Advisory Committee on Pesticides Annual Report 2001

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Section B: Applications for provisional approvals for products containing new active substances Section B: Applications for provisional approvals for products containing new active substances New provisional approvals The ACP considered provisional approval for products based on the following active substances: ● BETA CYFLUTHRIN ● CLOMAZONE ● CYAZOFAMID ● FLUFENACET ● IODOSULFURON-METHYL-SODIUM ● ● MEPANIPYRIM PICOLINAFEN 7 ● PICOXYSTROBIN ● PROPOXYCARBAZONE-SODIUM ● PYRACLOSTROBIN ● SILTHIOFAM ● SPINOSAD ● SULFOSULFURON ● ZOXAMIDE Beta-cyfluthrin The <strong>Committee</strong> considered the second evaluation of ‘Chinook’, a seed treatment product containing beta-cyfluthrin and imidacloprid. In 2000 members had concluded that insufficient data to address the environmental risk had been presented to recommend a commercial level of approval. New data were presented addressing the risks to birds and small mammals and the levels of beta-cyfluthrin likely to occur in surface waters as a result of drainflow. The <strong>Committee</strong> considered that these data indicated an acceptable
<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 risk to wildlife and recommended approval for the use on winter oilseed rape as proposed. The <strong>Committee</strong> also recommended that the approval holder be required to implement a user education scheme to minimise further any environmental effects. Clomazone Clomazone is a new isoxazolidinone herbicide that acts by inhibition of biosynthesis of photosynthetic pigments in plants. The ACP considered applications for approval of two products ‘Centium 50 WP’, a wettable powder (WP), and ‘Centium 360 CS’, a capsule suspension (CS), for residual control of broad-leaved weeds in winter oilseed rape. Clomazone was rapidly and extensively absorbed, metabolised and excreted in the rat, mainly via urine. Very little unmetabolised parent compound was excreted and a large number of metabolites were identified, mostly hydroxylated derivatives of the parent compound, especially 5-hydroxyclomazone. 8 The active substance is classifiable as ‘Harmful if swallowed and by inhalation’ based on acute oral and inhalational studies in rats. The <strong>Committee</strong> agreed that the main toxicological effect was liver enlargement and that the acceptable daily intake (ADI) should be based on the no observed adverse effect level (NOAEL) of 12.5 mg/kg bodyweight (bw)/day) from a one-year dog study. With a 100-fold assessment factor, this gave an ADI of 0.13 mg/kg bw/day. It was also considered appropriate that the shortterm systemic admissible operator exposure level (AOEL) should be derived in the same way. An acute reference dose (ARfD) of 0.3 mg/kg bw/day was agreed based on the NOAEL of 30 mg/kg bw/day for maternal toxicity in a rabbit teratogenicity study, with a 100-fold assessment factor. Members agreed that there were no apparent concerns in relation to genotoxicity, carcinogenicity or reproductive toxicity. Residue trials indicated that clomazone residues were present below the limit of quantification (LOQ) in oilseed rape at harvest, and calculations indicated that the consumer exposure would be acceptable. The exposures of operators from use of ‘Centium 50 WP’ were considered acceptable if protective gloves were worn when handling the product. For ‘Centium 360 CS’ coveralls and protective gloves should be required when handling the product. Exposures of bystanders and workers were regarded as acceptable. ‘Centium 360 CS’ was classifiable as a skin sensitiser on the basis of a Buehler test, and the ACP
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Advisory Committee on Pesticides Annual Report 2001

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