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ADVICE SUMMARY APPLICATION FOR REGISTRATION OF A CHEMICAL PRODUCT Product name: VACSOL TC RTU TIMBER PRESERVATIVE Applicant: ARCH WOOD PROTECTION (AUST) PTY LIMITED Product number: 64479 Application number: 48470 Purpose of Application and Description of Use: Registration of a 5g/L Permethrin and 795 g/L Liquid hydrocarbons liquid RTU product for the treatment of timber against attack by borers and termites in above ground situations (H1 & H2). Active Constituent(s): PERMETHRIN Regulatory Decision: To grant the application subject to the following conditions: Standard Conditions of Registration/Approval 1. Containers must meet AgVet Code Regulation 18 2. Agricultural products must meet Active Constituents Quality Assurance Requirements 3. Label must contain a Date of Manufacture and Batch Number For full conditions, refer to Standard Conditions for Applications on the APVMA website. 48470 Page 1 of 2 KP25S_F39 Version: 2 Issued: 14/08/2007 ADVICE Australian Government Department of Health And Ageing, Office Of Chemical Safety and Environmental Health Arch Wood Protection (Australia) Pty Ltd has applied to register a new timber insecticide product, Vascol TC RTU Timber Preservative containing permethrin at 5 g/L. The product is intended for the treatment of timber to protect against attack from wood consuming beetles and termites. The product is a ready-touse formulation for use in the vacuum pressure treatment of timber. The ADI of 0.05 mg/kg bw/day for permethrin was established in 1986 based on a NOEL of 5 mg/kg bw/day in chronic rat and dog studies, and using a 100fold safety factor. No ARfD has been established for permethrin and no data were submitted to enable an ARFD to be set. Toxicology data for the product was not submitted with this application. The acute toxicity of the product was estimated based on the acute toxicity data available for the active constituent and the other excipients. The product is estimated to be of low acute oral, dermal and inhalational toxicity. It is expected to be a skin, eye and respiratory irritant, and skin sensitiser. Permethrin is in Schedule 6 of the SUSMP except when included in Schedule 4 or 5, or is unclassified when present at less than 2%. Vacsol TC contains 0.5% (w/v) permethrin and is therefore unscheduled based on the above classification of permethrin (<2%). Vacsol TC contains liquid hydrocarbon solvent which is in Schedule 5 of the SUSMP. Therefore, the product is classified as Schedule 5 according to the SUSMP. Based on the estimated acute toxicity of the product, this classification is considered appropriate. Since no models are available to estimate exposure during treatment or rehandling of timber, a qualitative risk assessment was conducted. The information on the product provided and considered in this assessment justifies the Safety Directions established in the present evaluation and the Rehandling instructions recommended, both of which have been included in the RLPs. Furthermore, the proposed use of Vascol TC RTU Timber Preservative will not be an undue health hazard to humans according to the criteria stipulated in Section 14 of the Ag/Vet Code Act of 1994. Other Details About The APVMA’s Decision To Grant The Application Based on information held, the APVMA is able to be satisfied on all Section 14 criteria applicable to this product. * S = Data submitted with the application I = Data inherited (that is, referenced) from another application 48470 Page 2 of 2 KP25S_F39 Version: 2 Issued: 14/08/2007