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La présente Ligne directrice est une méthode d’essai en laboratoire destinée à évaluer la toxicité aiguë par voie orale des pesticides et d’autres produits chimiques pour des bourdons ouvriers adultes. Des bourdons ouvriers adultes sont exposés à une solution de saccharose à 50% en poids par unité de volume (500g/l), contentant le produit chimique testé. L’essai dure au minimum 48 heures. La mortalité est notée tous les jours et comparée avec les valeurs des témoins. On analyse les résultats afin de calculer la DL50 et la DSEO, si possible, à 24 heures et à 48 heures et, au cas où l’étude est prolongée, à 72 heures et à 96 heures.

La présente Ligne directrice est une méthode d’essai en laboratoire destinée à évaluer la toxicité chronique par contact pendant une période d’exposition de 10 jours pour des ouvrières adultes. De jeunes abeilles (âgées de deux jours au maximum) sont nourries en continu et ad libitum avec une solution aqueuse de saccharose contenant le produit chimique d’essai pendant 10 jours. La mortalité et les comportements anormaux sont observés et notés quotidiennement. Les effets chroniques du produit chimique testé sont évalués en comparant les résultats du groupe traité à ceux du groupe témoin. Les effets suivants sont déterminés : la CL50 (concentration létale médiane) et de la LDD50 (dose alimentaire létale médiane) après 10 jours d’exposition ; la CSEO (concentration sans effet observé) et DASEO (dose alimentaire sans effet observé). 

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.

In this document the importance of mechanistic consideration in quantitative structure-activity relationship ((Q)SAR) analysis, the critical role of mechanistic consideration in improving various (Q)SAR approaches and possible integrative approaches of combining chemoinformatics and bioinformatics are discussed, mainly using carcinogenicity as an illustrative toxicity endpoint. The principles and issues described in this document are general and may also be used for various types of chemical assessment. The intended target of readership is for global chemical hazard/risk assessors in regulatory agencies, industries, non-governmental organization and academia who require reliable and scientifically supportable (Q)SAR information and predictions in their assessments as well as for developers/researchers who endeavour to produce scientifically reliable (Q)SAR predictive models and tools.

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.

In this document a strategy is presented to facilitate the ecological risk assessment of organometallic compounds (OM) and organic metal salts (OMS), outlining key steps that are based on elucidation of the fate of these substances in the environment. This document puts forth the recommendation that the initial determination of their fate in the environment is a primary factor for deciding how these substances should be assessed recognising that regulatory and program requirements will vary with each jurisdiction.

This document presents a harmonized method for characterising, for assessment purposes, a specific subcategory of UVCBs (Substances of Unknown or Variable composition, Complex reaction products or Biological materials): hydrocarbon solvent substances. The method presented in this document gives guidance on how hydrocarbon solvent substances can be characterised in a way that their composition is accurately and consistently reflected. This ensures that substances with the same chemical composition, manufactured in different countries, can be characterised with the same description for hazard assessment purposes. A common understanding and approach to characterising UVCBs would enable regulatory authorities to increase cooperation in the field of hazard assessment and help industry deal with regulatory requirements from multiple jurisdictions.

This Guidance Document proposes an integrated approach on testing and assessment (IATA) for skin corrosion and irritation. It also provides consistent information on key characteristics of each of the individual information sources of the IATA, and relevant guidance on how to integrate information for decision making (including decisions on the need for further testing) for final decisions for classification and labelling.