# I EPA REGISTRATION DIVISIO N COMPANY NOTICE OF FILI NG FOR PESTI CIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER E PA Registration Divis ion contact: P\' Shah, (703 ) 308-18..i6 

### INST R UCTIONS: P lease utilize thi s o utline in prep a rin g th e p esticid e p etition . In cases w he r e th e o utlin e elem e nt d oes not appl y, pl ease insert ":'IA -R e m ove" a nd m a inta in th e o utlin e. P lease d o n o t c h a n ge the m a r g in s, font , o r fo rmat in your p es ti cid e p e titio n . S impl y r e place th e in s tru cti o n s th a t appear in green , i .e., " [ins ert company name] ," w ith th e info r m a ti o n s p ecific to your ac ti o n . 

### T

EM PLAT E: Doos an Corporation [Insert Jetition numherj 

### EP,\ ha-, n.:-cci\Ld .1 pc,ticidc pe111inn (li n'>ert Jl'lition numlwrl l fmm D oo... an Corporation . 

### 86-+ B /5F. Aict. 

### 86-+-I. l ui-<lnng . Yeongtong-gu . Sll\\On--,i. Gyeonggi-<lo. K orea 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 CF R 180.910 in pe..,ticide fnrmulatiorh . EP \ ha s cll'll'rmined that the petition contain s data or information r l'garding th l' eleml ' nls s et forth in se ction 

### 408 (cf 

### )( 2 ) of 

### FDDC :\ ; hcmner. 

### EPA ha!-. not 

### full y e' aluakd the**uffidl'm ·~·**  of 

### the s uhmittt>d data at thi s timt' or whether the data s upport s granting o t' the petition . ,\dditional data**ma~** he need ed b e fore E PA rule s on th e p etition .

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

### i \Ill. 

### .2. Ana l y tical llll'tlwd. J\A remm e 

### J . . \/ag11itudi• of rc. \idt1l 1

. \. l\A rcmoYe IJ. 

### T o

xicological**Pn /ih** **•** I. 

### tcutc toxicit y. 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 3 8 of 46wa:-. cla,,ified a.... EPA Toxicity Category I ll 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 inhal u.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 mutati c, 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\ lon o ·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\\O gener.itinn rcprc ducti\ 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-.; I000 

### 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'1 r 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

### "abhi t-;) at which time wei!!h ts 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 S 11hch ..0 11ic 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 OAE L 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 of46to 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: I n 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 t o 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/m 1 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 ou t 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. H o\\'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. Hemat ology . 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 

### 46th) 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 1 e-.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. I n '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 lll l Rl'-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 int i> protein-.. The first step ol mammalian and a\'ian metaholi-;m after either derma l or oral cxpo!-.ure i!-. oxidali, · e dcam nation to produce glycolaldchyde and ammonia. I n rat" aml mice. glycnlaldeh)<k 'then midi1ed to glycolate and gl)O\)late and can enter the TCA C)cle "here it i-. u..,e l ;.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) m n noethanolamine ) . I n 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 

### C0 2 

### 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<' 

## o r 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 . \ l etabolites o f monoet h ano la min e are e ndogen o u s hi oc he micals "ith low tm.icity pote n tia l. 

### The lir....i .... 1ep of mammalian and a' ian metabo lism 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 ....phatidy l 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\\ 

### o h) 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 · " EDS P 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 meth od" 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 

### Page 44 of 46dcri\·cd for the general L'S population and ..,uh-groups of the population using the Dietary L:\po-.,urc E' aluJtion**~**fodcl.**DEE~ I**  "' · T he DI::.E\1 residue data '>C l 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 Adjus ted Dose (c PA D J of 1.2 mg/kg/day. C h ildren age I to 2 year-; old ha\'C the highest C'>timatcd exposu re 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\lonoethan olamin e 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 I ngredient**Re'~\\** 1CIRl and the FOX.., Voluntar) (o,metic Rcgiqra1inn Program ( VCRP). The VC R P reported in 20 1 1 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 '1 el hanol amine can be concluded for aggregate e'po-.,u rt?'> from d**iet~tr)** and n o n-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 l ar 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 . [T here 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\ Page 45 

### of 46

### stud) in rals "a' chosen a' the critical effect for monoethanolaminc for the calculation of a benchmark dose. This maternal NOAE L 

### \'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 <c PAD>. 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 

### NIA 

### Remme

Page 46 of 46