Advisory Committee on Pesticides Annual Report 2001

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Section B: Applications for provisional approvals for products containing new active substances soil metabolite would be present in this study. Members therefore agreed that the risks to earthworms posed by the metabolite were acceptable. The <strong>Committee</strong> recommended to Ministers that provisional approval should be granted for the product ‘AC 900001’ for a period of three years, pending the Commission decision on inclusion of picolinafen in Annex I of Council Directive 91/414/EEC. Picoxystrobin Picoxystrobin is a new strobilurin fungicide. The <strong>Committee</strong> considered an application for approval of one product, ‘Acanto’, in which picoxystrobin was formulated as an emulsifiable concentrate for use on wheat and barley. The active substance was also being considered for inclusion in Annex I of Directive 91/414/EEC with Ireland acting as Rapporteur Member State. Members agreed that the acceptable daily intake (ADI) should be based on the no observed adverse effect level (NOAEL) of 4.6 mg/kg bodyweight (bw)/day in a one-year dog dietary study. With a 100-fold assessment factor, an ADI of 0.05 mg/kg bw/day was derived. The ACP agreed that the appropriate value for the acceptable operator exposure level (AOEL) was also 0.05 mg/kg bw/day. The <strong>Committee</strong> was content that the estimates of exposure for operators, workers and bystanders were acceptable. 19 The <strong>Committee</strong> agreed that in the absence of more relevant data, the acute reference dose (ARfD) should be the same as the ADI, 0.05 mg/kg bw/day. A residue definition of picoxystrobin was considered appropriate, and estimates of consumer intake were regarded as acceptable. With respect to efficacy, the <strong>Committee</strong> noted that in general strobilurins did not have curative action and it agreed that some changes to the proposed label were required. The submitted environmental data were discussed and the <strong>Committee</strong> was content that the risk to aquatic organisms was acceptable. It was agreed that ‘Acanto’ should be classified as ‘Dangerous to fish or other aquatic life’, on the basis of acute toxicity to Daphnia. The ACP discussed earthworm mortalities, which had been seen in a few field trials conducted in France in 2001. It was noted that the toxicity exposure ratio (TER) in the risk assessment was very close to the trigger value and it considered that the observed mortalities were therefore a concern. The <strong>Committee</strong> suggested that an interaction with environmental stresses such as flooding could have caused the earthworm
<strong>Advisory</strong> <strong>Committee</strong> on Pesticides Annual Report 2001 deaths, but that further earthworm data should be required to clarify the risk assessment with a study protocol to be agreed with PSD. The <strong>Committee</strong> recommended provisional approval for use of ‘Acanto’ on cereals pending the Commission decision on inclusion of picoxystrobin in Annex I of Council Directive 91/414/EEC. Propoxycarbazone-sodium Propoxycarbazone-sodium (MKH 6561) is a sulfonylaminocarbonyltriazolinone herbicide, which acts by inhibiting the enzyme acetolactate synthase (ALS). The ACP considered an application for approval of propoxycarbazone-sodium in a plant protection product ‘Attribut’, for use to control grass weeds in wheat. The formulation was defined as a water soluble granule (SG), based on the compound’s solubility in water. At the time of <strong>Committee</strong> consideration, propoxycarbazone-sodium was new to the EC, with Germany acting as the Rapporteur Member State (RMS) for its inclusion in Annex I of Council Directive 91/414/EEC. 20 Propoxycarbazone-sodium was of low acute toxicity. It was not classifiable as a skin or eye irritant, nor as a skin sensitiser. The compound was not shown to be oncogenic in mice or rats, or to have any neurotoxic potential. The ACP was satisfied that there was sufficient evidence to conclude that the compound was not genotoxic and did not present a significant immunotoxicological hazard. The residue definition in crops was agreed to be the major plant metabolite M01 (2-hydroxy propoxy MKH 6561) only, based on supporting crop metabolism data and the results of residue trials. Members agreed that the acceptable daily intake (ADI) should be based on the NOAEL of 43 mg/kg bodyweight (bw)/day from a 24-month combined chronic toxicity/carcinogenicity study in rats. With a 100-fold assessment factor, this gave an ADI of 0.4 mg/kg bw/day. An ARfD of 1 mg/kg bw was also agreed based on the NOAEL of 100 mg/kg in a rabbit developmental toxicity study, with a 100-fold assessment factor. Both of these reference values were considered applicable for the metabolite M01. The ACP agreed that the short-term systemic acceptable operator exposure level (AOEL) should be based on the NOAEL of 100 mg/kg bw/day in a rabbit developmental toxicity study, (taking into account oral absorption of 24 percent). With a 100-fold assessment factor, this gave an AOEL of 2 mg/kg bw. A long-term systemic AOEL was not considered appropriate because of the short duration of use of the product.
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Advisory Committee on Pesticides Annual Report 2001

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