With QSAR models and powerful tools we are able to predict chemically induced toxicological effects for substances with few or no experimental test data. These models can reduce the number of animal tests necessary in the assessment of chemical substances. They can increase the information for a given substance (including metabolites and degradation products), and save time and money.
FOCUS simulation models and FOCUS scenarios are used to calculate the concentrations of plant protection products in groundwater and surface water in the EU review process according to Regulation (EC) No 1107/2009. Plant protection products have an important role in agricultural production and food security, and ensuring their safety to man and the environment is of paramount importance.
In the past experiemntal tests were essential during drug validation process. In some cases using experimental data - if possible - from a similar structure substance can be used according to the regulations to substitute the completion of the exact time and money consuming tests. Therefore faster and cost effective results can be achieved if possible.
The FOCUS groundwater scenarios became available around 1 January 2001. They are used to assess the potential movement of active substances and metabolites of plant protection products to groundwater. They form a part of the review process for active substances in the EU in the context of Directive 91/414/EEC.
Surface water is the second environmental compartment covered by the activities of FOCUS.
The possibilities of contamination of surface waters by the application of plant protection products (PPP) are already recognised for a long time. Main processes involved in the loading of surface waters with plant protection products are e.g. drift, drainage and run-off. The estimation of the concentration of the active substance of PPP is therefore required in the registration process in the European Union according to Directive 91/414/EEC.
The activities to determine the Predicted Environmental Concentration (PEC) in surface waters were distinguished into two parts. Firstly, the inventory of possible mathematical models suitable for this task and secondly, the development of a tiered approach to estimate these PECs for the benefit of the registration. The first part has been carried out from 1995 through 1996 and the second part from 1997 through 2002 (see Documentation of FOCUS Surface water).
Visit OECD.
Visit Danish (Q)SAR Database.
Visit EUROPEAN SOIL DATA CENTRE (ESDAC).
Visit A Way To Obtain Data Accordingly To Current Regulations.
Alternative methods endorsed by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), the U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and/or the Organisation for Economic Co-operation and Development (OECD) are listed below.
Visit PETA INTERNATIONAL SCIENCE CONSORTIUM.
Or download the exact directive here.
May 2016 updates to Annex VIII state that in vivo testing for skin irritation/corrosion is required only when in vitro studies are not applicable or the results of the in vitro studies are not adequate for classification and labeling.
May 2016 updates to Annex VIII state that in vivo testing for serious eye damage or eye irritation is required only if the in vitro studies are not applicable, the results obtained from the studies are not applicable, or the results obtained from the in vitro studies are not adequate for classification or labeling.
Testing does not need to be conducted if the substance is highly insoluble in water or unlikely to cross biological barriers, or if a long-term fish toxicity study is already available.
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