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Journal articles on the topic 'Chronic toxicity testing'

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Published: 4 June 2021
Last updated: 19 February 2022

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1

Schmitt, Marcel, Georg Gellert, Jost Ludwig, and Hella Lichtenberg-Fraté. "Phenotypic yeast growth analysis for chronic toxicity testing." Ecotoxicology and Environmental Safety 59, no. 2 (October 2004): 142–50. http://dx.doi.org/10.1016/j.ecoenv.2004.06.002.

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2

Prieto, Pilar. "Barriers, Nephrotoxicology and Chronic Testing In Vitro." Alternatives to Laboratory Animals 30, no. 2_suppl (December 2002): 101–5. http://dx.doi.org/10.1177/026119290203002s15.

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In many organs of the human body, there are effective physiological barriers which contribute to regulation of the uptake, transport and secretion of endogenous and exogenous materials. ECVAM is involved in the development of several in vitro models for detecting damage to various barriers, including, the renal epithelium, the intestinal barrier, and the blood–brain barrier, after acute and chronic exposure to chemicals and products of various kinds. Long-term toxicity testing is an important issue in toxicology. At present, there are no generally accepted in vitro models available for replacing chronic testing in animals. Under chronic exposure conditions, the cellular response is greater than that which can be predicted in the standard cytotoxicity models. Therefore, the approach to predicting chronic toxicity will need to involve more-complex in vitro models. Several currently available in vitro long-term toxicity systems are under evaluation.
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3

Khan, A., D. Kent, J. Barbieri, S. Khan, and F. Sweeney. "Effectiveness of a Secondary Impoundment System in Reducing Industrial Wastewater Toxicity." Water Science and Technology 26, no. 9-11 (November 1, 1992): 2349–52. http://dx.doi.org/10.2166/wst.1992.0734.

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Aquatic toxicity testing was employed over a three year period to test the effectiveness of a secondary impoundment system in reducing biological toxicity of an industrial wastewater discharge. A two tiered approach was used to determine the effects of the wastewater on two cladoceran species, Daphniamagna and Ceriodaphniadubia, and two sensitive life stages of a vertebrate, Pimephalespromelas. Endpoints measured were both acute (lethality) and chronic (growth and reproduction). Results from the first year of testing, conducted on wastewater collected from the inflow to the secondary impoundment system, indicated both lethal and sublethal effects. Results from the second year of testing, conducted on the outflow of the secondary impoundment system, showed reduced chronic toxicity and complete absence of acute toxicity. Minor modifications were made to the existing treatment system and toxicity testing was conducted for the second consecutive year on the outflow of the secondary impoundment system. Results from the third year of testing showed no acute or chronic toxicity, indicating improved wastewater treatment.
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4

Slabbert, J. L., and E. A. Venter. "Biological assays for aquatic toxicity testing." Water Science and Technology 39, no. 10-11 (May 1, 1999): 367–73. http://dx.doi.org/10.2166/wst.1999.0684.

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A number of aquatic toxicity tests have been established for South African use, which include fish and Daphnia lethality tests, microbiotests, and short-term chronic tests. Studies on effluents and surface waters showed that all the tests have a viable role to play in water quality management. The most advantageous use of the tests is in battery form, so that tests can complement each other. The fish and Daphnia lethality tests, and algal growth inhibition test are recommended for regulatory and management purposes of effluents. If receiving water is used for drinking water purposes, the Ames Salmonella mutagenicity and toad embryo teratogenicity tests should be included in the battery of tests. Some of the rapid microbiotests, e.g. the protozoan oxygen uptake test, bacterial growth test and enzyme tests, could be valuable screening tools to identify and categorize toxic effluents.
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5

Vu, Vanessa, J. Carl Barrett, Joseph Roycroft, Loretta Schuman, David Dankovic, Paul BBaro, Ted Martonen, William Pepelko, and David Lai. "Chronic Inhalation Toxicity and Carcinogenicity Testing of Respirable Fibrous Particles." Regulatory Toxicology and Pharmacology 24, no. 3 (December 1996): 202–12. http://dx.doi.org/10.1006/rtph.1996.0128.

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6

Dom, N., D. Knapen, W. De Coen, and R. Blust. "Toxicity prediction of chloro-substituted anilines versus acute and chronic toxicity testing in Daphnia magna." Comparative Biochemistry and Physiology Part A: Molecular & Integrative Physiology 154, no. 1 (September 2009): S23—S24. http://dx.doi.org/10.1016/j.cbpa.2009.05.082.

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7

Dyachok, I. L., O. R. Pinyazhko, and O. L. Ivankiv. "Сhronic toxicity testing complex phytopoliextraction of sedative action." Farmatsevtychnyi zhurnal, no. 5-6 (August 14, 2018): 42–48. http://dx.doi.org/10.32352/0367-3057.5-6.17.05.

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Development and introduction in medical practice sedative meals on the base of complex phytopoliextracts from the domestic medical plants permitted for medical application is highly actual because of incrised incidence of abnormal psychology disorders determined by socioeconomical problems, global informative boom, ecological problems, worsening of life quality. The aim of a study – determination of the sedative phytopoliextraction complex chronic toxicity parameters in experiments after oral administration to laboratory rats. Standardized phytopoliextraction сomplex which is composed of extracts of medical plants (Valeriana officinalis L., Crataégus, Melissa officinalis L., Hypericum, Mentha piperita L., Húmulus lúpulus, Viburnum). It was determined that phytopoliextraction complex is non-toxic compound – LD50 drug after a single oral administration to mice is > 5.0 ml/kg, to rats > 10.0 ml/kg. A two-month administration of a phytopolietextraction complex in an effective and sub-toxic dose (1 ml/kg and 5 ml/kg, respectively) does not exert a toxic effect on the general state of the behavior and the increase in the weight of the animals. Phytopolietextraction complex in the subtotoxic dose does not change the functional state of the CNS in male rats, but in the effective state it increases the research activity. At the same time, it exerts a certain stimulating effect on females, due to the content of ethyl alcohol, and in a sub-toxic dose has a hypoglycemic effect largely due to the presence of ethyl alcohol. Thus, futher experiments have to be provided to learn other chronic toxicity parametres like local localirritating action, embrio- and gonadotoxicity.
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8

Cheng, Shin, David Wang, and Eric P. Smith. "ADJUSTING FOR MORTALITY EFFECTS IN CHRONIC TOXICITY TESTING: MIXTURE MODEL APPROACH." Environmental Toxicology and Chemistry 19, no. 1 (2000): 204. http://dx.doi.org/10.1897/1551-5028(2000)019<0204:afmeic>2.3.co;2.

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9

Wang, Shin Cheng David, and Eric P. Smith. "Adjusting for mortality effects in chronic toxicity testing: Mixture model approach." Environmental Toxicology and Chemistry 19, no. 1 (January 2000): 204–9. http://dx.doi.org/10.1002/etc.5620190124.

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10

Schuh, Michael J., and Sheena Crosby. "Chronic Anticholinergic Toxicity Discovered in a Pharmacogenomics, Polypharmacy Patient." Senior Care Pharmacist 36, no. 6 (June 1, 2021): 304–10. http://dx.doi.org/10.4140/tcp.n.2021.304.

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Objective: To report a case of chronic anticholinergic toxicity in a referred, pharmacogenomics (PGx), polypharmacy patient. Summary: The patient is a 67-year-old male who was referred to the polypharmacy service for a PGx consult. This patient has had episodic fever of unknown origin, general cutaneous vasodilation, tremors, jerks, and brain fogginess which have been unexplained. He has seen specialists from infectious disease, rheumatology, endocrinology, and neurology with no contributory condition causing these symptoms, so he was referred for PGx testing and evaluation by the polypharmacy pharmacist. Conclusion: This case demonstrates the importance of pharmacist-patient consultations and how a PGx consult may expose polypharmacy medication-related problems of greater significance than the PGx indication for the consult. In addition, the case demonstrates positive interprofessional collaboration between pharmacists and physicians to more effectively solve complex medication-related problems that may not be easily diagnosed through objective lab or diagnostic testing.
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11

Winneke, Gerhard. "Screening for Neurotoxic Potential of Chemicals in the Federal Republic of Germany." Journal of the American College of Toxicology 8, no. 1 (January 1989): 233–35. http://dx.doi.org/10.3109/10915818909009108.

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The German Chemicals Act (Chemikaliengesetz) requires that new chemicals be tested for toxicity according to a stepwise procedure based on production quantities. If the expected total annual production exceeds 1,000 tons, screening for “behavior-disrupting properties” is required as part of chronic toxicity testing. A test guideline based on cageside observations was published in 1985. The protocol covers outer appearance as well as motor, sensory, and autonomic functions and signs indicative of central nervous system (CNS) functions. So far, no chemical has been screened for behavioral toxicity according to this guideline because the expected production quantities never exceeded the threshold required for chronic toxicity testing.
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12

Holmgren, Gustav, Anna-Karin Sjögren, Isabel Barragan, Alan Sabirsh, Peter Sartipy, Jane Synnergren, Petter Björquist, Magnus Ingelman-Sundberg, Tommy B. Andersson, and Josefina Edsbagge. "Long-Term Chronic Toxicity Testing Using Human Pluripotent Stem Cell–Derived Hepatocytes." Drug Metabolism and Disposition 42, no. 9 (June 30, 2014): 1401–6. http://dx.doi.org/10.1124/dmd.114.059154.

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13

Weingand, Kurt, John Bloom, Michael Carakostas, Robert Hall, Maria Helfrich, Kenneth Latimer, Barry Levine, et al. "Clinical Pathology Testing Recommendations for Nonclinical Toxicity and Safety Studies." Toxicologic Pathology 20, no. 3-2 (May 1992): 539–43. http://dx.doi.org/10.1177/0192623392020003217.

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Clinical pathology testing in nonclinical toxicity and safety studies is an important part of safety assessment. In recent years, clinical laboratory testing has rapidly expanded and improved. Some government regulatory agencies provide guidelines for clinical pathology testing in nonclinical toxicity and safety studies. To improve these testing guidelines and the resultant safety assessments, the American Association for Clinical Chemistry's Division of Animal Clinical Chemistry and the American Society for Veterinary Clinical Pathology formed a joint committee to provide expert recommendations for clinical pathology testing of laboratory species involved in subchronic and chronic nonclinical toxicity and safety studies. These recommendations include technical recommendations on blood collection techniques and hematology, serum chemistry, and urinalysis tests.
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14

Barron, Mace G., Robyn N. Conmy, Edith Holder, Peter Meyer, Gregory J. Wilson, Vanessa E. Principe, and Morgan M. Willming. "Overview of Aquatic Toxicity Testing under the U.S. EPA Oil Research Program." International Oil Spill Conference Proceedings 2017, no. 1 (May 1, 2017): 2017–063. http://dx.doi.org/10.7901/2169-3358-2017.1.2017-063.

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2017-063 ABSTRACT The U.S. EPA Office of Research and Development is developing baseline data on the ecotoxicity of selected petroleum products, chemical dispersants, and other spill mitigating substances as part of its Oil Research Program. Two diluted bitumens (dilbits) from the Alberta Tar Sands region are being tested for acute and chronic toxicity to standard freshwater and marine organisms given their spill potential during shipment within the United States. Separately, crude oils representing a range of characteristics and representative dispersants are being tested to evaluate acute and chronic toxicity to marine organisms in support of proposed regulatory amendments to Subpart J of the U.S. National Contingency Plan. Water accommodated fractions (WAF) of oil are prepared using traditional slow-stir methods and toxicity tests follow U.S. EPA standard effluent testing guidelines, modified for testing petroleum products. WAFs are characterized for petroleum hydrocarbons including alkyl PAH homologs. Future research plans include evaluating oil spill mitigating substances such as surface washing and bioremediation agents. The results of the research program will assist the U.S. EPA in assessing toxicity of unconventional oils (dilbits), and establish baseline toxicity data for selected crude oils and spill mitigating substances in support of planning and response activities.
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15

Grindon, Christina, Robert Combes, Mark T. D. Cronin, David W. Roberts, and John F. Garrod. "An Integrated Decision-tree Testing Strategy for Repeat Dose Toxicity with Respect to the Requirements of the EU REACH Legislation." Alternatives to Laboratory Animals 36, no. 1 (February 2008): 93–101. http://dx.doi.org/10.1177/026119290803600110.

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This paper presents some results of a joint research project conducted by FRAME and Liverpool John Moores University, and sponsored by Defra, on the status of alternatives to animal testing with regard to the European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for the safety testing and risk assessment of chemicals. The project covered all the main toxicity end-points associated with REACH. This paper focuses on the use of alternative (non-animal) methods (both in vitro and in silico) for repeat dose (sub-acute, sub-chronic and chronic) toxicity testing. It reviews the limited number of in silico and in vitro tests available for this endpoint, and outlines new technologies which could be used in the future, e.g. the use of biomarkers and the ‘omics’ technologies. An integrated testing strategy is proposed, which makes use of as much non-animal data as possible, before any essential in vivo studies are performed. Although none of the non-animal tests are currently undergoing validation, their results could help to reduce the number of animals required for testing for repeat dose toxicity.
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16

Grindon, Christina, Robert Combes, Mark T. D. Cronin, David W. Roberts, and John F. Garrod. "An Integrated Decision-tree Testing Strategy for Repeat Dose Toxicity with Respect to the Requirements of the EU REACH Legislation." Alternatives to Laboratory Animals 36, no. 1_suppl (October 2008): 139–47. http://dx.doi.org/10.1177/026119290803601s11.

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This paper presents some results of a joint research project conducted by FRAME and Liverpool John Moores University, and sponsored by Defra, on the status of alternatives to animal testing with regard to the European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for the safety testing and risk assessment of chemicals. The project covered all the main toxicity end-points associated with REACH. This paper focuses on the use of alternative (non-animal) methods (both in vitro and in silico) for repeat dose (sub-acute, sub-chronic and chronic) toxicity testing. It reviews the limited number of in silico and in vitro tests available for this endpoint, and outlines new technologies which could be used in the future, e.g. the use of biomarkers and the ‘omics’ technologies. An integrated testing strategy is proposed, which makes use of as much non-animal data as possible, before any essential in vivo studies are performed. Although none of the non-animal tests are currently undergoing validation, their results could help to reduce the number of animals required for testing for repeat dose toxicity.
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17

Northup, Sharon J. "Safety Evaluation of Medical Devices: US Food and Drug Administration and International Standards Organization Guidelines." International Journal of Toxicology 18, no. 4 (June 1999): 275–83. http://dx.doi.org/10.1080/109158199225431.

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During the last 20 years, safety evaluation of medical devices has evolved from screening assays to the “pharmaceutical model” of preclinical testing. Biocompatibility testing guidelines for medical devices are published in the International Organization for Standardization (ISO) document 10993–1: Biological evaluation of medical devices—Part 1: Evaluation and testing. These guidelines are recognized by most national regulatory bodies and supplement, but do not supersede, the guidelines published by the individual nations or the testing requirements for a specific medical device. The ISO 10993 series includes screening tests for nonspecific mechanisms of toxicity (cytotoxicity, acute systemic toxicity, subchronic toxicity, local toxicity, and chronic toxicity) and specific mechanisms (blood compatibility, genotoxicity, carcinogenicity, pyrogenicity, and reproductive and developmental toxicity). Other ISO 10993 standards cover chemical characterization of materials, degradation products, toxicokinetics, sample preparation, permissible limits of sterilization and process residues, and clinical studies. This review examines the scope of these standards and identifies exceptions between these guidelines and selected national and vertical standards for medical devices.
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18

Grindon, Christina, Robert Combes, Mark T. D. Cronin, David W. Roberts, and John F. Garrod. "Integrated Decision-tree Testing Strategies for Environmental Toxicity with Respect to the Requirements of the EU REACH Legislation." Alternatives to Laboratory Animals 36, no. 1_suppl (October 2008): 29–42. http://dx.doi.org/10.1177/026119290803601s04.

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Liverpool John Moores University and FRAME recently conducted a research project sponsored by Defra on the status of alternatives to animal testing with regard to the European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for safety testing and risk assessment of chemicals. The project covered all the main toxicity endpoints associated with the REACH system. This paper focuses on the prospects for using alternative methods (both in vitro and in silico) for environmental (aquatic) toxicity testing. The manuscript reviews tests based on fish cells and cell lines, fish embryos, lower organisms, and the many expert systems and QSARs for aquatic toxicity testing. Ways in which reduction and refinement measures can be used are also discussed, including the Upper Threshold Concentration — Step Down (UTC) approach, which has recently been retrospectively validated by ECVAM and subsequently endorsed by the ECVAM Scientific Advisory Committee (ESAC). It is hoped that the application of this approach could reduce the number of fish used in acute toxicity studies by around 65–70%. Decision-tree style integrated testing strategies are also proposed for acute aquatic toxicity and chronic toxicity (including bioaccumulation), followed by a number of recommendations for the future facilitation of aquatic toxicity testing with respect to environmental risk assessment.
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19

Mihaich, Ellen M., Urs Friederich, Norbert Caspers, A. Tilghman Hall, Gary M. Klecka, Stephen S. Dimond, Charles A. Staples, Lisa S. Ortego, and Steven G. Hentges. "Acute and chronic toxicity testing of bisphenol A with aquatic invertebrates and plants." Ecotoxicology and Environmental Safety 72, no. 5 (July 2009): 1392–99. http://dx.doi.org/10.1016/j.ecoenv.2009.02.005.

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20

Zhou, Lang, Samuel M. Wallace, Kevin J. Kroll, Nancy D. Denslow, Jean‐François Gaillard, Peter Meyer, and Jean‐Claude J. Bonzongo. "Acute and Chronic Toxicity Testing of Drinking Water Treatment Residuals in Freshwater Systems." Environmental Toxicology and Chemistry 40, no. 7 (May 25, 2021): 2003–12. http://dx.doi.org/10.1002/etc.5061.

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21

Taylor, Nadine, Alex Gavin, and Mark Viant. "Metabolomics Discovers Early-Response Metabolic Biomarkers that Can Predict Chronic Reproductive Fitness in Individual Daphnia magna." Metabolites 8, no. 3 (July 23, 2018): 42. http://dx.doi.org/10.3390/metabo8030042.

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Chemical risk assessment remains entrenched in chronic toxicity tests that set safety thresholds based on animal pathology or fitness. Chronic tests are resource expensive and lack mechanistic insight. Discovering a chemical’s mode-of-action can in principle provide predictive molecular biomarkers for a toxicity endpoint. Furthermore, since molecular perturbations precede pathology, early-response molecular biomarkers may enable shorter, more resource efficient testing that can predict chronic animal fitness. This study applied untargeted metabolomics to attempt to discover early-response metabolic biomarkers that can predict reproductive fitness of Daphnia magna, an internationally-recognized test species. First, we measured the reproductive toxicities of cadmium, 2,4-dinitrophenol and propranolol to individual Daphnia in 21-day OECD toxicity tests, then measured the metabolic profiles of these animals using mass spectrometry. Multivariate regression successfully discovered putative metabolic biomarkers that strongly predict reproductive impairment by each chemical, and for all chemicals combined. The non-chemical-specific metabolic biomarkers were then applied to metabolite data from Daphnia 24-h acute toxicity tests and correctly predicted that significant decreases in reproductive fitness would occur if these animals were exposed to cadmium, 2,4-dinitrophenol or propranolol for 21 days. While the applicability of these findings is limited to three chemicals, they provide proof-of-principle that early-response metabolic biomarkers of chronic animal fitness can be discovered for regulatory toxicity testing.
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22

Camfield, Peter, and Carol Camfield. "Acute and Chronic Toxicity of Antiepileptic Medications: a Selective Review." Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques 21, S3 (August 1994): S7—S11. http://dx.doi.org/10.1017/s0317167100040750.

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Abstract:Acute and chronic toxicity complicates all antiepileptic medications (AED) and is idiosyncratic. Acute toxicity can be categorized into 1) acute brain dysfunction or 2) acute organ dysfunction when AED’s are started. Despite promisingin vitrolymphocyte testing, anticipation of acute reactions cannot be offered. Furthermore, screening for AED toxicity by routine blood and urine tests in asymptomatic patients is of doubtful value and should be abandoned. Patients should be informed of possible reactions and immediately report early symptoms. Treatment for acute reactions is largely unstudied. It is unclear how to reintroduce AED’s following acute reactions. Often patients are sensitive to drugs with a similar chemical structure. The “desensitization” protocol of Purvis may be of merit. Three major chronic toxicities of AED’s have been noted – soft tissue and gum hypertrophy, progressive ataxia, and peripheral neuropathy. New AED’s require careful post-marketing surveillance since long term toxicity data are not yet available.
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23

Morrow, P. E. "The Setting of Particulate Exposure Levels for Chronic Inhalation Toxicity Studies." Journal of the American College of Toxicology 5, no. 6 (November 1986): 533–44. http://dx.doi.org/10.3109/10915818609141024.

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This paper briefly reviews the development of regulatory agency guidelines for toxicity testing and the impact of the maximum tolerated dose (MTD) concept on chronic study designs within and outside of the regulatory arena. From the orientation of an inhalation toxicologist, the MTD is viewed as a difficult and costly concept to implement and one that is generally inappropriate as a general basis for setting dust exposure levels in sub-chronic and chronic inhalation toxicity studies. Two possible alternatives are discussed, especially in the context of accumulating evidence that most dusts, even the most innocuous, when presented in excessive amounts produce a spectrum of pulmonary responses that cannot be dissociated from injury.
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24

Doan, Cong Dang Phi, Dan Phuoc Nguyen, An Khanh Huynh, and Hai Xuan Son Tran. "ASSESSMENT OF TOXICITY OF TYPICAL INDUSTRIAL EFFLUENTS." Science and Technology Development Journal 12, no. 2 (January 28, 2009): 121–31. http://dx.doi.org/10.32508/stdj.v12i2.2212.

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This study aims to assess acute and chronic toxicity of some typical industrial wastewater such as textile, latex processing, paper mill, alcohol processing and leachate from municipal landfills. This result of EC50 and LC50 tests using different testing organisms showed that the toxicity of effluent is not directly proportional to COD concentration, but it depends upon BOD, ammonia, nitrite and TDS. Based on results of this study, the limited COD value of the industrial effluent quality standards for the typical industry is suggested.
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25

Flohr, Letícia, Armando Borges de Castilhos Júnior, and William Gerson Matias. "Acute and Chronic Toxicity of Soluble Fractions of Industrial Solid Wastes onDaphnia magnaandVibrio fischeri." Scientific World Journal 2012 (2012): 1–10. http://dx.doi.org/10.1100/2012/643904.

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Industrial wastes may produce leachates that can contaminate the aquatic ecosystem. Toxicity testing in acute and chronic levels is essential to assess environmental risks from the soluble fractions of these wastes, since only chemical analysis may not be adequate to classify the hazard of an industrial waste. In this study, ten samples of solid wastes from textile, metal-mechanic, and pulp and paper industries were analyzed by acute and chronic toxicity tests withDaphnia magnaandVibrio fischeri. A metal-mechanic waste (sample MM3) induced the highest toxicity level toDaphnia magna(CE50,48 h=2.21%). A textile waste induced the highest toxicity level toVibrio fischeri(sample TX2,CE50,30 min=12.08%). All samples of pulp and paper wastes, and a textile waste (sample TX2) induced chronic effects on reproduction, length, and longevity ofDaphnia magna. These results could serve as an alert about the environmental risks of an inadequate waste classification method.
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26

Tišler, Tatjana, and Jana Zagorc-Končan. "Toxicity evaluation of wastewater from the pharmaceutical industry to aquatic organisms." Water Science and Technology 39, no. 10-11 (May 1, 1999): 71–76. http://dx.doi.org/10.2166/wst.1999.0632.

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The aim of our research was to evaluate the acute and chronic toxicity of wastewater from the pharmaceutical industry to some aquatic organisms. The toxicity of three 24h proportional samples of wastewater was determined with the acute toxicity tests using the bacterium Vibrio fischeri and daphnid Daphnia magna. The inhibition of bacterial luminescence was measured after a 30 min exposure period and the immobility of daphnids was determined after 24 and 48h. The chronic effects on daphnid survival and reproduction were observed for three weeks. The toxicity tests indicated that all investigated samples were acutely toxic to the organisms, but in each sample the responses of bacteria and daphnids were quite different. Acute and chronic effects on daphnids were observed when testing the first sample of wastewater, but no influence on bacteria was determined. The second sample was acutely toxic to both organisms. The third sample was toxic only to bacteria, while no influence on daphnid survival and reproduction was found. The reason for the different toxicity of the samples lay in their compositions. The comparison between chemical analyses and toxicity data showed that for daphnids the main cause of toxic effects was zinc.
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27

Mitchell, R. I., D. J. Donofrio, and W. J. Moorma. "Chronic Inhalation Toxicity of Fibrous Glass in Rats and Monkeys." Journal of the American College of Toxicology 5, no. 6 (November 1986): 545–75. http://dx.doi.org/10.3109/10915818609141025.

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Numerous reports have shown that fibrous glass has the potential to cause fibrogenic and carcinogenic responses in test animals. The experiments producing significant response have, however, used unrealistic routes of exposure. The increased demand for fibrous glass for insulating purposes where respirable fibers may exist presents considerable concern for potential health problems. Therefore, a long-term inhalation study was conducted with F344 rats and cynomolgus monkeys exposed in treatments characterized by fibers of varying geometry and mass concentrations. A workweek type of exposure (7 hours/day, 5 days/week) was maintained for 18 months with monkeys and 21 months with rats, which were subsequently held to 80% mortality. The evaluation of response included life table analysis, body weights, clinical signs, hematological testing, respiratory function, ophthalmic examinations, clinical biochemical analysis, and gross and microscopic pathological examinations. Both species demonstrated pulmonary macrophage aggregates and granulomas containing fibrous glass. The rats had grossly visible pleural plaques, which were not seen in the monkeys. There was no evidence of pulmonary or mesothelial carcinogenicity or fibrogenicity in either species. There were no other significant responses with the exception of a statistically increased mononuclear cell leukemia in each fiber-exposed rat group.
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28

Abbiramy, K. S., P. Ronald Ross, and Joothi Paramanandham. "Validation of Tropical Artificial Soil by Chronic Toxicity Studies on Eisenia fetida against Superphosphate." International Letters of Natural Sciences 13 (April 2014): 31–40. http://dx.doi.org/10.18052/www.scipress.com/ilns.13.31.

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The research methodology recommended by the OECD (Organization of Economic Co-operation and Development) and ISO (International Organization for Standardization) guidelines for testing of chemicals meets the most criteria expected for ecotoxicological testing except the testing condition and the organic matter. The guidelines were initially developed by temperate countries, with testing conditions as 20 °C and the organic matter as sphagnum peat which is commonly available in those countries. But these two criterions are difficult to be followed in tropical countries. Thus there arises a need of modifying these criterions for toxicity studied in tropical regions. In this study a trial was made for substituting the fermented coir pith for sphagnum peat and the validation of the modified tropical artificial soil (TAS) was done by conducting chronic toxicity studies on Eisenia fetida against an inorganic fertilizer, superphosphate (SP) under tropical condition, i.e., 28 ±2 °C. The performed study showed that the SP determined lower earthworm mortality in TAS comparing to OECD soil for all tested concentration levels. The number of juveniles produced in OECD soil was also significantly reduced (p < 0.05) than in TAS. This may be due to the production of large amount of hydrogen ions when the temperature increases and making the medium acidic. The fermented coir pith was more suitable for ecotoxicity studies under tropical condition than sphagnum peat.
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29

Bailey, H. C., and Leslie Young. "A comparison of the results of freshwater aquatic toxicity testing of pulp and paper mill effluents." Water Science and Technology 35, no. 2-3 (February 1, 1997): 305–13. http://dx.doi.org/10.2166/wst.1997.0545.

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Freshwater short-term chronic toxicity tests were conducted quarterly on samples from pulp and paper mills under Cycle I of Canada's Environmental Effects Monitoring program. The toxicity tests included the 7-dayCeriodaphnia dubia partial life-cycle test for survival and reproduction, the 7-day rainbow trout (Oncorhynchus mykiss) embryo viability test, and the 72-hr Selenastrum capricornutum algal growth inhibition test. All three tests were performed on a routine basis with few failures. The responses of the different species were generally not correlated, suggesting that they responded to different constituents in the effluents. On a statistical basis, the algal test exhibited the greatest sensitivity, followed by the trout embryo and Ceriodaphnia tests. In general, the no-observable effect concentrations (NOECs) were lower than the corresponding IC25 estimates. Due to variability between samples from each mill, it was not possible to distinguish between different mill production processes with respect to their effect on toxicity. In general, mills that treated their effluent using aerated stabilization basins exhibited less toxicity than other treatment types. However, this observation is preliminary and also affected by variability in test results and limited sample size. Overall, the results suggest that toxicity tests have a useful role in identifying toxicity in these effluents and that Toxicity Identification Evaluations should be conducted to identify the cause of toxicity so that treatment and/or source control can be initiated as appropriate.
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Carter, J. T., J. Rhaly, and W. Carter. "A Case Study: Biological Interference in Chronic Whole Effluent Toxicity Testing of a Municipal Wastewater." Proceedings of the Water Environment Federation 2000, no. 5 (January 1, 2000): 410–18. http://dx.doi.org/10.2175/193864700785155993.

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Moore, Timothy F., Steven P. Canton, and Max Grimes. "Investigating the Incidence of type i errors for chronic whole effluent toxicity testing usingCeriodaphnia dubia." Environmental Toxicology and Chemistry 19, no. 1 (January 2000): 118–22. http://dx.doi.org/10.1002/etc.5620190114.

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Gellert, Georg. "Sensitivity and Significance of Luminescent Bacteria in Chronic Toxicity Testing Based on Growth and Bioluminescence." Ecotoxicology and Environmental Safety 45, no. 1 (January 2000): 87–91. http://dx.doi.org/10.1006/eesa.1999.1849.

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33

Rogers, S. E., and W. C. Lauer. "Denver's Demonstration of Potable Water Reuse: Water Quality and Health Effects Testing." Water Science and Technology 26, no. 7-8 (October 1, 1992): 1555–64. http://dx.doi.org/10.2166/wst.1992.0599.

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The product water of the Denver (Colorado) Potable Water Reuse Demonstration Plant is compared to national and international standards for drinking water quality and with the high quality of the present drinking water supply. For parameters which cannot be analyzed or quantified, health effects testing is performed on concentrates of the existing and the innovative supplies. In order to determine relative risk, the health effects are assessed using the measures of chronic toxicity, carcinogenicity, and reproductive toxicity. For measurable constituents, the potable reuse product water equals or exceeds the high quality of Denver's existing drinking water. The preliminary results of the health effects testing demonstrate no health effects associated with either water. Potable reuse is shown to be an acceptable alternative water source which should be evaluated with other traditional supplies.
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Homburger, F., C. G. Van Dongen, R. A. Adams, and E. Soto. "Hamsters and Gerbils: Advantages and Disadvantages as Models in Toxicity Testing." Journal of the American College of Toxicology 4, no. 1 (January 1985): 1–15. http://dx.doi.org/10.3109/10915818509014500.

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The need for additional species of laboratory animals for toxicity testing, especially for chronic (lifetime) carcinogenesis bioassay, becomes more apparent as data on such tests in mice and rats accumulate and undergo analysis. The results of approximately half of the lifetime carcinogenesis bioassays conducted by the National Cancer Institute and the National Toxicology Program were either equivocal or unevaluable. Some changes must, therefore, be considered for carcinogenesis bioassay guidelines, and foremost among such improvements would be the inclusion of a species with few spontaneous tumors, healthy parenchymal organs (especially liver), and proven susceptibility to administered standard carcinogens and other substances known to be carcinogenic to man or other laboratory animals. Mesocricetus auratus, the Syrian golden hamster, is such a species. A considerable body of background information on Syrian hamsters is available and continues to accumulate in the literature. Information on gerbils (Meriones unguiculatus) is less voluminous, but that which is known suggests that this species as well could contribute toward improvement in toxicological and carcinogenesis bioassays. There are some limitations, however, which apply to gerbils, namely, a much longer lifespan than most other laboratory rodents, fairly high frequency of spontaneous tumors, and great diversity in the nature of such naturally occurring tumors. Gerbil population genetics has been studied less thoroughly. Inbred Syrian hamsters and their genetically defined hybrids, standardized for carcinogenesis responsiveness, healthy and long-lived, are now readily available, making it possible to reproduce results at any time in different laboratories.
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Garcia, Ellen B., Cynthia Alms, Albert W. Hinman, Conor Kelly, Adam Smith, Marina Vance, Jadranka Loncarek, Linsey C. Marr, and Daniela Cimini. "Single-Cell Analysis Reveals that Chronic Silver Nanoparticle Exposure Induces Cell Division Defects in Human Epithelial Cells." International Journal of Environmental Research and Public Health 16, no. 11 (June 11, 2019): 2061. http://dx.doi.org/10.3390/ijerph16112061.

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Multiple organizations have urged a paradigm shift from traditional, whole animal, chemical safety testing to alternative methods. Although these forward-looking methods exist for risk assessment and predication, animal testing is still the preferred method and will remain so until more robust cellular and computational methods are established. To meet this need, we aimed to develop a new, cell division-focused approach based on the idea that defective cell division may be a better predictor of risk than traditional measurements. To develop such an approach, we investigated the toxicity of silver nanoparticles (AgNPs) on human epithelial cells. AgNPs are the type of nanoparticle most widely employed in consumer and medical products, yet toxicity reports are still confounding. Cells were exposed to a range of AgNP doses for both short- and-long term exposure times. The analysis of treated cell populations identified an effect on cell division and the emergence of abnormal nuclear morphologies, including micronuclei and binucleated cells. Overall, our results indicate that AgNPs impair cell division, not only further confirming toxicity to human cells, but also highlighting the propagation of adverse phenotypes within the cell population. Furthermore, this work illustrates that cell division-based analysis will be an important addition to future toxicology studies.
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Šestinová, Oľga, Lenka Findoráková, Silvia Dolinská, Jozef Hančuľák, Tomislav Špaldon, and Erika Fedorová. "Effect Of Environmental Load On The Toxicity Of Bottom Sediments." Nova Biotechnologica et Chimica 14, no. 1 (June 1, 2015): 78–86. http://dx.doi.org/10.1515/nbec-2015-0017.

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Abstract This study is devoted to Ecotoxicity tests, Terrestrial Plant Test (modification of OECD 208), Phytotoxkit microbiotest on Sinapis alba and chronic tests of Earthworm (Eisenia veneta), modification of OECD Guidelines for the testing of chemicals 317, Bioaccumulation in Terrestrial Oligochaetes on polluted sediments. Earthworms can accelerate the removal of contaminants from soil. The study materials are river sediments, which were obtained from a monitoring station - the Water reservoir the Ružín No.1 particularly, the river Hornád, Hnilec and sample from sludge bed Rudňany. The samples of sediment were used to assess of the potential phytotoxic effect of heavy metals on higher plants. Total mortality was established in earthworms using chronic toxicity test after 7 and 28 exposure days. Based on the phytotoxicity testing, phytotoxic effects of the metals contaminated sediments from the sludge bed Rudňany on S. alba seeds was observed. The largest concentration differences were recorded in the sample R7 after 7 days earthworms exposure. The earthworms mortality was not influenced by sediment neither after 7 nor 28 exposure days The spectra of samples H, HO and R showed broad peak at 1 419 - 1 512 cm−1 characteristic for carbonate radical. In the spectra of the samples (R and R7) the vibration of C-H groups at 2 926 and 2 921 cm−1, respectively were also observed, demonstrating the presence of organic matter. Our research will continue with determination of metals concentration in earthworms.
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Moore, Timothy F., Steven P. Canton, and Max Grimes. "INVESTIGATING THE INCIDENCE OF TYPE I ERRORS FOR CHRONIC WHOLE EFFLUENT TOXICITY TESTING USING CERIODAPHNIA DUBIA." Environmental Toxicology and Chemistry 19, no. 1 (2000): 118. http://dx.doi.org/10.1897/1551-5028(2000)019<0118:itioti>2.3.co;2.

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Lin, George H. Y., and Robert Mermelstein. "Acute Toxicity Studies of Xerox Reprographic Toners." Journal of the American College of Toxicology 13, no. 1 (February 1994): 2–20. http://dx.doi.org/10.3109/10915819409140650.

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Typical reprographic toners consist of a thermoplastic polymer or polymers as the major component, a colorant or colorants (carbon black or color pigments), and small quantities of additives such as charge control and/or lubricating/release agents. Another type of toner contains iron oxides and polymers) as the major components. As a complement to the recently published Xerox chronic inhalation studies of toners, we are reporting the acute toxicity studies of some typical Xerox toners. The studies include acute oral toxicity in rats, acute dermal toxicity in rabbits, acute inhalation toxicity in rats, eye irritation in rabbits, skin irritation in rabbits, skin sensitization in guinea pigs, and the repeated-insult patch test in humans. These studies represent our acute toxicity testing using different protocols with various toners carried out during the period 1969–1984. In addition, we recently carried out acute dermal toxicity testing at 5 g/kg with two representative toners, for the purpose of classification of waste toners in the State of California. The test results consistently indicate that all toners were practically nontoxic: oral LD50 from <5 to <35 g/kg; dermal LD50 from <2 to <5 g/kg; and inhalation LC50 (4 h) from <0.17 to <10.2 g/m3. They were nonirritating to the eye and nonirritating/ nonsensitizing to the skin.
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Dorgelo, Folke O., Erik Biessen, and Gerrit M. Alink. "Are Cultured Neonatal Rat Heart Cells a Suitable Model for Predicting Acute and Chronic Toxicity In Vivo?" Alternatives to Laboratory Animals 14, no. 1 (September 1986): 14–22. http://dx.doi.org/10.1177/026119298601400104.

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Beating heart cells isolated from neonatal rats were used in an in vitro assay for testing the influence of chemical compounds on beating frequency. Half of the studied compounds had a no-effect level (NEL) in vivo based on changes in body weight or organ weight. Correlations were obtained between in vivo parameters such as LD50 values in acute toxicity studies and NELs in chronic toxicity studies, and in vitro parameters such as reduction in beating frequency and arrest of contraction. The in vitro parameters correlated well with in vivo LD50 values, but poorly with NELs in vivo.
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40

Diener, Robert M. "Harmonization of Drug Safety Guidelines: A Perspective from the Pharmaceuticals Industry." Journal of the American College of Toxicology 11, no. 3 (May 1992): 293–97. http://dx.doi.org/10.3109/10915819209141864.

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The Pharmaceutical Manufacturers Association (PMA) and the International Federation of Pharmaceutical Manufacturers Association (IFPMA) have taken a leading role in the current harmonization efforts, which also include issues on quality assurance and clinical efficacy, although these subjects will not be addressed here. Important preclinical testing issues were identified by industry and regulatory expert working groups in Europe, Japan, and the United States. The most critical issues were then selected, and regulatory agencies in each country were encouraged to address the possible resolution of national differences. The issues under discussion include acceptable requirements for single-dose testing in rodents and nonrodents; clarification of no-effect, delayed-effect, and toxic-effect dose levels in repeated-dose toxicity studies; 6-versus 12-month requirements for chronic toxicity studies; clarification and harmonization of requirements for developmental toxicity studies; standards/issues for biotechnology safety studies; and the timing of toxicity studies versus the conduct of clinical trials. Final resolutions and agency positions were presented during the First International Conference on Harmonization held November 5–7 in Brussels, Belgium.
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41

Ruberg, Elizabeth J., Tony D. Williams, and John E. Elliott. "Review of petroleum toxicity in marine reptiles." Ecotoxicology 30, no. 4 (March 16, 2021): 525–36. http://dx.doi.org/10.1007/s10646-021-02359-9.

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AbstractWorldwide petroleum exploration and transportation continue to impact the health of the marine environment through both catastrophic and chronic spillage. Of the impacted fauna, marine reptiles are often overlooked. While marine reptiles are sensitive to xenobiotics, there is a paucity of petroleum toxicity data for these specialized fauna in peer reviewed literature. Here we review the known impacts of petroleum spillage to marine reptiles, specifically to marine turtles and iguanas with an emphasis on physiology and fitness related toxicological effects. Secondly, we recommend standardized toxicity testing on surrogate species to elucidate the mechanisms by which petroleum related mortalities occur in the field following catastrophic spillage and to better link physiological and fitness related endpoints. Finally, we propose that marine reptiles could serve as sentinel species for marine ecosystem monitoring in the case of petroleum spillage. Comprehensive petroleum toxicity data on marine reptiles is needed in order to serve as a foundation for future research with newer, unconventional crude oils of unknown toxicity such as diluted bitumen.
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42

Plengsuriyakarn, Tullayakorn, and Kesara Na-Bangchang. "Preclinical Toxicology and Anticholangiocarcinoma Activity of Oral Formulation of Standardized Extract of Zingiber Officinale." Planta Medica 86, no. 02 (November 27, 2019): 104–12. http://dx.doi.org/10.1055/a-1037-4081.

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AbstractCholangiocarcinoma (CCA) remains a significant public health problem in Thailand. New effective and safe drugs are urgently needed. Zingiber officinale Roscoe (ZO) is a widely used medicinal plant for the treatment of several ailments, and the animal study suggests a potential anti-CCA activity. The present study aimed to develop the oral formulation of standardized extract of ZO and investigate toxicological profiles (acute, repeated dose, and chronic toxicity), including anti-CCA activity of the ZO formulation. The oral pharmaceutical formulation of the standardized ZO extract was successfully developed with an acceptable level of contamination and physicochemical and pharmaceutical properties. Acute, subacute, and chronic toxicity tests were conducted in healthy Sprague Dawley rats according to the OECD guidelines. The results showed no evidence of toxicity and death in the acute and subacute toxicity testing with the maximum tolerated dose (MTD) of 5000 and 2000 mg/kg body weight, respectively. Chronic toxicity revealed MTD and No-Observed-Adverse-Effect level (NOAEL) of 1000 mg/kg body weight. The anti-CCA activity was evaluated in CCA-xenografted mouse model. The formulated ZO powder was fed to animals daily for 30 days. Significant anti-CCA activity on tumor growth inhibition and prolongation of survival time were demonstrated at the high (2000 mg/kg body weight) and moderate (1000 mg/kg body weight) dose levels. Further investigation to elucidate molecular targets of action of ZO against CCA cells is encouraged.
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43

Vergauwen, Lucia, Ronny Blust, Hilda Witters, Sandra Verstraelen, Daniel L. Villeneuve, Gerald T. Ankley, and Dries Knapen. "Development of an alternative testing strategy for the fish early life stage test for predicting chronic toxicity." Toxicology Letters 221 (August 2013): S104. http://dx.doi.org/10.1016/j.toxlet.2013.05.159.

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44

Sun, Kai, Gary F. Krause, Foster L. Mayer, Mark R. Ellersieck, and Asit P. Basu. "Predicting chronic lethality of chemicals to fishes from acute toxicity test data: Theory of accelerated life testing." Environmental Toxicology and Chemistry 14, no. 10 (October 1995): 1745–52. http://dx.doi.org/10.1002/etc.5620141015.

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45

Denoyelle, Mariéva, Emmanuelle Geslin, Frans J. Jorissen, Laurent Cazes, and François Galgani. "Innovative use of foraminifera in ecotoxicology: A marine chronic bioassay for testing potential toxicity of drilling muds." Ecological Indicators 12, no. 1 (January 2012): 17–25. http://dx.doi.org/10.1016/j.ecolind.2011.05.011.

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46

Millot, Frédéric, Joelle Guilhot, Brigitte Nelken, Jean-Pierre Lamagnère, Thierry Leblanc, Guy Leverger, Anne Notz, et al. "Results of a Phase II Trial Testing Interferon Alpha 2b and Cytarabine in Children with Chronic Myelogenous Leukemia." Blood 104, no. 11 (November 16, 2004): 1000. http://dx.doi.org/10.1182/blood.v104.11.1000.1000.

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Abstract Before the Imatinib era, a prospective phase II trial was conducted in 2000 to assess the efficacy and the tolerance a combination of interferon alpha 2b (IFN) and cytarabine in children and adolescents with chronic myelogenous leukemia in first chronic phase without a suitable HLA-identical donor. Children received daily IFN (5 million units/m2) and subcutaneous cytarabine (20 mg/m2) for monthly course of 10 days. Between September 2000 and March 2003, 14 children (10 males, 4 females) median age 12 years (range 2–16.5) were recruited from 12 french centres. Patients (pts) were evaluated for time to, rate of hematologic and cytogenetic responses, toxicity and progression free survival. The median duration of follow-up is 13 months (range 2–32 mo). Eight pts achieved a complete hematologic response after a median time of treatment of 3 months (range 0–4 mo) including a pt enrolled in complete hematologic response after 1 month of therapy with hydroxyurea. Three pts were not evaluable for the cytogenetic response (early discontinuation for toxicity, no achievement of complete hematologic response within 3 months of treatment, progression). The best cytogenetic response by 12 months was: major response in 7 pts including complete cytogenetic response in 2 pts, minor response in 3 pts and failure in 1 pt. The median time to major cytogenetic response was 7 months (range 3–12 mo). Thirteen pts discontinued treatment protocol with a median time of 11 months for the following reasons: absence of complete hematologic response at 3 months (2 pts), loss of hematologic response (2 pts), absence of major cytogenetic response at 12 months (1 pt ), loss of major cytogenetic response (2pts), progression (3 pts), adverse event (1pt), other (2 pts). Probability of progression free survival at 18 months was 66% (95% CI, 34–98%). No treatment-related death occurred. The most frequently reported drug-related events were fever, mucositis, neutropenia and thrombocytopenia. Grade 3 and 4 non hematologic toxicity (fever and mucositis) was observed in 4 pts and grade 3 and 4 hematologic toxicity (anemia, neutropenia and thrombocytopenia) in 7 pts. The median total dose of IFN and cytarabine administered was 3.7 million units/m2 /day (range 2.3–5.1) and 20 mg/m2 /day (range 11–23). The median duration of IFN therapy was 11 months (range1–117 mo). The median number of courses of cytarabine was 7 (range 1–37). The combination of IFN and cytarabine is a well tolerated therapy providing hematologic and cytogenetic responses in children and adolescents with CML. Rates of hematologic and cytogenetic responses compare favourably with results observed in adults. Results should be compared to these of imatinib in children and adolescents.
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47

Joseph, Lovelyn, Rejeesh Edavan Puthallath, and Sundarshanram Narayan Rao. "Acute and chronic toxicity study of Valeriana wallichii rhizome hydro-ethanolic extract in Swiss albino mice." Asian Journal of Medical Sciences 7, no. 2 (November 5, 2015): 49–54. http://dx.doi.org/10.3126/ajms.v7i2.13326.

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Aims and Objective: To evaluate acute and chronic (90 days) oral toxicity of Valeriana wallichii rhizome hydroethanolic extract in Swiss albino mice.Materials and Methods: Valeriana wallichii rhizome was subjected to extraction with Soxhlet apparatus, using ethanol (90%) + water (10%) mixture and dried withrotavapor. Phytochemical fingerprinting of the extract was done with LC/MS (Liquid chromatography–mass spectrometry). Limit Test for acute oral toxicity at 2000 mg/kg body weight was conducted according to OECD guideline no 425. Chronic 90 day oral toxicity study with three different dose groups (200, 600, 1800 mg/kg/body weight/day) with selected in life parameters (physical, behavioural) and post mortem parameters (haematological, biochemical, gross necropsy and histopathological) as per WHO guidelines for testing safety of herbs was conducted.Results: Acute toxicity: no signs of abnormality, morbidity or mortality were observed during 14 days of observation. Chronic toxicity: Significant differences between the treated and control groups were observed in the following parameters: Loss of Auditory startle, Aggressiveness (Control > treated), Nasal discharge, Dyspnoea. At necropsy, tracheitis was observed in 3 cases. Results from Photoactometer test indicates dose dependent increase in sedative property.Conclusion: From this work it could be concluded that Valerianawallcihii rhizome hydroethanolic extract didn’t exhibit mortality, morbidity or any other neurologic, hematologic or biochemical adverse effects apart from sedation which is extension of their known pharmacological activity, after single oral dose of 2000mg/ kg bw (14 days of observation) or after once daily 200mg/kg, 600mg/kg 1800mg/kg oral treatment for 90days in healthy adult Swiss albino mice.Asian Journal of Medical Sciences Vol.7(2) 2015 49-54
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48

Shank, Kaitlyn R., Priya Koppikar, Neha Bhagwat, Matthew D. Keller, Franziska Michor, Ross L. Levine, and Laura De Vargas Roditi. "Mathematical Optimization of JAK Inhibitor Dose and Scheduling for MPN Patients." Blood 124, no. 21 (December 6, 2014): 911. http://dx.doi.org/10.1182/blood.v124.21.911.911.

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Abstract The identification of JAK-STAT pathway mutations in the majority of patients with the myeloproliferative neoplasms (MPN) polycythemia vera (PV), essential thrombocytosis (ET), and primary myelofibrosis (PMF) led the to clinical development of JAK inhibitors, and the resultant approval of ruxolitinib for the treatment of PMF. However, despite this important therapeutic advance, there are significant limitations to JAK inhibitor therapy both with respect to efficacy and toxicity. First, although JAK inhibitors reduce splenomegaly, ameliorate symptoms, and improve long-term outcome, they do not achieve molecular or pathologic remission at currently utilized dosing strategies. Second, JAK2 has a role in hematopoiesis and other biological processes, and JAK inhibition leads to significant hematologic toxicities including anemia and thrombocytopenia. We recently used genetic and pharmacologic studies to demonstrate that JAK inhibitor persistent cells which survive JAK inhibitor therapy in vitro and in vivo remain JAK2 dependent, consistent with incomplete target inhibition. As such, we hypothesized that alternate dosing regimens which allow for intermittent, maximal target inhibition might increase efficacy and reduce toxicity. We therefore used experimental and modeling approaches to investigate the potential efficacy of alternate dosing regimens. We first explored the effects of chronic vs intermittent dosing in vitro by altering the treatment regimen in cell lines. To this end, we treated the JAK2 V617F mutant cell line, SET-2, and JAK2-wild-type (control) cell lines with ruxolitinib (1µM vs 0.5 µM) on a chronic or intermittent (alternating 1 week on and 1 week off the drug) basis. We then performed cell viability assays using flow cytometry to estimate the effect of the drug on the cell division and death rates of each cell population. Using this data, we developed a mathematical model to predict responses to varying dose therapy. Cell proliferation was described using an exponential growth model (pt2 = pt1 e(birth rate-death rate)Dt, p=population size). Birth and death rates as a function of the drug concentration was fitted using a simple iterative least squares estimation from the in vitro collected data, where death(c) = 0.0046log(1.5014 + 30.4910c) and birth(c) = 0.0098 + 0.0051e-1.2946c. Treatment cycles were modeled by ton + toff for pulsitile versus chronic (toff = 0) regimens for time on and off drug. We also added a toxicity constraint based on preclinical testing and the mathematical model T(c) = (α/c) –β, where α = 539 and β=5.2, which will inform our in vivo studies. Inputting these rates into a mathematical model to predict optimal treatment schedule, our in silico analysis suggest that high dose pulse treatment of INCB18424 has the same efficacy as chronic dosing and is associated with reduced toxicity. We are currently testing our dosing and administration schedules using in vivo models of MPN, and we will present these data at the meeting. Preliminary studies suggest intermittent JAK inhibition shows similar efficacy as chronic JAK inhibition, with reduced toxicity, suggesting our in silico models inform the development of more optimal dosing regimens. We are now testing higher doses of JAK inhibitors in an intermittent administration regimen in order to maximize efficacy and mitigate hematologic and non-hematologic toxicity. In conclusion, our proof-of-principle studies show that intermittent treatment with JAK kinase inhibitors demonstrates equivalent efficacy in vitro and our in silico data suggests that we will see reduced toxicity with intermittent dosing in the mouse models. Our in vivo data will inform further clinical optimization of treatment regiments for patients with myeloproliferative neoplasms Disclosures Koppikar: Amgen: Employment. Levine:Novartis: Consultancy, Grant support Other.
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49

Sachuk, R. M., Ya S. Stravsky, O. A. Katsaraba, and S. V. Zhigalyuk. "Parameters of chronic toxicity of the solution for intrauterine use “Yodozol”." Scientific Messenger of LNU of Veterinary Medicine and Biotechnologies 21, no. 95 (November 2, 2019): 139–43. http://dx.doi.org/10.32718/nvlvet9526.

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The study of the chronic toxicity of the solution for intrauterine use in the form of aerosol – “Yodosol”, is a mandatory stage of preclinical study of the drug, which is a new development of PE «Biopharm» and the Experimental Station of epizootology of the Institute of Infectious Diseases of NAAN. In a scientific experiment on laboratory animals, it is possible to evaluate the safety of the drug at different times of use, to determine the area of toxic action and doses that do not cause adverse health effects. Therefore, the purpose of the study was to study the chronic toxicity of the drug “Yodosol”, in particular the determination of tolerant and toxic doses for rodents. The experiments were carried out in accordance with the requirements for biomedical research, the selection of analogues for testing and control, ensuring the same conditions of feeding and retention, as well as accounting for results. “Yodosol” is a light yellow foamy liquid with 1 ml containing 5 mg iodine and 10 mg potassium iodide. The drug is used for the prevention and treatment of postpartum intrauterine infections in cows, pigs, sheep and goats (endometritis, pyrometers, cervicitis, vaginitis, delayed litter caused by iodine-sensitive microorganisms), after delivery of rhododerma, caesarean delivery and caesarean delivery. The drug has antimicrobial, anti-inflammatory and analgesic effects, improves proliferative processes in the tissues of the genital organs, helps to reduce the time of recovery of animals. The drug is used according to the guideline, after its livestock products are used without restrictions. No significant deviations in the behavior of the experimental animals were observed in the studies of chronic toxicity of the drug “Yodosol”. Visually noted only a slight inhibition of the rats of the experimental group, which received a 10-fold overdose. According to biochemical studies, in the group, compared with the control animals, there was a slight deviation of the indicators of protein metabolism and activity of hepatospecific enzymes: growth of total protein, alkaline phosphatase and aspartateaminotransferase. However, such changes in the blood parameters of the experimental animals were short-lived and restorative, characterizing the study drug as low-toxic. All studies conducted to determine the parameters of chronic toxicity of the solution for intrauterine use of “Yodosol” included in the registration materials of the medicinal product.
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50

Watts, Matthew M., and David Pascoe. "Selection of an appropriate life-cycle stage of Chironomus riparius meigen for use in chronic sediment toxicity testing." Chemosphere 36, no. 6 (March 1998): 1405–13. http://dx.doi.org/10.1016/s0045-6535(97)10041-8.

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