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Asulam
CASRN 3337-71-1
Contents
0284
Asulam; CASRN 3337-71-1
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 Asulam
File On-Line 06/30/1988
Category (section) Status Last Revised
----------------------------------------- -------- ------------
Oral RfD Assessment (I.A.) on-line 01/01/1995
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 -- Asulam
CASRN -- 3337-71-1
Last Revised -- 01/01/1995
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.
NOTE: The Oral RfD for asulam may change in the near future pending the
outcome of a further review now being conducted by the RfD/RfC Work Group.
___I.A.1. ORAL RfD SUMMARY
Critical Effect Experimental Doses* UF MF RfD
-------------------- ----------------------- ----- --- ---------
Lower ovarian weight, NOEL: None 1000 1 5E-2
lower liver/body mg/kg/day
weight LEL: 1000 ppm (50
mg/kg/day)
2-Generation
Reproduction Rat
Study
Rhone-Poulenc, 1981a
*Conversion Factors: none
___I.A.2. PRINCIPAL AND SUPPORTING STUDIES (ORAL RfD)
Rhone-Poulenc Chemical Company. 1981a. MRID No. 00098540. Available from
EPA. Write to FOI, EPA, Washington, DC 20460.
Asulam was administered to Charles River CD rats at levels of 0, 1000, 5000,
and 25,000 ppm (equivalent to 50, 250, and 1250 mg/kg/day). The systemic NOEL
was less than 1000 ppm. Effects noted in F1 female organ weights were: mean
ovarian weight significantly lower at 25,000 ppm as compared with controls;
mean absolute liver weight lower at 25,000 ppm; and mean relative weight
significantly lower than controls at 1000, 5000, and 25,000 ppm. The
reproductive NOEL was 1000 ppm. Fewer live births per litter were noted at
5000 and 25,000 ppm. There was a slightly lower fertility index in the F1
parents at 5000 and 25,000 ppm. The developmental NOEL was greater than
25,000 ppm. No abnormalities related to test substance were noted.
___I.A.3. UNCERTAINTY AND MODIFYING FACTORS (ORAL RfD)
UF -- An uncertainty factor of 100 was used to account for the inter- and
intraspecies differences. An additional UF of 10 was used to account for the
lack of an established systemic NOEL in the rat reproduction study.
MF -- None
___I.A.4. ADDITIONAL COMMENTS (ORAL RfD)
Upon submission of additional information, the 6-month dog study maybe
upgraded to core minimum and considered acceptable to fulfill the chronic and
subchronic nonrodent feeding data gaps.
Data Considered for Establishing the RfD:
1) 2-Generation Reproduction - rat: Principal study - see previous
description; core grade minimum
2) 107-108 Week Feeding (oncogenic) - rat: Systemic NOEL=1000 ppm (36
mg/kg/day); Systemic LEL=5000 ppm (180 mg/kg/day) (hyperplasia of thyroid
follicles and adrenal medulla); core grade minimum (Rhone-Poulenc, 1981b)
3) 6-Month Feeding - dog: NOEL=60 mg/kg/day; LEL=300 mg/kg/day (increased
mean absolute thyroid weights in females; in males and females at 1500
mg/kg/day); core grade supplementary (information missing) (Rhone-Poulenc,
1981c)
4) Developmental toxicity - rat: Maternal and Developmental NOEL=1500
mg/kg/day; core grade minimum (Rhone-Poulenc, 1981d)
5) Developmental toxicity - rabbits: Maternal and Developmental NOEL=750
mg/kg/day; [Severe weight loss (>20%) and mortality at 1500 mg/kg/day early in
the study caused the high dose (1500 mg/kg/day) to be lowered to 750
mg/kg/day]; core grade minimum (Rhone-Poulenc, 1981e)
Other Data Reviewed:
1) 18-Month (oncogenic) - mice: Systemic NOEL=none; LEL=214 mg/kg/day
(hyperkeratosis of skin and subcutis); core grade minimum (Rhone-Poulenc,
1981f)
Data Gap(s): Chronic Nonrodent Feeding Study; Subchronic Rodent and Nonrodent
Feeding Study
___I.A.5. CONFIDENCE IN THE ORAL RfD
Study -- Medium
Data Base -- Medium
RfD -- Medium
The critical study is of adequate quality and is given a medium confidence
rating. Additional studies are also of adequate quality; therefore, the data
base is given a medium confidence rating. Medium confidence in the RfD
follows.
___I.A.6. EPA DOCUMENTATION AND REVIEW OF THE ORAL RfD
Source Document -- This assessment is not presented in any existing U.S. EPA
document.
Other EPA Documentation -- Pesticide Registration Standard, August 1987;
Pesticide Registration Files
Agency Work Group Review -- 08/12/1987, 12/08/1994
Verification Date -- 08/12/1987
___I.A.7. EPA CONTACTS (ORAL RfD)
Please contact the Risk Information Hotline for all questions concerning this
assessment or IRIS, in general, at (513)569-7254 (phone), (513)569-7159 (FAX)
or RIH.IRIS@EPAMAIL.EPA.GOV (internet address).
__I.B. REFERENCE CONCENTRATION FOR CHRONIC INHALATION EXPOSURE (RfC)
Substance Name -- Asulam
CASRN -- 3337-71-1
Not available at this time.
_II. CARCINOGENICITY ASSESSMENT FOR LIFETIME EXPOSURE
Substance Name -- Asulam
CASRN -- 3337-71-1
This substance/agent has not undergone a complete evaluation and determination
under US EPA's IRIS program for evidence of human carcinogenic potential.
_VI. BIBLIOGRAPHY
Substance Name -- Asulam
CASRN -- 3337-71-1
Last Revised -- 11/01/1989
__VI.A. ORAL RfD REFERENCES
Rhone-Poulenc Chemical Company. 1981a. MRID No. 00098540. Available from
EPA. Write to FOI, EPA, Washington, DC 20460.
Rhone-Poulenc Chemical Company. 1981b. MRID No. 00098543, 00134021.
Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Rhone-Poulenc Chemical Company. 1981c. MRID No. 00098536, 40977601.
Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Rhone-Poulenc Chemical Company. 1981d. MRID No. 00098538. Available from
EPA. Write to FOI, EPA, Washington, DC 20460.
Rhone-Poulenc Chemical Company. 1981e. MRID No. 00098539. Available from
EPA. Write to FOI, EPA, Washington, DC 20460.
Rhone-Poulenc Chemical Company. 1981f. MRID No. 00081183. Available from
EPA. Write to FOI, EPA, Washington, DC 20460.
__VI.B. INHALATION RfD REFERENCES
None
__VI.C. CARCINOGENICITY ASSESSMENT REFERENCES
None
_VII. REVISION HISTORY
Substance Name -- Asulam
CASRN -- 3337-71-1
-------- -------- --------------------------------------------------------
Date Section Description
-------- -------- --------------------------------------------------------
11/01/1989 VI. Bibliography on-line
01/01/1992 IV. Regulatory Action section on-line
01/01/1995 I.A. Oral RfD noted as pending change
01/01/1995 I.A.6. Work group review date added
VIII. SYNONYMS
Substance Name -- Asulam
CASRN -- 3337-71-1
Last Revised -- 06/30/1988
3337-71-1
4-AMINO-BENZOLSULFONYL-METHYLCARBAMAT
ASILAN
Asulam
ASULFOX F
ASULOX 40
CARBAMIC ACID, SULFANILYL-, METHYL ESTER
JONNIX
MB 9057
METHYL 4-AMINOBEN- ZENESULPHONYL CARBAMATE
METHYL ((4-AMINOPHENYL)SULFONYL)CARBAMATE
METHYL 4-AMINOPHENYLSULPHONYL CARBAMATE
METHYL N-(4-AMINOBENZENESULFONYL)CARBAMATE
METHYL SULFANILYL CARBAMATE
Last updated: 5 May 1998
URL: http://www.epa.gov/iris/SUBST/0284.HTM
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