PAGE INTENTIONALLY LEFT BLANK William C. Herz Director of Scientific Programs M E M O R A N D U M TO: Product Testing Recipient FROM: William C. Herz, Director, Scientific Programs SUBJECT: Sodium Nitrate Product Testing Dossier DATE: March 15, 2003 It is with great pleasure that The Fertilizer Institute ( TFI) announces the completion and distribution of the final product testing dossier for Sodium Nitrate ( CAS # 7631 99 4).

As you are aware, TFI sponsored this four   year program to develop and summarize screeninglevel hazard information for high production volume ( HPV) chemicals. The data elements generated represent a broad overview of human health and ecological parameters. These include a physical  chemical characterization, environmental fate, mammalian toxicity and ecotoxicity. A health and environmental safety data summary dossier was prepared for each of the 23 materials. It summarizes the available literature data, new testing data, category description and read across data as well as provides a conclusion regarding the inherent hazards of the material.

Upon receipt of this data a 90 calendar day regulatory trigger starts within which you must update your material safety data sheets ( MS DS). Upon first product shipment you must also notify your distributors and employers once the MS DS has been updated. These regulatory requirements are detailed in 29 CFR 1910.1200( g)( 5) and 29 CFR 1910.1200( g)( 6)( i). The requirements are found in the Occupational Safety and Health Administration " Hazard Communication Standard" ( 29 CFR 1910.1200).

Please note that by receipt of this data; you agree not to distribute or sell this data beyond your own company. PAGE INTENTIONALLY LEFT BLANK HEALTH & ENVIRONMENTAL SAFETY DATA SUMMARY DOCUMENT SODIUM NITRATE CAS # 7631 99 4 Prepared for:

THE FERTILIZER INSTITUTE January 27, 2003 THE WEINBERG GROUP INC. 1220 Nineteenth St, NW, Suite 300 Washington, DC 20036 2400 e mail science@ weinberggroup. com WASHINGTON NEW YORK SAN FRANCISCO BRUSSELS PARIS Sodium Nitrate CAS # 7631 99 4 PAGE INTENTIONALLY LEFT BLANK Sodium Nitrate CAS # 7631 99 4 TABLE OF CONTENTS Page EXECUTIVE OVERVIEW................................................................................................... 1 SIDS DATA PROFILE.......................................................................................................... 7 SIDS SUMMARY................................................................................................................. 8 1. GENERAL INFORMATION.................................................................................... 11 2. PHYSICAL CHEMICAL DATA.............................................................................. 15 3. ENVIRONMENTAL FATE AND PATHWAYS..................................................... 20 4. ECOTOXICITY......................................................................................................... 22 5. TOXICITY................................................................................................................. 29 6. REFERENCES .......................................................................................................... 39 APPENDICES Appendix A SIDS Data Availability Summary Appendix B SIDS Data Summaries for the Nitrate Compounds Category: Ammonium Nitrate, Nitrogen Solutions ( primarily Urea Ammonia Nitrogen [ UAN]), Urea, Potassium Nitrate, Potassium Sodium Nitrate, and Sodium Nitrate ACRONYMS AND ABBREVIATIONS BCF Bioconcentration Factor bw Body Weight DAP Diammonium Phosphate DOT Department of Transportation FDA U. S. Food and Drug Administration g/ L Grams per Liter GLP Good Laboratory Practices GTSP Granular Triple Super Phosphate g/ mL Grams per Milliliter HSDB Hazardous Substance Data Bank IPCS International Programme for Chemical Safety KNO3 Potassium Nitrate Koc Organic Carbon Partition Coefficient Kow Octanol/ Water Partition Coefficient LC50 Median Lethal Concentration LD50 Median Lethal Dose LOAEL Lowest Observable Adverse Effect Level LOEC Lowest Observable Effect Concentration LOEL Lowest Observable Effect Level Sodium Nitrate CAS # 7631 99 4 M Molar MAP Monoammonium Phosphate mg/ kg Milligrams per Kilogram mg/ kg/ day Milligrams per Kilogram per Day mg/ L Milligrams per Liter MHb Methyl Hemoglobin mm Hg Millimeters of Mercury mmol/ L Millimoles per Liter NaNo3 Sodium Nitrate NFPA National Fire Prevention Association ( NH4) 2NO3 Ammonium Nitrate NIOSH National Institute for Occupational Safety and Health NO3 Nitrate NOAEL No Observable Adverse Effect Level NOEC No Observable Effect Concentration NOEL No Observable Effect Level OECD Organisation for Economic Co operation and Development Pa Pascal ppm Parts per Million SCAS Semi Continuous Activated Sludge SIDS Screening Information Data Set SSP Single Super Phosphate TLm Median Toxicity Level TLV Threshold Limit Value TFI The Fertilizer Institute UAN Urea Ammonia Nitrogen Sodium Nitrate CAS # 7631 99 4 1 EXECUTIVE OVERVIEW I. Introduction The Fertilizer Institute, on behalf of its member companies, initiated a Product Testing Project to collect, review, summarize, and where necessary develop additional health and environmental safety data for 23 of its high production volume inorganic fertilizer materials. These data and summaries provide valuable information that can be used to update Material Safety Data Sheets, answer customers' questions, and support product stewardship efforts. The chemical industry is also participating in a voluntary program of comparable scope for high production volume organic chemicals. 1 The 23 fertilizer materials were divided into five categories ( i. e., ammonia compounds, nitrate compounds, phosphate compounds, salts and acids) based on their primary constituents as shown in Table 1. The use of categories is a recognized and accepted method that allows health and environmental safety data from one chemical in the category to be used to represent one or more other related chemicals in the category ( USEPA 1999). The key is to find similar, or at least predictable, patterns and trends among the chemicals in a category. In this way, data can be pooled, resources are optimized, and fewer animals are used in testing, all without losing the ability to evaluate the hazards and safety of the individual chemicals. Note that some of the materials fall into more than one category ( e. g., diammonium phosphate [ DAP] is in both the phosphate and ammonia categories).

Searches were conducted using on line databases, standard reference texts, and other published sources for toxicity, ecotoxicity, environmental fate, and physical chemical properties. The collected data were reviewed for quality and acceptability and then summarized according to the Organization for Economic Cooperation and Development ( OECD) Screening Information Data Set ( SIDS) dossier format ( OECD 1997). The OECD countries ( including the United States) have agreed on a set of tests and on types of data that are generally necessary to characterize the chemical behavior and potential hazards of chemicals released into the environment. The OECD SIDS dossier was chosen as a standard format for the TFI Product Testing Project in order that it would be scientifically defensible, broadly applicable and easily understandable to a wide range of stakeholders.

The following sections of this Executive Overview provide the rationale for development of the Nitrate Compounds category ( Section II); a synopsis of the available data related to the physicalchemical properties, environmental fate, ecotoxicity and toxicity of the nitrate compounds in this category ( Section III); and a conclusion regarding the adequacy of the data to sufficiently characterize the category and the need for additional testing ( Section IV).

The data for sodium nitrate are summarized in the Chemical Profile and Data Summary tables. Because the evaluation of data adequacy relies on a category approach, the Data Summary table references Appendix B when data are available for one or more of the other materials in the category for those data elements where no sodium nitrate data are available. Appendix B provides a summary of the data for all of the nitrate compounds in the category. The individual 1 HPV Chemical Challenge Program; USEPA 1999 ( http:// www. epa. gov/ opptintr/ chemrtk/ volchall. htm) Sodium Nitrate CAS # 7631 99 4 2 studies for sodium nitrate itself are presented in subsequent pages of this document. Separate data summary documents are available for each of the nitrate compounds in the category.

II. Rationale for the Nitrate Compounds Category The nitrate compounds category for fertilizer materials includes ammonium nitrate, nitrogen solutions ( primarily Urea Ammonia Nitrogen [ UAN]), potassium nitrate, sodium nitrate, and potassium sodium nitrate. These compounds are structurally similar. In solution these compounds all dissociate into a common nitrate ion:

To this base, the compounds vary according to the simple cation present ( i. e., K+, Na+, NH4 +). The six compounds have similar and generally predictable patterns of behavior in the environment as well as toxicological properties. Nitrate itself is less toxicologically important than is nitrite. Nitrate is reduced to nitrite by the enzyme nitrate reductase which is found in plants, certain bacterial species, and mammalian gastric tissues ( Owens and Dubeski 1989). After ingestion nitrates are reduced to nitrites by bacteria in the lower intestine of the adult ( L'hirondel and L'hirondel 1998). In babies, it is this nitrite that can lead to a condition called methemoglobinemia (" blue baby syndrome") ( Burden 1961).

In addition to methemoglobinemia, some evidence indicates a possible formation of N nitroso compounds in foods and in tissues that contain excess nitrates/ nitrites ( Chow et al. 1980). Nnitroso compounds ( e. g., nitrosamines) are known to be potent mutagens/ carcinogens ( Lijinksy and Epstein 1970; Magee and Barnes 1967). However, the quantities of nitrosamines formed in mammals from nitrates in food are negligible and all of the epidemiological studies published since 1985 concluded that there is no positive correlation between nitrate intakes and the incidence of cancer ( Al Dabbagh et al. 1986; Forman et al. 1985; Leclerc et al. 1991; Lijinsky 1989; Lijinksy and Epstein 1970; Magee and Barnes 1967). In fact, some evidence suggests that nitrates in foods may actually play an anti carcinogenic role ( Lijinsky 1989).

In aquatic systems, the toxicity of the various nitrate materials is at least partially related to the cationic composition of the solution, although the available data suggest that aquatic toxicity is not a major concern ( Rubin and Elmaraghy 1977).

In terrestrial systems, nitrate absorbed by plants is reduced to nitrite by the enzyme nitrate reductase ( Owens and Dubeski 1989). The nitrite will be further reduced only when photosynthesis and carbohydrate synthesis are active ( Owens and Dubeski 1989). Under drought conditions, frost and shading, or deficiencies of other nutrients, each of which reduce photosynthesis and biosynthesis of protein, nitrate continues to be absorbed and may accumulate in plant tissue ( Owens and Dubeski 1989). Under most conditions, however, the nitrate ion will leach into the soil pore water and become indistinguishable from the natural nitrate already present. O N'

O O Sodium Nitrate CAS # 7631 99 4 3 III. Summary of Data Available for the Nitrate Compounds Category Physical Chemical Data The density of nitrate compounds varies from 0.75 2.109 g/ mL. All nitrate compounds are highly soluble in water with solubility ranging from 357 1,920 g/ L at 20 25 ° C. Although few vapor pressure values are available, based on the fact that these compounds are solids, it may be concluded that they have low volatility. Very low octanol/ water partitioning coefficients indicate a low bioaccumulation potential.

Environmental Fate and Pathway Nitrate compounds biodegrade in the environment under certain conditions. Their high solubility and expected low volatility suggest that they are present mostly in aqueous solutions. While the cation may bind to clay particles in the soil, the nitrate anion may show significant leaching to ground water. Nitrate is subject to plant uptake and loss from the ecosystem in runoff waters or by denitrification.

Ecotoxicity The acute 96 hour LC50 values for fish range from 327 mg NO3/ L to greater than 9,300 mg NO3/ L. In addition, acute fish toxicity studies were conducted on nitrogen solutions ( UAN) and potassium sodium nitrate under Good Laboratory Practice ( GLP) conditions. The resultant LC50 values were greater than approximately 100 mg/ L, the highest concentrations tested. Acute studies with Daphnia magna resulted in EC50 values ranging from 300 to 2,614 mg NO3/ L. Chronic toxicity studies on aquatic invertebrates resulted in NOEC values of 300 mg/ L and TLm values of 327 880 mg NO3/ L. Algal toxicity studies resulted in EC50 values from 83 to 1,233 mg NO3/ L. The available ecotoxicity data indicate nitrate compounds have relatively low toxicity to terrestrial plants. Based on the standard Federal Insecticide Fungicide and Rodenticide Act ( FIFRA) acute toxicity ratings for fish and Daphnia ( below), the compounds in this category are considered practically non toxic.

EC/ LC50 ( mg/ L) Toxicity Description < 0.1 Very Highly Toxic 0.1 1 Highly Toxic 1 10 Moderately Toxic 10 100 Slightly Toxic > 100 Practically Non Toxic Sodium Nitrate CAS # 7631 99 4 4 Mammalian Toxicity Acute toxicity The acute oral LD50 values for mammals were reported as 1,166 mg NO3/ kg bw ( potassium nitrate) and up to 5,200 mg/ kg bw for most of the remaining nitrate compounds. In addition, acute oral toxicity studies were conducted under GLP conditions for UAN and potassium sodium nitrate. Results of the acute oral toxicity studies for both materials confirmed that they were of low toxicity concern ( LD50 values > 2000 mg/ kg. An acute inhalation study using ammonium nitrate reported an LC50 of > 88.8 mg/ L, while a similar study with dogs reported an NOEC of 5 mg NO3/ m3 ( the only dose tested). Acute dermal studies were also conducted under GLP conditions. The resultant LD50s were > 5000 mg/ kg bw for both ammonium nitrate and potassium nitrate. Based on the standard FIFRA acute toxicity ratings for mammals ( below), the compounds in this category are considered to be of low to very low toxicity ( 40 CFR 156.62).

Toxicity Category I II III IV Toxicity Rating High Moderate Low Very Low Oral LD50   50 mg/ kg > 50 500 mg/ kg > 500 5000 mg/ kg > 5000 mg/ kg Dermal LC50   200 mg/ kg > 200 2000 mg/ kg > 2000 20,000 mg/ kg > 20,000 mg/ kg Inhalation LC50   0.2 mg/ L > 0.2 2 mg/ L > 2 20 mg/ L > 20 mg/ L Genotoxicity All nitrate compounds tested negative for mutagenicity using in vitro bacterial tests. Positive responses were observed at high doses ( 7.2 mg/ mL) in in vitro chromosome aberration studies with sodium nitrate only. In vivo assays were generally negative except for sodium nitrate at very high doses ( 706 mg NO3/ kg).

Repeated dose and developmental toxicity Repeat dose studies on ammonium nitrate, potassium nitrate, and sodium nitrate indicate that materials in the nitrate category are of low acute toxicity. Developmental or teratogenic toxicity was not observed for any of the three nitrate materials for which data were available. A new repeat dose study on potassium nitrate has been conducted using the OECD Guideline 422 protocol under GLP conditions. This study provides data for three different endpoints: repeat dose toxicity, reproductive toxicity, and developmental toxicity. Results demonstrate no adverse effects on general toxicity, reproductive, or developmental endpoints. The resultant NOAEL was 1,500 mg/ kg/ day.

IV. Conclusion for the Nitrate Compounds Category Sodium Nitrate CAS # 7631 99 4 5 Substantial literature data were available for the fertilizer materials comprising the nitrate compounds category. The exceptions were nitrogen solutions ( UAN) and potassium sodium nitrate for which no specific data were available. However, UAN is an aqueous solution of ammonium nitrate and urea while potassium sodium nitrate is a simple blend of potassium nitrate and sodium nitrate. Extensive data are available for those base materials and are therefore applicable for characterization of the mixtures. In addition, aquatic and mammalian acute studies were conducted under GLP conditions to provide specific information on UAN and potassium sodium nitrate. Additional studies were also conducted under GLP conditions on ammonium nitrate and potassium nitrate to further characterize these key materials in the category. The existing data, and the results from the additional studies, adequately characterize the nitrate compounds category. 5 Sodium Nitrate CAS # 7631 99 4 TABLE 1: CATEGORIES FOR PRODUCT TESTING PROJECT CATEGORY COMPOUND CAS NUMBER Ammonia Compounds Anhydrous ammonia Aqua ammonia Ammonium nitrate Ammonium sulfate Ammonium thiosulfate Nitrogen solutions ( UAN) Ammonium phosphate sulfate Diammonium phosphate ( DAP) Monoammonium phosphate ( MAP) Urea 7664 41 7 1336 21 6 6484 52 2 7783 20 2 7783 18 8 15978 77 5 12593 60 1 7783 28 0 7722 76 1 57 13 6 Nitrate Compounds Sodium nitrate Ammonium nitrate Potassium nitrate Potassium sodium nitrate Nitrogen solutions ( UAN) 7631 99 4 6484 52 2 7757 79 1 7757 79 1/ 7631 99 4 15978 77 5 Phosphate Compounds Diammonium phosphate ( DAP) Monoammonium phosphate ( MAP) Liquid polyphosphate Single superphosphate** Granular triple superphosphate** 7783 28 0 7722 76 1  8011 76 5 65996 95 4 Salts Potassium chloride Potassium magnesium sulfate Potassium nitrate Potassium sodium nitrate Potassium sulfate Calcium sulfate 7447 40 7 14168 73 1 7757 79 1 7757 79 1/ 7631 99 4 7778 80 5 7778 18 9 Acids Phosphoric acid Nitric acid Sulfuric acid 7664 38 2 7697 37 2 7664 93 9 * = Nitrogen solutions are primarily Urea Ammonia Nitrogen ( UAN; 15978 77 5) ** = Single superphosphate and granular triple superphosphate are combined into a single health and environmental safety data summary document.  = No CAS number readily available 6 Sodium Nitrate CAS # 7631 99 4 V. REFERENCES CITED 40 CFR 156.62. Toxicity Category.

Al Dabbagh, S., Forman, D., Bryson, D., Stratton, I. and Doll, R. 1986. Mortality of nitrate fertilizer workers. British Journal of Industrial Medicine. 43: 507 515.

Burden, E. H. W. J. 1961. The toxicology of nitrates and nitrites with particular reference to the potability of water supplies. The Analyst. 86( 1024): 429 433.

Chow, C. K., Chen, C. J. and Gairola, C. 1980. Effect of nitrate and nitrite in drinking water in rats. Toxicology Letters. 6: 199 206.

Forman, D., Al Dabbagh, S. and Doll, R. 1985. Nitrates, nitrites and gastric cancer in Great Britain. Nature. 313( 6004): 620 625.

Leclerc, H., Vincent, P. and Vandevenne, P. 1991. Nitrates in drinking water and cancer. Bull. Acad. Natl. Med. 175( 4): 651 666.

L'hirondel, J., L'hirondel, J. L. 1998. Nitrates and Man: The Myth of Their Toxicity.

Lijinsky, W. and Epstein, S. S. 1970. Nitrosamines as environmental carcinogens. Nature 225( 227): 21 23.

Lijinsky, W. 1989. Environmental cancer risks   real and unreal. Environmental Research 50: 207 209.

Magee, P. N. and Barnes, J. M. 1967. Carcinogenic nitroso compounds. Adv. Cancer Res. 10: 163 264.

OECD. 1997. SIDS Manual. OECD Secretariat, 3rd Revision, July 1997.

Owens, F. N. and Dubeski, P. 1989. Nitrate toxicity in ruminants. ASAS Production & Management Symposium.

Rubin, A. J. and Elmaraghy, G. A. 1977. Studies on the toxicity of ammonia, nitrate and their mixtures to guppy fry. Water Research 11: 927 935.

USEPA. 1999. Development of Chemical Categories in the HPV Challenge Program. www. epa. gove/ chemrtk/ catdoc29. pdf. 7 Sodium Nitrate CAS # 7631 99 4 SIDS DATA PROFILE Date: January 27, 2003 1.01 A. CAS No. 7631 99 4 1.01 C. CHEMICAL NAME ( OECD NAME) Sodium nitrate 1.01 D CAS DESCRIPTOR Sodium nitrate 1.01 G STRUCTURAL FORMULA NaNO3 OTHER CHEMICAL IDENTITY INFORMATION Not applicable 1.5 QUANTITY 50,000   100,000 tonnes per annum 1.7 USE PATTERN Fertilizer, manufacture of enamels for pottery, matches, catalyst in manufacture of sulfuric acid, in pickling meats 1.9 SOURCES AND LEVELS OF EXPOSURE Low human exposure is expected because sodium nitrate is manufactured in closed systems. Exposure to dusts is possible during fertilizer application. ISSUES FOR DISCUSSION No further testing is needed. The data for sodium nitrate should be evaluated in combination with the other materials in the nitrate category. 8 Sodium Nitrate CAS # 7631 99 4 SIDS DATA SUMMARY Date: January 27, 2003 SODIUM NITRATE ( CAS NO. 7631 99 4) SPECIES PROTOCOL RESULTS PHYSICAL CHEMICAL DATA 2.1 Melting Point 308 ° C; 307 ° C 2.2 Boiling Point 380 ° C at 760 mm Hg 2.3 Density 2.26 g/ cm3 at 20oC 2.4 Vapor Pressure Not expected to volatilize 2.5 Octanol/ Water Partition Coefficient OECD Guideline 107  3.8 at 25 ° C 2.6A Water Solubility 874 g/ L at 20 ° C 2.6B pH value 7 in aqueous solution 2.7 Flash Point Not applicable 2.8 Auto Flammability Does not burn 2.9 Flammability Not flammable 2.10 Explosive Properties May explode at high temperatures or contact with reducing agents 2.11 Oxidizing Properties Strong oxidizer 2.12 Oxidation: Reduction Potential See Appendix B results* 2.13 Additional Data See text ENVIRONMENTAL FATE and PATHWAY 3.1.1 Photodegradation Does not photodegrade 3.1.2 Stability in Water Stable 3.1.3 Stability in Soil Binds to clay particles 3.3.2 Distribution Fugacity Level III ( Mackay type) 0.001% to air 45.3% to water 54.7% to soil 0.076% to sediment 3.5 Biodegradation Biodegradable 3.7 Bioaccumulation Does not bioaccumulate * See Appendix B results for data on other chemicals in the nitrate category. 9 Sodium Nitrate CAS # 7631 99 4 SODIUM NITRATE ( CAS NO. 7631 99 4) SPECIES PROTOCOL RESULTS ECOTOXICITY 4.1 Acute Toxicity to Fish Lepomis macrochirus ( bluegill) Lepomis macrochirus ( bluegill) Oncorhynchus tshawtscha ( chinook salmon)

Salmo gairdneri ( rainbow trout) 96 hrs 24 hrs 96 hrs + LC50 > 8,753 mg NO3/ L TLm = 9,331 mg NO3/ L TLm ( freshwater, salmon) = 5,800 mg NO3/ L TLm ( 15 ppt salinity, salmon) = 4,400 mg NO3/ L TLm ( freshwater, trout) = 6,000 mg NO3/ L TLm ( 15 ppt salinity, trout) = 4,650 mg NO3/ L 4.2 Acute Toxicity to Aquatic Invertebrates Daphnia magna 48 hrs TLm = 3,581 mg NaNO3/ L Various penaeid shrimp Penaeus monodon larvae Crassostrea virginica and Mercenaria mercenaria 48 hrs 40 hrs 96 hrs LC50 = 3,400 mg NO3  N/ L NOEC = 2,000 mg NO3  N/ L LC50 > 100 mg NO3/ L LC50 ( C. virginica) = 15,810 mg NO3/ L ( adults); 23,040 mg NO3/ L ( juveniles) LC50 ( M. mercenaria) > 19,840 mg NO3/ L ( adults and juveniles) 4.3 Toxicity to Aquatic Plants ( Algae) Scenedesmus quadricauda Toxicity threshold = 1,233 mg NO2 / L 4.4 Toxicity to Bacteria See Appendix B results* 4.5.1 Chronic Toxicity to Fish Amphiprion oscellaris 3 months % survival in larvae ( lownitrate system) = 37% % survival in larvae ( high nitrate system) = 34% 4.5.2 Chronic Toxicity to Aquatic Invertebrates Penaeus monodon 3   5 weeks LC50 > 200 mg NO3  N/ L 4.6.2 Toxicity to Terrestrial Plants See Appendix B results* 4.6.3 Toxicity to Other Non Mammalian Terrestrial Species Coturnix coturnix japonica ( Japanese quail) 7 days to 15 weeks LC100 = 5,280 ppm ( by day 3 post treatment) LC100 = 5,940 ppm ( by day 4 post treatment)

* See Appendix B results for data on other chemicals in the nitrate category. 10 Sodium Nitrate CAS # 7631 99 4 SODIUM NITRATE ( CAS NO. 7631 99 4) SPECIES PROTOCOL RESULTS TOXICITY 5.1.1 Acute Oral Toxicity Rabbit Rat LD50 = 2680 mg/ kg/ bw LD50 = 1267, 3236, 3430, and 5200 mg/ kg/ bw 5.1.2 Acute Inhalation Toxicity Dog, sheep 7.5 minutes to 4 hrs NOEC ( dog) = 5 mg/ m3 NOEC ( sheep) = 1 mg/ m3 5.1.3 Acute Dermal Toxicity See Appendix B results* 5.1.4 Acute Toxicity, Other Routes Dogs i. v.; 60 minutes NOEC = 100 mg NaNO3 5.2.1 Skin Irritation/ Corrosion See Appendix B results* 5.2.2 Eye Irritation Corrosion See Appendix B results* 5.3 Skin Sensitization See Appendix B results* 5.4 Repeated Dose Toxicity Rat Rat 6 weeks 14 months MTD = 5% in the diet See Appendix B results* 5.5 Genetic Toxicity in vitro Salmonella typhimurium Chinese hamster ovary cells Bacterial reverse mutation assay Chromosome aberration test Negative Positive 5.6 Genetic Toxicity in vivo Swiss mice and Wistar rats Mice Micronucleus assay Mouse germ cells Positive Positive 5.7 Carcinogenicity Rats 104 weeks Not significantly different from controls 5.8 Toxicity to Reproduction Beagle dog Two generation study No significant adverse effects 5.9 Developmental Toxicity/ Teratogenicity Rat, Mouse, Rabbit, Syrian hamster No significant adverse effects 5.10 Metabolism and Toxicokinetics Readily absorbed and excreted 5.11 Human Experience See text 1.8 Occupational Exposure Limits TLV as inert dust 15 mg/ m3 * See Appendix B results for data on other chemicals in the nitrate category. 11 Sodium Nitrate CAS # 7631 99 4 1. GENERAL INFORMATION 1.01 SUBSTANCE INFORMATION A. CAS number 7631 99 4 B. Name ( IUPAC name) Sodium nitrate C. Name ( OECD name) Sodium nitrate D. CAS Descriptor Not applicable E. EINECS Number 231 554 3 F. Molecular Formula NNaO3 G. Structural Formula NaNO3 SMILES: [ Na] O( N(= O)= O)

H. Substance Group Not applicable I. Substance Remark Not applicable J. Molecular Weight 84.99 1.02 OECD INFORMATION A. Sponsor Country Not applicable B. Lead Organization Name of Lead Organization: Not applicable C. Name of Responder Name: Mr. William C. Herz, Director of Scientific Programs Address/ Phones: The Fertilizer Institute Union Center Plaza 820 First Street, NE, Suite 430 Washington, DC 20002 USA Tel: ( 202) 962 0490 Fax: ( 202) 962 0577 12 Sodium Nitrate CAS # 7631 99 4 1.1 GENERAL SUBSTANCE INFORMATION A. Type of Substance element [ ]; inorganic [ X]; natural substance [ ]; organic [ ]; organometallic [ ]; petroleum product [ ]

B. Physical State ( at 20 ° C and 1.013 hPa)

gaseous [ ]; liquid [ ]; solid [ X]

C. Purity Fertilizer grade usually 99.5   99.8% purity Reference: United Nations Industrial Development Organization ( UNIDO) and International Fertilizer Development Center ( IFDC). 1998. Fertilizer Manual. Kluwer Academic Publisher, The Netherlands.

1.2 SYNONYMS Nitric acid, sodium salt Nitrate of soda Soda niter Chile saltpeter Niter Cubic niter 1.3 IMPURITIES None identified 1.4 ADDITIVES None identified 1.5 QUANTITY Remarks: 50,000 100,000 tonnes per annum. 52,370 tonnes produced in the US in 1982. In 1994, it was reported that the US imported 100,000 tonnes per annum. References: Hazardous Substances Data Bank ( HSDB). 1999. Sodium Nitrate. National Library of Medicine, Bethesda, MD.

1.6 LABELING AND CLASSIFICATION DOT Labeling Hazard class: 5.1 Labels required: Oxidizer ( UN1498)

NFPA Rating Health: 1 ( slight hazard) 13 Sodium Nitrate CAS # 7631 99 4 Fire: 0 ( no hazard) Reactivity: 3 ( serious hazard) Specific: Oxidizer Remarks: Sodium nitrate is a strong oxidizer. Contact with other materials may result in fire. Decomposes explosively when heated to very high temperatures (> 1000 ° F). Sensitive to mechanical impact. References: 1) Mallinckrodt Baker, Inc. 1999. MSDS: Sodium Nitrate. No. S4442. 2) NIOSH, IPCS, International Chemical Safety Cards (# 0185). Sodium Nitrate. 3) Sax, I. and Lewis, R. 1994. Dangerous Properties of Industrial Materials. 8th ed. New York: Van Nostrand Reinhold.

1.7 USE PATTERN A. General Type of Use: Category:

( a) main Wide dispersive use industrial Agricultural industry use Fertilizer ( b) main Non dispersive use industrial Chemical industry use Manufacture enamels for pottery, in matches, catalyst in manufacture of sulfuric acid, in pickling meats Reference: 1) Hazardous Substances Data Bank ( HSDB). 1999. Sodium Nitrate. National Library of Medicine, Bethesda, MD. 2) United Nations Industrial Development Organization ( UNIDO) and International Fertilizer Development Center ( IFDC). 1998. Fertilizer Manual. Kluwer Academic Publisher, The Netherlands.

B. Uses in Consumer Products Remarks: Sodium nitrate is a direct and indirect food additive. References: Hazardous Substances Databank ( HSDB). 1999. Sodium Nitrate. National Library of Medicine, Bethesda, MD. 14 Sodium Nitrate CAS # 7631 99 4 1.8 OCCUPATIONAL EXPOSURE LIMIT VALUE Exposure limit value Type: OSHA PEL Value: 15 mg/ m3 total dust; 5 mg/ m3 respirable fraction. Remark: No specific limit has been set, however, the federal OSHA PEL for particulates not otherwise regulated applies to all fertilizer dusts. Regulated limits may vary in local jurisdictions.

Short term exposure limit value Remarks: No TLV has been established. Reference: 1) European Commission. 2000. Sodium Nitrate. International Uniform Chemical Information Database. Year 2000 CD ROM Edition. 2) Mallinckrodt Baker, Inc. 1999. MSDS: Sodium Nitrate. No. S4442.

1.9 SOURCES OF EXPOSURE Remarks: Sodium nitrate can be absorbed into the body by inhalation of its aerosol and by ingestion, although significant human and environmental exposures during manufacture are unlikely if the process is well managed. Engineering controls such as mechanical ventilation, process or personnel enclosure, control of process conditions, and process modifications significantly reduce exposure. Local exhaust ( ventilation) control as close to the point of generation is both the most economical and safest method to minimize personnel exposure to airborne concentrations. Personal protective equipment includes neoprene or nitrile gloves, dusk masks or fume hoods as appropriate, chemical safety goggles, and impervious apron, sleeves and boots. Field exposure to workers is possible when handling and using on farms as a fertilizer. However, fertilizers are applied by mechanical spreaders, which reduces contact exposure. Environmental releases are controlled at the manufacturing plant. Gaseous emissions are low due to use of scrubbers and liquid effluent is recovered as much as possible. Exposure to environmental receptors is dependent on the amount used as fertilizer on fields, the climatic conditions, and the hydrological conditions of the area of application. Nitrate materials are common in the environment and are essential nutrients for both plants and animals. 15 Sodium Nitrate CAS # 7631 99 4 References: 1) European Commission. 2000. Sodium Nitrate. International Uniform Chemical Information Database. Year 2000 CD ROM Edition. 2) Hazardous Substances Data Bank ( HSDB). 1999. Sodium Nitrate. National Library of Medicine, Bethesda, MD. 3) Mallinckrodt Baker, Inc. 1999. MSDS: Sodium Nitrate. No. S4442. 4) NIOSH, IPCS, International Chemical Safety Cards (# 0185). Sodium Nitrate.

1.10 ADDITIONAL REMARKS A. Options for disposal Remarks: Sodium nitrate must be disposed of in accordance with federal, state, and local environmental control regulations. For spills, seep spilled substance into plastic or glass containers, wash away remainder with plenty of water. References: 1) Hazardous Substances Data Bank ( HSDB). 1999. Sodium Nitrate. National Library of Medicine, Bethesda, MD. 2) Mallinckrodt Baker, Inc. 1999. MSDS: Sodium Nitrate. No. S4442. 3) NIOSH, IPCS, International Chemical Safety Cards (# 0185). Sodium Nitrate.

2. PHYSICAL CHEMICAL DATA 2.1 MELTING POINT Value: 308; 307 ° C Decomposition: Yes [ ] No [ X] Ambiguous [ ] Sublimation: Yes [ ] No [ X] Ambiguous [ ] Method: Not described GLP: Yes [ ] No [ ] ? [ X] References: 1) Budavari, S. ( ed). 1996. Merck Index. Whitehouse Station: Merck Research Laboratories. 2) Lide, D. R. ( ed.). 1999. CRC Handbook of Chemistry and Physics. 12th ed. New York: CRC Press.

2.2 BOILING POINT Value: 380 ° C Pressure: 760 mm Hg Method: Not described 16 Sodium Nitrate CAS # 7631 99 4 GLP: Yes [ ] No [ ] ? [ X] Remarks: Decomposes at 380 ° C References: 1) ECDIN 1999. Nitric acid sodium salt. No. 0034349. 2) Mallinckrodt Baker, Inc. 1999. MSDS: Sodium Nitrate. No. S4442.

2.3 DENSITY ( Relative Density)

Type: Bulk density [ ]; Density [ X]; Relative Density [ ] Value: 2.26 g/ cm3 Temperature: 20 ° C Method: Not described GLP: Yes [ ] No [ ] ? [ X] References: 1) Budavari, S. ( ed.). 1996. Merck Index. Whitehouse Station: Merck Research Laboratories. 2) Lide, D. R. ( ed.). 1999. CRC Handbook of Chemistry and Physics. 12th ed. New York: CRC Press.

2.4 VAPOR PRESSURE No data available. Would not be expected to volatilize to a significant degree.

2.5 PARTITION COEFFICIENT logPow Log Pow:  3.8 Temperature: 25 ° C Method: Calculated [ ]; Measured [ X] OECD Guideline 107 " Partition Coefficient ( noctanol water), flask shaking method" GLP: Yes [ X] No [ ] ? [ ] Remarks: Study conducted by BASF and reported in IUCLID. References: European Commission. 2000. Sodium Nitrate. International Uniform Chemical Information Database. Year 2000 CD ROM Edition.

2.6 WATER SOLUBILITY A. Solubility Value: 874 g/ L; 909 g/ L; 545 g/ L Temperature: 20 ° C; 25 ° C; 100oC Description: Miscible [ ]; Of very high solubility [ X]; Of high solubility [ ]; Soluble [ ]; Slightly soluble [ ] 17 Sodium Nitrate CAS # 7631 99 4 Of low solubility [ ]; Of very low solubility [ ]; Not soluble [ ] Method: Not described GLP: Yes [ ] No [ ] ? [ X] Remarks: Slightly soluble in ethanol and methanol. References: 1) Budavari, S. ( ed.). 1996. Merck Index. Whitehouse Station: Merck Research Laboratories. 2) Lide, D. R. ( ed.). 1999. CRC Handbook of Chemistry and Physics. 12th ed. New York: CRC Press.

B. pH Value pH Value: 7 Concentration: aqueous solution Temperature: 25 ° C Method: Not described GLP: Yes [ ] No [ ] ? [ X] References: Lide, D. R. ( ed.). 1999. CRC Handbook of Chemistry and Physics. 12th ed. New York: CRC Press.

2.7 FLASH POINT ( liquids)

Not applicable to solids 2.8 AUTO FLAMMABILITY ( solid/ gases)

Remarks: Does not burn, but may increase the flammability of combustible materials. References: 1) Hazardous Substances Data Bank ( HSDB). 1999. Sodium Nitrate. National Library of Medicine, Bethesda, MD. 2) Mallinckrodt Baker, Inc. 1999. MSDS: Sodium Nitrate. No. S4442. 3) NIOSH, IPCS, International Chemical Safety Cards (# 0185). Sodium Nitrate.

2.9 FLAMMABILITY Results: Extremely flammable [ ]; Extremely flammable   liquified gas [ ]; Highly flammable [ ]; Flammable [ ]; Non flammable [ ]; Spontaneously flammable in air [ ]; Contact with water liberates highly flammable gases [ ]; Other [ X] Method: Not described GLP: Yes [ ] No [ ] ? [ X] Remarks: Not flammable, but may increase the flammability of combustible substances. 18 Sodium Nitrate CAS # 7631 99 4 19 Sodium Nitrate CAS # 7631 99 4 References: 1) Hazardous Substances Data Bank ( HSDB). 1999. Sodium Nitrate. National Library of Medicine, Bethesda, MD. 2) Mallinckrodt Baker, Inc. 1999. MSDS: Sodium Nitrate. No. S4442. 3) NIOSH, IPCS, International Chemical Safety Cards (# 0185). Sodium Nitrate.

2.10 EXPLOSIVE PROPERTIES Results: Explosive under influence of a flame [ ]; More sensitive to friction than m dinitrobenzene [ ]; More sensitive to shock than m dinitrobenzene [ ]; Not explosive [ ]; Other [ X] Method: Not described GLP: Yes [ ] No [ ] ? [ X] Remarks: May explode when heated to over 1000oC. Risk of explosion on contact with reducing agents. References: 1) Hazardous Substances Data Bank ( HSDB). 1999. Sodium Nitrate. National Library of Medicine, Bethesda, MD. 2) Mallinckrodt Baker, Inc. 1999. MSDS: Sodium Nitrate. No. S4442. 3) NIOSH, IPCS, International Chemical Safety Cards (# 0185). Sodium Nitrate.

2.11 OXIDIZING PROPERTIES Remark: Sodium nitrate is a strong oxidizer. References: 1) Hazardous Substances Data Bank ( HSDB). 1999. Sodium Nitrate. National Library of Medicine, Bethesda, MD. 2) Mallinckrodt Baker, Inc. 1999. MSDS: Sodium Nitrate. No. S4442. 3) NIOSH, IPCS, International Chemical Safety Cards (# 0185). Sodium Nitrate. 4) United Nations Industrial Development Organization ( UNIDO) and International Fertilizer Development Center ( IFDC). 1998. Fertilizer Manual. Kluwer Academic Publisher, The Netherlands.

2.12 OXIDATION: REDUCTION POTENTIAL No data available 20 Sodium Nitrate CAS # 7631 99 4 2.13 ADDITIONAL DATA Remarks: Sodium nitrate can be stored and shipped in bulk under conditions of low humidity, but should be packed in moisture resistant bags when intended for use in damp or tropical climates. It decomposes on heating producing nitrogen oxides and oxygen, which increases fire hazard. It should be kept separate from incompatibles, combustibles, organic or other readily oxidizable materials. References: 1) Mallinckrodt Baker, Inc. 1999. MSDS: Sodium Nitrate. No. S4442. 2) NIOSH, IPCS, International Chemical Safety Cards (# 0185). Sodium Nitrate. 3) United Nations Industrial Development Organization ( UNIDO) and International Fertilizer Development Center ( IFDC). 1998. Fertilizer Manual. Kluwer Academic Publisher, The Netherlands.

3. ENVIRONMENTAL FATE AND PATHWAYS 3.1 STABILITY 3.1.1 PHOTODEGRADATION Remarks: Photodegradation is not a significant dissipation mechanism. Sodium nitrate is highly soluble in water and nonvolatile.

3.1.2 STABILITY IN WATER Remarks: Sodium nitrate is highly soluble in water and stable to hydrolytic degradation. References: 1) Hazardous Substances Data Bank ( HSDB). 1999. Sodium Nitrate. National Library of Medicine, Bethesda, MD. 2) Mallinckrodt Baker, Inc. 1999. MSDS: Sodium Nitrate. No. S4442. 3) NIOSH, IPCS, International Chemical Safety Cards (# 0185). Sodium Nitrate. 21 Sodium Nitrate CAS # 7631 99 4 3.1.3 STABILITY IN SOIL Remarks: There is extensive literature on nitrification and denitrification by microorganisms in soil. Sodium ions bind to clay particles and leach slowly or not at all to ground water, whereas the nitrate can leach significantly.

3.2 MONITORING DATA ( ENVIRONMENTAL)

No specific monitoring data available because nitrate is present naturally in the environment.

3.3 TRANSPORT AND DISTRIBUTION BETWEEN ENVIRONMENTAL COMPARTMENTS INCLUDING ESTIMATED ENVIRONMENTAL CONCENTRATIONS AND DISTRIBUTION PATHWAYS 3.3.1 TRANSPORT Remarks: Nitrate is not bound to soil and will follow water movements.

3.3.2 THEORETICAL DISTRIBUTION ( FUGACITY CALCULATION)

Method: Fugacity Level III ( Mackay type) Mass distribution by Environmental compartment: Air: < 0.001% Water: 45.3% Soil: 54.7% Sediment: 0.076% References: USEPA. 2000. EPISUITE Estimation Program V. 3.10. US Environmental Protection Agency.

3.4 IDENTIFICATION OF MAIN MODE OF DEGRADABILITY IN ACTUAL USE Remarks: Nitrate is converted to nitrogen via denitrification ( NO3    NO2). 22 Sodium Nitrate CAS # 7631 99 4 3.5 BIODEGRADATION Type: Probability of rapid biodegradation Results: Readily biodeg. [ X]; Inherently biodeg. [ ]; Under test condition no biodegradation observed [ ]; Other [ ] Method: estimated using EPIWINV. 3.10 Test substance: Sodium nitrate Remarks: The probability of rapid biodegradation according to the linear and non linear models were 0.7071 and 0.8584, respectively. According to the primary survey model, biodegradation of the parent compound takes days to weeks. The ultimate survey model estimated that complete biodegradation takes weeks. References: USEPA. 2000. EPISUITE Estimation Program V. 3.10. US Environmental Protection Agency.

3.6 BOD5, COD OR RATIO BOD5/ COD No data available 3.7 BIOACCUMULATION Remark: Does not bioaccumulate 4. ECOTOXICITY 4.1 ACUTE/ PROLONGED TOXICITY TO FISH ( a) Type of test: Static [ ]; Semi static [ ]; Flow through [ X]; Other ( e. g. field test) [ ]; Open system [ ]; Closed system [ X] Species: Lepomis macrochirus ( bluegill) Exposure period: 96 hours Results: LC50 ( 96 h) > 12,000 mg NaNO3/ L (> 8,753 mg NO3/ L) Analytical monitoring: Yes [ ]; No [ X]; ? [ ] Method: Five gallon glass jars containing 20 L of distilled water were placed in a constant temperature tank at 20oC. Ten fish were placed in each container and tests were run in duplicate for every concentration. Concentrations ranged from 10,000 to 13,500 mg NaNO3/ L. The pH ranged from 7.30 to 8.78. GLP: Yes [ ] No [ X] ? [ ] Test substance: Analytical grade sodium nitrate ( NaNO3) Remarks: No fish died at 10,000 mg/ L. 23 Sodium Nitrate CAS # 7631 99 4 References: Trama, F. B. 1954. The acute toxicity of some salts of sodium, potassium and calcium to the common bluegill ( Lepomis macrochirus Rafinesque). Proc. Acad. Nat. Sci. Philadelphia 106: 185 205.

( b) Type of test: Static [ X]; Semi static [ ]; Flow through [ ]; Other ( e. g. field test) [ ]; Open system [ X]; Closed system [ ] Species: Lepomis macrochirus ( bluegill) Exposure period: 24 hours Results: TLm ( 24 h; standard reference water) = 12,800 mg NaNO3/ L ( 9,331 mg NO3/ L) Analytical monitoring: Yes [ ]; No [ ]; ? [ X] Method: Bioassays were conducted with methods of Freeman, L. 1953. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) Remarks: A similar value was obtained for Carassius carassius ( goldfish). References: 1) Dowden, B. F. and Bennett, H. J. 1965. Toxicity of selected chemicals to certain animals. J. Water Pollut. Control Fed. 37( 9): 1308 1316. 2) Freeman, L. 1953. A standardized method for determining toxicity of pure compounds to fish. Sewage and Industrial Wastes. 25( 7): 845.

( c) Type of test: Static [ ]; Semi static [ ]; Flow through [ ]; Other ( e. g. field test) [ ]; Open system [ ]; Closed system [ ] ( Not stated) Species: Oncorhynchus tshawtscha ( chinook salmon), Salmo gairdneri ( rainbow trout) Exposure period: 96 hours + Results: TLm ( 96 h; freshwater, salmon) = 5,800 mg NO3/ L TLm ( 96 h; 15 ppt salinity, salmon) = 4,400 mg NO3/ L TLm ( 96 h; freshwater, trout) = 6,000 mg NO3/ L TLm ( 96 h; 15 ppt salinity, trout) = 4,650 mg NO3/ L Analytical monitoring: Yes [ ]; No [ ]; ? [ X] Method: Standard bioassay methods as outlined by American Public Health Association were followed. Each container contained 10 fish. Controls were run concurrently with each toxicity environment. Experiments were run in both freshwater and at 15 ppt salinity. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) Remarks: Nitrate at 15 ppt salinity was statistically more active than in freshwater according to relative potency calculations. Increased exposure time ( 7 days) increased mortality slightly among salmon and trout in both freshwater and 15 ppt tests. All trout subjected to nitrate 24 Sodium Nitrate CAS # 7631 99 4 concentrations showed acute signs after 2 d exposure; these signs were not observed in the lower nitrate concentrations of the chinook experiments until after 5 to 8 d. Signs included an inability to swim upright, labored respiration, and little movement altered by erratic swimming. Death usually followed a period of laying at the bottom of the container with opercular movements the only sign of life. References: Westin, D. T. 1974. Nitrate and nitrite toxicity to salmonoid fishes. The Progressive Fish Culturist. 36( 2): 86 89.

( d) Remarks: The IUCLID Data Sheet for sodium nitrate reports many additional studies. In all cases, no significant toxicity to fish was observed. Reference: European Commission. 2000. Sodium Nitrate. International Uniform Chemical Information Database. Year 2000 CD ROM Edition.

4.2 ACUTE TOXICITY TO AQUATIC INVERTEBRATES A. Daphnia Type of test: Static [ X]; Semi static [ ]; flow through [ ]; Other ( e. g. field test) [ ] Open system [ X]; Closed system [ ] Species: Daphnia magna Exposure period: 48 hours Results: TLm ( 48 h; University Lake water) = 3,581 mg NaNO3/ L Analytical monitoring: Yes [ ]; No [ ]; ? [ X] Method: Bioassays were conducted with methods of Anderson, B. G. et al. 1948. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) References: 1) Anderson, B. G., Andrews, T. F., Chandler, D. G., and Jahoda, W. J. 1948. The Evaluation of Aquatic Invertebrates as Assay Organisms for the Determination of the Toxicity of Industrial Wastes. Report of the Ohio State University Research Foundation to the American Petroleum Institute, New York. 2) Dowden, B. F. and Bennett, H. J. 1965. Toxicity of selected chemicals to certain animals. J. Water Pollut. Control Fed. 37( 9): 1308 1316.

B. Other aquatic organisms ( a) Type of test: Static [ ]; Semi static [ ]; Flow through [ ]; Other ( e. g. field test); [ X] Unknown 25 Sodium Nitrate CAS # 7631 99 4 Species: Various penaeid shrimp Exposure period: 48 hours Results: LC50 = 3,400 mg NO3 N/ L NOEC = 2,000 mg NO3 N / L Analytical monitoring: Yes [ ]; No [ ]; ? [ X] Method: Not described GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) Remarks: Reported in IUCLID data sheet References: European Commission. 2000. Sodium Nitrate. International Uniform Chemical Information Database. Year 2000 CD ROM Edition.

( b) Type of test: Static [ X]; Semi static [ ]; Flow through [ ]; Other ( e. g. field test) [ ] Unknown Species: Penaeus monodon larvae Exposure period: 40 hours Results: LC50 > 100 mg NO3/ L; Average percent survival in the control, 1, 10 and 100 mg NO3/ L experiments were 80, 66, 61 and 53%, respectively. No significant differences in survival between 1 and 10 mg NO3/ L or 10 and 100 mg NO3/ L were observed. Survival at 1 mg NO3/ L was lower than the controls, but was not significantly different statistically. Analytical monitoring: Yes [ X]; No [ ]; ? [ ] Method: Shrimp larvae at the protozoea I stage ( 55 to 60 hrs after hatching) were exposed to sodium nitrate at 1, 10 and 100 mg NO3/ L and a control. At the beginning of the experiments, 15 actively swimming larvae were transferred into 250 mL Erlenmeyer beakers holding 150 mL of seawater. These beakers were incubated in a rotary shaker ( 28 ° C, 90 rpm) for 40 hours, after which the number of surviving larvae in each treatment was determined. GLP: Yes [ ] No [ X] ? [ ] Test Substance: Sodium nitrate Remarks: Some variation in survival was observed between experiments, probably due to slight differences in the hatching conditions and/ or natural variability. Reference: Muir, P. R., Sutton, D. C., and Owens, L. 1991. Nitrate toxicity to Peneaus monodon protozoea. Marine Biology 108: 67 71.

( c) Type of test: Static [ X]; Semi static [ ]; Flow through [ ]; Other ( e. g. field test) [ ] Unknown Species: Crassostrea virginica and Mercenaria mercenaria Exposure period: 96 hours Results: LC50 ( C. virginica) = 15,810 mg NO3/ L ( adults); 23,040 mg NO3/ L ( juveniles) 26 Sodium Nitrate CAS # 7631 99 4 LC50 ( M. mercenaria) > 19,840 mg NO3/ L ( adults and juveniles) Analytical monitoring: Yes [ X]; No [ ]; ? [ ] Method: Adult or juvenile oysters or clams were placed in glass aquaria containing 30L of seawater at 20 ° C and 20  salinity. Each duplicate aquarium for each concentration received gentle but continuous aeration and 10 oysters or clams. Criteria for death were gaping of the valves and lack of response to mechanical stimulation of exposed body parts. After 96 hrs of exposure, surviving individuals were transferred to clean seawater for a 24 hr recovery period. GLP: Yes [ ] No [ X] ? [ ] Test Substance: Sodium nitrate Remarks: Both oysters and clams exhibit a high tolerance to sodium nitrate exposure. Reference: Epifanio, C. E. and Srna, R. F. 1975. Toxicity of ammonia, nitrite ion, nitrate ion, and orthophosphate to Mercenaria mercenaria and Crassostrea virginica. Marine Biology 33: 241 246.

4.3 TOXICITY TO AQUATIC PLANTS, e. g. algae ( a) Species: Scenedesmus quadricauda ( green algae) Endpoint: Biomass [ ]; Growth rate [ ]; Other [ X] Exposure period: 7 days Results: Toxicity threshold = 1,233 mg NO2 / L Analytical monitoring: Yes [ ]; No [ ]; ? [ X] Method: Two parallel dilution series were prepared. Each of the dilutions contains 1 part v/ v of the pollutant solution in 1 to 214 parts v/ v of mixture. The concentration of the algal suspension was measured turbidimetrically. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrite ( NaNO2 ) Remarks: The toxicity threshold is the concentration at which the mean extinction value is the > 3% below the mean extinction value for non toxic dilutions in the series. Results indicate limited toxicity of the test material, which was sodium nitrite. References: Bringmann, G. and Kuhn, R. 1980. Comparison of the toxicity thresholds of water pollutants to bacteria, algae, and protozoa in the cell multiplication inhibition test. Water Research. 14: 231 241.

4.4 TOXICITY TO BACTERIA No data available 27 Sodium Nitrate CAS # 7631 99 4 4.5 CHRONIC TOXICITY TO AQUATIC ORGANISMS 4.5.1 CHRONIC TOXICITY TO FISH Type of test: Static [ ]; Semi static [ X]; Flow through [ ]; Other ( e. g. field test) [ ] Open system [ X]; Closed system [ ] Species: Amphiprion ocellaris ( anemone fish) Endpoint: Length of fish [ ]; Weight of fish [ ]; Reproduction rate [ ]; Other [ X] Exposure period: 3 months Results: % survival in larvae ( 21 days; low nitrate system) = 37% % survival in larvae ( 21 days; high nitrate system) = 34% Analytical monitoring: Yes [ X]; No [ ]; ? [ ] Method: Three 57 L glass aquariums were used for juvenile fish and two 38 L aquariums were used for the larvae. Aquariums were equipped with bottom filters. The high nitrate system was spiked with NaNO3 over 10 days to achieve a concentration of ~ 100 mg NO3 N/ L. The average concentration in the low nitrate system was 16.1 mg NO3 N/ L and in the high nitrate system was 99.2 mg NO3 N/ L. Two juvenile tanks in each system were stocked with 21 fish aged 72 weeks, and the third tank was stocked with six fish aged 40 days. After the test concentration of nitrate N was reached, two tanks in each system were stocked with 50 newly hatched larvae. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) Remarks: The effects of elevated nitrate were most pronounced in larvae. Growth was inhibited in the high nitrate group. Histological examination of juveniles at 33 and 84 d were normal for both groups. The only abnormal results were found in post larvae that experienced delayed metamorphosis. They showed evidence of tubular necrosis and destruction of the kidneys. References: Frakes, T. and Hoff, Jr., F. H. 1982. Effect of high nitrate N on the growth and survival of juvenile and larval anemone fish, Amphiprion ocellaris. Aquaculture. 29: 155 158.

4.5.2 CHRONIC TOXICITY TO AQUATIC INVERTEBRATES Remarks: The growth of Penaeus monodon was not affected after 3 5 weeks exposure to concentrations over 200 mg NO3 N/ L. Growth and survival of Macrobracherim rosenbergii were affected after 3 weeks of similar levels 28 Sodium Nitrate CAS # 7631 99 4 of nitrate. Growth and survival LC50 values were 175 and 160 mg NO3 N/ L, respectively. Data summary as reported in IUCLID Data Sheet for Sodium Nitrate. References: European Commission. 2000. Sodium Nitrate. International Uniform Chemical Information Database. Year 2000 CD ROM Edition.

4.6 TOXICITY TO TERRESTRIAL ORGANISMS 4.6.1 TOXICITY TO SOIL DWELLING ORGANISMS No data available 4.6.2 TOXICITY TO TERRESTRIAL PLANTS No data available 4.6.3 TOXICITY TO OTHER NON MAMMALIAN TERRESTRIAL SPECIES ( INCLUDING AVIAN)

Species: Coturnix coturnix japonica ( Japanese quail) Endpoint: Mortality [ X]; Reproduction rate [ ]; Weight [ ]; Other [ X] Exposure period: 7 days to 15 weeks Results: LC100 = 5,280 ppm ( by day 3 post treatment) LC100 = 5,940 ppm ( by day 4 post treatment) Method: In three experiments, triplicate groups of 20, 30, and 20 day old quail, respectively, were randomly distributed into battery brooders and given well water with sodium nitrate. Experiments were terminated after 7 days. For a fourth experiment, triplicate groups of 15 quail were given various levels of nitrate in their drinking water from 1 day old to 15 weeks of age, to determine the effects from nitrate on growth, mortality, food and water consumption, and egg production. Quail were exposed to various nitrate concentrations ranging from 660 to 5940 ppm. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) Remarks: Levels of nitrate had a significant, but inconsistent effect on weight gain. Neither food nor water consumption during growing or laying phases nor hen day egg production were significantly affected by levels of nitrate used. References: Adams, A. W. 1974. Effects of nitrate in drinking water of Japanese quail. Poultry Science. 53( 2): 832 834. 29 Sodium Nitrate CAS # 7631 99 4 4.7 BIOLOGICAL EFFECTS MONITORING ( INCLUDING BIOMAGNIFICATION)

No data available 4.8 BIOTRANSFORMATION AND KINETICS No data available 4.9 ADDITIONAL REMARKS No further remarks 5. TOXICITY 5.1 ACUTE TOXICITY 5.1.1 ACUTE ORAL TOXICITY ( a) Type: LD0 [ ]; LD100 [ ]; LD50 [ X]; LDL0 [ ]; Other [ ] Species/ strain: Rabbit Value: 2680 mg/ kg bw. Method: Not described GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) References: Dollahite, J. W. and Rowe, L. D. 1974. The Southwestern Veterinarian. 27: 246 248 ( cited in European Commission 2000, DOSE database, RTECS).

( b) Type: LD0 [ ]; LD100 [ ]; LD50 [ X]; LDL0 [ ]; Other [ ] Species/ strain: Rat Value: 1267, 3236, 3430, and 5200 mg/ kg bw. Method: Using standard methods for rat acute studies. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) Remarks: Results of separate studies reported in cited references. References: 1) European Commission. 2000. Sodium Nitrate. International Uniform Chemical Information Database. Year 2000 CD ROM Edition. 2) Registry of Toxic Effects of Chemical Substances ( RTECS). 1999. Sodium nitrate. National Technical Information Service, Springfield, VA. 30 Sodium Nitrate CAS # 7631 99 4 5.1.2 ACUTE INHALATION TOXICITY Type: LC0 [ ]; LC100 [ ]; LC50 [ ]; LCL0 [ ]; Other [ X] Species/ strain: Dog, sheep Exposure period: 7.5 minutes to 4 hours Value: NOEC ( dog) = 5 mg/ m3 NOEC ( sheep) = 1 mg/ m3 Method: Sodium nitrate solution of 0.1, 0.5, and 1.0% gave aerosol concentrations of 0.9, 5, and 11 mg/ m3. Mongrel dogs weighing 13 to 55 kg were used in the experiments. In the first experiment series, one group of five dogs breathed aerosol generated from 0.1% solution of sodium nitrate. Measurements were made up until 180 minutes after termination of the aerosol exposure. The animals then breathed aerosols of 1% solutions for 7.5 minutes. In a third set of experiments, dogs were exposed to aerosols generated from 0.5% solutions of sodium nitrate administered over a 4 hour period. Conscious sheep were exposed to aerosols generated from 0.1% solutions of sodium nitrate, for 20 minutes. Groups of six sheep were used for these exposures. In another series of experiments, groups of six sheep breathed aerosols generated from a 0.5% solution of sodium nitrate for 4 hours. A control group breathed room air. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) Remarks: The breathing of 1 and 5 mg/ m3 sodium nitrate aerosol for 7.5 minutes did not significantly alter total respiratory resistance, functional residual capacity, lung compliance, specific lung compliance, and specific respiratory conductance in dogs. The breathing of 5 mg/ m3 for 4 h did not effect any cardiopulmonary parameters in dogs. The breathing of 1 and 0.9 mg/ m3 revealed no significant changes in tracheal mucous velocity after 20 m of exposure in sheep. References: Sackner, M. A., Dougherty, R. D., Chapman, G. A., Zarzecki, S., Zarzemski, L., and Schreck, R. 1979. Effects of sodium nitrate aerosol on cardiopulmonary function of dogs, sheep, and man. Environmental Research. 18: 421 436.

5.1.3 ACUTE DERMAL TOXICITY No data available 31 Sodium Nitrate CAS # 7631 99 4 5.1.4 ACUTE TOXICITY BY OTHER ROUTES OF ADMINISTRATION Type: LC0 [ ]; LC100 [ ]; LC50 [ ]; LCL0 [ ]; LD0 [ ]; LD100 [ ]; LD50 [ ]; LDL0 [ ]; Other [ X] Species/ strain: Dogs Route of Administration: i. m. [ ]; i. p. [ ]; i. v. [ X]; Infusion [ ]; s. c. [ ]; Other [ ] Exposure period: 60 minutes Value: NOEC = 100 mg NaNO3 Method: The experiments involved taking measurements after intravenous injection of 1 mg of sodium nitrate into a group of five dogs. Measurements were taken over a 60 minute period. The same experiment was repeated using 10 mg followed by an experiment with 100 mg. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) Remarks: Intravenous injection of 1, 10, and 100 mg sodium nitrate did not significantly affect respiratory resistance, lung compliance, specific lung compliance, pulmonary arterial pressure, systemic arterial pressure, cardiac output, heart rate, stroke volume, and arterial blood gases. References: Sackner, M. A., Dougherty, R. D., Chapman, G. A., Zarzecki, S., Zarzemski, L., and Schreck, R. 1979. Effects of sodium nitrate aerosol on cardiopulmonary function of dogs, sheep, and man. Environmental Research. 18: 421 436.

5.2 CORROSIVENESS/ IRRITATION 5.2.1 SKIN IRRITATION/ CORROSION No data available 5.2.2 EYE IRRITATION/ CORROSION No data available 5.3 SKIN SENSITIZATION No data available 32 Sodium Nitrate CAS # 7631 99 4 5.4 REPEATED DOSE TOXICITY ( a) Species/ strain: Fischer 344 rats Sex: Female [ ]; Male [ ]; Male/ Female [ X]; No Data [ ] Route of Administration: Diet Exposure period: 6 weeks Frequency of treatment: ad libitum Dose: 1.25, 2.5, 5, 10 and 20% Control group: Yes [ X]; No [ ]; No Data [ ] Concurrent no treatment [ X]; Concurrent vehicle [ ]; Historical [ ] Results: It was determined that the maximum tolerated dose of sodium nitrate was 5% in the diet. Method: A total of 240 5 week old rats were divided into groups of ten male and ten female rats. The control group was given basic diet only. All groups were given tap water freely. All animals were observed daily during the experimental period. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate Remarks: This study provided the MTD for a subsequent carcinogenicity study also reported. Sodium nitrite was also tested. References: Maekawa, A., Ogiu, T., Onodera, H., Furuta, K., Matsouka, C., Ohno, Y., and Odashima, S. 1982. Carcinogenicity studies of sodium nitrite and sodium nitrate in F 344 rats. Fd. Chem. Toxic. 20: 5 33.

( b) Species/ Strain: Sprague Dawley rats Sex: Female [ ]; Male [ X]; Male/ Female [ ]; No Data [ ] Route of Administration: Drinking Water Exposure period: 14 months Frequency of treatment: ad libitum Dose: 4,000 mg/ L Control group: Yes [ X]; No [ ]; No Data [ ] Concurrent no treatment [ X]; Concurrent vehicle [ ]; Historical [ ] Results: Nitrate had a moderate effect on plasma vitamin E level and the incidence of pulmonary lesions. No difference in methemoglobin level was observed between the nitrate treated and control animals. Method: Two month old male rats maintained on a commercial diet containing vitamin E were given water that contained either 0, 2,000, or 4,000 mg/ L sodium nitrate. Tail blood samples were collected every other week to measure the level of methemoglobin. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate 33 Sodium Nitrate CAS # 7631 99 4 Remarks: The toxic action of nitrate is generally attributed in part to its transformation to nitrite by the action of certain microbes. In this experiment, animals exposed to nitrite in the drinking water showed a greater effect on methemoglobin levels. Reference: Chow, C. K., Chen, C. J., and Gairola, C. 1980. Effect of nitrate and nitrite in drinking water on rats. Toxicology letters. 6: 199 206.

5.5 GENETIC TOXICITY IN VITRO A. Bacterial Test Type: Bacterial reverse mutation assay ( Ames test) System of testing: Salmonella typhimurium TA92, TA1535, TA100, TA1537, TA94, TA98, TA1530, G46 Concentration: Various Metabolic activation: With [ ]; Without [ ]; With and Without [ X]; No Data [ ] Results: See remarks Method: Standard Ames test GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate Remarks: Results reported from various sources. Results were generally negative under aerobic conditions. In one study under anaerobic conditions, the result was positive, primarily due to reduction of nitrate to nitrite and/ or nitroso compounds. References: 1) European Commission. 2000. Sodium Nitrate. International Uniform Chemical Information Database. Year 2000 CD ROM Edition. 2) Hazardous Substances Database ( HSDB). 1999. Sodium nitrate. National Library of Medicine, Bethesda, MD. 3) Registry of Toxic Effects of Chemical Substances ( RTECS). 1999. Sodium nitrate. National Technical Information Service, Springfield, VA.

B. Non bacterial in vitro test ( a) Type: Chromosome aberration test System of testing: Chinese hamster ovary calls Concentration: 7200 mg/ L Metabolic activation: With [ ]; Without [ ]; With and Without [ ]; No Data [ X] 34 Sodium Nitrate CAS # 7631 99 4 Results: Sodium nitrate tested positive in a chromosome aberration test. The dose that had the maximum effect was 7.2 mg/ mL. Method: A sub line of a Chinese hamster fibroblast cell line was used. The doubling time was estimated at 18.2 h at their exponential growth at 37o in a 5% CO2 atmosphere. Growth inhibition and chromosome aberration tests were performed on the cells. Positive result may be related to reduction of nitrate or nitroso compounds. GLP: Yes [ ] No [ X] ? [ ] Test substance: Sodium nitrate ( NaNO3) Remarks: Twenty two percent had chromatid gaps, chromatid or chromosomal breaks, translocation, or fragmentation. Sodium nitrate was not mutagenic, no conclusion was made regarding its carcinogenicity. References: Ishidate, Jr., M. and Odashima, S. 1977. Chromosome tests with 134 compounds on Chinese hamster cells in vitro   a screening for chemical carcinogens. Mutation Research. 48: 337 354.

5.6 GENETIC TOXICITY IN VIVO ( a) Type: Micronucleus assay Species/ strain: Swiss mice and Wistar rats Sex: Female [ ]; Male [ X]; Male/ Female [ ]; No Data [ ] Route of Administration: Intragastrically Exposure period: Twice in 24 hours Doses: 78.5, 235.5, 706.6 and 2,120 mg NO3/ kg bw. Results: See remarks Genotoxic effects: + ?  [ X] [ ] [ ] Method: Mice 12 14 weeks of age and rats 10 12 weeks of age were housed at 18 19oC. The animals were divided into 5 groups of 10 rats and 8 mice each. The four treatment groups received doses of 78.5, 235.5, 706.6, or 2,120 mg NO3/ kg. Four rats and all mice from each group were intragastrically treated twice, with an interval of 24 hours, with sodium nitrate. For micronuclei evaluation, mice were killed 6 hours after the second administration; for chromosomal aberration analysis, animals were killed 24 h after the second administration. The daily toxic administration was continued for 2 weeks in the other rats. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) Remarks: After acute exposure to nitrate, no significant difference between the frequency of chromosomal aberrations in the exposed and control groups was detected in either rats or mice with the exception of mice receiving a dose 35 Sodium Nitrate CAS # 7631 99 4 of 706.6 mg NO3/ kg. Rats treated for two weeks had significant increases in aberrant metaphases. The frequency of micronucleated polychromatic erythrocytes increased significantly only at the lower doses of nitrate. This occurrence was probably masked at the higher doses by the invasion of the marrow by peripheral blood, which probably indicates a cytotoxic effect of the nitrate in the marrow. References: Luca, D., Raileanu, L., Luca, V., and Duda, R. 1985. Chromosomal aberrations and micronuclei in rat and mouse bone marrow cells by sodium nitrate. Mutation Research. 155: 121 125.

( b) Type: In vivo genotoxicity in mouse germ cells Species/ strain: C3H x 101 male mice Sex: Female [ ]; Male [ X]; Male/ Female [ ]; No Data [ ] Route of Administration: Stomach Intubation Exposure period: 14 days Doses: 600 and 1,200 mg NaNO3/ kg/ day; 60 and 120 mg NaNO2/ kg/ day Results: 1,200 mg NaNO3/ kg/ day was determined as the maximum dose tolerated or the highest dose at which all animals survived. Sex chromosomal univalency and abnormal sperm head frequency were significantly higher at both doses compared to controls. No heritable translocations, sperm abnormalities, or morphological changes were demonstrated in F1 males originating from treated P1 males. Method: Mature F1 male and female mice ( 10 12 weeks old) were used. Animals were exposed to 600 or 1,200 mg NaNO3/ kg/ day or 60 or 120 mg NaNO2/ kg/ day over 14 days. Each treatment group consisted of 25 males. The males were then mated with 2 virgin females. Remarks: At 1,200 mg NaNO3/ kg/ day, there was a reduction in fertility and litter size, but the difference was not statistically significant. References: Alavantic, D., Sunjevaric, I., Pecevski, J., Bozin, D., and Cerovic, G. 1988. In vivo genotoxicity of nitrate and nitrites in germ cells for male mice. I. Evidence for gonadal exposure and lack of heritable effects. Mutation Research. 204: 689 695.

5.7 CARCINOGENICITY ( a) Species/ strain: Fischer 344 rats Sex: Female [ ]; Male [ X]; Male/ Female [ ]; No Data [ ] Route of Administration: Diet Exposure period: 104 weeks 36 Sodium Nitrate CAS # 7631 99 4 Frequency of treatment: ad libitum Post exposure observation period: 21 weeks Doses: 2.5%, 5.0% in the diet Control group: Yes [ X]; No [ ]; No Data [ ] Concurrent no treatment [ ]; Concurrent vehicle [ ]; Historical [ ] Results: No. with tumors ( 0% ; male) = 47 ( 94%) No. with tumors ( 0%; female) = 46 ( 92%) No. with tumors ( 2.5%; male) = 50 ( 100%) No. with tumors ( 2.5%; female) = 43 ( 86%) No. with tumors ( 5%; male) = 48 ( 96%) No. with tumors ( 5%; female) = 39 ( 80%) Method: The rats were housed four to a cage and were maintained at 25oC. Sodium nitrate was administered in the diet. Experiments began when the rats were 8 w old. The animals were divided into groups comprising 50 male and 50 female rats. The experimental groups were given diets containing 2.5% or 5% ( maximum tolerated dose determined from subchronic study) of sodium nitrate ad libitum for 2 years. Rats in the control group were given a basic diet without nitrate. Administration of chemicals was stopped at week 104. Observation was continued until week 123 when all survivors were killed. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) special grade reagent; purity 99.5% Remarks: The incidence of tumors was nearly 100% in all male groups in the nitrate study. There was a reverse doseeffect relationship in the incidence of tumors in the females. In all groups of males, tumors of the testis were the most frequent, followed by those of the mammary gland, adrenal gland, and liver. Tumors of the mammary gland, pituitary gland, uterus, and adrenal gland were those detected most frequently in the female rats. None of the treatment groups showed a significant increase in the incidence of any specific tumor compared with the control. However, there was a significant reduction in the incidence of tumors of the haematopoietic organs in the experimental groups relative to the control. There was no significant difference in the incidence of malignant tumors between experimental and control groups. References: Maekawa, A., Ogiu, T., Onodera, H., Furuta, K., Matsuoka, C., Ohno, Y., and Odashima, S. 1982. Carcinogenicity studies of sodium nitrite and sodium nitrate in F 344 rats. Fd. Chem. Toxic. 22: 25 33. 37 Sodium Nitrate CAS # 7631 99 4 ( b) Remarks: The DOSE database summarizes carcinogenicity studies conducted on sodium nitrate. Male and female rats were exposed orally for 2 years to 0, 0.1, 1.0, 5.0 or 10% sodium nitrate. There was no evidence of significant adverse effects or increase in tumor incidence ( Lehman 1958). In another study, male and female MRC derived rats were exposed orally for 84 wks to 0.0 or 0.5% sodium nitrate and euthanized 20 weeks later. Statistically significant differences in tumor incidence were observed ( Lijinsky et al. 1973). Male and female/ GR mice were exposed orally to 0, 25,000, or 50,000 mg/ kg for their lifespan. No difference in tumor incidence was observed ( Sugiyama et al. 1979). References: 1) Lehman, A. J. Q. 1958. Bull Assoc. Food Drug Off. 22: 136 138. 2) Lijinsky, W. et al. 1973. J. Natl. Cancer Inst. 50: 1061 1063. 3) Sugiyama, K. et al. 1979. Acta Scholae Med. Univ. Gifu. 27: 1 6.

5.8 TOXICITY TO REPRODUCTION Type: Fertility [ ]; One generation study [ X]; Two generation study [ ]; Other [ ] Species/ strain: Beagle dog Sex: Female [ ]; Male [ ]; Male/ Female [ ]; No Data [ X] Route of Administration: Drinking water Exposure period: 16 months Frequency of treatment: continuously in drinking water Doses: 300, 600 and 1,000 mg/ L Control group: Yes [ X]; No [ ]; No Data [ ] Concurrent no treatment [ X]; Concurrent vehicle [ ]; Historical [ ] Results: No indication of significant adverse effect on development, fertilization or hypothyroidism was observed. Method: Beagle dogs were given sodium nitrate continuously in the drinking water for 16 months. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) Remarks: As cited in IUCLID Data Sheet References: Kelley, S. T., et al. 1974. Toxicol. Appl. Pharmcol. 27: 200 203.

5.9 DEVELOPMENTAL TOXICITY/ TERATOGENICITY Species/ strain: Wistar rat, CD 1 mouse, Dutch rabbit, Syrian hamster Sex: Female [ X]; Male [ ]; Male/ Female [ ]; No Data [ ] 38 Sodium Nitrate CAS # 7631 99 4 Route of Administration: Gavage Duration of the test: 14 29 days Exposure period: 6 18 days Frequency of treatment: daily Doses: 2.5 to 400 mg/ kg bw. depending on species Control group: Yes [ X]; No [ ]; No Data [ ] Concurrent no treatment [ X]; Concurrent vehicle [ ]; Historical [ ] Results: Results for the four species were similar. In most cases, no maternal toxicity, fetal toxicity, or teratogenic effects were observed. No significant effects on body weight, fetal malformation, or other parameters was noted. Method: Fifteen to 27 females of various test animals were exposed to sodium nitrate via gavage for up to 29 days. GLP: Yes [ ] No [ ] ? [ X] Test substance: Sodium nitrate ( NaNO3) Remarks: These studies were reported in IUCLID and cited a 1972 NTIS Document ( PB 221 775). References: European Commission. 2000. Sodium Nitrate. International Uniform Chemical Information Database. Year 2000 CD ROM Edition.

5.10 OTHER RELEVANT INFORMATION Type: Metabolism and toxicokinetics Remarks: When ingested, it is readily absorbed from the proximal small intestine and following absorption is rapidly distributed throughout the body in both experimental animals and humans. In rats given oral doses of 55% of ( 15) N labeled compound, it excreted unchanged in the urine and 11% was excreted as urea and ammonia in urine and feces, leaving approximately 35% unaccounted for. In humans given sodium nitrate orally, 65 70% was excreted in the urine; excretion was maximal at approximately 5 hours. and completed with 18 hours. Excretion has been reported to follow first order kinetics with an elimination half life of approximately 5 hours. All data as cited in DOSE database. References: 1) Balish, E. et al. 1981. Banbury Report No. 7 pp. 305 319. 2) Bartholomew, B. A. et al. 1984. Food Chem. Toxicol. 22: 789 795. 3) Green, L. C. et al. 1981. Proc. Natl. Acad. Sci. 78: 7764 7768. 4) Schultz, D. S. et al. 1985. Carcinogenesis. 6: 847 852. 39 Sodium Nitrate CAS # 7631 99 4 5.11 EXPERIENCE WITH HUMAN EXPOSURE Remarks: Nitrate as such does not produce methemoglobinemia. Sodium nitrate is rapidly absorbed and excreted unchanged, causing few reactions other than diuresis and catharsis. Under some circumstances, appreciable amounts of nitrate are converted to nitrite. One example is drinking water from wells that are heavily contaminated with nitrates and coliform bacteria. Methemoglobinemia is particular to children who have not yet developed the HCl in their stomachs. Signs of toxicity following ingestion include dizziness, abdominal cramps, vomiting, bloody diarrhea, a muscular weakness, convulsions, accelerated heart rate, dyspnea and collapse. In severe cases, progressive cyanosis may occur, first visible as a bluish discoloration of the mucus membranes and leading to torpor, coma, and death. Reference: Hazardous Substances Databank ( HSDB). 1999. Sodium nitrate. National Library of Medicine, Bethesda, MD.

6. REFERENCES Adams, A. W. 1974. Effects of nitrate in drinking water of Japanese quail. Poultry Science. 53( 2): 832 834.

Alavantic, D., Sunjevaric, I., Pecevski, J., Bozin, D., and Cerovic, G. 1988. In vivo genotoxicity of nitrate and nitrites in germ cells for male mice. I. Evidence for gonadal exposure and lack of heritable effects. Mutation Research. 204: 689 695.

Anderson, B. G., Andrews, T. F., Chandler, D. G., and Jahoda, W. J. 1948. The Evaluation of Aquatic Invertebrates as Assay Organisms for the Determination of the Toxicity of Industrial Wastes. Report of the Ohio State University Research Foundation to the American Petroleum Institute, New York.

Balish, E. et al. 1981. Banbury Report No. 7 pp. 305 319.

Bartholomew, B. A. et al. 1984. Food Chem. Toxicol. 22: 789 795.

Bringmann, G. and Kuhn, R. 1980. Comparison of the toxicity thresholds of water pollutants to bacteria, algae, and protozoa in the cell multiplication inhibition test. Water Research. 14: 231 241.

Budavari, S. ( ed). 1996. Merck Index. Whitehouse Station: Merck Research Laboratories.; BASF AG.

Chow, C. K., Chen, C. J., and Gairola, C. 1980. Effect of nitrate and nitrite in drinking water on rats. Toxicology letters. 6: 199 206. 40 Sodium Nitrate CAS # 7631 99 4 Dollahite, J. W., and Rowe, L. D. 1974. The Southwestern Veterinarian. 27: 246 248 ( cited in European Commission 1996, DOSE database, RTECS).

Dowden, B. F. and Bennett, H. J. 1965. Toxicity of selected chemicals to certain animals. J. Water Pollut. Control Fed. 37( 9): 1308 1316.

ECDIN 1999. Nitric acid sodium salt. No. 0034349.

Epifanio, C. E. and Srna, R. F. 1975. Toxicity of ammonia, nitrite ion, nitrate ion, and orthophosphate to Mercenaria mercenaria and Crassostrea virginica. Marine Biology 33: 241 246.

European Commission. 2000. Sodium Nitrate. International Uniform Chemical Information Database. Year 2000 CD ROM Edition.

Frakes, T. and Hoff, Jr., F. H. 1982. Effect of high nitrate N on the growth and survival of juvenile and larval anemone fish, Amphiprion ocellaris. Aquaculture. 29: 155 158.

Freeman, L. 1953. A standardized method for determining toxicity of pure compounds to fish. Sewage and Industrial Wastes. 25( 7): 845.

Green, L. C. et al. 1981. Proc. Natl. Acad. Sci. 78: 7764 7768.

Hazardous Substances Data Bank ( HSDB). 1999. Sodium Nitrate. National Library of Medicine, Bethesda, MD.

Ishidate, Jr., M. and Odashima, S. 1977. Chromosome tests with 134 compounds on Chinese hamster cells in vitro   a screening for chemical carcinogens. Mutation Research. 48: 337 354.

Kelley, S. T., et al. 1974. Toxicol. Appl. Pharmcol. 27: 200 203 ( cited in European Commission 1996).

Lehman, A. J. Q. 1958. Bull Assoc. Food Drug Off. 22: 136 138.

Lide, D. R. ( Ed.). 1999. CRC Handbook of Chem. & Physics 12th Ed.

Lijinsky, W. et al. 1973. J. Natl. Cancer Inst. 50: 1061 1063.

Luca, D., Raileanu, L., Luca, V., and Duda, R. 1985. Chromosomal aberrations and micronuclei in rat and mouse bone marrow cells by sodium nitrate. Mutation Research. 155: 121 125.

Maekawa, A., Ogiu, T., Onodera, H., Furuta, K., Matsuoka, C., Ohno, Y., and Odashima, S. 1982. Carcinogenicity studies of sodium nitrite and sodium nitrate in F 344 rats. Fd. Chem. Toxic. 22: 25 33.

Mallinckrodt Baker, Inc. 1999. MSDS: Sodium Nitrate. No. S4442. 41 Sodium Nitrate CAS # 7631 99 4 Muir, P. R., Sutton, D. C., and Owens, L. 1991. Nitrate toxicity to Peneaus monodon protozoea. Marine Biology 108: 67 71.

NIOSH, IPCS, International Chemical Safety Cards (# 0185). Sodium Nitrate.

Registry of Toxic Effects of Chemical Substances ( RTECS). 1999. Sodium nitrate. National Technical Information Service, Springfield, VA.

Sackner, M. A., Dougherty, R. D., Chapman, G. A., Zarzecki, S., Zarzemski, L., and Schreck, R. 1979. Effects of sodium nitrate aerosol on cardiopulmonary function of dogs, sheep, and man. Environmental Research. 18: 421 436.

Sax, I. and Lewis, R. 1994. Dangerous Properties of Industrial Materials. 8th ed. New York: Van Nostrand Reinhold.

Schultz, D. S. et al. 1985. Carcinogenesis. 6: 847 852. Bartholomew, B. A. et al. 1984. Food Chem. Toxicol. 22: 789 795.

Sugiyama, K. et al. 1979. Acta Scholae Med. Univ. Gifu. 27: 1 6.

Trama, F. B. 1954. The acute toxicity of some salts of sodium, potassium and calcium to the common bluegill ( Lepomis macrochirus Rafinesque). Proc. Acad. Nat. Sci. Philadelphia 106: 185 205.

United Nations Industrial Development Organization ( UNIDO) and International Fertilizer Development Center ( IFDC). 1998. Fertilizer Manual. Kluwer Academic Publisher, The Netherlands.

USEPA. 2000. EPISUITE Estimation Program V. 3.10. US Environmental Protection Agency.

Westin, D. T. 1974. Nitrate and nitrite toxicity to salmonoid fishes. The Progressive Fish Culturist. 36( 2): 86 89. Sodium Nitrate CAS # 7631 99 4 APPENDIX A   SIDS Data Availability Summary Sodium Nitrate CAS # 7631 99 4 Explanation of Appendix A Appendix A is a SIDS Data Summary table that provides an overview of availability and quality of the data used in this Health and Environmental Safety Data Summary for Sodium Nitrate. Y ( Yes) and N ( No) designations indicate whether data are available that meet the criteria for each column. The columns are described as:

Information: Data exist that were useful for describing the data element. These data may be from standard laboratory tests or from generally recognized published sources or professional experience.

OECD Study: The data were developed using standard OECD or essentially similar ( e. g., EPA harmonized protocols) guidelines.

GLP: The data were developed under standard Good Laboratory Practice provisions. These generally represent the highest quality data.

Other Study: Studies were conducted that could not be definitively identified as following OECD or GLP protocols. These studies were included when they were determined to be of adequate quality and provided relevant information to the characterization of the compound.

Estimation Method: In some cases, data may be estimated using established structure activity relationships. These methods are common for physical chemical parameters such as octanolwater partition coefficients and water solubility.

Acceptable: This column indicates whether the data are deemed acceptable by standard acceptability criteria and professional judgment. Only the data meeting adequacy standards are included in this summary document.

SIDS Testing Recommended: This column indicates whether additional testing is recommended based on an evaluation of the available data summarized in this document. It is generally not necessary to fill all of the apparent data gaps in order to adequately characterize the inherent hazard of chemicals. Information from other data elements and from other chemicals in the category, along with professional judgment, are useful in the final determination of the need for further testing. Sodium Nitrate CAS # 7631 99 4 SIDS DATA AVAILABILITY SUMMARY DATE: January 27, 2003 Sodium Nitrate CAS No: 7631 99 4 Information OECD Study GLP Other Study Estimated Method Acceptable SIDS Testing Recommended STUDY Y/ N Y/ N Y/ N Y/ N Y/ N Y/ N Y/ N PHYSICAL CHEMICAL DATA 2.1 Melting Point Y N N Y N Y N 2.2 Boiling Point Y N N Y N Y N 2.3 Density Y N N Y N Y N 2.4 Vapor Pressure Y N N N N Y N 2.5 Partition Coefficient Y Y Y N N Y N 2.6 Water Solubility Y N N N N Y N pH and pKa Values Y N N Y N Y N 2.8 Auto Flammability Y N N N N Y N 2.9 Flammability Y N N N N Y N 2.10 Explosive Properties Y N N N N Y N 2.11 Oxidizing Properties Y N N N N Y N 2.12 Oxidation: Reduction Potential Y N N Y N Y N OTHER P/ C STUDIES RECEIVED Y N N Y N Y N ENVIRONMENTAL FATE and PATHWAY 3.1.1 Photodegradation Y N N Y N Y N 3.1.2 Stability in Water Y N N Y N Y N 3.1.3 Stability in Soil Y N N N N Y N 3.2 Monitoring Data N N N N N  N 3.3 Transport and Distribution Y N N N Y Y N 3.5 Biodegradation Y N N Y Y Y N 3.7 Bioaccumulation Y N N N N Y N OTHER ENV FATE STUDIES RECEIVED Y N N Y N Y N ECOTOXICITY 4.1 Acute Toxicity to Fish Y N N Y N Y N 4.2 Acute Toxicity to Daphnia Y N N Y N Y N 4.3 Toxicity to Algae Y N N Y N Y N 4.5.1 Chronic Toxicity to Fish Y N N Y N Y N 4.5.2 Chronic Toxicity to Daphnia N N N N N  N 4.6.1 Toxicity to Soil Dwelling Organisms N N N N N  N 4.6.2 Toxicity to Terrestrial Plants N N N N N  N 4.6.3 Toxicity to Birds Y N N Y N Y N OTHER ECOTOXICITY STUDIES RECEIVED Y N N Y N Y N Sodium Nitrate CAS # 7631 99 4 Sodium Nitrate CAS No: 7631 99 4 Information OECD Study GLP Other Study Estimated Method Acceptable SIDS Testing Recommended STUDY Y/ N Y/ N Y/ N Y/ N Y/ N Y/ N Y/ N TOXICITY 5.1.1 Acute Oral Y N N Y N Y N 5.1.2 Acute Inhalation Y N N Y N Y N 5.1.3 Acute Dermal N N N N N  N 5.1.4 Acute Toxicity by Other Routes of Administration Y N N N Y Y N 5.2.1 Skin Irritation N N N N N  N 5.2.2 Eye Irritation N N N N N  N 5.3 Skin Sensitization N N N N N  N 5.4 Repeated Dose Y N N Y N Y N 5.5 Genetic Toxicity in vitro . Gene mutation Y N N Y N Y N . Chromosomal aberration Y N N Y N Y N 5.6 Genetic Toxicity in vivo Y N N Y N Y N 5.7 Carcinogenicity Y N N Y N Y N 5.8 Reproduction Toxicity Y N N Y N Y N 5.9 Development/ Teratogenicity Y N N Y N Y N 5.11 Human Experience Y N N Y N Y N OTHER TOXICITY STUDIES RECEIVED Y N N Y N Y N Sodium Nitrate CAS # 7631 99 4 APPENDIX B   SIDS Data Summaries for the Nitrate Compounds Category: Ammonium Nitrate, Nitrogen Solutions ( UAN), Potassium Nitrate, Potassium Sodium Nitrate, and Sodium Nitrate SIDS DATA SUMMARIES FOR NITRATES CATEGORY Date: January 27, 2003 Sodium Nitrate CAS # 7631 99 4 Ammonium Nitrate Nitrogen Solution ( UAN)

DATA ELEMENTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS PHYSICAL CHEMICAL DATA 2.1 Melting Point 169.6oC 2.2 Boiling Point 210oC 2.3 Density 1.725 g/ mL at 25oC 2.4 Vapor Pressure 15 hPa at 20oC 2.5 Octanol/ Water Partition Coefficient OECD 107  3.1 at 25oC 2.6A Water Solubility 1,920 g/ L at 20oC 2.6B pH and pKa values pH = 5.43 in aqueous solution 2.7 Flash Point Not applicable 2.8 Auto Flammability Not flammable 2.9 Flammability Not flammable 2.10 Explosive Properties May explode under high temperature or strong shocks 2.11 Oxidizing Properties Strong oxidizer SIDS DATA SUMMARIES FOR NITRATES CATEGORY Date: January 27, 2003 Sodium Nitrate CAS # 7631 99 4 Ammonium Nitrate Nitrogen Solution ( UAN)

DATA ELEMENTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS ENVIRONMENTAL FATE and PATHWAY 3.1.1 Photodegradation Does not photodegrade 3.12 Stability in Water Stable 3.1.3 Stability in Soil Binds to clay particles 3.3 Transport and Distribution 3.3.2 Distribution Calculated,

Fugacity Level III 0.251% to air 45.4% to water 54.2% to soil 0.0757% to sediment 3.5 Biodegradation Readily biodegraded 3.7 Bioaccumulation Does not bioaccumulate SIDS DATA SUMMARIES FOR NITRATES CATEGORY Date: January 27, 2003 Sodium Nitrate CAS # 7631 99 4 Ammonium Nitrate Nitrogen Solution ( UAN)

DATA ELEMENTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS ECOTOXICITY 4.1 Acute toxicity to Fish Cyprinus carpio L. 48 hrs LC50 = 1.15   1.72 mg unionized NH3/ L Oncorhynchus mykiss 96 hrs LC50 > 103 mg/ L Chinook salmon, rainbow trout, bluegill 96 hrs LC50 = 420   1,360 mg NO3/ L Pimephalas promelas 96 hrs LC50 between 100 and 500 mg/ L 4.2 Acute Toxicity to Aquatic Invertebrates Daphnia magna EC50 = 555 mg/ L 4.3 Toxicity to Aquatic Plants ( Algae) Scenedesmus quadricauda EC50 = 83 mg/ L 4.5.2 Chronic Toxicity to Aquatic Invertebrates Bullia digitalis Up to 7 days NOEC = 300 mg/ L 4.6.1 Toxicity to Soil Dwelling Organisms 4.6.2 Toxicity to Terrestrial Plants 4.6.3 Toxicity to Other Non Mammalian Terrestrial Species SIDS DATA SUMMARIES FOR NITRATES CATEGORY Date: January 27, 2003 Sodium Nitrate CAS # 7631 99 4 Ammonium Nitrate Nitrogen Solution ( UAN)

DATA ELEMENTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS TOXICITY 5.1.1 Acute Oral Toxicity Rat OECD 401 LD50 = 2,800 mg/ kg bw Rat OECD 425 LD50 > 2,000 mg/ kg bw Rat OECD 401 LD50 = 2,462 mg/ kg bw Rat OECD 401 LD50 = 2,950 mg/ kg bw Rat LD50 = 4,500 mg/ kg bw 5.1.2 Acute Inhalation Rat 4 hrs LC50 > 88.8 mg/ L 5.1.3 Acute Dermal Toxicity Rat OECD 402 LC50 > 5,000 mg/ kg 5.1.4 Acute Toxicity,

Other Routes White rat Injected; 3 hrs Minimum lethal dose = 0.065 mg NH4NO3   N 5.2.1 Skin Irritation/

Corrosion Rabbit Moderately irritating Rabbit Not irritating 5.2.2 Eye Irritation/ corrosion 5.3 Skin Sensitization 5.4 Repeated Dose Rat Inhalation; 2 weeks NOAEL = 185 mg/ m3 Rat Inhalation; 4 weeks NOAEL = 1 mg/ m3 5.5 Genetic Toxicity in vitro . Gene mutation Salmonella typhimurium Bacterial reverse mutation assay Negative . Chromosomal aberration 5.6 Genetic Toxicity in vivo 5.7 Carcinogenicity SIDS DATA SUMMARIES FOR NITRATES CATEGORY Date: January 27, 2003 Sodium Nitrate CAS # 7631 99 4 Ammonium Nitrate Nitrogen Solution ( UAN)

DATA ELEMENTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS 5.8 Toxicity to Reproduction 5.9 Development Toxicity/ Teratogenicity Rat NOAEL > 57 mg/ kg/ day 51.0 Additional Information No sensory irritation 5.11 Human Experience See text 1.8 Occupational Exposure Limits TLV as inert dust SIDS DATA SUMMARIES FOR NITRATES CATEGORY Date: January 27, 2003 Sodium Nitrate CAS # 7631 99 4 Potassium Nitrate Potassium Sodium Nitrate Sodium Nitrate DATA ELEMENTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS PHYSICAL CHEMICAL DATA 2.1 Melting Point 344oC 308oC; 307oC 2.2 Boiling Point 400oC at 760 mm Hg 380oC at 760 mm Hg 2.3 Density 2.109 g/ mL at 16oC 2.26 g/ cm3 at 20oC 2.4 Vapor Pressure EPISUITE V. 3.10 1.39x10 15 hPa at 25oC Not expected to volatilize 2.5 Octanol/ Water Partition Coefficient EPISUITE V. 3.10  0.79 at 25oC OECD 107  3.8 at 25oC 2.6A Water Solubility 357 g/ L at 25oC 874 g/ L at 20oC 2.6B pH and pKa values pH ~ 7 at 25oC pH = 7 in aqueous solution 2.7 Flash Point Not applicable Not applicable 2.8 Auto Flammability Not flammable Does not burn 2.9 Flammability Not flammable Not flammable 2.10 Explosive Properties May explode on contact with reducing agents and/ or impact. May explode at high temperatures or contact with reducing agents 2.11 Oxidizing Properties Strong oxidizer Strong oxidizer SIDS DATA SUMMARIES FOR NITRATES CATEGORY Date: January 27, 2003 Sodium Nitrate CAS # 7631 99 4 Potassium Nitrate Potassium Sodium Nitrate Sodium Nitrate DATA ELEMENTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS ENVIRONMENTAL FATE and PATHWAY 3.1.1 Photodegradation Does not photodegrade Does not photodegrade Does not photodegrade 3.1.2 Stability in Water Stable Stable 3.1.3 Stability in Soil Stable Binds to clay particles 3.3.2 Distribution Fugacity Level III ( Mackay type) 8.34x10 9 % to air 45.3% to water 54.7% to soil 0.0755% to sediment Fugacity Level III ( Mackay type) 0.001% to air 45.3% to water 54.7% to soil 0.076% to sediment 3.5 Biodegradation Biodegradable Biodegradable 3.7 Bioaccumulation Does not bioaccumulate Does not bioaccumulate SIDS DATA SUMMARIES FOR NITRATES CATEGORY Date: January 27, 2003 Sodium Nitrate CAS # 7631 99 4 Potassium Nitrate Potassium Sodium Nitrate Sodium Nitrate DATA ELEMENTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS ECOTOXICITY 4.1 Acute toxicity to Fish Lepomis macrochirus 96 hrs LC50 = 1,839 mg NO3/ L Oncorhynchus mykiss 96 hrs LC50 > 98.9 mg/ L Lepomis macrochirus 96 hrs LC50 > 8,753 mg NO3/ L Lepomis macrochirus 24 hrs TLm = 9,331 mg NO3/ L Oncorhynchus tshawtscha 96 hrs + TLm ( freshwater,

salmon) = 5,800 mg NO3/ L TLm ( 15 ppt salinity, salmon) =

4,400 mg NO3/ L Salmo gairdneri ( rainbow trout) TLm ( freshwater,

trout) = 6,000 mg NO3/ L TLm ( 15 ppt salinity, trout) =

4,650 mg NO3/ L 4.2 Acute Toxicity to Aquatic Invertebrates Daphnia magna 48 hrs TLm = 300 mg NO3/ L Daphnia magna 48 hrs TLm = 3,581 mg NaNO3/ L Various penaeid shrimp 48 hrs LC50 = 3,400 mg NO3 N/ L NOEC = 2,000 mg NO3 N/ L Penaeus monodon larvae 40 hrs LC50 > 100 mg NO3/ L Crassostrea virginica 96 hrs LC50 = 15,810 mg NO3/ L ( adults);

23,040 mg NO3/ L ( juveniles)

Mercenaria mercenaria 96 hrs LC50 > 19,840 mg NO3/ L ( adults and juveniles)

4.3 Toxicity to Aquatic Plants ( Algae) See text Scenedesmus quadricauda Toxicity threshold = 1,233 mg NO2/ L SIDS DATA SUMMARIES FOR NITRATES CATEGORY Date: January 27, 2003 Sodium Nitrate CAS # 7631 99 4 Potassium Nitrate Potassium Sodium Nitrate Sodium Nitrate DATA ELEMENTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS 4.5.1 Chronic Toxicity to Fish Amphiprion oscellaris 3 months % survival in larvae ( low nitrate system) = 37%

% survival in larvae ( high nitrate system) = 34%

4.5.2 Chronic Toxicity to Aquatic Invertebrates Nereis grubei Neanthes arenaceodentata Dorvilliea articulata Capitella capita TLm = 327 mg NO3/ L TLm = 496 mg NO3/ L TLm = 880 mg NO3/ L TLm = 713 mg NO3/ L Penaeus monodon 3   5 weeks LC50 > 200 mg NO3   N/ L 4.6.3 Toxicity to Other Non Mammalian Terrestrial Species Coturnix coturnix japonica ( Japanese quail) 7 days to 15 weeks LC100 = 5,280 ppm ( by day 3 post treatment)

LC100 = 5,940 ppm ( by day 4 post treatment) SIDS DATA SUMMARIES FOR NITRATES CATEGORY Date: January 27, 2003 Sodium Nitrate CAS # 7631 99 4 Potassium Nitrate Potassium Sodium Nitrate Sodium Nitrate DATA ELEMENTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS TOXICITY 5.1.1 Acute Oral Toxicity Rat LD50 = 3,750 mg/ kg bw Rat OECD 425 LD50 > 2,000 mg/ kg bw Rabbit LD50 = 2,680 mg/ kg bw Rabbit LD50 = 1,166 NO3/ kg Rat LD50 = 1,267,

3,236, 3,430, and 5,200 mg/ kg bw Cow, Sheep Lethal dose ( cow)

= 75 140 mg NO3

N/ kg Lethal dose ( sheep) = 70 mg NO3  N/ kg Goat LD100 = 1,000

1,500 mg/ kg 5.1.2 Acute Inhalation Dog, sheep 7.5 minutes to 4 hrs NOEC ( dog) = 5 mg/ m3 NOEC ( sheep) = 1 mg/ m3 5.1.3 Acute Dermal Toxicity Rat OECD 402 LD50 > 5,000 mg/ kg 5.1.4 Acute Toxicity,

Other Routes Dogs i. v.; 60 minutes NOEC = 100 mg NaNO3 5.4 Repeated Dose Rat OECD 422 NOAEL = 1,500 mg/ kg/ day Rat 6 weeks MTD = 5% in the diet Rat 14 months See text 5.5 Genetic Toxicity in vitro . Gene mutation Salmonella typhimurium Bacterial reverse mutation assay Negative Salmonella typhimurium Bacterial reverse mutations assay Negative Bacillus subtilis recombination assay Negative . Chromosomal aberration Chinese hamster ovary cells Chromosome aberration test Positive SIDS DATA SUMMARIES FOR NITRATES CATEGORY Date: January 27, 2003 Sodium Nitrate CAS # 7631 99 4 Potassium Nitrate Potassium Sodium Nitrate Sodium Nitrate DATA ELEMENTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS SPECIES PROTOCOL RESULTS 5.6 Genetic Toxicity in vivo Rat 10 weeks Negative Swiss mice and Wistar rats Micronucleus assay Positive Mice Mouse germ cells Positive 5.7 Carcinogenicity Rats 104 weeks Not significantly different from controls 5.8 Toxicity to Reproduction Rat OECD 422 NOAEL = 1,500 mg/ kg/ day Beagle dog Two generation study No significant adverse effects Guinea pig One generation study NOAEL Parental =

10,000 ppm NOAEL F1 Offspring = 10,000 ppm Rat Two generation study NOAEL Parental =

2.5%

5.9 Development Toxicity/ Teratogenicity Rat OECD 422 NOAEL = 1,500 mg/ kg/ day Rat, Mouse,

Rabbit,

Syrian hamster No significant adverse effects Mouse Oral; 10 day exposure NOAEL > 400 mg/ kg bw 5.10 Metabolism and Toxicokinetics Readily absorbed and excreted 5.11 Human Experience See text See text 1.8 Occupational Exposure Limits TLV as inert dust 15 mg/ m3 TLV as inert dust 15 mg/ m3 TLV as inert dust 15 mg/ m3