{"title":"Extended One-Generation Reproductive Toxicity Study (EOGRTS) (OECD TG 443)","authors":"","doi":"10.1787/9789264304741-34-en","DOIUrl":"https://doi.org/10.1787/9789264304741-34-en","url":null,"abstract":"","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85914251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Uterotrophic Bioassay in Rodents (UT assay) (OECD TG 440) (including OECD GD 71 on the procedure to test for anti-estrogenicity)","authors":"","doi":"10.1787/9789264304741-20-en","DOIUrl":"https://doi.org/10.1787/9789264304741-20-en","url":null,"abstract":"650. This assay is a short-term in vivo screening assay in female rodents for chemicals that interact with the estrogen receptor (ER). It is based on the increase in uterine weight (or uterotrophic response) that is elicited by ER agonists in animal models where endogenous estrogen levels are minimal. There are two variants of the assay; one uses immature animals, the other uses ovariectomised animals. The immature rodent assay may detect modalities acting via mechanisms other than ER, as the animals have an intact hypothalamic/pituitary/gonadal (HPG) axis, but the ability to detect these is limited. The assay may be conducted using rats or mice, but the there is more experience with the rat assay and this species was used in the OECD validation of this assay (OECD, 2006). Route of administration of test substance is via oral gavage or subcutaneous injection. This assay has been considered to be the “gold standard” bioassay screen for identifying ER agonists. A recently curated database of bioactivity with results from over 2 500 Uterotrophic Bioassays in rats and mice provides comprehensive information on this assay (Kleinstreuer et al., 2016).","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"50 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85126411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Fish, Early-Life Stage (FELS) Toxicity Test (OECD TG 210)","authors":"Tg","doi":"10.1787/9789264304741-13-en","DOIUrl":"https://doi.org/10.1787/9789264304741-13-en","url":null,"abstract":"391. This test is widely used as a sub-chronic assay for non-endocrine disrupting (ED) chemicals, and can be used to predict concentrations causing chronic effects on growth and reproduction in fish. It was developed before concerns about endocrine disrupting chemicals (EDCs) arose and cannot be used to identify these chemicals. It exposes fish from immediately post-fertilisation to the larval free-feeding stage (28-60 days post-hatch [dph], depending on species). Permitted species include rainbow trout (Oncorhynchus mykiss), fathead minnow (Pimephales promelas), zebrafish (Danio rerio), medaka (Oryzias latipes), sheepshead minnow (Cyprinodon variegatus) and silverside (Menidia sp.). The main endpoints include mortality, time to hatching, hatching success, growth, morphological abnormalities and abnormal behaviour.","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"23 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91089433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Two-Generation Reproduction Toxicity Study (OECD TG 416)","authors":"Tg","doi":"10.1787/9789264304741-33-en","DOIUrl":"https://doi.org/10.1787/9789264304741-33-en","url":null,"abstract":"942. The OECD Two-Generation Reproduction Toxicity Study is an apical assay designed to provide general information concerning the effects of a chemical on the male and female reproductive systems including gonadal function, the estrus cycle, mating, conception, gestation, parturition, lactation, weaning, and growth and development of the offspring. The rat is the preferred species. The recommended route of administration is oral, via the diet, by gavage or in drinking water. The study is not specifically designed to detect endocrine active substances (EASs), but has many endpoints relevant for the assessment of possible endocrine disruption and provides data on adverse effects related to reproduction and development. OECD TG 416 was revised in January 2001 to include a more comprehensive range of endpoints. These endpoints include sexual maturation (VO and PPS) which are particularly sensitive to EASs. One-generation studies and two-generation studies conducted prior to the adoption of the revised OECD TG 416 are therefore unlikely to provide as much data as studies conducted to the revised OECD TG 416, particularly with respect to endocrine disruption. They do, however, provide a great deal of useful data, particularly on adverse effects on reproduction, that may be sufficient for hazard assessment purposes even if the etiology of the effect(s) is not fully characterised.","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82344701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Repeated Dose 28-Day Oral Toxicity Study in Rodents (OECD TG 407)","authors":"","doi":"10.1787/9789264304741-22-en","DOIUrl":"https://doi.org/10.1787/9789264304741-22-en","url":null,"abstract":"","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"109 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78103148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"General Guidance on Endocrine Assessment: Assays and Endpoints","authors":"","doi":"10.1787/9789264304741-2-en","DOIUrl":"https://doi.org/10.1787/9789264304741-2-en","url":null,"abstract":"33. The purpose of this section is to provide background information on the relevance of various types of data for supporting decisions about the endocrine disrupting properties of chemicals and other test materials (e.g. effluents, natural waters, contaminated foods, etc.) in humans and non-mammalian vertebrates. Interpretation of results from some invertebrate test guidelines is also included, but due to the rather poor current understanding of endocrinology in most invertebrates, and the lack of diagnostic screening endpoints with these taxonomic groups (e.g. OECD [2010c]), guidance cannot yet be given for many of these assays. Nevertheless, non-OECD test assays, including those utilising invertebrate species, may provide information that can be used in a weight of evidence (WOE) approach. Furthermore, the document only deals with estrogen-, androgenand thyroidmediated endocrine disruption, and with interference with steroidogenesis (although some guidance is also provided for evaluation of juvenile hormone, ecdysteroid and retinoid activity). It does not cover other possible types of endocrine disruption, such as effects on the hypothalamus-pituitary-adrenal axis or other receptor pathways. Some advice on the endocrine control of neural development is provided, but this is only rudimentary. The section is organised according to the OECD Conceptual Framework (CF) (see Section A.2), as updated in 2017 with tests which were unavailable or not included when it was first proposed.","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89986163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Avian Reproduction Test (OECD TG 206)","authors":"","doi":"10.1787/9789264304741-16-en","DOIUrl":"https://doi.org/10.1787/9789264304741-16-en","url":null,"abstract":"","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"271 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83512459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Amphibian Metamorphosis Assay (AMA) (OECD TG 231)","authors":"Tg","doi":"10.1787/9789264304741-8-en","DOIUrl":"https://doi.org/10.1787/9789264304741-8-en","url":null,"abstract":"311. Modality detected/endpoints: thyroid activity (advanced development; asynchronous development; delayed development in absence of non-specific systemic toxicity; thyroid histopathology), but note that this covers several different modes of action (MOA), including thyroid agonists and antagonists, as well as substances interfering with thyroid hormone synthesis and transport. According to OECD TG 231, there is disagreement about the implications of the different endpoints in this larval development screen. Some experts accept that changes in one of the thyroid-relevant apical endpoints (advanced development; asynchronous development; delayed development in absence of non-specific systemic toxicity) may on their own provide information on thyroid activity, while others will only reach this conclusion if one of the apical endpoints is accompanied by significant thyroid histopathology, such as moderate or severe follicular hypertrophy and/or hyperplasia (OECD, 2007). Note that the AMA is subject to indirect thyroid effects such as those that result from cytochrome P450 induction (e.g. phenobarbital, the model compound for the latter effect, tests positive in the AMA). Therefore, interpretation of the AMA may be complicated.","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"157 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77634380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Fish Sexual Development Test (FSDT) (OECD TG 234)","authors":"Tg","doi":"10.1787/9789264304741-14-en","DOIUrl":"https://doi.org/10.1787/9789264304741-14-en","url":null,"abstract":"406. Modality detected/endpoints: estrogens (♀ and ♂ VTG ↑; phenotypic sex ratio ♀↑); anti-estrogens (♀ VTG ↓; phenotypic sex ratio ♂↑; sexually undifferentiated fish ↑); androgens (phenotypic sex ratio ♂↑; ♀ VTG ↓); anti-androgens (intersex fish ↑; ♀ VTG ↑; phenotypic sex ratio ♀↑); aromatase inhibitors (♀ VTG ↓; phenotypic sex ratio ♂↑); (optional endpoints – gonadal histopathology; genetic sex in medaka and stickleback). OECD TG 234 (FSDT) has been fully validated for Japanese medaka, zebrafish and stickleback. The test may also be responsive to certain thyroid-disrupting chemicals. It is known that thyroid hormone receptors TRα and TRβ are both present in fish early embryos and larvae (Power et al., 2001), and that maternally derived thyroxine (T4) is important for thyroiddependent processes in fish early life stages (Nelson et al., 2014). One of these processes is swimbladder inflation, an endpoint which could be recorded in the FSDT test, and which is vital for the survival of fish fry. It has been shown, for example, that fathead minnow embryos exposed to a thyroid peroxidase (TPO) inhibitor (2-mercaptobenzothiazole) do not develop inflated swimbladders, probably because inhibition of TPO leads to decreased thyroid hormone synthesis (Villeneuve et al., 2013; Nelson et al., 2014). Also, Liu and Chan (2002) have shown that metamorphosis from embryo to larva in zebrafish is arrested by exposure to amiodarone (a TR antagonist) and by the goitrogen methimazole. Furthermore, Shi et al. (2008) demonstrated that the thyroid disrupter perfluorooctanesulfonic acid (PFOS) is able to delay hatching and cause developmental malformations in zebrafish embryos while upregulating two thyroid-related developmental genes, hhex and pax8. However, it is important to note that many non-ED chemicals will also cause these types of apical response, but by different mechanisms.","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76370060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}