Advisory Committee on Pesticides Annual Report 2001

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Section B: Applications for provisional approvals for products containing new active substances agreed that the feasibility of removal of the sensitising co-formulant from the formulation should be explored. The <strong>Committee</strong> agreed that clomazone was of low toxicity to birds and animals and that the risks to bees, arthropods, earthworms, soil macroand micro-organisms and biological methods for sewage treatment were acceptable. The most sensitive aquatic organisms were green algae, and based on toxicity to this group ‘Centium 50 WP’ was classified as ‘Harmful to fish or other aquatic life’ whilst ‘Centium 360 CS’ was less toxic, requiring the warning phrase ‘Do not contaminate waters or ditches with chemical or used container’. However, the risk to aquatic life from spray drift and drainflow was regarded as acceptable. The ACP expressed serious concern about the potential risk to non-target flora from spray drift and possible volatilisation of the active substance. The <strong>Committee</strong> recommended that for spray drift management, a ‘coarse’ spray setting, in accordance with the British Crop Protection Council (BCPC) classification, should be specified for both products. The ACP agreed that there was less volatilisation potential from the capsule formulation ‘Centium 360 CS’ and that provisional approval could be recommended. However, no appropriate risk management strategy had been proposed to reduce potential adverse effects on non-target flora for ‘Centium 50 WP’ and provisional approval could not be recommended for this product. The <strong>Committee</strong> agreed that a monitoring programme should be undertaken to assess adverse off-target effects on flora, including from long-term exposure. Members also agreed that, as greater volatilisation was likely in warmer weather, the additional ecotoxicological data specified should be required to support any application for spring use of clomazone. 9 The ACP noted that satisfactory weed control had been demonstrated but stipulated that cultivations should be at least 15 cm deep to minimise effects in following crops in fields where reduced tillage was used. Concerns were also expressed with respect to residues in adjacent crops when using ‘Centium 50 WP’ due to vapour drift. The <strong>Committee</strong> advised that provisional approval be recommended for use of ‘Centium 360 CS’, subject to label amendments, the confirmatory data specified and a product stewardship programme, to be agreed with PSD. A commercial level of approval for ‘Centium 50 WP’ was not recommended in view of the potential adverse effects on non-target flora.
<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 Cyazofamid Cyazofamid (codename IKF-916) is the proposed name for 4-chloro-2cyano-N, N-dimethyl-5-P-tolylimidazole-1-sulfonamide. It belongs to a new chemical class of fungicide based on the cyanoimidazole moiety. Cyazofamid inhibits respiration specifically at cytochrome bc1 complex in the mitochondria of Oomycetes fungi, acting on the Qi site (ubiquinone-reducing site) of the complex. The active substance is also being considered for inclusion in Annex I of Directive 91/414/EEC with France acting as Rapporteur Member State. The ACP considered an application for a plant protection product, ‘Ranman’, which is packaged in a dual compartment pack with ‘IKF-916 400SC’ in one compartment and an approved organosilicone adjuvant in the other. ‘IKF-916 400SC’ is a suspension concentrate (SC) formulation containing 400 g/l cyazofamid. The proposed use of the product was as a contact/protective fungicide against potato blight (Phytophthora infestans). 10 Cyazofamid is rapidly absorbed when ingested by mammals, but the extent of absorption is limited and there was no evidence of retention in organs and tissues. Further studies showed the major pathway for the elimination of absorbed radiolabel was in urine with a significant amount, predominantly conjugates, being eliminated in bile. Unabsorbed cyazofamid was eliminated in faeces. In metabolism studies, the metabolites identified indicated that, following oral administration, cyazofamid was hydrolysed, removing the N, N- dimethylsulfonamide group. The 4-chloro-5-p-tolylimidazole-2-carbonitrile (CCIM) generated by this hydrolysis was considered to be the primary metabolite from which others were derived. CCIM was, however, not detected as a major metabolite in urine. Instead, the benzyl methyl group underwent oxidation to form 4-(4-chloro-2-cyanoimidazol-5-yl)benzoic acid (CCBA) or conjugation with glutathione and oxidation to form other metabolites. Cyazofamid was shown to be of low acute toxicity. The compound was not classified as a primary eye irritant or a skin irritant and did not produce delayed contact hypersensitivity in a skin sensitisation test. The toxicological studies submitted indicated that the compound was not genotoxic, carcinogenic or teratogenic, and no adverse reproductive effects had been observed. The ACP agreed an ADI of 0.2 mg/kg bodyweight (bw)/day, based on a no observed adverse effect level (NOAEL) of 500 ppm from a rat two-year study. Effects at the next dose were an increase in kidney weight, increased urine volume and higher chloride levels in urine. Estimated consumer exposures
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Advisory Committee on Pesticides Annual Report 2001

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