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Soil samples, with different characteristics, are treated with the test substance and incubated in the dark in biometer-type flasks under controlled laboratory conditions of temperature and soil moisture. After appropriate time intervals, soil samples are extracted and analysed in order to determine the parent substance and the (known) transformation products/metabolites contents. The test should normally ended 120 days after the test substance application, no longer, to ensure an adequate soil microbial activity expected in an artificial laboratory system. A plot of the test substance concentrations versus time allows an estimation of its transformation half-life/DT50. Major transformation products have to be identified and their concentrations versus time plotted to show their rates of formation and decline.
1 concentration of the the test substance is tested in different soil types.
Analytical determination of the parent substance and the transformation products content in soil:
2 replicates/sampling date for treated soil
1 replicate/sampling date for untreated soil
Additional replicates for microbial biomass determination:
2 replicates/sampling date for treated and for untreated soil
Additional replicates as spare samples
Recovery quality check at 2 fortification levels:
1 replicate for sampling date/fortification level for untreated soil
Repeatability of the analytical method:
Duplicate analysis of the same extract of soil at proper sampling dates
LOD (for the test substance and the transformation products): 0.01 mg/kg of soil or ≤ 1% of the initial amount applied to the soil and LOQ determination.
Analyses performed using a method validated according to SANCO/3029/99 rev.4 guidance document.
Where relevant, cartridges or traps to determine the active substance volatile fraction or volatile by-products are used.
Kinetics analysis and calculation of DT50 and DT90 values.
Transformation products pattern.
Study includes GLP management and reporting.
REFERENCES AND GUIDELINES
OECD Guideline for Testing of Chemicals, No. 307 (24th April 2002) - Aerobic and anaerobic transformation in soil.
SANCO/3029/99 rev.4 (11/07/2000) - Residues: guidance for generating and reporting methods of analysis in support of pre-registration data requirements for Annex II (Part A, section 4) and Annex III (Part A, section 5) of Directive 91/414.