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Permethrin (CASRN 52645-53-1)

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0185

Permethrin ; CASRN 52645-53-1

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 Permethrin

File First On-Line 03/31/1987

Category (section)
Status
Last Revised
Oral RfD Assessment (I.A.) on-line 01/01/1992
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 — Permethrin
CASRN — 52645-53-1
Last Revised — 01/01/1992

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

Increased liver weights

2-Year Rat Feeding
Study

FMC Corp., 1977

NOEL: 100 ppm (diet)
(5 mg/kg/day)

LEL: 500 ppm (diet)
(25 mg/kg/day)

100
1
5E-2
mg/kg/day

*Conversion Factors: 1 ppm = 0.05 mg/kg/day (assumed rat food consumption)

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

FMC Corporation. 1977. MRID No. 00057105, 00070950, 00110686. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Four groups of 60 male and 60 female Long-Evans rats were dosed at either 0, 20, 100 or 500 ppm (0, 1, 5 or 25 mg/kg/day) for 104 weeks. No effects were noted at 1 mg/kg/day, but slight liver weight increases were seen at 5 mg/kg/day; this increase is considered below the level of toxicological significance. A definite effect level for liver weight increases was observed at 25 mg/kg/day.

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

UF — Based on a chronic exposure study, an uncertainty factor of 100 was used to account for inter- and intraspecies differences.

MF — None

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

Data Considered for Establishing the RfD:

1) 2-Year Feeding (oncogenic) - rat: Principal study - see previous description; core grade minimum

2) 1-Year Feeding - dog: NOEL=5 mg/kg/day; LEL=100 mg/kg/day (increased alkaline phosphatase, increased liver weights and hepatocellular swelling); core grade guideline (ICI Americas, Inc., 1982)

3) 3-Generation Reproduction - rat: NOEL=none; LEL=500 ppm (25 mg/kg/day) (offspring show centrilobular hepatocyte hypertrophy and cytoplasmic eosinophilia and buphthalmos with persistent pupillary membranes; body tremors in parents at 1000 ppm and 2500 ppm and in offspring at 2500 ppm); core grade guideline (FMC Corp., 1978)

4) Teratology - rat: Not teratogenic at 200 mg/kg; no definite maternal or fetotoxic effects evident; core grade minimum (FMC Corp., 1976a)

5) Teratology - rabbit: Not teratogenic at 400 mg/kg; no definite maternal or fetotoxic effects evident; core grade minimum (FMC Corp., 1976b)
q Other Data Reviewed:

1) 2-Year Feeding (oncogenic) - mice: Systemic NOEL=20 ppm (3 mg/kg/day); Systemic LEL=2500 ppm (375 mg/kg/day) in females (liver and lung weight increases); 500 ppm (75 mg/kg/day) in males (testis weight depression deaths); no core grade (FMC Corp., 1979)

Data Gap(s): None

__I.A.5. Confidence in the Oral RfD

Study — High
Database — High
RfD — High

The critical study is of good quality and is given a high confidence rating. Additional studies are very supportive; therefore, the database is given a high confidence rating. High 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 Files

Agency Work Group Review — 10/28/1986

Verification Date — 10/28/1986

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 permethrin conducted in August 2003 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 — Permethrin
CASRN — 52645-53-1

Not available at this time.

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_II.  Carcinogenicity Assessment for Lifetime Exposure

Substance Name — Permethrin
CASRN — 52645-53-1

Not available at this time.

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


_VI.  Bibliography

Substance Name — Permethrin
CASRN — 52645-53-1
Last Revised — 01/01/1992

_VI.A. Oral RfD References

FMC Corporation. 1976a. MRID No. 00029824, 00057099, 00070579. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

FMC Corporation. 1976b. MRID No. 00029826, 00057101, 00070580. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

FMC Corporation. 1977. MRID No. 00057105, 00070950, 00110686. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

FMC Corporation. 1978. MRID No. 00069702, 00120271. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

FMC Corporation. 1979. MRID No. 00027579, 00029495, 00044323, 00061901, 00062806, 92142033. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

ICI Americas, Inc. 1982. MRID No. 00129600, 92142031. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

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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 — Permethrin
CASRN — 52645-53-1

Date
Section
Description
02/01/1990 II. Carcinogen assessment now under review
01/01/1992 I.A.4. Citations added
01/01/1992 IV. Regulatory Action section on-line
01/01/1992 VI. Bibliography on-line
08/01/1995 II. 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.
10/28/2003 I.A.6 Screening-Level Literature Review Findings message has been added.

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_VIII.  Synonyms

Substance Name — Permethrin
CASRN — 52645-53-1
Last Revised — 03/31/1987

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