Abstract:
:The fixed-dose procedure (FDP) was introduced as OECD Test Guideline 420 in 1992, as an alternative to the conventional median lethal dose (LD50) test for the assessment of acute oral toxicity (OECD Test Guideline 401). The FDP uses fewer animals and causes less suffering than the conventional test, while providing information on the acute toxicity to allow substances to be ranked according to the EU hazard classification system. Recently the FDP has been revised, with the aim of providing further reductions and refinements, and classification according to the criteria of the Globally Harmonized Hazard Classification and Labelling scheme (GHS). This paper describes the revised FDP and analyses its properties, as determined by a statistical modelling approach. The analysis shows that the revised FDP classifies substances for acute oral toxicity generally in the same, or a more stringent, hazard class as that based on the LD50 value, according to either the GHS or the EU classification scheme. The likelihood of achieving the same classification is greatest for substances with a steep dose-response curve and median toxic dose (TD50) close to the LD50. The revised FDP usually requires five or six animals with two or fewer dying as a result of treatment in most cases.
journal_name
Hum Exp Toxicoljournal_title
Human & experimental toxicologyauthors
Stalla N,Whitehead A,Ridgway Pdoi
10.1191/0960327102ht239oasubject
Has Abstractpub_date
2002-04-01 00:00:00pages
183-96issue
4eissn
0960-3271issn
1477-0903journal_volume
21pub_type
杂志文章abstract::1. The effect of pyridostigmine on cardiorespiratory function after oxime + atropine injection was investigated in tabun poisoned guinea-pigs and without tabun poisoning. 2. The trachea, a carotid artery and jugular vein were cannulated in female urethane-anaesthetised Pirbright-white guinea-pigs. After baseline measu...
journal_title:Human & experimental toxicology
pub_type: 杂志文章
doi:10.1177/096032719501400803
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journal_title:Human & experimental toxicology
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doi:10.1177/0960327110382130
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abstract::The color of the teeth is an important topic for many people and can be influenced by intrinsic and extrinsic stains. There is an increasing demand for whitening of the teeth year by year. The most popular way of whitening is "bleaching," which is the result of the breakdown of pigments located in the enamel and/or th...
journal_title:Human & experimental toxicology
pub_type: 临床试验,杂志文章
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abstract::1. The herbicide, paraquat, is accumulated by the energy-dependent polyamine uptake pathway of alveolar type II cells. There it undergoes redox cycling that results in an amplified production of toxic reactive oxygen species and depletion of NADPH and other reducing equivalents. These processes account for the lung be...
journal_title:Human & experimental toxicology
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journal_title:Human & experimental toxicology
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journal_title:Human & experimental toxicology
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pub_type: 历史文章,杂志文章,评审
doi:10.1177/0960327110363974
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journal_title:Human & experimental toxicology
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journal_title:Human & experimental toxicology
pub_type: 杂志文章
doi:10.1177/096032719801701203
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journal_title:Human & experimental toxicology
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doi:10.1177/096032719401300212
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pub_type: 杂志文章
doi:10.1177/096032719101000309
更新日期:1991-05-01 00:00:00
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doi:10.1177/0960327112467040
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journal_title:Human & experimental toxicology
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:Human & experimental toxicology
pub_type: 杂志文章
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journal_title:Human & experimental toxicology
pub_type: 临床试验,杂志文章
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journal_title:Human & experimental toxicology
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journal_title:Human & experimental toxicology
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journal_title:Human & experimental toxicology
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journal_title:Human & experimental toxicology
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更新日期:2011-01-01 00:00:00