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Carbofuran (CASRN 1563-66-2)

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0218

Carbofuran; CASRN 1563-66-2

Human health assessment information on a chemical substance is included in the IRIS database only after a comprehensive review of toxicity data, as outlined in the IRIS assessment development process. Sections I (Health Hazard Assessments for Noncarcinogenic Effects) and II (Carcinogenicity Assessment for Lifetime Exposure) present the conclusions that were reached during the assessment development process. Supporting information and explanations of the methods used to derive the values given in IRIS are provided in the guidance documents located on the IRIS website.

STATUS OF DATA FOR Carbofuran

File First On-Line 09/30/1987

Category (section)
Status
Last Revised
Oral RfD Assessment (I.A.) on-line 09/30/1987
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 — Carbofuran
CASRN — 1563-66-2
Last Revised — 09/30/1987

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

RBC and plasma
cholinesterase
inhibition, and
testicular and uterine
effects

One-Year Dog Feeding
Study

FMC Corp., 1983

NOEL: 0.5 mg/kg/day

LEL: 12.5 mg/kg/day

100
1
5E-3
mg/kg/day

*Conversion Factors: none

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

FMC Corporation. 1983. MRID No. 00129507. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Six beagle dogs of each sex were fed 0, 0.25, 0.50, and 12.5 mg/kg/day carbofuran for 1 year. The following results were noted: 1) decreased plasma and RBC AChE depression throughout the year in both sexes at 12.5 mg/kg/day; 2) no change in food consumption and body weight; 3) changes in clinical chemistry (decreases in protein, calcium, and sodium levels, and lowered hematocrit, hemoglobin, and RBC at 12.5 mg/kg/day); 4) histopathology showed testicular seminiferous tubule degeneration, giant cell formation, and aspermia at 12.5 mg/kg/day; and 5) uterine hyperplasia and hydrometra at 12.5 mg/kg/day.

An RfD of 5E-3 mg/kg/day (UF=10) can also be derived from human data that indicate a possible NOEL of 0.05 mg/kg/day for cholinesterase inhibition. This study was not chosen as the principal study because of severe deficiencies, short duration, and inappropriate route of exposure. However, the human data suggest that the RfD based on the dog study is in the right range.

__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.

MF — None

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

Data Considered for Establishing the RfD:

1) 1-Year Feeding - dog: Principal study - see previous description; core grade minimum

2) 2-Year Feeding (oncogenic) - rat: Systemic NOEL=1 mg/kg/day; Systemic LEL=5 mg/kg/day; core grade minimum (FMC Corp., 1979a)

3) 3-Generation Reproduction - rat: NOEL=1.0 mg/kg/day; LEL=5 mg/kg/day; core grade minimum (FMC Corp., 1979b)

4) Teratology - rat: Fetotoxic NOEL=1.0 mg/kg/day; Fetotoxic LEL=3 mg/kg/day (reduced body weight); core grade minimum (FMC Corp., 1981a)

5) Teratology - rabbit: Fetotoxic NOEL=2.0 mg/kg/day (HDT); Fetotoxic LEL=none; core grade minimum (FMC Corp., 1981b)

Other Data Reviewed:

1) 2-Year Feeding (oncogenic) - mice: Systemic NOEL=18.75 mg/kg/day; ChE NOEL=3 mg/kg/day; core grade guideline (FMC Corp., 1980)

2) Acute Oral - human: Approximate NOEL=0.05 mg/kg/day (ChE inhibition); core grade supplementary; insufficient study (FMC Corp., 1976)

Data Gap(s): None

__I.A.5. Confidence in the Oral RfD

Study — High
Database — High
RfD — High

The principal study appears to be of good quality and is given a high confidence rating. The supporting database is also of high quality and, therefore, is given a high confidence rating. High confidence in the RfD follows.

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

Pesticide Registration Files

Agency Work Group Review — 03/ll/86, 03/18/1987

Verification Date — 03/18/1987

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 Carbofuran 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 — Carbofuran
CASRN — 1563-66-2

Not available at this time.

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_II.  Carcinogenicity Assessment for Lifetime Exposure

Substance Name — Carbofuran
CASRN — 1563-66-2

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 — Carbofuran
CASRN — 1563-66-2
Last Revised — 11/01/1989

_VI.A. Oral RfD References

FMC Corporation. 1976. MRID No. 00092826. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

FMC Corporation. 1979a. MRID No. 00030498. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

FMC Corporation. 1979b. MRID No. 00030514, 00030570, 00043747. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

FMC Corporation. 1980. MRID No. 00030512, 00043745. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

FMC Corporation. 1981a. MRID No. 00058611. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

FMC Corporation. 1981b. MRID No. 00076762. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

FMC Corporation. 1983. MRID No. 00129507. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

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_VI.B. Inhalation RfD References

None

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_VI.C. Carcinogenicity Assessment References

None

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_VII.  Revision History

Substance Name — Carbofuran
CASRN — 1563-66-2

Date
Section
Description
03/01/1988 III.A. Health Advisory added
11/01/1989 VI. Bibliography on-line
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 — Carbofuran
CASRN — 1563-66-2
Last Revised — 09/30/1987

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