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DOI10.1016/j.yrtph.2012.12.006
Performance standards and alternative assays: Practical insights from skin sensitization
Kolle, Susanne N.1; Basketter, David A.2; Casati, Silvia3; Stokes, William S.4; Strickland, Judy5; van Ravenzwaay, Bennard1; Vohr, Hans-Werner6; Landsiedel, Robert1
发表日期2013-03-01
ISSN0273-2300
卷号65期号:2页码:278-285
英文摘要

To encourage the development and validation of alternative toxicity test methods, the effort required for validation of test methods proposed for regulatory purposes should be minimized. Performance standards (PS) facilitate efficient validation by requiring limited testing. Based on the validated method, PS define accuracy and reliability values that must be met by the new similar test method. The OECD adopted internationally harmonized PS for evaluating new endpoint versions of the local lymph node assay (LLNA). However, in the process of evaluating a lymph node cell count alternative (LNCC), simultaneous conduct of the regulatory LLNA showed that this standard test may not always perform in perfect accord with its own PS. The LNCC results were similar to the concurrent LLNA. Discrepancies between PS, LLNA and LNCC were largely associated with "borderline" substances and the variability of both endpoints. Two key lessons were learned: firstly, the understandable focus on substances close to the hazard classification borderline are more likely to emphasise issues of biological variability, which should be taken into account during the evaluation of results; secondly, variability in the results for the standard assay should be considered when selecting reference chemicals for PS. (C) 2013 Elsevier Inc. All rights reserved.


英文关键词Performance standards;Validation;Local lymph node assay;Lymph node cell counts;Skin sensitization;Alternatives
语种英语
WOS记录号WOS:000315429200012
来源期刊REGULATORY TOXICOLOGY AND PHARMACOLOGY
来源机构美国环保署
文献类型期刊论文
条目标识符http://gcip.llas.ac.cn/handle/2XKMVOVA/61429
作者单位1.BASF SE, Expt Toxicol & Ecol, D-67056 Ludwigshafen, Germany;
2.DABMEB Consultancy Ltd, Sharnbrook, Beds, England;
3.EURL ECVAM, JRC, Ispra, Italy;
4.Natl Toxicol Program Interagcy Ctr Evaluat Altern, Natl Inst Environm Hlth Sci, Res Triangle Pk, NC USA;
5.Integrated Lab Syst Inc, Res Triangle Pk, NC USA;
6.Bayer HealthCare, Bayer Pharma, Wuppertal, Germany
推荐引用方式
GB/T 7714
Kolle, Susanne N.,Basketter, David A.,Casati, Silvia,et al. Performance standards and alternative assays: Practical insights from skin sensitization[J]. 美国环保署,2013,65(2):278-285.
APA Kolle, Susanne N..,Basketter, David A..,Casati, Silvia.,Stokes, William S..,Strickland, Judy.,...&Landsiedel, Robert.(2013).Performance standards and alternative assays: Practical insights from skin sensitization.REGULATORY TOXICOLOGY AND PHARMACOLOGY,65(2),278-285.
MLA Kolle, Susanne N.,et al."Performance standards and alternative assays: Practical insights from skin sensitization".REGULATORY TOXICOLOGY AND PHARMACOLOGY 65.2(2013):278-285.
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