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This Guidance Document is intended to provide guidance to industry and regulatory authorities, on regulatory approaches that can be taken for assessment and approval of bacteriophages to be used as plant protection products. Bacteriophages (or phages) are a group of microorganisms that are viruses specifically infective to bacteria, which can be considered a niche use.
This document provides guidance for the methods to address dissolution rate and dispersion stability for nanomaterials with focus on environmental aqueous media. The definition of nanomaterials as having one dimension between 1 and 100 nm is generally accepted. The guidance provided here is relevant for solids in the nanoscale as well as their aggregates and agglomerates and it focuses on their fate and behaviour in aqueous media. In particular it presents the influence of various experimental conditions on the performance and outcomes of the discussed methods. In addition, this GD addresses modifications or additions to the methods and aims to give support for the interpretation of the test results.
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). However, there is a need for a systematic framework to characterise the individual biological and toxicological relevance of alternative methods in assessing chemicals in predicting toxicological endpoints. This framework could also inform their potential use in combination with other tools and methods to benefit from an integrated approach by applying mechanistic knowledge and understanding. This document outlines an approach for the use of the AOP concept in developing IATA. It builds upon the workshop held in 2014 on a framework for the development and use of IATA and experience to date with the development of IATA.
The Adverse Outcome Pathway (AOP) framework has been developed to facilitate the collection of mechanistic information derived from toxicological science in a structured manner, to assist in establishing causal relationships between molecular and cellular events that lead from stressor perturbation of the biology to adverse effects, and to identify critical data gaps in the understanding of those pathways. The objective of the present document is to provide guidance on the quality standards required for the scientific review of an AOP on the AOP-Wiki. It defines the core principles associated with AOP scientific review in order to enable consistent scientific reviews to be conducted, regardless of who is doing the review, and thus will facilitate OECD endorsement.
This Guidance Document provides information for both the regulated community and regulators to assist with the choice of the most appropriate Guideline to enable particular data requirements to be met while reducing the number of animals used and animal suffering.
The goals of this document are to provide guidance on the collection of morphologic data and preparation of thyroid tissues, from Xenopus laevis, for histopathological analysis to fulfill the needs of the Amphibian Metamorphosis Assay. This document draws from the guidance developed for the “Histopathology guidelines for Phase 1B of the OECD Fish Screening Assay for EDC’s” and the guidance given in the general protocol for the Phase 2 Amphibian Metamorphosis Assay. The recommended procedures were derived from pathologists experienced with preparing and analyzing thyroid tissues of Xenopus laevis, from previous documents relating to histotechniques associated with preparing amphibian tissues, and from the scientific literature. The procedures are to guide the handling of animals and preparation of tissues for thyroid histology. These methods may not apply to studies that involve other amphibian species, at earlier or later life stages, under alternate treatment durations, or for different desired endpoints.
This document provides the second edition of Guidance Document 23 on Aqueous-Phase Aquatic Toxicity Testing of Difficult Test Chemicals.
Whilst this guidance is targeted towards tests described by the OECD Test Guidelines identified it may also be relevant to other tests. The guidance relates to the practical aspects of carrying out valid tests with “difficult” test chemicals and mixtures and presenting the results. The guidance is considered to reflect good practice but it is important to recognise that some test chemicals and mixtures will present specific scientific and technical issues that may fall outside its scope. This document is divided into five substantive sections covering guidance for carrying out a preliminary assessment of test chemical stability; general considerations on selection of exposure systems; stock and test solution preparation and exposure systems; sampling of test solution for analysis; and calculating and reporting test results.
This document provides guidance for the testing of substances, and mixtures, classed as “difficult to test” for the purposes of determining their aquatic toxicity. Whilst the guidance given is targeted towards tests described by the OECD Guidelines identified it may also be relevant to other tests. The guidance relates to the practical aspects of carrying out valid tests with “difficult” test substances and mixtures and presenting the results. The guidance is considered to reflect good practice but it is important to recognise that some test substances and mixtures will present specific scientific and technical issues that may fall outside its scope. This document is divided into five substantive sections covering guidance for carrying out a preliminary assessment of test substance stability; general considerations on selection of exposure regimes; development of media preparation and exposure systems; sampling of test media for analysis, and calculating and reporting test results.
This document provides guidance for aquatic (including sediment) ecotoxicity testing of Manufactured Nanomaterials (MNs) to determine their hazard. The definition of MNs as having one dimension between 1 and 100 nm is generally adopted. However, the guidance provided here should also be relevant for colloidal (nano) particles (e.g., 1 to 1000 nm) with primary or aggregate/agglomerate sizes greater than the range for MNs. The guidance focuses on freshwater aquatic and sediment toxicity test methods described by the OECD Test Guidelines. More specifically, this guidance document addresses practical aspects of carrying out valid tests with MNs including interpreting and reporting the results, and addresses the specific issues. It also addresses modifications or additions to OECD TG procedures intended to incrementally improve the accuracy, intra-laboratory repeatability, inter-laboratory reproducibility and intra-laboratory reproducibility of test results. While the focus was specifically on adapting the OECD TGs for reliable MNs testing, the methods and principles discussed herein are likely more widely applicable to aquatic toxicity test methods published by other organisations.
This Guidance Document addresses aspects of OECD Test Guideline 305 (TG 305) on Fish Bioaccumulation. Following major revisions to TG 305 in 2012, it became clear that separate and detailed guidance was necessary to address complex areas of fish bioaccumulation testing, data treatment and interpretation. The aim of this document is to give guidance to the experimenter and user of the bioconcentration or bioaccumulation data on how to perform the test, calculate the results and interpret them. This guidance document should be seen as an explanation to the revised OECD TG 305, not as a substitute for it.
This document provides guidance on conducting laboratory tests to determine and assess the efficacy of test substances and/or the effectiveness of test products used as baits for the control of cockroach species in indoor environments. It is based upon a German guideline (Federal Environment Agency 2001) and incorporates information from the American Product Performance Guidelines 810-3500 (US EPA 1998). For the the scientific evaluation of the efficacy of a bait product and of validity of the test results, a minimum of three repetitions of the assay at different times (considering the claimed application conditions) and with different batches of test animals should be conducted.
This document provides guidance to both industry and regulatory authorities on how procedures and data requirements can be applied to facilitate the submission of a complete data package/dossier for botanical active substances used in plant protection products, and the subsequent evaluation of this data package/dossier by the regulatory authorities. The document additionally provides a summary of the legal frameworks and registration procedures for botanical active substances as plant protection products in several OECD member countries.
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.
Crop Field Trials (also referred to as supervised field trials) are conducted to determine the magnitude of the pesticide residue in or on raw agricultural commodities, including feed items, and should be designed to reflect pesticide use patterns that lead to the highest possible residues. While the OECD Guideline for the Testing of Chemicals on Crop Field Trial (TG 509 published in September 2009) provides a harmonised approach to conducting and reporting crop field trials in OECD countries, this Guidance Document on Crop Field Trials will help in planning the trials in OECD countries and in interpreting the results.
This document provides additional detailed guidance on crop field trials conducted according to OECD TG 509 (Testing of Chemicals on Crop Field Trial) and helps in planning the trials and in interpreting the results. The publication is organised in two parts: the core document on guidance for conducting crop field trials and the three Annexes containing additional information.
The OECD Secretariat received almost simultaneously three proposals for an OECD Test Guideline on Direct Phototransformation in Water, i.e. aqueous photolysis. The purpose of this Guidance Document is to situate these proposals in a broad context consisting of the basic concepts of photochemistry applicable to aqueous photolysis, the existing national guidelines and standards, and the results of a ring test held under the aegis of ECETOC.
This document provides information on key elements of a PRTR to national governments that are designing new PRTRs or considering revising an existing PRTR and describes considerations for developing PRTR systems whose data are compatible and can be integrated with data from other PRTRs for global scale analysis. For each element, this document compares how existing PRTRs have been designed, presents recommendations from the OECD Council on Implementing PRTRs, and provides options for designing a PRTR that 1) meets the needs of the country implementing the PRTR, and 2) collects data that are harmonised with data from existing PRTRs where possible. This document is also useful for users of PRTR data, particularly those who use PRTR data from different PRTRs. Those who plan to examine different PRTR data can consider the points raised in this document. In this document the terms “harmonise” and “harmonisation” means to make compatible, miscible or combinable. Similarly, the term “harmonised” means to be compatible, miscible, combinable, or combined (integrated).
This document provides information on key elements of a PRTR to national governments that are designing new PRTRs or considering revising an existing PRTR and describes considerations for developing PRTR systems whose data are compatible and can be integrated with data from other PRTRs for global scale analysis. For each element, this document presents recommendations from the OECD Council on Implementing PRTRs, and provides options for implementing a PRTR that 1) meets the needs of the country implementing the PRTR, and 2) collects data that are harmonised with data from existing PRTRs where possible. This document is also useful for users of PRTR data, particularly those who use PRTR data from different PRTRs. Those who plan to examine different PRTR data can consider the points raised in this document.
This Guidance Document intends to provide an introduction to Emission Scenario Documents (ESDs) and thereby, to facilitate their development and use in Member countries and at the OECD level. It is also expected that this Guidance Document could contribute to the increase of consistency of emission scenario documents at various levels (e.g., national, regional, international).