TC«K
-/EPA
O
ITS
Pesticide
Fact Sheet
Name of Chemical
Reason for Issuance: REGISTRATION STANDARD
Date Issued: 10/01/86
Fact Sheet Number: 101
1. DESCRIPTION OF CHEMICAL
Generic nane:
Ccnncxn na.ie:
Traie
FPA ShajcKnessy Co3e:
^^ " A^scra TT
Yea- nr I u*ial
Reg s'. ration
Pesticide Type-
CheniLcal Family:
U.S. Producer:
N- (mercaptomethyl)
phthalimide S-(O,O-dimethyl
phosp^ioroli t>ii oate)
Prosmet
Phthalofos, PMP, Appa, Imidan,
Kerolate, Prolate, R-1504
059201
732-1:-c
1966
lnse.rt.icide-etcaricide
Organopihospihate
Stauffer Chemical Conpany
2. USE PATTERNS AND FDRMJIATIOK?
Applicatj.cn Sites; Terrestrial fcr>!. cropa (field, vegetable and orchard
crops such as alfalfa, apples, alncmds, apricots, blueberries, citrus,
corn, cotton, grapes, nectarines, pears, peaches, pecans, plums,
and potatoes): terrestrial non-food crops (nursery and ornamental
crops); dcfnestiT outdoor anl in3o^r.
Types of fornulationst Dust [1% an.i 5% active ingredie-it (A'.I.)],
wettable powders (7.5%, 12%, 12.5%, 50%, and 70% A.T.).
iit^egnated resins (15% A.T.^ and emulsifiable concentrates
[1 pound (Ib.) per gallon (gaUl, 3 Ib/gal, and 12.5% A.I.]
Methods of Application; Foliar applications, aerial applications,
animal treatments, stored ccjmoiity treatments, and
impregnated materials
Usual Carrier: Water
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3. SCI INDIN
Phosret is a m ther of a chenical faru V knc as the orga osp 3tes
(OPs). OP pesticides act on the nervo.is syste by interfering with
an enzyn acetylcholinesterase. This effect (kn n as choithesterase
inhibition) is reversible awe exposure stps. There are antidotes
for this type of poisoning (atr ine ar i 2-PAM). Pn srr t has a
nr,derate to acute oral, der l, arx eye/skin irritation toxicity.
It is noderately toxic (Toxicity Category II) to h ns by ingestion.
Additional data (acute inhalation ar dernul sensitization) is required
to cc lete the acute toxicity profile for technical o Tet. Insufficient
data exist to fully assess the s .bchronic der 1, rivtagenicity, onco-
genicity, an3 general netabolisrn of pho t. Reentry data is necessary
in order to establish pernanent orker reentry intervals.
P nzsrnet has been classified as a “tentative’ category C carcinogen.
This conclusion s reached after review of a 2—year n .ise oncogenicity
study. Additional studies are being rea-uired to c lete the oc e
assessn nt of the chenical. Currently available data indicate that
pho ret does not cause neurotoxic, teratogenic, or reproductive
effects.
The envirorii ntal fate of phoEr t is not ll doczented. A review
of preliminary data indicates phosret is noierately rrdile to inrniDile
in soil and hydrolyzes rapidly in soil. The *iysical-chemi cal cr aracter_
isti of the chenical indicate a potential for p snet and possibly its
degradates to contaminate grc n ater. Hydrolysis, soil dissipation,
anaer uc soil netaboli n, leaching, photcxlegradation, arj 1 rotationa
cr and reentry data are required. -
Ph Tet is practically non-toxic to slightly toxic to birds, and mildly
toxic to n iuii alS. It is t likely that pho et w ild be lethal to birds
or na imis after a single application. Available data indicates the
possibility of reproductive effects in birds and uiinitals due to the buildup
of o tet on avian and n nnalian food itei (apples, corn, cotton, and
alfalfa) fran repeat applications. Residue nonitoring data on these food
iterts is required to determine the nagnitude of exposure. Phc r t
is highly toxic to lx,ne t ees, fish, equatic and estuarine invertebrates.
Field nt,nitoring studies are being required to determine the magnitude
of exposure fran the major cp uses. Additional fish and aquatic
invertebrate studies are being required to ozzrplete the evaluation
of h rd.
thenical tharacteristics : Information listed beloQ references the technical
grade active ingredient ziless specified as the pure active ingredient (PAl).
Physical state: Crystalline solid
Qlor: ite to greyish— iite
Odor: Typical phosi*Iorodithioate
Boiling point: bt applicable — the technical is a solid
at taiperature
Flash point: ot available in Agency files
Melting point: 72.0 — 72.7°C (PAl)
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CEI Cnaracteri sti cs (conti n
Snecific qra .’ tv: 1.0s a- 2 C
1ubiiity: At 2’ C, ir. water, 2 o acetone,
> 1,00Ct ararts’ilter(g”i’: kerosene, 10 g.’l
xy. ene. 203 g ’l.
Stability: Not available in Agency files
T xico1ogica1 C iaracteristics:
Acute toxicity . iosmat has mderate to low acute oral, dermal, and
eye/skin irritation. Phosnet, like other or nc hos *iate die nicals,
can be absorbed by irthalation and skin penetration.
Acute Oral (rat): 113-304 mg/kg.
Acute dermal (rabbit): >3,160 mg/kg
Primary eye irritation: Proauced mild redness - en instilled in the unwashed
eyes of 3 rabbits at 24 hours after exposure. P sT t a1s prod aced corneal
acity, redness, cherosis, and discharge in 1 of 3 rabbits. Eyes were
normal within 7 days.
Inhalation: Undetermined
Prirrary derrrel: Non—irritant
DerTral sensitization: Undetermined
Q ronic toxicity:
Onoogenicity : ia ret has been classified as a ‘tentative’ Category C
ca.rcinogen. This conclusion was readied after review of t (a 2-year
nouse and a 2-year rat) oncogenicity studies. io t was associated
with a significantly elevated incidence of liver tuitors (adenciras, and
adenonas plus carcincxzas thined) in male B6C3F 1 mice at the hi iest
dose tested. These incidences were associated with liver hyperplastic
chances and a decrease in the time to tt r occurrence. In ferale
B6C3F 1 mice, the dienical was associated only with positive dose—related
trends for liver adeno as and carcirxitias. A 2—year rat onoogenicity
study was considered inadequate (the nui ber of animals sacrificed at
the end of the study were too ral1 to fully evaluate tLzTor responses).
The dienical was essentially non-nutagenic (only one positive result
occurred in a limited and inadequate battery of tests) and no positive
correlation with respect to czioogenicity and nutagenicity could be
made with known structural analogs. After a 2-year rat oncogenicity
study and additional nutagenicity studies are stbnitted and evaluated,
the Agency will reassess the oncogenicity issue and determine if dietary
and w rker risk assessments are necessary.
Mut.agenicity : E io net was evaluated in several nutagenicity assays.
The thenical was found to be positive only ien tested in S. t *iimirium
strain TA-lO0. No nutagenicity study of *ao t was performed in
u i;ialian cells in culture. Additional nutagenicity studies are required.
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rera .c erucity : ? teratog?rUC effe :s were rerort.e fo: tc-IOS7TEt
in orai teratology st Les in norikeys (‘ D = 8.0 m kg’ an
rabbits (ND .. = 60 mg kg .
Reproductive effects : Ph t ha no adverse reproductive performance
effects in a 3— neration oral reproduction study in rats.
(NOEL = 80 ppi ).
Neurotoxicity : Delayed neurotoxic effects were not served at levels
up to 2,050 mg/kg of phosiTet. Bxiy wei t, food o s .mption, and egg
production were significantly decreased in the 2,050 mg/kg test group.
Metaboli n : t ta indicates that phosnet is rapidly eliminated, with
78% being eliminated in the urine and 19% in the feces within 72
ho s after administration of a single oral dose in rats. However,
the major water soluble urinary mat.abolites have only been “tentatively’
identified. A general rretabolism study will be ra uired.
Physiological and Behavioral ( iaracteristics : Mechanism of Pesticide
Action - - or ncphosphate d linesterase inhibition.
virc mental Q aracteristics and Groundwater ncerns : Fe data are
available on the enviroruerital fate of I* osrret. Phosrret appears to
be Tro erately n ile to rmx±)ile in soils ranging in texture frar
sand to silty clay loam. Because of phosn t’ s physio-chet%ical
prcpertles the rx tential exists for I* ositet, and possibly its degradates,
to contaminate grotr dwater. To date the Agency is r t aware of
incidents iere J* o Tet has contaminated groundwater. To fully assess
and catu lete the envirorjrent.al fate profile of phosrret, the Agency is
reguiring hydrolysis, soil dissipation, anaer ic soil rTetabolisin,
leadüng, photodegradation, rotational crcp and reentry data.
Ecological tharacteristics :
Avian acute toxicity: Mallard duck - 2009 mg/kg
? vian dietary toxicity: B thite quail - 501 ppi
Japanese quail - 2000 n
Mallard duck — >5000 pprt
Avian reproduction: Bt ite quail - 60-150 ppn
Mallard duck - 25-60
Fish: Reirto trout — 230 p
Bluegill sunfish — 70 çb
1 uatic invert rates: De nia magna — 5.6 p ±
Garrira fasciatus - 2.0 - 4.2 pç±
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S f i ien: data are avE.iia. ie to characterize te n.iCa. p -io r : as very
highly toxic to war :e fish an highly toxic to coidwater fish. The
cheruca. is also very highly toxic to aquatic an -i estuaririe irivert.ebrates.
?‘ bnitoring data in r .r off water follo Q’ing terrestrial applications of
phosmet is being required to c rplete the hazard asses nt.
Phos.-ret is practically non-toxic to slightly toxic to birds arid manrals.
Phosnet may cause reproiuctive irTpairTrent in birds arid rr imals due to a
buildup of residues on avian food it ns. Residue monitoring of avian
and rraimalian fo od itens (a les, corn, cotton, arid alfalfa) will be
required to catplete an evaluation of the reproductive hazards.
Phosnet is very highly toxic to honeybees and displays extended residual
toxicity.
Endangered Species : Use on apple arid pear orchards, alfalfa, corn, arid
cotton crcps, could place endangered species in the vicinity of treated
areas at risk. Also t o endangered insect species in the vicinity of
fcxid crcp uses in certain co zities of California could be threatened.
Residue roiitoring data will be require 3 to aid in cxiipletion of the
assessrrerit of haz rds to endangered species.
Tolerance Assessrrent : Tolerances have been established for residues of
onos rpt in raw a ricu1tura1 canrroiities, neat, fat and neat byproducts
(4k) CFk 183. 261) arr in processed food (21 CF’R 193 . 279) for pho tet and
its oxy - arialo? a: le .‘eLs ranging fran 0.1 to 40.0 p .
The n t bolism of phos-i t in plants arid animals is not adequately
urrierstood. Mditioric i residue data and rretabolisn data will be
required to reassess the adequacy of existing tolerances and to
issue n tolerances. Processing studies are also being required for
potatoes, ajples, pltrns, peaches, grapes, field corn grain, and cotton-
seed.
The acceptable daily intake (1 DI) for humans was based on a 2-year
chronic feeding study in rats. The AD in humans was calculated
to be 0.02 mg/kg/day and the naxiJTu.]m permitted intake (MPI)
is equal to 1.2 mg/kg/day with a NDEL of 40 ppii and a safety
factor of 100. Using these calculations the percent utilization
of the ADI would be 98.29 percent. Since virtually all of
the DI has been used up by the 1MRZ and the Agency is aware of
a potential onooganic resjxnse to phosnet, new tolerances and/or
new uses will not be issued if they contribute significantly to the
‘Th C and/or result in a significant increase in the dietary
exposure.
Reported Pesticide incidents : In the period fran 1978 to 1979.
67 incidents irivolvina a flea dip forrailation (Parainite) of
phosnet were reported to the Agency. Of these 67 incidents,
39 involved cats only, 16 involved dogs only, 2 involved cats arid
dogs, 8 involved human reactions, arid 2 involved dogs arid h .nan
reactions. Reported mortalities fran these incidents were 20 cats
(one leukenic) arid 12 dogs. Additional incidents of adverse animal
reactions (primarily cats) involving the sane fornu laUon have
been reported up through 1985. The Agency is re-evaluating the
use of phosnet on pets.
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EsTAa: ,IsF ;:) P )S1 TERZSNE5
O . iit xlity Parts Per Million
Alfalfa 40.0
A1na d, hulls 10.0
Apples 10.0
Apri ts 5.0
B1u erries 10.0
Cattle, fat 0.2
Cattle, neat 0.2
Cattle, nt,y 0.2
therries 10.0
Citrus fruits 5.0
Corn, fresh (including
s et K + 6 W 1R) 0.5
Corn, fodder 10.0
Corn, forage 10.0
Corn, grain 0.5
Cottonseed 0.1
Cranberries 10.0
Goats, fat 0.2
Goats, tbyp 0.2
Goats, rr t 0.2
Grapes 10.0
Hogs, fa 0.2
Hogs, rrbyp 0.2
Hogs, ITeat — 0.2
Horses, fat 0.2
Horses, nbyp 0.2
Horses, rreat 0.2
Kiwi fruit 25.0
Nectarines 5.0
Nuts 0.1
Peaches 10.0
Pears 10.0
Peas 0.5
Peas, forage 10.0
Peas, hay 10.0
Plums (fresh pnries) 5.0
Potatoes 0.1
Sheep, fat 0.2
Sheep, rrbyp 0.2
Sheep, meat. 0.2
Sweet pDtatoes 10.0
Tatatoes 2.0
Cottonseed oil 0.2
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4. Or R I !O POSITIONS A RTI D L ES
— No referral to Specia Review is belnQ rr e at this t1rr . A
repeat rat oncoge.rucity study and adthtiona. imitageriicity studies
rmist be si.bmi tted. The Ager -y will reassess the oncxgenicity issue
and determine if dietary and orker carcinogenicity risk assessrrerits
are necessary. The available data also indicate that pho iet is
highi’ toxic to fish. Terrestrial residue analysis and aquatic
runoff nix3eling indicate that certain use patterns could result
in exposure of certain aquatic organi to hazardous levels
of the pesticide. Additional data are needed before the Agency
can ccrrplete a full assess ient of this hazard p tential.
- The Agency will reassess the adequacy of the existing tolerances
after required netaboli n data and residue data are s mitted.
- Ne Q tolerances and uses will be issued on a case—by-case basis.
- The toi rance expression for phosrTet under 40 CFR 180.261 will
be a- rkdei by deleting the reference to “cholinesterase—in] -iibitir g”
residues.
— The Agency has determined that endangered species label restrictions
are necessary in order to prevent unreasona,le adverse effects on
the envirc -uent.
- In the absence of reports of fish kills foilc ’ina oho ret apolication
arE] actual field m nitorino data, the Agency will not restrict, certain
uses of pho ret to certified applicators, but has determined, based
on the hi toxicity of phos ret to aquatic organisms, that precautionary
labeling will be required. The restricted use classification may be
required if additional studies indicate that pho ret use poses risks
to aquatic organi that could be mitigated by increased xz trols
in application.
- The Agency is irrposing a 24-hour reentry interval. Fbliar dissipation
data are req uired on orcps whose prcpagation requires human tasks that
involve s stsntial, prolonged h an contact.
— Protective clothing is reuired for mixers/loaders and applicators.
- The Agency will analyze the safety and efficacy data of a * osniet
flea dip fornulation (Paramite) to determine if further regulatory
action is warranted. A warning statenent indicating that i.nproper
dilution of the product could cause serious injury to pets is being
required.
- The Agency has determined that the tolerance for cranberries should
be revc ced because there there are no registered uses for r* osmet
on crarberries.
- The Agency is requiring processing data for the follo dng agricultural
caiirodities: potatoes, apples, plums, peacthes, grapes, field c rn
grain, arE] cottonseed.
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- T i A en is not re a: ina a rotatio1a cr resricio.. If
re uire d t d i nstr te th . fo1lo .’-up cr t& e U2 - sm t
residaes fr r so i, rct io- cr restr1c io or toierance
jii those cr s.rr y be necessary.
- The Agency is not irrpDslng a ground water advisory stat nt
on phos ret labeling at this tine, bat is requiring data
to fully characterize the potential of this cheT ical to reach
ground water.
- Wnile data gaps are being filled, currently registered end-use
products containing phosr et as the sole active irrredient
nay be sold, distributed, and used, s .bject to the tern and
conditions specified in the Registration Standard.
5. SU* RY OF W JOR TA GAPS
Prcx3tt - Ch nistiy
Product O e istry Feb. 1987
Residue ( nistry
Plant/Livestock Metabolism Feb. 1988
Plant /Anirral Residues Fec. 1988
Storage Stability Feb. 1988
Envirorinental Fate
Hydro lysis/Photcxdegradation July 1987
P4bility Studies Sept. 1987
Accu,m.ilation (Rotational) Crcps Dec. 1989
Glove Pernaability ?br. 1987 - protoco.
Nov. 1987 — final report
Anaerc*Dic Soil Met.aboli n Dec. 1988
Soil Dissipation Dec. 1988
Toxicology
Acute Inhalation Toxicity (rat) July 1997
Dental Sensitization July 1987
2l-Dey Dental (rabbit) Sept. 1987
C cogenicity (rat) Nov. 1990
Gene Mutation July 1987
Structural C raiosc te Aberration Sept. 1987
Other Genotoxic Effects Sept. 1987
General Metaboli&n Sept. 1988
Ecologi .1 Effects
Acute Toxicity to Fresh ter Invertebrates July 1987
Acute Toxicity to Estuarine and Marine OrganiwrE Sept. 1987
Fish Early Life Stage and quatic Invertebrate Life Dec. 1987
Cycle
Field t. itoring (avian, aquatic, and uannalian) Feb. 1988
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6. TA’ PERS AT EP
GeDroe T. L aRocca
Prcx i Manager 15
U.S. Env2 .ror Tenta1 Protection Agency
TS—767C
401 M Street S.W.
Wa&- ington, D.C. 20460
(703) 557—2400
DIS AIP€R: The information in this Pesticide Fact Sheet is for
informational purp es only and may not be used to fulfill data
re uiret nts for pesticide registration and reregistration.
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