Advisory Committee on Pesticides Annual Report 2001

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Section B: Applications for provisional approvals for products containing new active substances of a modest interaction. Again during the recovery period the effects of treatment were shown to be reversible. An acceptable daily intake (ADI) of 0.03 mg/kg bodyweight (bw)/day was agreed based on the no observed adverse effect level (NOAEL) for decreased bodyweight in a two-year combined carcinogenicity/chronic feeding study in rats and applying a standard assessment factor of 100. Iodosulfuron is not acutely toxic and therefore, the <strong>Committee</strong> concluded that it was not appropriate to set an acute reference dose (ARfD). An acceptable operator exposure level (AOEL) of 0.07 mg/kg bw/day was derived from the NOAEL in both 90-day and 12-month feeding studies in the dog (haemopoietic hyperplasia and increases in cholesterol levels in females were seen at higher doses) and applying a standard assessment factor of 100. As levels of radioactivity found in the urine in the dog ADME (absorption, distribution, metabolism and excretion) study indicated that, oral absorption is almost complete (> 95 percent), a correction factor for incomplete oral absorption was not needed. Estimates of the exposure of operators, bystanders and workers to iodosulfuron resulting from the proposed use of ‘Chekker’ were considerably below the AOEL. However, mefenpyr-diethyl has photo-irritancy properties and therefore operators must wear coveralls and gloves when handling the concentrated product. 15 Satisfactory data were submitted on the nature and magnitude of residues in cereals when iodosulfuron was used in accordance with the principles of good agricultural practice and also on residues in crops likely to be grown in succession. These data were considered to address the effects of the use of the crop safener mefenpyr-diethyl on crop residues. Estimates of dietary intakes by adults, children, toddlers and infants were substantially below the ADI. Iodosulfuron was shown to be of low toxicity to birds in acute, short-term dietary and reproduction studies. The risk to birds was considered to be acceptable. The risks to mammals, bees, non-target terrestrial arthropods, earth-worms, soil microbial processes and to sewage treatment processes were all considered acceptable. On the basis of the effects observed in algae, iodosulfuron was categorised as ‘Very toxic to aquatic organisms’. As iodosulfuron is not readily biodegradable, it was categorised as ‘May cause long-term adverse effects in the aquatic environment’. The product, ‘Chekker’ is highly toxic to the aquatic plant Lemna gibba (the most sensitive aquatic
<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 organism tested) and should be classified as ‘EXTREMELY DANGEROUS TO FISH OR OTHER AQUATIC LIFE’. However, the risk to aquatic plants was considered to be acceptable with a five metre buffer zone. In soil, the main degradation product of iodosulfuron is metsulfuron-methyl (also an approved sulfonylurea herbicide). Iodosulfuron, metsulfuron-methyl and amidosulfuron could all reach surface water via drainflow. To address the potential risk to aquatic plants exposed to these substances as a consequence of drainflow, the applicant submitted data generated by the preferential flow model, MACRO 4.2. This was used to predict the movement of all three substances to field drains under a range of conditions that could be encountered when ‘Chekker’ was applied to cereals. These data indicated that only in a very few exceptional scenarios would the concentrations of iodosulfuron, metsulfuron-methyl and amidosulfuron in surface water pose a risk to higher aquatic plants. 16 Iodosulfuron is a broad spectrum herbicide. Given its high level of activity, there is a potential risk from spray drift onto non-target plants adjacent to treated areas. Therefore, in line with other sulfonylurea based products, the warning phrase ‘Take extreme care to avoid drift onto crops and non-target plants outside the target area’ must appear on the product label. The <strong>Committee</strong> recommended provisional approval for ‘Chekker’ for use on cereals pending the Commission decision on inclusion of iodosulfuron in Annex I of Council Directive 91/414/EEC. Mepanipyrim Mepanipyrim is a new anilinopyrimidine fungicide. The <strong>Committee</strong> considered an application for approval of the product ‘Frupica’, a wettable powder, for use on strawberries to control Botrytis cineria. The active substance is also being considered for inclusion in Annex I of Directive 91/414/EEC with Italy acting as Rapporteur Member State. Neither mepanipyrim nor the formulated product required classification for acute toxicity. An acceptable daily intake (ADI) of 0.025 mg/kg bodyweight (bw)/day was established, based on the no observed adverse effect level (NOAEL) of 2.5 mg/kg bw/day for liver pathology, abnormal clinical chemistry and haematological changes seen in a rat carcinogenicity study and applying a standard assessment factor of 100. An acute reference dose (ARfD) of 0.3 mg/kg bw was derived from the NOAEL of 30 mg/kg bw/day in rat and rabbit developmental toxicity studies (effects on maternal bodyweight) and applying a standard assessment factor of 100. A short-term acceptable operator
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Advisory Committee on Pesticides Annual Report 2001

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