&EPA
Ohtoef
OffiM*
DC
Pesticide
Fact Sheet
Name of Chemical: Propham (isopropyl cartanilate )
Reason for Issuance-Registration Standard
Date Issued: | 1
123
Fact Sheet Number:
30 MAR 1987
1. DESCRIPTION OF CHEMICAL
Generic Name:
Common Name:
Trade Name:
EPA Shaughnessy Code:
Chemical Abstracts
Service (CAS) Number:
Year of Initial
Registration:
Pesticide Type:
Chemical Family:
U.S. and Foreign
Producers:
Isopropyl carbanllate
Propham
Chem-Hoe«, Blrgln, Triherbide
OW01
122-H2-9
1967
Herbicide
Carbamate
Propham Is produced In the Federal
Republic of Germany by Bayer AG;
In the Netherlands by Pennwalt
Holland B.V.; and In the United
States by PPG Industries, Inc.
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2. USE PATTERNS AND FORMULATIONS
Application aite8: Propham Is regIstered for use on
terrestrIal food crops such as sugar beets, lettuce,
alfalfa, clover, peas, lentils, safflower, and spinach
and nonfood crops including established grasse8 grown
for seed, flax and established perennial grass and
fallow land. Most propham usage Is confined to the
western United States.
Percent of pesticide applied to particular crops: The
significant uses of propham are in forage legumes
(alfalfa and clover), sugar beets, and lettuce, which
account for nearly 100 percent of its use.
Types and methods of application: Propham may be applied
preplant, preemergence, and postemergence by ground
or aerial equipment. The flowable concentrate formu-
lation may also be applied in irrigation water or
through center pivot sprinkler irrigation systems for
certain uses. In limIted areas, propham may be tank
mixed with other herbicides for application to lettuce,
spinach grown for seed, and fallow land to be planted
to wheat. Also, since herblcidal action is mainly
through the roots, soil surface applications must be
moved Into the root zone of’ weeds by raInfall or
Irrigation soon after applIcation.
Application rates: The flowable concentrate is applied
at the rate of’ 1 to 6 pounds of’ a.i. per acre depending
on the soil, site, and pest controlled. The granular
formulation is applied at the rate of 4.1 to 5.25
pounds a.i. per acre, depending on soil type.
Types of’ formulations: Flowable concentrations (43 and
31 percent active ingredient) and granular (15 percent
active ingredient) formulations.
Usual carrier: Water
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3. SCIENCE FINDINGS
Summary science statement: Propham has low acute oral and
dermal toxicity and IS classifIed ifl toxicity Category
III. ’ Additional toxicological assessment is not
possible at this time due to insufficient data.
Based on the available informatIon, applicatIon of
propham on proposed use sites Is unlikely to result
In environmental hazard to nontarget organisms other
than plants because of Its low toxicity to wildlife.
Additional data are required before the environmental
fate, Including potential to contaminate ground
water, of propham can be assessed.
Chemical characteristics:
Physical state: Solid
Color: Tan to light grey
Odor: Faint amIne—lIke odor
Melting poInt: 87 to 88 °C
Octanol/water
partition coefficient: 41 5 + 17 over a propham
concentration range of 0.5
to 100 ppm (pure active
ingredIent)
ToxIcologIcal characteristics: Only acute oral arid dermal
toxicity studies are available. Other studies are
required.
Acute Oral Toxicity : Category III
2360 + 118 mg/kg (female rats)
3000 232 mg/kg (male rats)
Acute Dermal ToxIcity: Category III
Greater than 3000 mg/kg (rabbits)
Major route of exposure: Dermal.
Subchronlc toxicologIcal results: Only one supplemental
study, a 90—day feedIng stuly In ret8, 18 available.
In that study the no observed effect level (NOEL)
was 250 ppm (approximately 12.5 mg/kg/day). Additional
studIes are required.
‘ Refer to 140 CFR 162.10 for a dIscussIon of the toxicity
categorIes.
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Chronic and Developmental tox colog cal results: The only
acceptable study available is a rat teratology study.
In that study, NOEL’s for maternal toxicity and develop-
mental effects were 375.8 and 37.6 mg/kg, respectively.
Additional chronic and developmental studies are required.
Phya1o1og cal characteristics:
Follar absorption — Intact leaf surfaces do not absorb
an appreciable amount of propham.
Translocat on - Propham is absorbed by roots and a
portion is translocated via the apoplastic system
to the shoots and the balance metabolized in the
roots. That which reaches the shoots may be
metabolized or volatilized.
Mechanism of pesticide action — Propham is a mitot c
Oi5Ofl that kills roots by inhibiting cell dIvision.
Propham produced rapid Inhibition of cell activity
and contraction of chromosomes, probably at all
stages of cell diViSiOn.
Environmental characteristics: WIth the exception of an
aerobic soil metabolIsm study, available data are
insuffIcient to fully assess the environmental fate
of, and the exposure of humans and nontarget organisms
to, propham. Data are requIred.
Under aerobic condItions, propham degraded with a half—
lIfe of 7 to 114 days in sandy loam soil. Two degradates
were isolated from the soil but not Identified.
EcologIcal characteristics:
Hazards to fIsh and wIldlife — Propharn has a very low
acute oral toxicity to birds, it is slightly toxic
to coidwater and warmwater fIshes and moderately
toxic to freshwater invertebrates. The following
are toxicity levels from available data:
Avlan oral toxicity : > 2000 ppm; addi-
tional data
requested
Avlan dietary toxicity : Data requIred
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Freshwater fish toxicity
(BluegIll) : 29 to 3L .8 ppm
(Rainbow trout) : 23.5 to 38 ppm
Freshwater invertebrate
toxicity ( Daphnia pulex ) : 8 ppm
PotentIal problems related to endangered species:
None.
Tolerance assessment:
List of crops and tolerances — Interim tolerances
are establIshed for residues of propham in or on
raw agricultural commodIties as follows (40 CFR
180.319):
Commodities Parts Per MillIon
Hay of alfalfa, clover, and grass 5.0
Alfalfa, clover, and grass 2.0
Flaxseed, lentils, lettuce, peas, 0.1
safflower seed, spinach, and sugar
beets (roots and tops)
Eggs; milk; and the meat, fat, and 0.05
meat byproducts of cattle, goats,
hogs, horses, poultry, and sheep
Results of tolerance assessment: The Provisional Limiting
Dose (PLD) for propham is 0.0125 mg/kg. This PLD is
based on a 3—month rat feeding study, with a NOEL of’
12.5 mg/kg/day (approximate conversion from 250 ppm),
and applying a safety factor of 1000. This IS equiva-
lent to a PLD of’ 0.75 mg/day for a 60 kg indIvidual.
The Theoretical MaxImum ResIdue Concentration (TMRC),
based on the total tolerances listed and a daIly food
Intake of 1.5 kg, is 0.0 3 mg/day, utIlizIng 5.7
percent of the PLD.
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4• SUMMARY OF REGULATORY POSITION AND RATIONALE
1. The Agency Is not Initiating a SpecIal RevIew of
propham at this time.
Rationale : Since avaIlable data are limited, the
Agency IS not yet able to make a determination as
to whether any of the criteria specIfied in 4O CFR
1514.7 have been met or exceeded.
2. No new significant’ tolerances will be considered until
the Agency has received data sufficient to thoroughly
evaluate propham.
Rationale : The toxIcology data base on propham is not
sufficIent to consider establIshment of new significant
tolerances. In addition, the metabolism of propham
ifl plants and animals Is not adequately defined.
3. The Agency Is requiring the following resIdue chemistry
data: plant and anImal metabolIsm and storage stability
studIes; resIdue studies for sugar beet roots, sugar
beet tops, lettuce, spinach, peas (succulent and dry),
lentils, grass forage, grass hay, alfalfa forage, alfalfa
hay, flaxseed, and safflower seed; and processing studies
to determIne residues ifl dried pulp, molasses, and
refined sugar from sugar beets; meal and hulls from
flaxseed; and meal and Oil from safflower seed.
Petitions for food/feed additive tolerances, will be
required if residues concentrate.
Rationale : Adequate data are not available to assess
the adequacy of existing tolerances or to ascertain
the need for food/feed addItive tolerances In processed
comlnoditie8.
4. The Agency is requiring the registrant to: (I) propose
appropriate Pre Grazing Intervals/Pre Harvest Intervals
(PGIS/PHI8) for clover, lettuce, spinach, and sugar
beets; (ii) designate propham registration for grasses
as either paature or rangeland use, and propose an
appropriate PGI and PHI if pasture use Is desIgnated;
and (iii) propose tolerances and provIde supportIng
residue data or propose feeding restrictions for pea
vInes, pea vine hay, lentil forage, lentil hey, and
flax straw. These proposals must be submitted with the
revIsed labeling and in accordance with the timeframe
required by thIs document for submittal of revIsed
labelIng or the Agency wIll impose appropriate feedIng
restrIctions. (refer to chapter IV, D of thIs document,
Required LabelIng)
• SIgnIficant new use Is defIned in 1414 FR 279314, May 11, 1979.
In the case of a new food or feed use, the Agency will
consIder as sIgnifIcant an Increase in the TheoretIcal
Maximum ResIdue Contribution of greater than 1 percent.
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Rationale : Data are either unavailable or do not
support the existing PGI/PHI or do not demonstrate
that no PGI/PHI is needed for the cited crops.
Adequate information is not available regarding the
use for grasses and this use must be clarified and
fully supported. There is currently no protective
mechanism (either tolerances or feeding re8trictions)
to prevent excessive residues of propham in pea vines,
pea vine hay, lentil forage, lentil hay, and flax
straw.
5. The Agency iS requiring the registrant to propose that
the interim tolerances under Lb CPR 180.319 be converted
to “permanent” tolerances under a separate paragraph
of the published tolerance expressions at the same
or, if necessary, different concentrations and provide
the requested residue data to support these tolerances.
In addition, the registrant must propose the following
changes to commodity definitIons in the tolerance state-
ment: (1) “alfalfa” to “alfalfa forage”; (ii) “clover”
to “clover forage”; (iii) “grass” to “grass forage”; and
(lv) “peas” to “peas (succulent and dry)”.
Rationale : Interim tolerances were establIshed when
petitions for tolerances for negligible residues were
pending. Since available data do not support the interim
tolerances, as established, permanent tolerances can not
be set based on currently avaIlable data. Therefore, when
data are submitted in accordance with this document, the
regIstrant must request conversion to permanent tolerances,
and revise the commodity definitions to conform to current
terminology or the Agency will propose revocation of the
tolerances.
6. The Agency is requiring additional toxicological data,
as set forth in Table A of this document to assess the
tOXiCity of propham. CertaIn Acute, Subchronic, and
Chronic te8ting is required.
Rationale : The8e data are normally required under kO CFR
158 for products wIth propham’s use patterns. ExIsting
data are insufficIent to permIt the Agency to thoroughly
assess the toxicity of propham.
7. The Agency Is requirIng addItional ecologIcal effects
data (see Table A).
Rationale : Available data are Insufficient or lacking
to fully assess the hazard from propham use to the avlan
population.
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8. The Agency iS requiring environmental fate data as set
forth in Table A.
Rationale : Because the requirements have not been
fully satisfied, available data are insufficient to
fully assess the environmental fate of propham.
The leaching data that is available indicate a potential
for ground water contamination. Hydrolysis, photo-
degradation, metabolism, leaching, dissipation, and
accumulation studies are required.
9. The Agency is not establishing a reentry interval at
this time.
Rationale : Data adequate to assess the need for a
reentry interval for field workers are not available.
Once data are received and evaluated, the Agency will
determine the need for such an interval. An interim
interval is not required because of the low acute
toxicity demonstrated by the available data.
10. The Agency is requiring environmental precautionary
labelIng.
Rationale : The Agency’s regulations (140 CFR 162.10)
require environmental hazards labeling. Updated
labeling consistent wIth 162.10 is required. Additional
required labeling statements to protect wetlands are
specified in the registration standard Section D.3.
11. The Agency has identified certain data that will
receive priority review when 8ubmitted.
Rationale : Certain data are essential to the Agency’s
assessment of this pesticide and its uses and br may
trigger the need for further studies which 8hould be
initiated as soon as possible. The following studies
have been Identified to receIve priority review as
soon as they are received by the Agency:
§158.130 Environmental Fate
161—i Hydrolysis
161—2,3 Photodegrarlatlon
163—1 Leaching and Adsorptlon/Desorption
1614—1 Soil Dissipation (Field)
165—1 Rotational Crops (confined)
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12. While data gaps are being filled, regIstered manufact-
uring—use products (MPs) and end—use products (EPs)
containing propham as the sole active IngredIent may
be sold, distributed, formulated and used, subject
to the terms and condItions specified in this Standard.
Registrants must provIde or agree to develop additIonal
data, as specIfied ifl the Data AppendIces, in order to
maintain existing registrations.
Rationale : Under FIFRA, the Agency does not normally
cancel or withhold registration simply because data are
missing or are inadequate (see FIFRA section 3(c)(2)(B)
and 3(c)(7)). The limited, available data do not
indIcate any ImmedIate, serious concern.
Issuance of thIs Standard provides a mechanism for
identIfying data needs. These data wIll be revIewed
and evaluated, after whIch the Agency will determine
if addItional regulatory changes are necessary.
Unique warning statements required on labels:
a. Manufacturing—Use Products
“Do not discharge effluent contaIning this product
into lakes, streams, ponds, estuaries, oceans, or
publIc waters unless this product is specifIcally
Identified and addressed in an NPDES permit. Do
not discharge effluent containing this product to
sewer systems without previously notifying the
sewage treatment plant authority. For guidance,
contact your State Water Board or regIonal office
of EPA.”
b. End—Use Products
“Do not apply directly to water or wetlands (swamps,
bogs, marshes, and potholes). Do not contaminate
water by cleaning of equipment or dl8posal of wastes.”
5. SUMMARY OF MAJOR DATA GAPS
Study Due Date ’
ToxIcology:
Acute Testing 9 months
90-Day Feeding (rodent) 15 months
90-Day FeedIng (nonrodent) 18 months
21—Day Dermel 12 months
ChronIc ToxIcIty (rodent 50 months
and nonrodent)
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Oncogenicity (rat and mouse) 50 months
Teratogen .city (rabbit) 15 months
Reproduction 39 months
Gene Mutation 9 months
Chromosomal Aberration 12 months
Other Mechanisms of
Mutagen c1ty 12 months
General Metabolism 2 months
Residue chemistry:
MetabolIsm 18 month8
Storage stability 15 months
Residue studies 18 months
Processed Commodity Studies 2 months
Environmental fate:
HydrolysIs 9 months
Photodegradatlon (water, soil) 9 months
Anaerobic Soil 27 months
MobIlity (leaching and
adsorptlon/desorption) 12 months
SOil dissipation 27 months
Rotational crops 39 months
Fish accumulation 12 months
Reentry 27 months
Ecological effects:
Avian oral and dietary 9 months
6. CONTACT PERSON AT EPA
Robert J. Taylor
Product Manager 25
Office of Pesticide Programs
Registration Division (TS—767C)
EnvIronmental Protection Agency
4O1 N Street SW.
Washington, DC 20160
Telephone: (703) 557—1800
DISCLAIMER: The Information presented In thIs Pesticide Pact
Sheet Is for informational purposes only and may not be used
to fulfill data requirements ror pesticIde regIstration and
reregistration.
*Indlcates months due after issuance of Standard or, in some
cases of resIdue chemistry data, after fIrst planting season
after issuance of Standard. Refer to Standard for more
information.
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