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This document addresses considerations in the safety assessment of GM foodstuffs, including the fate of DNA and protein in animal feeding, animal feeding studies, and future GM feedstuffs. There is also background material on the various organisms and traits constituting GM plants used as animal feeds.
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This consensus document addresses compositional considerations for new varieties of tomato by identifying the key food and feed nutrients, toxicants and allergens. A general description of these components is provided. As well, there is background material on the production, processing and uses of tomato and considerations to be taken when assessing new tomato varieties. Constituents to be analysed, related to food use and to feed
The OECD biosafety consensus documents identify elements of scientific information used in the environmental safety and risk assessment of transgenic organisms which are common to OECD member countries.&a
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This brochure describes the OECD Database on Research into the Safety of Manufactured Nanomaterials and how users can access, search and contribute to it.
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The purpose of this Emission Scenario Document (ESD) is to provide realistic worst-case emission estimates for chemicals used in the electronics industry.
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The purpose of this Emission Scenario Docuemtn (ESD) is to provide realistic worst-case emission estimates for fragrance oils blended into commercial and consumer products.
Ten new and updated Test Guidelines have been adopted by Council on 22 July 2010
This Test Guideline describes an in vitro procedure that may be used for the hazard identification of irritant chemicals (substances and mixtures) in accordance with the UN Globally Harmonized System of Classification and Labelling (GHS) Category 2. It is based on reconstructed human epidermis (RhE), which in its overall design closely mimics the biochemical and physiological properties of the upper parts of the human skin. Cell viability is measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that is quantitatively measured after extraction from tissues. Irritant test substances are identified by their ability to decrease cell viability below defined threshold levels (below or equal to 50% for UN GHS Category 2). This Test Guideline also includes a set of Performance Standards for the assessment of similar and modified RhE-based test methods. There are three validated test methods that adhere to this Test Guideline. Depending on the regulatory framework and the classification system in use, this procedure may be used to determine the skin irritancy of test substances as a stand-alone replacement test for in vivo skin irritation testing, or as a partial replacement test, within a tiered testing strategy.
The Local Lymph Node Assay: BrdU-ELISA (LLNA:BrdU-ELISA) is a non-radioactive modification to the LLNA method for identifying potential skin sensitizing test substances and measuring the proliferation of lymphocytes they induce in the auricular lymph nodes. The method described in mouse (CBA/JN strain) is based on the use of measuring 5-bromo-2-deoxyuridine (BrdU) content, an analogue of thymidine, as an indicator of this proliferation. A minimum of four animals is used per dose group, with a minimum of three concentrations of the test substance, plus a concurrent negative control group and a positive control group. The experimental schedule is during 6 days. Thereafter, the animals are killed and a single cell suspension of lymph node cells (LNC) is prepared. The procedure for preparing the LNC is crucial, in particular for the small lymph nodes in NC animals. Then the BrdU content in DNA of lymphocytes is measured by ELISA using a commercial kit. This study includes: measurements (weighing, BrdU) and clinical daily observations. The results are expressed as the Stimulation Index (SI) obtained by calculation from the mean BrdU labelling index. The SI should be ¡Ý1.6 before further evaluation of the test material as a potential skin sensitizer is warranted.
This Guideline is designed to assess the effects of prolonged exposure of chemicals to the life-cycle of the sediment-dwelling freshwater dipteran Chironomus sp. First instar chironomid larvae are exposed to five concentrations of the test chemical in sediment-water systems. The test substance is spiked into the water or alternatively the sediment, and first instar larvae are subsequently introduced into test beakers in which the sediment and water concentrations have been stabilised. Chironomid emergence, time to emergence, and sex ratio of the fully emerged and alive midges are assessed. Emerged adults are transferred to breeding cages, to facilitate swarming, mating and oviposition. The number of egg ropes produced and their fertility are assessed. From these egg ropes, first instar larvae of the 2nd generation are obtained. These larvae are placed into freshly prepared test beakers (spiking procedure as for the 1st generation) to determine the viability of the 2nd generation through an assessment of their emergence, time to emergence and the sex ratio of the fully emerged and alive midges. All data are analysed either by a regression model to estimate the concentration that would cause X% reduction in the relevant endpoint, or by using hypothesis testing to determine a No Observed Effect Concentration (NOEC).