DRAFT - DO NOT CITE OR QUOTE INCEA trackl"" n° f°r drafts or EPA ID for final] www.epa.gov/iris 4>EPA ANNOTATED REFERENCE OUTLINE FOR THE TOXICOLOGICAL REVIEW OF Ammonia (CAS No. 7664-41-7) In Support of Summary Information on the Integrated Risk Information System (IRIS) 12/12/08 NOTICE This document is an Agency Review draft. This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency determination or policy. It is being circulated for review of its technical accuracy and science policy implications. U.S. Environmental Protection Agency Washington, DC 10/8/2009 1-1 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 REVIEWS Clayton, GD; Clayton, FE; eds. (1993) Ammonia. In: Patty's industrial hygiene and toxicology. New York, NY: John Wiley & Sons; pp. 756-762. ACGIH (American Conference of Governmental Industrial Hygienists). (1991) Ammonium chloride fume. 6th edition. Cincinnati, OH: American Conference of Governmental Industrial Hygienists; p. 58. AGCIH. (2001) Threshold limit values for chemical substances and physical agents and biological exposure indices. Cincinnati, OH: American Conference of Governmental Industrial Hygienists. ACGIH. (1991) Ammonia. In: Documentation of the threshold limit values and biological exposure indices. Cincinnati, OH: American Conference of Governmental Industrial Hygienists Inc; pp. 58-59. Albrecht, J. (1996) Astrocytes and ammonia neurotoxicity. In: Role of Glia in Neurotoxicity. 2nd edition. New York, NY: CRC Press; pp. 137-153. Amshel, CE; Fealk, MH; Phillips, BJ; et al. (2000) Anhydrous ammonia burns case report and review of the literature. Burns 26(5):493-497. ATSDR (Agency for Toxic Substances and Disease Registry). (2004) Toxicological profile for ammonia (update). Atlanta, GA. Budavari, S. (1996) Ammonium bicarbonate. In: Budavari, S; ed. The Merck index-an encyclopedia of chemicals, drugs, and biologicals. 12th edition. Whitehouse Station, NJ: Merck and Co., Inc.; p. 87. Butterworth, RF. (2002) Pathophysiology of hepatic encephalopathy: A new look at ammonia. Metab Brain Dis 17(4):221-227. Cole, D; Todd, L; Wing, S. (2000) Concentrated swine feeding operations and public health: A review of occupational and community health effects. Environmental Health Perspectives 108(8):685-699. European Commission. (2000) Iuclid dataset Cas no. 6484-52-2. European Chemicals Bureau, European Commission. Available online at http://ecb.jrc.ec.europa.eu/esis/index.php. Accessed on December 10, 2008. European Commission. (2000) Iuclid dataset Cas no. 12125-02-9. European Chemicals Bureau, European Commission. Available online at http://ecb.jrc.ec.europa.eu/esis/index.php. Accessed on December 10, 2008. Faint, V. (2006) The pathophysiology of hepatic encephalopathy. Nurs Crit Care ll(2):69-74. 10/8/2009 1-2 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 Felipo, V; Butterworth, RF. (2002) Neurobiology of ammonia. Progress in Neurobiology 67:259-279. Gantilli, R. (1991) Drinking water health advisory for ammonia. Environmental Protection Agency, Office of the Assistant Administrator for Water. Washington, DC. PB 92 135 425. Gosselin, RE; Smith, RP; Hodge, HC. (1984) In: Clinical toxicology of commercial products. Baltimore, MD: Williams and Wilkins; p. Ill - 22. Heidelberger, C; Freeman, AE; Pielka, RJ; et al. (1983) Cell transformation by chemical agents - a review and analysis of the literature. Mutation Research 114:283-385. International Programme on Chemical Safety. (1990) Ammonia - health and safety guide. World Health Organization, Distribution and Sales Service. Available online at http://www.inchem.org/documents/hsg/hsg/hsg037.htm. Accessed on December 12, 2008. IRIS (Integrated Risk Information System). (1988) Ammonia. Integrated Risk Information System. U.S. Environmental Protection Agency, Washington, DC. IRIS. (2002) Ammonia. Integrated Risk Information System. U.S. Environmental Protection Agency, Washington, DC. Jalan, R; Shawcross, D; Davies, N. (2003) The molecular pathogenesis of hepatic encephalopathy. Int JBiochem Cell Biol 35(8): 1175-1181. Johanson, G; Alexandrie, A; Jarnberg, J; et al. (2006) Nordic expert group: Evaluation of health risks of ammonia. Toxicol Sci 90(1-S):332. Karim, Z; Szutkowska, M; Vernimmen, C; et al. (2005) Renal handling of NH3/NH4+: Recent concepts. Nephron Physiol 101(4):p77-81. Katayama, K. (2004) Ammonia metabolism and hepatic encephalopathy. Hepatol Res 30S:73- 80. Latenser, BA; Lucktong, TA. (2000) Anhydrous ammonia burns: Case presentation and literature review. Journal of Burn Care and Rehabilitation 21(1 PT l):40-42. Lehninger, AL. (1975) Oxidative degradation of amino acids. In: Biochemistry: The molecular basis of cell structure and function. 2nd edition. Worth Publishers, Inc.; pp. 579-585. Lewis, RJ. (1996) Ammonia. In: Sax's dangerous properties of industrial materials. New York, NY: p. 210. Liesivuoru, J; Nordic Expert, G. (2005) The nordic expert group for criteria documentation of health risks from chemicals. 137. Ammonia. Arbete och Halsa 13. Makarovsky, I; Markel, G; Dushnitsky, T; et al. (2008) Ammonia—when something smells wrong. Isr Med Assoc J 10(7):537-543. 10/8/2009 1-3 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 Marcaggi, P; Coles, JA. (2001) Ammonium in nervous tissue: Transport across cell membranes, fluxes from neurons to glial cells, and role in signaling. Progress in Neurobiology 64:157-183. NIOSH (National Institute for Occupational Safety and Health). (1974) Criteria for a recommended standard: Occupational exposure to ammonia. Cincinnati, OH: National Institute for Occupational Safety and Health. Hew publication number 74-136. O'Neil, MJ. (2001) Potential symptoms of overexposure to fumes are irritation of eyes, skin, respiratory system; cough, dyspnea, pulmonary sensitization. In: O'Neil, MJ; ed. The Merck index- an encyclopedia of chemicals, drugs, and biologicals. Whitehouse Station, NJ: Merck and Co., Inc.; p. 89. Pierce, JO. (1993-1994) Biological effects. In: Clayton, GD and Clayton, FE; eds. Patty's industrial hygiene and toxicology. 4th edition. New York, NY: John Wiley & Sons, Inc.; p. 758. Pierce, JO. (1993-1994) Absorption, metabolism, and excretion. In: Clayton, GD and Clayton, FE; eds. Patty's industrial hygiene and toxicology. 4th edition. New York, NY: John Wiley & Sons, Inc.; p. 760. Prager, JC. (1995) Ammonia. In: Environmental contaminant reference databook. New York, NY: Van Nostrand Reinhold; p. 137. Ryer-Powder, JE. (1991) Health effects of ammonia. Plant/Operations Progress 10(4):228-232. Seiler, N. (2002) Review: Ammonia and Alzheimer's disease. Neurochemistry International 41:189-207. Tonelli, AR; Pham, A. (2008) Bronchiectasis, a long-term sequela of ammonia inhalation: A case report and review of the literature. Burns Jun 5. [Epub ahead of print] U.S. EPA (Environmental Protection Agency). (1999) Ambient water quality criteria for ammonia, 1999 update. Office of Water. Washington, DC. EPA-822-R-99-014. Verschueren, K. (1983) Ammonium acetate. In: Handbook of environmental data on organic chemicals. 2nd edition. VanNorstrand Reinhold Company; p. 196. Visek, WJ. (1968) Some aspects of ammonia toxicity in animal cells. J Dairy Sci 51(2):286-295. Visek, WJ. (1984) Ammonia: Its effects on biological systems, metabolic hormones, and reproduction. Journal of Dairy Science 67(3):481-498. Walaszek, DR. (2003) Occupational ammonia injuries and sodium thiosulfate treatment: A review. Ammonia Plant Safety & Related Facilities 44:119-126. Weiner, ID; Hamm, LL. (2007) Molecular mechanisms of renal ammonia transport. Annu Rev Physiol 69:317-340. White, CE; Park, MS; Renz, EM; et al. (2007) Burn center treatment of patients with severe anhydrous ammonia injury: Case reports and literature review. J Burn Care Res 28(6):922-928. 10/8/2009 1-4 DRAFT - DO NOT CITE OR QUOTE ------- Winek, CL. (1985) Drug and chemical blood-level data 1985. Pittsburgh, PA: Allied Fischer Scientific. World Health Organization. (1986) Ammonia. Geneva, Switzerland: World Health Organization. 10/8/2009 1-5 DRAFT - DO NOT CITE OR QUOTE ------- 1 2. CHEMICAL AND PHYSICAL INFORMATION 2 3 10/8/2009 2-1 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 3. TOXICOKINETICS 3.1. ABSORPTION ACGIH. (1991) The average nasal retention of ammonia by human subjects was found to be 83%. Cincinnati, OH: American Conference of Governmental Industrial Hygienists; p. 58. Boyd, EM; MacLachlan, ML; Perry, WF. (1944) Experimental ammonia gas poisoning in rabbits and cats. Journal of Industrial Hygiene and Toxicology 26(l):29-34. Castell, DO; Moore, EW. (1971) Ammonia absorption from the human colon. Gastroenterology 60:33-42. Dalhamn, T. (1963) Effect of ammonia alone and combined with carbon particles on ciliary activity in the rabbit trachea in vivo, with studies of the absorption capacity of the nasal cavity. International Journal of Air and Water Pollution 7:531-539. Egle, JL. (1973) Retention of inhaled acetone and ammonia in the dog. American Industrial Hygiene Association Journal 34:533-539. Landahl, HD; Hermann, RG. (1950) Retention of vapors and gases in the human nose and lung. Archives of Industrial Hygiene and Occupational Medicine 1:36-45. Manninen, A; Anttila, S; Savolainen, H. (1988) Rat metabolic adaptation to ammonia inhalation. Proceedings of the Society for Experimental Biology and Medicine 187(3):278-281. Metges, CC; Petzke, KH; El-Khoury, AE; et al. (1999) Incorporation of urea and ammonia nitrogen into ileal and fecal microbial proteins and plasma free amino acids in normal men and ileostomates. American Journal of Clinical Nutrition 70(6): 1046-1058. Mossberg, SM; Ross, G. (1967) Ammonia, movement in the small intestine: Preferential transport by the ileum. Journal of Clinical Investigation 46(4):490-498. Schaerdel, AD; White, WJ; Lang, CM; et al. (1983) Localized and systemic effects of environmental ammonia in rats. Laboratory Animal Science 33(l):40-45. 3.2. DISTRIBUTION Brown, RH; Duda, GD; Korkes, S; et al. (1957) A colorimetric micromethod for determination of ammonia; the ammonia content of rat tissues and human plasma. Archives of Biochemistry and Biophysics 66:301-309. Conn, HO. (1972) Studies of the source and significance of blood ammonia iv. Early ammonia peaks after ingestion of ammonia salts. Yale Journal of Biology and Medicine 45:543-549. 10/8/2009 3-1 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 da Fonseca, J; Brito, MJ; Freitas, J; et al. (1998) Acute colitis caused by caustic products. American Journal of Gastroenterology 93(12):2601-2602. da Fonseca-Wollheim, F. (1995) The influence of ph and various anions on the distribution of NH4+ in human blood. European Journal of Clinical Chemistry and Clinical Biochemistry 33(5):289-294. Huizenga, JR; Tangerman, A; Gips, CH. (1994) Determination of ammonia in biological fluids. Annals of Clinical Biochemistry 31(6): 529-543. Jozwik, M; Pietrzycki, B; Chojnowski, M; et al. (2005) Maternal and fetal blood ammonia concentrations in normal term human pregnancies. Biol Neonate 87(l):38-43. Pitts, RF. (1971) The role of ammonia production and excretion in regulation of acid-base balance. New England Journal of Medicine 284:32-38. Salvatore, F; Bocchinti, V; Cimino, F. (1963) Ammonia intoxication and its effects on brain ammonia levels. Biochemical Pharmacology 12:1-6. Stabenau, JR; Warren, KS; Rail, DP. (1958) The role of ph gradient in the distribution of ammonia between blood and cerebro-spinal fluid, brain and muscle. Journal of Clinical Investigation 38:373-383. Takagaki, G; Berl, S; Clarke, DD; et al. (1961) Glutamic acid metabolism in brain and liver during infusion with ammonia labeled with nitrogen-15. Nature 189:326. Vitti, TG; Vukmirovich, R; Gaebler, OH. (1964) Utilization of ammonia nitrogen, administered by intragastric, intraperitonal, and subcutaneous routes: Effects of growth hormone. Archives of Biochemistry and Biophysics 106:475-482. Warren, KS; Nathan, DG. (1958) The passage of ammonia across the blood-brain-barrier and its relation to blood ph. Journal of Clinical Investigation 37:1724-1728. 3.3. METABOLISM Cooper, AJ; Freed, BR. (2005) Metabolism of [13N]ammonia in rat lung. Neurochem Int 47(1- 2): 103-118. Duda, GD; Handler, P. (1958) Kinetics of ammonia metabolism in vivo. Journal of Biological Chemistry 232:303-314. Gay, WMB; Crane, CW; Stone, WD. (1969) The metabolism of ammonia in liver disease: A comparison of urinary data following oral and intravenous loading of [15n]ammonium lactate. Clinical Science 37:815-823. Katayama, K. (2004) Ammonia metabolism and hepatic encephalopathy. Hepatol Res 30S:73- 80. 10/8/2009 3-2 DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 Keiding, S; Sorensen, M; Bender, D; et al. (2006) Brain metabolism of 13n-ammonia during acute hepatic encephalopathy in cirrhosis measured by positron emission tomography. Hepatology 43(l):42-50. Lockwood, AH. (2007) Controversies in ammonia metabolism: Implications for hepatic encephalopathy. Metab Brain Dis 22(3-4):285-289. Mohanachari, V; Reddy, KS; Indiri, K. (1984) Metabolic fate of ammonia in the rat after ethanol loading. Toxicology Letters 20:225-228. Morimoto, Y; Ukida, M; Tsuji, T. (1988) Dynamic relationship between urea and glutamine synthesis in the mechanism of ammonia detoxication: A tracer study using 15NH4C1 in fulminant hepatic failure rats. Gastroenterologia Japonica 23(5):538-545. Saul, RL; Archer, MC. (1984) Oxidation of ammonia and hydroxylamine to nitrate in the rat and in vitro. Carcinogenesis 5(1):77-81. Schenker, S; Warren, KS. (1962) Effect of temperature variation on toxicity and metabolism of ammonia in mice. Journal of Laboratory and Clinical Medicine 60(2):291-301. Souba, WW. (1987) Interorgan ammonia metabolism in health and disease: A surgeon's view. Journal of Parenteral and Enteral Nutrition 11(6):569-579. Summerskill, WHJ; Wolpert, E. (1970) Ammonia metabolism in the gut. American Journal of Clinical Nutrition 23:633-639. Zange, J; Gronczewski, J; Jans, AWH. (1993) NH4+ metabolism and the intracellular ph in isolated perfused rat liver. Biochemical Journal 293:667-673. 3.4. ELIMINATION Barrow, CS; Steinhagen, WH. (1980) NH3 concentrations in the expired air of the rat: Importance to inhalation toxicology. Toxicology and Applied Pharmacology 53:116-121. Benyajati, S; Goldstein, L. (1975) Renal glutaminase adaptation and ammonia excretion in infant rats. American Journal of Physiology 228:693-698. Davies, BMA; Yudkin, J. (1952) Studies in biochemical adaptation. The origin of urinary ammonia as indicated by the effect of chronic acidosis and alkalosis on some renal enzymes in the rat. Biochemical Journal 52:407-412. Flessner, MF; Wall, SM; Knepper, MA. (1992) Ammonium and bicarbonate transport in rat outer medullary collecting ducts. American Journal of Physiology 262(1 Pt 2):F1-F7. Giroux, M; Bremont, F; Salles, JP; et al. (2002) Exhaled NH3 and excreted NH4+ in children in unpolluted or urban environments. Environment International 28:197-202. 10/8/2009 3-3 DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 Han, KH; Croker, BP; Clapp, WL; et al. (2006) Expression of the ammonia transporter, rh C glycoprotein, in normal and neoplastic human kidney. J Am Soc Nephrol 17(10):2670-2679. Handlogten, ME; Hong, SP; Westhoff, CM; et al. (2005) Apical ammonia transport by the mouse inner medullary collecting duct cell (mimcd-3). Am J Physiol Renal Physiol 289(2):F347-F358. Hunt, RD. (1977) Measurement of partial pressure of ammonia in breath and arterial blood: Evidence for secretion of ammonia into expired gas by metabolism of monoamines in the lung. Dissertation Abstracts International Section B Physical Sciences and Engineering 37:3279. Karim, Z; Szutkowska, M; Vernimmen, C; et al. (2005) Renal handling of NH3/NH4+: Recent concepts. Nephron Physiol 101(4):77-81. Kupprat, I; Johnson, RE; Hertig, BA. (1976) Ammonia: A normal constituent of expired air during rest and exercise. Federation Proceedings 35:478. Larson, TV; Covert, DS; Frank, R; et al. (1977) Ammonia in the human airways: Neutralization of inspired acid sulfate aerosols. Science 197:161-163. Lotspeich, WD. (1965) Renal hypertrophy in metabolic acidosis and its relation to ammonia excretion. American Journal of Physiology 208:1135-1142. Muntwyler, E; Iacobellis, M; Griffin, GE. (1956) Kidney glutaminase and carbonic anhydrase activities and renal electrolyte excretion in rats. American Journal of Physiology 184:83-90. Richards, P; Brown, CL; Houghton, BJ; et al. (1975) The incorporation of ammonia nitrogen into albimum in man: The effects of diet, uremia and growth hormone. Clinical Nephrology 3(5):172-179. Robin, ED; Travis, DM; Bromberg, PA; et al. (1959) Ammonia excretion by mammalian lung. Science 129:270-271. Turner, C; Spanel, P; Smith, D. (2006) A longitudinal study of ammonia, acetone and propanol in the exhaled breath of 30 subjects using selected ion flow tube mass spectrometry, sift-ms. Physiol Meas 27(4):321-337. Utell, MJ; Mariglio, JA; Morrow, PE; et al. (1989) Effects of inhaled acid aerosols on respiratory function: The role of endogenous ammonia. Journal of Aerosol Medicine 2:141-147. Van Slyke, DD; Phillips, RA; Hamilton, PB; et al. (1943) Glutamine as source material of urinary ammonia. Journal of Biological Chemistry 150:481-482. 3.5. PHYSIOLOGICALLY BASED TOXICOKINETIC MODELS Diack, C; Bois, FY. (2005) Pharmacokinetic-pharmacodynamic models for categorical toxicity data. Regul Toxicol Pharmacol 41(l):55-65. 10/8/2009 3-4 DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 4. HAZARD IDENTIFICATION 4.1. STUDIES IN HUMANS—EPIDEMIOLOGY, CASE REPORTS, CLINICAL CONTROLS Ali, BA. (2001) Pulmonary function of workers exposed to ammonia: A study in the eastern province of Saudi Arabia. International Journal of Occupational and Environmental Health 7(1): 19-22. Altmann, L; Berresheim, H; Kruell, H; et al. (2006) Odor and sensory irritation of ammonia measured in humans. Naunyn Schmiedebergs Arch Pharmacol 372(Suppl. 1):99. Amshel, CE; Fealk, MH; Phillips, BJ; et al. (2000) Anhydrous ammonia burns case report and review of the literature. Burns 26(5):493-497. Andersson, BO. (1991) Lithuanian ammonia accident, March 20th 1989. Institution of Chemical Engineers Symposium Series 124:15-17. Ballal, SG; Ali, BA; Albar, AA; et al. (1998) Bronchial asthma in two chemical fertilizer producing factories in eastern Saudi Arabia. International Journal of Tuberculosis and Lung Disease 2(4):330-335. Brautbar, N; Wu, MP; Richter, ED. (2003) Chronic ammonia inhalation and interstitial pulmonary fibrosis: A case report and review of the literature. Arch Environ Health 58(9):592- 596. Buff, R; Koller, EA. (1974) Studies on mechanisms underlying the reflex hyperpnoea induced by inhalation of chemical irritants. Respiration Physiology 21:371-383. Burns, TR; Greenberg, SD; Mace, ML; et al. (1985) Ultrastructure of acute ammonia toxicity in the human lung. American Journal of Forensic Medicine and Pathology 6:204-210. Caplin, M. (1941) Ammonia-gas poisoning: Forty-seven cases in a London shelter. Lancet 241:95-96. Choudat, D; Goehen, M; Korobaeff, M; et al. (1994) Respiratory symptoms and bronchial reactivity among pig and dairy farmers. Scandinavian Journal of Work Environment and Health 20(l):48-54. Christesen, HB. (1995) Prediction of complications following caustic ingestion in adults. Clinical Otolaryngology 20(3):272-278. Cole, TJ; Cotes, JE; Johnson, GR. (1977) Ventilation, cardiac frequency and pattern of breathing during exercise in men exposed to o-chlorobenzylidene malonitrile (CS) and ammonia gas in low concentrations. Quarterly Journal of Experimental Physiology and Cognate Medical Sciences 62:341-351. 10/8/2009 4-1 DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 Cormier, Y; Israel-Assayag, E; Racine, G; et al. (2000) Farming practices and the respiratory health risks of swine confinement buildings. European Respiratory Journal 15(3):560-565. Counturier, Y; Barbotin, M; Bobin, P; et al. (1971) Apropos of three cases of toxic lung caused by vapors of ammonia and hydrogen sulfide. Bulletin de la Societe Medicale d'Afrique Noire de Langue Francaise 16(2):250-252. Crook, B; Robertson, JF; Travers Glass, SA; et al. (1991) Airborne dust, ammonia, microorganisms, and antigens in pig confinement houses and the respiratory health of exposed farm workers. American Industrial Hygiene Association Journal 52(7):271-279. de la Hoz, RE; Schlueter, DP; Rom, WN. (1996) Chronic lung disease secondary to ammonia inhalation injury: A report on three cases. American Journal of Industrial Medicine 29(2):209- 214. Dilli, D; Bostanci, I; Tiras, U; et al. (2005) A non-accidental poisoning with ammonia in adolescence. Child Care Health Dev 31(6):737-739. Donham, KJ; Cumro, D; Reynolds, SJ; et al. (2000) Dose-response relationships between occupational aerosol exposures and cross-shift declines of lung function in poultry workers: Recommendations for exposure limits. Journal of Occupational and Environmental Medicine 42(3):260-269. Donham, KJ; Knapp, LW; Monson, R; et al. (1982) Acute toxic exposure to gases from liquid manure. Journal of Occupational Medicine 24:142-145. Donham, KJ; Reynolds, SJ; Whitten, P; et al. (1995) Respiratory dysfunction in swine production facility workers: Dose-response relationships of environmental exposures and pulmonary functions. American Journal of Industrial Medicine 27(3):405-418. Douglas, RB; Coe, JE. (1987) The relative sensitivity of the human eye and lung to irritant gases. Annal Occup Hyg 31(2):265-267. Duke-Elder, S; MacFaul, PA. (1972) Injuries: Non-mechanical injuries. In: Duke-Elder, S; ed. System of ophthalmology. St. Louis, MO: C. V. Mosby Company; pp. 1079-1085. Dworkin, MS; Patel, A; Fennell, M; et al. (2004) An outbreak of ammonia poisoning from chicken tenders served in a school lunch. J Food Prot 67(6): 1299-1302. Ferguson, WS; Koch, WC; Webster, LB; et al. (1977) Human physiological response and adaption to ammonia. Journal of Occupational Medicine 19:319-326. Flury, KE; Dines, DE; Rodarte, JR; et al. (1983) Airway obstruction due to inhalation of ammonia. Mayo Clinic Proceedings 58:389-393. Furst, P; Josephson, B; Maschio, G; et al. (1969) Nitrogen balance after intravenous and oral administration of ammonium salts to man. Journal of Applied Physics 26:13-22. George, A; Bang, RL; Lari, AR; et al. (2000) Liquid ammonia injury. Burns 26(4):409-413. 10/8/2009 4-2 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 Gilbert, GJ. (1988) Acute ammonia intoxication 37 years after ureterosigmoidostomy. Southern Medical Journal 81(11): 1443-1445. Gomzi, M. (1999) Indoor air and respiratory health in preadolescent children. Atmospheric Environment 33(24-25):4081-4086. (Note: Will also be discussed in Section 4.8) Gomzi, M; Saric, M. (1997) Respiratory impairment among children living in the vicinity of a fertilizer plant. International Archives of Occupational and Environmental Health 70(5):314- 320. (Note: Will also be discussed in Section 4.8) Gueye, L; Samb, A; Ciss, M; et al. (2001) [ammonia-gas poisoning: Respiratory troubles evaluated by functional exploration], Dakar Med 46(1):8-11. Hatton, DV; Leach, CS; Beaudet, AL; et al. (1979) Collagen breakdown and ammonia inhalation. Archives of Environmental Health 34:83- 86. Heederik, D; van Zwieten, R; Brouwer, R. (1990) Across-shift lung function changes among pig farmers. American Journal of Industrial Medicine 17(l):57-58. Holness, DL; Purdham, JT; Nethercott, JR. (1989) Acute and chronic respiratory effects of occupational exposure to ammonia. American Industrial Hygiene Association Journal 50(12):646-650. Ihrig, A; Hoffmann, J; Triebig, G. (2006) Examination of the influence of personal traits and habituation on the reporting of complaints at experimental exposure to ammonia. Int Arch Occup Environ Health 79(4):332-338. Kalandarov, S; Bychkov, VP; Frenkel, ID; et al. (1984) Effect of an increased ammonia content in an enclosed atmosphere on the adrenocortical system in man. Kosmicheskaya Biologiya i Aviakosmicheskaya Meditsina 18:75-77. Kass, I; Zamel, N; Dobry, CA; et al. (1972) Bronchiectasis following ammonia burns of the respiratory tract. Chest 62(3):282-285. Latenser, BA; Lucktong, TA. (2000) Anhydrous ammonia burns: Case presentation and literature review. Journal of Burn Care and Rehabilitation 21(1 PT l):40-42. Leduc, D; Gris, P; Lheureux, P; et al. (1992) Acute and long term respiratory damage following inhalation of ammonia. Thorax 47(9):755-757. Lee, HS; Chan, CC; Tan, KT; et al. (1993) Burnisher's asthma-a case due to ammonia from silverware polishing. Singapore Medical Journal 34(6):565-566. Levy, DM; Divertie, MB; Litzow, TJ; et al. (1964) Ammonia burns of the face and respiratory tract. JAMA the journal of the American Medical Association 190(10):95-98. Lopez, G; Dean, BS; Krenzelok, EP. (1988) Oral exposure to ammonia inhalants: A report of 8 cases. Veterinary and Human Toxicology 30:350. 10/8/2009 4-3 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 MacEwen, JD; Theodore, J; Vernot, EH. (1970) Human exposure to EEL concentrations of monomethylhydrazine. Wright-Patterson Air Force Base, OH: Aerospace Medical Research Laboratory; pp. 355-363. Melbostad, E; Eduard, W. (2001) Organic dust-related respiratory and eye irritation in Norwegian farmers. American Journal of Industrial Medicine 39(2):209-217. Megarbane, B; Brunneel, F; Bedos, JP; et al. (2000) Ammonium chloride poisoning: A misunderstood cause of metabolic acidosis with normal anion gap. Intensive Care Medicine 26(12): 1869. Montague, TJ; Macneil, AR. (1980) Mass ammonia inhalation. Chest 77:496-498. Morton, K. (2005) Fatal exposure to anhydrous ammonia in a food manufacturing plant. J Occup Environ Hyg 2(6):D40-D43. Mulder, JS; Van der Zalm, HO. (1967) Fatal case of ammonia poisoning. Tijdschrift voor Sociale Geneeskunde 45:458-460. Petrova, M; Diamond, J; Schuster, B; et al. (2008) Evaluation of trigeminal sensitivity to ammonia in asthmatics and healthy human volunteers. Inhal Toxicol 20(12): 1085-1092. (Note: Will also be discussed in Section 4.8) Price, S. (2008) Ammonia gas incident. Anaesthesia 63(8):894-895. Price, SK; Hughes, JE; Morrison, SC; et al. (1983) Fatal ammonia inhalation- a case report with autopsy findings. South African Medical Journal 64:952-955. Prudhomme, JC; Shusterman, DJ; Blanc, PD. (1998) Acute-onset persistent olfactory deficit resulting from multiple overexposures to ammonia vapor at work. Journal of the American Board of Family Practitioners ll(l):66-69. Rahman, MH; Bratveit, M; Moen, BE. (2007) Exposure to ammonia and acute respiratory effects in a urea fertilizer factory. Int J Occup Environ Health 13(2): 153-159. Reynolds, SJ; Donham, KJ; Whitten, P; et al. (1996) Longitudinal evaluation of dose-response relationships for environmental exposures and pulmonary function in swine production workers. American Journal of Industrial Medicine 29(l):33-40. Sigurdarson, ST; O'Shaughnessy, PT; Watt, JA; et al. (2004) Experimental human exposure to inhaled grain dust and ammonia: Towards a model of concentrated animal feeding operations. Am J Ind Med 46(4):345-348. Silverman, L; Whittenberger, JL; Muller, J. (1949) Physiological response of man to ammonia in low concentrations. Journal of Industrial Hygiene and Toxicology 31:74-78. Sobonya, R. (1977) Fatal anhydrous ammonia inhalation. Human Pathology 8:293-299. 10/8/2009 4-4 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 Sotiropoulos, G; Kilaghbian, T; Dougherty, W; et al. (1998) Cold injury from pressurized liquid ammonia: A report of two cases. Journal of Emergency Medicine 16(3):409-412. Stroud, S. (1981) Ammonia inhalation- a case report. Critical Care Nurse 1:23-26. Suh, HH; Spengler, JD; Koutrakis, P. (1992) Personal exposures to acid aerosols and ammonia. Environmental Science and Technology 26(12):2507-2517. Sundblad, BM; Larsson, BM; Acevedo, F; et al. (2004) Acute respiratory effects of exposure to ammonia on healthy persons. Scand J Work Environ Health 30(4):313-321. Tepper, A; Constock, GW; Levine, M. (1991) A longitudinal study of pulmonary function in fire fighters. American Journal of Industrial Medicine 20(3):307-316. Tonelli, AR; Pham, A. (2008) Bronchiectasis, a long-term sequela of ammonia inhalation: A case report and review of the literature. Burns Jun 5. [Epub ahead of print], Tsimakuridze, M; Saakadze, V; Tsereteli, M. (2005) [the characteristic state of health of ammonia nitrate producing workers], Georgian Med News (122):80-83. Tunnicliffe, WS; Harrison, RM; Kelly, FJ; et al. (2003) The effect of sulphurous air pollutant exposures on symptoms, lung function, exhaled nitric oxide, and nasal epithelial lining fluid antioxidant concentrations in normal and asthmatic adults. Occup Environ Med 60(1 l):el5. Tuskes, PM; Tilton, MA; Graff, RM. (1988) Ammonia exposures of blue-line printers in Houston, Texas. Applied Industrial Hygiene 3:155-157. Verberk, MM. (1977) Effects of ammonia in volunteers. International Archives of Occupational and Environmental Health 39:73-81. Vogelzang, PFJ; van der Gulden, JWJ; Preller, L; et al. (1997) Bronchial hyperresponsiveness and exposure in pig farmers. International Archives of Occupational and Environmental Health 70(5):327-333. Vogelzang, PFJ; van der Gulden, JWJ; Folgering, H; et al. (2000) Longitudinal changes in bronchial responsiveness associated with swine confinement dust exposure. Chest 117(5): 1488- 1495. Voisin, C; Guerrin, F; Robin, H; et al. (1970) Sequelles fonctionnelles respiratoires des intoxications par l'ammoniac (a propos de 8 observations). Le Poumon et le Coeur 26:1079- 1095. Walton, M. (1973) Industrial ammonia gassing. British Journal of Industrial Medicine 30:78-86. Ward, K; Costello, GP; Murray, B. (1983) Acute and long-term pulmonary sequelae of acute ammonia inhalation. Irish Medical Journal 76(6):279-281. Wason, S; Stepman, M; Breide, C. (1990) Ingestion of aromatic ammonia smelling salts capsules. American Journal of Diseases of Children 144(2): 139-140. 10/8/2009 4-5 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 Weir, DC; Robertson, AS; Jones, S; et al. (1989) Occupational asthma due to soft corrosive soldering fluxes containing zinc chloride and ammonium chloride. Thorax 44(3):220-223. Weiser, JR; Mackenroth, T. (1989) Acute inhalatory mass ammonia intoxication with fatal course. Experimental Pathology 37(l-4):291-295. Wen, SL; Shao, JY; Wu, XH. (2004) [acute and long term respiratory damage following severe ammonia poisoning], Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi 22(l):75-76. White, CE; Park, MS; Renz, EM; et al. (2007) Burn center treatment of patients with severe anhydrous ammonia injury: Case reports and literature review. J Burn Care Res 28(6):922-928. White, ES. (1971) A case of near fatal ammonia gas poisoning. Journal of Occupational Medicine 13:543-550. Wise, PM; Canty, TM; Wysocki, CJ. (2005) Temporal integration of nasal irritation from ammonia at threshold and supra-threshold levels. Toxicol Sci 87(1):223-231. Yang, GY. (1987) An industrial mass ammonia exposure. Veterinary and Human Toxicology 29:476-477. Zhang, YX; Chen, SF; Wang, FJ; et al. (2003) [detection of myocardial lesion in patients with acute ammonia poisoning], Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi 21(4):247-249. 4.2. SUBCHRONIC AND CHRONIC STUDIES AND CANCER BIOASSAYS IN ANIMALS—ORAL AND INHALATION 4.2.1. ORAL Barzel, US; Jowsey, J. (1969) The effects of chronic acid and alkali administration on bone turnover in adult rat. Clinical Science 36:517-524. Barzel, US. (1975) The effect of chronic ammonium chloride ingestion on parathyroid hormone function. Nephron 14:339-346. Bodansky, A; Jaffe, HL; Chandler, JP. (1932) Serum phosphatase changes in calcium deficiency and in ammonium chloride osteoporosis. Proceedings of the Society for Experimental Biology and Medicine 29:871-873. Bodega, G; Suarez, J; Boyano, MC; et al. (1993) High ammonia diet: Its effect on the glial fibrillary acidic protein (GFAP). Neurochemical Research 18(9):971-975. Boyano-Adanez, MC; Bodega, G; Barrios, V; et al. (1996) Response of rat cerebral somatostatinergic system to a high ammonia diet. Neurochemical Research 29(5):469-476. Gupta, BN; Khanna, RN; Data, KK. (1979) Toxicological studies of ammonium sulfamate in rat after repeated oral administration. Toxicology 13:45-49. 10/8/2009 4-6 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 Janicki, RH. (1970) Renal adaptation during chronic NH4C1 acidosis in the rat: No role for hyperplasia. American Journal of Physiology 219:613-618. Kawano, S; Tsujii, M; Fusamoto, H; et al. (1991) Chronic effect of intragastric ammonia on gastric mucosal structures in rats. Digestive Diseases and Sciences 36(l):33-38. Kienzle, E; Wilms-Eilers, S. (1994) Struvite diet in cats: Effect of ammonium chloride and carbonates on acid base balance of cats. Journal of Nutrition 124(Suppl 12):2652S-2659S. Konsenko, E; Kaminsky, YG; Felipo, V; et al. (1993) Chronic hyperammonemia prevents changes in brain energy and ammonia metabolites induced by acute ammonium intoxication. Biochimica etBiophysica Acta 1180(3):321-326. Lina, BA; Kuijpers, MH. (2004) Toxicity and carcinogenicity of acidogenic or alkalogenic diets in rats; effects of feeding NH(4)C1, KHCO(3) or KC1. Food Chem Toxicol 42(1): 135-153. Ota, Y; Hasumura, M; Okamura, M; et al. (2006) Chronic toxicity and carcinogenicity of dietary administered ammonium sulfate in f344 rats. Food Chem Toxicol 44(1): 17-27. Seegal, BC. (1927) Chronic acidosis in rabbits and in dogs. Archives of Internal Medicine 39:550-563. Tsujii, M; Kawano, S; Tsuji, S; et al. (1992) Ammonia: A possible promoter in helicobacter pylori-related gastric carcinogenesis. Cancer Lett 65(1):15-18. Tsujii, M; Kawano, S; Tsujii, S; et al. (1993) Cell kinetics of mucosal atrophy in rat stomach induced by long-term administration of ammonia. Gastroenterology 104(3):796-801. Tsujii, M; Kawano, S; Tsujii, S; et al. (1995) Mechanism for ammonia-induced promotion of gastric carcinogenesis in rats. Carcinogenesis 16(3):563-566. Uzvolgyi, E. (1985) In vivo formation of a carcinogenic substance from diethyl pyrocarbonate in the presence of ammonia. Archives of Toxicology. Supplement 8:490-493. Uzvolgyi, E; Bojan, F. (1980) Possible in vivo formation of a carcinogenic substance from diethyl pyrocarbonate and ammonia. Journal of Cancer Research and Clinical Oncology 97:205- 207. 4.2.2. INHALATION Broderson, JR; Lindsey, JR; Crawford, JE. (1976) The role of environmental ammonia in respiratory mycoplasmosis of rats. American Journal of Pathology 85:115-130. Coon, RA; Jones, RA; Jenkins, LJ; et al. (1970) Animal inhalation studies on ammonia, ethylene, glycol, formaldehyde, dimethylamine and ethanol. Toxicology and Applied Pharmacology 16:646-655. 10/8/2009 4-7 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 Dodd, KT; Gross, DR. (1980) Ammonia inhalation toxicity in cats: A study of acute and chronic respiratory dysfunction. Archives of Environmental Health 35:6-14. Done, SH; Chennells, DJ; Gresham, AC; et al. (2005) Clinical and pathological responses of weaned pigs to atmospheric ammonia and dust. Vet Rec 157(3):71-80. Donham, KJ. (1991) Association of environmental air contaminants with disease and productivity in swine. American Journal of Veterinary Research 52(10): 1723-1730. Drummond, JG; Curtis, SE; Simon, J; et al. (1980) Effects of aerial ammonia on growth and health of young pigs. Journal of Animal Science 50(6): 1085-1091. Gaafar, H; Girgis, R; Hussein, M; et al. (1992) The effect of ammonia on the respiratory nasal mucosa of mice. A histological and histochemical study. Acta Oto Laryngologica Stockholm 112(2):339-342. Gustin, P; Urbain, B; Prouvost, JF; et al. (1994) Effects of atmospheric ammonia on pulmonary hemodynamics and vascular permeability in pigs: Interaction with endotoxins. Toxicology and Applied Pharmacology 125(1): 17-26. Inoiatov, F. (2004) [morphologic features of the liver changes in rats of both gender exposed to aerogenic toxicants for a long period of time], Lik Sprava (3-4):78-83. Kamildzhanov, AK; Dadazhanov, SN; Inoyatov, FS; et al. (2002) Some indicators of the functional state of liver and reproductive organs exposed to ammonia inhalation. Toksikologicheskii Vestnik (3): 17-21. Neumann, R; Mehlhorn, G; Buchholz, I; et al. (1987) Experimental studies of the effect of chronic exposure of suckling pigs to aerogenous toxic gas with ammonia of varying concentrations. Zentralblatt fur Veterinaermedizin Reihe B 34:241-253. Smith, LG; Busch, RH; Buschbom, RL; et al. (1989) Effects of sulfur dioxide or ammonium sulfate exposure, alone or combined, for 4 or 8 months on normal and elastase-impaired rats. Environmental Research 49(l):60-78. Weatherby, JH. (1952) Chronic toxicity of ammonia fumes by inhalation. Proceedings of the Society for Experimental Biology and Medicine 81:300-301. 4.3. REPRODUCTIVE/DEVELOPMENTAL STUDIES—ORAL AND INHALATION Diekman, MA; Scheidt, AB; Sutton, AL; et al. (1993) Growth and reproductive performance, during exposure to ammonia, of gilts afflicted with pneumonia and atrophic rhinitis. American Journal of Veterinary Research 54(12):2128-2131. Minana, MD; Marcaida, G; Grisolia, S; et al. (1995) Prenatal exposure of rats to ammonia impairs NMDA receptor function and affords delayed protection against ammonia toxicity and glutamate neurotoxicity. Journal of Neuropathology and Experimental Neurology 54(5):644- 650. 10/8/2009 4-8 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 4.4. OTHER DURATION- OR ENDPOINT-SPECIFIC STUDIES Allen, WM. (1993) Bovine deaths associated with ammoniated straw. Veterinary Record 132(16):419. Ambrose, AM. (1943) Studies on the physiological effects of sulfamic acid and ammonium sulfamate. Journal of Industrial Hygiene and Toxicology 25(l):26-28. Appelman, LM; ten Berge, WF; Reuzel, PGJ. (1982) Acute inhalation toxicity of ammonia in rats with variable exposure periods. American Industrial Hygiene Association Journal 43(9):662-665. Bajpai, A; Tikaria, A; Kabra, SK; et al. (2004) Hyperchloraemic acidosis consistent with ammonium chloride administration. Arch Dis Child 89(1):92. Beare, JD; Wilson, RS; Marsh, RJ. (1988) Ammonia burns of the eye: Old weapon in new hands. British Medical Journal 296:590. Benson, RA; Slobody, LB; et al. (1949) The treatment of ammonia dermatitis with diaparene; report on 500 cases. J Pediatr 34(l):49-51. Boyd, EM; MacLachlan, ML; Perry, WF. (1944) Experimental ammonia gas poisoning in rabbits and cats. Journal of Industrial Hygiene and Toxicology 26(l):29-34. Boyd, EM; Seymour, KGW. (1946) Ethylenediamine dihydrochloride or chlor-ethamine. Ii. Untoward and toxic reactions. Experimental Medicine and Surgery:223-227. Buckley, LA; Jiang, XJ; James, RA; et al. (1984) Respiratory tract lesions induced by sensory irritants at the rd50 concentration. Toxicol Appl Pharmacol 74:417-429. Capuco, AV. (1977) Ammonia: A modulator of 3t3 cell growth. Dissertation Abstracts International Section B Physical Sciences and Engineering 38(9):4085. Close, LG; Catlin, FI; Cohn, AM. (1980) Acute and chronic effects of ammonia burns of the respiratory tract. Archives of Otolaryngology 106:151-158. Doig, PA; Willoughby, RA. (1971) Response of swine to atmospheric ammonia and organic dust. Journal of the American Veterinary Medical Association 159:1353-1361. Fazekas, IG. (1939) Experimental suprarenal hypertrophy induced by ammonia. Endokrinologie 21:315-337. Gamble, MR; Clough, G. (1976) Ammonia build-up in animal boxes and its effect on rat tracheal epithelium. Lab Anim. 10:93-104. Garcia, MV; Lopez-Mediavilla, C; Juanes de la Pena, MC; et al. (2003) Tolerance of neonatal rat brain to acute hyperammonemia. Brain Res 973(1):31-38. 10/8/2009 4-9 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 Garcia, MV; Lopez-Mediavilla, C; Juanes de la Pena, MC; et al. (2004) Antioxidant defence of the neonatal rat brain against acute hyperammonemia. Brain Res 1001(1-2): 159-163. Greenlee, AR; Ellis, TM; Berg, RL. (2004) Low-dose agrochemicals and lawn-care pesticides induce developmental toxicity in murine preimplantation embryos. Environ Health Perspect 112(6):703-709. Hagiwara, A; Tanaka, H; Tamano, S; et al. (1994) Inhibiting effects of diethylmaleate or NH4C1 on nahco3, but not butylated hydroxyanisole, promotion of urinary bladder carcinogenesis in male 344 rats initiated with n-butyl-n-(4-hydroxybutyl)nitrosamine. J Toxicol Sci 19(4): 189- 195. Hawkins, RA; Miller, AL; Nielsen, RC; et al. (1973) The acute action of ammonia on rat brain metabolism in vivo. Biochemical Journal 134:1001-1008. Heifer, U. (1971) [Casuistic contribution to acute lethal inhalation poisoning by ammonia], Lebensversicherungsmedizin 22:60-62. (German) Helmers, S; Top, FH; Knapp, LW. (1971) Ammonia injuries in agriculture. Journal of the Iowa Medical Society 61(5):271-280. Hilado, CJ; Casey, CJ; Furst, A. (1977) Effect of ammonia on Swiss albino mice. Journal of Combustion Toxicology 4:385-388. Jarudi, MD; Golden, MD. (1973) Ammonia eye injuries. Journal of the Iowa Medical Society 63:260-263. Jones, JB; Burgess, LR; Webster, AJF; et al. (1996) Behavioral responses of pigs to atmospheric ammonia in a chronic choice test. Animal Sci 63(3):437-445. Kane, LE; Barrow, CS; Alarie, Y. (1979) A short-term test to predict acceptable levels of exposure to airborne sensory irritants. Am Ind Hyg Assoc J 40:207-229. Kapeghian, JC; Jones, AB; Waters, IW. (1985) Effects of ammonia on selected hepatic microsomal enzyme activity in mice. Bulletin of Environmental Contamination and Toxicology 35:15-22. Kapeghian, JC; Mincer, HH; Jones, AL; et al. (1982) Acute inhalation toxicity of ammonia in mice. Bulletin of Environmental Contamination and Toxicology 29:371-378. Kerstein, MD; Schaffzin, DM; Hughes, WB; et al. (2001) Acute management of exposure to liquid ammonia. Military Medicine 166(10):913-914. Klein, J; Olson, KR; McKinney, HE. (1985) Caustic injury from household ammonia. American Journal of Emergency Medicine 3:320. Klendshoj, NC; Rejent, TA. (1966) Tissue levels of some poisoning agents less frequently encountered. Journal of Forensic Sciences ll(l):75-80. 10/8/2009 4-10 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 Klucinski, W; Targowski, SP. (1984) Ammonia toxicity for mammalian and avian lymphocytes from blood. Immunopharmacology 8(l):47-52. Koenig, H; Koenig, R. (1949) Production of acute pulmonary edema by ammonium salts. Proceedings of the Society for Experimental Biology and Medicine 70(3):375-380. Konsenko, E; Felipo, V; D., MM; et al. (1991) Ammonium ingestion prevents depletion of hepatic energy metabolites induced by acute ammonium intoxication. Archives of Biochemistry and Biophysics 290(2):484-488. Kosenko, E; Kaminsky, Y; Solomadin, I; et al. (2007) Acute ammonia neurotoxicity in vivo involves increase in cytoplasmic protein p53 without alterations in other markers of apoptosis. J Neurosci Res 85(ll):2491-2499. Lamar, C. (1970) Ammonia toxicity in rats: Protection by a-methylglutamic acid. Toxicology and Applied Pharmacology 17:795-803. Lane, M; Gardner, DK. (1994) Increase in postimplantation development of cultured mouse embryos by amino acids and induction of fetal retardation and exencephaly by ammonium ions. Journal of Reproduction and Fertility 102(2):305-312. Laskin, DL; Morio, L; Hooper, K; et al. (2003) Peroxides and macrophages in the toxicity of fine particulate matter in rats. Res Rep Health Eff Inst (117): 1-51; discussion 53-63. Lee, JH; Kim, WH; Cho, H; et al. (1998) N-carbamoyl-l-glutamate plus 1-arginine can protect ammonia intoxication in rats with reduced functional liver mass. Biochemical and Biophysical Research Communications 248(2):391-394. Leonardos, G; Kendall, D; Barnard, N. (1969) Odor threshold determinations of 53 odorant chemicals. Journal of the Air Pollution Control Association 19(2):91-95. Lin, S; Raabe, W. (1985) Ammonia intoxication: Effects on cerebral cortex and spinal cord. Journal of Neurochemistry 44:1252-1258. Manninen, A; Anttila, S; Savolainen, H. (1988) Rat metabolic adaptation to ammonia inhalation. Proceedings of the Society for Experimental Biology and Medicine 187(3):278-281. Manninen, ATA; Savolainen, H. (1989) Effect of short-term ammonia inhalation on selected amino acids in rat brain. Pharmacology and Toxicology 64(3):244-246. Mayan, MH; Merilan, CP. (1972) Effects of ammonia inhalation on respiration rate of rabbits. Journal of Animal Science 34:448-452. Mayan, MH; Merilan, CP. (1976) Effects of ammonia inhalation on young cattle. New Zealand Veterinary Journal 24:221-224. 10/8/2009 4-11 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 McCandless, DW; Looney, GA; Modak, AT; et al. (1985) Cerebral acetylcholine and energy metabolism changes in acute ammonia intoxication in the lower primate tupaia glis. Journal of Laboratory and Clinical Medicine 106:183-186. McCandless, DW; Schenkler, S. (1981) Effect of acute ammonia intoxication on energy stores in the cerebral reticular activating system. Experimental Brain Research 44:325-330. McGuinness, R. (1969) Ammonia in the eye. British Medical Journal:2:575. Mellea, TP; Kucan, JO; Smoot, EC. (1989) Anhydrous ammonia injuries. Journal of Burn Care and Rehabilitation 10(5):448-453. Michaels, RA. (1999) Emergency planning and the cute toxic potency of inhaled ammonia. Environmental Health Perspectives 107(8): 617-627. Minana, MD; Felipo, V; Grisolia, S. (1988) Protective effect of long term ammonium ingestion against acute ammonium intoxication. Biochemical and Biophysical Research Communications 153(3):979-983. Mori, S; Kaneko, H; Mitsuma, T; et al. (1998) Implications of gastric topical bioactive peptides in ammonia-induced acute gastric mucosal lesions in rats. Scandinavian Journal of Gastroenterology 33(4):3 86-393. Murakami, M; Saita, H; Teramura, S; et al. (1993) Gastric ammonia has a potent ulcerogenic action on the rat stomach. Gastroenterology 105(6): 1710-1715. Nagy, L; Kusstatscher, S; Hauschka, PV; et al. (1996) Role of cysteine proteases and protease inhibitors in gastric mucosal damage induced by ethanol or ammonia in the rat. Journal of Clinical Investigation 98(4): 1047-1054. Noda, K; Chikamori, K. (1976) Effect of ammonia via prepyriform cortex on regulation of food intake in the rat. American Journal of Physiology 231:1263-1266. Qin, C; Foreman, RD; Farber, JP. (2007) Inhalation of a pulmonary irritant modulates activity of lumbosacral spinal neurons receiving colonic input in rats. Am J Physiol Regul Integr Comp Physiol 293(5):R2052-2058. Qin, C; Foreman, RD; Farber, JP. (2007) Afferent pathway and neuromodulation of superficial and deeper thoracic spinal neurons receiving noxious pulmonary inputs in rats. Auton Neurosci 131(l-2):77-86. Raabe, W. (1984) Ammonia, postsynaptic inhibition and CNS-energy state. Brain Research 303:67-76. Raabe, W; Gumnit, RJ. (1975) Inhibition of cat motor cortex by ammonia. Journal of Neurophysiology 38:347-355. Rejniuk, VL; Schafer, TV; Ovsep'yan, RV; et al. (2007) Effect of atmospheric ammonia on mortality rate of rats with barbiturate intoxication. Bull Exp Biol Med 143(6):692-694. 10/8/2009 4-12 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 Richard, D; Bouley, G; Boudene, C. (1978) [Effects of continuous inhalation of ammonia in the rat and mouse]. Bulletin Europeen de Physiopathologie Respiratoire 14:573-582. (French). Richard, D; Jouany, JM; Boudene, C. (1978) [Acute toxicity of ammonia gas in the rabbit by inhalation], Comptes Rendus Hebdomadaires des Seances de 1 Academie des Sciences Serie D 287:375-378. (French). Rooke, JA; Ewen, M; Mackie, K; et al. (2004) Effect of ammonium chloride on the growth and metabolism of bovine ovarian granulosa cells and the development of ovine oocytes matured in the presence of bovine granulosa cells previously exposed to ammonium chloride. Anim Reprod Sci 84(l-2):53-71. Rosenbaum, AM; Walner, DL; Dunham, ME; et al. (1998) Ammonia capsule ingestion causing upper aerodigestive tract injury. Otolaryngology and Head and Neck Surgery 119(6):678-680. Sadasivudu, B; Murthy, RK. (1978) Effects of ammonia on monoamine oxidase and enzymes of GABA metabolism in mouse brain. Archives Internationales de Physiologie et de Biochimie 86:67-82. Sadasivudu, B; Rao, TI; Radhakrishna, C. (1977) Acute metabolic effects of ammonia in mouse brain. Neurochemical Research 2:639-655. Sadasivudu, B; Rao, TI; Radhakrishna, M. (1979) Chronic metabolic effects of ammonia in mouse brain. Archives Internationales de Physiologie et de Biochimie 87:871-885. Salvatore, F; Bocchinti, V; Cimino, F. (1963) Ammonia intoxication and its effects on brain ammonia levels. Biochemical Pharmacology 12:1-6. Sato, A; Gonmori, K; Yoshioka, N. (1999) A case of fatal intoxication with ammonium sulfate and a toxicological study using rabbits. Forensic Science International 101(2): 141-149. Schaerdel, AD; White, WJ; Lang, CM; et al. (1983) Localized and systemic effects of environmental ammonia in rats. Laboratory Animal Science 33(l):40-45. Schenker, S; Warren, KS. (1962) Effect of temperature variation on toxicity and metabolism of ammonia in mice. Journal of Laboratory and Clinical Medicine 60(2):291-301. Schoeb, TR; Davidson, MK; Lindsey, JR. (1982) Intracage ammonia promotes growth of Micoplasma pulmonis in the respiratory tract of rats. Infection and Immunity 38:212-217. Silver, SD; McGrath, FP. (1948) A comparison of acute toxicities of ethylene imine and ammonia to mice. Journal of Industrial Hygiene and Toxicology 30:7-9. Sinawat, S; Hsaio, WC; Flockhart, JH; et al. (2003) Fetal abnormalities produced after preimplantation exposure of mouse embryos to ammonium chloride. Hum Reprod. 18(10):2157- 2165. 10/8/2009 4-13 DRAFT - DO NOT CITE OR QUOTE ------- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 Sjoblom, E; Hojer, J; Kulling, PE; et al. (1999) A placebo-controlled experimental study of steroid inhalation therapy in ammonia-induced lung injury. Journal of Toxicology Clinical Toxicology 37(l):59-67. Slot, GMJ. (1938) Electrocardiograms in 80 cases of angina of effort. Lancet: 1356-1357. Stombaugh, DP; Teague, HS; Roller, WL. (1969) Effects of atmospheric ammonia on the pig. Journal of Animal Science 28:844-847. Stupfel, M; Romary, F; Magnier, M; et al. (1971) [Comparative acute toxicity of several atmospheric pollutants, in male and female mice: Automobile exhaust gases, nitrogen oxides, sulfur dioxide, ozone, ammonia and carbon dioxide], Comptes Rendus des Seances de la Societe de Biologie et des ses Filiales 19:1869-1872. (French). 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(1992) Mechanism of gastric mucosal damage induced by ammonia. Gastroenterology 102(6): 1881-1888. Tsujii, M; Kawano, S; Tsujii, S; et al. (1992) Ammonia: A possible promoter in helicobacter pylori-related gastric carcinogenesis. Cancer Letters 65(1): 15-18. Walsh, PJ; Veauvy, C. (2005) Ammonia toxicity and cerebral failure: Parallels with hypoxia? Comp Biochem Physiol A Mol Integr Physiol 141:S178. 10/8/2009 4-21 DRAFT - DO NOT CITE OR QUOTE ------- 1 Wibbenmeyer, LA; Morgan, LJ; Robinson, BK; et al. (1999) Our chemical burn experience: 2 Exposing the dangers of anhydrous ammonia. Journal of Burn Care and Rehabilitation 3 20(3):226-231. 4 5 Worcel, A; Erecinska, M. (1962) Mechanism of inhibitory action of ammonia on the respiration 6 of rat-liver mitochondria. Biochimica et Biophysica Acta 65:27-33. 7 8 Wu, M; Qin, C; Foreman, RD; et al. (2007) Transient receptor potential vanilloid receptor-1 does 9 not contribute to slowly adapting airway receptor activation by inhaled ammonia. Auton 10 Neurosci 133(2): 121-127. 11 12 Yadav, JS; Kaushik, VK. (1997) Genotoxic effect of ammonia exposure on workers in a fertility 13 factory. Indian Journal of Experimental Biology 35(5):487-492. 14 15 Zander, DL; Thompson, JG; Lane, M. (2006) Ammonium impairs mitochondrial function and 16 homeostasis in murine 2-cell embryos. Biol Reprod (Spec no): 125-126. 17 18 Zielinska, M; Law, RO; Albrecht, J. (2003) Excitotoxic mechanism of cell swelling in rat 19 cerebral cortical slices treated acutely with ammonia. Neurochem Int 43(4-5):299-303. 20 21 22 4.6. SYNTHESIS OF MAJOR NONCANCER EFFECTS 23 24 4.6.1. Oral 25 26 4.6.2. Inhalation 27 28 4.6.3. Mode of Action Information 29 30 4.7. EVALUATION OF CARCINOGENICITY 31 32 4.7.1. Summary of Overall Weight-of-Evidence 33 34 4.7.2. Synthesis of Human, Animal, and Other Supporting Evidence 35 36 4.7.3. Mode of Action Information 37 38 4.7.2.1. Hypothesized Mode of Action 39 40 4.7.2.2. Experimental Support for the Hypothesized Mode of Action 41 10/8/2009 4-22 DRAFT - DO NOT CITE OR QUOTE ------- 1 4.7.2.3. Other Possible Modes of Action 2 3 4.7.2.4. Conclusions About the Hypothesized Mode of Action 4 5 6 4.8. SUSCEPTIBLE POPULATIONS AND LIFE STAGES 7 8 Petrova, M; Diamond, J; Schuster, B; et al. (2008) Evaluation of trigeminal sensitivity to 9 ammonia in asthmatics and healthy human volunteers. Inhal Toxicol 20(12): 1085-1092. 10 11 Schubiger, G; Bachmann, C; Barben, P; et al. (1991) N-acetylglutamate synthetase deficiency: 12 Diagnosis, management and follow-up of a rare disorder of ammonia detoxication. European 13 Journal of Pediatrics 150(5):353-356. 14 15 Tunnicliffe, WS; Harrison, RM; Kelly, FJ; et al. (2003) The effect of sulphurous air pollutant 16 exposures on symptoms, lung function, exhaled nitric oxide, and nasal epithelial lining fluid 17 antioxidant concentrations in normal and asthmatic adults. Occup Environ Med 60(1 l):el5. 18 10/8/2009 4-23 DRAFT - DO NOT CITE OR QUOTE ------- |