was used to derive the reference values. As zoxamide was of low acute toxicity no ARfD was set. The exposures of operators, bystanders and workers to zoxamide were low and considered to be at acceptable levels. An extensive data package was presented on the nature and magnitude of residues in potatoes, grapes and rotational crops that were likely to result from the use of zoxamide in accordance with the principles of Good Agricultural Practice. Estimates of dietary exposure for humans and domestic animals were low. 29 Given the effects seen in tests with the alga Scenedesmus subspicatus, and evidence that the active substance was not readily biodegradable, zoxamide was categorised as ‘Very toxic to aquatic organisms’ and ‘May cause long-term adverse effects in the aquatic environment’. On this basis, zoxamide was classified as ‘Dangerous for the environment’. The formulated products were classified as ‘Dangerous to fish and other aquatic life’. The risks to birds, terrestrial vertebrates, bees, earthworms and soil microorganisms from the proposed use of zoxamide and from metabolites formed in the environment were considered acceptable. The risk to aquatic life was acceptable with appropriate risk mitigation measures. Uses on potatoes and grapes were recommended in the UK with five metre and twenty metre buffer zones respectively for the protection of aquatic life. The need for risk mitigation measures, to be considered at Member State level, was highlighted for non-target arthropods. In the UK, it was proposed that this be addressed by an advisory label phrase for the product. The <strong>Committee</strong> recommended provisional approval for ‘RH-7281/mancozeb 75% WG’ for use on potatoes and grapes pending the Commission decision on inclusion of zoxamide in Annex I of Council Directive 91/414/EEC. It was also
<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 agreed that the draft assessment report could be forwarded to the European Commission for consideration of inclusion on Annex I of Council Directive 91/414/EEC. Commodity substances Commodity substances are compounds, which have a variety of alternative and often widespread non-pesticidal uses but also have potential use as a pesticide. For a commodity substance to be used as a pesticide it requires approval under COPR. Approval is given only for use of the substance, which is not formulated; (approval is not given for sale, storage, supply or advertisement). There is no approval holder and no pesticide product label but the approval and associated conditions of use are published in the ‘Pesticides Guide’ on www.pesticides.gov.uk/blue_book/contents.htm No new applications for commodity substances approval were considered during 2001. 30
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Advisory Committee on Pesticides Annual Report 2001

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