Abstract：
:The conventional method for the assessment of acute inhalation toxicity (OECD Test Guideline 403, 1981) uses death of animals as an endpoint to identify the median lethal concentration (LC50). A new OECD Testing Guideline called the Fixed Concentration Procedure (FCP) is being prepared to provide an alternative to Test Guideline 403. Unlike Test Guideline 403, the FCP does not provide a point estimate of the LC50 but aims to identify an airborne exposure level that causes clear signs of nonlethal toxicity. This is then used to assign classification according to the new Globally Harmonized System of Classification and Labelling scheme (GHS). The FCP has been validated using statistical simulation rather than by in vivo testing. The statistical simulation approach predicts the GHS classification outcome and the numbers of deaths and animals used in the test for imaginary substances with a range of LC50 values and dose-response curve slopes. This paper describes the FCP and reports the results from the statistical simulation study assessing its properties. It is shown that the procedure will be completed with considerably less death and suffering than Test Guideline 403, and will classify substances either in the same or a more stringent GHS class than that assigned on the basis of the LC50 value.
journal_name
Hum Exp Toxicoljournal_title
Human & experimental toxicologyauthors
Stallard N,Whitehead A,Indans Idoi
10.1191/0960327103ht395oasubject
Has Abstractpub_date
2003-11-01 00:00:00pages
575-85issue
11eissn
0960-3271issn
1477-0903journal_volume
22pub_type
杂志文章abstract：:Omeprazole is one of the most used acid-suppressing medications. This fact emphasizes the questions concerning the safety of this compound. Healthy volunteers (n=33) were included in this prospective study. All study subjects were analysed for their CYP2C19 genotype. Of the 33 individuals, 24 were homozygous for the w...
journal_title：Human & experimental toxicology
pub_type： 临床试验,杂志文章
doi：10.1191/0960327104ht431oa
更新日期：2004-03-01 00:00:00
abstract：OBJECTIVES:The aim of this study was to evaluate, the cytotoxicity of orthodontic composites in vitro as a function of degree of conversion (DC) and the light curing units (LCU) employed on mouse fibroblast (L929). MATERIALS AND METHODS:Cured samples of the composites Light bond (Reliance Orthodontic Products, Itasca,...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327113520020
更新日期：2014-10-01 00:00:00
abstract：:Enterococcus faecalis is a facultative anaerobic gram-positive commensal bacterium common in the gastrointestinal tract of animals and humans. This study aimed to investigate the protective effects of heat-killed E. faecalis EF-2001 (EF-2001) on acute gastric ulcer using a murine model of ethanol (EtOH)-induced acute ...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327119899987
更新日期：2020-05-01 00:00:00
abstract：:Lead exposure was assessed in a random cohort of 70 male papier mâché workers and compared with 35 age and sex matched controls. Blood-lead levels in workers were significantly higher than in controls (Mean 68.07 +/- 44.64 ug/dl vs 25.52 +/- 16.56 ug/dl respectively; P < 0.001). Urinary lead was also higher in workers...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/096032719701600510
更新日期：1997-05-01 00:00:00
abstract：:The aim of this study was to determine the safety of azelaic acid (AA) and its derivatives in nanovesicles for pharmaceutical and cosmetic uses. The hydrophilic property of AA was modified by complexing AA with hydroxypropyl-beta-cyclodextrin (AACD). The lipophilic property of AA was improved to diethyl azelate (DA) b...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327109105164
更新日期：2009-06-01 00:00:00
abstract：:The National Toxicology Program (NTP) Technical Reports online database was reviewed to find chemicals that were reported to show clear evidence of carcinogenicity in the NTP rodent studies and for which data on human exposure could be found. Six representative compounds were selected. Three volatile compounds: ethyl ...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1191/0960327103ht374oa
更新日期：2003-09-01 00:00:00
abstract：:Personal reflections on radiation hormesis for the past 50 years are presented. The causes of ignoring and rejections of this phenomenon by international and national bodies and by radiation protection establishment are analyzed. The opposition against nuclear weapons and preparations for nuclear war was probably the ...
journal_title：Human & experimental toxicology
pub_type： 历史文章,杂志文章,评审
doi：10.1177/0960327110363974
更新日期：2010-04-01 00:00:00
abstract：:The purpose of the present study is to establish a new animal model of azithromycin (AZ)-induced liver injury and study the molecular pathological change during the process. First, mice were respectively injected intraperitoneally with AZ of different high doses. Our results showed that 800 mg/kg AZ injection signific...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327115595684
更新日期：2016-05-01 00:00:00
abstract：:1. A modified mouse liver slice culture technique was established and the viability of the system was assessed on the basis of leakage of cytosolic enzymes viz. lactate dehydrogenase (LDH), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartic aminotransferase (AST) and slice histology. 2. This system w...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/096032719601500202
更新日期：1996-02-01 00:00:00
abstract：:1. Six healthy male volunteers received intravenous injections of 26Al as citrate. Accelerator mass spectrometry and gamma-ray spectrometry were used to determine levels of the tracer in blood and excreta at times up to 5-6 d. 2. There was a rapid clearance from blood (mean 2% of injection remaining after 1 d) and maj...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/096032719501400707
更新日期：1995-07-01 00:00:00
abstract：:This study evaluated the protective potential of curcumin on the possible side effects of bortezomib (Bt) therapy on normal cells in mice. The mice were segregated into three groups (n = 10) that included normal control, Bt-treated, and Bt + curcumin-treated groups. The Bt treatment resulted in significant decrease in...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327114555928
更新日期：2015-07-01 00:00:00
abstract：:Dermal exposure is an important factor in risk characterization. In occupational settings it becomes relatively more important because of the continuous reduction in inhalation exposure. In the public health arena, dermal exposure may also form a significant contribution to the total exposure. Dermal exposure, however...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327107085830
更新日期：2008-04-01 00:00:00
abstract：:Predictive toxicology plays a critical role in reducing the failure rate of new drugs in pharmaceutical research and development. Despite recent gains in our understanding of drug-induced toxicity, however, it is urgent that the utility and limitations of our current predictive tools be determined in order to identify...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327115605440
更新日期：2015-12-01 00:00:00
abstract：:Serrapeptase (SP) and nattokinase (NK) are proteolytic enzymes belonging to serine proteases. In this study, we hypothesized that SP and NK could modulate certain factors that are associated with Alzheimer's disease (AD) pathophysiology in the experimental model. Oral administration of aluminium chloride (AlCl3) in a ...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327112467040
更新日期：2013-07-01 00:00:00
abstract：:Phosphorus flame retardants are a group of chemicals that are used to slow or prevent the spread of fire. These compounds have been detected in different environments including human organism. In the present study, we have investigated DNA-damaging potential and effect on DNA methylation of tris(2-chloroethyl) phospha...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327119839174
更新日期：2019-06-01 00:00:00
abstract：:The effects of low lead exposure were investigated in 96 children (7-12 years old) living and studying within a 1 km radius of a lead smelter (exposed population) located in Torreón, Coahuila, México, and compared with 30 children living and studying 4.5 km from the same smelter (control population). Both populations ...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/096032719601500406
更新日期：1996-04-01 00:00:00
abstract：:Vigabatrin (VGB) is an antiepileptic drug thatincreases brain γ-aminobutyric acid (GABA) levels through irreversible inhibition of GABA transaminase. The aim of this study was to evaluate neurotoxicological effects of VGB measuring motor activity and genotoxic and mutagenic effects after a single and repeated administ...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327115611970
更新日期：2016-09-01 00:00:00
abstract：:The benefits and costs are discussed for the possibility of using pups generated in breeding studies for additional assessments, such as evaluating immunotoxicity. Such an approach is logistically challenging, but not overwhelming. ...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1191/0960327102ht291oa
更新日期：2002-09-01 00:00:00
abstract：:Silver nanoparticles are used in many commercial products in daily life. Exposure to nanosilver has hepatotoxic effects in animals. This study investigated the cytotoxicity associated with polyvinylpyrrolidone-coated nanosilver (23.44 ± 4.92 nm in diameter) exposure in the human hepatoma cell line (HepG2) and normal h...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327118769718
更新日期：2018-12-01 00:00:00
abstract：:Acute and chronic arsenic exposure result in toxicity both in human and animal beings and cause many hepatic and renal manifestations. The present study stated that mushroom lectin prevents arsenic-induced apoptosis. Apoptosis was measured by morphological alterations, cell proliferation index (CPI), phagocytic activi...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327110372642
更新日期：2011-04-01 00:00:00
abstract：:In this study, we aimed to investigate disulfide/thiol homeostasis in trichloroethylene (TCE) exposure. The study was carried out in 30 nonsmoker TCE-exposed workers with a variety of occupations. Additionally, 30 healthy nonsmoker volunteers were recruited as the control group. TCE exposure was determined by measurin...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327115608928
更新日期：2016-09-01 00:00:00
abstract：:Inhalation of zinc fumes may lead to the acute respiratory distress syndrome. The mechanisms of pulmonary zinc toxicity are not yet understood. Therefore we investigated zinc-dependent depression of protein and RNA synthesis in rat and human lung cell lines. 1. After exposure to 120 or 150 micromol/l zinc, RNA synthes...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/096032719801701203
更新日期：1998-12-01 00:00:00
abstract：INTRODUCTION:Poisoning from organophosphates and carbamates is a significant cause of morbidity and mortality worldwide. Concerns have been expressed over the safety and efficacy of the use of oximes such as pralidoxime (2-PAM) in patients with carbamate poisoning in general, and more so with carbaryl poisoning specifi...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327107070849
更新日期：2007-02-01 00:00:00
abstract：:Accidental ingestion of electrical batteries occurs commonly in children. This rarely is associated with severe morbidity and mortality. Significant symptoms can arise due to leakage of alkali or heavy metals from the battery after degradation in the gastrointestinal tract. The main heavy metal of concern in electrica...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1191/0960327104ht433oa
更新日期：2004-04-01 00:00:00
abstract：:In vivo antidotal efficacy of new bis- quaternary 2-(hydroxyimino)- N-(pyridin-3yl) acetamide derivatives (HNK series), to counter multiples of lethal doses of nerve agent sarin (GB) and reactivation of acetylcholinesterase (AChE), was evaluated in Swiss albino mice. [Protection index PI; median lethal dose (LD50) of ...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327116637109
更新日期：2017-01-01 00:00:00
abstract：:Lipid peroxidation is one of the main manifestations of oxidative damage and has been found to play an important role in the toxicity and carcinogenicity of many xenobiotics. In the present study, we investigated the possible induction of lipid peroxidation by aluminium in human foreskin fibroblast cultures by assayin...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1191/096032701682693053
更新日期：2001-09-01 00:00:00
abstract：:The time-dependent changes in lead (Pb) concentrations in major tissues, serum and urine, and the Pb biomarker delta-aminolevulinic acid (ALA) concentration in urine were studied in rats after sub-chronic Pb exposure. Female Sprague-Dawley (SD) rats were exposed to Pb in drinking water at concentrations of 100 ppm and...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/0960327109107046
更新日期：2009-10-01 00:00:00
abstract：:Sibutramine mesylate is a new anti-obesity drug. It is a crystalline salt of sibutramine developed to improve the solubility of sibutramine hydrochloride. Methanesulfonic acid was used as a salt-forming acid instead of hydrochloric acid, resulting in a greatly improved solubility of 1000 mg/mL in water. Sibutramine me...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1191/0960327105ht510oa
更新日期：2005-03-01 00:00:00
abstract：:The phenomenon of subtoxic stimulation of organism response is not uncommon in aquatic toxicology experiments. We describe the presence of hormesis in both growth and reproduction experiments in aquatic toxicology where these responses are observed in both animals and plants and at different trophic levels of an ecosy...
journal_title：Human & experimental toxicology
pub_type： 杂志文章,评审
doi：10.1177/096032719801700505
更新日期：1998-05-01 00:00:00
abstract：UNLABELLED:A single dose of monocrotaline, a pyrrolizidine alkaloid, was injected into rats in order to produce 25 (Group I) and 45 (Group II) days later a progressive and so called delayed liver injury. The present study investigated the prostanoid production of Kupffer cells and endothelial cells separated from Monoc...
journal_title：Human & experimental toxicology
pub_type： 杂志文章
doi：10.1177/096032719801701007
更新日期：1998-10-01 00:00:00
