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Exposure of fathead minnow (Pimephales promelas), Japanese medaka (Oryzias latipes) and zebrafish (Danio rerio) to endocrine disrupting chemicals may result in histopathological alterations of gonadal structure and microarchitecture. The diagnosis of such histopathological changes may, therefore, assist in the detection of endocrine disrupting chemicals. Given the long historical background of piscine histopathology and diverse traditions in the terminology in different fish species and in different regions, there is a need for harmonisation in order to facilitate non-biased comparisons of results from different laboratories and, thus, to optimise reproducibility and reliability of histopathological diagnoses. The purpose of this document is to provide guidance for the preparation and histopathological evaluation of gonads from fathead minnow, Japanese medaka and zebrafish following exposure to chemicals potentially disrupting the endocrine system.

Efficacy of the biocide incorporated in a treated article against target organisms in the intended use must be demonstrated as one component of an application dossier. This guidance document covers efficacy testing of articles treated with antimicrobials in the manufacturing process with the intention of the achieving an external effect and of articles which have been in some way modified during service so as to exert an antimicrobial effect.

This document provides guidance on using efficacy and crop safety data generated in other countries and regions (as well as from other sources) and evaluations conducted by other regulatory authorities. The document does not provide guidance on the generation of data itself or related scientific principles of data assessment or extrapolation but rather discusses broad principles that may be considered and possibly assist with minor use registrations.

The method described in this guidance document assesses the effects of plant protection products (PPPs), and has been validated using the active Fenoxycarb, which is known to act as an insect growth regulator (IGR), to the honey bee brood (Apis mellifera L.) under semi-field conditions (tunnel conditions followed by field conditions). The method can be used to address concerns regarding the impact on the brood development in honey bee colonies which are exposed to treatments of PPPs in agricultural crops. The aim of this test is to fill an identified gap or complement the sequential testing scheme with the development of a test method under semi-field conditions and to produce quantitative data that can be used as the basis for the evaluation of IGRs and other larvicidal compounds.

This document presents guidance for conducting the Syrian Hamster Embryo Cells Transformation Assay (SHE CTA). The purpose of this Guidance document is to allow the regulatory community to use the described method as part of a weight of evidence approach in the testing of substances for carcinogenic potential. There are a number of issues which have impeded consensus on the approval of the Test Guideline; these issues mainly include the subjective nature of evaluating transformed phenotypic morphology, the limited understanding of causal molecular mechanisms leading to the transformed SHE colonies, the relatively small number of bona fide non-genotoxic carcinogens, as compared to genotoxic carcinogens, that have been tested in the SHE cell transformation assay, and the way the assay might be used in a regulatory framework.

A joint review is an evaluation of a pesticide dossier through work-sharing between two or more countries. The participating regulatory authorities review the work of the primary reviewers for each particular science discipline, and the end product (ideally a complete monograph or key components of the monograph) is used by all participating countries (and others) as the basis for regulatory decisions. In conjunction with the requirements, this guidance document was prepared to support joint reviews in order to maximize opportunities of work-sharing arrangements between regulatory authorities in OECD countries. This guidance document includes two main phases of a joint review, planning and implementation phases, with a view to helping industries and regulatory authorities conduct the joint review process.

The purpose of this Guidance Document is to apply the principles of the Three Rs to the use of animals in regulatory toxicity tests. The OECD encourages the humane use of animals in regulatory toxicity and safety evaluation studies and fully endorses the principles of the 3Rs, Replacement, Reduction, Refinement.

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.

This document is intended to provide guidance when testing and/or evaluating effectiveness of biocide products (public health insecticides) used as baits for the control of Lasius ant colonies nesting in, or in close proximity to, buildings. This document does not deal with efficacy consideration for products used as pesticides, for example products aimed at outdoor ant elimination.

This Guidance Document is addressed to those who are involved in risk assessment and management of chemicals called POPs (persistent organic pollutants) or PBTs (persistent and bio-accumulating toxics). It is about using multimedia models, i.e. generic evaluative models that can calculate overall environmental persistence (Pov) and potential for long-range transport (LTRP) covering multiple compartments such as air, water, sediment and soil: what models you can use to identify and characterize POPs/PBTs, what data to use, and how to use model calculations.

This document provides a description of a Harmonised System for the Classification of Chemicals which are Hazardous for the Aquatic Environment and guidance to how the system will work as well as guidance to the interpretation of data for use in applying the classification criteria.

This Guidance document focuses on the antioestrogenic protocol; it is the outcome of the experience gained during the validation test programme and the results obtained thereby with the use of a strong oestrogen receptor antagonist. Due to insufficient validation of this antioestrogenic protocol, this Guidance Document is provided for experimental purpose only. The test will provide supporting evidence in relation to antioestrogenic activity.

The purpose of this document is to provide guidance on issues related to the validation of new or updated test methods consistent with current approaches. This document provides a synopsis of the current state of test method validation, in what is a rapidly changing and evolving area. Guidance on the more general aspects of OECD Test Guideline development is provided in the OECD Guidance Document for the development of OECD Test Guidelines for the testing of chemicals. While the principles of validation as described in this document were written for biology-based tests, they may be applicable to other Test Methods.

To keep (Q)SAR applications on a solid scientific foundation, an international effort to articulate principles for (Q)SAR technology and to develop a guidance document for use of (Q)SAR in regulatory applications. This document presents those principles and helpful guides for validating (Q)SAR technology for a variety of applications.

The document provides guidance to both industry and regulatory authorities in the context of pre-submission consultations prior to submission of applications for the registration of microbial biological control agents. This document describes the procedure and the information which should be submitted at a pre-submission consultation.

This Guidance Manual includes detailed explanations on how to implement the OECD Decision C(2001)107/FINAL, as amended; copies of the Decision C(2001)107/FINAL (Annex A), including Appendices 3 and 4, and Appendix 8 which have been amended by C(2008)156; the updated consolidated lists of waste subject to the Green and Amber control procedures (Annexes B and C); other relevant information to facilitate the implementation of the OECD Decision C(2001)107/FINAL, such as applicable international transport agreements and a sample contract; and queries of the interactive database aiming to facilitate the paperwork of all parties involved in transboundary movements of wastes by providing the necessary information to complete the forms for the notification and movement documents. The database includes the information required by the Decision C(2001)107/FINAL, as amended and some practical information for each OECD member country (http://www2.oecd.org/waste).

Following the adoption of Council Recommendation C(2004)100 in 2004 on Environmentally Sound Management of Waste, member countries wished to reinforce the implementation of this legal Act by issuing a practical Guidance Manual. This publication aims at facilitating the implementation of an environmentally sound waste management policy by governments on one hand, and by waste treatment facilities on the other hand. Every element of the Recommendation C(2004)100 is explained in detail, as well as the different core performance criteria which characterise environmentally sound management of waste, through various types of information (such as technical, financial, regulatory). Waste management practices applied in certain member countries are presented as examples...

These Guidance Notes outline core concepts in order to obviate the need to consult large numbers of text books, while still pointing the reader to sources of more detailed or specific information. They are intended to complement OECD Test Guidelines and other OECD publications, including Guidance for Industry Data Submissions and Guidance for Country Data Review Reports on Plant Protection Products and their Active Substances – Monograph Guidance

This document presents a general guide to the analysis and evaluation of data from studies involving repeated exposures of toxicity test species to pesticides and other chemicals; and outlines the kind of information which should be included in an independent assessment of toxicity studies.