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This Test Guideline describes a chronic oral toxicity test on adult worker honey bees under laboratory conditions over an exposure period of 10 days. Young bees (max. 2 days old) are exposed to 50 % (w/v) aqueous sucrose solution containing the test chemical by continuous and ad libitum feeding over a period of 10 days. Mortality and behavioural abnormalities are observed and recorded daily during the 10 day test period. The chronic effects of the test chemical are evaluated by comparing the results of the test chemical treated group to those of the respective control group. The test is designed for the determination of the following endpoints  LC50 (median Lethal Concentration) and the LDD50 (median Lethal Dietary Dose) values after 10 days of exposure, and NOEC (No Observed Effect Concentration) and NOEDD (No Observed Effect Dietary Dose).  

This test guideline is a laboratory test method, designed to assess the acute contact toxicity of pesticides and other chemicals to adult worker bumblebees. Adult worker bumblebees are exposed to the test chemical dissolved in an appropriate carrier, by direct application to the dorsal thorax (droplet). The test duration is at least 48 h. Mortality is recorded daily and compared with control values. Results are analysed in order to calculate the LD50 and NOED, if possible, at 24 h & 48 h and furthermore at 72 h & 96 h in case the study is prolonged.

With a view to assisting the evaluation of integrated approaches to testing and assessment (IATA) in regulatory decision-making within OECD Member Countries, this guidance document provides guidance on the reporting of defined approaches to testing and assessment in the area of skin sensitisation using the adverse outcome pathway (AOP) as a conceptual framework. Annex 1 (page 25) outlines twelve illustrative case studies for skin sensitisation and Annex 2 (page 279) lists information sources used within the case studies.

With a view to assisting the evaluation of integrated approaches to testing and assessment (IATA) in regulatory decision-making within OECD Member Countries, this guidance document provides a set of principles for reporting defined approaches to testing and assessment that can be used as one of the components within IATA. Templates are also provided to enable a structured approach to their documentation in order to facilitate their evaluation. A defined approach to testing and assessment consists of a fixed data interpretation procedure (DIP) applied to data generated with a defined set of information sources to derive a result that can either be used on its own, or together with other information sources within an IATA, to satisfy a specific regulatory need. Thus, a defined approach to testing and assessment can be used to support the hazard identification, hazard characterisation and/or safety assessment of chemicals. This guidance is intended to be used alongside similar guidance aimed at harmonising the reporting of other IATA components such as QSARs, grouping and read-across strategies, and non-guideline in vitro methods.

Acute toxicity tests are an area of focus for developing alternative assays and approaches to address animal welfare concerns. In the context of this document, acute toxicity studies refer to studies involving a single exposure to a test chemical and include those assessing systemic toxicity as well as those assessing local irritation, corrosion or sensitization. One approach to minimizing the use of animals for acute toxicity testing is to consider waiving a study that may be required based on scientific criteria. Another approach to reducing or eliminating animal testing is to use existing hazard information that is informative for the acute toxicity endpoint for the test chemical; this would include the use of hazard information for one or multiple similar test chemicals to characterize the hazard for another or for mixtures, the use of recognized calculation approaches and bridging concepts. This Document provides clarification on these approaches to ensure that regulatory authorities are provided with the appropriate data required for decision-making and that reduced animal testing can be undertaken without compromising the integrity of the hazard information.  

OECD member countries have been making efforts to expand the use of alternative methods in assessing chemicals. The OECD has been developing guidance documents and tools for the use of alternative methods such as (Q)SAR, chemical categories and Adverse Outcome Pathways (AOPs) as a part of Integrated Approaches for Testing and Assessment (IATA). There is a need for the investigation of the practical applicability of these methods/tools for different aspects of regulatory decision-making, and to build upon case studies and assessment experience across jurisdictions. The objective of the IATA Case Studies Project is to increase experience with the use of IATA by developing case studies, which constitute examples of predictions that are fit for regulatory use. The aim is to create common understanding of using novel methodologies and the generation of considerations/guidance stemming from these case studies. This document reports the learnings and lessons obtained from the review experience of the four case studies submitted to the 2015 review cycle of the IATA Case Studies project. The topics discussed in this document include the strongest aspects and uncertainties of each case study, and the document identifies areas for developing further guidance on IATA.