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Ammonium sulfamate (CASRN 7773-06-0)

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0007

Ammonium sulfamate; CASRN 7773-06-0

Health assessment information on a chemical substance is included in IRIS only after a comprehensive review of chronic toxicity data by U.S. EPA health scientists from several Program Offices and the Office of Research and Development. The summaries presented in Sections I and II represent a consensus reached in the review process. Background information and explanations of the methods used to derive the values given in IRIS are provided in the Background Documents.

STATUS OF DATA FOR Ammonium sulfamate

File First On-Line 01/31/1987

Category (section)
Status
Last Revised
Oral RfD Assessment (I.A.) on-line 03/01/1991
Inhalation RfC Assessment (I.B.) no data  
Carcinogenicity Assessment (II.) no data  

_I.  Chronic Health Hazard Assessments for Noncarcinogenic Effects

_I.A. Reference Dose for Chronic Oral Exposure (RfD)

Substance Name — Ammonium sulfamate
CASRN — 7773-06-0
Last Revised — 03/01/1991

The oral Reference Dose (RfD) is based on the assumption that thresholds exist for certain toxic effects such as cellular necrosis. It is expressed in units of mg/kg-day. In general, the RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime. Please refer to the Background Document for an elaboration of these concepts. RfDs can also be derived for the noncarcinogenic health effects of substances that are also carcinogens. Therefore, it is essential to refer to other sources of information concerning the carcinogenicity of this substance. If the U.S. EPA has evaluated this substance for potential human carcinogenicity, a summary of that evaluation will be contained in Section II of this file.

__I.A.1. Oral RfD Summary

Critical Effect
Experimental Doses*
UF
MF
RfD
Decrease in body
weights

90-Day Rat Feeding
Study

Gupta et al., 1979

NOEL: 214.3 mg/kg/day

LEL: 428.6 mg/kg/day 
1000
1
2E-1
mg/kg/day

*Conversion Factors: Actual dose tested x 6/7 (6 days/week)

__I.A.2. Principal and Supporting Studies (Oral RfD)

Gupta, B.N., R.N. Khanna and K.K. Datta. 1979. Toxicological studies of ammonium sulfamate in rat after repeated oral administration. Toxicology. 13(1): 45-49.

Rats were administered ammonium sulfamate 6 days/week for 90 days at the following dose levels: 0 (group 1), 100 (group 2), 250 (group 3) and 500 mg/kg/day (group 4) [Dose Conversion: 85.7, 214.3, and 428.6). No adverse effects were observed in respect of appearance, behavior or survival of animals. No significant difference in the body weights of rats was observed except in case of adult rats (group 4) where the body weight was significantly less than the controls after the end of 60 days. Results included gradually reduced food intake and increased water intake. No significant change in relative organ weights were noticed in all groups of rats.

__I.A.3. Uncertainty and Modifying Factors (Oral RfD)

UF — An uncertainty factor of 100 was to account for the inter- and intraspecies differences. An additional UF of 10 was used to account for the fact that the most sensitive toxicological endpoint has not been determined; i.e. the lack of chronic exposure studies.

MF — None

__I.A.4. Additional Studies/Comments (Oral RfD)

Data Considered for Establishing the RfD

1) 90-Day Feeding - rat: Principal study - see previous description; no core grade

2) 3-Generation Reproduction - rat: Reproduction NOEL=500 ppm (25 mg/kg/day); no core grade (du Pont, 1966)

3) 105-Day Feeding - rat: NOEL=10,000 ppm (500 mg/kg/day) (1%); LEL=20,000 ppm (1000 mg/kg/day) (inhibited growth weights and induced a slight cathartic action); no core grade (Rosen et al., 1965)

4) 6-Day Feeding - dog: Dogs fed 1 g of test material for 6 days; No systemic effects were observed: no core grade (Ambrose, 1943)

Data Gap(s): Chronic Rat Feeding Study; Chronic Dog Feeding Study; Rat Teratology Study; Rabbit Teratology

__I.A.5. Confidence in the Oral RfD

Study — Medium
Database — Low
RfD — Low

The critical study is of fair quality and is given a medium confidence rating. Since there are major data gaps existing for ammonium sulfamate, the database is given a low confidence rating. Low confidence in the RfD follows.

__I.A.6. EPA Documentation and Review of the Oral RfD

Pesticide Registration Files

Agency Work Group Review — 06/24/1986, 07/20/1988

Verification Date — 07/20/1988

Screening-Level Literature Review Findings — A screening-level review conducted by an EPA contractor of the more recent toxicology literature pertinent to the RfD for Ammonium sulfamate conducted in September 2002 did not identify any critical new studies. IRIS users who know of important new studies may provide that information to the IRIS Hotline at hotline.iris@epa.gov or (202)566-1676.

__I.A.7. EPA Contacts (Oral RfD)

Please contact the IRIS Hotline for all questions concerning this assessment or IRIS, in general, at (202)566-1676 (phone), (202)566-1749 (FAX) or hotline.iris@epa.gov (internet address).

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_I.B. Reference Concentration for Chronic Inhalation Exposure (RfC)

Substance Name — Ammonium sulfamate
CASRN — 7773-06-0

Not available at this time.

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_II.  Carcinogenicity Assessment for Lifetime Exposure

Substance Name — Ammonium sulfamate
CASRN — 7773-06-0

This substance/agent has not undergone a complete evaluation and determination under US EPA's IRIS program for evidence of human carcinogenic potential.

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_III.  [reserved]
_IV.  [reserved]
_V.  [reserved]

_VI.  Bibliography

Substance Name — Ammonium sulfamate
CASRN — 7773-06-0
Last Revised — 03/01/1991

_VI.A. Oral RfD References

Ambrose, A.M. 1943. Studies on the physiological effects of sulfamic acid and ammonium sulfamate. J. Ind. Hyg. Toxicol. 25(1): 26-28.

E.I. du Pont de Nemours & Company, Inc. 1966. MRID No. 00092903, 00143472, 00145269. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Gupta, B.N., R.N. Khanna and K.K. Datta. 1979. Toxicological studies of ammonium sulfamate in rat after repeated oral administration. Toxicology. 13(1): 45-49.

Rosen, D.E., C.J. Krister, H. Sherman, E.F. Stula. 1965. Toxicity studies on ammonium sulfamate. The Toxicologist. Fourth Ann. Meeting Society of Toxicology, Williamsburg, Va. March 8-10.

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_VI.B. Inhalation RfC References

None

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_VI.C. Carcinogenicity Assessment References

None

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_VII.  Revision History

Substance Name — Ammonium sulfamate
CASRN — 7773-06-0

Date
Section
Description
03/01/1988 I.A.1. Critical effect identified, LOAEL specified
03/01/1988 I.A.2. Principal study citation corrected
03/01/1988 I.A.2. Text revised
12/01/1988 I.A. Withdrawn; new RfD verified (in preparation)
01/01/1989 I.A. Oral RfD summary replaced; RfD changed
03/01/1991 I.A.4. Citations added
03/01/1991 III.A. Health Advisory on-line
03/01/1991 VI. Bibliography on-line
06/01/1991 III.A.4. 70-kg 'child' corrected to 70-kg adult in assumptions
01/01/1992 IV. Regulatory actions updated
04/01/1997 III., IV., V. Drinking Water Health Advisories, EPA Regulatory Actions, and Supplementary Data were removed from IRIS on or before April 1997. IRIS users were directed to the appropriate EPA Program Offices for this information.
12/03/2002 I.A.6. Screening-Level Literature Review Findings message has been added.

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_VIII.  Synonyms

Substance Name — Ammonium sulfamate
CASRN — 7773-06-0
Last Revised — 01/31/1987

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