"n - 'it t -V < ues -me Toxic Sui-'su-if-rss IVash - gton 3C ?04t-0 Identification and Evaluation of Potential Physiological Toxicity Assays Final Report ------- IDENTIFICATION AND EVALUATION OF POTENTIAL PHYSIOLOGICAL TOXICITY ASSAYS George H. Kidd, John M. Rice, Melanie E. Davis, Mark A. Hurst, Mickey F. Arthur, Steven E. Pomeroy and Martin L. Price BATTELLE Columbus Laboratories 505 King Avenue Columbus, Ohio 43201 Final Report Contract No. 68-01-5043 Prepared for U.S. Environmental Protection Agency Office of Pesticides and Toxic Substances Washington, D.C. January 1980 ------- DISCLAIMER This report has been reviewed by the Office of Pesticides and Toxic Substances, U.S. Environmental Protection Agency, and approved for publication. Approval does not signify that the contents necessarily reflect the views and policies of the U.S. Environmental Protection Agency, nor does mention of trade names or commercial products constitute endorsement or recommendation for use. ------- SUMMARY Battelle's Columbus Laboratories has contracted with the Office of Pesticides and Toxic Substances, U.S. Environmental Protection Agency, to develop a list of physiological assays as potential toxicity screening tests and to assess the strengths and weaknesses of these assays (Contract No. 68-01-5043). After an extensive literature search, Battelle has compiled a list of 24 assays, covering all of the categories cited by OPTS/EPA in its Technical Directive. Brief descriptions of assay methods and tables containing critiques .of each assay are presented, along with literature references for all of the assays. ------- TABLE OF CONTENTS Page Disclaimer i Summary ii INTRODUCTION 1 Initial Identification and Screening of Potential Assays 2 Organization of Information About Assays 7 Explanation of Data Tables Accompanying Each Assay 7 Assays From Woodard (1976) 11 DISCUSSION AND RECOMMENDATIONS 15 POTENTIAL TOXICITY ASSAYS—DESCRIPTIONS, METHODS, AND ASSESSMENTS 19 Nitrogen Fixation 19 Photosynthesis 20 Respiration 28 High-Energy Phosphate Production 30 Growth and Cell Division 34 Catalysis (Enzymatic Activities) 47 Other Cellular Processes 55 Other Potential Physiological Toxicity Assays 67 TABULAR COMPARISON OF CRITERIA 71 REFERENCES 78 APPENDIX: LITERATURE SEARCH METHODS A-l LIST OF TABLES Table 1. Assays Considered but Not Evaluated 3 Table 2. Potential Toxicity Assays Addressed in This Report 5 Table 3. Commercial Sources of Test Organisms 6 Table 4. Acetylene Reduction 21 Table 5. Hill Reaction 23 ------- LIST OF TABLES (CONT'D.) Page Table 6. Greening 25 Table 7. RuDP Carboxylase Activity 27 Table 8. Photosynthetic Oxygen Evolution 29 Table 9. Respiration in HeLa Cells 31 Table 10. Adenylate Energy Charge 33 Table 11. Cloning L929 Mouse Cells 36 Table 12. Protozoan Clonal Viability 38 Table 13. Human KB Cell Growth Rate 40 Table 14. Human Embryonic Lung Fibroblast (WI-38) Cytotoxicity 42 Table 15. Mitogen Stimulation of Lymphocytes 44 Table 16. Chick Embryo Development 45 Table 17. Trypan Blue Dye Exclusion by Human KB Cells 48 Table 18. RNA Polymerase Activity 50 Table 19. Adenyl Cyclase Activity 52 Table 20. Lysosomal Enzyme Release 54 Table 21. Macromolecular Synthesis in Human KB Cells 56 Table 22. Cyclosis 58 Table 23. Hemolysis 59 Table 24. Protozoan Vacuole Contraction . 62 Table 25. Protozoan Motility 64 Table 26. Phagocytosis by Alveolar Macrophages 66 Table 27. Ami no Acid Transport 68 Table 28. Source of Test Organism 72 i v ------- LIST OF TABLES (CONT'D.) Page Table 29. Test Organism and Organismal Level or Parameter Evaluated 73 Table 30. Special Equipment 74 Table 31. Times,' Cost, and Technician Skill 75 Table 32. Data Base and Comments 76 LIST OF FIGURES Figure 1. Schematic representation of viability test adapted to toxicity testing 37 ------- INTRODUCTION In this report, Battelle's Columbus Laboratories develops a list of potential cellular, organellar, and enzymatic toxicity tests (here collec- tively referred to as physiological toxicity tests or assays) for rapid screening of potential toxicants by the Office of Pesticides and Toxic Substances-Environmental Protection Agency (OPTS/EPA, Contract No. 68-01-5043). This study also documents, on the basis of a review of the published scientific literature and of ongoing research efforts, the strengths and weaknesses of selected physiological toxicity test methods. At present, the testing strategies proposed for premanufacture evaluation of chemical hazards to ecological systems utilize 96- or 48-hour acute toxicity tests on fish or invertebrates, respectively, as the primary (or only) screening methods to identify the need for further testing. There are several problems with these assays. First, such acute tests are usually poor predictors of the results of chronic studies, phytotoxicity tests, behav- ioral tests, and multispecies ecological studies. Second, the standard short- term acute tests depend significantly, not only on the toxic biological activ- ity of a chemical substance, but also on its solubility, dispersability, and/or ability to penetrate target cells or organs in the test organisms. Such penetration is highly variable among species. Third, the time and cost of the standard acute tests mentioned above are great. To circumvent the problems arising from the fish and invertebrate toxicity tests, a battery of rapid, in vitro, physiological tests could be developed as a first screening tier of a step-sequenced testing strategy for assessing ecological effects of chemicals. These physiological assays would measure effects on major metabolic and cellular functions, and from these functions, would attempt to predict effects on various test species and on ecosystem function. It is further assumed by this approach that chronic effects are the result of chemical toxicity at the cellular or subcellular level, and that these rapid, physiological tests can predict chronic effects. In sum, physiological assays might best serve as preliminary tests in ecologi- cal effects test schemes. ------- Described below are the theory and experimental procedures of these potential physiological toxicity assays. Each assay method is evaluated by several criteria, including the advantages and limitations, response to chemi- cals, and special equipment required. Pertinent references are included along with the criteria for each assay, as well as in bibliographic form at the end of the report. Initial Identification and Screening of Potential Assays In the initial stage of Battelle's literature search (see Appendix), some 45 potential toxicity tests were identified for consideration by OPTS/EPA. Potential assays were either of particular interest to OPTS/EPA, referenced in Woodard (1975), or independently identified by Battelle. Of the 45 physiological assays considered, 21 have little promise for development as rapid toxicity screening tests (Table 1). The assays marked with an asterik (*) in Table 1 were not considered strong candidates for rapid toxicity screens because they required use of isolated organs and tissues. Isolated organs and tissues have been very useful in studying the mechanisms of toxic action and in providing an understanding of mechanisms by which chem- icals exert toxic effects. In this role, such systems should become increas- ingly important. However, the use of isolated organs has serious limitations for studying physiological or toxicological effects, partly because of the modulating systems existing in the whole organism which can either increase or decrease a chemical effect. The usefulness of organ systems for rapid toxi- cological screening remains limited, primarily because such systems are most useful for screening large numbers of chemicals for a site-specific effect as opposed to screening a chemical for multiple biological effects. Also, in most cases, isolated organ assay systems use almost as many animals as an in vivo test would require. Consequently, there are little savings in total animal usage. Given these considerations, no rapid, physiological toxicity assays using tissue or organs are critiqued in this report. Other potential assays (oxidative activity in rabbit endothelium, chromosome breakage in human leukocytes, oxygen consumption by human leukocytes) were rejected because of GLP problems. Endothelia and leukocytes ------- TABLE 1. ASSAYS CONSIDERED BUT NOT EVALUATED IN DETAIL IN THIS REPORT Plant callus growth Inhibition of cell division of plant suspension cultures Glycogen conversion in perfused rat liver* Malting Inhibition of axon myelation* Invertase activity in duodenum culture* Epithelial growth in mouse kidney tissue* Cholinesterase inhibition in cerebral cortex* Collagen synthesis in human pleura cultures* Vitamin 8^2 uptake in monkey illeum* Trachea! muco-ciliary transport rate* Aldosterone synthesis in the adrenal gland* Fatty acid synthesis in adipose tissue* Mutagenesis in Saccharomyces** Mitotic frequency in duck embryonic lung cells (L132) t Oxidative activity in rabbit endothelium t Chromosome breakage in human leukocytes t Enzyme leakage in perfused liver* Oxygen consumption by human leukocytes t Osmotic and ionic changes in leaf guard cells Inhibition of regeneration in Hydra * Assays described in Woodard (1976)—Organs and Tissues. ** Assays described in Woodard (1976)--Bacteria, Fungi, Protozoa, and Plant Cells. t Assays described in Woodard (1976)—Mammalian and Avian Cell Culture Systems. ------- are genetically and developmentally heterogeneous, and thus create problems with quality control and uniformity of response. Malting, osmotic and ionic changes in leaf guard cells and inhibition of regeneration in Hydra were not considered promising assays because a very small, if any, data base on toxic chemical effects existed. Those potential toxicity screens involving plant tissue cultures (plant callus growth, inhibition of cell division of plant suspension cultures) were rejected because a very long time (as much as 2 months) is required to complete a toxicity assay involving callus or suspen- sion cultures. Also, plant cell cultures are easily contaminated, especially since aseptic conditions must be maintained without antibiotics for the duration of the assay. The final tv/o rejected assays [mutagenesis in Saccharomyces and mitotic frequency in duck embryonic lung cells (L132)] may be effective for screening a wide variety of mutagens. But, while all mutagens are toxicants, not all toxicants are mutagens. These assays are probably responsive only to chemicals that interact with or influence DNA. The remaining assays, which are evaluated in this report, appeared reproducible, well -documented, and straightforward (Table 2). The selection of these final 24 assays was based on several criteria. First, the test organism in each of these assays is either commercially available or easily grown or cultured from commercially available materials (e.g., seeds) (Table 3). Second, the methods for each assay are well docu- mented and have been performed in many laboratories worldwide. For example, estimates of RuDP carboxylase activity have been made in many laboratories throughout the U.S., Japan, Europe, and many other locations. Third, many of the physiological processes measured by these assays have been tested with some chemicals for possible toxic effects. So, at least some data base on toxic chemical effects is available for each of the 24 assays. Fourth, the selected assays are generally more rapid (assays per unit time) than the rejected candidate assays. Each of these protocols is currently the most streamlined process available. With more research and development, the potential for further streamlining exists. ------- TABLE 2. POTENTIAL TOXICITY ASSAYS ADDRESSED IN THIS REPORT Gel 1 ill ar process Specific assay Nitrogen fixation* Photosynthesis* Respiration* High-energy phosphate production Growth and cell division* Catalysis (enzymatic activities) Other cellular processes Acetylene reduction Hill reaction Greening RuDP carboxylase activity Photosynthetic oxygen evolution Respiration in HeLa cells** Adenylate energy charge Cloning L929 mouse cells** Protozoan clonal viability Human KB cell growth rate Human embryonic lung fibroblast (WI-38) cytotoxicity Mitogen stimulation of lymphocytes Chick embryo development** Trypan blue dye exclusion by human KB cells RNA polymerase activity Adenyl cyclase activity Lysosomal enzyme release Macromolecular synthesis in KB cells Cyclosis* Hemolysis* Protozoan vacuole contraction* Protozoan motility* Phagocytosis by alveolar macrophages Ami no acid transport *Subjects mentioned in EPA directive to Battelle. **Subjects mentioned in Woodard (1976). ------- TABLE 3. COMMERCIAL SOURCES OF TEST ORGANISMS Organism Source Algae: Scenedesmus Euglena Chlorella Chlamydomonas Chara Elodea NlteHa Bacteria: Azotobacter vinelandii Escherlchia coll Clostrldlum pasteurianum Protozoan: Tetrahymena pyrlformls Human Cell Lines HeLa KB WI-38 Human erythrocytes Other mammalian Cell Lines: Mouse L929 Mouse lymphocytes Rabbit alveolar macrophages Rat erythrocytes Higher Plant (seeds): Spinach oleracea Hordeum vulgare Phaseolus vulgaris Canavalia ensiformis Higher Animal: Mice Rabbits Rats Chickens ATCC* ATCC ATCC ATCC Starr** Starr Starr ATCC ATCC ATCC ATCC ATCC ATCC ATCC Calbiochem ATCC Mouse colony Rabbit colony Rat colony DeKalb Agresearch t DeKalb Agresearch DeKalb Agresearch DeKalb Agresearch Jackson Labs, Bar Harbor, ME Jackson Labs, Bar Harbor, ME Jackson Labs, Bar Harbor, ME Reliable local hatchery *ATCC—American Type Culture Collection. **Dr. Richard Starr, algal culture collection, University of Texas at Austin. t Or other company with genetically homogeneous seeds [good sources can be confirmed by the American Seed Trade Association (ASTA)]. ------- Organization of Information About Assays In the following pages, 24 physiological assays which could be devel- oped for rapid toxicity testing are described and assessed. As shown in Table 2, assays are organized under seven different cellular processes which were suggested by OPTS/EPA. The information on each assay is divided into two parts. First, there is a brief description of each assay along with the biological meaning of the test results. Second, data tables accompany each assay description for easy access of relevant information. The protocols and data tables are com- plementary, so both should be considered for objective evaluation of the individual assays. The information organization described above allows easy evaluation and comparison of individual assays. A tabulation summarizing pertinent data on the assays is presented in the Discussion and Recommendations section at the beginning of the report. Explanation of Data Tables Accompanying Each Assay Each potential toxicity assay has been assessed according to seven criteria. The scope and meaning of each criterion are given below. Test Organism— A representative test organism (or organisms) is suggested for each assay. Each organism mentioned in this report has been the object of most of the particular studies in toxicity evaluations. Observations have been made on these organisms, and on others mentioned in certain assays, in terms of growth and survival, hallmark metabolic process, or changes in gross morphol- ogy or ultramorphology. These test organisms were also selected because relatively large quantities of these cells or tissues can be quickly grown or inexpensively purchased (Table 3). Enzymes used in certain toxicity assays (e.g., RNA polymerase activity) were selected because of their abundance in particular tissues, commercial availability, stability of activity, or rele- vance of the metabolic process in which the enzyme participates. ------- Advantages and Limitations— Some advantages and limitations of each method,are listed in the following tables and these are straightforward in interpretation. One factor considered was the level of technical skill needed to per- form each assay. We identified three different levels of technical competen- cy. Highly skilled technicians are defined as individuals with master's degrees and research experience. Skilled technicians are individuals who have had college or university research experience and who hold a technical bache- lor's degree. Unskilled technicians are defined as individuals with a minimal scientific background (e.g., associate or junior college degree). If un- skilled technicians could be used to perform an assay, this fact was listed as an advantage. On the other hand, if a skilled or highly skilled technician was required, this fact was considered a limitation. As each particular assay method is standardized and becomes routine for a given laboratory, a lesser degree of technical skill than mentioned in the table for that assay may be utilized. Response to Chemicals— Each potential toxicity assay was assessed with regard to its re- sponse to certain chemicals. Most of these assays have not been developed as toxicity tests as such, but were used to study certain physiological pro- cesses. Any toxicity testing has been incidental (i.e., to determine physio- logical effect of a chemical, not to determine a chemical's toxicity). A sampling of chemicals and chemical classes has been included in each table to give an idea about the range of chemicals that affect the assay. Other chemicals may (or may not) affect the physiological process in each assay, but these chemicals have either not been studied or were not revealed during our literature search. In every assay listed (except hemolysis and lysosomal enzyme re- lease), the term "response to chemicals" refers to chemical inhibition of the observed physiological process. For instance, in respiration in HeLa cells, malonate lowers (or in sufficiently high concentrations, stops) mitochondrial oxygen uptake. The chemicals listed in hemolysis, however, promote the lysis ------- of red blood cells rather than inhibit it. In each assay the chemicals listed affect the physiological process in a concentration-dependent manner. When available, the concentrations of some chemicals affecting the assays were included. Affecting chemical concentrations v/ere abbreviated EC, I, LC, or MEC. ECX (effective concentration) is the concentration that induces detrimental effects in x percent of the test organisms. For example, in the hemolysis assay, £659 would be a chemical concentration that causes 50 percent of the red blood cells to lyse. Ix is defined as the chemical concentration causing x percent inhibition of a physiological process (e.g., greening or enzymatic catalysis activity). LCX (lethal concentration) is the chemical concentration causing the death of x percent of the test cells or organisms. For instance, LCX is used for chemicals causing chick embryo death. MEC (minimal effective concentration) is defined as the lowest chemi- cal concentration at which toxic effects are first observed. MEC is used in the mammalian cell culture assays. In the assays examined in this report (Table 2), the test chemicals have elicited a unidirectional physiological response (e.g., inhibition of respiration, inhibition of KB cell growth rate). It is possible that future studies may reveal chemicals having an opposite effect (e.g., stimulation of respiration, stimulation of KB cell growth rate). Would a chemical that stimulated, instead of inhibited, a cellular process be considered toxic? Assay Time— The times required for each assay (including preparation time, tech- nician time, etc.) were assessed and are included in each data table. There are four numbers listed opposite Assay Time in each table. The first number is the time (in hours) to perform an assay set (i.e., one chemical, three replicates of each of five concentrations). If several replicates of diffe- rent chemicals could be assayed simultaneously, this was considered an advan- tage. It was considered a limitation when an assay set required long periods of time or when only one individual assay could be completed at a time. The second number listed in the Assay Time category is the total time for an assay set to be completed. This includes cell growth period, solution preparation, data recording, and laboratory cleanup and is an estimate of time from ------- 10 start-up to expression of results. The third number is total technician time. Since technicians can do several operations simultaneously (e.g., prepare solutions during cell growth period) and some processes may continue unsuper- vised overnight, this number may be significantly less than the total assay time. The last number is the administrative time required. This includes Ph.D. supervision time, managerial time, data analysis, and reporting of re- sults. It was necessary to separate this from technician time since a more highly trained person is usually required for administration. These times are estimated for assays that are in the late developmental stage. As the assay method is standardized and becomes routine, times would probably become shorter. Specialized Equipment-- Specialized equipment needed to accomplish each assay is listed in the table accompanying each assay description. Not all equipment required for each test is presented. All of these potential toxicity assays can be per- formed routinely only in a laboratory equipped with basic analytical instru- ments (centrifuges, balances, etc.), minimal cell culture equipment (incuba- tors, culture dishes or flasks, etc.), and biochemicals (buffers, metabolites, etc.). If the other necessary special equipment was rare or costly, this was considered a limitation. For example, mammalian cell culture facilities, needed in many of the mammalian cell cytotoxicity assays, require a sterile working area such as laminar flow hood or transfer room. Such apparatus is probably not standard in most laboratories and may cost as much as $7000. Other special equipment, such as a spectrophotometer or colorimeter, is rela- tively inexpensive and is found in many laboratories. Such special equipment is listed in the data tables but is not considered a limitation. The assays listed in Table 2 already involve certain levels of auto- mation. For example, protozoan motility utilizes a microphotography unit and RNA polymerase activity uses a multipurpose filtration manifold. Many other assays (e.g., mitogen stimulation of lymphocytes, adenyl cyclase activity, amino acid transport) are partially automated by using scintillation counters with statistical data analyzers. The need for automation of any particular assay is dependent on the volume of chemicals to be tested--if many chemicals ------- are to be tested, automation or development of automation v/ould ensue. In several assay descriptions we suggest potential points for automation (e.g., use of computer and TV in protozoan motility assay). Cost— The estimated cost for an assay set is included in each data table as well as in a comprehensive comparison table at the end of the report (Table 29). To calculate the estimated costs, the technician's hourly v/age was multiplied by the total number of technician hours, and this was multiplied by a factor of 2.64. This is the estimated labor factor for Battelle's Bioenvi- ronmental Sciences Section, and is used for determining the approximate total cost for performing a task, including labor, supplies, use of equipment, and use of other facilities (e.g., electricity, water, maintenance). The technicians' hourly wages are based upon average pay for similar technicians at Battelle, including 2 weeks annual vacation and other fringe benefits. Annual salaries of these technicians are: highly skilled techni- cian, $18,000; skilled technician $12,000; and unskilled technician, $9,500. The cost of supervision by a Ph.D. level research scientist and managerial costs are also included. These annual salaries are estimated to be $25,000 and $35,000 for a Ph.D. scientist and manager, respectively. The approximate costs listed in this report are only for purposes of comparison of assays. Actual costs may vary 20 to 25 percent from these figures at different laboratories. Developmental work on the assays would be considerably higher than these estimates for semi routine testing. As the test comes into routine use, however, costs could decline sharply because of sim- plified and standardized methods (disregarding inflation). Data generated in any one of the assays described in this report would be analyzed by routine statistical methods (e.g., variance analysis). Assays from Woodard (1976) In the report by Woodard (1976) to OPTS/EPA, potential physiological toxicity assays for studies on chemicals were reviewed under four categories: ------- 12 (1) use of fertilized eggs, (2) use of isolated organs and tissues, (3) use of mammalian and avian cell cultures, and (4) use of bacteria, fungi, protozoa, and plant cells. In the following paragraphs, we consider in vitro tests derived from each of Woodard's test groupings. The literature on the use of fertilized eggs in studies on chemicals focuses almost exclusively on the development and use of fertilized chicken eggs as a toxicity bioassay. The production of abnormalities in the devel- oping embryo as a result of the administration of thallium was first demon- strated by Karnofsky in 1950 using the fertile chicken egg. However, the chick embryo development assay requires a long period of time to complete (1 month), calls for expensive specialized equipment, and does not have a universally standardized end point such as embryo death or abnormal limb development (Table 16). In general, the use of fertilized chicken eggs has enjoyed some attention in studies on the teratogenic potential of chemicals, but this method is still regarded by toxicologists as only marginally useful in screening for other types of toxic effects. Toxicity tests have also been conducted using two types of inverte- brate eggs as test subjects. However, few data exist concerning chemical effects on hatching of brine shrimp or on the early development of sea urchin embryos, and a tremendous amount of developmental research would be needed to adapt these assays for routine toxicity testing. As for present data on these two test systems, the inhibitory or stimulatory effects on hatching or devel- opment apparently do not correlate with the carcinogenic effects of known chemical compounds tested (Woodard, 1976). So these assays are apparently not immediately useful as potential toxicity screens. Woodard's category on the use of isolated organs and tissues in studies on chemicals was reviewed. The advantages and limitations of these bioassay systems are discussed on page 2 in relationship to Table 1. Several rapid, potential toxicity assays using mammalian cell cul- ture, bacterial, protozoan, and plant test systems are critiqued later in this report. Cytotoxicity assays employing mammalian cells in culture measure quantitatively cellular and metabolic impairment or death resulting from in vitro exposure to soluble and particulate toxicants. Mammalian cells derived ------- 13 from various tissues and organs can be maintained as short-term primary cultures or, in some cases, as continuous cell strains or lines. Primary cultures exhibit many of the metabolic and functional attributes of the original tissue. Some of these attributes may be lost after a prolonged time in culture. There are certain requirements basic to any assay that requires the use of mammalian cells in vitro. Paramount among these are aseptic facilities for the propagation and handling of cultured cells and qualified personnel trained in safe and proper cell culture technique. There are many advantages in using mammalian cell culture systems in toxicity assays. First, they are generally more rapid and less costly than whole animal tests. Second, a lesser quantity of potential toxicant is required for these in vitro tests. Third, specific physiological or biochem- ical alterations are more easily evaluated in cell culture systems, and fourth, the systems provide useful information about the relative cellular toxicity of unknown samples (Woodard, 1976). Cell culture toxicity screens also have several drawbacks. Since the assays employ isolated cells and not intact animals, they can provide only preliminary information about the ultimate health hazards of toxic chemicals. In many instances, some metabolic action in an animal renders a chemical toxic or nontoxic. So, a chemical which appears toxic at the cellular level may actually be innocuous at the tissue or higher level because of metabolic deactivation. Likewise, a toxic chemical could appear nontoxic at the cellu- lar level since metabolic activation of a chemical to a toxic form could occur in vivo but might not occur in cell culture. Another disadvantage is that cell culture test systems may become contaminated with latent viruses or Mycoplasma sp., which can alter cellular metabolism. Also, media constituents (such as calf serum) must be carefully monitored and controlled since they may affect cellular metabolism or form complexes with the test chemical (Woodard, 1976). Both neoplastic (tumor-derived) and nonneoplastic (primary) cell lines are utilized in assays described in this report. Although neoplastic cells are abnormal and have probably lost some metabolic capabilities as compared with primary cultures, they respond equally well in many cytotoxicity ------- 14 assays. Neoplastic cells are generally used because they grow rapidly and are more readily propagated than primary cultures. The only neoplastic cell lines used include human HeLa and KB. Nonneoplastic cell lines utilized include human WI-38, rabbit alveolar macrophages, mouse L929, and mouse lymphocytes. Other mammalian cell types can be used as alternatives to these cell lines. Several of the cell culture assays described here could be combined to form one assay which could assess several parameters. This would provide a more cost-effective means for using cell culture systems for screening toxic chemicals. As described by Woodard (1976), the use of nonmammalian cell systems in toxicity testing is now well established. The potential for bacteria, pro- tozoan, and plant systems in physiological assays is also great. Most assays involving these systems are more rapid and less expensive than mammalian systems. Also, many potential toxicants can generally be screened simulta- neously, and often only unskilled technicians are required to perform the test. A drawback to the use of plant, bacteria, and protozoan systems in toxicity screens is the questionable extrapolation of data obtained from these systems to mammals. The converse is also true in that mammalian systems as toxicity screens cannot always be extrapolated to plant or microbial systems. Although all cells have certain structural and metabolic properties in common, certain processes which only occur in whole animals or plants (e.g., uptake and transportation of potential toxicants) still are not fully understood. ------- 15 DISCUSSION AND RECOMMENDATIONS The objective of this report was to identify potential physiological toxicity tests in the literature and to assess each on the basis of several criteria. Even though each assay has advantages and disadvantages, it is difficult to rank them on the basis of a literature review alone. Before any final decision on the utility of any assay is made, laboratory evaluation is necessary. However, on the basis of the literature review, it is possible to approximate the degree of laboratory development needed to adapt and validate these protocols as routine toxicity screens. We have identified three levels of assay development: those requiring minimal development, those requiring some development, and those requiring significant development. Assays are placed in one of these categories on the basis of the criteria listed in Tables 28 through 32. Assays that would require little development for use as toxicity assays (i.e., immediate validation) include greening, hemolysis, human KB cell growth rate, phagocytosis by alveolar macrophages, macroinolecular synthesis in human KB cells, RNA polymerase activity, and human embryonic lung fibroblast (WI-38) cytotoxicity. Assays that would require some development for use as toxicity assays include acetylene reduction, the Hill reaction, RuDP carboxyl- ase activity, adenylate energy charge, chick embryo development, protozoan clonal viability, cloning L929 mouse cells, trypan blue dye exclusion by human KB cells, protozoan motility, and amino acid transport. Assays that would require extensive development include cyclosis, protozoan vacuole contraction, photosynthetic oxygen evolution, respiration in HeLa cells, mitogen stimula- tion of lymphocytes, lysosomal enzyme release, and adenyl cyclase activity. Some assays naturally drop from consideration. These tests meet few (or none) of the criteria used for assay evaluation (simplicity, rapidity, cost effectiveness, documentation, reproducibility, etc.). For example, cyclosis is one of the most expensive and time-consuming assays. It has a poor data base, and results are probably not ecologically significant. Protozoan vacuole contraction, photosynthetic oxygen evolution, and respira- tion in HeLa cells require extensive development and have been rejected for immediate use because several of the criteria are not optimum. Adenyl cyclase ------- 16 activity, mitogen stimulation of lymphocytes, and lysosomal enzyme release have poor data bases with regard to toxic chemical effects. In addition, it appears difficult to relate results from adenyl cyclase activity to cellular or tissue toxicity. Mitogen stimulation of lymphocytes requires maintenance of an expensive mouse colony. Those assays in the second category (some development) are more dif- ficult to evaluate since their advantages and limitations are more equally balanced. In some assays (Hill reaction, chick embryo development) very good data bases on toxic chemical effects exist. However, there are GLP problems with the Hill reaction since chloroplast activity may vary. Chick embryo development requires a long time to complete and lacks a standardized end point. RuDP carboxylase activity has a poor data base and GLP problems, even though it is rapid and inexpensive. Protozoan motility is time consuming and expensive, but automation could make test results easier to obtain. The clonal assays (cloning L929 mouse cells and protozoan clonal viability) both have good data bases and are simple. However, each requires a long time to complete. The membrane assays (amino acid transport, trypan blue dye exclusion) were not considered easily developed assays because they have poor data bases. Development of these assays should be considered because tests results can be extrapolated to all membranes. Even though acetylene reduction monitors a vital physiological and ecological process, the current assay method needs streamlining (e.g., use of a multisample gas chromatograph). The remaining assays are rapid, simple, reproducible, cost-effective, and well documented. In many cases, it is advisable to combine several tests (or give a single test multiple end points) and to correlate the results to give the responses to chemicals broader ecological or biological meaning. Greening, Hill reaction, chlorophyll fluorescence, and a growth test (e.g., seedling growth) could possibly be combined to give a good indication of phytotoxicity if the same organism were used in all assays (Kratky and Warren, 1971). It also would be possible to combine RNA polymerase activity and macromolecular synthesis in human KB cells to detect chemical inhibition of RNA synthesis. Phagocytosis by alveolar macrophages and amino acid transport ------- 17 (and/or trypan blue dye exclusion by human KB cells) could be combined to detect inhibition of mammalian membrane function. Hemolysis appears to be one of the best potential toxicity assays because it is cost-effective and can be performed by unskilled technicians. Also, the lysis of erythrocytes is a generally accepted standard of toxicity because mammalian tissues depend on hemoglobin for transport of gases and nutrients. Human KB cell growth rate and human embryonic lung fibroblast (WI-38) cytotoxicity also should require little development since they are already used as toxicity assays by the National Cancer Institute. Since these assays are well documented, simple, and inexpensive, they could probably be quickly validated as toxicity screens, with implementation following. Comments In evaluating and ranking these 24 potential physiological toxicity test methods, there are several points that merit consideration. Physiological test methodologies have proved very useful for studying mechanisms of toxic action and for evaluating large numbers of toxic chemi- cals. Physiological tests (predominately in vitro) have several advantages over in vivo methods (e.g., time, cost, and quantisation of results), but results from physiological tests can at best give preliminary information on a chemical's toxicity. As described on page 13, an in vivo system may mediate a chemical's toxic activity by metabolic activation or deactivation. This can- not occur in in vitro systems. Hence, physiological methodologies could give false positive or negative results. Results obtained from cellular, organellar, or enzymatic test systems cannot usually be extrapolated to ecosystem effects for several reasons. First, only one physiological parameter of a single test organism is monitored in each assay. These assays are by no means an intensified ecological study, and no direct extrapolations from these tests could effectively be made to ecosystem effects. Second, test organisms such as mammalian cells or algae are genetically homogeneous because these test cells are clonally derived. Since cells and tissue systems differ greatly in whole animals, these cellular systems are usually not good indicators of in vivo responses. Third, a ------- 18 selected test organism may be unusually sensitive or insensitive to certain chemicals and give inconclusive (or false) results. Physiological test systems, both mammalian and nonmammalian, could be effectively used as toxi- city screens to identify the need (or lack of need) for further testing. Information obtained from one cellular physiological test can often be extrapolated to a more complex multicellular system because of certain structural and functional similarities. All cells are enclosed by virtually identical semipermeable membranes, contain DNA, and respire. It is not usual- ly safe to extrapolate beyond this, however. In summary, since most previous toxicity test methods have been in vivo, the effectiveness of cellular or subcellular test methods has yet to be demonstrated. The in vitro test methods have several advantages over in vivo ones (e.g., time and cost), but they still have certain practical and scien- tific limitations involving correlation of toxic effects on cellular metabol- ism to toxic effects in ecological systems. ------- 19 POTENTIAL TOXICITY ASSAYS—DESCRIPTIONS, METHODS, AND ASSESSMENTS NITROGEN FIXATION Acetylene Reduction The conversion of atmospheric nitrogen into organic compounds by living organisms is called nitrogen fixation. This process is carried out by microorganisms, including the free-living bacteria, blue-green algae, and bacteria associated in a symbiotic condition with plant roots. The enzyme nitrogenase catalyzes the transfer of electrons from an electron source to ni- trogen, resulting finally in the production of ammonium ions. The acetylene- ethyl ene assay for nitrogen fixation is based on the nitrogenase-catalyzed reduction of acetylene to ethylene. Ethylene concentration is determined by using a gas chromatograph equipped with a hydrogen-flame analyzer. This assay involves incubation of bacteria with an energy source and reductant in a flask sealed with a serum cap. After repeated flushing with a source of acetylene, the bacteria are added aseptically through the cap. The reaction mixture is incubated on a rotary shaker at 30 C for 30 minutes, and the incubation is stopped by addition of 0.5 ml 6N sulfuric acid. Samples of the gas phase are then measured with a hydrogen2-flame ionization detector after gas chromatographic separation. As described by Hardy et al (1968), the complete assay system con- tains 4 ml liquid volume and 36 ml gas volume. The liquid reaction mixture includes 50 mM Tris-HCl, 56 mM creatine phosphate, 5 mM ATP, 5 mM magnesium chloride, 20 mM disodium thiosulfate, 0.2 mg of creatine kinase, and 4 mg of heated extract of ammonia-grown _A. vinelandii. The gas phase of the reaction mixture contains 0.1 atmosphere of acetylene and 0.9 atmosphere of helium. Chemicals to be tested are added to the reaction vessels at various concen- trations. Inhibition of acetylene reduction, expressed as a percentage of control values, can be calculated for the various levels of a test chemical. ------- 20 Monitoring the effects of toxic chemicals on nitrogen fixation is important because captured atmospheric nitrogen is converted into amino acids, the building blocks of all proteins. Details on acetylene reduction are summarized in Table 4. PHOTOSYNTHESIS Hill Reaction Robin Hill discovered that light-induced oxygen evolution can be observed in cell-free granular preparations (chloroplasts) extracted from green leaves. Illumination of such chloroplast preparations in the presence of artificial electron acceptors, such as ferricyanide or reducible dyes, causes evolution of oxygen and simultaneous reduction of the electron acceptor, according to the general equation H20 + Ah+ AH2 + 1/2 02 where A is the electron acceptor and AH2 is its reduced form. In a photo- synthesizing plant, A is nicotinamide adenine dinucleotide phosphate (NADP). NADP accepts the electrons, and the reduced form of NADP is used to reduce carbon dioxide into sugars. Hov/ever, in the in vitro Hill assay described below, dyes are used to accept the electrons liberated from water. As the dyes are reduced, they change color and this color change is quantitated. For the Hill assay, chloroplasts are isolated from plants grov/n under controlled conditions or from batch cultures of Euglena or Chlorella. Accord- ing to the chloroplast isolation method of Wald et al (1966), algae or leaves are homogenized with 0.5 M sucrose solution at 0 C for 30 seconds in a Waring Blendor. The suspension is then filtered through tv/o layers of cheese cloth. The filtrate is centrifuged at 50 g for 10 minutes. The supernatant is then decanted and centrifuged for 10 minutes at 600 g. The supernatant is decanted and discarded. The pellet at the bottom, containing the chloroplasts, is suspended in 0.5 M sucrose. It is important to keep the chloroplasts at 0 C because they deteriorate rapidly at higher temperatures. It is advisable to examine the chloroplast preparation under a micro- scope to ensure that the chloroplasts are of uniform size, intact, and free of other cellular debris. ------- 21 TABLE 4. ACETYLENE REDUCTION Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time, hours Special Equipment Cost § References Either Azotobacter vinelandii or Clostridium pasteurianum may be used. The analytical method can detect as little as 1 picomole of ethylene. The tests organisms are simple to culture. The assay may be utilized in either the field or laboratory. The phase of the potential toxicant may be solid, liquid, or gas. A short time is required to obtain the results of this assay. Acetylene is a very explosive gas and requires care in handling. Nonnitrogenase catalysis of the reduction may occur. Specialized equipment is needed. The assay and gas chromatography must be performed by skilled technicians. Chlorinated aliphatics [trichloroacetic acid, ethylene glycol bis(trichloroacetate)] Arsenicals (cacodylic acid, disodium methanearsonate) Metabolic inhibitors (2,4-dinitrophenol) Gases (carbon monoxide-I^gg is 0.18 atm) 2.5*, 54**, 12t, 8t Gas chromatograph with a hydrogen-flame analyzer $620 Hardy et al, 1968 Rubinstein, et al, 1975 *Time for one assay set—three replicates of each of five concentrations of ore chemical. **Total assay set time, including cell growth, solution preparation, and data recording. t Total technician time, including GLP, performing assay, and solution preparation. t Administrative time (Management, Ph.D. supervision, data analysis, and reporting). § Estimated cost for comparative purposes. Actual costs may differ 20 to 25 percent (see p. 11). ------- 22 The Hill reaction assay mixture contains 2 ml of 0.1 M phosphate buffer (pH 6.5), 2 ml of 2.5 x 10-4 M dichlorophenolindophenol, 0.1 of chloroplast suspension, 1 ml of toxicant or chemical to be tested, and 5 ml of distilled water. Chemicals to be tested are incubated with the chloroplast suspension prior to addition of the electron acceptor. Each reaction mixture is then exposed to the same bright light for 10 minutes. Over the course of the 10 minutes, the absorbance of the dye is monitored at 620 nm (Wald et al, 1966). The effect of a potential toxicant on the rate of this photosynthetic reaction is reflected by the rate at which the dye is reduced and turns from blue to clear. Details on the Hill reaction are summarized in Table 5. Greening Potential toxicants alter plants' chlorophyll content by a number of mechanisms. Chlorophyll biosynthesis is affected by specific chemical stimu- lation or inhibition of DNA, RNA, or protein synthesis. Some chemicals affect chloroplast development or structure, resulting in an altered chlorophyll content. Other chemicals degrade or induce the degradation of the chlorophyll molecule (Wolf, 1977). To measure the effect of a chemical on chlorophyll accumulation, dark-grown plants are subjected to a series of chemical concentrations prior to greening. In detail, etiolated barley plants 7 to 9 days old are sprayed (misted) with solutions of a chemical. The spray is directed at the coleop- tiles (or hypocotyl hooks) from above. For every 200 seedlings, about 50 ml of solution is used. Alternatively, seedlings could be grown in soil amended with toxicant. The seedlings are transferred to an irradiation chamber 1 hour after being treated. The plants are irradiated for 24 hours by white fluores- cent lamps at an intensity of 1000 ftc. Except during white-light irradia- tion, plant material is handled in dim green light (Margulies, 1962). Chlorophyll is extracted from 2-g leaf samples by heating in boiling water for 30 seconds, and then by grinding in a Virtis-type homogenizer with 80 percent acetone. The macerate is centrifuged, and the chlorophyll content of the resulting supernatant is measured spectrophotometrically at 663, 645, ------- 23 TABLE 5. HILL REACTION Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time,* hours Special Equipment Cost* References oleracea), Chlorella, Spinach (Spinacia Euglena The test organisms are simple to grow or are readily available. A short time is required to obtain the results of this assay. The assay is capable of detecting very minute quantities of potential toxicants. The assay can be performed by unskilled technicians. Chloroplast activity varies among preparations and declines with age. Reducing or oxidizing agents may interfere with and produce variation in the assay. Antibiotics (chloramphenicol-Igg is 4 mg/ml) Ureas (3-cyclooctyl-l,1-dimethylurea, l-(2-methylcyclohexyl)-3-phenylurea) Herbicides (2-chloro-4,6-bis(isopropylamino)- s-triasine, 2-methoxy-4,6-bis(ethylamino)- s-triazine) Inorganic salts (ammonium chloride) Inorganic ions-heavy metals (cadmium, zinc) 3, 57, 18, 11 Spectrophotometer (Beckman Spec 20) or colorimeter $820 Hill, 1937 Margulies, 1962 Morel and and Hill, 1962 Anderson and Boardman, 1964 Wald et al, 1966 Brown and Haselkorn, 1972 Hamp et al, 1975 Rubinstein et al, 1975 *See time and cost explanation, pp. 9-11 in text. ------- 24 and 626 nm by the method of Anderson and Boardman (1964). This method takes into account the absorbance of protochlorophyll , the precursor of chlorophyll, as well as chlorophylls a and b. The following equations can then be solved to give the individual pigment concentrations in yg/ml: C = 12.67E663 - 2.65E6« - 0.29E626 a Cb = -4.23E663 + 23.60Es« - O.SSEsas P = -3.99Es63 - 6.76E6« + 29.60Es26 - This bioassay is especially sensitive to photosynthetic and respira- tory inhibitors, but results do not usually correlate with results from growth Assays (Kratky and Warren, 1971). Details on the greening assay are summarized in Table 6. RuDP Carboxylase Activity Ribulose-l,5-diphosphate carboxylase (RuDPCase) is a soluble enzyme localized in the chloroplast stroma of vascular plants. This enzyme catalyzes the primary fixation of carbon dioxide during photosynthesis in some monocots and in most dicots. This assay employs cell-free extracts of leaves or algae. Leaves are obtained from spinach plants grown under controlled conditions and the algae Euglena and Chlamydomonas are easily grown in batch cultures. As described in the greening assay, test organisms are exposed to a chemical prior to isola- tion and determination of RuDPCase. Alternatively, chemicals to be tested can be incubated with the enzyme preparation prior to additon of the other reac- tion reagents (see below). To prepare an extract, as described by Goldthwaite and Bogorad (1971), 1 g of leaves or algae is ground in a small Waring Blendor for 2 min- utes in 2 ml of an ice-cold buffer containing 0.2 M sodium bicarbonate (pH 8.0), 1 percent polyvinyl pyrrol idone, and 1 mM dithiothreitol. The homoge- nate is filtered through cheesecloth and Miracloth and then is centrifuged at 35,000 g for 15 minutes at 4 C. The resulting supernatant is assayed for enzymatic activity. ------- 25 TABLE 6. GREENING Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time,* hours Special Equipment Cost* References Barley seedlings (Hordeum vulgare) are the major test organism. Pinto beans (Phaseolus yulgaris) and jack beans (Canavalia ensiformis) may also be used. The test is capable of identifying many different chemicals as potential toxicants. A relatively short time is required to obtain the results (chlorophyll determinations) of this assay. The test organisms are simple to grow. There is a direct relationship between the concentration of the chemicals investigated and percentage of chlorophyll inhibition. The assay can be performed by unskilled technicians. Specialized equipment is needed. The total time, including greening and chlorophyll determinations, is lengthly. Antibiotics (streptomycin, chloramphenicol) Nucleic acid analogues (5-fluorouracil, Z-thiouracil-Igy is 5 mM) Amino acid analogues (ethionine, p-fluorophenylalanine) Plant hormones (2,4-dichlorophenoxy acetic acid, naphthalene acetic acid, abscisic acid) Herbicides (amino triazole, paraquat, atrazine) Growth retardants (coumarin, N,N-dimethylamino succinamic acid) Ureas [diphenylurea, 3-(4-chlorophenyl)- l-(l-dimethylurea)] Fungal metabolites (alternaric acid, tentoxin) Alcohols (ethanql-Iigo is 100%) nickel, lead, and aluminum ions) 10 mM, fructose, glucose) carbon monoxide, methane, Inorganic ions (cobalt. Sugars (sucrose-Igg is Gases (carbon dioxide, ethylene) 29, 150, 9, 8 Spectrophotometer or colorimeter growth chamber $560 Arnon, 1949 Margulies, 1962 Anderson and Boardman, 1969 Keller and Huffaker, 1967 Kratky and Warren, 1971 Rubinstein et al, 1975 Borque et al, 1976 Wolf, 1977 *See time and cost explanation, pp. 9-11 in text. ------- 26 RuDPCase activity is measured by incorporation of radioactive sodium bicarbonate (NaH^cc^) into acid-stable products in the presence of ribulose 1,5-diphosphate (RuDP). A 25-yl aliquot of enzyme is mixed on the surface of a planchet with 100 yl of reaction mixture containing the following (all are final concentrations): 100 mM Tris-HCl (pH 8.0); 50 mM NaHl4co3 (sp. act. 0.20 yCi/ymole); 0.3 mM RuDP; 10 mM magnesium chloride; 6 mM reduced gluthathione; 0.1 mM ethylenediaminetetraacetic acid. After 10 minutes at room temperature, the reaction is stopped by addition of 6 N acetic acid. The planchets are dried and counted in a gas-flow counter. The reaction is linear with enzyme concentration until 30 to 50 percent of the RuDP is consumed. Incorporation in the absence of RuDP is Tess than 2 to 3 percent of that when PuDP is added. Details on this assay are summarized in Table 7. Photosynthetic Oxygen Evolution In the presence of sunlight, algae and .terrestrial green plants photosynthesize and thus convert carbon dioxide and water into carbohydrates and oxygen (02). Even though 02 evolution is used as a measure of photo- synthesis, the 02 evolved from a plant cell is equal to the 02 released by photosynthesis minus the 02 consumed by respiration. The assay described here is based on comparing the rates of 02 evolution from algal cells pre- incubated with a test chemical to the rate of 02 evolution from algal cells not treated with the test chemical. The green, unicellular alga Scenedesmus is used in this assay. Scenedesmus obliquus, strain 03, is grown in a glucose-yeast extract medium until a packed cell volume of about 10 yl/ml is obtained. About 40 ml of cells are collected and washed in 0.05 M potassium phosphate buffer (pH 6.5). The washed cells are incubated in a buffer containing concentrations of the test chemical. Following exposure to the test chemical, cells are washed free of the chemical by suspension and centrifugation. Then, 2 ml of the algal suspension is added to each of two Warburg flasks and 0.5 ml of p-benzoquinone is added to each side arm to inhibit respiration. Also, diuron is added to the side arm of the first flask (control) to inhibit photosynthesis, and water ------- 27 TABLE 7. RUDP CARBOXYLASE ACTIVITY Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay time,* hours Special Equipment Cost* References Spinach (Spinacia oleracea), Euglena, Chlamydomonas The test organisms are easy to grow or obtain. A short time is required to obtain the results of this assay. There is usually a direct relationship between the concentration of the chemicals investigated and percent of enzyme inhibition. The enzymatic activity varies among preparations and declines with storage. The growth conditions of the plants dramatically affect enzymatic activity. Some specialized equipment is needed. The assay is performed by highly skilled technicians. Antibiotics (cycloheximide-Iioo 1S 0.01 mg/ml; puromycin, streptomycin) Herbicides (paraquat) Growth regulators (N-(dimethylamino) succinamic acid) Arsenicals (cacodylic acid) 2, 54, 12, 8 Gas flow counter or scintillation counter $750 Keller and Huffaker, 1967 Goldthwaite and Bogorad, 1971 Rubinstein et al, 1975 *See time and cost explanation, pp. 9-11 in text. ------- 28 i'S added to the side arm of the second flask. The flasks are equilibrated in the water bath of a Warburg apparatus at 25 C for 20 minutes. The contents of the side arms of the two flasks are then tipped into the bottom of the flasks, and immediately the measurement of 03 evolution with high light intensity is started. In the Warburg apparatus, volume changes are measured in an enclosed atmosphere in direct contact with the liquid under conditions in which oxygen is the only substance undergoing a net transfer between the liquid and gas phases. Results from this manometric measurement are expressed as the percent of inhibition of 02 evolution as a function of test chemical concentration. An oxygen electrode can be used instead of the Warburg apparatus. Details on this assay are summarized in Table 8. RESPIRATION Respiration in HeLa Cells Mitochondria are present in virtually all living cells. Both the Krebs (tricarboxylic acid) cycle and electron transport systems, the final two stages of cellular respiration, occur in the mitochondria. In these final stages, oxygen is consumed, and carbon dioxide and water are evolved. The net equation for cellular respiration is: CCH,,,0C + 60,, -> 6CO, + 6H00 + energy. O I i. 0 C. <- c. To measure cellular respiration, it is possible to monitor either consumption of oxygen or evolution of carbon dioxide. In this assay, HeLa (human) cells are grown in Eagle's medium to a density of 4 x 10^ cells/ml. Other mammalian cell types can be used, but it is not feasible to use algal cells which both photosynthesize and respire. The cells and a potential toxicant are placed in the test chamber of a precalibrated oxygen electrode, which can be purchased from a commercial source or made as described in Bruening et al (1970). The dissolved oxygen is monitored at 10 minute intervals for 1 hour. A graph of dissolved oxygen versus time is plotted, and the slope of the plot represents the rate of oxygen consumption. ------- 29 TABLE 8. PHOTOSYNTHETIC OXYGEN EVOLUTION Criteria Critique/Comments Test Organism Advantages Limitations Response to Chemicals Assay Time,* hours Special Equipment Cost* References Scenedesmus obliquus, strain D^ The test organism is simple to culture. Oxygen electrode can be used in place of the Warburg apparatus. Specialized equipment is needed. A great deal of time is required to equilibrate flasks and accurately determine gas exchange rates. This assay must be performed by skilled technicians. Variation in respiratory and photosynthetic Og evolution make interpretation of results difficult. Herbicides (l,l-dimethyl-3-pheny1urea, 3-(p-chlorophenyl)-l,l-dimethylurea) 50, 100, 84, 11 Warburg manometric apparatus $2330 Pratt and Bishop, 1968 Rubinstein et al, 1975 time and cost explanation, pp. 9-11 in text. ------- 30 To note the effect of a potential toxicant, a different concentration of the test chemical is added to a chamber of fresh HeLa cells, and again dissolved oxygen is monitored at specific time intervals. This is carried out at several different chemical concentrations, and a graph is plotted for each concentration. Inhibition or stimulation of respiration is determined by comparing the rates of oxygen consumption for the test chemicals with those of the standard. Toxic chemicals that inhibit respiration would most certainly influ- ence the metabolism and viability of the organism since respiration is the process by which aerobic cells obtain energy from the oxidation of fuel mole- cules by molecular oxygen. Details on this assay are summarized in Table 9. HIGH-ENERGY PHOSPHATE PRODUCTION Adenylate Energy Charge Even though the production of adenosine-51 triphosphate (ATP) is a common goal of both anaerobic and aerobic metabolic activities, the measure- ment of ATP alone may not be an accurate index of both biomass and metabolic activity. The total energy level of the cell is dependent upon the balance between the adenosine phosphates. ATP contains two high-energy anhydride bonds, ADP contains one, and AMP none. Atkinson (1969) and Atkinson and Walton (1967) proposed an adenylate energy charge (AEC) as a fundamental metabolic control parameter: acr _ ATP + 1/2 ADP tL AMP + ADP + ATP The expression is a measure of the anhydride-bound phosphate groups per adenine moiety and is written so that the parameter will range in value from 0 to 1. In general, when the AEC > 0.5, ATP-utilizing systems increase their activities; AEC < 0.5, ATP-regenerating sequence dominates (Atkinson, 1969; Ching et al, 1974). In this assay, cells are incubated with various concen- trations of a toxicant, and the adenosine phosphates are then isolated from ------- 31 TABLE 9. RESPIRATION IN HELA CELLS Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References HeLa (human) cells The test results are straightforward and easily obtainable. The test organism is easy to grow. The assay shows the effect of chemicals on a major metabolic pathway, respiration. This assay must be performed by skilled technicians. Only one chemical at one concentration can be tested at a time. Some special equipment is required. Reducing or oxidizing agents may inter- fere with and produce variation in this assay. Metabolic inhibitors (malonate) Detergents (Triton X-100, sodium deoxycholate) 30, 80, 51, 13 Oxygen electrode, mammalian cell culture facilities $2350 Bruening et al, 1970 *See time and cost explanation, pp. 9-11 in text. ------- 32 the cells and quantitated. This assay can be applied to bacterial, fungal, algal, mammalian, and plant cells or to mixed cultures and microbial assem- blages. However, for development as an in vitro toxicity assay, the rapidly growing bacterium Escherichia coli, the green alga Euglena, or the human cell line HeLa are excellent cellular candidates. In this assay, a known number of cells are incubated at 37 C for 1 to 2 hours with a toxicant. Adenosine phosphates are then extracted from cells with chloroform (Bostick and Ausmus, 1978; Nannipieri et al, 1978). Quantita- tion of ATP is based on reactions with hexokinase and glucose-6-phosphate dehydrogenase. In these enzymatic reactions, ATP causes the production of reduced nicotinamide adenine dinucleotide (NADH). NADH can then be quanti- tated fluorometrically down to 10~12 M. For determining AMP and ADP, ade- nylate kinase and pyruvate kinase are added to the mixture to convert these two adenosine phosphates to ATP. This ATP is then measured using the hexoki- nase method described above (Bostick and Ausmus, 1978). A ready-made ATP determination kit is commercially available from Calbiochem. Comparison of calculated AEC per cell values allows conclusions to be drawn on the physio- logical status of cell populations exposed to toxicant. Details on this assay are summarized in Table 10. ------- 33 TABLE 10. ADENYLATE ENERGY CHARGE Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost References Escherichia coli is the major test organism. Euglena or the human cell line HeLa may also be used. This is a rapid indication of metabolic state. Test organism^, coli is commercially available and relatively inexpensive. This assay is applicable to a wide range of organisms and environmental and chemical conditions. The assay can be converted to microbially immobilized macronutrients in the microbial energy charge assay. Three parameters, AMP, ADP, and ATP, must be measured. The test requires a skilled technician. Analysis must be promptly performed. Unknown 8, 62, 23, 9 Spectrophotometer $920 Atkinson and Walton, 1967 Atkinson, 1969 Ching and Ching, 1972 Bostick and Ausmus, 1978 *See time and cost explanation, pp. 9-11 in text. ------- 34 GROWTH AND CELL DIVISION Cloning 1929 Mouse Cells The L929 cloning assay is an in vitro bioassay to examine the cyto- toxic effect of a variety of toxicants. The toxicants may include particulate or soluble (aqueous or limited organic) toxicants. The L929 cell line is carried in Eagle's Minimal Essential Medium containing 10 percent fetal calf serum, 10,000 units of penicillin per 100 ml medium, 10,000 yg of streptomycin per 100 ml medium, and 10,000 ug of my- costatin per 500 ml medium. Cells are cultured in 75 cm2 tissue culture flasks. When cells are 75 to 90 percent confluent, 0.25 percent trypsin is used to remove cells from the flask. A 1:10 dilution of cells is made u'sing complete media, and cells are seeded into new flasks. Cells should be split every 3 to 4 days. A flask of L929 cells is trypsinized, and the cells are counted and diluted to 1 x 103 cells/ml, 8 x 102 cells/ml, 6 x 102 cells/ml, 4 x 102 cells/ml, and 2 x 102 cells/ml. The dilutions of the cells are plated onto to 60-mm dish containing 4 ml of complete medium. Twenty plates are needed at each cell concentration for one complete test. The cells are per- mitted to attach to the tissue culture dishes for 24 hours. The plates are then treated with various concentrations of the test chemical. Five concen- trations of test chemical should be assayed in each cell dilution. Therefore, six sets of five plates should be made: one for each of the five concentra- tions of the test chemical plus one set to be used as an untreated control. The cells are exposed to the test chemical for 24 hours. Following the treat- ment period, the cells are washed twice with phosphate-buffered saline and fed normal growth medium. Microscopic examination of the plates should discern discrete colonies in approximately 10 to 12 days. At this time the plates are washed with phosphate-buffered saline, fixed with methanol, and stained by Giemsa. The colonies on the plates are counted, and a plating efficiency is determined. The plating efficiency is calculated as the number of surviving cells expressed as a percentage of the cells planted: £ of colonies per plate X 100 # of cells seeded ------- 35 An evaluation of the cytotoxic effect of the test chemical may be made by comparing the plating efficiency of the test plates with that of control plates. Details are summarized in Table 11. Protozoan Clonal Viability This assay is based on the observation that when cells are subjected to toxicants or stresses, only a fraction of the population survives and re- produces. Heaf and Lee (1971) first developed this method to measure the viability of Tetrahymena after exposure to low temperatures. This viability assay is currently being adapted for toxicity testing (Persoone and Dive, 1978). In the assay J. pyriformis is grown axenically in the dark. The cul- tures are then diluted to about 5 cells/ml. One ml of the dilution is placed in each well (cup) of a 100-hole, plastic, hemagglutination tray. Also, a toxicant is added in increasing concentrations to the wells containing Tetrahymena. After 6 days at 28 C, cells surviving certain toxicant concen- trations will proliferate, while those affected by other toxicant concentra- tions will not divide. The number of wells containing growing populations, as well as the number of organisms in each well, can be counted with the naked eye and recorded. A schematic of the clonal viability test method is shown in Figure 1. The details on this assay are summarized in Table 12. Human KB Cell Growth Rate Nephelometric measurements, such as changes in the optical density or macromolecular complement of cell cultures, provide a basis for monitoring the growth of cell populations. In this assay, the inhibition (or possible stimu- lation) of mammalian cell growth is determined by measuring colorimetrically the total protein present in dividing cells both before and after incubation with a test chemical (Oyama and Eagle, 1956). Even though any of several cell lines could be employed, the rapidly growing human tumor line KB or the mouse tumor lines P388 or L1210 are excellent candidates for this assay. ------- 36 TABLE 11. CLONING L929 MOUSE CELLS Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References L929 mouse cell line. The test organism is simple to culture. Several concentrations of potential toxicants may be assayed simultaneously. This assay must be performed by skilled technicians. Specialized equipment is needed. A very long time is required to obtain results of this assay. Aromatic hydrocarbons (benzene, toluene- MEC is 5 to 50 ppm) Detergents (sodium dodecyl sulfate-MEC is .005% w/v) Inorganic ions-heavy metals (cobalt, nickel-MEC is 0.11 to 1 244, 326, 15, 9 Mammalian cell culture facilities $750 Duke et al , 1977 Richardson, et al , 1977 *See time and cost explanation, pp. 9-11 in text. ------- 37 ^ r0| r^ ^ o o /T-- O, 1 •»• GOG GCG ceo + ^* - COO OGG IGSQ 1 TOXICANT 1 1 1 1 I , 1 LlNCL'3ATiCN I ^^>r GOG COG '-^ T\ /T\ [ Vj Op 1 1 1 | kC 1 1 Figure 1. Schematic Representation of Viability Test Adapted to Toxicity Testing. From Persoone and Dive (1978). ------- 38 TABLE 12. PROTOZOAN CLONAL VIABILITY Criteria Critique/Comments Test Organism Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References Tetrahymena pyriformis Rapidly dividing cultures of test organisms are easily grown. Many replicates and chemical concentrations can be done simultaneously. The assay is not disrupted by particulate matter or color of the potential toxicant. The TLso can ^e easily determined. The assay can be performed by unskilled technicians. A long time is required to obtain the results of this assay. Gases (ethylene oxide) 148, 210, 14, 9 None $660 West et al, 1962 Heaf and Lee, 1971 Gardinono et al, 1973 Mouton and Hendrickx, 1974 *See time and cost explanation, pp. 9-11 in text. ------- 39 The test is conducted as follows: KB cells, seeded at 1020 - g/ml protein (2 to 3 x 10^ cells/ml), and the appropriate concentrations of test chemical are mixed and incubated for 72 hours at 37 C. After incubation, total protein is determined in the test and untreated control cultures as de- scribed by Lowry et al (1951). For significance, untreated control cultures must go through at least six cell divisions. The number of cultures in the control group varies according to the formula 2Vn~T where n is the test cul- tures or number of chemicals being tested. A positive control, cells treated with 6-mercaptopurine, exhibits an ED 50 between .05 and 0.5 pg/ml. Criteria for cytotoxicity of test chemicals would be any inhibition of growth caused by the test chemical. The influence of a toxicant on cell growth rate could be possibly extrapolated to the development and prolifera- tion of tissues and organs (e.g., KB cell growth rate to nasopharynx lining proliferation). Details of this assay are summarized in Table 13. Human Embryonic Lung Fibroblast (HI-38) Cytotoxicity This assay is used to measure growth-inhibition effects of various toxicants on mammalian cells. Human embryonic lung fribroblasts (WI-38) are cultured in 75-cm2 Falcon flasks with Eagle's Minimum Essential Medium plus mycostatin (10,000 units/500 ml medium), penicillin (10,000 units/500 ml medium), streptomycin (10,000 ug/100 ml medium), and heat-inactivated fetal calf serum (10 percent). Cells are incubated in 10 percent carbon dioxide-humidified atmosphere at 37 C. Only cells between the 15 and 35 subculture should be used. After the cells reach about 90 percent confluence, one flask of cells is used for conducting this assay. There are eighteen 60-mm plates per assay. After assembling medium, cells, and plates, 4 ml of medium is pipetted into each plate. The stock cells in a 75-cm2 Falcon flask are then trypsinized. After cell counts and dilutions are made, a 2 x 10^ cells/ml suspension is seeded into each 60-mm plate. After cells have grown to 100 percent confluence (4 to 5 days), test toxicant is added. Cells and test chemicals are then incubated for 20 hours. ------- 40 TABLE 13. HUMAN (KB) CELL GROWTH RATE Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References Human KB eel Is The test organism is easy to culture. Many potential toxicants at several concentrations may be tested simultaneously. Inhibition of cell growth is usually an accepted standard of toxicity. National Cancer Institute routinely uses this assay for cytotoxicity screening. Specialized equipment is needed. A skilled technician is required to perform this assay. Inorganic ions-heavy metals (cadmium, nickel-MEC is 0.1 to 10 ug/ml) Nucleotide analogues (deoxy-adenosine S'-triphosphate-MEC is > 5 x lO'5 M) Aromatic hydrocarbons (toluene, benzene-MEC is 1 to 5 ppm) Detergents (sodium dodecyl sulfate, Triton X-100-MEC is .001 to .005%) Carcinogenic nitrosamines (dimethyl- nitrosamine-MEC is 5 to 20 ug/ml) 75, 125, 12, 8 Mammalian cell culture facilities, spectrophotometer $620 Oyama and Eagle, 1956 *See time and cost explanation, pp. 9-11 in text. ------- 41 Following incubation, the three plates of cells per test chemical concentra- tion (five different concentrations) are washed in phosphate-buffered saline twice and then trypsinized. The cells are collected by centrifugation at 500 g for 5 minutes. The supernatant is poured off, and 1 ml of medium is added to the centrifuge tube. The cells are suspended and counted with a hemocytom- eter. The average number of cells recovered from each test chemical concen- tration and from control plates is determined. Cell counts from the plates are averaged for all the concentrations of the test chemicals and the con- trols. The average counts from the test chemical plates are then expressed as a function of the number of cells obtained from the control plates. A cyto- toxicity curve for the test chemical is constructed. The curve is an expres- sion of the cellular survival as a function of concentration of the toxicant. Effects of toxic chemicals on fibroblasts could be extrapolated to effects on human connective or pulmonary tissue. Details on this assay are summarized in Table 14. Mitogen Stimulation of Lymphocytes Blastogenic transformation of lymphocytes is considered to be a mani- festation of lymphocytes in cellular immunity. Measurement of the effect of test chemicals on this mitogen-induced blast transformation is a measurement of the effects on immune function. Thymus, spleen, or lymph-note cell suspen- sions are cultured in the presence of mitogens such as Concanavalin A (Con A), phytohemagglutinin-P (PHA), and Pokewood mitogen (PWM). Certain cells within these populations respond to the presence of mitogens by undergoing blastogen- esis. The response is quantitated by monitoring ^H-thymidine incorporation in mitogen stimulated and nonstimulated cultures. Varying concentrations of the test substance are added to microlym- phocyte cultures in Falcon microtest II multi-well plates. Each well is a microculture of 5 x 10^ lymphocytes growing in the presence or absence (control) of a mitogen (PHA, 50 yg/ml final; Con A, 100 pg/ml final). Each dosage of the test chemical is tested in quadruplicate with the lymphocyte cultures. Incubation is pulsed with 1 yCi of 3H-thymidine. Twenty-four hours after pulsing, the cultures are harvested on glass-fiber filters using a ------- 42 TABLE 14. HUMAN EMBRYONIC LUNG FIBROBLAST (WI-38) CYTOTOXICITY Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References Human embryonic lung fibroblasts (WI-38) An automatic cell counter can be used to simplify this assay. Many replicates and chemical concentrations can be tested simultaneously. The assay result's are easily obtained by direct counting. A skilled technician with experience in microscopy is required. Some specialized equipment is needed. The possibility of human mistakes due to fatigure and boredom exists because of the tedious nature of the data collection. Inorganic ions-heavy metals (nickel, cadmium-MEC is 0.1 to 1 yg/ml) Gases (carbon monoxide) Aromatic hydrocarbons (benzene, toluene, ethyl benzene-MEC is 0.5 to 50 yM) 27, 176, 14, 9 Mammalian cell culture facilities, binocular microscope (optional), hemocytometer $730 Baiile and Hardegree, 1970 *See time and cost explanation, pp. 9-11 in text. ------- 43 multisample harvesting unit. ^-thyroidine incorporation is determined by counting the filters, using liquid scintillation spectrophotometry. To analyze the data, one must (1) compute mean radioactive counts per minute (cpm) and standard error of mean for all control values, i.e., PHA, Con A, and medium; (2) compute mean cpm and standard error of mean for each quad- ruplicate cell control, i.e., cells and medium; (3) compute mean cpm and stan- dard error of mean for each quadruplicate PHA- and Con A-stimulated cultures; (4) for stimulation index, divide each of the quadruplicate cpm values for PHA-stimulated cells by the mean cpm value of the same cells nonstimulated, and average the four indices determined in this manner for a mean stimulation index (repeat for Con A and PHA); and (5) compare index of test-substance treated and untreated cultures. Impairment of lymphocyte function by toxic chemicals may foreshadows the impairment of antibody formation and immune response in mammals. Details of this assay are summarized in Table 15. Chick Embryo Development The assay is an attempt to predict toxicologic or teratologic (tera- togenic) effects on higher vertebrates based on responses of chick embryos to potentially harmful compounds. Fertilized white leghorn eggs are candled to locate the air cell. A hole drilled through the shell over the air cell is the site of aseptic injection of 0.1 ml of a test chemical into the yolk of the developing embryo. The hole is covered with tape and the eggs are incu- bated at 38 C and periodically candled. Dead embryos are pathologically examined and surviving chicks are examined over a 2 to 6-week period for weight change, gross abnormalities, and mortality. At least 20 eggs are used for each chemical concentration tested to add statistical significance to the results. Eggs hatch after 21 days so the entire procedure may be performed in approximately 1 month. Details are summarized in Table 16. ------- 44 TABLE 15. MITOGEN STIMULATION OF LYMPHOCYTES Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References Mouse lymphocytes The effect of a potential toxicant is defined for a developmental parameter as well as a growth parameter. It is possible to determine a developmental change before a loss in viability or growth potential of test eel Is. Some variation of responsivenss of lymphocyte preparations may interfere with this assay. Great expense is incurred maintaining a mouse colony as a source of lymphocytes. Specialized equipment is needed. The assay must be performed by highly skilled technicians. Fungal toxins (aflatoxins-MEC is 5 to 20 ug/ml) Inorganic ions-heavy metals (nickel, cadmium-MEC is 0.1 to 1 ug/ml) 76, 76, 11, 8 Scintillation counter, spectrophotometer, animal rearing facilities, mammalian cell culture facilities. $820 Save! et al, 1970 *See time and cost explanation, pp. 9-11 in text. ------- 45 TABLE 16. CHICK EMBRYO DEVELOPMENT Criteria Critique/Comments Test Organisms Advantages Limitations White Leghorn chick embryos Large numbers involved make the results of this assay statistically meaningful. Responses of test organism correlate well with other animal responses to traditionally toxic chemicals (lead acetate, mercury II chloride). Since eggs are incubated under controlled conditions, maternal influence is not a variable, as it is in placental animals. The rapidly dividing cells may reduce the time necessary to elicit a response to possible toxicants. This assay can be performed by unskilled technicians. There is a lack of standardized methods in this assay. An extremely long time is required to obtain the results of this assay. Since responses are dependent on critical periods of development, responses may vary with each test chemical. One species of test organism selected, White Leghorn, may be unrealistically sensitive or insensitive to some chemicals. Response depends on several different variables: specific gravity, solubility, pH, ionic concentration, and coagulating effect. Negative results may not be significant. The lack of a placental barrier gives a questionable correlation between responses of chick embryos and responses exhibited by mammals. Specialized equipment is needed. ------- 46 TABLE 16. (Continued) Criteria Critique/Comments Response to Chemicals Assay Time*, hours Special Equipment Cost* References Inorganic ions-heavy metals (lead, mercury, cobalt-LC/i is 0.1 mg) Food additives (monosodium glutamate, sodium benzoate) Nucleic acid analogues (5-fluorouraci1) Antibiotics (tetracycline, methacycline, doxycycline) Dithiocarbamates [bis(dimethyl thiocarbamoyl)-disulfide] Organic solvents (carbon tetrachloride, n-butanol) Hallucinogens [lysergic acid diethylamide, (LSD)] Lathyrogenic agents (B-aminopropionitrile- LC62 is 0-63 mg) Metabolic inhibitors (2,4-dinitrophenol) 720 (1 month), 720, 108, 11 Incubators, hatching facilities, rearing facilities, sterile injecting facilities. $2510 Feldman et al, 1958 Mclaughlin et al, 1963 Gebhardt and Van Logten, 1968 Kury and Crosby, 1968 Hall, 1972 Pagnini et al, 1972 Flick et al, 1973 Messier, 1973 Palmer et al, 1973 Hulbert and Klawitter, 1974 Hall, 1976 Swartz, 1977 Zagris, 1977 Lee, 1978 Loomis, 1978 *See time and cost explanation, pp. 9-11 in text. ------- 47 Trypan Blue Dye Exclusion by Human KB Cells The ability of cultured human cells to exclude the dye trypan blue is a measure of a functioning cell membrane. Monolayer cultures of KB cells are incubated with a test chemical for 24 hours. Following the incubation period, the cells are removed from the plates with a rubber policeman. The cell suspension is placed in 15 ml coni- cal centrifuge tubes and centrifuged at 600 g for 5 minutes. The supernatant is discarded, and the cells are resuspended in 2 ml of phosphate buffered saline. An 0.66-ml aliquot of the cell suspension is mixed with 0.66 ml of a 0.4 percent trypan blue solution. A cell count and a viability determination are carried out for each concentration level, using a hemocytometer or cytograf. Viable cells are those cells that do not take up the trypan blue dye. Viability is calculated by: No. of viable cells : X 100 = percent viability total cell # A Viability Index is also calculated as follows: u- U-T-J. T j mean total cell count of test . , .,. Viability Index = mean tota1 Ce11 count of Contro1 X mean percent^viability Information from this assay may be extrapolated to other cellular or subcellular membranes because other cells are enclosed by semi permeable membranes which are structurally and functionally similar to the lipid bilayer surrounding KB cells. Details of this assay are summarized in Table 17. CATALYSIS (ENZYMATIC ACTIVITIES) RNA Polymerase Activity RNA polymerase is a multimeric enzyme that catalyzes the synthesis of RNA chains from the nucleoside triphosphates ATP, CTP, GTP, and UTP. The synthetic reaction has an absolute requirement for a divalent metal ion and ------- 48 TABLE 17. TRYPAN BLUE DYE EXCLUSION BY HUMAN KB CELLS Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References Human KB cells This assay can be partially automated by the use of a hemocytometer. The test results are straightforward and easily obtainable. A relatively short time is required to obtain the results of this assay. Specialized equipment is needed. A skilled technician with experience in microscopy is required. Detergents (Triton X-100), sodium dodecyl sulfate-MEC is .001 to .005%) Polycyclic aromatic hydrocarbons (naphthalene, anthracene-MEC is 0.5 to 75 uM) Inorganic ions-heavy metals (cadmium, lead-MEC is 0.1 to 1 ug/ml) 30, 77, 11, 8 Binocular microscope, mammalian cell culture facilities, hemocytometer $600 Corning and Firth, 1969 *See time and cost explanation, pp. 9-11 in text. ------- 49 normally requires DNA as a template. RNA polymerase recognizes and binds to certain base sequences in DNA, initiates RNA synthesis, elongates the RNA chain, and finally terminates RNA synthesis with a release of a new RNA molecule. The standard wheat germ RNA polymerase II assay mixture, in a final volume of 0.25 ml, contains 2.5 umol of Tris-HCl (pH 7.9); 0.25 umol of manga- nese chloride; 12.5 ymol of ammonium sulfate; 100 nmol each of GTP, CTP, and ATP; 1 yCi of (5-3H)UTP diluted to a specific radioactivity of 1 uCi/0.1 nmol; 50 ug of heat-denatured calf thymus DNA; and 125 ug of bovine serum albumin. The assays mixture is 'incubated for 15 minutes at 25 C, and the RNA is precipitated by adding 2 ml of 5 percent (w/v) ice-cold trichloroacetic acid containing 25 mM sodium pyrophosphate. After 5 minutes at 0 C, the pre- cipitates are collected on Whatman GF/C filters and are washed under suction with five 4-ml rinses of ice-cold 2 percent trichloroacetic acid containing 10 mM sodium pyrophosphate followed by 2 ml of 95 percent ethanol. After the filters are dried under a heat lamp, they are assayed for radioactivity by liquid scintillation counting. By changing only the template and the radioactive nucleotide, one can assay for several other polymerase activities involved in gene replication and expression. These enzymatic activities include DNA polymerase, poly(A)- polymerase, and polynucleotide phosphorylase. In all of these polymerase assays, test chemicals can be added to the reaction mixture prior to the ad- dition of the enzyme. By effecting RNA polymerase activity, a toxic chemical would be modifying the mechanism by which all new cellular proteins and enzymes are produced. Since RNA polymerase is present in all living organisms, results could be extrapolated to all life forms. Details of this assay are summarized in Table 18. Adenyl Cyclase Activity Adenyl cyclase is a hormonally activated surface membrane enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic ------- 50 TABLE 18. RNA POLYMERASE ACTIVITY Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* Reference Either RNA polymerase purified from wheat germ or Escherichia coli may be used. RNA polymerase is present in every living organism. All assay components as well as E. coli and wheat germ enzymes are commercially available and are relatively inexpensive. Hundreds of assays can be completed daily. . Many replicates and chemical concentrations can be done simultaneously. Noting the effects of chemicals on RNA polymerase will contribute to pinpointing molecular mechanisms of chemical action. A very short time is required to obtain the results of this assay. Colored chemicals and precipitates inter- fere with this assay. A high degree of technical skill and training is necessary to assay for RNA polymerase. Specialized equipment is needed. Metal carcinogens (cobalt-Iso is 0.5 mM, lead) Antibiotics (actinomycin D, proflavine, mithramycin, rifamycin) Carcinogenic nitrosamines (dimethyl- nitrosamine, azobenzene derivatives) Polyanions (heparin, polyethylenesulfonate) Metal mutagens (lithium-Igg is 0.2 M) Fungal toxins (alpha-amanitin, aflatoxin) Nucleotide analogues (2'-0-methyl-adenosine S'-triphosphate) 1.5, 5, 5, 8 Millipore filtration manifold, liquid scintillation counter $530 Polya, 1973 Jendrisak and Burgess, 1975 Hoffman and Niyogi, 1977 Glazer, 1978 *See time and cost explanation, pp. 9-11 in text. ------- 51 adenosine monophosphate (cAMP). The latter (cAMP) is an important regulatory molecule in both prokaryotic and eukaryotic cells. WI-38 human diploid cells are seeded at 2 x 106 cells/60-mm dish. Various doses of the test chemical are added at the time of culture seeding. Cultures are incubated for 24 hours. Treated and control cells are then processed to determine adenyl cyclase activity. After trypsinization, cell pellets are obtained by centrifugation and washed three times in a 10 mM Tris buffer (pH 7.4) containing 0.1 mM dithiothreitol at 0 to 4 C. After the final wash, buffer is added followed by ice-cold magnesium chloride and sucrose to final concentrations of 3 mM and 250 mM, respectively. Better than 99 percent breakage of WI-38 cells is observed. Broken cells are subsequently centri- fuged at 2000 g for 15 minutes, and the pellet is suspended in buffer contain- ing 250 mM sucrose, 3 mM magnesium chloride, 0.1 mM dithiothreitol, and 10 mM Tris buffer (pH 7.4)'. The broken cell pellet is used for the adenyl cyclase assay. Reaction mixtures contain 2 mM ATP, 6.6 mM magnesium chloride, 1.0 mM dithi- othreitol, 40 mM Tris buffer (pH 7.4), and 0.05 M sucrose in a final volume of 0.5 ml. Reactions are initiated by adding 40 to 80 g of protein to the cell preparation. After incubation at 37 C for 15 minutes, the reaction is stopped by adding trichloroacetic acid to a final concentration of 5 percent. After centrifugation, the supernatant is treated three times with ethyl ether to remove the trichloroacetic acid. The solution is analyzed for cAMP using a radiotracer competitive protein binding method (commercially available). An ATP regenerating system composed of 10 mM creatine phosphate and five units of creatine phosphokinase/0.5 ml of incubation mixture is used in all experi- ments. Enzymatic activity is expressed as the amount of cAMP produced. Despite the fact that cAMP plays a key role in controlling biological processes, the correlation between a chemical effect on adenyl cyclase and cellular or tissue toxicity would require extensive research and development. Details of this assay are summarized in Table 19. Lysosomal Enzyme Release The destabilization of internal cellular membranes produced by toxic chemicals can be assessed by measuring the release of certain enzymes from the ------- 52 TABLE 19. ADENYL CYCLASE ACTIVITY Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References WI-38 human diploid cells The assay measures a specific enzymatic activity at a surface membrane. This enzyme plays a key regulatory role in cellular metabolism. This assay assesses a specific physio- logical process as well as an organellar function. A relatively short time is necessary to obtain the results of this assay. Screening large numbers of chemicals is time consuming due to the requirement for processing cell membranes before the enzyme assay, followed by the cAMP assay. Some specialized equipment, is needed. This assay must be performed by highly skilled technicians. Inorganic ions-heavy metals (lead, nickel-MEC is .05-10 ug/rnl) Detergents (Triton X-100-MEC is .001-.05%) 29, 79, 14, 9 Mammalian cell culture facilities, liquid & scintillation counter $880 Klein et al, 1978 *See time and cost explanation, pp. 9-11 in text. ------- 53 lysosomes into the cytoplasm. In this assay, the release of the lysosomal enzyme acid phosphatase is measured histochemically. KB cells, seeded at 10$ cells per 60-mrn dish, are pipetted onto coverslips and then various doses of a test chemical are administered. After treatment for 24 hours, coverslips are washed in isotonic saline and then are incubated for 15 minutes in a medium of 10 mM g-glycerophosphate and 50 mM acetate buffer (pH 5.0) containing 4 mM lead nitrate and 50 mM sodium chlor- ide. Following incubation, the coverslips are fixed for 10 seconds in one percent acetic acid, transferred to hydrogen sulfide-saturated water for 5 minutes, washed in distilled water, and mounted. Staining of acid phos- phatase is indicative of damaged lysosomal membranes because intact lysosomal membranes are impermeable to the g-glycerophosphate substrate. Other mammalian cell lines (HeLa, mouse L) can be used in this assay. It should be noted that this assay measures the effect of a toxicant on an organellar membrane inside the cell. This assay does not measure cell lysis. This assay measures the perturbation of an important cellular com- ponent. So, the enzymes, released from lysosomes ruptured by a toxicant, can kill cells and cause tissue necrosis. This assay can be used as quick, quali- tative screen. Microspectrophotometric techniques could be used to quantitate this assay. Details are summarized in Table 20. Macromolecular Synthesis in KB Cells This assay is used to assess the effects of test chemicals on the syntheses of macromolecules. The rate of incorporation of radiolabelled pre- cursors into an acid precipitable form (macromolecular form) is used as a measure of the synthetic rate, ^^-uridine incorporation is used to measure RNA synthesis, ^H-thymidine incorporation to measure DNA synthesis, and 3H-leucine incorporation to measure protein synthesis. The protocols for measuring any of these three parameters are the same since the radiotracer is the only variable. ------- 54 TABLE 20. LYSOSOMAL ENZYME RELEASE Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References Human KB cells This assay measures a specific membrane alteration before a loss in viability occurs. The test results are straightforward and easily obtainable. A relatively short time is required to obtain the results of this assay. This assay requires carefully controlled conditions of incubation to prevent nonspecific lysosomal damage or staining. A skilled technician with experience in microscopy is required. Specialized equipment is needed. Abrasives (silica) Detergents (Triton X-100-MEC is .05-1%) 29, 76, 9, 8 Microscope, mammalian cell culture facilities $560 Grasso et al, 1973 *See time and cost explanation, pp. 9-11 in text. ------- 55 Approximately 2.0 x 10^ KB cells are seeded into 60-mm petri dishes. Various dosages of the test chemical are added at the time of seeding of the cultures. Untreated controls are included. After 24 hours of incuba- tion, the cultures are pulsed with 1 uCi/ml of the appropriate radiotracer (^H-thymidine, ^H-uridine, or 3n_-|euc-jne). After a 2-hour pulse, the monolayer is rinsed with cold physiological saline, trypsinized, and resus- pended in saline. Aliquots of the suspensions are taken for cell count. The remaining cells are lysed by the addition of sodium deoxycholate to a final concentration of 0.5 percent. An equal volume of cold 10 percent trichloro- acetic acid is added to the suspension, and the resulting precipitate is collected on glass-fiber filters. The filters are then dried, and the radioactivity is determined by liquid scintillation spectrophotometry. The results are calculated as counts per minute of isotope incorporated per cell. This assay could be combined and correlated with other biochemical or enzymatic assays. For example, the chemical inhibition of cellular RNA synthesis could be correlated with the effect of that chemical on RNA poly- merase activity. Also, this assay protocol can be expanded to monitor other cellular syntheses by simply utilizing other labelled precursors (e.g., -fy- acetate for fatty acid synthesis). Details of this assay are summarized in Table 21. OTHER CELLULAR PROCESSES Cyclosis Cyclosis or protoplasmic streaming is the regular, cyclic movement of particles within a cell. Lucas (1977) has devised an assay to measure the inhibition of cyclosis caused by various levels of ammonium sulfate. This as- say could be adapted for toxicity testing. In this procedure, internodal cells of the al ga Chara are cut from an algal mat 1 day prior to the experiment. After cutting, the cells are soaked in 1.0 mM sodium bicarbonate buffer (pH 9.0) and are subjected to a regime of 13 hours of light and then 11 hours of dark. All cells are illuminated under fluorescent lights (10 W/sqm) for 2 hours before the start of an experiment. ------- 56 TABLE 21. MACROMOLECULAR SYNTHESIS IN KB CELLS Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References KB Human cell cultures This assay measures specific functional properties of cells and can be indicative of functional alteration or loss before general toxic effects (such as death) are observed. A relatively short time is required to obtain the results of this assay. This assay must be performed by skilled technicians. Specialized equipment is needed. Inorganic ions-heavy metals (nickel, lead-MEC is 0.1 to 10 yg/ml) Polycyclic hydrocarbons (naphthalene- MEC is 1 to 50 uM) Detergents (hexachlorophene-MEC is 5 to 100 ug/ml) 34, 78, 11, 8 Liquid scintillation counter, mammalian cell culture facilities $720 Carr and Ligaton, 1973 *See time and cost explanation, pp. 9-11 in text. ------- 57 At the beginning of the test, cells are soaked for 1 hour in a solution of the chemical to be tested. After exposure to the chemical, cells are examined, and cyclosis is measured with a binocular microscope having an ocular microm- eter. The time required for a standard-size cytoplasmic particle to traverse 1000 urn is measured with a stopwatch. Rates of cyclosis are measured in 10 cells and are expressed as the mean _+ standard error. It would be difficult to correlate a specific chemical effect on algal cyclosis with a chemical effect on metabolic processes in mammalian cells and tissues. Details on this assay are summarized in Table 22. Hemolysis This bioassay is capable of identifying the hemolytic effect of various potential toxicants. To measure this hemolytic effect, solutions of varying concentrations of the suspected toxicant, and a buffered saline solution containing 0.1 mM ethylenediaminetetraacetate (EDTA), are prepared and washed rat erythrocytes are added. The concentration of these cells should be 0.5 percent (volumetrically). The solutions are incubated for 1 hour and then centrifuged for 10 minutes at 1000 g to remove intact red cells. The supernatant fraction is then spun for 15 minutes at 20,000 g to remove any remaining particulate matter. The optical densities of the final supernatant fractions are measured at 542 nm to estimate hemoglobin. Addition of a like amount (0.5 percent) of red blood cells to water gives the value for 100 per- cent hemolysis. Information from this assay may be extrapolated to other cellular and subcellular membranes because other cells are enclosed by semipermeable mem- branes which are structurally and functionally similar to the lipid bilayer surrounding erythrocytes. Also, since erythrocytes contain hemoglobin which transports oxygen to tissues, any erythrocyte aberation would cause detrimen- tal effects elsewhere in the body. Details on this assay are summarized in Table 23. ------- 58 TABLE 22. CYCLOSIS Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References Chara coral!ina is the major organism. Nitella translucens and Elodea may also be used. None Inhibition of cyclosis goes from 0 to 100 percent with a small change in the concentration of certain interfering chemicals. The test organism is very difficult to culture. A skilled technician experienced in microscopy is necessary. A relatively long time is required to obtain the results of this assay. Some chemicals may cause increased, instead of decreased streaming. Only one assay at one test chemical concentration can be performed in one hour. There is a variable rate of streaming which is dependent on cell volume. Specialized equipment is needed. Metabolic inhibitors (2,4-dinitrophenol). Chlorinated aliphatics (chloroform). Inorganic salts (ammonium sulfate- 125 is 0.5 mM). Gases (oxygen) Sugars (mannitol, sucrose) 30, 141, 58, 11 Binocular microscope with ocular micrometer $1810 Pfeffer, 1938 Thaine, 1964 Geis and Morrison, 1971 Lucas, 1977 *See time and cost explanation, pp. 9-11 in text. ------- 59 TABLE 23. HEMOLYSIS Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost Rat or human erythrocytes \ This assay can be performed by an unskilled technician. A very short time is required to obtain the results of this assay. The test results are straightforward and easily obtainable. Erythrocytes from several sources are commercially available. Many chemicals and varying chemical concentrations may be tested simultaneously. Rat and human erythrocytes vary from batch to batch because of nutritional and genetic differences in donors. With some chemicals it is difficult to establish a dose-response relationship. Sulfhydryl inhibitors (p-chloromer- curibenzoic acid-EC4Q is 37.4 mg) Inorganic ions-heavy metals (lead, mercury) Hormones (epinephrine, prostaglandin £2) Peroxides (peroxidized microsomal lipids, hydrogen peroxide) Abrasives (silica) Arylhydrazines (phenyldrazine-ECyy is 100% solution, m-toylhydrazine) Detergents (Triton X-100) Inorganic ions-halides (iodide) Ionic surfactants (alkyltrimethylammonium halides) Chlorinated antibacterials (hexachloro- phene) Industrial particulates (asbestos) Buffers (Tris-HCl-ECioo is 100% solution) 2, 4, 4, 8 Spectrophotometer or colorimeter $440 ------- 60 TABLE 23. (Continued) Criteria Critique/Comments References Sheets et al, 1956 Allen and Rasmussen, 1971 Lessler and Walter, 1973 Itano et al, 1974 Klebanoff and Clark, 1975 Luthra et al, 1975 Majer, 1975 Light and Wei, 1977 Summerton et al, 1977 Pesh-Iman et al, 1978 Zaslavsky et al, 1978 *See time and cost explanation, pp. 9-11 in text. ------- 61 Protozoan Vacuole Contraction This assay is based on the observations that contractile vacuoles function in regulating osmotic pressure (Rifkin, 1973) and expelling waste substances from the cell. Nilsson (1974) developed an assay to measure the effect of a foreign substance on vacuolar contraction in Tetrahymena. Under favorable conditions, the vacuole contracts at regular intervals. However, when the protozoan is stressed, the timing of the intervals may be altered. In the assay, J_. pyriformis is grown axenically in an enriched medium. Aliquots of the cells are then incubated at 28 C in the test chemical solution. Observations are made using a light microscope, a Reichert anoptral optical system or a similar viewing system, during the 1-hour period, with expulsion intervals of vacuoles from several cells being recorded. The time required to reach normal size and the expulsion intervals for control cells are also recorded. The time intervals for individual cells are recorded separately. It would be difficult to correlate results from this assay with data obtained from mammalian cells and tissues. However, if vacuolar contraction were developed as a toxicity assay, those results could complement data ob- tained from the protozoan clonal viability assay and the protozoan motilty assay. The use of protozoans as test organisms in toxicity studies would appear to bridge the gap between undifferentiated prokaryotic organisms, such as bacteria, and the more complex metazoa (Woodard, 1976). Details on this assay are summarized in Table 24. Protozoan Motility Bergquist and Bovee (1974) conceived an original method for measuring the motility of ciliates by microphotography. Tetrahymena pyriformis is centrifugally pelleted and separated from axenic growth medium, washed, and again pelleted centrifugally. Then it is introduced by pipette into a holding chamber. For the assay, greater than 98 percent of the organisms should be motile. The test chamber is covered at its ------- 62 TABLE 24. PROTOZOAN VACUOLE CONTRACTION Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References Tetrahymena pyriformis The test organism is easy to obtain commercially and culture. The effects of potential toxicants can be easily observed. Vacuolar contraction can be standardized by controlling temperature, the age of cells, and the nutritional state of eel Is. Response times may vary even in a single cell. A long time is required to obtain the results of this assay. The assay must be performed by skilled technicians with experience in microscopy. Vacuolar contraction varies with vacuole size and a cell may contain more than one vacuole. Numerous observations must be made. Dipolar solvents (dimethyl sulfoxide) 17, 143, 30, 10 Light microscope, temperature control unit $1130 Rifkin, 1973 Nilsson, 1974 Patterson and Sleigh, 1976 *See time and cost explanation, pp. 9-11 in text. ------- 63 bottom by #5 Whatman filter paper and suspended in 200 ml of test solution. The pH is monitored and readjusted to 7.0 as needed. After 1 hour, samples are pipetted onto clean slides for microscopic examination. Multiple-exposure photographs are taken stroboscopically using a perforated aluminum disc attached to a stirring motor, which is equipped with a variable-speed reduc- tion gear, permitting optimal image-spacing. The revolving perforated disc is interposed between a Zeiss RA microscope and the removable light, permitting full use of the microscope's optics and lighting. Negative-image films are then projected onto a frosted glass screen and maximal-speed paths and linear spacings are measured. As an end point, the distances between the ciliates in the multiexposed photomicrographs are measured very easily by projection of the negatives onto a large screen. This method permits large data samples to be obtained quickly and easily. The results are then tested statistically for comparative and descriptive purposes. This assay might be automated by em- ploying a computer and a TV. A chemical inhibition of protozoan flagellar or ciliary function might be similar to effects on mammalian tracheal tissues. The advantage of using protozoans in toxicity studies is mentioned in the description of the vacuole contraction assay. Details on the assay are summarized in Table 25. Phagocytosis by Alveolar Macrophages This assay employs a primary cell line, alveolar macrophages, to define the acute cellular toxicity of particulates and other chemicals. Toxic effects are assessed by measuring a macrophage function, phagocytosis. Rabbit alveolar macrophages are harvested. The cellular composition should contain a minimum of 95 percent alveolar macrophages. The cell suspen- sion is then adjusted to a concentration of 1 x 105 cells/ml. One-mi aliquots of the cell suspension are placed in 60-mm tissue culture plates and the macrophages allowed to adhere. After 2 hours, the medium is decanted and 5 ml of fresh medium is added to each plate. The test chemical is diluted to the desired concentration with cell culture medium and 1-ml aliquots are added to each plate. Initially, three ------- 64 TABLE 25. PROTOZOAN MOTILITY Criteria Cri t i que/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References Tetrahymena pyriformis is the major test organism. Paramecium caudatum may also be used. The test organisms are easy to culture. The decrease in motility is usually related to the concentration of the potential toxicant. Large data samples may be easily obtained. Precipitates or particulate matter may interfere with this assay. Specialized equipment is needed. There is a lengthy film development period in microphotography. This assay requires a skilled technician with experience in microscopy. Heavy metals (nickel, cadmium) Ionic detergents (sodium dodecylsulfate, sodium stearate) 23, 136, 27, 9 Microphotography unit $1000 Andrivon, 1968, 1972 Dryl and Bujwid-Cwik, 1972 Berquist and Bovee, 1973, 1974 Perkins and Cieresko, 1973 *See time and cost explanation, pp. 9-11 in text. ------- 65 concentrations of test chemical are used with three replicates per dose. The plates are incubated in a humidified 95 percent air, 5 percent carbon dioxide atmosphere at 37 C for 20 hours. The plates may be rotated for the first hour to ensure uniform exposure of the test material. At the end of the incubation period, the medium is decanted and fresh medium added. Phagocytic activity is measured by addition of 1.1 urn polystyrene latex particles to alveolar macrophages cultured in Lab-Tek four-chamber microslides (approximately 25 particles/cell in 1 ml of medium). One hour after the addition of latex particles, the slides are then exposed for an additional 5 to 6 minutes with 1:1 aqueous dilution of Wright's stain. After air drying, the slides are placed in xylene for one hour to dissolve extra- cellular particles. Following an additional drying step, the slides are mounted with permount. Phagocytic activity is determined under oil immersion by scoring a minimum of 200 cells. Each cell that contains at least one particle is considered phagocytically active. Typically, 80 to 90 percent of the cells in control cultures ingest one or more particles. This assay is already in limited use as a toxicity assay. Details on this assay are summarized in Table 26. Ami no Acid Transport A measurement of plasma membrane function is active transport and exchange of molecules into and out of the cell. This assay tests membrane function by measuring the active transport of the amino acid histidine into KB cells. For this assay, 10^ KB cells in 3 ml of suspension culture medium are exposed to various doses of the test chemical for 24 hours. At the end of the exposure period, the cells are washed and then suspended in incubation medium containing 131 mM sodium chloride, 5.2 mM potassium chloride, 1.3 mM magnesium sulfate, and 1.0 mM calcium chloride in 10 mM sodium phosphate buffer (pH 7.4). One uCi of ^H-histidine is added, and the mixture is in- cubated with agitation at 37 C. Samples are taken every minute for 5 minutes for radioactivity and cell number determinations. For measurements of histi- dine uptake, the cells in each sample are washed in cold saline to remove ------- 66 TABLE 26. PHAGOCYTOSIS BY ALVEOLAR MACROPHAGES Criteria Crit1que/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References Rabbit alveolar macrophages The assay measures a functional process of macrophages, phagocytosis, and indicates specific functional alterations produced by test substances. A relatively short time is required to obtain the results of this assay. Alterations in phagocytosis occur before any general loss in cellular viability. A great expense is incurred maintaining a rabbit colony as a source of macrophages. The assay can be performed by skilled technicians. Other specialized equipment is needed. The assay is labor intensive in the preparation of macrophages and in monitoring results. Macrophage preparations may vary in responsiveness from day to day. Gases (cigarette smoke, fly ash-MEC is 10 to 100 ug/ml) Inorganic ions-heavy metals (cadmium, zinc-MEC is 25 to 100 mM) 27, 27, 17, 9 Microscope, animal rearing facilities, mammalian cell culture facilities $890 Green and Carol in, Duke et al, 1977 1967 *See time and cost explanation, pp. 9-11 in text. ------- 67 extracellular histidine. The total radioactivity in the cells is determined by liquid scintillation counting. Rates of histidine transport are then determined and compared by plotting the concentration of intracellular, labelled histidine against the extracellular concentration by the classic method of Lineweaver and Burke. Toxicity is indicated by decreases in the rate of histidine transport as compared to untreated controls. Information from this assay may be extrapolated to other cellular or subcellular membranes because other cells are enclosed by semi permeable mem- branes which are structurally and functionally similar to the lipid bilayer surrounding KB cells. Details on this assay are summarized in Table 27. OTHER POTENTIAL PHYSIOLOGICAL TOXICITY ASSAYS Several other assays show promise as toxicity screens and are cri- tiqued below. In each case, few data on the assay or on effects of known toxicants exist. For the chlorophyll fluorescence assay, much of the information is in press and will appear in the near future. However, it is impossible for us to develop a complete protocol for these assays with the information presently available. The Microtox bacterial luminescence assay designed by Beckman Instruments, Carlsbad, California, shows promise as a potential toxicity screen. All living organisms have certain structural and metabolic similari- ties. It is often possible to extrapolate studies performed on one organism to other living systems because of these similarities. Cells of luminescent bacteria are structurally and functionally similar to other living cells. The semipermeable membranes surrounding all cells are quite similar. In addition, certain metabolic processes (e.g., respiration) are common to all cells. According to Beckrnan, the Microtox system is simple, rapid, inexpen- sive, and accurate. From the data available, this appears to be true. Preliminary test results also seem to correlate with results of the 96-hour fish acute toxicity test. Although this assay appears to be an effective toxicity screen, the methods and results still need to be validated by ------- 68 TABLE 27. AMI NO ACID TRANSPORT Criteria Critique/Comments Test Organisms Advantages Limitations Response to Chemicals Assay Time*, hours Special Equipment Cost* References Human KB cells Simple kinetics (one or tv/o points) could allow time for several chemical concentrations to be tested simultaneously. The test organism is easy to culture. The assay can detect alternations in a specific membrane process before generalized toxicity. A relatively short time is required to obtain the results of an assay. If detailed kinetic measurements are made, only one concentration of one specific chemical can be tested at a time. A highly skilled technician is required to perform this assay. Many measurements are required to obtain the results of this assay. Some specialized equipment is required. Detergents (Triton X-100, sodium deoxychloate-MEC is .001 to .05%) Inorganic ions-heavy metals (nickel, cadnrium-MEC is 10 to 50 mM) Inorganic salts (magnesium chloride, calcium carbonate) 29, 53, 11, 8 Liquid scintillation counter, mammalian cell culture facilities $810 Matthews et al, 1970 *See time and cost explanation, pp. 9-11 in text. ------- 69 independent researchers. After significant testing with known toxicants, an objective decision can be made about the utility of the Microtox system. Another promising assay is the chlorophyll fluorescence assay de- veloped by Arntzen, Steinback, and others at the USDA laboratory at the University of Illinois, Urbana. Fluorescence of living leaves has been known for over 100 years, having been recognized by Muller in 1874 as a pathway of energy dissipation which competes with energy utilization in photosynthesis and with heating of the leaf. Since Muller's time, studies of in vivo chlorophyll fluorescence in algae, in leaves, and in chloroplasts of higher plants have improved our pres- ent understanding of the light reactions of photosynthesis. Quite recently, in vivo chlorophyll fluorescence measurement has also begun to be recognized as a means of detecting damage in intact plants sub- jected to environmental stresses and deleterious agents. The technique is an attractive one because data collection is easy, fast, and nondestructive, and can be done in the field. The potential applications of fluorescence measure- ment at the whole plant level probably will not be limited to detection of stress-induced damage but may be extended to use as a versatile diagnostic tool in plant pathology and as a screening tool in plant genetics. This fluorescence assay could be used to complement results from the Hill reaction and/or greening assays and to provide a broad data base about toxic effects on plants. McFarlane, Rogers, and Bradley at U.S. EPA, Environmental Monitoring and Support Laboratory, Las Vegas, are developing a rapid toxicity assay involving tritium oxidation by soil microorganisms. In this assay, v/ater is added to air-dried soil in a reaction vessel, and the slurry is incubated overnight. Tritium is injected into the reaction vessel and, after a fixed time, the amount of tritium oxidized to water is determined using a liquid scintillation spectrophotometer. Toxicity is determined by adding a fixed amount of potential toxicant to the reaction vessel prior to the addition of the tritium. The oxidation rate of this test sample is compared with that of the standard (untreated) sample. Even though several chemicals (e.g., silver nitrate, monuron, cadmium chloride) have been tested using this assay, the test organisms are not standardized, and different soil samples may contain ------- 70 different populations of microbes. This toxicity assay could probably be used only as a pretest to indicate the need for further testing. From the limited available information, these assays appear to be excellent candidates for use as toxicity assays. Since we do not have suffi- cient information to evaluate them by the same criteria used to evaluate other assays in this report, any decision about their utility as toxicity screens would be premature. However, it appears that little laboratory development of these assays would be necessary. As more information on these assays becomes available, objective ratings will be possible. ------- 71 TABULAR COMPARISON OF CRITERIA On the following pages are five tables (Tables 28 through 32) which show the relative strengths and weaknesses of these 24 physiological assays. These tables provide, at a glance, comparative data on which specific recom- mendations are based (see Discussion and Recommendations). With the exception of the "data base" category (Table 32), the criteria used in these five tables are defined and discussed in the introduction. The "data base" category in Table 32 refers to the relative amount of data available about chemical effects on a physiological process. The data base for each assay was rated as good (+++), fair (++), or poor (+). This is merely a subjective rating based upon sources revealed during our literature search (see Appendix). ------- 72 TABLE 28. SOURCE OF TEST ORGANISM Culture Animal Commercially Assay or grow facility prepared Acetylene Reduction X Hill Reaction X Greening X RuDP Carboxylase Activity X Photosynthetic Oxygen X Evolution Respiration in HeLa Cells X Adenylate Energy Charge XX X Cloning L929 Mouse Cells X Protozoan Clonal Viability X Human (KB) Cell Growth Rate X Human Embryonic Lung Fibroblast X (WI-38) Cytotoxicity Mitogen Stimulation of X Lymphocytes Chick Embryo Development X Trypan Blue Dye Exclusion by X Human KB Cells RNA Polymerase Activity X X Adenyl Cyclase Activity X Lysosomal Enzyme Release X Macromolecular Synthesis in X KB Cells Cyclosis X Hemolysis X X Protozoan Vacuole Contraction X Protozoan Hotility X Phagocytosis by Alveolar Macrophages X Ami no Acid Transport X ------- TABLE 29. TEST ORGANISMS AND ORGANISMAL LEVEL OR PARAMETER EVALUATED Test organism Level or parameter Assays Other Higher Human vertebrate Protozoan plant Alga Bacteria Organising.! Cellular Qrcjanellar Enzymatic Acetylene Reduction Hill Reaction Greening RuDP Carboxylase Activity Photosynthetic Oxygen Evolut ion Respiration in HeLa Cells Adenylate Energy Charge Cloning L929 Mouse Cells Protozoan Clonal Viability Human KB Cell Growth Rate Human Embryonic Lung Fibro- blast (WI-38) Cytotoxicity Mitogen Stimulation of Lymphocytes Chick Embryo Development Trypan Blue Dye Exclusion by Human KB Cells RNA Polymerase Activity Adenyl Cyclase Activity Lysosomal Enzyme Release Macromolocular Synthesis in KB Cells Cyclosis llemolysis Protozoan Vacuole Contraction Protozoan Moti1ity Phagocytosis by Alveolar Macrophages Ami no Acid Transport ------- TABLE 30. SPECIAL EQUIPMENT Assays Scintillation Centrifuge Microscope Spectrophotonietcr Counter Mammalian cell culture facilities Other equipment Acetylene Reduction Hill Reaction Greeninu HuDP Carboxylase Activity Photosynthetic Oxygen Evolution Respiration in HeLa Cells Adenylato Energy Charge Cloning L9i!9 Mouse Cells Protozoan Clonal Viability Human (KB) Cell Growth Rate Human Embryonic Lung Fibro- blast (WI-38) Cytotoxicity Hitogen Stimulation of Lympho- cytes Chick Embryo Development Tryjian Blue Oye Exclusion by Human Kli Cells RNA Polymeraso Activity Adenyl Cyclase Activity Lysosomal Enzyme Release Macromoleciilar Synthesis in KI3 Cells Cyclosis llemolysis Protozoan Vacuole Contraction Protozoan Hotility Phagocytosis liy Alveolar Macrojihacjc's Ami no Acid Transport Gas chromatograph Warburg apparatus Oxygen electrode llemocytometer Aniu:al rearing facilities Incubators, hatching and rearing facilities, sterile injecting facilities llemocytometer Mil 1 ipori> filtration manifold Microphotography unit Animal rearing facilities ------- Ji . I ihi LUil'ilLiAii SKILL Assay Acetylene Reduction Hill Reaction Oreening RuOP Carboxylase Activity Photosynthetic Oxygen Evolution Respiration in HeLa Cells Adcnylatc Energy Charge Cloning L929 Mouse Cells Protozoan Clonal Viability Human (KB) Cell Growth Rate Hunan Embryonic Lung Fibro- blast (WI-38) Cytotoxicity Hitogen Stimulation of lymphocytes Chick Embryo Development Trypan Blue Dye Exclusion by Human (KB) Cells UNA Polymerase Activity Adenyl Cyclase Activity Lysosouidl Enzyme Release Macromolecular Synthesis in KB Cells Cyclosis llemolysis Protozoan Vacuole Contraction Protozoan Motility Phagocytosis by Alveolar Macrophages Amino Acid Transport Assay Set time*, hours 2.5 3 29 2 50 30 8 244 148 75 27 76 720 (1 month) 30 1.5 29 29 34 30 2 17 23 27 29 Total assay set fime**, hours 54 57 150 54 100 80 62 326 210 125 176 76 720 77 5 79 76 78 141 4 143 136 27 53 Total technician Technician timet, hours Skill t 12 ++ 18 * 9 t 12 t++ 84 ++ 51 ++ 23 +t 15 ++ 14 t 12 ++ 14 ++ 11 +++ 108 + 11 ++ 5 t++ 14 +++ 9 ++ 11 ++ 58 + + 4 + 30 tt 27 ++ 17 ++ 11 +++ Other (administrative) time5, hours 8 11 8 8 11 13 9 9 9 8 9 8 11 8 8 9 8 8 11 8 10 9 9 8 Other Approximate costs and total cost*. consideration $35 (greenhouse fee) $100 (animal facility fee and rearing $150 (animal facil ity fee and rearing) $30 (special algal culture facilities) $100 (animal facil ity fee and rearing) . $ 620 820 560 750 2330 2350 920 750 660 620 730 820 2510 600 530 880 560 720 1810 440 1J30 1000 890 810 --J en •Three replicates of five chemical concentrations. **Including cell growth, solution preparation, organelle or enzyme preparation, and data recording. '''Including GLP, running assay, and solution preparation. fHated from + (unskilled) to >n (highly skilled). 'Including Ph.D. supervision, managerial time, data analysis, and reporting. "costs are estimated for the purpose of comparison only. Actual costs may vary to 20 to 25 percent from these figures at different laboratories. ------- 76 TABLE- 32. DATA BASE AND COMMENTS Assay Data base* Comments Acetylene Reduction ++ Hill Reaction +++ Greening +++ RuDP Carboxylase Activity + Photosynthetic Oxygen Evolution Respiration in HeLa Cells Adenylate Energy Charge ++ Cloning L929 Mouse Cells ++ Protozoan Clonal Viability ++ Human (KB) Cell Growth Rate ++ Human Embryonic Lung Fibro- blast (WI-38) Cytotoxicity Mitogen Stimulation of Lympho cytes Chick Embryo Development Trypan Blue Dye Exclusion by + Human KB Cells RNA Polymerase Activity ++ Adenyl Cyclase Activity very explosive. activities Acetylene gas is Chloroplasts and vary This assay has already been used to test many chemicals. This assay is rapid and rela- tively inexpensive, but activity varies. Respiratory and photosynthe- tic rates may vary. An extensive time and great cost are required to com- plete an assay set. No chemical effects on this assay are known, but it measures a universal meta- bolic process. A long time is required to complete an assay set. A long time is required to complete an assay set, but many assays can be per- formed simultaneously. This assay has already had limited use as a toxicity screen. Toxic chemical effects could be extrapolated to human pulmonary tissues. A great expense is incurred in maintaining a mouse colony. Extensive time and great cost are required to complete an assay set. There is no standardized endpoint. Results from this assay can be extrapolated to all membranes. Hundreds of assays can be completed daily and correl- ated to all life forms. It is difficult to correlate assay results with cellular or tissue toxicity. ------- 77 TABLE 32. (Continued) Assay Data base* Comments Lysosomal Enzyme Release Macromolecular Synthesis in ++ KB Cells Cyclosis Memolysis +++ Protozoan Vacuole Con- + traction Protozoan Motility ++ Phagocytosis by Alveolar +++ Macrophages Ami no Acid Transport + Results from this assay can be extrapolated to cellular and tissue levels. This assay could be combined with RNA polymerase activity to detect chemical inhibition of RNA synthesis. This assay has little relevance to mammalian cell and tissues. The assay is rapid, inexpen- sive, and results can be extrapolated to many systems. Results may be correlated to other assays involving protozoans. A long time and great expense is required to complete an assay set. This assay is already in limited use as a toxicity screen. The results of this assay can be extrapolated to other membranes. *Rated +++ (good), ++ (fair), and + (poor). ------- 78 REFERENCES Nitrogen Fixation Hardy, R.W.F., R. D. Holsten, E. K. Jackson, and R. C. Burns. 1968. 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The Physiology of Plants: A treatise upon the metabolism and sources of energy in plants. Oxford, The Clarendon Press, pp. 283-293. Rifkin, J. L. 1973. The role of the contractile vacuole in the osmoregulation of Tetrahymena pyriformis. J. Protozool, 20:108-114. Sheets, R. F., H. E. Hamilton, and E. L. DeGowin. 1956. Hemolysis of human erythrocytes by a sulfhydryl inhibitor-p-chloromercuribenzoic acid. Proc. Soc. Exp. Biol. Med., 91:423-427. Summerton, J., S. Hoenig, C. Butler, and M. Chvapil. 1977. The mechanism of hemolysis by silica and its bearing on silicocis. Exp. Mol. Path., 26:113-128. Thaine, R. 1964. The protoplasmic theory of phloem transport. Jour. Exp. Bot., 15:470-484. Zaslavsky, B. Yu., N. N. Ossipov, and S. V. Rogozhin. 1978. Action of surface-active substances on biological membranes III. Comparison of hemolytic activity of ionic and nonionic surfactants. Biochim. Biophys. Acta, 510:151-159. General Reference Woodard, G. 1976. Draft survey and evaluation of in vitro toxicity test methods, EPA 560/5-75-007. U.S. Environmental Protection Agency, Office of Toxic Substances, Washington, D.C., 110 pp. ------- APPENDIX LITERATURE SEARCH METHODS ------- A-l APPENDIX LITERATURE SEARCH METHODS LITERATURE SEARCH To obtain information on physiological assay methods and on the effects of potential toxicants on these assays, manual literature searches of published articles, reviews, abstracts, and bibliographies as well as com- puterized searches of selected data bases were conducted. This literature search was conducted over a period of 6 weeks from May 7, 1979, to June 15, 1979, by the methods outlined in Van Voris, et al (1979). Hand Searches In the hand literature searches, 50 of the most widely used and sub- scribed journals in biochemistry, molecular biology, enzyrnology, cell biology, pharmacology, botany, zoology, toxicology, ecology, and microbiology were scanned over the past year (May, 1978-April, 1979) for references pertaining to rapid physiological toxicity assays (Table A-l). Additional references were located by reviewing the abstract and bibliographic publications Biblio- graphy of Agriculture, Environmental Abstracts, Biological Abstracts, and Chemical Abstracts. These bibliographic publications were searched over a 5-year period (usually 1974-1979). The applicability of the indexed articles was based upon the titles only, or the abstracts when available. In many instances it was necessary to make subjective decisions as to whether an article pertained to in vitro physiological assays, particularly when abstracts were not available. Addi- tional references were reviewed on the basis of bibliographic citations in individual papers. Several articles familiar to the authors of this report were also reviewed. ------- A-2 Computer Searches Computer searches were conducted on data bases simultaneously with the hand searches. The rationale of the data bases selected was to give coverage to all types of literature reporting ecological effects of toxic chemicals. The bases searched were: • Bioscience Information System (BIOSIS) which focuses on life sciences worldwide since 1964. The data base is journal pub- lications containing the entire life sciences and including microbiology, plant and animal sciences experimental medicine, agriculture, pharmacology, ecology, bioengineering, biochemistry, and biophysics. The producer is BioSciences Information Service of Biological Abstracts. • Toxicology Information On-line (TOXLINE) which gives worldwide coverage to toxicology studies on animals and humans since 1971. The data base includes toxicology studies on environmental pollutants and chemicals, adverse drug reactions, and other toxic materials. It is produced by the National Library of Medicine. BIOSIS, searched from 1969 to the present, printed only titles. We found this data base to be particularly useful because it has controlled vocabularies with articles referenced by both key words and topics (e.g., Hill reaction and photosynthesis) so that all references pertaining to a desired subject under a topic are printed. TOXLINE was the more comprehensive data base (searched since 1971), overlapping somewhat with BIOSIS. The information retrieved from computer searches is dependent on words entered into the computer by the user as well as the key word descrip- tors used by authors or reviewers of articles used in the different data bases. In many cases, the key words used by a reviewer omit important facets of the article or refer to lightly covered topics because of misleading titles. The key words to be entered in the computer by the searchers v/ere determined by assay title, test organism, and cellular processes involved. Key words (assays, organism, and processes) were taken from Table 2 of this report. For example, for protozoan vacuole contraction, the key words protozoan and contractile vacuole were among those entered in the computer. Articles that appeared relevant were then reviewed and specific information was extracted from them. ------- A-3 TABLE A-l. JOURNALS SCANNED IN LITERATURE SEARCH Agricultural and Biological Chemistry Analytical Biochemistry Annual Review of Microbiology Applied and Environmental Microbiology Biochemical and Biophysical Research Communications The Biochemical Journal Biochemistry Biochimica et Biophysica Acta (Nucleic Acids, Enzymology, Reviews on Cancer, Lipids, Bioenergetics) Botanical Gazette Botanical Review Canadian Journal of Biochemistry Carbohydrate Research Cell Developmental Biology Ecology Ecotoxicology and Environmental Safety Environmental Science and Technology European Journal of Biochemistry Experimental Cell Biology Experimental Cell Science Experientia FEES Journal Food and Cosmetics Toxicology Histochemistry and Cyto- chemistry Journal of Bacteriology Journal of Biological Chemistry Journal of Cell Biology Journal of Cell Science Journal of Cellular Physiology Journal of Experimental Botany Journal of General Micro- biology Journal of Molecular Biology Journal of Protozoology Methods in Enzymology Molecular and General Genetics Molecular Pharmacology Nature Nucleic Acids Research Parasitology Pesticide Biochemistry and Physiology ------- A-4 TABLE A-l. (Continued) Physiologia Plantarum Plant Physiology Plant Science Letters Planta Proceedings of the National Academy of Science Proceedings of the Society for Experimental Biology and Medicine Sabouraudia Science Toxicology and Applied Pharmacology Virology Weeds ------- A-5 REFERENCE Van Voris, P., S. Pomeroy, H. Grotta, and A. Rudolph. March, 1979. Literature Evaluation of Field-Observed Effects of Toxic Chemicals. OPTS/EPA Contract No. 68-01-5043. 27 pp. ------- TECHNICAL REPORT DATA (Please read Instructions on ihe reverse before completing) 1. REPORT NO. EPA-560/11-80-001 2. 3. RECIPIENT'S ACCESSION NO. 4. TITLE AND SUBTITLE Identification and Evaluation of Potential Physiological Toxicity Assays 5. REPORT DATE February 1980 6. PERFORMING ORGANIZATION CODE 7. AUTHOR(S) 8. PERFORMING ORGANIZATION REPORT NO. G. H. Kidd, J. M. Rice, M. E. Davis, M. A. Hurst, M. F. Arthur, S. E. Pomeroy, and M. L. Price 9. PERFORMING ORGANIZATION NAME AND ADDRESS Battelle-Columbus Laboratories 505 King Avenue Columbus, OH 43201 10. PROGRAM ELEMENT NO. 11. CONTRACT/GRANT NO. 68-01-5043 12. SPONSORING AGENCY NAME AND ADDRESS EPA, Office of Pesticides and Toxic Substances 401 M Street, S. W. Washington, D.C. 20460 13. TYPE OF REPORT AND PERIOD COVERED Final Report: 4/79 - 2/80 14. SPONSORING AGENCY CODE EPA-560/H 15. SUPPLEMENTARY NOTES EPA i_ civic IN i Mn T r*u \ co project officer for this report is Ronald A. Stanley 16. ABSTRACT Battelle's Columbus Laboratories has contracted with the Office of Pesticides and Toxic Substances, U.S. Environmental Protection Agency, to develop a list of physiological assays as potential toxicity screening tests and to assess the strengths and weaknesses of these assays. After an extensive literature search, Battelle has compiled a list of 24 assays, covering seven physiological cate- gories cited by OPTS/EPA. Those categories included nitrogen fixation, photo- synthesis, respiration, high-energy phosphate production, growth and cell div- ision, catalysis, and other cellular processes. Brief descriptions of assay methods and tables containing critiques of each assay are presented along with literature references for all of the assays. Assays that are simple, rapid, cost-effective, reproducible, and well-documented are highlighted. 17. KEY WORDS AND DOCUMENT ANALYSIS DESCRIPTORS b.IDENTIFIERS/OPEN ENDED TERMS t. COSATI Field/Group Analyzing/Assessing Bioassay Physiological/Cellular Toxicity Physiological Toxicity Tests Biological Toxicity Cellular and Subcell- ular Mechanisms of Toxicity 18. DISTRIBUTION STATEMENT Unlimited 19. SECURITY CLASS (This Kcportj Unclassified 21. NO. OF PAGES 93 20. SECURITY CLASS (Timpage) Unclassified 22. PRICE EPA Form 2220-1 (R»». 4-77) PREVIOUS EDITION is OBSOLETE ------- |