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Oxyfluorfen (CASRN 42874-03-3)

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0084

Oxyfluorfen; CASRN 42874-03-3

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 Oxyfluorfen

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 — Oxyfluorfen
CASRN — 42874-03-3
Primary Synonym — Goal
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

Increased absolute
liver weight and
nonneoplastic lesions

20-Month Mouse
Feeding Study

Rohm & Haas, 1977a

NOEL: 2 ppm
(0.3 mg/kg/day)

LEL: 20 ppm
(3 mg/kg/day)

l00
1
3E-3
mg/kg/day

*Conversion Factors: 1 ppm = 0.15 mg/kg/day (assumed mouse food consumption)

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

Rohm and Haas Company. 1977a. MRID No. 00037939. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Fifty Charles River CD-l mice/sex/dose were fed diets containing 2, 20, and 200 ppm of oxyfluorfen (87.7% active ingredient) for 20 months. The following results were noted: 1) increased absolute liver weight at 20 ppm; 2) necrosis, regeneration, and hyperplastic nodules in liver at 20 ppm; and 3) increased incidence of effects at 200 ppm.

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

UF — An uncertainty factor of 100 was used to account for the interspecies differences and the spectrum of sensitivity in the human population.

MF — None

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

Data Considered for Establishing the RfD

1) 20-Month Feeding (oncogenic) - mice: Principal study - see previous discussion; core grade minimum

2) 2-Year Feeding - dog: NOEL=100 ppm (2.5 mg/kg/day); LEL=600 ppm (15 mg/kg/day), (increased liver weight, elevated alkaline phosphatase; increased bile pigmented hepatocytes); core grade minimum (Rohm and Haas, 1981)

3) 2-Year Feeding (oncogenic) - rat: Systemic NOEL=40 ppm (2 mg/kg/day); Systemic LEL=800/600 ppm (40/30 mg/kg/day) (minimal hypertrophy of centrilobular hepatocytes of the liver); core grade minimum (Rohm and Haas, 1977b)

4) 3-Generation Reproduction - rat: NOEL=10 ppm (0.5 mg/kg/day); LEL=100 ppm (5 mg/kg/day); core grade minimum (Rohm and Haas, 1977c)

5) Teratology - rat: Fetotoxic NOEL=l00 mg/kg/day; Fetotoxic LEL=l000 mg/kg/day; Teratogenic NOEL=1000 mg/kg/day (HDT); core grade minimum (Rohm and Haas, 1977d)

6) Teratology - rabbit: Maternal NOEL=l0 mg/kg/day; Maternal LEL=30 mg/kg/day (anorexia, decreased body weight gain); Fetotoxic NOEL=l0 mg/kg/day; Fetotoxic LEL=30 mg/kg/day (fused sternebrae); Teratogenic NOEL=l000 mg/kg/day; core grade supplementary (Rohm and Haas, 1982)

Data Gap(s): Rabbit Teratology Study

__I.A.5. Confidence in the Oral RfD

Study — High
Database — High
RfD — High

The principal study appears to be of good quality and, therefore, is given a high rating. The data and supporting studies are of high quality; thus, 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

Pesticide Registration Files

Agency Work Group Review — 06/10/1986

Verification Date — 06/10/1986

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 Oxyfluorfen conducted in September 2002 identified one or more significant new studies. IRIS users may request the references for those studies from 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 — Oxyfluorfen
CASRN — 42874-03-3
Primary Synonym — Goal

Not available at this time.

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_II.  Carcinogenicity Assessment for Lifetime Exposure


Substance Name — Oxyfluorfen
CASRN — 42874-03-3
Primary Synonym — Goal

Not available at this time.

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


_VI.  Bibliography


Substance Name — Oxyfluorfen
CASRN — 42874-03-3
Primary Synonym — Goal
Last Revised — 03/01/1991

_VI.A. Oral RfD References

Rohm and Haas Company. 1977a. MRID No. 00037939. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Rohm and Haas Company. 1977b. MRID No. 00083445, 00135072. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Rohm and Haas Company. 1977c. MRID No. 00135073. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Rohm and Haas Company. 1977d. MRID No. 00083444. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Rohm and Haas Company. 1981. MRID No. 00071918. Available from EPA. Write to FOI, EPA, Washington, DC 20460.

Rohm and Haas Company. 1982. MRID No. 00094502. 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 — Oxyfluorfen
CASRN — 42874-03-3
Primary Synonym — Goal

Date
Section
Description
12/01/1988 I.A.1. Species corrected
03/01/1991 I.A.4. Citations added
03/01/1991 VI. Bibliography on-line
01/01/1992 IV. Regulatory Action section on-line
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 — Oxyfluorfen
CASRN — 42874-03-3
Primary Synonym — Goal
Last Revised — 01/31/1987

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