Evidence-based Toxicology Collaboration

Last updated

The non-profit Evidence-based Toxicology Collaboration (EBTC) comprises a group of scientists and experts with ties to governmental and non-governmental agencies, chemical and pharmaceutical companies, and academia that have banded together to promote the use of what are known as "evidence-based approaches" in toxicology. [1] The discipline of evidence-based toxicology (EBT) is a process for transparently, consistently, and objectively assessing available scientific evidence in order to answer questions in toxicology. [2] EBT has the potential to address concerns in the toxicological community about the limitations of current approaches. [1] These include concerns related to transparency in decision making, synthesis of different types of evidence, and the assessment of bias and credibility. [3] [4] [5] The evidence-based methods and approaches now being proposed for toxicology are widely used in medicine, which is the basis for their nomenclature. [6] The need to improve how the performance of toxicological test methods is assessed was the main impetus for translating these tools to toxicology. [7]

Contents

Goals and benefits

The EBTC's overall goals are to bring together the international toxicology community to facilitate uses of evidence-based toxicology to inform regulatory, environmental and public health decisions. [8] The group aims for improving the public health outcomes and reduce human impact on the environment by bringing evidence-based approaches to safety sciences [8] The organization's members envision that as these efforts succeed, all interested parties –including stakeholders in government, industry, academia, and the general public –should have confidence and trust in the process by which scientific evidence is assessed when addressing questions related to the safety of chemicals to human health and the environment. [8] All individuals affiliated with the organization are volunteers, except those serving in the organisation's secretariat, which is sponsored by the Johns Hopkins University's Center for Alternatives to Animal Testing (CAAT).

The EBTC's members stress that evidence has always been used in toxicology. [9] The evidence-based approach that the collaboration is championing have been used in medicine for decades. Evidence-based medicine (EBM) is a widely respected discipline and it has strengthened the scientific foundation of decision-making in clinical medicine by providing a structured way of assessing the evidence bearing on healthcare questions.

The EBTC foresees that the evidence-based approach will provide similar benefits to toxicology, especially at a time when remarkable advances in biochemistry and molecular biology are enhancing scientists’ ability to understand the nature and mechanisms of the adverse effects that can be caused by chemicals. [8]

Origins

The EBTC builds upon the outcomes of the First International Forum Toward Evidence-based Toxicology, held in Cernobbio/Como, Italy, on October 15–18, 2007. [10] The forum was motivated by increasing concerns in the scientific community about the limitations of toxicological decision-making.

EBT was next a major topic of discussion at a 2010 workshop held at Johns Hopkins University on 21st century validation for 21st century methods. [11] The enthusiasm for EBT at this workshop inspired the EBTC's formation with an inaugural conference on March 10, 2011, as a satellite to the 50th annual Society of Toxicology meeting in Washington, DC. At the workshop, speakers presented the concept of EBT as it pertains to decision-making about the utility of new toxicity tests and their implementation into the risk assessment process. [12]

Tools

The EBTC is translating the tools used in evidence-based medicine (EBM) to toxicology, as well as developing new approaches to respond to the challenges presented by the discipline of toxicology. [8] The primary tool of EBM is the systematic review, which includes a variety of steps: framing the question to be addressed and deciding how relevant studies will be identified and retrieved; determining which studies will be excluded from the analysis, and how the included studies will be appraised for quality/potential for bias; and how the data will be synthesized across studies (e.g., meta-analysis). [13] Scientists have made progress in their efforts to apply systematic reviews to evaluate the evidence for associations between environmental toxicants and human health risks. To date, researchers have shown that important elements of the systematic review methodology established in evidence-based medicine can be adopted into EBT, and a limited number of such studies have been attempted. [14] [15] [16] EBTC scientists are promoting and conducting systematic reviews of toxicological test methods. [1] [17] [18]

Organization

The EBTC is governed by a board of trustees that has the fundamental responsibilities to provide strategic and fiduciary oversight, and direction. In addition, the Scientific Advisory Council has been established to provide the expertise needed to develop the new EBT methods, to conduct specific projects and to advise the Board and the EBTC Director on new areas of research and other scientific issues of relevance to the broader toxicology community. [8] The organization also has working groups charged with producing guidance documents tailored to toxicology on conducting systematic reviews and their components. Working groups are also focused on the application of evidence-based tools to various toxicological practices.

Scientists affiliated with the EBTC are conducting pilot studies to demonstrate the value of evidence-based approaches for helping researchers evaluate new laboratory tools and tests for assessing chemical toxicity.

See also

Related Research Articles

Evidence-based medicine (EBM) is "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients". The aim of EBM is to integrate the experience of the clinician, the values of the patient, and the best available scientific information to guide decision-making about clinical management. The term was originally used to describe an approach to teaching the practice of medicine and improving decisions by individual physicians about individual patients.

<span class="mw-page-title-main">Toxicology</span> Study of substances harmful to living organisms

Toxicology is a scientific discipline, overlapping with biology, chemistry, pharmacology, and medicine, that involves the study of the adverse effects of chemical substances on living organisms and the practice of diagnosing and treating exposures to toxins and toxicants. The relationship between dose and its effects on the exposed organism is of high significance in toxicology. Factors that influence chemical toxicity include the dosage, duration of exposure, route of exposure, species, age, sex, and environment. Toxicologists are experts on poisons and poisoning. There is a movement for evidence-based toxicology as part of the larger movement towards evidence-based practices. Toxicology is currently contributing to the field of cancer research, since some toxins can be used as drugs for killing tumor cells. One prime example of this is ribosome-inactivating proteins, tested in the treatment of leukemia.

Polychlorinated dibenzodioxins (PCDDs), or simply dioxins, are a group of long-lived polyhalogenated organic compounds that are primarily anthropogenic, and contribute toxic, persistent organic pollution in the environment.

<span class="mw-page-title-main">Perfluorooctanoic acid</span> Perfluorinated carboxylic acid

Perfluorooctanoic acid is a perfluorinated carboxylic acid produced and used worldwide as an industrial surfactant in chemical processes and as a material feedstock. PFOA is considered a surfactant, or fluorosurfactant, due to its chemical structure, which consists of a perfluorinated, n-heptyl "tail group" and a carboxylate "head group". The head group can be described as hydrophilic while the fluorocarbon tail is both hydrophobic and lipophobic.

<span class="mw-page-title-main">Perfluorooctanesulfonic acid</span> Fluorosurfactant and persistent organic pollutant

Perfluorooctanesulfonic acid (PFOS) is a chemical compound having an eight-carbon fluorocarbon chain and a sulfonic acid functional group and thus a perfluorosulfonic acid. It is an anthropogenic (man-made) fluorosurfactant, now regarded as a global pollutant. PFOS was the key ingredient in Scotchgard, a fabric protector made by 3M, and related stain repellents. The acronym "PFOS" refers to the parent sulfonic acid and to various salts of perfluorooctanesulfonate. These are all colorless or white, water-soluble solids. Although of low acute toxicity, PFOS has attracted much attention for its pervasiveness and environmental impact. It was added to Annex B of the Stockholm Convention on Persistent Organic Pollutants in May 2009.

<span class="mw-page-title-main">Endocrine disruptor</span> Chemicals that can interfere with endocrine or hormonal systems

Endocrine disruptors, sometimes also referred to as hormonally active agents, endocrine disrupting chemicals, or endocrine disrupting compounds are chemicals that can interfere with endocrine systems. These disruptions can cause cancerous tumors, birth defects, and other developmental disorders. Found in many household and industrial products, endocrine disruptors "interfere with the synthesis, secretion, transport, binding, action, or elimination of natural hormones in the body that are responsible for development, behavior, fertility, and maintenance of homeostasis ."

Toxicogenomics is a subdiscipline of pharmacology that deals with the collection, interpretation, and storage of information about gene and protein activity within a particular cell or tissue of an organism in response to exposure to toxic substances. Toxicogenomics combines toxicology with genomics or other high-throughput molecular profiling technologies such as transcriptomics, proteomics and metabolomics. Toxicogenomics endeavors to elucidate the molecular mechanisms evolved in the expression of toxicity, and to derive molecular expression patterns that predict toxicity or the genetic susceptibility to it.

<span class="mw-page-title-main">Endosulfan</span> Chemical compound

Endosulfan is an off-patent organochlorine insecticide and acaricide that is being phased out globally. It became a highly controversial agrichemical due to its acute toxicity, potential for bioaccumulation, and role as an endocrine disruptor. Because of its threats to human health and the environment, a global ban on the manufacture and use of endosulfan was negotiated under the Stockholm Convention in April 2011. The ban has taken effect in mid-2012, with certain uses exempted for five additional years. More than 80 countries, including the European Union, Australia, New Zealand, several West African nations, the United States, Brazil, and Canada had already banned it or announced phase-outs by the time the Stockholm Convention ban was agreed upon. It is still used extensively in India and China despite laws against its use. It is also used in a few other countries. It is produced by the Israeli firm Makhteshim Agan and several manufacturers in India and China. On 13.05.2011, the India Supreme Court ordered a ban on the production and sale of endosulfan in India, pending further notice.

<span class="mw-page-title-main">Homosalate</span> Chemical compound

Homosalate is an organic compound used in some sunscreens. It is made by the Fischer–Speier esterification of salicylic acid and 3,3,5-trimethylcyclohexanol, the latter being a hydrogenated derivative of isophorone. Contained in 45% of U.S. sunscreens, it is used as a chemical UV filter. The salicylic acid portion of the molecule absorbs ultraviolet rays with a wavelength from 295 nm to 315 nm, protecting the skin from sun damage. The hydrophobic trimethyl cyclohexyl group provides greasiness that prevents it from dissolving in water.

Ultrafine particles (UFPs) are particulate matter of nanoscale size (less than 0.1 μm or 100 nm in diameter). Regulations do not exist for this size class of ambient air pollution particles, which are far smaller than the regulated PM10 and PM2.5 particle classes and are believed to have several more aggressive health implications than those classes of larger particulates. In the EU UFP's in ambient air are empirically defined by a technical specification. The important detail is the definition of size, stated: "The lower and upper sizes considered within this document are 7 nm and a few micrometres, respectively". Although the most common referral to UFP is "less than 0.1μm", this is incorrect for ambient air in the EU.

The Comparative Toxicogenomics Database (CTD) is a public website and research tool launched in November 2004 that curates scientific data describing relationships between chemicals/drugs, genes/proteins, diseases, taxa, phenotypes, GO annotations, pathways, and interaction modules. The database is maintained by the Department of Biological Sciences at North Carolina State University.

Perfluorononanoic acid, or PFNA, is a synthetic perfluorinated carboxylic acid and fluorosurfactant that is also an environmental contaminant found in people and wildlife along with PFOS and PFOA.

Fluorotelomer alcohols, or FTOHs, are fluorotelomers with an alcohol functional group. They are volatile precursors to perfluorinated carboxylic acids, such as PFOA and PFNA, and other compounds.

<span class="mw-page-title-main">Perfluorooctanesulfonamide</span> Chemical compound

Perfluorooctanesulfonamide (PFOSA) is a synthetic organofluorine compound. It is a fluorocarbon derivative and a perfluorinated compound, having an eight-carbon chain and a terminal sulfonamide functional group. PFOSA, a persistent organic pollutant, was an ingredient in 3M's former Scotchgard formulation from 1956 until 2003, and the compound was used to repel grease and water in food packaging along with other consumer applications. It breaks down to form perfluorooctane sulfonate (PFOS). The perfluorooctanesulfonyl fluoride-based chemistry that was used to make sulfonamides like PFOSA was phased out by 3M in the United States (US) during 2000–2002 but it has grown in China by other producers.

<span class="mw-page-title-main">2,3,7,8-Tetrachlorodibenzodioxin</span> Polychlorinated dibenzo-p-dioxin, chemical compound

2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD) is a polychlorinated dibenzo-p-dioxin (sometimes shortened, though inaccurately, to simply 'dioxin') with the chemical formula C12H4Cl4O2. Pure TCDD is a colorless solid with no distinguishable odor at room temperature. It is usually formed as an unwanted product in burning processes of organic materials or as a side product in organic synthesis.

The Klimisch score is a method of assessing the reliability of toxicological studies, mainly for regulatory purposes, that was proposed by H.J. Klimisch, M. Andreae and U. Tillmann of the chemical company BASF in 1997 in a paper entitled A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data which was published in Regulatory Toxicology and Pharmacology. It assigns studies to one of four categories as follows:

The discipline of evidence-based toxicology (EBT) strives to transparently, consistently, and objectively assess available scientific evidence in order to answer questions in toxicology, the study of the adverse effects of chemical, physical, or biological agents on living organisms and the environment, including the prevention and amelioration of such effects. EBT has the potential to address concerns in the toxicological community about the limitations of current approaches to assessing the state of the science. These include concerns related to transparency in decision making, synthesis of different types of evidence, and the assessment of bias and credibility. Evidence-based toxicology has its roots in the larger movement towards evidence-based practices.

eTOX Toxicology data consortium

eTOX is a temporary consortium established in 2010 to share and use toxicology data. It is a pre-competitive collaboration which main goal is to create and distribute tools to predict drug side-effects based on pre-clinical experiments. Aims are a better in silico predictability of potential adverse events and a decrease of the use of animals in toxicological research. eTOX is funded by the Innovative Medicines Initiative (IMI).

<span class="mw-page-title-main">Arene oxide</span>

In chemistry, an arene oxide is an epoxide of an arene. Two important families of arene oxides are benzene oxides and naphthalene oxides as these are intermediates in the oxidative degradation of benzene and naphthalene, two common pollutants. Benzopyrene is also converted to an epoxide, (+)-benzo[a]pyrene-7,8-epoxide.

<span class="mw-page-title-main">N6AMT1</span> Protein-coding gene in the species Homo sapiens

N-6 adenine-specific DNA methyltransferase 1 is a protein that in humans is encoded by the N6AMT1 gene.

References

  1. 1 2 3 Stephens, M.; Andersen, M.; Becker, R.A.; Betts, K.; et al. (2013). "Evidence-based toxicology for the 21st century: Opportunities and challenges". ALTEX. 30 (1): 74–104. doi: 10.14573/altex.2013.1.074 . PMID   23338808.
  2. ↑ Hoffmann, S.; Hartung, T (2006). "Toward an evidence-based toxicology". Hum Exp Toxicol. 25 (9): 497–513. doi:10.1191/0960327106het648oa. PMID   17017003. S2CID   42202416.
  3. ↑ Schreider, J.; Barrow, C.; Birchfield, N.; et al. (2010). "Enhancing the credibility of decisions based on scientific conclusions: transparency is imperative". Toxicol Sci. 116 (1): 5–7. doi:10.1093/toxsci/kfq102. PMID   20363830.
  4. ↑ Adami, H.O.; Berry, S.C.; Breckenridge, C.B.; Smith, L.L.; et al. (2011). "Toxicology and epidemiology: improving the science with a framework for combining toxicological and epidemiological evidence to establish causal inference". Toxicol Sci. 122 (2): 223–234. doi:10.1093/toxsci/kfr113. PMC   3155086 . PMID   21561883.
  5. ↑ Conrad, J.W.; Becker, R.A. (2011). "Enhancing credibility of chemical safety studies: an emerging consensus on key assessment criteria". Environ Health Perspect. 119 (6): 757–764. doi:10.1289/ehp.1002737. PMC   3114808 . PMID   21163723.
  6. ↑ Eddy, D.M. (2005). "Evidence-Based Medicine: A Unified Approach". Health Aff. 24 (1): 9–17. doi:10.1377/hlthaff.24.1.9. PMID   15647211.
  7. ↑ Hoffmann, S.; Hartung, T (2005). "Diagnosis: toxic! Trying to apply approaches of clinical diagnostics and prevalence in toxicology considerations". Toxicol Sci. 85 (1): 422–428. doi: 10.1093/toxsci/kfi099 . PMID   15689419.
  8. 1 2 3 4 5 6 "EBTC About Us" . Retrieved September 26, 2017.
  9. ↑ Hartung, T. (2009). "Food for thought... on evidence-based toxicology". ALTEX. 26 (2): 75–82. doi: 10.14573/altex.2009.2.75 . PMID   19565165.
  10. ↑ "Cernobbio/Como: First international forum toward evidence-based toxicology". ALTEX. 4: 354. 2007.
  11. ↑ Rudacille, D. (2010). "Summary of the July 2010 Workshop, "21st Century Validation Strategies for 21st Century Tools"". ALTEX. 27 (2): 279–284. doi: 10.14573/altex.2010.4.279 .
  12. ↑ "Conference Report: Evidence-based Toxicology Collaboration Kick-off Meeting". Altex. 28 (2): 52. 2011.
  13. ↑ Hoffmann, S.; de Vries, R.B.M.; Stephens, M.L.; et al. (2017). "A primer on systematic reviews in toxicology". Arch Toxicol. 91 (7): 2551–2575. doi:10.1007/s00204-017-1980-3. PMC   5489636 . PMID   28501917.
  14. ↑ Navas-Ancien, A.; Guallar, E.; Silbergeld, E. K.; Rothenberg, S. J. (2007). "Lead exposure and cardiovascular disease – a systematic review". Environ Health Perspect. 115 (3): 472–482. doi:10.1289/ehp.9785. PMC   1849948 . PMID   17431501.
  15. ↑ Meyer-Baron, M.; Knapp, G.; Schäper, M.; et al. (2009). "Performance alterations associated with occupational exposure to manganese: a meta-analysis". NeuroToxicology. 30 (4): 487–496. doi:10.1016/j.neuro.2009.05.001. PMID   19465050.
  16. ↑ Johnson, P.I.; Sutton, P.; Atchley, D.S.; et al. (2014). "The Navigation Guide – evidence-based medicine meets environmental health: systematic review of human evidence for PFOA effects on fetal growth". Environ Health Perspect. 122 (10): 1028–1039. doi:10.1289/ehp.1307893. PMC   4181929 . PMID   24968388.
  17. ↑ Hartung, T. (2010). "Evidence-Based Toxicology – the Toolbox of Validation for the 21st Century?". ALTEX. 27 (4): 253–263. doi: 10.14573/altex.2010.4.253 . PMID   21240468. S2CID   13100355.
  18. ↑ Silbergeld, E.; Scherer, R.W. (2013). "Evidence-based toxicology: Strait is the gate, but the road is worth taking". ALTEX. 30 (1): 67–73. doi: 10.14573/altex.2013.1.067 . PMID   23338807.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.