UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

September 14, 2012 

MEMORANDUM 

SUBJECT: Ammonia and Ammonium Sulfate: Human Health Registration Review 

Scoping Document 

PCCode:005302,005601 DP Barcode: 404903,401474 

Decision No.: NA Registration No.: NA 

Petition No.: NA Regulatory Action: Registration Review 

Risk Assess Type: Single Chemical Case No.: 7440, 5073 

TXRNo.:NA 

MRIDNo.: NA 

. FROM . 

THROUGH: 

TO: 

CAS No.: 7664-41-7, 7783-20-2 

40CFR: NA 

Ttmothy C. Dole, CIH, Industna Hygt r""~ I 7 ~6~ 

Jenny Tao, Senior Toxicologist - · 

William Hazel, Ph.D., Senior Cll mist a~~ / 

Risk Assessment and Science Support Bran~t ~s'si3Jf" 

Antimicrobials Division (7 51 OP) 

Timothy 

Risk Assessment 

Leighton, 

and 

Senior 

Science 

Scientist 

Support Branch 

/-~ (RASSB) 

Antimicrobials Division (7510P) /A 

1 

• 

c/(//M! Steve Weiss, Acting Branch Chief 2J~ 

Risk Assessment and Science Support Branch (RASSB) 

Antimicrobials Division (751 OP) 

Rebecca von dem Hagen, Chemical Review Manager 

Regulatory Management Branch II (RMBII) 

Antimicrobials Division (751 OP) 

Page 1 of 11 
EXECUTIVE SUMMARY 

Ammonium sulfate is registered for paper mills and industrial water systems. It is used in 

conjunction with sodium hypochlorite (12.5 percent) in a closed system to produce 

monochloramine. The specified dose on product labels is 1 to 10 ppm available chlorine for both 

initial and subsequent treatments. 

The toxicology database is considered to be adequate for the currently registered uses and no 

additional studies are needed. Toxicity endpoints for ammonium sulfate have not been selected and 

quantitative risk assessments are not warranted. Based on its natural occurrence, being a human 

metabolite, history of safe use as a direct food additive, and due to the absence of adverse effects in 

test animals at high doses, there is no hazard expected from human exposure to ammonium sulfate 

from the registered uses. 

No dietary (food) risks are expected to be associated with the existing uses. The only potentially 

toxic compound resulting in the water system from the uses of ammonium sulfate is chloramine, 

however, any monochloramine not consumed in the water system is expected to degrade under 

the high temperature conditions of the paper drying process ( 110° C) and it is not expected to 

remain in the paper to migrate to food. 

No drinking water risks are expected from the proposed uses of ammonium sulfate. Very low 

levels of chloramine may survive to the point of discharge. EPA has established a maximum 

residual disinfectant level (MRDL) of 4.0 ppm and water utilities are required to maintain total 

chloramines at or below this MRDL. Given this limit, the fact that the maximum application rate 

is 10 ppm (for paper mills) and the fact that most ofthe monochloroamine will be consumed 

during the treatment process, it is highly unlikely that drinking water exposures to chloramine 

will result in risks of concern. 

Occupational exposures are not anticipated to result in any risks of concern for ammonium 

sulfate because ammonium sulfate is of low toxicity and it is handled in a closed system. It is 

also understood that the reaction of ammonium sulfate with the chlorine source is controlled to 

enhance the production of monochloramine, which is non-volatile, while minimizing the 

production of trichloramine, which is volatile. It is recommended that the conditions needed to 

prevent the production of trichloramine be stated on the label. 

Given the above, no toxicology or exposure data will be needed for registration review of 

ammonium sulfate. The Agency does not anticipate the need to conduct a quantitative human 

health risk assessment on ammonium sulfate. 

Page 2 of 11 
1.0 BACKGROUND INFORMATION 

1.1 Product Types 

According to OPPIN, there are two products that list ammonia (PC Code 005302) as the active 

ingredient (ai) and two products that list ammonium sulfate (PC Code 005601) as the ai. These 

products are listed in Table 1. 

Table 1 - Registered Products Containing Ammonia and Ammonium Sulfate 

EPA Reg. Product Company Active Ingredient Listed Active Ingredient 

Number Name Name on Label - Percent A.I. Expressed as Percent A.I. 

Ammonium Sulfate 

9386-49 Fennosurf 586 Kemira Ammonia (total) -7.59% Ammonium Sulfate- 28% 

1706-240 Nalco 60620 Nalco Ammonium Sulfate- 20% Ammonium Sulfate- 20% 

1448-433 Busan 1215 Buckman Ammonia (total) -7.59% Ammonium Sulfate- 28% 

1448-432 BCMW Buckman Ammonia (total) -7.59% Ammonium Sulfate- 28% 

1.2 Summary of Registered Uses 

Ammonium sulfate is registered for paper mill and industrial water system uses as listed in Table 

2. It is used in conjunction with sodium hypochlorite (12.5 percent) in a closed metered 

chemical feed system to produce monochloramine. The treatment can be administered using the 

slug, intermediate or continuous feed methods. The specified dose is 1 to 10 ppm available 

chlorine for both initial and subsequent treatments. 

Table 2 -Ammonium Sulfate Antimicrobial Uses 

Use Application Rate 

_(Available Chlorine) 

Pulp and Paper Mill Water Systems I to 10 ppm 

Industrial Cooling Towers lto5ppm 

Recirculating Cooling Water Systems lto5ppm 

Evaporative Condensers lto5ppm 

Influent water Systems lto5ppm 

Brewery and Food Pasteurizers lto5ppm 

Industrial Fresh Water Systems lto5ppm 

Seawater desalination and reverse osmosis systems lto5ppm 

Paint booth sumps lto5ppm 

Decorative fountains and ponds used for cooling purposes lto5ppm 

Sewage and wastewater systems 1 to 5 ppm 

1.3 Chemical and Physical Properties 

The chemical and physical properties of ammonium sulfate that are relevant for human health 

risk assessment are listed in Table 3. 

Page 3 of 11 
Table 3 - Chemical and Physical Properties of Ammonium Sulfate 

Property Value Reference 

Molecular Formula CNH4)2S04 HSDB 

Molecular Weight 132 gm/mole HSDB 

Physical State Solid HSDB 

Melting Point 280 C (decomposes) HSDB 

Water Solubility 77.6 gm/100 gm H20 at 25 C HSDB 

Vapor Pressure 1 x 10'22 mm Hg at 25 C HSDB 

Henry's Law Constant 5.5 X 10'9 atm-m3

/mole HSDB 

HSDB =Hazardous Substances Database (www.toxnet.nlm.nih.gov) 

2.0 TOXICOLOGY 

When ammonium sulfate was registered, the toxicology databases for ammonium sulfate and 

monochloramine were considered to be adequate and no additional studies were required (EPA, 

2011). No additional studies have been submitted by the registrants or published in the open 

literature. The toxicity information for ammonium sulfate was taken mainly from the OECD 

SIDS Dossier for ammonium sulfate (SIDS, 2004) and is reviewed by the agency in D401626 

(EPA, 2012). The toxicology database for monochloramine has been reviewed previously in 

D386325 (EPA, 2011b) and is discussed below. 

2.1 Acute Toxicity 

The acute toxicity studies indicate that ammonium sulfate is of low acute toxicity (i.e. toxicity 

category III or IV) by all routes of administration and is not a dermal sensitizer. 

2.2 Subchronic and Chronic Toxicity of Ammonium Sulfate 

Inhalation Study in Rats (Pepelko, et al, 1980) 

A 14-day inhalation study on rats is included in the SIDS Dossier for ammonia sulfate. During 

this study, 10 male rats were exposed to an ammonium sulfate aerosol for 8 hours/day at a 

concentration of 300 mg/m3 (count mean particle diameter: 1 - 2 f.!m). Arterial blood gases were 

measured after 1, 3, 7, and 14 days. Pulmonary function tests were performed after 14 days of 

exposure and histological examinations were performed at the end of the exposure period. The 

exposure did not result in any significant changes in lung morphology, lung volumes, and arterial 

blood gases. The histological examinations did not reveal any changes in the trachea, bronchial 

lymph nodes, and lungs and the exposure had no adverse effects on body weight. A NOAEL of 300 

mg/m3 for toxicity to the lower respiratory tract can be deduced from the study. 

Subchronic Oral Study in Rats (Takagi et al, 1999) 

A 13-week oral toxicity study of ammonium sulfate was performed in F344 rats ofboth sexes by 

feeding them a CRF-1 powder diet containing concentrations ofO%, 0.39%, 0.75%, 1.5% and 

3.0% of the substance. Rats were randomly divided into 5 groups each consisting of 10 males 

and 10 females. Male animals in the 3% group exhibited diarrhea during the administration 

period. No changes indicating obvious ammonium sulfate toxicity were observed in the body 

weights, organ weights, hematological, serum biochemical or histopathological examinations. 

Page 4 of 11 
Based on the results, the NOAEL of ammonimn sulfate was judged to be 1.5% of the diet of 

males (866 mg/kg/day) and 3% of females (1975 mg/kg/day). It was also determined that the 

maximmn tolerated dose (to be used in the 2-year carcinogenicity studies) was 3.0% or more in 

the diet. 

Chronic Toxicity/Carcinogenicity Oral Study in Rats (Ota et al, 2006) 

Chronic toxicity and carcinogenicity studies of ammonimn sulfate were performed in male and 

fe~ale Fisher 344 rats at dietary concentrations of 0%, 0.1 %, 0.6% and 3% in a 52 week toxicity 

study and 0%, 1.5% and 3% in a 104 week (2 year) carcinogenicity study. Significant increases 

in kidney and/or liver weights were observed in males and females of the 3.0% diet group, but no 

effects were found on survival rate, body weights, and hematological, sermn biochemistry, or 

histological parameters at any dose levels in the chronic study. Regarding carcinogenicity, no 

significant influence on the incidences of tumors in any of the organs and tissues examined was 

observed. It was concluded that the NOAEL was 0.6% of the diet, which is equivalent to 256 

and 284 mg/kg/day in males and females, respectively, and that the compound is not carcinogenic under the conditions of the study. 

Metabolism 

Absorbed ammonimn ion is transported to the liver and ultimately incorporated in nitrogenous 

waste compounds such as uric acid and urea and excreted in the urine. Ammonimn ion is also an 

endogenous substance that serves a major role in the maintenance of the acid-base balance. 

Minor amounts of ammonimn nitrogen are incorporated in the physiological N-pool. Sulfate is a 

normal intermediate in the metabolism of endogenous sulfur compounds, and is excreted 

unchanged or in conjugated form in urine. 

Mutagenicity 

Ammonimn sulfate was not mutagenic to bacteria (Ames test) and yeasts with or without 

metabolic activation. It did not induce chromosomal aberrations in mammalian or hmnan cell 

cultures. No in vivo genotoxicity tests are available. Based on the negative results from in vitro 

studies and the negative results in the in vivo micronucleus test using ammonimn chloride, 

mutagenic activity of ammonimn sulfate in vivo is unlikely. Similar to other salts, high doses of 

ammonimn sulfate may have the capability oftmnor promotion in the rat stomach; it is, however, 

much less potent than sodimn chloride when tested under identical conditions. 

Reproductive and Developmental Toxicity 

There are no reproductive and developmental toxicity studies for ammonimn sulfate in the 

Agency's hazard database. As ammonimn sulfate dissociates into ammonimn (NH4 +)and 

sulfate (S04-

2

) ions, studies with other ammonimn and sulfate salts, as analogues, available in 

the open literature and unpublished studies were included in the SIDS Dossier (SIDS, 2004) and 

summarized below. 

Reproduction/Developmental Toxicity Screening Study (Fertilizer Institute, 2002) 

This study was performed according to OECD Test Guideline 422. Rats were administered 

diammonimn phosphate at dose levels of 0, 250, 750, and 1500 mg/kg/day by gavage (animals 

were paired 2 weeks after start of treatment). No mortality was reported, and no treatmentrelated signs of clinical toxicity were observed. Some treatment-related effects on hematology 

Page 5 of 11 
parameters were noticed at the mid- and high-dose levels. Body weight gain was reduced 

temporarily in the high-dose group. Banding of the enamel of the incisors of the parent animals 

were observed from the mid-dose group, which was likely due to the inhibiting effect of 

phosphate on mineralization of the teeth. There were no effects on the offspring of parents 

exposed to diarnmonium phosphate. There were no effects on the time to achieve conception 

and pregnancy length. Viability up to day 4 postpartum and macroscopic necropsy showed no 

effect on the pups. The NOAEL for developmental toxicity was determined to be 1500 

mg/kg/day 

One Generation Reproduction Study in Mice (Andres, et al, 1989). 

Female ICR mice were treated with sodium sulfate at doses of 840, 2040, 4320, or 6560 

mg/kg/ day in drinking water from one week prior to breeding until study end (day 21 of second 

parity). No treatment-related effects were found in litter size, litter weaning weights, or 

gestational or lactational weight gain of the dams. However, no fertility indices were measured 

nor were fetuses examined histopathologically. 

Developmental Study in Mice (Seidenberg et al, 1986) 

Aqueous sodium sulfate was administered by gavage to 28 pregnant ICR mice at a single dose of 

2800 mg/kg/day from gestation days 8 through 12. The dose selected was at or near the dose 

level producing overt maternal toxicity in preliminary range-finding studies with non-regnant 

animals. No macroscopic effects or adverse effects on body weight gain were detected in the 

pups, however, the pups were not examined histopathologically and the exposure period was 

short compared to a valid guideline study, therefore the study is oflimited reliability. 

2.3 Subchronic and Chronic Toxicity of Monochloroamine 

Developmental/Reproductive Toxicity 

The developmental and reproductive toxicity of monochloramine has been examined in rats, 

but with suboptimal studies. However, due to the chemical relationship between monochloramine and chlorine, the Agency believes that the reproductive and developmental studies 

for chlorine may be used to satisfy these data gaps for monochloramine. The available 

studies do not indicate concerns for increased sensitivity of the fetus or offspring. 

Reproductive Study in Rats (Carlton et al., 1986) 

Chloramine was administered by gavage in water at doses ofO, 2.5, 5.0 and 10 mg/kg/day to 

male (12/dose group) and female (24/dose group) rats for a total of66-76 days. Males were 

treated for 56 days and females for 14 days prior to mating. Dosing continued during the 1 0-

day mating period and afterward females were dosed with chloramine daily during gestation 

and lactation. Males were necropsied at the end of the mating period. Dams and some 

offspring were necropsied at 21 days after birth. Other offspring were dosed with chloramine 

after weaning until they were 28-40 days old. No statistical differences were observed 

between control and exposed rats in fertility, viability, litter size, day of eye opening or 

average day of vaginal patency. There were no alterations in sperm count, direct progressive 

sperm movement, percent mobility or sperm morphology in adult males. Weights of male 

and female reproductive organs were not significantly different among control and test 

groups, and there were no significant morbid anatomic changes evident on tissue examination. 

There were no signs of toxicity, changes in blood counts, or effects on body weight in adult 

Page 6 ofll 
rats of either sex at any dose level. The mean weight of the pups was not affected by 

chloramine treatment. A NOAEL of 10 mg/kg/day for reproductive effects can be defined 

from this study. 

Developmental Study in Rats (Abdel-Rahman, et al, 1982) 

Monochloramine was administered in the drinking water to female Sprague-Dawley rats 

(6/dose group) at 0, 0.15, 1.5 and 15 mg/kg/day. Treatment did not increase the number of 

fetal resorptions or affect fetal weight nor did it induce soft-tissue anomalies or skeletal 

malformations. The developmental NOAEL is 15 mg mg/kg/day although confidence is low 

due to the small number of animals exposed. 

Mutagenicity/Carcinogenicity 

Monochloramine is not classifiable as to human carcinogenicity (Group D) based on 

inadequate human data and equivocal evidence of carcinogenicity from animal bioassays. A 

two-year bioassay showed marginal increase in mononuclear cell leukemia in female F344/N 

rats. No evidence of carcinogenic activity was reported in male rats or male or female 

B6C3F1 mice. Genotoxicity studies, both in vitro and in vivo, gave negative results. 

Chronic Toxicity (NTP, 2002) 

The long-term effects of chloraminated water were examined in F344/N rats and B6C3F1 

mice. Groups of rats (70/sex/dose) and mice (70/sex/dose) were administered chloraminated 

drinking water at 0 (controls), 50, 100 or 200 ppm for 103-104 weeks. Based on body 

weight and water consumption data provided in the study, the intake of chloramine was 0, 2.6, 

4.8, and 8.7 mg/kg/day for male rats; 0, 3.4, 5.3 and 9.5 mg/kg/day for female rats. Consumption 

of chloramine in mice was 0, 5.0, 8.9, and 15.9 mg/kg/day for males; and 0, 4.9, 9.0, and 17.2 

mg/kg/day for females. Interim sacrifices (1 0/sex/dose) were conducted at weeks 14 and 66. In 

both species, there were no statistically significant findings attributable to chemical exposure at 

the highest dose tested of200 ppm. Based on the study results, the NOAEL was determined to 

be 200 ppm, or 9.5 mg chloramines/kg/day for rats and 17.2 mg chloramines/kg/day for mice. 

3.0 DIETARY ASSESSMENT 

3.1 Dietary Exposure 

Dietary exposures to ammonium sulfate and monochloroamine were evaluated in D391302 

(EPA, 2011a) which was written for the registration of ammonium sulfate as Nalco 60620. 

Ammonium sulfate products are mixed on site with sodium hypochlorite to form monochloramine which is used as a slimicide in paper and paperboard water systems at a residual 

chlorine level of 1-10 ppm. Treated paper and paperboard may be used for food contact. 

Ammonium sulfate has low acute toxicity. Longer term mammalian dosing studies resulted in 

such low toxicity that toxicity endpoints could not be selected. The only potentially toxic 

compound resulting from ammonium sulfate uses in the water system is monochloramine. Any 

monochloramine not consumed in the water system is expected to degrade under the high 

temperature conditions of the paper drying process (11 0 °C). Although only limited toxicity data 

are available on monochloramine, it is not expected to remain in the paper to migrate to food. 

The chemical species likely to remain to be incorporated into the dried/finished paper and 

Page 7 ofll 
paperboard are ammonium ion, sulfate ion, nitrate ion, and chloride ion for which there are no 

dietary toxicity concerns. It is only these benign compounds that could potentially migrate into 

food from food-contact paper or paperboard. Therefore, no dietary (food) risks are expected to be 

associated with the proposed uses and a dietary risk assessment is not anticipated for this 

registration review. 

3.2 Drinking Water Exposure 

No drinking water risks are expected from the proposed uses of ammonium sulfate. Very low 

levels of monochloramine may survive to the point of discharge. EPA has established a 

maximum residual disinfectant level (MRDL) of 4.0 ppm and water utilities are required to 

maintain total chloramines at or below this MRDL. Given this limit, the fact that the maximum 

application rate is 10 ppm (for paper mills) and the fact that most ofthe monochloramine will be 

consumed during the treatment process, it is highly unlikely that drinking water exposures to 

monochloramine will result in risks of concern. 

4.0 OCCUPATIONAL AND RESIDENTIAL EXPOSURES 

Occupational exposures to ammonium sulfate and monochloroamine were evaluated in 

D391275 (EPA, 2011c) which was written for the registration of ammonium sulfate as Nalco 

60620. The Agency determined that exposures were not anticipated to result in any risks of 

concern for ammonium sulfate because ammonium sulfate is of low toxicity and it is handled in 

a closed system. It was also anticipated that the reaction of ammonium sulfate with sodium 

hypochlorite would be controlled to enhance the production of monochloramine, which is nonvolatile, while minimizing the production of trichloramine, which is volatile. It was 

recommended that the conditions needed to prevent the production of trichloramine be stated on 

the label. 

Residential exposures are not anticipated for ammonium sulfate and monochloroamine because 

these products are only used in industrial areas. 

5.0 AGGREGATE AND CUMULATIVE EXPOSURE 

As there are no dietary (food or drinking water) or residential exposures associated with the 

currently registered uses of ammonium sulfate there is no need to estimate aggregate risks. 

As discussed in D391302 (EPA, 2011a), it was assumed that, for the purposes of the section 3 

registration action, that ammonium sulfate does not have a common mechanism of toxicity with 

other substances largely because it elicits no adverse effects in mammals. No new data have 

become available that would change that assumption. 

6.0 INCIDENTS 

There are nine human exposure incidents in the OPP incident database that are associated with 

ammonia or ammonium sulfate. All of these incidents are classified as minor (HD). One of 

Page 8 ofll 
these incidents involves hand exposure to a spray adjuvant inert product, two involve foreign 

products that are not registered in the U.S. and six involve a currently registered antimicrobial 

product. No other information is included in the incident reports. 

7.0 TOLERANCES 

Residues of ammonium sulfate are exempted from the requirement of a tolerance when used as a 

solid diluent or carrier in accordance with good agricultural practices as inert (or occasionally 

active) ingredients in pesticide formulations applied to growing crops or to raw agricultural 

commodities after harvest (40 CFR 180.910). 

8.0 ENDOCRINE DISRUPTION EFFECTS 

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. A human health risk assessment identifying the most sensitive endpoints has 

not been conducted for the ammonia/ammonium sulfate case. As required by FFDCA section 

408(p), ammonia/ammonium sulfate is subject to the endocrine screening part of the Endocrine 

Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate." The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, ofthe Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. Under FFDCA 

section 408(p ), the Agency must screen all pesticide chemicals. Between October 2009 and 

February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which 

contains 58 pesticide active ingredients and 9 inert ingredients. Ammonium sulfate is not 

among the group of 58 pesticide active ingredients on the initial list to be screened under the 

EDSP. For further information on the status of the EDSP, the policies and procedures, the list of 

67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website: http:/ /www.epa.gov/endo/. 

Page 9 of 11 
9.0 ANTICIPATED DATA NEEDS 

9.1 Toxicology Studies 

No additional studies are needed to assess the hazards of ammonium sulfate or monochloramine. 

9.2 Exposure Studies 

No dietary or occupational and residential exposure studies are needed to assess the 

antimicrobial uses of ammonium sulfate. 

10.0 REFERENCES 

Abdel-Rahman et al, 1982. Effect of chlorine and monochloramine in drinking water on the 

developing rat fetus. Journal Applied Toxicology 2(3):156-9. (MRID 48865601) 

Andres CJ, Cline TR (1989). Influence of sulfate in drinking water on mouse reproduction 

during two parities. Journal Animal Science 67, 1313-1317. (MRID 48865607) 

BASF AG, 1989. Department of Toxicology. Unpublished report (88/736). 26 June 1989. (Cited 

in SIDS, 2004) 

Carlton et al, 1986. Reproductive Effects of Alternate Disinfectants. Environmental Health 

Perspectives 69:237-41. (MRID 48865602) 

Fertilizer Institute, 2002. Unpublished data. DAP 4-Week General Toxicity and 

Reproductive/Developmental Toxicity Screening Test. WBG 001/022948. 20 November 2002 

Litton Bionetics, 1975. Mutagenic evaluation of compound FDA 73-42: Ammonium sulfate 

granular food grade. Submitted to the US Food and Drug Administration, 30 June 1975. 

National Technical Information Service PB 245-506. 

NTP, 1992. Toxicology and Carcinogenesis Studies ofChlorinated and Chloraminated Water 

(CAS Nos. 7782-50-5, 7681-52-9 and 10599-90-3) in F344/N Rats and B6C3F1 Mice 

(drinking water studies), NTP TR 392, National Toxicology Program, National Institutes of 

Health. 1992 

Ota et al, 2006. Ota Y, Hasumura M, and Okamura M, Chronic toxicity and carcinogenicity of 

dietary administered ammonium sulfate in F344 rats. Food Chern Toxicology. 2006 

Jan;44(1):17-27. (MRID 48834401) 

Pepelko et al, 1980. Toxicology of ammonium sulfate in the lung. Bulletin Environmental 

Contamination Toxicology. 24, 156-160. (Cited in SIDS, 2004) 

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Seidenberg et al, 1986. Validation of an in Vivo Developmental Toxicity Screen in the Mouse. 

Teratogenesis, Carcinogenesis, and Mutagenesis 6, 361-374. (MRID 48865608- Cited in SIDS, 

2004) 

SIDS, 2004. OECD SIDS Initial Assessment Report for SIAM 19 Ammonium Sulfate. BMU 

(Bundesministerium fiir Umwelt, Naturschutz und Reaktorsicherheit), 19-22 October 2004. 

Takagi et al, 1999. 13-week subchronic oral toxicity study of ammonium sulfate in rats 

[Abstract; article in Japanese]. Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku 

1999;(117):108-14. (MRID 48865603- Cited in SIDS, 2004) 

U.S. Environmental Protection Agency, 1987. Recommendations for and Documentation of 

Biological Values for Use in Risk Assessment. Prepared by the Environmental Criteria and 

Assessment Office, Office of Health and Environmental Assessment, Cincinnati OH for the 

Office of Solid Waste and Emergency Response, Washington, DC. EPA/600/6-87/008. NTIS 

PB88-179874/AS. 

US EPA, 2005. Integrated Risk Information System for Monochloramine. 

http :/www. epa. gov /iris/subst/0644 .htrn. 

US EPA, 2011 a. Nalco Co. Proposed Registration ofNalco 60620 Slimicide Containing 

Ammonium Sulfate for Use in Paper and Paperboard Water Systems: Ecological and Human 

Health Risk Assessments, D391302, 6/29/11. 

US EPA, 2011b. Hazard Assessment of Ammonium Sulfate (Part 1) and Monochloramine (Part 

2). D386325, 4/19/11. 

US EPA, 2011 c. Occupational Exposure Assessment for the Proposed Use of Ammonium Sulfate 

as Nalco 60620 in Pulp and Paper Mill Water Systems. D391275. 6/29/11 

US EPA, 2012. Ammonium Sulfate: Summary of Mammalian Toxicology Data for the Registration 

Review Scoping Document. D401626. 

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