Product Assessment

Physico-chemical, analytical, residue, ecotoxicological, toxicological and detailed efficacy studies will be designed. The exact details of silo trials and sampling for resistance research will be designed based on the current availability of test sites and stored commodities, information on infested grain pools, information on the final formulation, information on use instructions for the equipment and instructions for sampling from the resistance research laboratory. We will synthesise these information and create the final plan for field testing prototypes. 

Our work consist of development of formulation recipes based on key objectives and requirements, as well as on the results of preliminary testing and assessments. Information needed for the implementation will be gathered, basic requirements / conditions for different parameters of the compounds will be set and theoretical composition of the formulation will be designed. We will also perform preliminary assessment on (eco)toxicological impact of components. Basic risks and hazards will be assessed based on chemical composition and literature / regulatory data and information on (eco)toxicological effects of the compounds. Creating stable lab-batches of formulation variants with validated active substance content is also one of our tasks. Effective, stable, applicable formulation variants will be created using compounds which are compatible with each other and passed the preliminary (eco)toxicological assessment. Basic analytical validation and designing manufacturing processes will also be performed with preliminary cost estimates for manufacturing. 8-10 variants are expected to be developed, of which approx. 5 will be tested for e.g. stability, examined from a preliminary toxicological or ecotoxicological point of view, etc. From these variants we will select 1 that will undergo further detailed testing. Screening studies in lower quantities of grain will be performed with lab-scale prototype variants to test different application rates and to compare efficacy of different formulations under simulated-use conditions.

Physico-chemical properties and stability of the prototypes will be tested including the development of analytical methods for exact measuring of the active substance, residues and impurities in different matrices. Metabolites and residues will be analysed in plant and animal model systems. We will also be performing detailed toxicological, metabolic and ecotoxicological assessments. Absorption, distribution, metabolism and excretion after exposure, genotoxicity, long-term toxicity and carcinogenicity and endocrine disrupting properties as well as toxicity profile of metabolites will be investigated in detail in laboratory studies using standard model systems. Effects on wildlife: toxicity studies on non-target organisms, endocrine disrupting properties and bioconcentration will be investigated in detail in laboratory studies using standard model systems before testing the prototype in the field; environmental fate and degradation of the active substance and its residues will be investigated in water and soil. Performing detailed exposure estimation and risk assessment for human health and environment is also one of our tasks. The safe use of the developed product will be demonstrated. Based on current relevant EU guidelines, the exposure of the environment to the product will be estimated and compared to the determined ecotoxicological limit values. 

Other tasks include performing complex efficacy testing under laboratory, simulated-use and practical conditions. The final formulation will be assessed either in preventive treatment as single use application, or in curative treatment in combination with commonly used adulticides already on the market. Single use tests are intended to prove proper long-term preventive effect of S- methoprene on the development of stored grain attacking insect larvae in different plant matrices. Curative, mixed use tests with the larvicide product in combination with widely used adulticides are planned to be performed to demonstrate proper overall insect population control effect of the combined application using the new, dual-channel spraying system. With the help of these studies it can be also tested whether simultaneous use of the S-methoprene larvicide containing product could let us lower the dose of adulticides to e.g. half of their starting dose by providing the same good insect population controlling effect. We will also be creating data package for dissemination and building a decision support system. In order to assess complex behaviour of the formulation and the active substance in living organisms and in the ecosystem and to predict environmental fate by studying biological effects on target and non-target organisms, performing detailed analysis on physico-chemical properties and metabolic, toxicological and ecotoxicological profile as well as testing efficacy in the laboratory and under simulated-use and practical (field) conditions will be performed under GEP and GLP directions. Study data will be collected, and a detailed data package will be created for dissemination purposes and for building a decision supporting system. Besides, a manufacturing-scale batch of the final, validated formulation will be created. As a final step, manufacturing scale-up will be designed and performed to create manufacturing-scale batches of the final, validated formulation ready for authorization and introducing in the market.