I 

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: P\' Shah, (703) 308-18..i6 

INSTRUCTIONS: Please utilize this outline in prepa ring the pesticide petition. In 

cases where the outline element d oes not apply, please insert ":'IA-Remove" a nd 

ma inta in the outline. Please do not cha nge the ma r gins, font, or format in your 

pesticide petition. Simply replace the instructions that appear in green, i.e., " [insert 

company name]," with the informa tion specific to your action. 

TEMPLATE: 

Doosan Corporation 

[Insert Jetition numherj 

EP,\ ha-, n.:-cci\Ld .1 pc,ticidc pe111inn (lin'>ert Jl'lition numlwrl l fmm Doo ... an 

Corporation. 86-+ B/5F. Aict. 86-+-I. lui-<lnng. Yeongtong-gu. Sll\\On--,i. Gyeonggi-<lo. 

Korea prnpn-,ing. pur-,u.1111 1) -,ectinn -Hl:Std I ,,f the Federal l ·1)1kl. Drug .• 111d Cn-,mctic \Lt 

( rr-DC \ 1. ~I l".S.C. J-t6atd 1. to amend -.+O CJ-R pan I XO. 

In e....iabli-.h .Ill l'\Cll1plilll1 fr1)1l1 till' l"l.'.Ljlliremcnt 11f .I tolerance l°or 

monoethanolamine <CAS #1-H-·B-5> \\hen u"ed a-, an inert .... ohent applie<l 10 

growing crop.., or h;.tr\ c .... 1e<l crop" under -W CFR 180.910 in pe..,ticide fnrmulatiorh. EP \ 

has cll'll'rmined that the petition contains data or information rl'garding thl' 

eleml'nls set forth in section 408 (cf )( 2) of FDDC:\ ; hcmner. EPA ha!-. not fully 

e' aluakd the uffidl'm·~· of the suhmittt>d data at this timt' or whether the data 

supports granting ot' the petition. ,\dditional data ma~ he needed before EPA rules 

on the petition. 

J. f'/cllJ{ ll/C'ltlf>t1f i \Ill . 

.2. Analytical llll'tlwd. J\A re mm e 

J . . \/ag11itudi• of rc.\idt1l1

.\. l\A rcmoYe 

IJ. Toxicological Pn /ih• 

I. tcutc toxicity. The acute oral tn\icit\ of mo1wc1hanolamine ha" heen te'>ted in 

..,c, era! rat "tudie .... and the LD,, "a.., determined to be I 7~0-n5o mg/kg bod) weight. It 

Page 38 of 46 
wa:-. cla,,ified a .... EPA Toxicity Category Ill for acute oral toxicity. The dermal LD,0 or 

monoethanolamrnc wa" determined for male and female rah to be 250.+ and 2881 mg/kg 

b\\. rc,pecti\el). It wa" cla:-.,ified a" EPA Toxicity Categor) Il l for acute uermal to:-..icit). 

The acute inhalu.tion LC'" \\a" determined in rat:- expo,ed ''hole-bod) to he > 1.3 mg/L. 

the theoretical ~aturated \ apor concentration at room temperature. Cl111ical ... ign" of 

tO\icity were nn ob:-.cn ed. \fonoethanolamine i:-. therefore d.1 ... sificd a .... EPA Toxicit) 

Category Ill for acute inhalation toxicity. Monoethanolaminc wa..., corro:-.i\'c to rabbit "kin 

and eye" and i:-. cla...,...,ifiecl a" EPA Toxicity Category I for dermal irritation and ocular 

irritation. It \\'a" not "c11"iti1ing according to the guinea pig maximi?atinn te"t and a local 

I) mph nouc a""u). 

1. Guw uxicty. \1onoethanolamine ha" been c\·aluated for mutagenic acti\'it) in 

multiple in 1·itro re\cr...,e mutation a":-.a):-- in Sa/111011£'//<1 ryphi11111ri11111 and Escherichia 

coli. Unuer all condition" te:-.ted. including bacterial :-train. the pre!'>encc nr ab:-.ence of 

metabnlic actin1tion. and a range of concentration .... up to the appearunce or C) 101oxicity. 

monoeth<1nolam ne """ not rnutagenic. Additionall). monocthanolamine did not induce 

forn ard mutatic,n..., .11 the HGPRT lncu" in Chine .... c ll.1m,tcr lung cell" ( V79) in the 

ab,ence or meta 'ol ic act i' at ion. 

~onncthanolam ne wa" e\aluated for cla<.,1ogenicity in rat hcpatocyte celb (RL.+) in the 

ab-.cnce of meta'lolic acti\ at ion at concemration .... up to .+00 ~1g/mL. The number nf cell" 

'' ith chrnmo"rn ial aberration.., wa" not greater in the pn: ... encc or monoethanolamine . 

.... ugge\ling the 1.ompounc.J i" not c1<1,10gcnic. In a chrnmo-.omal aberration .... cud) u~ing 

human !) mphoc\ tes. 0.61-61.08 ~1g/111L monocthanolamine ''a:- '' eakly ptbiti\'e in the 

ab-,cncc or mc1aholic acti\ at ion. 

Mnnncthanolam ne Jid not induce "i"ter chromatic.I e\changc in human I) mphoc) tc-. at a 

conccn1ra1ion of 0.61 - 61.08 !tg/mL in the ab-,cnce of metaholic acli\ at ion. 

~1onoctlianolam nc wa .... C\aluated for cla ... cogenici1y in an OECD .+7...J. guideline 

micronuclcu .... st1.;dy in NMRI mice. Fi\e micc/sex/do-.e recci\'ed a single g.a\agc dose of 

375. 750. or 150) mg/kg bw monocihannlaminc. Arter 2.+ or ...J.8 hour ..... hune marrow wa:-. 

e\amincc.J and ll C frequel1C) of polychromatic Cr) throe) IC:- containing micronuclei \\a..., 

a""e""ec.J. l\ lono ·1hanolaminc did not cau...,c a significant increa..,c in the number of 

rnicronuclcated .:r) throq cc..., under an) condition of thi" a""ay. The po-.iti\ c comrol. 

'incri,tine. g,a\ t: the e:-..pccted rc .... ult ..... The rc ... ults of thi:-- a"say support the theory that 

monocthanolamiric doe" not inuucc chromthomc damage. 

J. /frpn 1uctil( and derdopmmtal toxicity. .-\n OECD .+16 Guic.Jcline l\\Ogener.itinn rcprcducti\ e "tud) ''as carried out on nmnoethanolaminc Lhing Wi .... tar 

!Crl:WI (I-fan)) rat!'>. Rat" (25/...,cx/utN?) rccei\cd 0. 100. :.oo or 1000 mg/kg h\\'/Ua) 

mnnncthanolamiric in the diet for al lca\I 75 Jay:- prior to mating. throughout mating. 

during pregnancy and throughout the weaning oft he FI oft\pring. FI oft\pring continued 

to rccei\'c the te t -.uh,tance c.Juring gn)\\ th. mating. and production and \\c,1ning or the 

F.2 generation. f )od con,umption and bod) \\eight-. \\ere monitored for hoth the FO and 

Fl generation. F and r 2 pup-. were \C\ed and weighed through da) 21 po,t-partum and 

Page 39 of 46 
after necrop!\y weights of brain ..... plcen and thymu .... were recorded. fatrou.., cycle data 

were C\aluated for FO and Fl female.., and .... perm parameter.., (motility. '>perm head count. 

morphology) \\ere examined in all FO and Fl male'>. Endpoints of '>Y'>temic toxicil) 

recorded in the FO generation included hody weight. food con-,umption and te'>t '>Ub!-.tance 

intal..e. Gross pathology and weight \\ere e\ aluuted for the following: lh er. kidney'>. 

adrenal glands. te..,te!-.. epididy mi de..... cauc.Ja epic.Jid) mi'>. prostate. !-.Cm inal vesicle'>. 

0\ aric ..... uterus. spleen. brain. pituitary gland. thyroid glands (\Vith parathyroid). Organs 

with g,ros-. lesion .... \\'Cre fixed. procc""ed for hi-.1ology. and examined by light 

micro .... cope. Li\·er" \\ere analyzed for choline concentration and O\ arie:-. of FI female:-. 

(cont ml and high do'>e) "ere e\ aluatctl for primorcliul and growing follicle ..... All -;tillborn 

pup'> and all pup.., that died before \\Caning \\Crc e\amined C\ternall) and their orgarh 

were a .... ,e .... ..,ed macrlbCopically. 

S1a1i .... 1ically -;ignificant re..,ults on FO parents at I 000 mg/kg bw/day included yellow 

di,colored urine (male'> anJ female .... ): decreased hod) weight gain of dam!\ during 

ge'>tation (8'1 lcmcr body weight compared to control rats on gc..,tation clay 20): 

decrea'>cd food corhumption during h1<.:tation: decrea'>ed '>perm head coum in the cautla 

cpitlidymi!\: decrea-.ed ah..,olute and rclati\t~ weight of epididymidcs. cauda epididymide!\ 

and prostate: fewer implantation ..,ite:-.: higher po-.t-implantation los!\: and '>mailer litter ..... 

When the Fl generation wa.., the parental generation. the -.;ame stati'>lically significant 

cffech 011 the high dn'>e group were noted with one difference: the number nf 

homogcnin1tion re'>i'>lanl caudal cpidid~ mal !\perm\\ a'> .... tight!). but '>ignificantly reduced 

in the 1-0 generation indicating a -,light dccrea'>e in ..,perm production. and the ub~olute 

and rclati\'e \\'eight!\ of the pro..,tate wen: not signiticanll) different in the FI generation. 

In the 300 Lind I 00 mg/kg bw/day groups. there were no adverse effects of 

monocthanolamine on FO nr Fl parental animal..... There \\ere no effect!\ on the Fl or F2 

pup.., in an~ do'>e group. including effect'> on pup \'iability. hod) weight. "ex ratio and 

'>e\ual maturation. Therefore the ~o Ob .... cn-cd Ad\ cr'>e Effect Le\ cl ( ~OAEL) for 

parental "Y'>lemic lO\icit). fertilit). and rcproducti\e to\icil) in the parental rat" i'> 300 

mg/l..g bw/day. There \\ere no de\elnpmental or reproclucti\'e effect... nh .... cr\'ecl in pup..,: 

the NOA EL for dc\'elopmemal effect.., i-.; I 000 mg/kg. bw/day. 

Oral /)en'lop111e111al T<J.\icitr in Rats: A "tudy wa" conducted to e\'aluatc the effech of 

monoethanolamine on the de\elopment of \\'i~tar rah. Group.., of -W pregnant female rah 

recei\ cd ga\ age do"e" of 0. -lO. 120. or -l50 mg/kg of mnnoethanolaminc on gestation 

clay'> 6-15. On gestation day 20. 25 darm/group were sacrificed and fetu-.es were 

rcmm cd by Cac:-.arean section and examined. The remaining dams littered and reared 

their pup'> umil day 21 po .... 1partum al which time they were .... acrificed and examined. 

Dam'> in the high do .... e group '>hO\\ cd denca .... es in feed con'>umption on ge'>lation da)" 6-

8 and 17-20 and on po .... tpartum days 0--l. S1a1i-.ticall) ..,ignificant decrc<N~'> in mean 

maternal body weight.., were obsened 011 ge..,tation day.., 15. 17. and 20 and on lactation 

day:-. 0. -l. 7. and 21. Body weight gain wa.., 13'7< decreased relative 10 controls on 

ge,tutinn days 15-20. Darm in the high dose group exhibited clinical .... ign.., of toxicity 

during the exposure period. including ruffled fur. recumbcncy. apnea. and in -l dam-.. a 

comatn"e .... 1a1e. >Jo clinical '>ign-. or other effect... \\Cre reported in danh of the two IO\\ er 

Page 40 of 46 
dn"c group .... T>icre were no fetal effect' or e\ idencc or treatment-related effect" nn 

po .... tnatal growth or' iabilit) in any of the do"e group ..... The ~OAEL for maternal effech 

\\a" 120 mg/kg b\\/day \\hile the de\elopmental l'\OAEL "a" the highc .... 1 do:-.c. 450 

mg/kg/day. t\ prcliminar) range-finding .... 1udy hy thc:-.c author" ... bowed .... imilar re:-ulh. 

that i-;. maternal but not developmental toxicity. at 500 mg/kg-day. 

A .... econd ....iud) had "imilar re ... u11 .... There \\a" a decrca .... e in mean bod) \\eight and feed 

crni....umption ol Wi .... tar rat dams admini-.tered 450 mg/kg/day monoethanolaminc. but no 

dc\·elopmental l )Xicity or incrca..,ccl incidence" of malformation' or alteration-. in fetu:-.e' 

or pup ..... 

/)en11al De1·e/01111e111a/ I o.rici1,· in Rahhil.\ and Rar,·: Pregnant Sprague-D~I\\ Icy rat" and 

l\e''' Zealand \\ hite rabbits recci\'ed dermal application" of 0. I 0. 25. or 75 mg/kg/day of 

monoethannlam ne for approximately 6 hour:-./day on ge:-.tation day:-. 6 through 15 (rah l 

or 6 through 18 rahhih ). There wa .... al"o a 225 mg/kg bw do .... e in rah onl). Animal-. were 

a ........ e-.-.ed dail) f'1r effech. including -.kin irritation. feed (rat" and rabbih) con .... umption 

and water (rah onlyl con .... umption. Ofl\pring were deli\·cred by Ce:-.arean .... ection on Da) 

21 (rat...) or 29 1 "abhit-;) at which time wei!!hts or the maternal li\'cr. kidnev:-.. and ~ffa\ id ... . ~ 

uteri were recP ·Jed. and number of corpora lutca plus the number-; and pmition or 

implantatio1i..... 1\ 'olution ..... and Ii' e or de.id fetu-.c-. were recorded. 

In rabbit:-. and r~ i.... of the two high do:-.c groups. 75 and 225 mg/kg bv .. ·. re:-pec.:tively. :-.kin 

wa .... ,e,erely i Titated. progre-;..,ing from erythcma 10 nccro,i:-. ..... cabbing and :-.car 

formation. The-.· finding-. arc con'>i .... 1cnt '' ith the corrn"i'e nature of monocthanolaminc. 

Bot.I) weight-.'' .!re -.ignilkantly IO\\ er mer the cour-.e of expo..,urc for both .... pecic-. at the 

highe....i do,c-. ('S and 225 mg/kg h\\' for rabbit:-. and rats. rc,pecti' el) J. The "econc.1 

highc-.t dn:-.c-. produced minor irri1a1ion only in both 'pecie:-.. with no other a<l,·er:-.e 

l.!ffech. '.\lo cviocnce of dcH~lopmcnwl elTec.:t:-. or fctntoxic.:ity "~...., ob,encd for either 

.... pee ie-; at an) dt -.c le\ e I. 

-t S11hch .. 011ic toxicity. T1rn-<ie11era1io11 Oral Toxici1r .\ltllfr: In a two-generation 

oral-route to\ic ty :-tudy (rcproducti\ e toxicity. OECD guideline 416). ethanolaminc 

hydrochloride (J urit) >99<,) wa .... admini..,tered in the diet nf 25 \\'i,tar tCrl:WI (Han)) 

rah per '>e\ al (. 100. 300 or 1000 mg/kg lm/da). FO gencratinn rat:-. recci\cd the te-.t 

"uh:-.tal1CC in the Jiet for at lea'it 75 day-. prior lO mating. 

Endpoint" or -.y-.tcmic to\icity recorded in the FO generation included bod) \\eight. food 

con .... umption ,md te:-.t '>llh..,tance intake. Gro-. .... patholng) and \\eight were C\ aluated for 

the fnllm' ing: lt\·er. kidnc) "· adrenal gland ..... 1c .... le'>. epidid) mi de ..... pro,tatc. 'eminal 

vc,i<.:les. m·arie'> uteru ..... -.plccn. brain. pituitary gland. thyroid gland" (with parathyroid). 

Organ'> with grc "" lc..,ion-. were fixed. hi:-tologicalf) proce-. .... cd and examined b) light 

micro-.copc. LiH r-. were anal)LCd for choline concentration. 

In 1hc FO genera ion. the OAEL for .... y-.temi<.: toxicity in the parent generation wa .... 300 

111!..?./k!..?. b\\/dav fc r male" and female:-.. The NOAEL wa"' ba,cd on the followin!..?. cf'fc<.:t'> at ~ ~ ~ ~ 

the high dn-.c. 1000 mg/kg h\\/day: yellow Ji-.colored urine (male-. and lemale .... J: 

dccrca .... ed bnd\ \eight gain or Jam-. during ge....iation !8'1 k)\\Cf blld)' \\eight compared 

Page 4 1 of46 
to control rat' on ge'.-.tation day 20): and decrea'.-.ed food con .... umption during lactation. 

The rest or the effect' ''ere to the male rcproducti\e organ' and female reprodw.:1ion. all 

al the highe'I dose. The-.e are summari1cd belo\\' in the reproducti\e toxicil) -.ec:tion. 

90-lJar Feedini: Studr in Rats: In a 90-day reeding '-lltdy. 10 rats/dose received bet\veen 

100 and 2670 mg/kg h\\/da) monocthanolaminc. The :"JOAEL \\a:-. 320 mg/kg b,,/day 

ha,ed on increa,es in Ii\ er and kitlne) "eight al 6-W mg/kg/tla). Some monalit) and 

microscopic lesions were observed at dn..,c'.-. al and e\ceeding 1280 mg/kg hwl<ht). 

90-Da r !11/1c1/mio11 S111clr: Monoet hannlami ne "a' e' al uatetl for ten ici I) fol lo\\ i ng 

inhalation C\po,ure. A 28-da) OECD Guideline .+ 12 '>!Ud) "<h conducted in male :.11H.l 

female \\'i!-.tar r;.u ..... Rah rccei\cd n<.he-nnly at.lmini .... 1ration or monoethanolamine \apor 

or liquid aero .... ol at concentration!-. or I 0. 50 or 150 mg/nr' (-L 20. or 61 ppm) 6 hotir'.-./day. 

5 days/week. Particle ,i;e measurements in the high concentration group re'.-.ultcd in 

:\17'1AD' of I. I and 1.2 ~1111 and GSD or 5.3 and 6.-i. The calculated nrn" rraction'.-. of 

particle<.. hel<m 3 ~1111 o.u:nxl)namic ..,i;e were 70.0 and 70.3 rr. and thlh lil-.ely to he 

depo'.-.ited in the lung'.-.. The measured endpoini.... included clinical 'ign!-.. mortality. body 

weight/gain. food consumption. ophthalmoscopy. hematology. clinical chemi...,try. organ 

"eight!-.. gro..,.... pathology. and histopathnlogy. 

The :"Jo Ob .... ened Ad,cr...,c Effect Concentration !l\'OAEC) '""' 10 mg/m1 and \\as ha,ed 

on local effects in the larynx. trachea and lung!-.. There \\'ere no systemic effects or 

monoethanolamine ol1'en·cd in 1hi.., .... 1udy: the o Ob'.-.en·ed Effect Concen1ra1ion 

(. OECl wa-, 150 mg/m '. During e\po-.urc a re" animal' in all te!-.I group-. showetl 

!-.ali\ at ion after exposure'' herea!-. animal.., !-.hO\\ed nn clinical -.ign' or toxicit) at the po .... 1-

e\posure check. 

A range linding ...,IUd) carried out pnor to Lhi' inhalation !!Uidclinc .... 1uc.(\ had similar 

re .... ult' at much higher concenLraLion ..... Some rai.... cxpo'.-.c<l to 200 and 500 rng/m' 

monoe1hanolaminc !-ohm\ ed .... everc le!-. ion!-. in the lar) nx. minimal to mild le...,ion..., in the 

nasal ca\'ity. and minimal to mild sign!-. or irritation in the trachea and bronchiolar 

epithelia. Ho\\'e\'er. no '-Y'.-.lemic effect' (clinical ob...,ervation'. gros!-. pa1hology. organ 

\\Cighh) \\'ere nOled C\·en al the highe'-t do...,e Of 50() mg/m' 

5. Chronic toxicity. 2-Year Feeding S11ulr i11 Dogs: In a 2-year dietary .... wdy. 

group.., of ..,ix beagle dog.., per '.-.ex per do .... e were fed a hair dye composite tha1 contained 

2Yc monoe1hanolamine. The compo .... itc was Jo,ed al 0. 19.5 or 97.5 mg/1-.g/day. The 1c .... 1 

'-llb!-.Lance \\a-, incorporated into the diet. \\hich \\ere prepared fre'.-.h 7 da)s/week. Dail) 

oh!-.er\'ations were made for clinical .... ig.n'.-. of tm.icity anti food intake and body weight 

\\'ere mea .... ured daily and weekly. re,pecti,·ely. Periodic examination of eyes. and hean 

! E:-.KG ). blond prc-;sure. pul'c raLc. and temperature were conducted. Hematology. blood 

chemi!-.lr) and urinal) ,i..., \\ere e' aluated in dog' in the high do..,e and con1rol group!-. anti 

on three male and three female dogs in the IO\\ do!-.e group. Necropsie:-. were performed 

on individual' at 6, J 2 and 18 month'.-.. and on all '.-.Urvi' ing dog!-. al :-,tudy termination. The 

following organ weighi.... were mea .... ured: pituitar'). adrenal ..... thyroid. Ii, er. spleen. 

1-.idne) "· and gonad-,. .\ 1 icroscopic C\amination or the folln'' ing organ.., "a:-. made: 

Page 42 of 46 
th) mu!'>. heart. aorta. lung!'>. eye-.. -.ali' ary gland. lymph node-.. thyroid. trachea. 

c-.ophagu-.. li'e . gall hladder. -;pleen. pancrea-.. -.wmach. !'>mall inte-.tinc. large intc-.iinc. 

adrenal:-.. J..idne) :-.. gonad-.. uteru-.. mammary gland. urinar) bladder. ga-.trncnemiu-. 

mu-.de. !-.Ciatic nen c. femur. :-.pinal cor<l. brain. pituitury. and abdominal -.kin. There 

were no -.1a1i-.1i ·all). toxicologically -.ignificant difference!'> bel\\cen dogs receh·ing the 

L'ontrol and the 1e-.t -.ub-.tance for an) endpoint mea-.urcd. 

6. ,\11i111 ti 111eta/Jolis111. Monnethanolamine i!-. an intermediate in the mctaholi-.m 

nf amino acid-. , nd a prernr-.or biochemical to phospholipid!-. and choline. In 'itro -.tudie-. 

of mou-.e Ii' er. at Ii \Cl'. rat uteru-.. ha1n-.tcr heart and chick neuronal and gl ial cell". and 

in 'i'o rat and llllRl'-e -.tudic ... all -.ho\\ that monocthanolamine i.., incorporated in 

plHbpholipitb It e pho-.phatidyl cthanolaminc. pho!-.phatidyl choline. pho:-.phatidyl !'>erim~. 

ly-.opho,phatid) I ethannlamine. and -.phingomyelin. Monocthanolamine can al!-.O be 

tran-.formed 'ia 1ran..,<11nina-.e" into the amino acid" gl) cine and -.erinc. '' hich arc then 

incorporated inti> protein-.. 

The first step ol mammalian and a\'ian metaholi-;m after either dermal or oral cxpo!-.ure i!-. 

oxidali,·e dcam nation to produce glycolaldchyde and ammonia. In rat" aml mice. 

glycnlaldeh)<k 'then midi1ed to glycolate and gl)O\)late and can enter the TCA C)cle 

"here it i-. u..,el ;.I!\ a -.ource of encrg) and ultimately oxicli1cd 10 carbon dioxide. or 

incorporated inti) phospholipids or proteins. The amine group i' excreted in the urine in 

the t'orm or urea or uric acid. 

The 1urno,er of rnonocthanolaminc in the hod) i-. lair!) rapid .. \ -.tud) in rah fed 

labeled monoc hanolamine in the diet found 1hat 18'< or body"" natural 

m01'.oe1hanolam111e wa-. replaced hy radiolaheled chemical within three day!-.. In addition 

IO ~N-labekd rho-.phatid) I ethanolaminc. 1-'1'\-phn-.phatid) I choline \\'~h l"<)Ullcl (I I .SC< 

t"rom dietar) mnnoethanolamine ). In organ protein'. 0.7' < of glycine and 0.9'< nr 

glutamic acid \\~re labelled and the third da~ \ urine contained >.-V7r labelled urea and 

.+.Wk ammonia . 

..\-, part or a rerroducti\e to\icity -.tud) carried nut on Wi-.tar rah. monoethanolamine 

concentration-. 1r pla-.ma "ere mea ... ured during wecJ.. 10 or do..,ing <before mating). ~1ale 

and female rat' ,,·ere cxpn-.ed to 0. I 00. JOO or I 000 mg/kg bw/day monoethanolaminc 

hydrochloride i11 the diet. Pla:-ma concentration-. nr monocthanolaminc were do-.c 

dependent.'' ith e-. .... than 3 mg/J..g h'' in the pht ... ma for all control animal'.<> - .+ mg/J..g 

for the lo\\ do-.e .111imak 8 - 11 mg/k.g for the mid dn-.c animal" and 60 - 81 mg/kg for 

the high do..,e an mal .... 

Dama/: The in \'itro penetration and metaholi-.m of monoeth.111olarnine "a" e\ aluated 

u-.ing pig -.J..in a id the in ,i,·o metaholi-,m "a' C\aluatcd \\'ith human !-.J..in grafted onto 

nude mice and "ith ..,J..in or nude mice thcmseh c'>. Topically-applied monoc1hanolamine 

penetrate.., the ... ~in and is readily metaholi7ed in the "kin and in other organ" in the 

mnti...e. Pcnctrati :111 i" -.hm. a" e' idenced hy high rc-.idual radinacti' it) i11 1·11m. i11 l'irn. 

Page 43 of 46 
and in rim" ith "kin graft..,: it i" fa..,ter in rirn. Ab:-.orbed radiolahelcd monoetlwnolamine 

''a~ oxidiLed 10 C02 and exten"i,·ely 111c1aboli1ed. Radioacti\ ity from monoethanolamine 

appeared in amino acids. protein~ and pho .... pholipid~ of the skin and li\'er. The liver wa" 

the mn .... 1 acti\l~ .... i1c of mctaboli .... m. Monocthanolaminc in the Ii\ er \\'a" mcthvlatcd to 

choline and con\crted 10 .... erinc ''hich in turn ''a" made inlO hepatic protein ..... 

Radiolabclcd mnnoethanolaminc. choline. and ~erinc \Vere all found incorporated into 

hepatic pho .... pholipict ..... In the "kin. monocthanolaminc \\'a" the only pho~pholipicl ba .... c 

'' ith radioacti\ it). Radioacti\ e urinar~ mctaholitcs in the mice \\ere urea <39.9<' or 

acti\ it). 7.6C/r or do .... e) and glycine ( .20...l'k of acti\ it). 3.9',( of dcN~l. along "ith ~mailer 

concentrations of ~erinc. monoethanolaminc. choline and uric acid. Similar re~u lt s were 

found in feeding .... wdie" in rah ''here excretion product.... including urea. hippuric acid 

and uric acid. were found at low le\ ct ..... 

7 . . lletabolite toxirnlugy. \ letabolites of monoethanolamine are endogenous 

hiochemicals "ith low tm.icity potentia l. The lir....i .... 1ep of mammalian and a' ian 

metabolism arter either dermal or oral expo~urc i" oxidati,·e deamination 10 produce 

glycolaldehyde and ammonia. In rah and mice. glycolaldehydc i .... then oxidiLcd to 

gl)COlate and gl)oxylate and can enter the TCA cycle ''here it i" u .... ed a" .i .... ource of 

cnerg.) and ultimate!) oxidi1ed to carbon dioxide. or incorporated into pho .... pholipid~ lik.c 

phnsphatidyl ethanolaminc. pho .... phatidyl choline. pho..,phatidyl .... erine. ly .... ophosphatidyl 

ethanolamine. and "Phingomyclin. t<.1onocthanolamine can abn be tran..,formed 'ia 

tran .... amina"e" into the amino acid" glycine and .... erinc. '' hich arc then incorporated ill!n 

protein ..... 

8. Endocrine di.vuption . .\1onoethanolaminc ''a" negati\l~ in the yea"t l\\ oh) brid a .... say. '' hich e 'aluate" the e~trogenicil) of a .... ubstance ba .... e<l on it" acth it) 

relative to I 7f~ e .... 1racliol. Further information related to endocrine disruption v;a;; not 

oh .... cned in the current!) a'ailable monoethanolamine databa .... c. A" the .... cicnce de,elnp .... 

and re .... ources al km ..... crccning of additional compoumh may be added to the Endocrine 

Di .... ruptor Screening Program ( EDSP). When the appropriate .... crccning and/or te .... ting 

protocol" being cori....idercd under the Agency·" EDSP ha\ e been de,·eloped. 

monoethanolamine ma) he -.ubjectcd to ad<litional .... creening and/or 1e .... 1ing 10 heller 

characterize effect... related to endocrine di .... ruption. 

C. .1ggn·gatt• Exposure 

1. Dietm:r expomrt'. The c-.timated chronic dietary expo .... ure to 

monoethanolamine ,,.a.., determined u .... ing method" 10 e....iimatc chronic dictar) expo .... urc 

for a !!Cneric inert irH!rcdient. Thi" a..,....e .... sment cnn~idcr .... drinkin!! \\atcr and crop-.... pccilic - - .. residues from prehar\'e"l application" or agricultural insecticide!->. herbicide" and 

fungicides. a""uming the highe"t established tnlerance Jc,·el residue for each commodity. 

The a ........ e ........ melll a ........ ume" that the inert ingrcdielll i" u"ed on all crops. and that J()OC'( of all 

crop" arc treated '' ith the inert. The inert ingrcdielll i" a .... sumed to be in the formulation 

at a concentration of 5()<k for the default a .... sc-; .... menl. a con .... crrnti\'C a ........ e ........ ment becau .... e 

the u .... e-le,el \\ill not actually he thi" high. Chronic diet<ff) e\pn .... ure c .... 1i111a1c .... \\ere 

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dcri\·cd for the general L'S population and ..,uh-groups of the population using the Dietary 

L:\po-.,urc E' aluJtion ~ fodcl. DEE~I "' · The DI::.E\ 1 residue data '>Cl de' eloped b) EP ,\ 

,,.a, u...,ed for tllL anaJy..,i-.,. The estimated C\posurc for the total LS population i.., 15.8<"( nf 

the chronic Poi ulation Adjusted Dose (cPA D J of 1.2 mg/kg/day. Children age I to 2 

year-; old ha\'C the highest C'>timatcd exposure at 58.9'k of the cPAD. T hc-.,c arc expected 

tn he panicularl) high e-.,1imatcs gi,en that aerobic hiodegradation is rapid an<l the leH~I 

of the inert ... uh ... ance in the formulation j, less than 50«·. 

i. rood. Dietar) exposure-., of concern arc not anticipated for monocthanolaminc 

due lo ii... read~ 1iodeg.rada1inn in the en\ ironment and lo\\ general tO\icit). 

ii. /)rin~ing water. J\lonoethanolamine e:-.posure \'ia drinking water from use as 

an inert ingredielll i:-. not expected to be significant. Ba-;ed on the physical-chemical 

cl1aracteri-.,1ic..,. the compound is expected to ultimately partition into water. "here it \\ill 

readily hiodcg.r~ Jc. ExptN1re ,·ia the drinking'' atcr ''a" estimated in the DEE\1 dietar~ 

C\po-.,ure a..., .... c..,...,111ent a...,suming a concentration of I 00 pph 

2. ,\011-< ieta1:r <'Xf'O\ltrl'. ~fonncthanolaminc j..., thcd c\lcn...,i\'CI) "" a co-,me1ic-., 

ingredient. Dl'n 1al e:-.pti...,ure from ctNnetic .... u .... e ,..., \\ell-charac1cri1cd b) the Co'111c1ic 

Ingredient Re'~\\ 1CIRl and the FOX.., Voluntar) (o,metic Rcgiqra1inn Program 

( VCRP). The VCRP reported in 20 11 that monoethanolamine is used in 788 co...,metic or 

hair dye fonnult tion ..... all or which are rin-,e-off product... al concentration-., ranging from 

0.000 I tn 18' < The dermal expo-.,urc to monocthanolamine from its u..,e a.., an inert 

ingredient in .1g"1cu1Lural pe...,ticide .... j..., not c:-..pectcd 10 -.,igniticantl) add 10 the c,i...,ting 

lc\cl or denna exposure e-.:pericnced by cnn-.,umcr .... particular!) gi,·cn its read) 

hiodcgradation i 1 the en\'imnment and -.,low dermal penetration rate. Therefore. a safct) 

finding for mon '1el hanol amine can be concluded for aggregate e' po-.,u rt?'> from d iet~tr) 

and non-dictar) '\P<' '>ltrC'> for con .... umer .... 

I>. Ct111wlalil'(' llffecl.\ 

Section -l081h)(_ )(0 ) (9\) or the FfDCA require..., that. ''hen considering \\hether to 

C'>tahlish. modi I •. or req1h.c a tolerance. the Agenq con .. ider ··a,·ailahlc information·· 

concerning the cumtilati,·e effect.., of a particu lar pc..,ticidc·..., residue-., and "other 

.... ub-.,tance.., that I ;.l\e a cummon mechani-.,m or tt1\icil) ... EPA ha-., not made a commnn 

mechani...,m of to:-.icit) tinding. a-., 10 monoethanolamine and other compound .... 

\lnnoethanolam nc doe" not appear ltl produce to\ic rnetahnlite-., in common '' ith other 

.. uhstance ..... 

1:· . . \'afety /h•frm i11atio11 

1. l ' .. \'. p 1pulatio11. [There i-., a rea .. onable certainty that no harm to human:- ''ill 

re-.,ult from the u-.e or monoethanolaminc <h an inert ingredient in pe-.,1icide products. The 

~O \EL for mat.:rnal ")"tcmic toxicit~ nf l~O mg/h.g/da) in the Je,elopmcntal toxicit\ 

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stud) in rals "a' chosen a' the critical effect for monoethanolaminc for the calculation of 

a benchmark dose. This maternal NOAEL \'alue was lower than the NOAEL for toxicit) 

in other valid studie". Therefore. the OAEL or 120 mg/kg/day identified for maternal 

rat'> e\po .... ed to monoethanolamine 'ia ga\'agc in the de\ clopmental toxicity 'tudy i .... an 

appropriate point of departure for a chronic population atlju..,ted tlose <cPAD>. 

lntraspecies and interspecic..., uncertainty factors of I 0 each combine to a total uncertainty 

factor of 100 that is 'uitahle to deri\'c a cPAD for monocthanolamine. An additional 

FQPA ..,afet) factor is not ncce-,sa1') becau'e the dataha'e is atlequate anti reliable and 

there i' no C\'idence for increased '>llsccptihility or '-Cnsiti\C '-llbpopulation". The 

resulting monocthanolamine cPAD i" 1.2 mg/kg/day. 

2. Infant\ and childrc11. There i' a rea'>onablc ccnaint) that no harm to infani... 

and children will result from the use of monocthanolamine as an inert ingredient in 

pe..,ticide produci.... Mammalian teratology tc-,i... in rah and rahhits demonstrate that 

monnethanolamine doe .... not cause a{I\ erse effect' on fetal deYelopment. Thu' at this time 

there is no concern for potential 'C11'iti\ it) to infant-. and children. and therefore the 

default IOX FQPA safety factor Jll<I) be reduced to IX. 

F. /11tl'r11atio11al Tofrrm1n•s 

NI A Remme 

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