Asulam (CASRN 3337-71-1)
view QuickView
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 First 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, 2-Generation Rhone-Poulenc, 1981a |
NOEL: None LEL: 1000 ppm (50 |
1000
|
1
|
5E-2
mg/kg/day |
*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 Studies/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
Database — 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
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 Asulam conducted in November 2001 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).
_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.
_III.
[reserved]
_IV. [reserved]
_V. [reserved]
_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 |
08/01/1995 | I.A., I.A.6. | EPA's RfD/RfC and CRAVE workgroups were discontinued in May, 1995. Chemical substance reviews that were not completed by September 1995 were taken out of IRIS review. The IRIS Pilot Program replaced the workgroup functions beginning in September, 1995. |
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. |
_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