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Good Cell Culture Practice (GCCP) 良好细胞培养规范(GCCP)
Pub Date : 2018-12-14 DOI: 10.1787/9789264304796-16-en
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引用次数: 0
Performance of the method 方法性能
Pub Date : 2018-12-14 DOI: 10.1787/9789264304796-13-en
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引用次数: 0
Guidance Document on Good In Vitro Method Practices (GIVIMP) 良好体外方法规范指导文件(GIVIMP)
Pub Date : 2018-12-10 DOI: 10.1787/9789264304796-en
Emma Pedersen, Kristina Fant
Guidance Document on Good In Vitro Method Practices (GIVIMP) : Series on Testing and Assessment No. 286
良好体外方法规范指导文件(GIVIMP):测试和评估系列第286号
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引用次数: 105
Annexes 附件
Pub Date : 2018-12-10 DOI: 10.1787/g2836fccb6-en
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引用次数: 0
Considerations for Assessing the Risks of Combined Exposure to Multiple Chemicals 评估多重化学品联合暴露风险的考虑
Pub Date : 2018-12-06 DOI: 10.1787/ceca15a9-en
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引用次数: 58
Developmental Neurotoxicity Study (OECD TG 426) 发育神经毒性研究(OECD TG 426)
Pub Date : 2018-09-03 DOI: 10.1787/9789264304741-27-en
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引用次数: 1
Larval Amphibian Growth and Development Assay (LAGDA) (OECD TG 241) 两栖动物幼虫生长发育测定(LAGDA) (OECD TG 241)
Pub Date : 2018-09-03 DOI: 10.1787/9789264304741-15-en
Tg
422. Modality detected/endpoints: OECD TG 241 has three endpoints indicating generalised toxicity (mortality, abnormal behaviour and growth), and several providing specific information about endocrine disruption or impaired reproduction (histopathology of thyroid, gonads, kidney and liver, time to metamorphosis [NF stage 62]; secondary sex characteristics (nuptial pads); vitellogenin (optional); genetic and phenotypic sex ratio). Most of these specific endocrine endpoints are likely to respond to interference with the hypothalamic/pituitary/gonadal (HPG) axis, while thyroid histopathology and time to metamorphosis may respond to interference with the hypothalamic/pituitary/thyroid axis (as may the “generalised toxicity” indicator, growth).
422. 检测到的模式/终点:OECD TG 241有三个终点表明一般毒性(死亡率、异常行为和生长),还有几个终点提供有关内分泌干扰或生殖受损的具体信息(甲状腺、性腺、肾脏和肝脏的组织病理学,变态时间[NF 62期];第二性征(婚垫);卵黄蛋白原(可选);遗传和表型性别比)。大多数这些特定的内分泌终点可能对下丘脑/垂体/性腺(HPG)轴的干扰有反应,而甲状腺组织病理学和变态时间可能对下丘脑/垂体/甲状腺轴的干扰有反应(“一般毒性”指标,生长也是如此)。
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引用次数: 2
OECD in vitro screens (Conceptual Framework Level 2) OECD体外筛选(概念框架2级)
Pub Date : 2018-09-03 DOI: 10.1787/9789264304741-4-en
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引用次数: 1
Combined Chronic Toxicity/Carcinogenicity Studies (OECD TG 451-3) 慢性毒性/致癌性联合研究(OECD TG 451-3)
Pub Date : 2018-09-03 DOI: 10.1787/9789264304741-24-en
Tg
745. These assays determine the general toxicity (OECD TG 452 and TG 453) and carcinogenicity (OECD TG 451 and TG 453) of chemicals in laboratory animals after exposure for a period lasting most of the lifespan. Route of administration may be oral, dermal or inhalation, although oral via diet is the most common. OECD TG 453 was revised in September 2009 and replaced OECD TG 451 (older studies may have used OECD TG 451). General toxicity studies usually have a duration of 12 months whilst carcinogenicity studies usually have a duration of 18 or 24 months depending on the species tested. They provide information on major toxic effects, target organ toxicity and carcinogenicity. Although they have not been validated for the detection of endocrine disruptors (EDs), they contain many endpoints that are suitable for the determination of endocrine effects. Organ weights are not always included in the carcinogenicity phases of these studies as neoplastic changes may confound them, but they are generally determined at 12 months. A comparison can be made with validation of the OECD TG 407 (28-Day Oral Toxicity Study) for endocrine endpoints (OECD, 2006) where substances that were moderate and strong EDs for (anti)estrogenicity and (anti)androgenicity (e.g. ethinylestradiol and flutamide) and weak and strong modulators of thyroid hormone-related effects (e.g. propylthiouracil, T4 and methyl testosterone) were detected. Steroidogenesis inhibition was also detected although only one (potent) chemical was used in the validation study (CGS 18320B). OECD TG 453 and TG 452 are likely to be more sensitive than OECD TG 407 because of the extended dosing period and the larger number of animals per group (20 or 50 rodents per sex per group for chronic or carcinogenicity studies respectively compared with 5 in OECD TG 407). OECD TG 453 and TG 452, however, do not contain some sensitive endpoints (e.g. thyroid hormones, estrous cyclicity) that may be included in OECD TG 407.
745. 这些试验确定了化学物质在实验动物的大部分生命周期内暴露后的一般毒性(OECD TG 452和TG 453)和致癌性(OECD TG 451和TG 453)。给药途径可能是口服、皮肤或吸入,但最常见的是通过饮食口服。OECD TG 453于2009年9月修订,取代OECD TG 451(较早的研究可能使用OECD TG 451)。一般毒性研究通常需要12个月的时间,而致癌性研究通常需要18或24个月的时间,这取决于测试的物种。它们提供了关于主要毒性作用、靶器官毒性和致癌性的信息。虽然它们尚未被验证用于检测内分泌干扰物(EDs),但它们包含许多适合测定内分泌影响的终点。器官重量并不总是包括在这些研究的致癌性阶段,因为肿瘤改变可能会混淆它们,但它们通常在12个月时确定。可以与经合组织tg407(28天口服毒性研究)对内分泌终点的验证进行比较(经合组织,2006年),其中检测到具有(抗)雌激素性和(抗)雄激素性的中度和强ed物质(如炔雌醇和氟他胺)以及甲状腺激素相关作用的弱和强调节剂(如丙硫脲嘧啶、T4和甲基睾酮)。虽然在验证研究中只使用了一种(有效的)化学物质(CGS 18320B),但也检测到类固醇生成抑制作用。经合组织TG 453和TG 452可能比经合组织TG 407更敏感,因为给药期更长,每组动物数量更多(在慢性或致癌性研究中,每组每性别20或50只啮齿动物,而经合组织TG 407为5只)。然而,经合组织TG 453和TG 452不包含经合组织TG 407中可能包含的一些敏感终点(如甲状腺激素、发情周期)。
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引用次数: 1
21-Day Fish Assay (OECD TG 230) 21天鱼类化验(OECD TG 230)
Pub Date : 2018-09-03 DOI: 10.1787/9789264304741-7-en
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引用次数: 0
期刊
OECD Series on Testing and Assessment
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