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At least 19 recordsLinked to original sources
PubMed2006

Evaluating the risk to aquatic ecosystems posed by leachate from tire shred fill in roads using toxicity tests, toxicity identification evaluations, and groundwater modeling.

The risk to adjacent aquatic systems posed by leachates from scrap tires used in engineering applications has not been characterized adequately. Toxicity testing, toxicity identification evaluation (TIE), and groundwater modeling were used to determine the circumstances under which tire shreds could be used as roadbed fill with negligible risk to aquatic organisms in adjacent water bodies. Elevated levels of iron, manganese, and several other chemicals were found in tire shred leachates. However, chronic toxicity tests with Ceriodaphnia dubia and fathead minnows (Pimephales promelas) showed no adverse effects caused by leachates collected from tire shreds installed above the water table. Exposure to leachates collected from tire shreds installed below the water table resulted in significant reductions to both survival and reproduction in C. dubia. The TIE results indicated that exposure to soluble metals (likely ferrous iron primarily) and the formation of iron hydroxide precipitates on this invertebrate species likely were the causes of the observed effects. The available chemistry data show that iron concentrations in the affected groundwater decreased substantially within a short distance (0.61 m) downgradient of tire shred fill. Based on geochemical modeling, the use of tire shreds in applications below the water table is appropriate in settings where dissolved oxygen is greater than 2.0 mg/L, pH is greater than 5.8, and a downgradient buffer of approximately 3.0 m exists between the fill and the surface water. For settings with lower dissolved oxygen concentrations or lower pH, results of groundwater modeling indicate that a greater buffer distance (approximately 11 m) is needed to dilute the leachate to nontoxic levels under various soil and groundwater conditions solely through advection and dispersion processes.

Animals↗
PubMed2004

An assessment of five Australian polychaetes and bivalves for use in whole-sediment toxicity tests: toxicity and accumulation of copper and zinc from water and sediment.

The suitability of two polychaete worms, Australonereis ehlersi and Nephtys australiensis, and three bivalves, Mysella anomala, Tellina deltoidalis, and Soletellina alba, were assessed for their potential use in whole-sediment toxicity tests. All species except A. ehlersi, which could not be tested because of poor survival in water-only tests, survived in salinities ranging from 18 per thousand to 34 per thousand during the 96-hour exposure period. No mortality was observed in any of the species exposed to sediment compositions ranging from 100% silt to 100% sand for 10 days, thus demonstrating the high tolerance of the five species to a wide range of sediment types. All species showed decreased survival after exposure to highly sulfidic sediments in 10-day whole-sediment tests. In 96-hour water-only tests, survival decreased, and copper accumulation in body tissues increased with exposure to increasing copper concentration for all species except A. ehlersi, which again could not be tested because of its poor survival in the absence of sediment. S. alba and T. deltoidalis were the most sensitive species to aqueous copper (LC50s of 120 and 150 microg Cu/L, respectively). All species tested were relatively insensitive to dissolved zinc up to concentrations of approximately 1,000 microg/L. In addition and with the exception of N. australiensis, all species accumulated significant levels of zinc in their body tissues. Whole-sediment tests were conducted over a 10-day period with copper-spiked (1,300 microg/g) and zinc-spiked (4,000 microg/g) sediments equilibrated for sufficient time to ensure that pore water metal concentrations were well below concentrations shown to have any effect on organisms in water-only tests. Survival was decreased in the bivalves T. deltoidalis and S. alba after exposure to copper-spiked sediments, and all species-except T. deltoidalis, in which 100% mortality was observed-accumulated copper in their tissues. Exposure to zinc-spiked sediments significantly decreased the survival of only one species, T. deltoidalis. Both polychaetes appeared to regulate concentrations of zinc in their body tissues with no significant uptake of zinc occurring from the sediment phase. Of the five species assessed in this study, T. deltoidalis was found to be the most sensitive to copper- and zinc-contaminated sediments, and based on commonly used selection criteria (ASTM 2002a, ASTM 2002b, ASTM 2002c) is recommended for development as test species in whole-sediment toxicity tests.

Animals↗
PubMed2005

Assessing contaminant sensitivity of endangered and threatened aquatic species: part III. Effluent toxicity tests.

Toxicity tests using standard effluent test procedures described by the U.S. Environmental Protection Agency were conducted with Ceriodaphnia dubia, fathead minnows (Pimephales promelas), and seven threatened and endangered (listed) fish species from four families: (1) Acipenseridae: shortnose sturgeon (Acipenser brevirostrum); (2) Catostomidae; razorback sucker (Xyrauchen texanus); (3) Cyprinidae: bonytail chub (Gila elegans), Cape Fear shiner (Notropis mekistocholas) Colorado pikeminnow (Ptychocheilus lucius), and spotfin chub (Cyprinella monacha); and (4) Poecillidae: Gila topminnow (Poeciliopsis occidentalis). We conducted 7-day survival and growth studies with embryo-larval fathead minnows and analogous exposures using the listed species. Survival and reproduction were also determined with C. dubia. Tests were conducted with carbaryl, ammonia--or a simulated effluent complex mixture of carbaryl, copper, 4-nonylphenol, pentachlorophenol and permethrin at equitoxic proportions. In addition, Cape Fear shiners and spotfin chub were tested using diazinon, copper, and chlorine. Toxicity tests were also conducted with field-collected effluents from domestic or industrial facilities. Bonytail chub and razorback suckers were tested with effluents collected in Arizona whereas effluent samples collected from North Carolina were tested with Cape Fear shiner, spotfin chub, and shortnose sturgeon. The fathead minnow 7-day effluent test was often a reliable estimator of toxic effects to the listed fishes. However, in 21 % of the tests, a listed species was more sensitive than fathead minnows. More sensitive species results varied by test so that usually no species was always more or less sensitive than fathead minnows. Only the Gila topminnow was consistently less sensitive than the fathead minnow. Listed fish species were protected 96% of the time when results for both fathead minnows and C. dubia were considered, thus reinforcing the value of standard whole-effluent toxicity tests using those two species. If the responses of specific listed species are important for management decisions, our study supports the value in developing culture and testing procedures for those species.

Animals↗
PubMed1977

Pertussis vaccine: mouse-weight-gain (toxicity) test.

Toxicity tests based on mouse-weight-gain (whether control of pertussis, DPT, cholera or typhoid vaccine) are not satisfactory, particularly since the vaccines may be adsorbed and non-adsorbed preparations. Comparison between results of tests in animals some of which were treated with vaccine and others with saline does not allow to make conclusions as valid as those supplied by a standard control vaccine (adsorbed and not adsorbed) instead of saline.

Animals↗
PubMed1983

Relevance of parameters related to fertility and reproduction in toxicity testing.

Toxicity data of 37 compounds tested in both a subchronic study and one or more studies focused on reproduction were evaluated to obtain information on the significance of fertility and reproduction parameters in setting no-effect levels (NEL). It appeared that a) the test system aimed at reproduction and development was more sensitive than the subchronic study for 35% of the selected compounds and was equally sensitive for another 35%; b) for 65% of these compounds parameters related to reproduction and development were at least codecisive in determining the minimal-effect level (MEL); c) for 21% of all compounds, parameters related to reproduction were the most sensitive and therefore decisive for the MEL. It was concluded that reproduction in its broadest sense is a very sensitive tool in toxicity testing. The possibilities of either applying a simple screen of fertility and reproduction at an early stage of toxicity testing or incorporating fertility and reproduction parameters in the current subchronic study are discussed.

Animals↗
PubMed2005

In vivo zebrafish assays for toxicity testing.

Toxicity, due to complications of in vivo adsorption, distribution, metabolism and excretion (ADME), is a major cause of failure during drug development; many drugs shown to be safe in cell culture prove toxic in animal studies. Effective in vivo toxicity screening early in the development process can reduce the number of compounds that progress to laborious and costly late-stage animal testing. The transparent zebrafish provides accessibility to internal organs, tissues and even cells, and has emerged as an invaluable model organism for toxicity testing and drug discovery. Straightforward in vivo zebrafish assays can serve as an intermediate step between cell-based and mammalian testing, thus streamlining the drug development time-line.

Animals↗
PubMed2000

A new screening test for toxicity testing of dental materials.

OBJECTIVES: The development of a micro plate assay for cytotoxicity testing of dental materials based on a bioassay using brine shrimp larvae (artemia salina) as sensitive organisms. METHODS: Brine shrimp larvae are commonly used for cytotoxicity assays in pharmacology. These larvae are sensitive to toxic substances. The ratio between dead larvae (no motility) and living larvae (high motility) in comparison to a control without any toxic substances is used to estimate the toxicity of the test solutions. The test materials (Arabesk((R)), Solitaire((R)), Pertac((R)) II, Tetric((R)), Herculite((R)) and the compomer materials Dyract((R)), Hytac((R)), Compoglass((R))) were polymerized and consecutively milled. After incubation of 1g in 4ml distilled water at 37 degrees C for 48h, the solid materials were separated by centrifugation. The solutions were equibrilated with NaCl to a salt content of 25g/l. Aliquots of 200microl were distributed in eight micro wells and 50microl of a artemia salina containing (n=8-14) solution were added to each well. As controls eight wells with 250microl salt solution containing a comparable number of brine shrimp were used. At baseline, after 2, 5, 24 and 48h, the dead shrimp were counted using a stereo microscope. Finally all shrimps were sacrificed using Na-acid (5%) and counted to get the number of shrimps per well. RESULTS: All compomers and Solitaire caused 100% brine shrimp lethality after 24h and showed significantly (p<0.01, signed rank test) higher toxicities than the remaining composites. With the exception of Pertac II, all composites showed significantly higher toxic values than the control. Pertac II did not show any differences from the controls used. CONCLUSIONS: This new technique has some advantages for toxicity testing of restorative materials, because it can quickly be carried out at low costs. The disadvantage is the high quantity of material used and the low sensitivity.

Animals↗
PubMed1999

International Conference on Harmonisation; guidance on the duration of chronic toxicity testing in animals (rodent and nonrodent toxicity testing); availability. Notice. Food and Drug Administration, HHS.

The Food and Drug Administration (FDA) is publishing a guidance entitled "S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and is intended to provide guidance on the duration of chronic toxicity testing in rodents and nonrodents as part of the safety evaluation of a drug product. FDA is also noting circumstances in which it may accept durations of chronic toxicity testing in nonrodents that differ from the duration generally recommended by ICH.

Animals↗
PubMed1986

The effects of purified components of Bordetella pertussis in the weight gain test for the toxicity testing of pertussis vaccines.

The effects of highly purified preparations of three Bordetella pertussis components--pertussis toxin (PT), lipopolysaccharide (LPS) and filamentous haemagglutinin (FHA)--were examined in the mouse weight gain test, a toxicity test for pertussis vaccine. When these components were administered alone, PT enhanced initial weight gains of the mice, LPS produced an initial weight loss and FHA had no detectable effect on the weights of the mice. However, testing the components in combinations revealed that the effect of PT and LPS together was not simply the sum of their individual effects. This combination generally produced lower weights than LPS alone, particularly in the later stages of the test.

Animals↗
PubMed2002

An investigation of new toxicity test method performance in validation studies: 1. Toxicity test methods that have predictive capacity no greater than chance.

An approach commonly used to measure new toxicity test method (NTM) performance in validation studies is to divide toxicity results into positive and negative classifications, and the identify true positive (TP), true negative (TN), false positive (FP) and false negative (FN) results. After this step is completed, the contingent probability statistics (CPS), sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) are calculated. Although these statistics are widely used and often the only statistics used to assess the performance of toxicity test methods, there is little specific guidance in the validation literature on what values for these statistics indicate adequate performance. The purpose of this study was to begin developing data-based answers to this question by characterizing the CPS obtained from an NTM whose data have a completely random association with a reference test method (RTM). Determining the CPS of this worst-case scenario is useful because it provides a lower baseline from which the performance of an NTM can be judged in future validation studies. It also provides an indication of relationships in the CPS that help identify random or near-random relationships in the data. The results from this study of randomly associated tests show that the values obtained for the statistics vary significantly depending on the cut-offs chosen, that high values can be obtained for individual statistics, and that the different measures cannot be considered independently when evaluating the performance of an NTM. When the association between results of an NTM and RTM is random the sum of the complementary pairs of statistics (sensitivity + specificity, NPV + PPV) is approximately 1, and the prevalence (i.e., the proportion of toxic chemicals in the population of chemicals) and PPV are equal. Given that combinations of high sensitivity-low specificity or low specificity-high sensitivity (i.e., the sum of the sensitivity and specificity equal to approximately 1) indicate lack of predictive capacity, an NTM having these performance characteristics should be considered no better for predicting toxicity than by chance alone.

False Negative Reactions↗
PubMed1996

Situational smoke toxicity testing: hazard assessment as the 'front end' of a smoke toxicity test.

Traditionally, the toxic potency of the smoke from a material or product is part of the assessment of the fire hazard in a given scenario. The assessment also requires a knowledge of virtually all the details of the fire environment and, until they are identified, a 'safe' or 'acceptable' level of smoke toxicity is a term without meaning. This paper suggests a method of using the knowledge of these factors to simplify smoke toxicity testing. Faster, cheaper, and better-targeted smoke toxicity tests would result if the rest of the hazard assessment were carried out first. This is accomplished by determining or specifying all the relevant fire properties except the toxic potency, identifying the other environmental conditions (such as those typical of an aircraft cabin interior) and the desired tenability limits (such as the minimum necessary escape time), and then solving the equations for the buildup of toxic conditions in terms of the single remaining unknown, the toxic potency. The result is the greatest toxic potency which would meet the requirements of the analysis. In this approach, a material or product is acceptable if its smoke is no more toxic then the computed result and unacceptable if it is not. It would not be necessary to obtain an EC50 (product concentration which will cause an effect in half the animals) or dose-response profile, only the response at whatever dose is dictated by the analysis. Two sample cases are presented to illustrate the technique.

Administration, Inhalation↗
PubMed2006

Alternative approaches can greatly reduce the number of fish used for acute toxicity testing.

Acute toxicity tests with algae, daphnids, and fish are required for the classification and environmental risk assessment of chemicals. The degree of risk is determined by the lowest of these acute toxicity values. Many ecotoxicological programs are seeking to reduce the numbers of fish used in acute toxicity testing. The acute threshold test is a recently proposed strategy that uses, on average, only 10 (instead of 54) fish per chemical. We examined the consequences of reducing the number of fish used in toxicity testing on the ultimate outcome of risk assessments. We evaluated toxicity data sets for 507 compounds, including agrochemicals, industrial chemicals, and pharmaceuticals from our internal database. Theoretical applications of the acute threshold test gave similar results to those obtained with the standard fish median lethal concentration (LC50) test but required only 12% as many fish (3195 instead of 27,324 fish used for all compounds in the database). In 188 (90%) of the 208 cases for which a complete data set was available, the median effect concentration for algae or daphnids was lower than the LC50 for fish. These results show that replacement of the standard fish LC50 test by the acute threshold test would greatly reduce the number of fish needed for acute ecotoxicity testing without any loss of reliability.

Animals↗
PubMed2004

Simultaneous modeling of multiple end points in life-cycle toxicity tests.

Standard toxicity tests do not allow extrapolations to the population level, mainly because these tests apply a short, fixed exposure time and focus on a single end point only. These limitations can be overcome by (partial) life-cycle toxicity testing, although these test results are harder to analyze. DEBtox is an existing software tool for the process-based analysis of standardized bioassays, and this paper presents two extensions of this method, making it applicable to life-cycle tests: the simultaneous assessment of end points and the description of aging (senescence) of the animals. We demonstrate these adaptations by describing life-cycle tests with the springtail Folsomia candida, exposed to cadmium and triphenyltin in their food. The extended model is able to describe the data for all end points simultaneously overtime with few, physiologically relevant parameters. Furthermore, the analysis reveals these chemicals to have distinctly different modes of action: cadmium apparently decreases the assimilation of energy from the food whereas triphenyltin increases the maintenance costs. The model fit allows calculation of the intrinsic rate of population increase, integrating effects on survival and reproduction. As the analysis is process based, population responses under food limitation can be explored, which depends critically on the selected mode of action.

Aging↗
PubMed2006

The enhancement of the subacute repeat dose toxicity test OECD TG 407 for the detection of endocrine active chemicals: comparison with toxicity tests of longer duration.

The OECD conventional 28-day repeat dose toxicity test (OECD TG 407) is widely employed in the initial hazard identification and characterization for commercial chemicals. The OECD has recently undertaken an international effort to "enhance" the conventional 28-day repeat dose toxicity test (OECD TG 407) in order to ensure that chemicals acting through (anti)estrogenic, (anti)androgenic, and (anti)thyroid mechanisms are identified. The enhancements include additional parameters based on the respective target organs from the male and female reproductive tracts, the thyroid, and circulating hormone levels. Ten chemicals with known endocrine modes of action and different potencies were administered using the "enhanced TG 407" test protocol to investigate the performance of this procedure. In the present evaluation, these "enhanced TG 407" protocol results, drawn from a report of the OECD validation studies, are compared to studies of the same or similar chemicals with longer and/or in utero exposures in order to evaluate the capability of the this "enhanced TG 407" in identifying the chemicals' mode of action. The major conclusions that can be drawn from these comparisons are: 1. The "enhanced TG 407" will reliably identify chemicals with a strong to moderate potential to act through endocrine modes of action on the gonads and the thyroid. In addition, this test method gives a first indication for the dose-related potency. 2. Substances with a low potency for an endocrine mode of action, i.e., having only marginal effects in the most comprehensive in vivo studies such as multi-generation studies, may not elicit clear endocrine-related effects in the "enhanced TG 407". In these cases, the primary or principal effects observed will be driven by other toxic actions of the test materials in the "enhanced TG 407". 3. It may be concluded from the present database that prolongation of exposure from 28 days up to 90 days is unlikely to improve the chance of detecting an endocrine-mediated effect 4. A number of higher tier studies with in utero and pubertal exposure show that prenatally exposed rats may be more sensitive to exposures to compounds with very low estrogenic or antiandrogenic potential in some cases than young adult rats as used in the "enhanced TG 407". 5. Overall, these comparisons support the use of the "enhanced TG407" for the detection of endocrine active chemicals. It is therefore recommended to fully accept the enhancements and include them in the test method for toxicological and regulatory use.

Animals↗
PubMed2001

Use of newborn Girardia tigrina (Girard, 1850) in acute toxicity tests.

Acute toxicity tests, exposing Girardia tigrina to potassium dichromate (K(2)Cr(2)O(7)), showed good reproducibility. The 95% confidence intervals among tests were 0.0262+/-0.0141 g for 48-h LC(50) (N=6) and 0.0129+/-0.0078 g for 96-h LC(50) (N=5). The 96-h LC(50) for G. tigrina was below that of oligochaetes and above that of cladocera.

Animals↗
PubMed2004

Validation of alternative methods for developmental toxicity testing.

Developmental toxicity testing according to current international guidelines involves exposure of pregnant animals, mostly rats and rabbits, and subsequent assessment of toxic effects in their fetuses. Alternative methods have been developed since the early 1980s. They include cell differentiation assays using either primary cell cultures or immortalized cell lines. At a higher integration level the development of organ anlagen in vitro has been employed in assays for developmental toxicity. The most complex assays in this area make use of isolated postimplantation rodent embryos which are cultured in vitro during the phase of major organogenesis. The possibilities for their application as toxicity screens have been investigated in various validation studies. The most elaborate validation study of embryotoxicity assays carried out to date included the embryonic stem cell test EST, the limb bud micromass MM, and whole embryo culture WEC. In each test 20 chemical compounds were tested in four independent laboratories. The results have shown a marked success in the reproducibility of results. The extrapolation of these results of a limited set of chemicals to a generalized judgment of the tests for the world of chemicals remains a matter for further discussion.

Abnormalities, Drug-Induced↗
PubMed2003

Critical evaluation of CROSERF test methods for oil dispersant toxicity testing under subarctic conditions.

The aquatic organisms toxicity testing protocols developed by the chemical response to oil spills: Ecological Research Forum (CROSERF) were evaluated for applicability to assessing chemical dispersant toxicity under subarctic conditions. CROSERF participants developed aquatic toxicity testing protocols with the foremost objective of standardizing test methods and reducing inter-laboratory variability. A number of refinements are recommended to adapt the CROSERF protocols for testing with subarctic species under conditions of expected longer oil persistence. Recommended refinements of the CROSERF protocols include testing fresh and moderately weathered oil under conditions of moderate mixing energy, preparing toxicity test solutions using variable dilutions rather than variable loading, performing tests with subarctic species using static exposures in open chambers, increasing the duration of tests from 4 to 7 days, quantifying approximately 40 PAHs and their alkyl homologs, assessing the potential for photoenhanced toxicity, and incorporating a bioaccumulation endpoint by measuring tissue concentrations of PAHs. Refinements in the preparation of oil dosing solutions, exposure and light regimes, and analytical chemistry should increase the utility of the test results for interpreting the toxicity of chemically dispersed oil and making risk management decisions regarding dispersant use under subarctic conditions.

Animals↗