• Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals. (europa.eu)
  • Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation. (europa.eu)
  • No repeated dose inhalation toxicity study is available. (europa.eu)
  • Toxicogenomics is a relevant approach for the identification of biomarkers associated with toxicity and can be employed in endpoint analysis following exposure to DNTs. (plos.org)
  • He is known for his contributions to the fields of developmental and reproductive toxicology (DART), pharmacokinetics, and risk assessment, including extensive experience with study design, data interpretation, and interspecies extrapolation of health effects data. (wikipedia.org)
  • In comparison to a subacute 28-day study the OECD TG 422 study provides additional information on fertility and developmental toxicity, which justifies the Assessment factor of 4. (europa.eu)
  • thus, to achieve goals for anemia reduction and assess progress, standardized approaches are required for the assessment of anemia and its causes. (cdc.gov)
  • The work group has evaluated the current testing paradigm for genotoxicity assessment of nanomaterials and is publishing the findings and recommendations for modifying the tests as needed. (hesiglobal.org)
  • These alternatives to animals are often referred to as new approach methodologies (NAMs), which are broadly defined as any novel method and/or approach that can support chemical risk assessment without using animals (i.e., in vitro or in silico methods). (diffundit.com)
  • Finally, the emergence of three-dimensional cell cultures and complex organ-on-a-chip technologies, that recapitulate aspects of human physiology, are further bridging the gap between NAMs and in vivo toxicity assessment. (diffundit.com)
  • 2023. Advancing exposure assessment approaches to improve wildlife risk assessment . (sfu.ca)
  • Further testing is, however, not required, as there are reliable oral repeated dose toxicity data available for the hazard assessment and therefore, the requirements defined in Regulation (EC) No 1907/2006, Annex IX, 8.6 are fulfilled. (europa.eu)
  • According to EPA, the quarterly series will focus on the use of new approach methodologies (NAM), or alternative methods to reduce vertebrate animal testing, for risk assessment within EPA and CDPR. (braginfo.org)
  • For outcomes that were reported in both preprints and journals, common discrepancies were differences in numerical values and statistical significance, additional statistical tests and subgroup analyses and longer follow-up times for outcome assessment in journal publications. (bmj.com)
  • The scientific basis, toxicologic data and risk assessment approach used to derive the IDLH value are summarized to ensure transparency and scientific credibility. (cdc.gov)
  • The HESI GTTC is pleased to share its newest publication, " Error-corrected next-generation sequencing to advance nonclinical genotoxicity and carcinogenicity testing ," published in Nature Reviews Drug Discovery . (hesiglobal.org)
  • Here, we provide information about carcinogenicity tests - tests to determine whether a substance can cause cancer or not. (invitrojobs.com)
  • For approval, these substances have to be tested first for its potential to cause cancer (carcinogenicity). (invitrojobs.com)
  • Welfare in Europe and Japan, for immuno- ods for developmental neurotoxicity and System toxicity testing in adult rodents. (cdc.gov)
  • The webinar will cover recent updates from the Organization for Economic Cooperation and Development (OECD), including information about its developmental neurotoxicity in vitro test battery. (braginfo.org)
  • Notable human health toxicity effects identified from human and/or animal studies include respiratory cancer, non-cancer toxicity effects following inhalation, dermatitis, and reproductive effects. (mdpi.com)
  • One of the primary ways to test the toxicology of a compound has been to inject it into a lab animal, see if the animal gets sick, and then conduct an autopsy to observe the damage done to their internal organs. (scientificamerican.com)
  • Dr. Holson is an editor and author of the textbook Regulatory Toxicology and an author of two significant chapters in the textbook Developmental and Reproductive Toxicology: A Practical Approach, Second Edition. (wikipedia.org)
  • Dr. Holson joined Science Applications International Corporation (SAIC) in La Jolla, California during March 1980 to establish research and development and chemical testing programs in toxicology. (wikipedia.org)
  • On 30 June 22, the Organisation for Economic Cooperation and Development (OECD) published Test #470: Mammalian Erythrocyte Pig-a Gene Mutation Assay , a Test Guideline (TG) that describes an in vivo gene mutation assay that can be combined with other genetic and general toxicology tests to promote the efficient use of animal resources. (hesiglobal.org)
  • From the available data on two acute oral toxicity studies, it is concluded that the oral LD50 for the substance is greater than 2000 mg/kg bw (study 1: no mortality was observed) and greater from 10000 mg/kg bw (study 2: mortality was observed). (europa.eu)
  • In accordance to the approach followed in the RAR, only acute data from standardised test protocols were considered in the analysis for setting the reference value for classification. (europa.eu)
  • Prescriptions from standard protocols were strictly followed, e.g. data from an acute Daphnia test exceeding 48 hrs were not used. (europa.eu)
  • In accordance to the approach followed in the RA, acute data obtained in natural waters that contained e.g. significant amount of DOC, were not used. (europa.eu)
  • More recent (obtained after 1996 to the present) short-term acute toxicity data on standard organisms were included in the database. (europa.eu)
  • The short-term acute aquatic toxicity database covers 10 species (1 algae, 4 invertebrates and 5 fish species). (europa.eu)
  • Mapping of in vitro assay targets to toxicity endpoints of regulatory importance uses literature-based mode-of-action information and controlled terminology from existing knowledge organization systems to support data interoperability with external resources. (nih.gov)
  • Additional efforts are exploring the utility of computational models that estimate freely dissolved concentrations of test chemicals by accounting for in vitro assay conditions and physicochemical properties. (diffundit.com)
  • This article describes updates to ICE, including improved accessibility and interpretability of in vitro data via mechanistic target mapping and enhanced interactive tools for in vitro to in vivo extrapolation (IVIVE). (nih.gov)
  • Recent work has established that application of in vitro to in vivo extrapolation (IVIVE) models to NAM data tends to provide surrogate points-of-departure (PoDs) that are protective of human health relative to in vivo animal PoDs. (diffundit.com)
  • Since the reproductive toxicity (e.g. (cdc.gov)
  • Hazard profiles are based principally on metrics regarding mode of toxic action, chemical reactivity, food web-derived internal toxicity thresholds, bioavailability, and chemical and biological activity. (canada.ca)
  • Differences in human toxicity potencies/potentials of different nickel chemical forms are correlated with the bioavailability of the Ni 2+ ion at target sites. (mdpi.com)
  • Likewise, Ni 2+ has been demonstrated to be the toxic chemical species in the environment, and models have been developed that account for the influence of abiotic factors on the bioavailability and toxicity of Ni 2+ in different habitats. (mdpi.com)
  • It contains descriptions and evaluations of toxicological studies and epidemiological investigations and provides conclusions, where possible, on the relevance of toxicity and toxicokinetic data to public health. (cdc.gov)
  • Breakout groups discussing Variability of Traditional Toxicity Tests, Relevance of Traditional Toxicity Tests, and Feedback on EPA Scientific Confidence Framework. (braginfo.org)
  • Based on the experimental results obtained with the analogue, the read-across approach is applied and the LD50 for substance Ultramarine Violet is considered to be greater than 2000 mg/kg bw. (europa.eu)
  • Toxicologists use experimental and scientific approaches for data collection, e.g. about chemical hazards, physicochemical features or toxicokinetics. (springer.com)
  • experimental approaches and assays available to assess developmental immunotoxicity. (cdc.gov)
  • The statement of task specifically directed the committee to address "how laboratory and mesoscale experiments could inform potential controlled field trials and what experimental methods are most appropriate for such tests. (nationalacademies.org)
  • Quantitative extrapolation from experimental data to the human situation is not undertaken. (who.int)
  • This is expected to generate data more relevant to humans, expand the number of chemicals tested and reduce the time, money and number of animals involved in current lab studies. (scientificamerican.com)
  • This sort of 'high-throughput' testing will enable researchers to generate more data relevant to humans, and at the same time reduce the amount of animal experimentation. (scientificamerican.com)
  • The cross-species extrapolation from animals to humans is 'not always as precise as it should be,' Wilson said. (scientificamerican.com)
  • For some time, regulatory authorities, the Industry and academia agreed, that animal testing should be no longer mandatory - primarily because at the time of the beginning of such tests there is already sufficient information available from animal experiments to estimate a possible risk of cancer in humans. (invitrojobs.com)
  • In all cases the same test has to be repeated on humans, with unknown risks and unpredictable results. (aerzte-gegen-tierversuche.de)
  • A consequence of this unscientific extrapolation from laboratory animals to humans is that drugs have had to be withdrawn from the market because of unforeseen hazards or even lethal side-effects in humans - effects which were not seen in animals. (aerzte-gegen-tierversuche.de)
  • Results from animal tests do not allow conclusions about effectiveness, tolerance nor safety for humans. (aerzte-gegen-tierversuche.de)
  • The reason why many drugs and medical procedures are relatively safe cannot be put down to animal experiments, but to the fact that all drugs have to be tested on humans, in the so-called clinical trials required by law. (aerzte-gegen-tierversuche.de)
  • This modern approach to investigating and developing drugs and chemicals yields results that are truly relevant for humans. (aerzte-gegen-tierversuche.de)
  • The framework has a supporting table with information on the diagnostic tests, biomarkers and proposed cutoffs, characteristics, and feasibility of collecting the myriad information that can help elucidate the anemia etiology. (cdc.gov)
  • To overcome these, they have different extrapolation methods and estimation procedures at their disposal. (springer.com)
  • When applying a precision health approach to pediatric IBD patients undergoing pharmacotherapy that suppresses the immune system, choosing age-appropriate disease monitoring methods is of utmost importance since off-label drug use is often standard of care. (ama-assn.org)
  • EPA must also promote the development and timely incorporation of alternative test methods or strategies that do not require new vertebrate animal testing. (braginfo.org)
  • The recordings and slides from the October 12-13, 2022, EPA New Approach Methods (NAM) Conference are available on the conference web page . (braginfo.org)
  • On August 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that registration was open for the 2022 Conference on the State of the Science on Development and Use of New Approach Methods (NAM) for Chemical Safety Testing . (braginfo.org)
  • 2000 mg/kg bw , key study with 6 female rats according to OECD Test Guideline 423. (europa.eu)
  • Therefore, the DNEL is derived on basis of an OECD TG 422 toxicity study performed in the rat. (europa.eu)
  • Table above presents an overview of the information available for short-term aquatic toxicity for zinc. (europa.eu)
  • The same algae species is also the most sensitive in the chronic aquatic toxicity database (see below) so this sensitivity pattern is consistent. (europa.eu)
  • The substance met the ecological categorization criteria for persistence, but did not meet the ecological categorization criteria for bioaccumulation potential or inherent toxicity to aquatic organisms. (gc.ca)
  • The agencies are hoping to coordinate their resources to better identify toxicity pathways, select chemicals for testing, analyze and interpret data, and promote their findings to scientific and regulatory communities. (scientificamerican.com)
  • Targeted pharmacotherapy is increasingly recognized as a preferable treatment approach as it accounts for differences in children's genes, environment, psychosocial functioning, and lifestyle. (ama-assn.org)
  • It is e.g. important to know the conditions under which the organisms were tested and cultured, because these conditions may result in acclimatisation and deviating toxicity response. (europa.eu)
  • Fish toxicity at low pH is also not critical in this respect, so the values for the daphnids are representative for the sensitivity of organisms to zinc at low pH. (europa.eu)
  • In 2018, EPA published a strategic plan to reduce the use of vertebrate animals in chemical testing. (braginfo.org)
  • He added that the effort-designed to expand the use of in vitro testing of human cells and cellular components to identify chemicals with toxic effects-represents the 'birth of a new approach to a crucial problem in public health. (scientificamerican.com)
  • But they acknowledged that some animal testing will continue at least until the technology proves its mettle in large-scale studies or until Congress passes a substance regulation act similar to the European Union's (E.U.) Registration, Evaluation, Authorization and Restriction of Chemicals, or ( REACH ), which regulates chemicals and their safe use. (scientificamerican.com)
  • This neurosphere model might provide the basis of a human-based cellular approach for the regulatory exploration of developmental impact of potential toxic chemicals. (plos.org)
  • The presentation will highlight NAM developments and provide examples where NAM testing strategies are being employed to screen chemicals with a potential for concern. (diffundit.com)
  • The new research model would allow scientists to test 100,000 compounds in 1,500 different concentrations in about two days compared with years if the testing was done on animals. (scientificamerican.com)
  • Exposure to a variety of TCE-related compounds, which include metabolites of TCE and other parent compounds that produce similar metabolites, can alter or enhance TCE metabolism and toxicity by generating higher internal metabolite concentrations than would result from TCE exposure by itself. (who.int)
  • Moving toward species-relevant chemical safety assessments and away from animal testing requires access to reliable data to develop and build confidence in new approaches. (nih.gov)
  • In addition, human models offer the advantage of better predictive power to man, since extrapolation of results across species is not an issue [6] . (plos.org)
  • The ERC is a risk-based approach that employs multiple metrics for both hazard and exposure, with weighted consideration of multiple lines of evidence for determining risk classification. (canada.ca)
  • Chemical risk assessments are undergoing a renaissance as the international regulatory community moves away from animal toxicity tests in favour of robust non-animal alternative tests. (diffundit.com)
  • They are currently considering publishing a series of protocols for genetic toxicity testing of products containing nanomaterials. (hesiglobal.org)
  • Also, combining such test systems allows the properties of substances to be studied in detail, for instance toxicity, or their potential to cause cancer, genetic disorders or congenital diseases. (aerzte-gegen-tierversuche.de)
  • Minamata disease is an example of organic toxicity. (medscape.com)
  • 2022. Development and testing of a mechanistic model for wetland treatment of neutral and polar organic contaminants in oil sands process-affected water: Application to the Kearl Treatment Wetland in Alberta, Canada. (sfu.ca)
  • The current Food and Drug Administration (FDA) approach to pharmacotherapy for pediatric IBD is a one-size-fits-all dosing strategy in which drug dosing and guidance are extrapolated from adult trials. (ama-assn.org)
  • 10 As a consequence, they cannot be detected using genotoxicity tests. (invitrojobs.com)
  • 2022. Treatment of naphthenic acids in oil sands process-affected waters with a surface flow treatment wetland: mass removal, half-life, and toxicity-reduction . (sfu.ca)
  • 1. HYPOTHESIS FOR THE ANALOGUE APPROACH: The analogue approach covers the substance Ultramarine Blue (EC nº 701-340-9) and the substance Ultramarine Violet (EC nº 701-186-2).The analogue Ultramarine Blue shares the same structure (Sodalite-type structure (SOD-Zeolite)) with the substance Ultramarine Violet. (europa.eu)
  • The analogue approach covers the substance Ultramarine Blue (EC nº 701-340-9) and the substance Ultramarine Violet (EC nº 701-186-2). (europa.eu)
  • The scientists were unable to provide a specific time frame for when the technology might produce significant results or predict how many fewer animals would be used in testing if their effort is a success. (scientificamerican.com)
  • HA535 trade name] may be used for pre-exposure prophylaxis (PrEP) as an additional prevention choice for adults and adolescents (weighing at least 35 kg) at substantial risk of HIV infection as part of combination prevention approaches. (who.int)
  • Top officials from the U.S. National Institutes of Health ( NIH ) and Environmental Protection Agency ( EPA ) Thursday announced a five-year deal promising to share technology, information and other resources that will improve the toxicity testing of chemical compounds used in food, medicine and other products using robots rather than lab animals. (scientificamerican.com)
  • The news here is the capacity to test many thousands of compounds, something we haven't had until this collaboration,' Samuel Wilson, acting director of the NIH National Institute of Environmental Health Sciences and NTP, said at the press conference. (scientificamerican.com)
  • We aim to provide a practical approach to assess anemia and its primary causes, both in clinical settings and in the context of public health programs. (cdc.gov)
  • In this paper, we review 3 challenges related to applying a precision health approach to pediatric IBD populations: selection of a disease monitoring method, pharmacotherapy optimization, and economic considerations in clinical decision making. (ama-assn.org)
  • 3,4 When considering precision health in this vulnerable pediatric population with IBD-for example, for differential diagnosis or prognostication 5,6 -the central focus should be a more targeted approach to immune suppressive pharmacotherapy that limits the opportunity loss described above and supports health gains throughout a child's life. (ama-assn.org)
  • However, ethical challenges arise when clinicians apply a precision health approach to pediatric IBD by adopting targeted dosing strategies. (ama-assn.org)
  • In many fields of medical research, using in vitro tests (including cell cultures, human tissue, microorganisms, and biochips) as well as epidemiological studies make a substantial contribution to understanding and curing human diseases. (aerzte-gegen-tierversuche.de)
  • EPA notes that the Toxic Substances Control Act (TSCA) directs EPA to reduce and replace the use of vertebrate animals in the testing of chemical substances or mixtures to the extent practicable and scientifically justified. (braginfo.org)
  • In this study we treated differentiating NT2.D1 neurospheres with LiCl or VPA in order to determine their effects using a toxicogenomic and phenotypic anchoring approach. (plos.org)
  • A Feature Paper should be a substantial original Article that involves several techniques or approaches, provides an outlook for future research directions and describes possible research applications. (mdpi.com)
  • Animal testing has always been a sore point for scientists and animal-rights advocates, following some high-profile cases of mistreatment of lab animals, such as monkeys discovered in 1981 at the Institute for Behavioral Research in Silver Spring, Md., in deplorable conditions. (scientificamerican.com)
  • Scientists present at the news conference agreed that animal testing has yielded some important medical breakthroughs. (scientificamerican.com)
  • They stressed that they plan to move quickly to test the new technology and reduce animal testing as soon and as much as possible. (scientificamerican.com)
  • Using animal testing, in spite of millions of animal victims and enormous economic investments the medical research system has failed to make real breakthroughs in the fight against the main diseases of today (e.g. cancer, heart and vascular diseases, diabetes, rheumatoid arthritis, allergies, AIDS, etc.), contrary to its countless promises. (aerzte-gegen-tierversuche.de)
  • They do not trigger any short-term mutations in eukaryotic and prokaryotic mutation tests and do not induce any direct DNA damage in the target organ. (invitrojobs.com)
  • Ditto animal rights activists who have long opposed testing drugs and conducting other experiments on animals. (scientificamerican.com)