Completion of data entry of pesticide ecotoxicology Tier 1 study endpoints in a XML schema – database
Accepted: 23 July 2012
The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.
The work developed under the present contract (CT/EFSA/PPR/2010/03) should be considered as an integration of the work done under the specific contract NP/EFSA/PPR/2009/04 under multiple framework contract CT/EFSA/AMU/2009/01. The main goal under these contracts was the completion of a database in IUCLID 5.2 on the ecotoxicological endpoints of the active substances and plant protection products (PPPs).
The completion of data entry has been outsourced in 2010 according to EFSA procurement procedures and fully carried out at EFSA premises by ChemService S.r.l..
Project developed on the procurement project CFT/EFSA/PPR/2010/03
In order to revise the Guidance Documents on Aquatic Ecotoxicology and Terrestrial Ecotoxicology, EFSA Panel on Plant Protection Products and their Residues-PPR decided that the creation of a database on pesticides ecotoxicological properties was essential for the validation of Toxicity Exposure Ratios (TERs) used in these Guidance Documents.
The project called “Data entry of pesticide ecotoxicology Tier 1 study endpoints in a XML schema – database” was outsourced by EFSA in 2009 after a procurement procedure to ChemService S.r.l.
The deliverable of specific contract NP/EFSA/PPR/2009/04, concluded on the 22nd of March 2011, was a database on ecotoxicological properties of pesticides including all Tier 1 ecotoxicology studies of dossiers where ecotoxicology higher tier studies were available in the context of Directive 91/414/EEC.
The work developed under the present contract (CT/EFSA/PPR/2010/03) should be considered as an integration of the work done under the specific contract NP/EFSA/PPR/2009/04 under multiple framework contract CT/EFSA/AMU/2009/007. The main goal under these contracts was the completion of a database in IUCLID 5.2 on the ecotoxicological endpoints of the active substances and plant protection products (PPPs).
The contract CT/EFSA/PPR/2010/03, provided also the inclusion of the Risk Assessment (RA) endpoints agreed during the peer review process carried out in context of Directive 91/414/EEC and Regulation (EC) 1107/2009, together with ecotoxicological Tier 1 endpoints not considered in the first step.
The selected data entry software was, as recommended, IUCLID 5.2. The IUCLID interface is based on the OECD harmonised template for reporting chemical test summaries and is suitable for querying and statistical analysis. It is currently used to store physico-chemical, toxicological and ecotoxicological data of existing chemical substances and biocides and it is the only accepted form for the submission of data required by the REACH Regulation.
The objective of the project was the completion of a database on Tier 1 ecotoxicology study endpoints following the OECD harmonised templates (OECD-XML-schema) using IUCLID 5.2 as data entry software.
The data base created by accomplishing the present contract was completed in March 2012, the final deliverable is a database following the OECD-XML-schema which covers all the ecotoxicology Tier 1 study endpoints and risk assessment endpoints available in the dossiers submitted in the context of Directive 91/414/EEC, including those not containing higher tier studies.
The total number of EPs and RA EP extracted from IUCLID at the end of both projects, was reported in the Table 1, the details for substance are shown in the Appendixes F and G.
Last updated: 25 February 2013