Assessment of additional testing needs under REACH Effects of (Q)SARS, risk based testing and voluntary industry initiatives (original) (raw)
Related papers
Regulatory Toxicology and Pharmacology, 2008
The goal of REACH is the safe use of chemicals. This study examines the efficiency and usefulness of two draft technical guidance notes in the REACH Interim Project 3.2-2 for the development of the chemical safety report and exposure scenarios. A case study was carried out for a paint system for protection of structural steel. The focuses of the study were risk assessment of preparations based on Derived No Effect Level (DNEL) and Predicted No Effect Concentrations (PNEC) and on effective and accurate communication in the supply chain. Exposure scenarios and generic descriptions of uses, risk management measures, and exposure determinants were developed. The study showed that communication formats, software tools, and guidelines for chemical risk assessment need further adjustment to preparations and real-life situations. Web platforms may simplify such communication. The downstream formulator needs basic substance data from the substance manufacturer during the pre-registration phase to develop exposure scenarios for preparations. Default values need to be communicated in the supply chain because these were critical for the derivation of applicable risk management demands. The current guidelines which rely on the available toxicological knowledge are insufficient to advise downstream users on how to develop exposure scenarios for preparations.
Archives of Toxicology
Hazard assessment, based on new approach methods (NAM), requires the use of batteries of assays, where individual tests may be contributed by different laboratories. A unified strategy for such collaborative testing is presented. It details all procedures required to allow test information to be usable for integrated hazard assessment, strategic project decisions and/or for regulatory purposes. The EU-ToxRisk project developed a strategy to provide regulatorily valid data, and exemplified this using a panel of > 20 assays (with > 50 individual endpoints), each exposed to 19 well-known test compounds (e.g. rotenone, colchicine, mercury, paracetamol, rifampicine, paraquat, taxol). Examples of strategy implementation are provided for all aspects required to ensure data validity: (i) documentation of test methods in a publicly accessible database; (ii) deposition of standard operating procedures (SOP) at the European Union DB-ALM repository; (iii) test readiness scoring accoding to defined criteria; (iv) disclosure of the pipeline for data processing; (v) link of uncertainty measures and metadata to the data; (vi) definition of test chemicals, their handling and their behavior in test media; (vii) specification of the test purpose and overall evaluation plans. Moreover, data generation was exemplified by providing results from 25 reporter assays. A complete evaluation of the entire test battery will be described elsewhere. A major learning from the retrospective analysis of this large testing project was the need for thorough definitions of the above strategy aspects, ideally in form of a study pre-registration, to allow adequate interpretation of the data and to ensure overall scientific/toxicological validity.
ALTEX, 2009
The EU REACH legislation for chemicals of 2006 represents the largest investment into consumer product safety ever. A reanalysis of cost and animal use estimates was carried out based on the final legislation, test guidance for industry published by the European Chemical Agency, and the preregistration completed in December 2008. The new estimates for the number of substances falling under REACH range from 68 to 101,000 chemicals, substantially exceeding the earlier estimates of 29,000 substances. The latter estimates were, however, based on data before 1994 and both expansion of the EU and growth of the chemical industry since have contributed to higher numbers today. The lower estimate of 68,000 chemicals was carried through current testing requirements with due regard to emerging alternative approaches, using in all cases the most optimistic assumptions (minimal animal numbers per test and neglecting most triggering of additional tests and confirmatory (re-)tests as well as tests...
Selected Integrated Testing Strategies (ITS) for the risk assessment of chemicals
2007
RIVM's investigation of integrated testing strategies (ITS) to reduce the use of experimental animals in the risk assessment of chemical substance focuses on the application of alternative and improved test methods. This research is highly desirable for the contribution it can make to the successful implementation of the new EU legislation for industrial chemicals, REACH, as of June 1, 2007. In this way RIVM will contribute to EU and OECD research into testing strategies.