EPA Registration Number

65615-1 

Volume 1

1
/\\ 

I 

2
Pages 3 through 56 contain FIFRA registration data and are not included in this copy
.. ~---~ ~.~~.~.-~------~~--

• • 

PROPOSED LABEL 

57
Treats . 5000 sq. ft .,. USPC .. lorOil •••• l00% 

"NET: 32 FL.OZ. (1 OT.) 946 mL ~~=~gF ;-

additional size. 64 oz., 128 oz., 5 gal 

; .. 

I 

""""r~D' ~ ...,.. .... .1 Motes can dig up300feet 

."'~r . of earth in one night 

. M~LE MoleseatenoiJghfoodto j ~, equal its weight eacll<lay. 

EVACUATOR NON-TOXIC, 

CONCENTRATE BIODEGRADABLE -,..---- .. . MOLES CAN'T WAIT TO MOVE ..... -~ 

SIMPLE and SAFE ~~';.'P?llCATOR SCO!IT MOLE ..-tor ",,1Iol becaUse 

mole. diSlike Ill. odor >nd Ia.teof iii. 1.,1 "",,-,.,., 

1l!'Y 

product will_ WIle. they 

>illY 

fils! 

aelM! 

S!IIOll5000T. 

tryiIlg II> !l't 

It 1m ~ 

.... y. WIleotlley _that il'sall around 5000 

'.1110111, they come to 1ile SIIffa<e and I.... SO.FT. 

. lor. laWn II1at _t "",II Ii •• SCOOT. 3500 

Moles usualy laM treated .area in 1 .. 2 j so. fT. 

_ aile, applicatiOn. The COfII'elIi"t 2000 

SllIllY applicalor allows to, easy, iCOIlomt- S<>. FT. 

,cal.wide_olmatollelrealed. 500 

OIRECTIOIIS: Shake weil be"',. using. SO.FT. 1..' ----....) 

• SpllIY SCOOT MOLE at rate.f 000 quart PEST SOLUTIONS 

per5000 "'1.11. usil)g Iao.!e $W1lOping rno- GRAND RAPIDS, MI49507 

Ii .... For ,,$I re.u1ts, apply in •• rly . Spring, Mill-Summer and eaJIy faI~ or H 

moles miIllllle lfOIII your neigilliorS yard 

,lteftlley tim U$II SCOOT. • 

CAIJI1OH: Keep out of reaGII III GIIDar ... 

OOIIfAINS::l00%<asloroiluSP 

EPl\fsl. I000OII fPA Rl!g.. #00000 6 

I 

• 

• 

58
• 

• 

UNITED STATES ENVlRDNMENTAL PROTECTION AGENCY 

Ms. Cristina GriffiI'l~ Agent 

Balk Family Trust DIBI A Scoot Producl' 

c/o Delta Analytical Corporation 

12510 Prosperity Drive, Suite# 160 

Silver Spring, MD 20904 

JUL 2 4200G 

Subject: Balk Family Trust D/B/A Scoot Products, Scoot Mole® Evacuator 

EPA Registration No. 65615-1 

Amendment to Add Pests and Update Label 

Application Dated 512216 

Dcar Ms. Griffin: 

The amendment referred to above, submitted in coIU1ection "ith registration under 

FlFRA section 3(c)(7)(A), is acceptable provided that you: 

I. Submit and/or cite all data required for registration/reregistration of your 

product under F!FRA section 3(c)(5) when the Agency requires all registrants 

of similar products to submit such. data. 

2. Submit three (3) copies of your final printed labeling before you release the 

product for shipment. Final printed labeling means the label or labeling of the 

product when distributed or sold. Clearly legible reproduciions or photo 

reductions will be accepted for unusual labels, such as those silk~screened 

directly onto glass or metal containers or Jarge bags. or drum labels. 

If these conditions are not complied with~ the registration will be subject to 

cancellation in accordance with FIFRA section 6(e). Your release for shipment of the 

product bearing the amended labeling constitutes acceptance of these conditions . 

I f you have any questions, contact Chris Pfeirer .t phone# 703-308-0031 or by email 

at pfciier.chris@epa.gOx, A stamped copy of the label is enclosed for your records. 

Enciooure 

Sincerely, /n / jJ) ;)/ 

~c~Jl~::d:ief Biochemical Pesticides Branch 

Biopcsticidcs and Pollution 

Prevention Division (7511 P) 

CONCURRENCES 

SVMBOl. .. ]$.J.!..r. ......... '1.0J.f ..... ::JS.ll~ ..... ........................................................................................................ .. SURNAME .£EEl. . ... e~ ... r.) ...•. " ................................................................................................................ . DATE 

EPAFonn 13 OFF1CIAJ.. FILE COPY 

59
• 

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• 

• 

• 

• 

• 

• 

• 

• 

SCOOT MOLE® EVACUATOR 

Mole repellent 

Lawn protection 

Treats 10,000 squM"Cfcct [per-quart] 

Hose ~nd application 

Easy to use hose end applicator 

Use to control [or repel] moles, volcs* & gophcrs* 

[rom lawns, ornamentals and turf 

Refill hottles available in various sues 

Use with Reusable Hose End Applicator 

KEEP OUT 011 [mACII 01<' CIIILDRRN 

CAUTION 

Castor Oil ...................... lo(l.O% 

[Graphics] 

Net, [32 fl. oz. (946 ml)] 

[64 tl 07.. (L91iters)] 

[128 fl. oz. (3.785litcrs)] 

[2.5 gal. (9.44lilorsJI 

[5 gal. (18.93 liters)] 

•••••• 

• •• • • .. ....... 

• • •• ...... • • ...... 

•••• o • ..... 

... .. o 0 

" 

o 

o 0 .. ,. ..... o 

.. . • • • • •• 

• ..... o • ..... 

, .... • o • .. . 7i13.1% 

60
• 

• 

Scoot Mole® Evacuator 

PRECAUTIONARY STATEMENTS 

E1'>VlRO:\'.\1E~IAL HAZARDS 

For terrestrial uses: Do not apply dfreclly 10 watc"f, 10 areas 

where surface \vater is present otto interlidal nrem; below the 

Illeml high w~ller mark. Do not cOJltaminale water when 

disposing of equipmL'll1 wa5hwaters or rinsale. 

DIRECTIONS FOR USE: 

It is a violation of fedemllaw to usc this product in a manner 

inconsiSlcnt wilh its labdiIlg. 

USE RESTRICTIONS: This product may be used to repel 

(:astern moles (,)'culopl1s aquatfclls). voles*-, and gophers*' 

from lawns. turf, omamenlals, golf courses, and athletic 

lields. 

LOCATING MOLES: The presence of Jlloles Ulay be 

indicated by a nClwork of surface ridges in the luti' or by a 

series of conical mounds of earth pllshed up from deep 

burrows. Treat all areas \vhich show signs of molcs' 

prcsence. 

APPLICATION OIRECnONS, 

[When sold in seif~di.\p2)ISi1lg cOII/(li,wrs:j 

Attaeh garden hose tightly to self-dispensing cOlllainer. Tum 

willer supply on to full pressure. Spmy SCOO'f® MOLE 

EVACUATOR over mole infcsled area at a rale of I quart of 

product pcr 10,000 sq. ft. (e.g., a 100 fl. by 100 n. rectangle). 

Adjust thc spray nozzle to "WATER", Continue to spmy 

with watcrto soak SCOOT® MOLE EVACUATOR into 

lhc soil. Apply SCOOT® MOLE EVACUATOR 

immediately aftCl' the presence ofmolcs is detected or in early 

Spring, mjd~Summer and carly Fall iflhcrc are moles llcarby 

but nolan your property. 

[THien sold in Refill barrles:] 

To be used in original Scoot Moledr' Evucuntor sdfdispensing containers only, Apply at 31 oz pcr 10,000 Sq. Fl. 

Pour eontcnls ofrelill Scoot Mole® Evacuator into original 

Scoot Mole® re;:ldy to usc (RTU) hose end applicator (x)ltle, 

attach garden hose tiglltly to self,dispensing conlailler. Tum 

water supply on to full pressure. Spray SCOOT® MOLE 

EVACUATOR over mole infested area :It a rate of 1 quart of 

product per 10,000 sq. ft. (c. g., a 100 ft. by laO ft. n,:~tangle). 

Adjust the spray nozzlc to "WATER". (ulItiIlue to sproy 

with water 10 soak SCOOT® MOLE EVACUATOR into 

Ihe soiL 

Apply SCOOT:t9 MOLE EVACUATOR 

imnlediatdy aller the preseI1ce ofmo1c>i i:\ 

detech;d or in carty Spring, mid-Summcr <Uld early 

Fall if 111cre are moles nearby but not on your 

property. 

These directions al~o apply to \'oles'" <'1Ild 

gophen;>I< . 

REUSABLE APPLICATOR: Refill bottles 

available. Use only \vith SCOOT® MOLE 

EVACUATOR. Do not contaminnte container 

with \vced killers or pesticides. 

STORAGE AND DISPOSAL 

Do not conL:'ullillatc food, feed or water by 

slomgc or disposal. 

STORAGE, 

Store only in original cnniainer, in'l dry place 

h13CCessiblc 10 children find pets. 

DISPOSAL, 

ff'empcy: ror nOll-rc-tlllable cOlltainers, dOllO! 

reuse tili;.; cotllainer. Place in tnlsh or ofter for 

R"C)'c1i ng if awtilable, 

fa,! 

For refillable cont<liller, after 1;:lsl usage, place in 

trash or offer for recycling if available. 

lfportlyJilled: Call your local solid waste 

agency or I-SOO-CLEANUP for disposal 

inslruetions. Never placc Ull1Ised product down 

.my indoor or Ol.ltdoor drain. 

'''arrant)' Disclaimer: Duyel' assumes all 

responsibililY for s(l[ety and usc llotJI\-.It:t ... r(!fI11Ce 

with directi<lns. • ••• 

,Hllmiftii;.fllwi hy: 

• •• 

••• • 

•• 

•• 

• 

• • • • ScoolooU.,.iiu,ts : ••••• 

Grand Rapid.~<l"d 49507 ... ~~, 0'" TeTe: (fl'''-"I,.~;92I, ••• 

••••• • 

EPA Reg.. 1\0. 65615-1 EPA p.~.-:'f1t.~.,'i615·\'J1·2 

"'Not approved for (be 011 gophers anti'"t''''es in 

Califomin. • •• : •• 

•• • 

61
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F-I ,e S ym 001 , 65615 . 1 

ISlte/USe] I Res lAg 

Label Review 

Date , 7/18/6 

lsoth) I (Food 

R eVlewer: - ns .S}:! r 

j~n'Food IBoth) 

Tox: (W=waived) AcOral; 4W /AcDerm: 4W IAclnhl: 4W IEyelrr: 4W ISkinlrr: 4W DermSens: N 

Label Requlrem(!)nt Acceptabte Not Acceptablo NlA Comments lRM3 

Recommendations 

Restricted Use Pesticide --_ .. _---- ---.. __ .-- ..... eh6 

Product Name -/ Pg 12·3 

Compny Name and Info -/ Pg 15·1 

Identification Numbers -/ eh 14 

Net Contents -/ Added Ch17 

Ingredients Statement -/ ehS 

Label Claims -/ Pgs 4-5, 5-7 

11-10&Ch12 

Altemate Formula -/ 5-12 

i .. jc>i ..• '> ..•.. > ... ~tiOn statemimtO. . .. . ..... /. ...... .." /' . ...•. >111)' _ .... 

Label Requlrement Acceptable No' NlA Comments lRM3 

Mccplable Recommendations 

KOROC -/ 3-1 & 9 

7-3 & 4 

Signal Word -/ Ch3 Ch7 

Ch 10 

General Heading -/ Moved. Enlarged. Ch 7 

Precautionary Statements 

First Aid (PRN 20001-1) -/ Ch3& 7 

Hazards to Humans -/ Ch 3. 7-3 

and Domestic Animals 

PPE (WPS) -/ Ch 7, Pg 7~12 

Engineering Controls Pgs 10-4, 15 

User Safety -/ Cn 10 

Requirements 

User Safety -/ Ch 10 

Recommendations 

Environmental Hazards -/ Edited Ch8 

Physical and Chemical -/ Pg 3-4 

Hazards ChO 

62
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. .. ... ., . . 

DI_.slot OSE (fIfRA Text, WPS pi .. Ski,. lII1d Disposal 

Label Requirement Acceptable 

Header Directions for ./ U,. 

ViolatIOn of Federal Law ./ 

Ie" 

WPS Toxt ./ 

(PPE) 

Non·WPS Texl ./ 

Storage and Disposal ./ 

Lalx!l Requirement Acceptable 

General Instructions and ./ 

Sub-Header 

Chemigation j ProhibHlon ./ 

REI ./ 

Label Requirement Acceptable 

General Info. (non-ailo!! ../ 

$p<!cllic inlc. '.'In o.:oos, pool~, 

mi);lrl1. afld Ioadir>q. tllM mWng< 

, 

General Precaullons and 

Restrictions 

Directions for Application 

Consistency with labol 

inslructions 

Not false or misleading ../ 

. ., . 

Not 

AcceptabJe 

Not 

Acceptable 

Not 

Acceptable 

NlA Comments 

Recommendations 

Enlarged 

NfA Comments 

Recommendations 

Edit 

NlA Comments 

Recommendations 

. 

LRM3 

10-16 

10-26,11-7 

ChlO,7-1 

7·\1 

7-12, CIllO 

11-16, Ch 13 

LRM3 

PR1\' 

Pg 10-20 

lRM.3 

12-n 

_ .. _--------------

63
BPl'D Label Amendment Check List 

Fast Track and PRlA Actions B68, B73 &B90 

EPA Reg. No.: 65615-1 RAt.: Chris Pfeifer Application Dale: 7/! Sf(i 

Application Form (EPA Form 8570-1) - signed & complete, including package type? IF NO, STOP~ Y 

Call' . and have thenl correct and rcsullmit. 

Amendment co\'cred by PR Notice 98-10 (>iotificnlions)? IF YES, STOP. Call applicant attd give 

them the option ofwithdrawiug this tffilCndiUent aud submitting :.Illolification. If the)' withdraw 

amendment, close out. OPPIN. 

y 

3. Final printed labeling received tor previous action'? IF NO, STOP! E-l1lUii applicant and request filla! Y 

printed (FPL). Let them know lhal FPL from the last accepted label is needed to support the 

current 

4;' Data and Data Matrix (EPA Form 8570-35) NA 

Seh:ctivc Method? SKll' TO ITEM 5. Matrix 

Complete Data Matrix, 

and Product 

Minimum Data Matrix tor 

data for 

inclwks: Product specific Acute Tox 

, claimed onlabcl, 

b. dat.a'! 

c, Registered source used for activc ingredient? IF YES, SKIP TO ITE;\e15. (Active ingredient is from a 

registered source and generic data shonld be satisfied by rCb>1st(;fel.i source,) If NO, generic data is 

d. Data PR Notice) 

e. Public Data Matrix provided? (I\s 

Certification with Respect to Citation of Oata presem. (EPA Form 8570-34): See 40 CFR 152.80-98 

aud PR Notice 98-5 [lrno data are required or $ubmilled, a Ccnifkation with Respcvt 10 Citathm efDala jimll 

isn't needed. This is often true fer minor 

Did check a Method 

Gencnu Offer to Pay checked for Crte-[\l! Metllod oreite-all under Selective Method? 

Is r!te fom) and dated? 

d. Check toml and Data M[ltrix. Arc Exclusive Use data cited fnllli other sources? 

d.!, IF YES, i~ the required authorization letter indudcd 

o. Labe!(s) Review natc of lAibcl Re .. 'icw: 417/6 

Toria, 

a. Label(s) 3b'Tees with CUrreJlt Label Rel'iew Manual and REDS. 

b. from Acule Tox. Product and for 

c. Nominal concentration of active sho\vlt in ingredients stntcment. 

d. Viability included as substatemcllt of IngretiieJ tt Statement 'microbial, i .C., 

c. illstructiOJIS with container listed on 

f. Namc for Same 

. claimed on labeL 

form. 

g. Docs CSt' list peanuts, tree nuts. milk, soybeans. eggs (includiug putresccllt eggs). ti:;h, crustucC'u, or 

wheat commodities? If YES, RAL must evaluure luhel use directions for compliance with 40 CFR 

180.1071. 

h. Corrections or nn::-"OT 

y 

y 

y 

y 

y 

y 

y 

N 

" 

64
Chris, 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

Cristina Griffin 

<cgrlffin@defta-ac.com> 

07113/200601 :33 PM 

WASHINGTON, D.C. 20460 

To Chris PfeiferfDC/USEPAlUS@EPA 

bee 

Subject address and efficacy question 

O~FICE OF 

PP-C'/f}<TIQN, PESllCIOES N,D 

10XIC SUtlSTA',C[S 

As we discussed on the telephone, here is the new address where all correspondence on Scoot Mole 

should be sent: 

Cristina Griffin, Agent for Balk FamHy Trust DBA Scoot Mole 

e Delta Analytical Corporation 

• 

12510 Prosperity Drive, Suite 160 

Silver Spring MD 20904 

Regarding efficacy data, Scoot Mole's staff informed me that he believes all elficacy data have been sent 

to EPA. One report is the 50 page report you said was in the file. Another is a second report by Scott 

Winterstein, Associate Protossor of Wildlife Biology, Michigan Slate University and Glenn Dudderar, Ph.D 

(I believe he also is at Michigan State), entilled "Efficacy Test of Scoot Mole Repellant at 1 Quart per 

10,000 square feet application rate" dated 10 January 1999, Therefore, assuming you have the 1999 

study, 1here is nothing new for uS to send to EPA. 

Best Regards, 

Cristina Griffin 

Delta Analy1kal Corp. 

c~1l1ail: cgrifl'in@delta.ac.com 

vok'e: 30f~680~7971 

fax: 301-680-7975 

/25 /U Pro_V)(!/"IfY lJrwc. S1Iitt' I fI(! 

Silwr Spring MD l090 I 

'~:e<~~: AQjr,'5:, (VR~i • r';l;l.::'VA,<"" ~p~ ~O, 

RecydedlRecydable • P~"k~ ·"d· V(gGI~~le Oil 0;1"-"" !,,'~,,~ lO~c-:. Pt:01CC''1~umN, f',cce~'. cr, )"M.~ F'N' "!CO"}-O 1'(: i'n~0r 

65
•• '"~ '0=, nOM. 

ft Uni:oo Stales o Registration opp Id-l:.ntjfI~r Numb!!-r 

0 EPA Environmental Protection Agency 

W;)shlnglon, DC 20460 i~:~dm.nt 306499 

I , for i -Section I 

1. Com~nylPr'¢du~ Numbar 2. EPAProduc! M~n~er 3. Prop<:tsed Cltl5Ilificatil)J'1 

65615-1 Sheryl Re-lIIy UN~ :.J Rutricted 

4. CompariylP:Oduct {N::Ime) P"' Balk Family Trust D/B/A 5000t Products/Scoot Molo Evacuator Biopesticides 

5. NOI.mo ,and Addralffi of AppliCOlnt 1/n~I(.'de ZIP Cod(!1 6. Expedi~ed Review. In ac:cCt'd.:noo Wilh flfAASec1io~ 3(c)(3){b)(iJ. my 

Balk FamllyTrust D/B/A Scoot Product!!> pnxludis similar or icenti~al in I;Ompo~ilion (llnd 13be!ing to: 

P.O. Box 150501 

Grand Rapids MI49515 EPA Rolg. NO. 

n C{Jed< if lhi& j~ iI nllw addro~& Protiucl Nama 

.: ,-II 

I • Ex;:.laln bol()' .... 

~~ i L responRll)Anel'lC",lletlerdalecl 10 A~r.(;)' l'ltl\!-t" d;,./e;;I Agn114,2ool> Ii 

i i , , , 

E:qJI:matlon: Usc addllion01 pi'lge(s.) U nCC\lse6ll~. (ForsOCliln I andSCCllOn !I.} 

Amendment to label to add changes suggested by EPA lelter daled April 14, 2006. 

, - III 

I, ; II "'"' 

Chiki·Rp-si§tant PaCilaging Unit PtK:~i!Qir>;l W3~er Sol\lble Paci;~gir:g Z. Type 01 Container 

:J Yes· ;~~s ::JYes [J Metal 

X:w x, XNd X Plastic 

o Glass 

If"YQ~: l! ''V"s,- o Pape:r 

~;wtif1t;IlUO~ mUll! Un,t Pu;kege wg~. NI>. pur contJiner Unit P=kegll' 1'19:. No. p~ canliliner o OItler (Spec~y) 

Nat Con.kI!'tLt Ir-Jortnl!tion 4. Si2.&(s} o! Rlrtail Conl"lnor ,. ,. PIIl!ction 

! I ""'" ;, i 

32 OZ" '64 OZ., 128 oz .• 2.5 gal., and 5 gal. ~ 2"'''''' , oro"" 

S. McmMr In WI1Ich Labol!$ Alflxcc to PI'oduCl OUtho;;!~11 oOth('U' 

x P3pern;lle~ 

,-IV 

., "-,- , , 

Niimllo 'TIitl.l (lnduoo Area Code) 

Agentfor Balk Family Trust " Cristina Griffin • D/B/A Scoot Products "' •• 

Certification -..•. i .... ~. 

\he Sliilklrnenls I have ,i , '"' I acknowledge "t an, k~ 

i , i , , • • 

I " ~! K' •••• 

:"(SMnpedl , ~ J. TIU$ ••• • 

h ~~ - Agent for Balk Family Trust D/~""~iOot • • 

Products .:: • •• 

• 

". Typed M.iITlf,! "----.J 5. Date •••• 

..... • 

Cristina Griffin MayS, 2006 ,. ... 

• • •• • 

·1 IR~.'''') ,..",,", , Whit.· EP FlloI5 Copy Y<II~ 

66
~---- --------..... - -_ ... _. 

• 

• 

:'vlay s. 2006 

Document .Processing Desk 

Offic~ or Pesticide Programs (7504P) 

U.S. Environmental Protection Agency 

Ariel Rios Building 

1200 Pennsylvania AVClllIC, K W. 

Washington, DC 20460 

Attn: Sheryl Reilly, Biopesticidcs 

~ DELTA 

II. N AI. YTlCi',L 

CORPOHATICN 

RE: ResubmissioH per EPA Ap.-il14, 2006 letter 

Product: Scoot l\:lole Eyacuator~ EPA # 656.15-1 

Company: Balk Family Trust D/B/A Scoot Products 

Dear 1\/15. Reilly: 

On behalf of Balk Family Tmst Om/A Scoot Products, we are submitting the infonnation you 

reqncsto::d in your letter dated April 14,2006, for the prnduct Scoot Mole Evacuator, EPA Reg. 

No. 65615-1. 

\Ve have made changes 10 EP;,\ fonn 8570-1 and added all the infomw.tion you requested 

in Section III 

• \Ve have added additional "refill bottle" direction language to the label. 

We have deleted the PreeautionaI)' Statements and First Aid sections since they arc not 

necessary for a Toxicity Category IV. 

\Ve havc added the additional wording to the last sentcnce in the Environmental Hazards 

section . 

Enclosures 

EPA [urn! 8570-1 

5 copies of the proposcd revised label (additions are highlighted) 

EPA letter dated April 14, 2006 

If you have any questions regarding this submission, please contact me at 301-652-5495 or 

ciITiffin(ii:dclta-ac.conL .... 

Sincerely. --

G~~~~ Cristina Gril1in ~ 

Agent for Balk Family nlst D/B/A Scoot Products 

"Enclosures 

...... 

• •• 

• 

~ ..... . .. · ~ ... . .... . 

... . . ... • .. •• 

...... • • 

· • • .. . ... 

•••• 

• •• . 

67
I" . 

• 

., 

S'(Me-Ot.-

\ 

UNJTEO STATES !:tN.YIROI'tMENTAL PROTECTIQ}i AGENCY 

Cluistilia Griffin 

Agent for Balk Family Trustt DBA Scoot Mole 

Delta Analytical Corporation 

7910 Woodmant Avenue 

Suite 1000 

Bethesda, MD 20814 

Subject: Scoot Mole Evacuator; EPA Reg. 65615~1 

Label amendment; Application dated October 25, 2005 

Dear Ms. Griffin: 

The application referred to above, submitted in connection with registration under FIFRA 

section 3(c)(5), cannot be approved until the following label issues are resolved: 

1. The EPA Form 8570-1, dated October 25,2005, does not indicate container sizes. 

2. 

The label as submitted indicates two sizes, one quart and 5 gallons. A previous label 

is annotated with the comment thallhe product was to be marketed in one quru1, one 

gallon, and 5 gallon sizes. Please complete a new 8570~ 1 with aU the information 

required to complete Section III. 

~ 

The claim that refiIi bottles arc available in various sizes would be only limited to 

two according to tius labeL Again, Section In of the application form needs to Est an 

sizes of the product, including refill sizes. 

3. Does the reuB container have any additional label language to indicate the end user 

has bought a refill and that the product is meant to be used in the hose end unit that 

ou sell? Are there instructions on the refiJi bottle on altcrnate types of hose end 

sprayers to use and the settings required to apply your product? Ifyol1f refill bottle 

bel does contain additional language or directions for use not on your current master 

labcl, thcn you need to submit an amended label that covers both the hose end bottle 

and the refill boUle labeling. 

4. Your label list the following precautlonary statement: "Avoid contact 'With eyes} skin 

or clothes.'} However, the label does not instruct the user what to do in the event they 

are exposed to your product via these routes of exposure. Whilc the Agency guidance 

allows you to drop the first aid language for products that are Toxidty Category N 

.ot il lll111'l:S c exposme I eI:f: s_ Oli e no teasao _Ot lstlng ptec,alluans f. 11 f h 1-0 In h fi l' . . 

C:OHCUUENas U:~f'lli 

.. :. .'Sli. H ................. ....... n ...... n. .......... n ••••• • .n ... •• .... _ u •• ...... ·.·~H ..... SU1'lNAAE 

Erl( C-

:''-~~ii • ... ................. • ..... H~ ••••••• ................. .. ................ . .............. CI\;T:E 1. 111,,,, . OFFI 

- .. .............. 

.... _ ........... 

FIL op 

68
• 

• 

• 

• 

wish to keep the precautionary language, then add the first aid sl:ltements for each 

route of exposure mentioned under "Precautionary Statements." 

5. TIle 'Environmental Hazards' section should end \vith the following sentence: "'Do 

not contaminate water when disposing of equipment \-vaslnvaters or rinsate:' 

Please eontacl Dr. Todd Peterson. at 703~308-7224, if you have any qnestions conccluing 

this application. 

Sincerely, 

/ 

/-'( '1 {_./ ~--) J 

<JJ' .' "liAt Y! I 'I ( !I .. -,_/:! ':" (L \, '---_--{,A_/vr/ 

Sheryl Reilly, Ph.D., Chief I 

Biochemical Pesticides BranFh 

Biopcsticides and Pollution Prevention 

Division 

69
• 

• 

• 

--------,-",,--,,'-""'-""-

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

Mr. Ronald Balk 

Scoot Products 

Balk Family Trust 

poe 150501 

Grand Rapids. /JJ. 49515 

Subject: EPA No: 65615·1 

'JAN 1 9 2006 

Product: Scoot Mole E_uotor 

Your Application Dated Octaber 26. 2005 

Notification to add pests. apdate storage and dispasollongoogc and 

other minor label chonges 

Dear Mr. Balk: 

Your submission concerning the abo"" chonges for EPA ~ 65615-1 Is NOt 

acceptable as a notification. It requires a formal application for amended registration and 

Agency approval. 

Therefore. the submission will be forwarded ta Lindo. Hollis ta be pracessed as 01\ 

amendment. As reqt.lired under 40 CFR section 152.44 this application to l'&IIiSe.tM lo.beling 

must be approved by the Agency before the abo"" praduct. as modified m<ry ~ be 

distributed or sold. For any questions or comments that you m<ry have ~ this ~ 

please contact Linda Hollis at 703/308·8733. or emoll her at hal\i!l.!~~. 

Sincerely. 

rjL~j k /2~e j sherylll~eillY. Ph.D .. ChJ 

Biochemical Pesticides Branch 

Siopesticides and Pollution 

Prevention Division (7511C) 

COHCUM!NC!S 

S),MSO!.. -,)-tlC 

... ~ .... ' . .-.. ~ ..... .. ..1.S·ift-. ......... h·· .•. .................. .... _ ............ ........... ...... . .. -............ . ............... ::;::,;l'INAME [-i61!CtiU) .. Ru .. , .. .. iTiiTofij" ................. . ............... . ................ ... .............. ..... _ ........ - ................. OA'!"€ 

~I iC./ ilv: 

-

ePA. < orm 1320--IA ( 1. 00) \ ' '! TrW OFFICIAl. 

70

Fll.€. COpy 
~-----------------------"-"-"-"- -

• 

• 

l 

Date: 1/10/06 

Note to Sheryl 

From: Carole P 

Subject: Notification EPA #656/5-1 

This is the notification we talked about yesterday re public health pests 

where we decided these were not public health pests. However, I don't want 

to stamp the notification as OK, until some things are cleared up in my mind. 

a. The last accepted label is dated 2/24/1998. 

b. There mayor may not have been a more recent label but it is not in 

OPPIN, not in our files or in the jacket. There are unidentified 

references to changes including reference to talking points for a 

meeting on 3/14/03 which was to include revising the CSF and 

updating the label per PR notices 2000-5: 2001-1 and 2001-6. [Note 

nowhere on this page is there a reference to the EPA number.] 

c. In this present submission (notification) the unchanged portion of the 

label is different from the original label of 1998 (i.e., there are more 

changes than those identified in the notification). 

There may be a later stamped accepted label or this product which we 

don't have. I'm wondering if this notificati should be administratively 

changed to an amendment: or, maybe we sh uld ask the registrant for a 

copy of their last accepted label. \ 

./ 

"~"" ""-""-------------------------- 71
• 

• 

SCOOT PRODUCTS 

October 26, 2005 

Document Processing Desk 

Office of Pesticide Programs (7504C) 

U.s. Environmental Protection Agency 

Room 266A, Crystal Mall 2 

1801 Bell Street 

Arlington VA 22202 

Attn: Sheryl Reilly, Biopesticides 

PO BOX 150501 

Grand Rapids, MI 49515 

Phone: 616243-9210 

Fax: 616243-5606 

RE: Notification per PR Notice 98-10 to add pests, update storage and disposal, and 

make other minor label changes 

Product: Scoot Mote Evacuator, EPA # 65615-1 

Company: Balk Family Trust D/B/A Scoot Products 

Dear Ms, Reilly: 

We are submitting a notification to make minor changes to the labeling for Scoot Mole 

Evacuator. As I discussed with you recently, previously we had submitted the notification to 

add gophers and voles to the Jabel, but the revised label does not appear in the EPA 

database, so we are resubmitting it. In addition, we are updating the storage and disposal 

language consistent with EPA's PR Notice 2D01..s. Note that since reusable hose end 

applicators can be used with this product, we have modified the storage and disposal 

language slightly to reflect this. We also are adding other minor changes. 

Once you have reviewed the notification, please send the enclosed self addressed stamped 

post card to us with the approval date stamped so that we can verify that the notification was 

approved. In addition, please ensure that this revised label appears on EPA's label 

database . 

Enclosures 

$ EPA form 8570-1 

S 2 copies of the revised label 

S Blank self addressed post card 

If you have any questions regarding this submission, please contact me at 616-243~921 O. 

Thank you for your help. 

sincereIY~/ r'/'" / ~~7 ~ ~ a 

{--f'L' ~ ~ 1~ 

Ronald Balk 

Balk Trust 

Enclosures 

•••• •• 

• •• 

• • 

••••• • 

• • 

•• 

••••• 

• • 

••••• 

· •••••• . • 

• • •••••• 

• 

• 

• ••• • • 

•••• 

• • 

••••• • • 

• 

•••• • • •••• 

• ••• • •• 

•• • 

72
I rr'~'~'~--------------------------------------

_R' ~"' 

II> U'I,I/ld S!~!e~ o Registration opp kk"t1fhor Numtw 

'0 EPA Environmental Protection Agency 

Wawfl\l\O!l, DC 2£l400 ~~:~dment 307012 

; 1 for I , - I 

1. ~r.ylP'C<lI:d N4mb« 2. EPA Product M~~( 3. Propo.Mid CI~wifQlI>:)!1 

65615·1 Sheryl Rollly [JN~ ~ R9~I'iCl!,!d 

4, Comp3I\ytPn.tdu~! ;Name) PMII 

Balk Family Trust D/B/A Scoot Products/Scoot Mo!o Evacuator B{cpesllcldos 

$. N~$.I\d~&oj AppI;cIl1!I (i",:JudelfPC<:><m) 6 Expedited Review. In II~OOIll:)(\C!! wilh FirM S¢ctInn 3{c)(3){bW), my 

Balk Family Trust OIBIA Scoot Produru p<ooue1l$ $im,IBr<)r j~en:jC31 in =XI$~-on a~d lab>!!Ong k'o: 

P.O. Box 150501 

Grand Rapids MI4951 5 EPA Re>;_ No. 

o C/l«k i!l/Iin i!;" fHJW rxklfll» f'tc&.x:.tNII'T'f.! 

- 1/ 

, , 10 Au()r,cy I!!ll'N daloo , ; ~. 

Exp~n"'Uon: the nddil'¢MI~f') i11'l!)Ce!l~;I'f {For $eren I am! Sed"" II.} 

Notification to add posts, to updato storage- and dlilposal language, and mako other minor revlslons to labol. 

f52.48. and no oIhor ~II;m1i1l$ IIav. bun mad. w 1M. , , " pro' d I , Ie U.S.C. S.c:. fOOl I!>wllifutly rruJkl! Iny f.l" stltllmolll w 

~~ ~~~ a" , ~ :and 40 Crn. f52.45, this pn)duct m,y be In v10tlllian 01 FtFRA 

'" 

·111 

. M. ,''" 

Chii<.l-Rfiiirtlltlt Pa<:](aging Un!lg~~s' WMg ~;bla P&ckaging 2. Typ<>oICoo'.M1M 

o Yon" OM~al aNo o PIMlic 

o GlIl$$ 

H "Ye:;: II "Yns: o Pope< 

musf UnitP~.wgt. No. par (m:IDr.er iJrrt P3ckagtl WIlt. No 1:<'>1 contam ;J O:h~ (Spe<;~Yi 

4. $lz6(slof Rulil~ Con:~!r.er " ~',""'l"'" """'~ 

Dt""' gg::,:e:~. . $. Ma/Irlf!r In 'Nh!di LnbIlt I~ AfI'il:&d:o F'rodvct , C Ot~<lr 

~ 

1-IV 

, 

- T:t'e Tnl(JOllOl"l€! NO. {t!\d>.lOO Area CoOO} ...... 

• 

, ~c., '"'' ., , , "" .'o~ Md "'.' , 

CertificatIon ,-", ... :.: 6.p;',-"" t I ncknowlOO;;u It>.nl ~1 kimf """"of 

; , •••• 

(;;;&~( 24 .::~ (Sf.Q1Alfd) 

z, Slgnal\JI1I 3. T~16 

• • 

/ !0 "rleF\T:- ...... • ••••• 

• • 

• 

4. Type<! !-Woo $. Dale ..... 

• • . - •••• 

1Zr;rvd rl ~n 1)( 10 I (}5)~?~?~",,~" • ••• • • • •• • 

• oow',,,. 

73
P/I';'U'"", ... , M "" F~A " OMS No, 2.070-0000 

United Stotell § Registration OF? Identifier NUmber 

&EPA Environmental Protection Agency Amendment 

Woohing!on, DC 20460 307012 Other 

Application for Pesticide - Section I 

1. Companyl?rodlJet Number 2. EPA Product Mtinooer 3. Prcpos",d C!ou'flelidon 

4. CompllnvlProduet (NlUT\O) PM' DNon" D R.;,trieted" 

S. NBtM and Addr$-" of Applicant (lncfudfJ ZfP Cod#/ 13. Expedited Review. In accordance with FIFRA Section 3(c)(3) 

(o){i). my product is simUar or identical in composition and labeling 

to: 

EPA Reg. No. 

D Check if this it; e now uddrQ2$ Product Name 

Section - 11 

0 Armmdrnlmt· Explftin tH;low. 0 Fin&! prin!1I'd !abelt in r.,§pordle to 

Agency letter dated 

• R''Iubmlllllion in rellPomle to ACency !ett!);1 dated 0 ·Me To"· Application. 

0 Notificatibn· Explain bclow. 0 Other· E~ain below. 

Explanatton: Us.additionol plitlelQ} if nee"t!1i111ry. lFor section! and Saction I!.j 

Section • III 

1. MOU.rllli Thk i'Tm:$uet WIU Be f.clc=oed In: 

Child·Resistant Pook.Gina Unit Paekaglng Watlll Soluble Psck~ng 2. TYJa of ConttiiMr 

Er'· - YK 8 y" 

- No No ~M". Plcotic 

No G!a,s 

~tionmust !f "Yrn" No. plfr !f "Yer." No. p"r Papor 

Unit f>aek~na wgt. contmner Paekll~ wgt conta,ner Other lSpceify) be submItted 

3. Looation of N"t Conten!1I InfclTnetkm 4. Sizels} Retail Contain,,' 5. loclltion of Label Diroetions 

0 o Contalner 

E3 Oo""*' ....,,1 On LWlltffno IWOCi'l"ipllfWlng p,oduet 

6. MBnmlr in Which label Ie Affixed to Product = UthoQrGph o Other 

Papllr ~ed ----- Stood "0 

Section . IV • • 

1. Contact Point rCcmpfiJtI iwm diu/crfV bmw fer farmrfr!C4Imn af lndMdu(J/ fo b. cont&Crod, if naee$$l'Jry, to jNOC$$$ this ~I)rk>n.i 

"- Titl. Teiephono No:onM4dll Arllo Coo .. } 

••••• • 

• 

• .. . C ertificatiofl •••••• 

tLoQetll Applieoticn 

! certify that th •• tatemen"" ! Iltlvllt moo"" en this form and an attachments thereto GI<lz truo, I'lccuwto and comt!1'lP~ R',,·c-.Jv&tl 

• • I ad:now!lJd:ge that oo:y knowinch' fuse or mill!uding s!a!mmmt mliy be pUNelioblll by fina or il'r-opriscnrm>Ol R' •• :··fStampod) both undtlf app!ic~ low. • • •••• • · 

2:. Signewro 3. TiUIl •••• 

• • •••• 

• ... • • • .. • 

4. T'{pfl:l N atnU S,DIl!e 

YfIIlow· Appllc.mt Copy 

74
,. _.",-< 

q~~~--~~'~-'~'"--~-----~-~I 

PAPERWORK REDUCTION ACT NOnCE and !NSTRucnONS 

?",bk 'N'Mti!\] bude;') lor lb" cclwe\i"n eJ ,dO/mOl,pi ,~ "'~"\>mn&1 to aNI";';'!! C,B5 hoti' [)N \

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, 

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75
• 

• 

SCOOTTM MOLE EVACUATOR 

:\101.:: repellent 

LU\,I.·ll protection 

Treals 10,000 square feet (per quartj 

Hose end application 

Easy to use hose end applicator 

Use to co'ntrol:[orrc'pel] moles, voles*" & gophers*' 

from lawns, ornamentals and tnrf 

Refill bottles :Lvail<lhlc in various i:::i7.es 

Use with Reusable Ho~c Em! Applicator 

KEEP ot:'r OF REACH OF CHILDREN 

CAUTION 

Castor Oil ................ " .... 100.0% 

/GraphicsJ 

:'\'ct: [32 F1. oz (94() 1111)1 [5 Gallons (8.51iters)] 

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• 

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... - •.... -.-.-.~~~~~~~~~~~~~~~--------

76
Scoof"! Mole Evacuator 

I>IRECTlONS FOR USE: 

fl I::) a violation offederal1aw to USt: Ihis ()roduct in n lOanner 

inCOllsiSlent with ils 13behng. 

USE RESTRfCTlOi'\S: Thl.s product may be used [0 repel 

e3slem moles (Sea/opus aqllim'C/i.I), \'olcs*) and gophers.*-

(rom lawns. ItIff, ol1laml.!lIlals. golf COUfSl'$, and athletic 

fields. 

LOCATING ;'\-rOLRS; "ll:!e presence of mules may be 

indicated by a nc'\\vork of surface ri·dges in the turr or by u 

series of c<mic<Jl I1lOunds of earth pushed up from deep 

burrows. Trea[ all11rcas which show signs ofl1lo1cs' tit presence. 

• 

APl'UCA TlO:"J DIRECTIONS: Shake cont.ainer \','c11 

before using pro-ducL Attach g:mlen hose tightly 10 :;,clfdispellsing container. Tum water supply on [0 full pressure. 

Spray SCOOTm MOl.E EVACI:ATOR over mole infested 

art'a at 1I. rale of 1 qU3rt of product per 10,000 sq. n. (e.g .. ,l 

100 ft. by 100 fl. rectllllg1c). Aqjustthe :.pray non1c to 

'·WATER". Continue to spray with w3ter to S03i:. SCOOTD.I 

j\.'iOLE EVACUATOR i])to the soli. At>ply S(,OOTL\I 

i\'IOLl~ EVACtlATOR ilUll1edi3tcJy lifter the lm~:.ctlce of 

moles is detected or in carly Spring, mid·Summer and early 

F,lIl If tlwre arc moles lIc3rby but not 011 your property. 

11!c;:;c qircctions ulsd (tpply 'to vol~s*'.and gophers* . 

lJRECAUTIONAR)" STATEMENTS 

Caution. A \'oid t~onlact with cy.::s, skill or clothes, 

fE"i'irrmmcllra[ JJa::m'ds' lai/guag>:ls/or 5 gal/OM OJ' more.} 

ENVIRONMENTAL HAZARDS 

Do ]]ot apply directly to water. to areas where ;;ul'f:lct, w3ter 

is prt'sent or to intertiual arcas below the Dlcan high water 

murk. Do not t:ontamin\ltc Willer when di;;posillg of 

equipment wash waters. 

REUSABLE APPLICATOR: Refill bottles 

3v3ilable. Use only with SCOOP:.'l\IOLE 

EVACUATOR Do nol contaminate ctll)lainer 

with weed killers or pe.5tiCides. 

STORAGE ANI) !)ISPOSAL 

Do not contaminate food, feed or \v;.Jt('r by 

storage or disposal. 

STOR,,<;E: 

Store only in original cOJllaincr, in a dry place 

inaccessible to c1llldren ::md l')\'ts. 

IllSPOSAL: 

l!empty:'l'or l;lon~reiillab1c COi)iainers, do not 

rtuse,JhJs ct)ntalner. Plaee 5n'tra.sh'or offer for 

recycling if available. 

[orJ 

For rcifiHabl¢ C91\,iainer;,ufttr'lost uS,af,..e, pl,ace 

in tnls.~"oihffcr,,'rdriCPYi:imidf\n'\',3iiil\)le. 

lfiJUrtly fillet/: Call your locaLsolid\\~.t$te 

agency ,or '1 ~800-CLEt;\...'\JUP tor disposal 

instruqiou's, '!\TeverVlacc unused product duwn 

any 11)door or outdoor drain. 

NOTICE; Buyer assumn; all responsibility for 

s3fety lUlU use not in llccord3nce with din.:ctions. 

ldllllJtjm:lllrel/ by: 

Scom PrOOllC!S 

Grand Rapids. :0,-0 49507 

Telc; (GHij 243-9210 

• • •••• •• • 

*1\ot approved for use on g.O}lher!'. utld vo-1c:; in • • ••••• Califomia. • 

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77
• MOLE 

REPELLENT_ 

LAWN 

PROTECTION 

SCOOT PRODUCTS 

GRAND RAPIDS. MI 49507 

The ground mole is a universal problem. They make a mess of lawns & gardens 

SCOOT MOLE BENEFITS: 

• DISPENSER BOTTLE 

• co-OP ADVERTISING 

ED POINT-OF-SALE 

BANNER 

• DATING 

PROGRAM 

o FREIGHT 

POLICY 

• REFILLS 

-------, .. MODEL SM·llQO 

1 quart bonle w~h 

Hose-end Spray Applicator 

treats 10,000 sq. ft 

UPC II 7·90664·20013-6 

12 per ",st'!. Weigh! 26 Ibs. 

Case size: 11 \? x 24 )( 12 111. 

p~rt~f!. ".Vcighl52 ius. 

r;::.~'{ .,.~as.;:Jzc: 1.1'f.. x 24 x 12 in . ••••• 

SM·1120 

. ft. 

78
~------

, 

• 

• 

-

- 1111 

I I 

"'i~1 

SCOOT PRODUCTS 

GRAND RAPIDS, MI 49507 

..... - , -.,"-"-r=1 

• 

EASYTQUSE 

HOSE-END APPUCATOR 

•••• • • •••• 

• • •••••• :-rQ,OOO'sq. ft. 

••••• • 

•••• • • •••• 

...... 

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79
• 

• 

Carole, 

Clora Fu&ntos/DC/USEPA/US 

01/09/0612:01 PM 

To Carole Po\lordfDC/USEPA/US@EPA 

cc 

bee 

SUbject Re: Public Health PestsGJ 

I do not see in the public heakth list. I'd soy no. However, Chipmunks are, and also Prairie dogs. 

Claro 

Carole PoVard/DC/USEPA/US 

Claro. 

Carole 

POllard/DC/USEPA/US 

Qlf09/200610:11 AM 

To Claro Fuenfes/DC/USEPAjUS@t?A 

cc 

SUctect Public HealTh Pests 

I am workIng on a notification to add voles and gophers to the label "Scoot Mole Evacuator." 

The oi is 100% castor oi!. Are moles, voles and gophers considered public health pests? 

80
• 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D,C, 20460 

SEP 0 5 2003 

Scoot Products 

PO Box 150501 

Grand Rapids, MI 49515 

Attention: 

Subject: 

?vfr. Ronald Bulk 

Your letter dated May 5, 2003 informing the Agency of an address change for 

your company, Scoot Products. 

ScootT~t Mole 

EPA Registration No. 65615-1 

Dear !Vir. Bulie: 

We have noted the address change and placed an note in the files of an of your products. 

\Ve also no red that your current compnny name, Scoot Products, is not listed in tile some of the 

records for these product. To avoid any confusion, we have placed a Note to the File in each of 

your products. 

Any questions you may have concerning this letter should be directed to Richard King at 

(703) 308-8052, 

Sincere!v. 

l~~l!dpPD Biopc5ticides and Pollution 

Prevention DiVision (7511 C) 

lnl0f1".M AQdru~ \URLj· nil:? ,'/www ~PJ. golr 

R«ycl.d':1,,~'{<;I~bl •• f'~nt ... 1 "rtM '1"-')<".':-;'" .-'J Ii!J,;&d :0'0.$ ,,". P,rc,t$.l '''\¥:N MIn"""", :,,". ?,,~I(c,,~urf""- 81
• 

• 

• 

United States Environmental Protection Agency 

SEP 0 5 2003 

Scoot Products 

PO Box 150501 

Grand Rapids, :vII 49515 

Attention: Mr. Ronald Bulk 

Subject: Your letter dated May 5, 2003 infonning the Agency of au address change for 

your company, Scoot Products. :;. . 

ScootT':l Mole 

EPA Registration No. 65615-1 

Dear Mr. Bulk: 

Wc have noted the address change and placed an note in the files of all of your products. 

We also noted that your current company name, Scoot Products, is not listed in the some of the 

records for these product. To avoid any confllsion, we have placed a Note to the File in each of 

your products. 

Any questions YaH may have conceming this letter should be directed to Rjchard King at 

(703) 308·8052. 

Sincerely, 

, /i: J;,{ ~/(, Ili! ~ ·~SilcW.ReiJlY, Chk.' PPD 

Biopesticides and Polhnion 

Prevention Division (7511 C) 

CONCURRENCES 

I ,.,,,see • i .-;~::<: .. .L:Il:H(....Lm .. . .. J .m. -)_...t.·_+·-

: :umvME II. .... ......j!~\~/..ij~.J4).. .L.I.+j~. l ';"~;";m';"""'" _~ 1'~' <V I '., Y I·;!, [ .. ~ ___ .'=_.,_~_.,_~~::_'_"'_' _____ _ 82
.. ~ 

• 

'2, 

"'" ,p 

0 • ~ <P 

• 

83
• 

• 

• 

• 

Note To The File 

We have Hoted the address change and placed an note in the :files of all of your 

products. We also noted [hat your current company name, Scoot Products, is not listed in 

the some ofthc records for these producl. To avoid any confusion, we have placed a Note 

to tlte File in each OfYOllf products. 

Scoot Products 

PO Box 150501 

Grand Rapids, MI 49515 

84
• 

• 

May 7, 2003 

Dr, Sheryl K. Reilly. Ph.D. (7511C) 

Chief, Biopesticide and Pollution 

Prevention Division 

192t Jefferson Davis Highway 

Arlitlgton, VA 22022 

Subject 

Dear Dr. Reilly: 

Change of mailing address 

EPA Registration Number65615~1 

Scoot® Mole 

Scoot Products 

1250 Ramona SE 

Grand R.apids, MI 495(}7 

Phone: (800) 460-7S7a 

(6'6)243-92'0 

Fax: (800) 758-7909 

(616) 243-0606 

E-mail: ron@sc:.oolprodlld:s.com 

Enclosed please find EPA Form 8570~1 to amend our mailing address If you or your team mates 

have any questions you may reach me at any of the phone numbers listed above. 

Very truly yours 

Ronald L. Balk 

1m" ..... , I '\ MailiJrikr 

Gardening . . &sfJciatio',/J) I 

• ••••• 

• •• • • ....... • .. • ••• lO' 

• • ••••• 

•••• • • ••• • t iii •• 

• •• •• • 

• 

• • •••••• • 

· .. •• • •••• 

• . .... • • •••• 

• • • •• 

85
@'J.~ . . . . ~ " . m.., No. ,..,US 

Unit&d Stalo. r;] Registration 0"" idantifillr Numb.t ,s,EPA Environmental Protection Agency [j Amendment /j r<IOs:r '7 "7 

WOlhington, DC 20400 Other c!.b , , I 

I , for , . I 

1, COfT\PMlvll'rl'lduet Numbor ! 2.. EPA. Product MftfllI<J(H J. Propolw Cl .. siflcetion 

EPA EST. 65615-MI·02! EPA REG. 65615-1 I Sheryl Reilly #91 ~NortO o Re.tri<:t..s 

4. Comptlny/Produet {Nam&) 

Scoot Mole Ip~~lC 

5. N&me and Addr." of Applieant 'lncludfl zrp CcdtJl 6. E)(tadited Reveiw. In accordance with FIFRA Section 3/eIl3) 

Scoot Products (bWI, my product is similar or identical in composition and labeling 

PO 80x 150501 to: 

Grand ,= MI 49515 

EPA Reg. No. 

r-;; Chnk if thn is. n,w.~ Product Name 

• II ! A~"'m,"'· "",,"" .olow. U Fin. printltd label. in repllon;o to 

0 AiGney lllttar del&d 

Auubmismol'l in Ie-sPool. to AgOMy lett", dotlJd. ~M" Too~ AppliclIlion. 

o Notification - EXphtin bolow. 0 OtMr - EXplnin bnlow. 

I Usa tldditionlll p4geltl it nec.Jury. (For loetlon I alld S"ction Il.l 

New MaiJing Addre$G 

-III 

ii~ ;w;" .. 

Packlgit19 U~ Pock&ging ~or Solublb Psckaging 2. Typl of Contlriner 

t. ~::' I-- V" ~ Yu M MIIta! P No P No [j "'estic 

mU$t '!' ~y~,O. wgt. elOnt";lUlr 

No. ",r It 

P1Ick.go 

~y",~ 

wgt 

No .• " td~:: , I 

!3. Looodon of Net 14. 51"", .",' of Label 

II" ''''''' I 1 4 Ol,,160z., 32oz. I f.=l Bao' 

i 6. Manner in Which Ltlbel i, Affixed to Product 

~ [J Otfar -

I' IV 

, p~", , ",,,,,-

iN- IT~' ! T efephono N, coo.l 

Ronald L Balk President ; . 

• 

. :-.... Certification • : 

I certify that the steumenta I hew mad, 01'1 this form and aU ,nachmont, ttaroto ale truo, accurato end effl,ne. • I .cknowllld~ tt"t !lIf1Y knowlingtly rol.o or mid,eding ,tlOt,mont may be puniohebla by fino lOr Itnprio~; or··: 11'....,...1 beth under eppllcablellw. •• • 

• • • 

C:~#~/-/~ . ; . •••• 

3. Titlo ••••• • 

Pmsidenl •••• 

• • •••• 14. TypwN_ S. Ooto • • • • • 

Ronald L Balk May 5,2003 •• .. 

;;-jS7O:-, ·IRlv. ........ . """, Vdow· 

86
d. ,. 'YO' 

Umtoo Slah!l$ Registration opp Id,,"tlfi .. r Numbltr 

&EPA Environmental Protection Agency -

- Amendment 280877 W,ul'lingtOIl. DC 20480 Other - lor - I 

. CompenylProduct Numb.t 2. EPA Product Mao'oar 13. PrOP(»led Clolllsificalion 

14. C<:>ITlf>enylP«xhlot INSI'M) PM, Sf "OM o R,,'(rn:t*<l 

I S, Name .. rod Addr .. u of Applieant flnclud# ZJP Cod.; 6. Expedited Review. FIFRA Section 31cH3) 

(bj{iJ, my product is similar or i in composltion and labeling 10, 

EPA Reg. No. / 

o ChfiCk If this h: .. now edr./res.s Name L 

"II / il A~oom,"I' "", •• b~ow. D I=l....! "~Z...(labfllll' in re3j')0ntt to 

detm.! 

Resubmiuion In t •• pons .. to Alleney lotter dllted 9;::'-' A,.,,="o •. 10 Notlflootioll' ExpIGln b .. IQw. [~1 Explein bolow. 

Explanation: u .. addltianlll pcuola) If neCltllS8fY. (For section I and .I. 

// 

.-

/ I - III 

h. ,- din, . Chlld-Rui;t&nt PacKaging I u~ Peek.ging I ~t Solub{a P#.Ck&ging 12.l ~ By'" YM rYe. Mer..! 

t- t- Plastle No No No Glilln 

i~~;~/ / No.p(l~ 

~ ,:I!~: wat 

No. pet Popet must w",. C(FntaitlGf container Othrtr 

"" , 

I'D "",:01"'" 0 > . 4. 5'"", n .. , I:::::J o~°.'..'i:" On l.w,ding accompanying product 

S. Mtmner in Whleh/~i$ Affixed to Product != I~' o Other . 

/ Section ~ IV 

! 1 ,dk~tly •• lew. of indb,Mu$l . ,. p~,- "'" 

Name Tit1. No. (lnclool) MOil Code) 

Certification •• D",t. Appl,c6uon 

I certify that tlu $teteJTl<)ntll I Mve made on!hi§ form and ell attachmentll tlwrbto me tru." IIccut~lte lind campl&{o. Roeoh/$d 

I ocknowlodQ* thAt IW'IY krwwinWY hils., Of mid&ooina lItatllment mllY be punidwbie by filH! or imf,:II'l,onment Ot (Stamped) 

both low. 

2. Signature 3. Title 

[4. Typed NIUll' 5. Date. 

EPA !Relf.3-94) , editions .rc "usohh. Whh. • C"!'y , Y.now - AppliclOOt Cop\, 

---- -

87
PAPERWORK REDUCTION ACT NOTICE aod INSTRUCTIONS 

PAPERWORK REDUCTION ACT NOTICE; Pubhc !'I'po!ting bUlQon fo! this c.oI!ection o::f informa\!on!~ fllHimlltoa to eve.!!",/! 0.85 nou, I'll! 

Ili>ijpon$a, i~r.g tima fOt revi1l!wing iMtructm~(chiilO Ul5tinO data $(ul'cou, I}I.IthlifiOl;! 3M maint4irnng the datil 1'1'»411111, i!l1'ld comp"~U'llllnd 

feviewing the ctillection of in((Hmetion. Send CO~IlU '"gordiI1Q the blJrden estimate Of ellY Olla. up .. et of thit coUoction of Information, including 

$uggmiortll for fedud!"ig thi~ bUHler'>, 10 Chh,r, InfcrmM1()n Policy 6I1HI~h, (213e), U.S. E"mnr()l\M(intal Protect";!,, AQ'l"ncy, 401 1.1 Street, SW, 

W&thin{tt()fl, DC 20400. 

INSTRUCTIONS; TN, {(}1m ($ to bOll used for aU GPplic1l!tlol"l$ ((,>I now feIPSl!ation, end UJe !1I!o!}inr&tion, INnend!"flent, (&wbmiU!on, to appfoclII;ons 

fO( n<)tifieatiOfWl, fiflo1 pnl1lod latalling, re!!lllil>Vl'Ijion, otc. In crder to P!OCUS en Dpp!ilalition fo' II new .egis\!stion 8ubmitted on this form, the 

f~lowing malftris!mu.t 8o/)'wfl,umy the applioation: 

1. c.rtlfioatioo with RMpo;ct to' CiteUon of Oeta (EPA Form 8570·291. (I( not exe ... ,pt~ by 40 em 152,81 (b) !4)j; 

2. Conf'kftIntiei St!rtMrl6nt of Fcl1'l'lVfa (EPA Form 8510·4): 

3. F¢rmv\etor', Exomptlon Sletomf>nt (EPA Form 8570·27); 

4. Ffw eopi •• of drllft labeling; 

S. ThfN copi •• of any d5t& aubmitted; 

6. Authorization lener wher. applicable; 

7. Merrie" WMto It9pl'¢&ble. 

! """mi •• Ion 01 ub.rlflil . Loheling ehauld timt be SUbmitted it> the form of d!aft fabel" with 1Ii~ appf,cstionu fOf rn'IW reoietretlon. Sue" df8f1: fabe!s ffillV b" 

typ(td Ia!»! h~X1 on 8.5 x 11 inch peper for "ubmil/mon O! II fl1()ckup of th$ propeeed litho]. if fHepllfod f(>! mockup, It ehoukf be I 'o~.,'u,' .. in II wey as to f.dlitlllO :!'IIO!ege in en $.5 x 11 inch file. Mockup fabels ;igrnfieendy smel!er than S.5 J( 11 (neM$ Ilhoukl bf! meunled Con lUi 

p~r for subrnistion. 

'Svbmi«iw •• ft .... - Det!!! $ubmitted In support of 1hi, application mUSI eli' subrrin'lld In IIcc\"danCII with PR NoticII 86·5, 

1~i!?'OJ;"!'K;jf:lj1:1:JiI1J;;]~l.!l~;.PICa!!e !1I$d th0' in!!t", .. "tion~ IiBt.a bolo-w b.lo'lj compfeting this. 'ppilcat;on. Fir~t C'lII€ltl"nIrn.> tn. type o( 'IIQi;tliltion 

in Blocl: A, for YOl). ere $ubmittmg th<g eppliC5tion, For epphcations subrnit!I){.! in Cl:!rm~Cl!on wijh Now R<:IUi5tllltio;lr'I &etwn" S''''''''I 

IV mtllt be cOfI"of'III!ed by the ;applical1t. For ;appliclI!.i(}l"I~ cubmitled 'n OOi1fl!jction with tlIm"ncled !O!I!>Il;$lUIi!on iIIIctior.$, !c~ubrnl.uicns, I "o"".ti~", nusWstratiom:-. etc., Sections I, rr. IJm! IV must b", compl!!teo by th!l f!ppi'cant. 

A· CMeO: thfll Ilpproprisle action (O! whiCh 'i(>\.! e!1\" S\JomittioO thd'; form. 

1~""(;Jrnl.!lu· Thi .. uetion mUll'l be ~ompllltiIKt ., appfj~ahfll, te! 1111 'eW$lHI\'On actiona, 

Comp<>ll'f/Produd Numlar· fmHlrt yol.lr Company Numb"', ,f 011$ Mil' blllln Gui"IIfIQ by EPA. This "",.nbC! mey haV$ been aClionOO to yoU 0; II 

blWic regilit/lilnt, .. diHritnJ!oT, o! /H, 81\ ,utabiishm'llIlL If you' p!oduct is r.,-gl&!lUmI, intll!1 tho Product Numt>lllr. 

EPA P!oduct MIII\$QIH' I( kl1own, flfl ;n the mlJ"~ eml PM numOff of th¢ EPA Product tm!nt:lGIH. 

f'rg" ..... d ~!f!e!!tion . Spncify the p!epOM!d cll!!W;(,cation of fha; plOduc!, 

Product Neme< - Enlllr dw comp!!!le prOO\.lC{ nome of !h,~ pe,-Uc,de liS it Wii! tlppG9r on the hID~. Tile f'l&!'nl! mutt be I!j»CIfic to thlll p"x1uct only_ 

Oup#c&tion of namea is not p'I!fmillml 11m::",\) p!educt!!' 1:\f th" lH!!flij comps,",¥_ 00 net "'cluti!> "ny t)lsm! rIl'!f'f'# (lr compeny ""'" dSj)i\lnbul}M 

He""" .wid AdOrNs of App!;C6!l! . Th", ~ ¢f lhll film o. PNMfI end .. ddr<l~" tho ..... n Hl YCW (lppi!cllt!(H', III the p..rsc-t\ Qr firm fa wham th~ 

fcQJiftrauon wi!! bo ,ssvod, tf yt>u af. a<;ti"iJ '" h .. hl)1f <Jf 4noth~! pa.ty, you m\tst lll>Jbrr>.1 lIu\hcnut'oll from thllt p.rtV ti) act io. tMm In ro-gillfiot.cn 

rN;li!!!iJ. An appfiC4f'l1 not Hwidin\) in tM Unit",d Slaton!- mun tl{lV':' lin ",lItho.ilW "'>I"m m~K.hn", in thtl United Sll1!t"g tl:! 1101 for them in ell 

r.:.gi~trlUtloflITUmCfS. Th1ll nom!!; ,..,'\d c(}mp!(\($ ma,!m\i addrnll of such IH1 at/cm mu~t eccorr.p .. ,.,y thill app1icetior!, 

6. txplHllted Ravfow, F1FRA lHICtlOtl J (c).3 IS) pW\f\des fo! exptdJled !tiviaw 01 applictltillnfi to! !~Q;SHtltiOfl, Of am",mlmlJll!S to ""t'i'.""t'''t,,"~ 

'.NIt are olmilar Of identk. to elMI P;.Iti!;c!de- pwriuct$ thll( ele CUrrlHIUy !'(!ols\er&\f with tt'll!! I:?A, In orCOI fOf y1:KI! cpplieel10n to bo $i'aible 

expedited. rllvi."", 'IOU mutt pfOvidc UI> with th", EPA ReoiIl1l01'0f' NUff'.bM "'tid P!¢{!uct l"IbITW of the t:uwuct you Wieve ill $itTh!~1 to o' :jt"ti~i!1 tQ 

yOU! pux:\uct, The PHWUct mu&t b-e slmihl! QI ,,:lllntic,,1 in both knnulation and !&be!ed. \JiM. 

1. Subioct of, .ubml.t.lon . Check th" IIpphcli-bl .. block lind p,,,,,,do th" Agef'lCy I"UII! dllte it cpP!oprillte PwV!dm s tHief eXp!i:mation of th$ pu.pc~eh1 

I", th<l submiuion, $u.;h 0$- ~th., addition of I) 1>i\ .. , put 01 (!OP (,p~~,iVf·, ~Qm"nd the Cordn!flutial St",!~"'ent Df F(umuis by ".; ~!>:t,,,g'$\'II!j<l" 

.ru~n~: .0"'M!!.u 1&b51 .t}Y!!Uon of use dicllletions." Attach.m allpeli"te pllc@-if add,tiol>l!! Sp&C0 ,~ Mlldad. 

~~~~~~, {Peeks!}ing and CQnrlliru)"f Info.ml!tioni· Tbe S(!ct:~m m'.l~t bo comphltod tor ali apphc"'lli>M s1Jbrr~jted in connection with ~w Of eppUubl. amer!dmen~. 

1, TY'P* of P"ekaomo' Chock the epPHIPfilltil block if YOUf Pf<xlU~t "",If be plleb.lQod or> the in:!,c"'!"..! PIICl\{lQ!nC t¥pell, 

Il'Idfcetl!i tn. $llt of ttl.:. ioolvidu81 packet, tloo /"lumber p"! r!l'taif Ct;mtmM!. 

2. T'fP'!' of RetmIJ Contaittor· Ind'clIl~ tyta or corlU;".! In wl!,eh p'Qdu~( ,....il b~ mafkel&d, 

3, lCGation 01 1'41>1 Coot&nt=· !rn.l!Cl!to !.hit looatie" of the net Qontcrl"lU m!oll'T»ltion lor your prodUct, 

4, Sizo!.! of Retail C¢lltalm~! • Sp~Gif'( Ina riM ':WlHents ot all fMoii contIMnlHt IQr YOlit proouct. 

'5, LOe8tKm o11..Ju OiraeUcrno . Ir.dio(!tt} tilt !ocllti{Hl of tflt< uS" dH"ct,orlll fer ',IoU! PfOducC 

5. M._1n whicll ~! ill aHlxfid 10 p!odUel . !rvjic;lteo th~ mothod IHodun lilbef IS etur.hed to rlll!<ii tontaiMf, 

1·5. $elf·oxphtnetoty, 

(L EPA U •• Ort!y. 

88
M. '0 , Unl1w Opp W.ntifl .. r Number StlileS' Registration &EPA Environmental Protection Agency - Amendment ?0::0877 Wllti'JngtOrl, DC 20460 - _ 'u " 

Other 

for , - I 

1. Comp&nylProo."ct Number 2, EPA Procluc1 M"'rmgllr 3. PropOlied a"'lIlfiClilion 

~- DNon. o fllI£tricl<>d 14. Company/F'roduet (Name) PM' 

S. NIIm& $ltd Addrll" of Applicant (mchKIfl ZiP Co(/ej 6. Expedited Review. In accordance with FIFRA Section 3(cli3) 

(b!iil. my product is similar or idenHcal in composition and labeling 

to' 

EPA Reg. No. 

neh , IF th/$ is a new addrass Product Nama 

1 - II 

~' AnmMm,"" E,,,,,," ,_ow, D Fin"'] printed lab.11I in re";'ponn to 

Agllney letter dated 

Rnubmluiofl in re'pmWl& to Agency fotter dlltoo D BMIt Too" Application. 

o NotifieDtion· Explain bo:s/Qw. D Other - EXpl&in below. 

Explanation: UlIII IIKIdilional plIoo(ol If neCIt!:s4ry. (For section f and SlIcti<ln II.) 

1 - III 

, 1. M."ri" Th" p,,,,",,, WlII .. 

P~flfJ lu~ ~r Scluble Ped:.aQina 2. Typa of Ccnltllrwr 

e- YIII" Y •• r-- Ylle 

l- i- - ~~'. PI •• tic 

L.- N. N. N. Gla:: 

~~T~: No. p .. r 1 ~:~ wOI No. per Papor must wat• eontairar contairwr Other (Speelivl be submitted 

3.1 . 

o C<lnairuH 

14 ."",,) ,,"" ~,~:.i,,!" o Label ::3 ~: t ... Ii". 

6. Manner in Which Label is Afflx&d to Product 

~ U OmlOr 

, -IV 

i L c,",,,,".'", .1,_, ,b, , ; If, " ", ,ro,_ <hI. 

N_ To", No. (Include Area Gt>clol 

Certification I G. ?Ilitll!l Appfic(lticn 

I cllrtiiy that the Iltatllmenl$ I havo moo& on this form end sli IIttachm",nts tb6roto lire tlUe, acCllr.ili11l and C~(ite. Received 

I eeknowledQ\ll th4t any kncwing!v f&I'II1' or mi,llIadina natemnnl rt'.ey be pUNthaWII bv 11M or imprisonment Of (Stamped) 

both under lew. 

2. SigNiture J. TIlle 

4. Typ,d N_, 5. Dau 

EPA Form 857(1-1 mev.6-94). , edition1r ,mll wtm •• EPA RkI Copy V.now· <Cop, 

89
PAPERWORK REDUCTION ACT NOTICE and INSTRUCTIONS 

PAPERWORK REPUCTION ACT NOTICE; PubliC r«porl!l'U );vrd1fn lor Ihi~ collection of infenTlllI!M ill .. t<1Imlll .. d to I\ve.raOt 0.S5 hour P'" 

r"'~IXH'=., ine1udinO time for roviow,flg lrn:truc1;Q-"rchino ""xi~tir->Q ClIla source!:, "nllwnnQ 11100 mnintnmino tho claw needed, e.w eompleuna ~nd 

i e~lect'on of inbrmf<tion. Send comAt.!n!!I rtQ<lrdml1 *. bYraMl .~tim/l!e or any olMr UP$ct t>1 thi~ coli.ctlon of in/<:;m· ... !\ion, Includ,nQ 

re4\Jc1nO th;~ burden. to Cluet, Informllilon Poli~y Crllnch, 12136!, U.S. !:nvi'onm ... ntc! Protection Agltncy, 40 t M Street, SW. 

, DC 20460, 

~~~~~:~~: Trull: form ig to be u~l)d for all "pp1iCf<tlC.O$ fer ,,\)W r .. gl~t'ation, ern! ;"" rltrog,$Ir!ltlon, 1'M'I»OOmMt, rONbrrd$ion, to 1l!Ppilc~tion' ler I final pnnte<! loo",lIn\ll, f6regj~trali<ln, .. tc. In older!(j process an app!lCtfben for e ri(OW rel,li$u"tlon ltubmitt(j;(j on lhill form, tta 

moterial must toCcomplinv tho appiic!!!!on: 

1. C .. rtificetion wtth Rup"ot to ChaMn of Ollila (EPA Form SS7D-2!H. [If not ~"empted by 40 CFR 1s;uii (b) 1411: 

2. Confld .. nti61 St1rtemefll of FOI'lTlUI" IEPA FOHn 8570-4); 

3. FofTnU!ator'1I £X~tioo Stalommot IEPA Fo,m 8570·27); 

4. R .... coplu of draft l.weti"g: 

5. ThfHl CGp<'l1l of CflV diltll IItIbmittod; 

S. AutMrizelron IlIIn"r wiwre applictlbl",,; 

7. Matticee where applicable. 

'Sob"'UI'~ of Lah.nl'lg· Looo!!no &no\lld fl'''1 btl s\.!brniU(Kj In th .. form of d, .. ft Iw"l$ w,th 1111 ",pp~ic .. l:"fl$ fer new r.,g;lHf$1.lOn. Such draflloo&ls may b .. 

ill th" fOm! Gf typed loo!!! till<"!; on 8.5:;: 11 inch pepM for II\.!brniMilOt> (If e mockup of the prGp01liW lab.,l. If pr"par&d for Tmlck.up, it eMultl bo 

. in & w"Y '" tCl fllc,IiHlIta s\t>reQe in an a.s x 11 Inch fiiJl. Mockup 1"001$ s,gnificantly smailer than a.s x 11 inch"" should b .. mcuntMl on Ix 11 ,nch PIIP'H for lIUbminion. 

of O,nll" Dlltll submit\&d In 9uppnrt of thii application must b!l $ubmittlld in IiIC(;OrdllnCe with PR NDlice B6,S. 

1~l'J"Jt!(;J!tiJgBlJl;:r]J;t!J§;', Plr.ulO rud the in$uuctlor.; k%toWl b"l<>w b~fol" comploling th,e "Pr!!;;"I'on. Fir~t doH$rrrnM In. typo!o of reWr>lOit.on 

I~c,~,on. lined in Block A, for which you tire IIubm'ttino thl5 &ppli,,"'tiofl. For app!iclltion~ l!ubmittoxl in ccr.n""lion wilh New RD;;p~lrlltion actiOns, S~"tion~ 

f ~ .Iii. tim! IV mutt hll c<>mphnfti1 );y the applicl:lnt. For appiic(\!,ans lIubrruttoo in conMnlicn Willi amended t!lr"(li$t(l!ttiofl fld:tI!H"':, , .. :ubmiu10nt. 

nNilicmti<>lW;, rDregist~&tionz, ole" SlIction>l> I, ii, end IV mu~t b~ cumpieted by the app!'cQnl. 

8k>clo; A ' ChllCK tht epproprl",u eetlnn fe' which yQU MO!O ,ubm,ttmQ th ... fQrm. 

IS§Jd]J;t!JUl.l- Thill eeetion m'.lst be ""mpl!>!\ld,@sapp!iclilili!,for all ~"\p\l1l8Iian actions. 

1. Comt'"",yf?tGduet Numb!,,· In~crt yow Company Numli!\!(, il one hIlS b()6n M~icrMd by EPA. This n",mber mey IH'Vtl pt>on I!nil1no(j to yo'" '''' § 

p"cic rtgi$w:mt, II dhnributor, or u; lin e~labli$hm~nl. If your prcduCI i~ reo'na,ed, IMfHt thlJ PreducI NumtHH 

,2, EPA Product MsollgGr· If kMwn, iii! In the 'lliffil! end PM number of the ePA ProducI Menager. 

3. PrepO$od ~ ... Wm3tlon . Spe;:ify Ih", prop,,*ed cIIlHifia(i!,on "f tru" pHxbct. 

4. ProdUct Natrn\ - Enter thi). ecmpl!tte rmx:luc! n!Hv .... 1 of true p"'''\lcicil! M It wiil epp~er on the I"bel. Th" !'am" must b<o "P«l,fja IQ thig P«'X!ud only, 

Duph:;tltion of fllmHHil !@ ",.;,t pNmin!>d ",m(lnll plOd"c\s of H"" IHHne u;mp1lt1Y. 011 not Include IIny brend f'illffill' or company ~n!!l d."ignauoM. 

5. N,,;rno .l>nll AdJ, ..... of Applioant - Th" n>!!m" of th. hm or P!WHHl "rVJ .i!Kl:hn!O shown ill VelW &pp1iolit'on lit th" P"l$O!' tn fiM'l 11' whem the 

r'il .... twt!Q" will be< iU\Jod. if Y"'" IH!!IsctinO 1'1 beh"J! 01 anDtiH'It Pilrt'i, yllu m\J§\ m",brml .. \JIholi~et,on hom th.t perty fO (Oct far them in r,,\;Htral,;;p 

rr-.eU"ra. An t1pphc&nt Mt reJidlng In t!Vi! UniHid 51",1,,9 own hllv" 1.1('l fIAJlIH')(il'l'd "i;l~H1t fe~id,"o in 1M Urule4 StatU to 1'Ict fer them in ali 

reC'GtuHlon mattel$, Tm n!)flVJ end compl!llle meiil11J edCrtHi$ of H)ch lUi I!QI!I1l must ec.:.omplinY !flit l!l1'pliclIll!:;n. 

6. ExpedluHj R.0111w· FlFRA ~tctJon:3 Ie) 3 (81 prOvide!! lor $Xpta.tw rtvtaw of epphcauons 1m r",iHlst,on, Of Mn(loome-nU to emilD"'" "",F",. 

thlit I"" !limier or Klentico/ Ie othe' Pl1I1tUCi;:l5 predUCI!! that J;'I! """rr~ntlv rf\:rnM~d w,th tM EPA, In crcer for veur $flrl,cal,of! to hI! ~'Wbl~ I 

expedil" r608 ..... , yo>J mu~t provid .. u~ will, tl!" r:rA n"Q'4tro':!(i"n N;lmber $00 plOdm:t!"H!ml:! of thll prodeJCI yo" bmiav<l i~ 1i1ff'~tl!r 10 or :d'H·,tlCilll0 

yOU! proouct. ThJl pmduct must b .. $,mdtr or ;O",1)u",,: ,n both fe'nwlst,,,,n and Isb"led u,;e". 

~:~e;~"'.!t'· n-,;,. ~6ctl<>n moJlit b .. <>>;>n1pI .. tw !e' "jI "ppiic"tiOI"',~ $UtlmitHiC to ..... "'00 lh1l> '''o>strl!ti(.>n only of " <:urrsrdy r!!'(I!1l't*'l!d 1',,,0'-'<:( 

, for a f .. submllieion in r~ .. ponu 10 ~n Agency I"'IG(, 10, n":';!ic!ltion~ 10 1hl> AjJ~n<:v, fer lh", ~ubm,..,,,::;n of fm"t priM~d I,.t.. .. i,,,>!, rN 

rer">I,llllllltion and for .any otiwr 1II0tion thel p",n4,n~ to ... 'pe;if,c r;f>A·r~G;$IM"d rr(>dHt't. Thi~ §1!clion I~ n£! 1Q!1!>: ,.ned for .. "",w applicelien fo' 

r&ai$tr&tion. 

1. $ull]"o:t of slJbml""I<)fI • ChICk tn .. &pplwebi1! bk.>ck nnd prO'm:i8 tile Ag"ncy I<ln"" tj,n~ If "f'p,,;priuta ?rc\~d" a t;,"oI'! o)(plan"t'oo of Ihe pwpMgr~1 

for the suhmiuien, tlwcn l!5 "It", IOdd,tion 0: 1I Z',le, pen 0' <;r<;.p 11l;1!!coiv1": ·lim~nd Ihe Con/odenhn! Stln.,meM of Formuia by .. ": "re'eG;"trnhm 

wbrr>Jui{!n~; -11*rilllr$l 1d>~1 r(lyoman of uce dIH,ctions. ~ Anllch <I sepllrm<:l P308 il eddaionel 1!paCII is riecd1!d, 

SECTION II! IPaek&g;"O and CO!'ltaiM( Into(1l'-iltknj . This Sntl"n muat be ",omplelt!d IN en 6Pplicn:'om lI.uuminf!{i in cOflnacti(m with n'!lw 

r.,gi;tnHio", IH $pplhIlOOI{! aMfloomentD. 

1, Twa (If Pacll.liIgmg . Clm;;k the t1ppropriule Lloek if your p,,,ducI IN.II bfl packaUI'd in th" ,fld,!;atl)d pud.ag"'Q Iypo~. 

Ind.eMt tlH' ilill) of thl! ioolvidtJlll ptcl:ets and number per roted cont6innr. 

2. Typ1i of nelaU Contelnor' Ind,calD typa (If COM/Hntr in wruch producl will hI! malk .. ted. 

3. L<>miIIICfl of N.t C<)fIl .. nt$· lookata tn. fo~a"o" of thi! 1',,; contento:, mlotmtll,on lor your product. 

4. Su:e(a) of R.w!l Cootlllnor· Spoeifl' the mit coMenh of ell rot&1 centmners for your prodUct. 

S. lOellllion <If Un Oifoc1lom: • Indi:;;lJt" tha loc"hon of the u~" d,rections lor you, product. 

6. Mmn.r in whien labal. afflud te. ptodUC1· Ind,clllcd Ihe method prodclcI Illbel IS afteth"d to r"t=il contalnllr. 

1·5. Seil·fI::.:p!lIinatory. 16. Ef>AU .. Ooiy, 

90
, 

t 

TaJking Points for S1:'·' -'1', ",,, '\ ri·! ,:', Marcil 14,2003 

Method ofrcgistr::nio; 

Data Matrix: 

Pby;..;ic' 

.\1'11lu[;> ! ! 

i\mli)li 

TOXICI1, 

CSF ~ ~\>tllSl 13c Rcvi,,,, 

Revised product Illlic-!; 

- ',-I: H 'TS exemption since you are not llsillg a registered 

-:<-,_! dl) or 100%, repack. 

,lcClivc I'vfetbou (their own data for P Chcm and Cite 

. l[' Tox). 

P,IY ~ Data Citations are oJder than J 5 years. 

',,',' Ural 

\ '- _ - Dennal 

-:Ul!ion 

::011 

; irritatioll 

k).6>_~v~ 

: 1 (JI/21/03 

dliceS 2000-5 ~ - Guidance for !vfLl11dilory and 

,< :.lotice 2001- t - - First Aid Statements on 

'<orice 2001 ~6 - . Disposu{ tnstructions ror Non-

- :~ti;d/Hollschold Esc Pesticide Products 

'.: in Ltr. Oti/21i03 

91
Pages 92 through 95 contain internal deliberative information and are not included in this copy
&EPA 

Unil.c SIlIU~ 

Environmental Protection Agen,:) 

om"", cf Puueldo ProgTtll'ml (750SC) 

Wachinqton. DC 20460 

NotIce of Supplemental Distribution of a Registered Pesticide Product 

a re~istrant has obtained final reaistration for the basic product, the registrant may then supplamentally 

I his/her product. One form must be submitted for elK:h distributor pfoduct and must be s.igned by the 

involved. The basic registqjtion number ~tnd the di;tributor comp.ny number must be shOwn. 

~i;~tri~~~~;'~~, has a potentitll distributor who does not have a company number assigned. shelhe should h:a...e the 

apply, on IGtterhead stationery, to the Registration Division to have It number assigned prior to submitting 

to the agency, 

I Notice of Supplemental Distribution must be submitted bv tho basic registrant. The completed form must have 

and signature of both the registrant and the dis.tributor. 

I 

Note: 00 not submit di!>tributl)r proOtiC'!. IDbe!s 

(Typf'; ifl#l.Id# ZiP cddv) 

~op<l.s _ > """- G."-,,v",---\':c,,~_ 

",,("{ N(YH ... _ \...o("'!sJ S-t 

LJ,I, J"A /7 Stf 3 

• •• 

•• •• 

• • ••• • • • 

••• • 

• 

• ••••• 

• • • • •••• 

• •• 

1, The distributor product mUSt have the $;lime composition as the basic product. .: •• 

The distributor product must be manufactured and packaged by the same person: who manufacttVep''ld packages 

the- registered basic product. • .... 

The labeling for the tUstributor product must bear the same claims as the basic product, provided, however, that 

specific claims may be deleted if by doing so, no other chances to the label are necessary. 

The product must rQmain in the manufacturer's unbroken contaiMr. 

The t3bel must bear the EPA re:gistratiOl'l number of the basic product, followed by a hyphen and the distributor's 

company number. 

Distributor product labels must bear the name and address of the distributor qV2!i1!ed hV such terms :<:> ~packe;j 

tor ... ~,"dlstributed by .•. ~; or "sold by ... • to show that the name is not that of the manufacturer. 

7. All conditions of the basic rt!lgistf3tion apply equaUy to distributor products. It is the responsibility of the basic 

r6Qistram to see that all distributor labeling is kept in compliance with requirements placed on the basic product. 

DistfibutOr 

Reg-istr:lnt 

(f1prf}fJ fhM IfiO dislrlbuMr ,.,,,mar! shnv" In/'r disrriblJrf1 Imd Stllllhl> OI::rribl.llor Prot/lICf $pfu;lfiad .COv,,_ $ubj.ct Ie th" OQndi!fon:l :lpf!CififHi oe...lf.is 

Nar;c.,. 

EPA POlm iS70·S (Rf!IJ. 5·94) WN(e· EPA 

... 

96
• Environmental Protection &EPA OfficII of Pes.leida 

WlIshlngtoh, DC 20460 

Notice of Supplemental Distribution of a Registered Pesticide Product 

a registrant has obtained final registration for the basic product, the registrant may then sUlJplementaUy 

i histhar product. One form must he submitted for each distributor product and must be .signed bv the . involved. The basic registration number and the distributor company number must be shown. 

~:,~~~~:~a.:~ has a potential distributor who does not have a company number assigned, sheJi1e should have the 

apply, on letterhead stationery, to the Registration Division to have ill number assigned prior to submitting 

to the agency. 

Notice of Supplemental Distribution must be S.~I,,,,~;d by the basic registrant. The completed form must have 

concurrenc& and fiignature of both the mQisUant distributor. 

Note: Do Hot submit dis1ributot product labels 

f\lO-rfO{VI"'i-1, D(;(i"[L 

w O!-l-L E: (L c~L 

r::f2b'CI">C-UI ell- 'l'floC/-

_dAD Signi"U 

1. The distributor product must have the same composition as the basic product. 

2. The distributor product must be manufactured and packaged by the same person who manufactures and packages 

the registeroo basic product. 

3. The labeling ior the distributor product must bear the same. claims as the basic product, provided, however, that 

specific claims may be deleted if by doing so, no other changes to the label are necessary. 

The product must remain in the manufacturer's unbroken container. 

label must bear the ~PA registration numbet of the basic product, followed by a hyphen and the distributor's 

company number. 

6. Distributor product labels must bear the name and address of the distributor qualified by such terms as "packed 

for ... R, "distributed by ..... ; or "sold bv ... ~ to show that the name is not that of the manufacturer. 

7. All condttions of the basic registration apply equally to distributor products. It is the respon$ibili~. 

registrant to see that all distributor labeling is kept in compliance with requirements placed on 

Distributor 

•••••• • I w, in,,"_' " trnfI'kor our prodllCt unrf"r the Dk:m'bvtw Prorfucr Name spfJcifflJd Irfwvo. siJbj,ct to tIllJ co~diticns:Spo~jflJd on this Norica. 

Registrant 

J lIflf#IfJ ihM ilt_ t;//:JtdblJtor "'Imlld W10'41 mllY (ii$triblJhI srnf $liff th. DistrlhIJt"r ~dl,Wt sppc/fl'ld abOVrI, SUbj6ct to thlt COtldi~cf",ifiad an this 

Notice. ... 

EPA FolTl'l 85100-'5 {Rev. 8-94) F'nIviOUB editionl are obllCllete. 

·U_S- GPO- 19l1G<l2""WB1004 

White - EPA 

97
6aperwork Reduction Act Notice. 

The annual respondent burden for the Notice of Supplemental Distribution of a Registered 

Pesticide Product is estimated to average 15 minutes per response, including time for 

reviewing the instructions, searching exIsting data sources, gathering and maintaining the 

data needed, and completing and reviewing the information. Send comments regarding this 

burden, to Chief, Information Policy Branch, 2136, U.S. Environmental Protection Agency, 

401 M Street, S.W., Washington, DC 20460; and to Paperwork Reduction Project (OMB No. 

2070~0044), Office of Management and Budget, Washington, DC 20503, Marked "Attention 

Desk Officer for EPA." 

• 

• 

• • 

•••••• 

• 

• •• 

• •• •• • . """ 

•• • 

• •• •••• 

•• • • •• •••• 

• •• •• • • •• 

•• • 

• • 

•••••• 

• • 

•• 

• •••• 

• • ••••• 

--~.-~.- --_. 

98
N •. 

&EPA 

Notice at Supplemental P.esticide Product 

At1.fI( ;a feQfstrlilnt has obuif\G.d fmal ft:Qit.ttlition IeI'm. butt;. pIoduct, tn. t6Qietrant may then &.uJ)p!ement31:v 

dl$trlbute hislher product, OnO 10ITn must be lubmittad for eac:h dt~ product and must be sIgned bv the 

distpbutOt invQlved. The basic regl'tr.ation liumbef anC mil chtrfbutor eompany numbor must be ~hown 

if • reo;sttant Ms a potential distributor wM d045 net have .a camp.,'!'( numb., jluianed. she!h9 should h;)v~ tne 

chsrnbvtOf.pply. Q/'Ile1.t.ornud Itltionerv. to the fl~ Otvision to heve. nUmo.! 1tssiuncd prior to SlJDf'ruttHlQ 

this fotm to th. agency 

Nc;rt!ce of SvpplemonW/ Distribution 

.1(1ei t:igruatur. of both 

Nota: O~ 

Trident Enterprises, Inc. 

9735 A Bethel Road 

Frederick, MD 

21702-2017 

t'VOiitrant, The complete" form must have 

•••••• 

• • 

• • ...... • • •• 

•• 

• 

• • •••••• 

• 

••• • •• •• 

. • •• , . •••• 

1, Thee dl&uibutQ! product mU,"f hi". ttl. aams composition ., the buic prOduct. : •••• 

2. The dfsuibvtor product must b. manufat:tumQ'no ~ by the OM_ person who m&t\ufacttJo'cJi ;~dPacl< .. ge!. 

the registered b.lsic Qrgduct. : 

3. Tho lab&ling for ttlo dtsttib/JtQt product moat.btnr m.! U~ Claims a:s thrt.ba.k; pl'"od~t. providoo. hoWever, \hilt 

specihe: dam,s mal( bG dek!t&d' If by doinS &0. no otttGr changes to the !.b4f art necessary. 

Tf'le pt'oduet must rem.in in IMl'I'latniflCturer'a unbrotc.n eontlfMt. 

label must bear the EPA reCiltration numb., Of the ba5-ic p.ro.duct. followed by i! h .... phttn and the distributor's 

c:omtlanv number, 

Diltributor prodUC'l: Ia.beb: 1'I'\U&1 bur th$ nume .and >d"" ... of the dlItribt.rtcr Qualified by such [erms ;JS • pJcked 

for. >. < -distributed by ... "; or ·,QId by ... • to $hOw rh .. name a.not that of the manUfacturer 

All cOl'tdition .. 0# the haslc t1tgittretion appty ,QU&UV ISWI.tributOl f)tOdu.cta. It is. the rO'PQOIOItHlitv of 1he tHlsle 

registrant [0 s •• that all distributor labafii'ti) 1$ k*pr wtth r'(!f.titements! placed on the basic Pfoouc!. 

l.grPl '''''1 II •• tfisffJ>OIlm J'lJ,,... .. fI ,p;/lll''''" ""'y di:Jf:ib",. _'d :toff til. ~~ /ilrrNIYlllr IIpIn'ilWHf ~...." UN""..,.., 10 "'" f'fH,,;,rl<>r>-3 "1f,,',I.~,1 ~ .. t''-'f 

mid'., 

99
" Bolola 

Unil"d Slate' CA. ?; ~ 4:iS 

Environmental Protection Agency &EPA Offico 01 PCl'lidde- Progrc.ms OS05CI I JUL i)' F"Pn 

Wa$hingtcn, DC 20460 '''',;) Ij;jo 

Notice of Supplemental Distribution of a Registered Pesticide Product 

Instructions 

til registrant has obtained final registration for the basic product, the registrant may then supplementally 

I ~:::;:g~:~;hiSlher product. One form must be s\lbmitted for each distributor product and must be signed by the 

II involved. The basic registration number and the distributor company number must be shown. 

I ~I.:t,,;.~;~~;'~~ has (it potential distributor who does not have a company number assigned, she/he should have the 

II apply, on letterhead stationery, to the Registration Division to have a number assigned prior to submitting 

form to the agency. 

Notice of Supplemental Distribution must be submitted by the basic registrant. The completed form must have 

and signature of both the registrant and the distributor. 

Company 

fCfl...-'10 L&'J 1p I.:;) ".- \ I ____ _ 7401 

Note: Do not submit distribUtor product labels 

Iiri~;;;",:;;:",,;;;lip;;'od;;;;,~ct (b8W·-O-p-ro-d-,-o-,-oq-mll acc@ptodbyffPA) I Dwnibulor 'Product Na;", ---- FERTI-LOME MOLEGQ MOLE REPELLENT 

VOLUNTARY PURCHASING GROUPS, INC. 

P.O. BOX 406 

BONHAM, TEXAS 75418 

Read All Conditions Before Signing 

1. The distributor product must have the same composition as the basic product. 

The distributor product must be manufactured and packaged by the same person who manufactures and packages 

the registered basic product. 

The labeling for the distributor product must bear the same claims as the basic product, provided, however, that 

specific claims may be deleted if by doing so, no other changes to the label are necessary. 

The product must remain in the manufacturer's unbroken conta·lnar. 

The label must bear the EPA registration number of the basic product, followed by a hyphen and the distributor's 

company number. 

Distributor product labels must bear the name and address of the distributor qualified by such terms as ~packed 

for. .... , ~distributed by ... H; or "sold by ... ~ to show that the name is not that of the manufacturer. 

All conditions of the basic registration apply equally to distributor products. It is the responsibility of the basic 

registrant to see that all distributor labeling is kept in compliance with requirements placed on the basic product, 

Distributor 

to markel ou' prDduct und"'~h ,slrJlJlJlor Product Name sDlw::rf,ud above, llubjiJct 10 Ihe cr:mddJonF spe>::lf/8d on HI'S NDtU::U. 

j1-~ ••• 

SignalUle and Till..- of D,\:trlbUlor o-~ t ~.A Date •••••• 

RAYMOND H. SMITH PRODUCT MANAGER 

Registrant 

:~f 

••••• 

• • 

•••• 

• •••• 

f !Jgre!! that Ifre dis/ljbulor named above ma)' distribute and sell rho Dislf)bu(o, Product sPN:ifiud aDOlf&', f;u!Jjuc!"tJ?,1h camJi\ionslpec,fh:d on till': 

Noric(J. : •••• 

•••• 

While-EPA 

100
Desk Clil;c;e; 

• •• •• • • •• 

• 

• • ••• ••• 

• 

•••• 

• •••• 

• 

" . • • • •• •• 

•••• •• • • •• 

• ••••• •• • • • 

• ••••• • • 

• • 

• •••• • • • •••• 

• Paperwork Reduction Act Notice • 

!( 

, 

101
Before --FO'rm FO'rm 

... .......... OMBNO', 8-31-97 

&EPA Environmental Protection Agency 

Offiee of Pc§tjcjdc Pmgnutlll (7505CI 

WlishingtO'I1, DC 20460 41991 

Notice of Supplemental Distribution of a Registered Pesticide Product 

a registrant has obtained final registration for the basic product, the registrant may then supplementally 

~:::;::~~:~,his/her product, One form must be submitted for each distributor product and must be signed by the 

involved, The basic registration number and the distributor company number must be shown, 

If a registrant has a potential distributor who does not have a company number assigned, she/he should have the 

distributor apply, on letterhead stationery, to the Registration Division to have a number assigned prior to submitting 

this form to the agency. 

Notice of be submitted by the basic registrant. 

and the distributor. 

The completed iorm.must have 

65615-1 

Note: 

Company 

• ••••• 

• 

• ---~ . . .,. ...... -.... -----

Do not submit distributor p(oduct labels • • : ••• :. 

Of Rogistcloo PIO'duct {basic product mm'tJ $ccl!prQd by EPA) 

... _--- _._-- .: "~------I"" ~ __ _ 

D,s.tlibl'\O'r Pwduct Naml! ..... • 

'" l~~~~;"~~;: .""~ __ " me end of DilltributO'r (Typo; fncludfl ZIP cadol 

IntAgra, Inc:. 

8500 Pillsbury Avenue South 

Minneapolis. MN 55420 

, . .. I GET Av.'AY Hole Repcllen·t·~cady-to~lJse -------.L ••••• • •• ~-- ----"-- ""----- -. - r:n: 

•••••• • •• 

• • 

•••••• • • 

Uti 

:uf·! 

.' 

•• •• 

• • 

Read All Condition$. Sefaro SIgnIng • • ••••• 

• .. •• • •••• 

Spray 

--~I 

1, The distributor product must have the same composition as the basic product. .... . 2" The distributor product must be manufactured and packaged by the same person who manufactums"iilQd packages 

the registered basic product. 

The labelfng for the distributor product must bear tha same cla.ims as the basic product, provided, hov...-evc(, that 

specific claims may be deleted if by doing so, no other changes to the label are necessary. 

The product must remain in the manufacturer's unbroken container. 

The- label must bear the EPA registration number of the basic product, followed by a hyphen and the distributor's 

company number. 

Distributor product labels must bear the name and address of the distributor qualified by such terms as ~packed 

for, .. ","distributed by ... ·; or "sold by ... ~ to show that the name is not that of the manufacturer. 

7. All conditions of the basic registration apply equally to distributor products. It is the responsibilitY of the basic 

registrant to see that all distributor labeling is kept in compliance with requirements placed on the basic produce 

Distributor 

I ",. I.,,"" '" mmpr our pror/ucr und,., rht) OLttriburOl Producr Name spedfifJd above, ",ub/oct to the condir,ons IJpedficd On this Noric/). 

Signoture IIndj~TI~'I~';';'!)i"'b"'W 

9/17/97 

Registrant 

Il!IiiJICC thM 1/00 diS-triburor (lvmed abow) may d'stlibu(c lind sc!! rhe Distributor Product specdie;id {)!;ove, subject to lite cO'ndrrians spaCifi€!d on t/lrs 

NofiCit. 

~~ ~_.~~cL /J ..-;;::' /I)e. if- cO 

__ 7 

Whito- EPA 

Q 

102
F 

b 

• • ••••• # 

• 

• • •••• • 

• • •••••• • 

• •• •• • • •• . ' . .. :""1 

• .,,, • 

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•• · " • • •• 

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• ••• 

• • •• 

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•• • • • 

• •••• 

• • •• 

••••• • ••••• 

• ••••• 

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• • 

•••••• • • 

•• 

• ••• · . ••••• 

, 

, 

103
• 

sYM80t., 

rumtMlE 

OA.TS; 

UNITED STATES EN.VIRONMENT AL PROTECTION' AGENCY 

Mr. Ronald L. Balk 

Cleaning Solutions Inc, 

DBA Pest Solutions 

1250 Ramona Strcet, S,E. 

Grand Rapids.;'!1 49507 

FEB 26 !998 

Subject: Proposed Label Amendment for SCOOT MOLE EVACUATOR"" 

EPA Registration Number 65615-1 

Dear Me Balk: 

We have no objection to the label amendments for SCOOT MOLE EVACUATORp..i, 

EPA Rcgistration Number 65615-1, proposed III your letter dated February 2, 1998 increasing 

the treatment area from 5,000 sq, ft to 10,000 sq, ft and the addition of the precautionary 

statement -- "Avoid contact with eyes, skin, orc1otlIes", 

Stamped copies of the product labels are enclosed for your records, 

. _ . 

~#.J. .l.fl~7;r 

Sincerely. ~_ ! 

rt~'/~Ij; i 

~ d-..fleX ILt6~" .,7<' I.r-

-1tl Janet L Andersen, Director 

Biopesticidcs and Pollution 

Prevention Division (7511 W) 

CONetlR!tEMC!;S .. . 

' ..... ,.-........ . ................. .... __ ........•.. ......... ~ ....... 

• .~ . . -

·:~;:f7~i·';,;.:;)~·i-· 1-/"',( \./' V ................ . ................ +,;;-'1', .... ...... "" ......... ...............•. ................. ................. '2~ c:r~(c . ................ ~I :> 

EPA FOOJl lm-1Al{m I 

OFFICIAL FtLE COpy 

104
• 

• 

ACCEPTED 

scoob M~LE EVACUATOR 

DIRECTIONS FOR USE H"''''~fi'F''''''''''la,"\!;;~HJ~''PJ_",;-,~1 

'"~l,,", volIn~. ~ 

USE RliSrrucTlONt T?4 v<>W<1 I'W;' 1)0" ~'M '0 ,_I U1!_""'_ iEur«:",. "'l<>~!"''''1 ,,«'" U!'I'M~ I)M~I'W"~& 

tMhrl. 

lOCAT1NG MOllS ~fWov~_ "'I'l<>'" "'~y ~ .. .",<&~~ 

by a "4t_k 0' .AiI"~ '~< .. mt ,d '" t# '" ",Btl' cl 

~""-' """'Ml> ~ .. ~ft~ NffiiKl \ijl1'a .. ,C.oP t",_, 

"'t,H\ ~n MUs ~ '''OW i'V'~ '" rWlg- P'BiV'~~ 

APPLICATION DIRECTIONS: ". ... C<if'l!a",,", ""ij ~"'" ~"';>'<&;W M*l;";<l"lWl 

h!>o~ hQWy »~.d;J~1i<9~",*, 7~m <4\~' i<.«Jy 

<>ri t"I\.o» P'*>_ Sp,~ SCOO"i' 4IOtr evACt.MTOI'I ~ 

"'_'>'I·~d "' •• ~ a la* o'O/\iI'QWl1 <)I ~U< It.WJ 

Jq II- (<!.g" ~ 1001'1 I>y 100 ~_IW,J.J A$MtU opIltj' 

ruuw »'WATiIr CenI""I' \0 ~ \'4M "lW 1<> _" 

SCOOT MOUi ~ ~;Wt /4t>¢t SCOOT MOl..!i ~1"'" 

",' N !l'~ of "**' " __ ~, "' udy $CIII>; 

1'I'l'(j • ........", ... ~ urtr r.t f ~f ."" nc~. Martly w rn:\ 

PA~ARY 

"')"W' ~ 

SV,T!i:MENTSCA\JTlON KiH::P O\JT or l'IiSlCH Ol' CHI\.DAPI ,o.'lI)lD 

CO>ffACT Wffi'f £VES. Zl':1"i, OR ClO"\'l1[!> 

nl\,~I'tONMP'T""-I-!AZAIlO:!! 

~ MI &wit $/iK\Iy \~ "'1\t+' Ii> 'it"' _'f .u"'~ ...... W 

'4' pt~ '" 1<1 0I\1~144t"'n.-.".., melM h*, """,W 

""jtJ< DIi"<X'Q($"'~<i'mJ~, .. t)"",*~v'~~ 

.~,,_ ""'V.M;I'''~' 

CO>i.TNNS 'X~. ,,";W ""llISr 

STORAGE AND DISPOSAL: 

(n ""I !<l"~.mfl~J~ I00:I, '~~d 0' ""'J~' 

roy _.,. '" ""r><>:>" 

STOMAOL 

$t1>'t""'t '" ""9"W~~a .... , 1(, ~ <1<) 

~'" 1I"\l« .. ..w. ~ <i1~~ am>~' I>ROCVCT tllSPOSAL 

V4.1iH '*""*"11 m.n \No "'''' '" t"4 __ """'l'lMOd~dC"_""~l 

a~ ~ ..... !<I ~ ... 14.#tl 

CON'l'ruNtR D1$l'O$AL' 

~ 

O!> ml rw;e ~ roI'I'...,.,J ""''''' 

S«i_J.,<W<;lp '" flV<\"~' 

~r.d --."" ., t" .. ,~_ 

[P"'~f~Uj$·1 ,,""'!::II: ~~UJ~II!t·, 

.," , 

• 

105
• 

• 

ACCEPTED 

SCo01 

M&LE 

EVACUATOR 

OIRECTIONS FO« USE ' ... .-e1f_ ......... "'''''"'','''''_ 

"'~"".,,-~-"'~ "'* "nl1'l'.:r<w~ fN.o ... ...,.,"", U "''''' ,,_~""'., ,~"'~.,..~..w-" .. """ ""'" ~.,-, ... ,-OCAI .. (\<lQU .,.,~,,,,,,,,,~,,,.<,., .. ~, •• ~"'''''''''''''W!_"*:m''''''''"'''' .. • ..... ·".,...""",."_¥ .. "'_t"'_"'~ 

..... _h","_'_-""_"""''' -~. 

APf'lICATfOtl OIRECTIONS: 1i ..... ~,_.-.~_ Mw< "' __ ~''''''_.'''"'''''i'_ "- ... "',_"" ...... "' .. """ _tCW7UCJtf !~~oo_ ......... _ ........ .,._ .. ,.. .. -"",,,, __ ·t_"~I''1 .'00.'" "-''' ''''~_'''"I''''''' ___ '''_~MOlf __ ''''''''''''R''' _ ... 001 _4Coo;~""""""",_ 

.... ""', ....... .-.. .....,....,."' . ...,,....., -..---, ... _ .... .,...._, ~ m"",...._, 

_~>JI¥S1~Il!\!Ii\l!1t 

C>UfiC<'< I'X[Povr()fr;u..::.;QIoem.t~~ 

~CO!(!I4' ... wrvu ~ .. Of\C1.0'4~ 

PNm::ml.'l'IM. MU'CS !)o'l«.I'M_"'_ ",,,,,,,,,,,,,,,_ .. -...._ .. ,.""....w~ ... _ ... "'.." 

'4''''''''''''''''' t>."", __ ", • ..-._", 

~OO!,..",. -~-~~-- _OQ ..... ""'d ur 

PEST SOLUTIONS 

GRAN]) RAI>iOS. ""4~*, 

EASY TO USE 

HOSE..£ND APPLICATOR 

REUSAUU! APPLICATOR I\"'-~"",,,,,,-" tl:CCfMQ<,~ O'...,WY~"""'. 

,""",,,,,, _~ .... 'Ifo", ., ;M'''''''''' 

STOf'IAGE AND DISPOSAL; """"'--.... ,,~ .. '" h"....,."'d~ 

5"';AAOt 

___ 

n-..", .. _~",."" ",_"" .. '4 • ." 

wo._,......., ~-~ .... ,.,.. ........ . --""_ .. ~ ..... --" .. ...... _ ...... , CQN"i_~J)I~ 

-"-"".....,,,-,.., ~ ... -.-""""""'-. w_ ....... MfflCIL __ .. ot,_, ... ....., .............. _- -

t"'I1<>:_',"'f>"-~"_'P"" 

106
----------_._ .. _._.-

. -

• 

• 

stOOh . M~LE EVACUATOR 

DIRECTIONS FOR USE 11 <$ '" vlGIAt>anol Fed&Bl Law to UM 1t11$ prod~t Il'I II m&r:nt'J 

InCQl\$;stltl\l with lis labBling 

USE RESTRICTIONS: ThJ$ p~t mtrt be lIM>d 10 repel 

o&SIem J1'IOi" (Se=Iopu$IIQW1ti""aj Item lijwns, :VNlm¢(',\$1 

antltllrf, 

LOCATING MOlES: The pr!!l~enoo of m~$ may be "whcnloul 

!11 a M\WofIo; 01 $I.IrlllOC mlges In tho lull 01 Ut A ulin!:lf 

c:mlC41 mO<l1'ids of lIanh pu~ up 110m dIIfP burrows 

Treat aij .11111$ vm!d\ shoW.~ of mclea' prctv>;;lI'. 

APPLtCATtON DIRECTIONS: 

Stake COI'1\III!M1' Vo'Ifi! ~e Ugin9 produCl Attach Qan.um 

how lightly to ~·dI$pffI&ing CQTIlairte'/, Tllm wnW $!.1lP/Y 

C!"IIQ [VI! p!'S$$\Ile. Spray seCOT MOLE EVACUATOR i;N1)' 

mclc.mle&lod IlIIN!.t a hI:t 01 one quarf 01 pflXfuct pe' 10,000 

$l'I. It (e,g., a 100 It by 100 ft loWlln9Ie). Ad~t!he $pray 

l\OulG 10 'WATER", Cor:~ \0 spray witt1 waterto soak 

SCOOT MOLE /rite lIl.lOil, Apply SCOOT MOL£: imm$olar.ly 

IIlIel the i»'"CflI:& of ITI¢Iesis d«ltdbO or in early Spring. 

mid-summlM, and early Fall fllhel1! "-,. moles neaJtly 001 

001 01'1 )'OVI property. 

?AECAunONARY STATEMENTS: 

CAUTION: KEEP OUT OF REACH OF CHILDREN AVOiD 

CONTACT WITH EYES, SKIN, 0fI CLOTHES 

ENVIRONMENTAL HAZARDS: 

Do rw, apply dlrtell;! I~ miler, ~o a'ca~ who,e SUrlllOO waltr 

is preunl Of ID Intel1kl41 areu l>tlow lhl! mea') tl'Jlh wau" 

Ma,k. Do!\OI COIllaminale waler who,., di5PC~n<J 01 

e\llJij)menl WGiahwat"~ 

CONTAINS 100% ~51or ciI US? 

Refin boWes available in various sizes 

STORAGE AND DISPOSAL: 

Do!Wt c»r.tamiMte!cod teed (" w,l.\tr 

by $!MIge or d!$nosal 

STORAGE: -

Slore WIly"': (l'i!p",,1 amtairlCr. In li dry 

pUlce itmccenill10 10 ehJl&en and P'lts. 

PRODUCT DlSPQSAL. 

WUIII$ r%Uitmg trom 1M 11$11 of 111<$ 

prodvc! may be di$po;!iId a! on $lt~ ~f at 

!,'l ~ Wli$le ditpoul frIcMy 

CONTNNER DISPOSAL: 

Co- not /'Wss empty cool&1r'ier. AiMe 

tl'ioroughty. Soevrllly wmp in I'eW$p&pIIt 

lind tfecard In traSh, 

EPA Reg.//6SG15--1 EPA Ell\' 115Sl;15-Mt-1 

PEST SOLUTIONS GRAND RA?IDS. 1.11 49$07 

107
• 

• 

February 5, 1998 

Dr. Roy Sjoblad 

PM-91 

RFCE/VED 

FfR i 7 1998 

OPP/BPPD 

Biopesticides and Poflution Prevention Division 7511W 

OPTIEPA 

Washington, DC 20460 

Dear Dr. Sjoblad: 

DBA Pest Solutions 

1250R"m"""" SE ~and R~pid$. MI 4%07 

P; 616.24:).055$ 

F; G1G24S.297G 

E; Clng&ol®:>oLccm 

Greetings. [hope that you are well. You may remember an email [ sent last \veek. My purpose for 

writing you today is to add the required supplements to the email] sent last week 

This morning I caDed Dan Peacock, re: some new infonnation we would like to add to our 

Scoot Mole label regarding primarily coverage. Dan informed me that our product has been 

shifted to your department now. I am sending you copies of our proposed labe] for your 

approval. There have been no changes on the front only a couple of changes on the back. If 

you could please expedite this project it would be greatly appreciated. 

I have seen to it that the label additions are highlighted for your review. Please review at your earliest 

convenience. All of the enclosed labels are identical with the exception of size and UPC code_ 

There are two reasons for this request. The first is that our product has been tested and proven to be 

effective at the rate of 10,000 square foot rather than 5,000. The second is)!lal the state of California 

has approved our product but;,::.oUId like an added caution listed to say/ AVOID CONTACT WITH 

EYES, SKIN, OR CLOTHES; In order to finalize our California EPA approval they must have a copy 

of our labels with the "Federal Stamp of approvaLn Dan tells me that this is where you come in . 

I know that your time is valuabl"e and thank you in advance for your help in this matter. 

Sincerely. 

Ronald L. Balk 

President 

•••••• 

• •• 

• • 

• ••••• 

• • 

•• 

• •••• • • 

••••• 

. ... • • •••• 

., 

•• • . • •• 

• • • ••••• 

• 

• • 

• ••••• 

• 

• 

., •• . . ... 

•• .. • .. . 

FEB 10m 

108

6Pf'D 
• 

• 

ACCEPTED 

scooh M~LE EVACUATOR 

DIRECTIONS FOR USE 

It ,$ a vCeILI,on cf federll' Lz,.", b uti! !h'!; p!cjJ~~"'" () m"N1Cf 

mccM.·~W·.1 w~h iw laOe,,,.;; 

USE RESTPICTIONS. ;Il,~ p'''ouct m&y 41>1 -~1"".':~ 'CDC' 

$a~llw'\ mc'.c5 i5c:ltcpu~ Jo::;uh~'C"'!;) I!::m 'a'f.n:: Cfl'll",y,t)1 

I!.rd :Ulf. 

LCCAll14G MCL!;:S: Tho pl¢~<F,q' of rrC;i':;; mll)" cn.,-:I ~11'/!'d 

Cy a n"l~rClk ef s~rf~ce mjgtt in lho l~rf :;-0/ a ':i.WtH d 

CC,"1i(;{l1 mc'~nd$ of el!rlh pJehed up Irem d>:;e., b-~"C'",~. 

Tf(nlll~1 MIlM wl1itlh ~I'~v,' "':;~,s c! Il1cl¢~ or"$cm:~. 

APPLICATION DIRECTIONS: 

$I';)\w {)ohla'/l>'ir w.:H t¢'~"'t !,;s.~,g prcdw;:1, ,'\n~ch gt.'Ct" 

1'1l~{i t'lih~I>' 1(; t ... lf·dlcoc~,tlq, C0rii\ll\e' Tv" .... ;ita· ~upfJ'Y 

C'11:i !<..iI pt:fU'1l SP'J!Y SCOOT MOLE EVAClIA,OH C"'CI 

!1lE);<;;·j'1l(!1;led at~lI a: ~ ~m~ ct C11f' qU'lrl :J! p,,;;d<.:~1:>1)r 10 C(lll 

N ~: (0 g .. ~ Il')(Hl by IC{j /1 r\l;;t""{II~) kJ.u;: Ii'!> qll~:.' 

<;cztltl:O 'WA1ER', CO!"I,nl;C:O $pr,J'i ,"".n ~,a(e, Ie ~c-~k 

SCOOT tI.oLE.,-b the $-~/ Ai'"t, SCOOT MOLt ;1\'.mC0-.~\<}~, 

,~~!F 1M PI"ze;.CII 01 rrcioc I~ aG\('~wd or;., ellr.y S~nng, 

,,","J·7um~~r, and e"')o <,,,:; ,( In~,,} 11'0 mo,.;~ '1f:n'Oy 1;',1: 

"1(;/ or ""'lOr ,,":lPCf)' 

?RECAUTICN ..... Ry STAT£ME~nS 

CAuTION' KEEP CUT OF REACH Of CHILORnr AVOID 

CONTACT WITH "YES SKIN OR CLOTHES 

EXVIRONIAENTAL HAZARDS, 

I> ~,(;t appl', c,l<l'cl'y to '[[:11(:' 10 ",ea~ wl'cre 5~lb~0 ,',J:r, 

'~;:'~n(in~ or I'.) ,~,t~'-V:!~I "-'(W~ \)$.{;W ~h1> [l1<1a"1 I',,},, w"-I~' 

""3')' Di>~,~t CCIl:a'Wt",ilN' wa~' >"hen:! ~po~,~,'; ut 

e-..l~tC·mOI': watnw:,;~'$, 

CONTAINS 10:1". C",S'~' e,' 05f-' 

Reldl bottles avoilnl'>lo in various sizes 

STORAGE AND DISPOSAL: D~ not cCC)!amina!~ j!::c<;, ked "r ,.,y", 

by ~:O!agQ ~[d'SpCiilll 

STORAGE. 

Slortt:nfl m c!igi"lal ccn~~,,,c', ," '" :!~,. 

"Iaco ;nOlcc~t~bl,,!? chldn" lI1'j pO:$ 

PRODUCT DISPOSAL 

'NJ,(;tc~ "';GLiI!,'),; lrom 1M ute 0;1 :r,5 

pc<Jucl ",.g)' be di"po~d ,,( 0'< H~ c, at 

il'l aoprc'<e¢ waste cii~P:!MI ;ac.'it/ 

CCHTAINER DiSPOSAL 

D" pet re ... ~e empty c"nl~'''''' Rn${; 

~10"""u9hly. SeCLf(fI, w'''' '" newsp.pc, 

.,nO ~L~Y'::II"lIr<!"'I' 

EJ'AfiF.g #C561::-1 EPA!O~t ~,,~;;15-r,I)-1 

••• • •••• 

'---------------------------------------------------------------------------------------!. •• . • 

.... ... • •• • • ~ ..... • .. • 

.. .... 

• • 

· .. 

• 

• • • ••••• 

• 

• • • ••••• 

• •••• • 

· ., .. . •••• 

.. . · ... ., 

109
• 

• 

ACCEPTED 

24 

Unda, the f~dgml !JWoctldde, 

Fungicide and Rod.elillcldo Act, tl$ an'wudod., fot tho P"lIcldo 

toglsteMd undot 

EPA Rog. N-o, -C I 

scoOh M~LE EVACUATOR 

DIRECTIONS FOR USE /:,. J ",:;I"""., dF0a/a' W", I~ J'!A l~'" ;·'(G.W ,"; ;-•• "nc· M,"n.;H~N",·j~ "" ,(,b<'i~; 

usc flE~rR~:;TlOi1S Te.;' v<,~.t' nty ~~ L~i~ '0 'ep~ 

AA":.'" "'~I'" (5~~'''p", ~~~~""~,: 1-".,. r;:=. ,,·OO""/'~.,' 

5~: ~,~. 

lOCA11'IC ."c~=s, fM r'-~,V'c,,:' ,ro-"'i "'''1 t~ -(~,"~:"i 

1:, ~ "~I"Cf< cI '/ .. 0 ,-<1]'. '" ,,,. td~' "( a if''''' 0' 

:0'" 1.:,' ~ •• :'j"'~' ~! Hr.i. p~~Mj V, '"n j;;<s ::UN'" 

T",z, ~'I M~~" wr.c" ,~~.,. ''JM ·,r T~''''-r'''''.c_o~ 

APPLICATION DIRECTIONS: 

S"~'~ "m:a"m ",,1 t"rc .. ""'''!IV~,I"o: "1:",,, ~~''''~ 

I'~", '9r'f/:~ .e·~·!~,,"·i"'.l cc"'M'~' TJm ".WI .~r"'1 

:>" 10 Ijl'r>I.""o'~ $p'4{ 1CCOT r"c~", t'<'ACVATOR ~ve' 

,~j~-"'~"t~ ~'H l' 0 1!1~ "·~N~".-:GI ~-,,;;'''''\ PP '0,0%- ,q "_l~ 9, ~ loon ;;yWO r; '~~'9"') "Ai~,,:N ~;'N;;I 

""'~4 :0 "I'{>'fl'1': CO~"c'J~ 1<1 $"S'J "'ffl'l ",M", ,~""~" 

secm ~'OlE 'm~ 'n ""' ~pp'y CCOCT MDLt: IT'~frl,S:~',' 

;"0' C~~ p'Hon"" ", T""~;" COI~'~"~ 0' ;" ''''''V 1Pl1",], . 

",'tl·~~o',,,,,>,. ~M ""~I hll ~ 'c~,~ "~ n'~'~'M_"V,b,; 

'ct c~ r.iJ' J)I""C'I~, 

"ll~C"_Ul'-C"MH STAT!;:I.IC'iT:< 

C;,VTiOk XC",," CUr 0;: fl",ICC'"! OF Cril! Dne. A','0I~' 

CCi'l;"-C, WIH! E"-<::S_ SW'" Oil C'.C1'-'('S 

FIN:RC-'. '/8nAL fl.~./AH;;i' 

i:;~· to' ~r,:l{ -;"""'1:1 ~o ,,~:;. :0 "'~t, '~~"'~ lAt'~ ",_',., 

STORAGE ANO DISPOSAL: o~ n:' '''~i~T,,""l~ (o<;d, l~~rl" "~I~' 

"t ","3g~ m ~40~' 

Sf-;)<t,,(,[. 

S(,,·~ ry-'Y'" ""J'M' "w·,~"", ,,' "'-"i' 

t'~"~ "5CCO£,r-m I~ cr .<11"" a''O P"" ~%.)DU(:T blSPCSAl 

\'I",'~~ ""~lr")I'~'" ,~~ "Oi'~' 1;',,$ 

PfOd<.-;;1 ~'*I ~e ~i""o,~: '" O""H c, M 

l" ~C?-·'''''H ""~:~ ~i;.\'",,1 ;.oo'_+'-

CQI,FAIUrn 1)1"05Al, -

rJO ~ ''-''j'~ ~~'plyc~c.an", R"'f 

".~,,,,,q' .y. $0'",",'/ ""#:J " n"'"'''r_'~~' 

J.-<l d"um ,0 I'~"~, 

I' 

Ii 

l ________ 'c'c'c':':":L'J:'CilC:'c<S::'_,':,::Jl'_':':":':':"':~ ,:' ?::G:, _____ I_~_, __ ) 

., ~'~$","_: 0' '" "'"",A~I tfi;~" M,","" .-" TdI' C {In M_"" 

TV" \)':. ~~, "".·,1_,,",'''0'0 m',"'o""C C' ';'«" '0'; " 

~qc ''''~'-1 ",,~,,~:,,~ 

CC'.'rA,fiS ,:,,', ,",'0' MUS" 

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• 

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• 

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•• • 

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110
-----------------~-~~~~~-~---- --

• 

• 

ACCEPTED 

stOOh M~LE EVACUATOR 

DIRECTIONS Fon USE 

" , ~ ·,c",~"" F.,., .. "'~ "'"'" F',~",'MF 

~," ~."..,"m~",~ """". ""~''i' 

v:t n~Sl"'cn~"., T'"",,,.1~1-.,-b e'''' 

';, ""~ ''''",'' ~"'"' F"."~"' ,",,0"''''': ""', ,~<c~ -''''-.''W''""'.r 

F ~o.n"':WAf:; no ".",~""",I~_" •• ~;';F,. 

,~_I~""I " '~1"", .. ',1 """,,. ",,,., n FF," ,. ,,' 

~, • '""" ,1 '''''41_ou."" <f .",,, ,'-"~ ~ ,",m ,,,,,t.,,.,.A-O_ 1,.,,-'1 ", .. ,..."t ';-.,~ ";r~" 

APPLICATION DIRECnONS: 

,,~'" ",h, .. , ~",n.lh' "4 r"""" ~"'oo ."j"""", F;)'~ ",," "_""~,,,W',";~,M h,o 'm'" ',H" ,,",'" 1.iF,,.,,,,," :~",t:7X, F,'~,!i 

'-w_~VI·fC~ "'" "'~.""'''N ;,-1, ", I,'. '" ""_ "-'", oF h-7-", 0", <~("" '" " ., ~ ~ '"," t·, """ '''''''=J'' "'i""~~ "'"'I "",.-,.",-,~gu,· 

c,,"~"" 'e ""-'r~"" ",I", >0«" $C~01 I.·~" 

'M_", d 'r"d~''AOH'~F /; "'ffl",,"~';,"« 

"""'~"C'" ,",,", ~ "."""" '" " oM, "",,, <C,", ,,,,,,,,, ~'~ eo'" ,,,,,,,.,. ~"'''''''"'''' 

,> 

""' <, y." 1""0"";' .c,~;."m~',MW '"A,,'O"~ 

c;,m'Y> K<lt C'-" iJ ;o£>.CH (;f <:"'F.~q', 

'-'~'n ~(:ilun '~Flil n'''. ,p, c~ ~l )'l"i'-' t';.'Wt";"'",.~ ~,~"n:~ 

C" ," 'F VC ~,<C". ,-, """ % ", •• , ~,~-" ',""'< ~"<"'r~.'" ." "'p'_H • • "", ,,",n 1 < - ·~o "" ~~>,,..,,, I» '<'<,""F""';-<~'. "'>'~ 

~'"""''''-' '.'~<" d"'~''''"'-; -.. ","'FIS "0', "'''H' .'\~ 

PEST SOLUTIONS GtlAND 11.0.1'10$. ~14~~t7 

EASY TO USE 

HOSE·END APPLICATOR 

REUSABLE APPLICATOR ,,"'" V'lF., "'~';:I. F I<-> "W, Nil, C" ;",1 I;C<.t D, ~~ =,_,,,,.,,. 

STORAGe: AND DISPOSAL: 

:~'''F "'''~'",'.F= ,.,.,c, ',m"' 

",.,..""." d"",,~ :TC~~Cl 

,"" ""1 ,. '""<>' "--'I",, r>A ,,",.,".,,,~w.,, eNU,," .,-" 

"nCCF.<~c",r"""'''l 

'i,;,,-, ,.".~eJ ',.,M F,.. "" ~'~,' 

,,,,,.,,,,,.,,, "_""_,,,,' d ",". ,'. " .. 

• , ,..,,,,oM ~.'" ,j","'A '""".- V)',:;V,~~IJF"'~M"'­

),""""~""¥,_JO"""". n"" 

F"''''''.,N,' ~",,,.", .,,""," .... ~'"'--""F ,,~ '~"',",n~~", 

,,~, 'of BJ,.' ",~"<>,, "".'. ~OF'> 

'"' W,F, "'" .My'",,'''''''''-. ~'" "''''c,,,o 

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• 

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111
" ' 

• 

• 

-----------------'---

ACCEPTED 

FEB 2 £\ 

Undot' tht! F~lIr~1lru!ectlcld6. 

Fung!.elde, and Rodenticlde Act, (U anutudod, WI" tho pOOlclde 

regkto.t«l under 

EPA :R.g. Ne, • s-; 

t001 

S M(9LE 

EVACUATOR 

DIRECTIONS FOR USE 

II III a viOIIIl,on 01 Fedelal Law to usc Ihl$ pr~d ... 'Ct 'D a m~nnN 

Il"ocoo~rolCn\ wilh 1I$1300tlr.g. 

LISE RESTRICTIONS TM, ~(rol.lcl mijY t;;r uwd to repel 

eastern molli'~ (S<;l)~PIIS aquMic! .. mj from Imwfl~, (}fr,J""~"r.;;1 

~nd tun 

LOCATING MOLES: nl.' pm""nco ~t mcl~$ ""a'l b9 ,noical"::! 

rr/!l; M\WOI!< oj $ur.ace rdg(!& ,0 the :.~.-f ~r tty (I $<:';(>$ 01 

coniC~1 ""'{)und~ ol "tilth ptJZheo U;l rrcm ducp ~urro,~~_ 

Tleat 3'~ Meas which shew si9nz 01 molc,,' 011.'!),"''1'". 

APPLICATION DIRECTIONS: 

Sh:ike <XIr:I~hcl well ~c'e '-'tins produc( Ar:<!cn ~ij~n 

h()~O fghUy to :;eU-<tspen~ing C()nla;n;;l. Tuff' wal~r wP91y 

'7Iio ru!\ P'C$5\.ift'). Spray SCOOT MOLE EVACUATOR O'/~' 

mc!u-lnloMed ,1I¢<'l1l1 <lltl:Ol' oj enOl' U.'.Uill cI ploducl per 10.000 

~q II. (e.g., a 100 tt.lly 100 It mcillnshlj. AdjUst th'" SP';jY 

ro:21c 10 'WATER'. Crn;in"e to spetiy wo'h 'hill~, Ie v.luk 

SCOOT MOLE hie lfj;'l ~Oll. Apply SCOOT MOLE iM:1't'dil!-l~I: .. 

'Iller l~e pun&",cl? 01 moll?;f; Po; :HlleC1CO or h ~rry S~W,,;. 

m'd-$ummer. ant! early F;;II illNue am mola:;l. n~nrby iJul 

nol 011 your propelt}~ 

PRECAUTIONARY STATEMENTS: 

CAUTION: KEEP OUT OF REACH OF CHilDREN AVCID 

CONTACT WITH EYES. SKIN. OR c .... OTHES. 

ENVIRONMENTAL HAZAROS; 

Do pul [<PFry di,udly ~o waler :0 IlICf;l! .. 'lore ~ ... rf3C0 w~~er 

i$ C;reLQr.1 0110 i1ter:ldo1llHoa~ t.m;~'" :~.e nlN.n hg~, Wij~n 

mllik Do nel con"lm.n;j~t V:ll:CI wh<:-r. tl.sj.--<>M,,'J 01 

",.;ui;lm!!nt ... a~rw'~:'W$. 

CONrA'NS ~OO"" c .. s~~r !i.I US? 

Refill betlles available in various sizes 

STORAGE AND DISPOSAL: 

Dc not ccnillminal¢ f¢od. ft~ 01 "«nlN 

by $torl!!;t Or dis;lO~~l 

STORAGE. 

S~OIe o,..,ly In ol1g;n;:i,1 COPIlI;~e', ,n a (lry 

place imlcco::l3ibi-e 10 children ,wd P'Cls. 

PRODUCT DISPOSAL. 

Wa~W$ n::~ulling hom tho U<re e~ Ihi$ 

prodUCI mlll' be dizpMI!d Cit en sile Of at 

;:11'1 JpproyOO WII$IO ::S~pMllaqli\j' 

CONTAINER DISPOSAL: 

Dc nel reua"" emply ccntll·/'HN. fl'M.o 

\h'I~"gilly SII;:mcly wmp in l1e~'~p"pN 

~"d d'ftard in tm~h. 

EPA Reg. 116$015--1 E?A EeL ~a:;6)5-MI-1 

PEST SOLUTIONS GRN'H) flAPIDS. MI 4%07' 

•••• • •••• 

'---------------------------------------------------------------------------------------'.. . •••••• • •• 

• • 

•••• •• • • •• ...... • • ••••• 

., . • •• 

• 

• • •••••• 

• 

• • • ••••• 

• 

• · ., ., . •••• 

•• • • •• •• • 

112
r-

~ 

Cleaning Solutions, Inc. 

1250 Ramons St., SE 

Grand Rapids, HI 49507 

January 3, 1996 

~ Attention: Mr. Ronald L. Balk 

Subject: Scoot Mole Evacuator 

• 

EPA Registration No. 65615-1 

Your letter of December 27, 1995 

The labeling referred to above, submitted in connection with 

registration under the Federal Insecticide, Fungicide and 

Rodenticide Act, as amended, is acceptable. A stamped copy is 

enclosed for your records. 

sincerely yours, 

PJ}5lll,/" Robert . Forrest 

Product Manager (.14) 

Insecticide-Rodenticide Branch 

Registration Division (H7504C) 

Enclosure: stamped Labeling 

Peacock WP#8:A:\65615-1.JAN:305-5407,-6600:1/3//96 

113
"'VI' ;i("lI:lfhi!l I 

ACTIVE INGREDIENT: 'lJ'":) 

CASTOR OL USP 100% 

• 

MOLE 

REPELLENT 

LAWN 

PROTECTION 

E 

• 

, 01 

SCLcgLE 

EVACUATOR 

DIRECTIONS FOR USE 

II Is a viokltlott 01 Flt[\IJra! law to ~se this prOOtiC! In <I manner 

lncC/'Isis!en! witb Its labeling. 

USE RESTRICTIONS: ThiS plOduCI may be uS€d to relict 

MStffn mo!(lS (~~) lram MWf1$. orl1a1'l€I1UI 

turt golf roiJlS11!l. ffi".Jj athle.tfc fie"Jd<: 

LOCA TIN{] MOtES: The PI etenCe 61 mOles tnJy be Indicated 

IT! a n~ 01 SlJl!a..."t ridlles In the lui! 0: tri a "eflts 01 

con:caJ mounds 01 earth pus1wJ up from dt€p b~flQ¥,'S 

Tlea! aU Jreas whiro show s\wls 01 mol~u' prese"lCe 

APPLICATION DIRECTIONS: 

Shake contaill1lf l\ttl! MI(!re lJsinlJ pHxlllCl. AIta0'1g31{fen 

hose tlghl1y to stlf-di:;penS111{j ccr.larnc;. TUfi1 waler $UPP'Y 

on to luI; pressure. Spray SCOOT WOlf EVACUATOR OVel 

n~cie·mlested Jlea al a lale cf om Q'Jart of p100ucf per 5,000 

SQ. fl. {C.3;j, a ~ It by tOO It ledarlQlB}. Adjll!il the spray 

noztie to 'WATER' Conflnue to spray wrtn water to soak 

SCOOT MOlE into the soH. Apply SCOOT WOlE Imme1;attly 

atter the presel'lct of moles IS detected or h early Spring, 

mi!.Hummer, and eal!y Fan it ttl(llC ~re moles neal by tut 

not Cf1 ~'OOr property. 

PRECAUTIONARY STATEMENTS. 

CAUTION; KEEP OUT OF REACH OF CHILDREN 

ENVIRONMENTAl HAZARDS: 

ifflc~ "oo! '''" "recttf to waltr, to ale;l.5- where sunata water 

is prosent or to intoctlda! alelS beloy; Ihe mUn high wa:H 

§:"'V# " ~~"l'T~k" "'N."," 0'''' 

STORAGE AND DISPOSAL: 

D1l not cnnt1mlnatc Iood, teed, or wllter 

by stora.;;e I)( dlS-pOsaI 

STQf!ADE~ 

StOfe OO~f tn origlflJI cor;tamer. ill a ort 

ptace lnacceSSlb'e to Children and pets 

PRODUCT DISPOSAL' 

Wastes restt!mg tlO'11 the 1M Of t!liS 

product may lYJ dI$Osed of on s:t~ 01 Jt 

WI appfO'l'ed was((: 1SPO~1 fJe.hty 

COi(fAltIER (}lS~SAL 

OJ) not I WS(l em!Xy cO-ntalner R,nse 

thorOO{lhty. Secur~~1 "'.'fap In neW$jjJ~r 

and discard I!1lrash. 

EPA Req, t'S.'I8tS·t EPAEst tG55tH,tI·1 

7 ""'90664"200161111 7 NET: 5 GALLONS 18.9liters PEST SOLUTIONS G'AhU RI.PIOS, M' "507 

0'" VtIAI, _f;C;;~1"; :7 ,J, 

FAX TRAN S MITT AL ~~;;:~~."~'-~:; 

C'7t:::--" 

-

'-- l--~ - ~ ,'-- /i~ ____ . 

~;;;: ~ 

/~t----. -d ' ~j '/" 

- I 

,'~. ~ 

_: / <)". :_ _ _ t/ ~ .70 U~\?T('/ -.? • " " I ,i 

, C :~, 

,{ 5'61;'-I I ~ ,,_., ",-,""" ""-, 

\_'"~T"",,,T_'n~,T, T,',"-,'T~:;--- . I,iiiij'--'- 'M' ,.d;fll-,,-,-,-,-,.',-,,-=~-, ';;F~r ;:, '.TR~,H'.\ 

""" :::>.'" .!' " ,-

X 

~ 

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?~ :l 

~ ~" 

" 

~ 

114
. 

! 

I 

• 

• 

MOLE 

REPELLENT 

LAWN 

PROTECTION 

656!r-! 

O PROOFS (Mld;/-iv,J REPR I " k //n ~ yi2 ,13'/ This line art is ready for assembly inlo your l{youlS . 

Enlarge or reduce to fit your needs. 

Wrile or call for additional proofs as needed 

MOLE 

REPELLENT 

PAOlfe~ 

PEST SOLUTIONS 

Phonc 6H3-243·921O 

115
I ! I .. ; 1:, " ,-

r 

{", c . 

,,,- '., f 

MOLE 

""'REPELLENT 

• 

116
• 

• 

THE 

ORIGINAL 

The ground mole is a universal problem. They make a mess of lawns & gardens 

SCOTT MOLE BENEF!TS: 

11\ DISPENSER BOTTLE 

III CO-OP ADVERTISING 

• POINT-OF-SALE 

BANNER 

411 DATING 

PROGRAM 

411 FREIGHT 

POLICY 

III REFILLS 

MODEL SM-1100 

1 quart bottle with 

Hose-end Spray Applicator 

Irealn 5,000 sq, ft 

UPC # 7-906&1-20013-6 

12 per case. Wcighl20lbs, 

Case size: I Ilh x 24 x 12 i(1, 

REFILL BOTTLES 

MODEL SM-1110 

'AI gallon reW! bottle 

treats 10,000 sq, ft. 

UPC It 7·900&HOO14·3 

12 percasc. Weighl52 los, 

Case size: II:hx24x 121n. 

MODEL SM-1120 

Gallon rem! boWe 

treats 20,000 sq. It 

UPC if 7-90664-20015-0 

i 34lbs. 

1::>6/'--/ ; ~-." .. ~_. ~·_.~i 

117
I ' 

r 

". 

• 

• 

• 

• 

MATERIAL SAFETY DATA SHEET 

AShland Chemical Co. 

CASTOR OIL USP 

?aqe 001 

Date Prepared: 02/10/95 

Date Printed: 11/18/95 

NSVS No: 0178552-002.004 

1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION 

ater Identity 

ra ct Name~ C8STOR OIL US2 G.~<a~~rtJG~.~n~.~r~ ern 

Company AShland Chemical Co. 

P.O. Box 2229 

COlumbUS, OR 43216 

614-790-3333 

Emergency Telephone Number: 

I-SOD-ASHLAND (1-800-274-5263) 24 hou~s evecyday 

RegUlatory Information Number: 

1-800-325-3")51 

2. COMPOSITION/INFORMATION ON INGREDIENTS 

ingredient (5) CAS Number % (by wei911t) 

CASTOR aIL 8001-79-4 100.0 

3. HAZARDS IDENTIFICATION 

Potential Health Effects 

No oata 

Skin 

No data 

Swallowing No data 

Inhalation 

No d.ata 

Symptoms of Exposure No data 

Target Organ Effects 

NO data 

Developmental Information 

No da':.a. 

Cancer Information 

No data 

Other Health Sf£ects 

... 0.0. 

• •• • • 

•••••• • • •• ~ ..... • • •• 0 •• 

• • •••••• • 

... 

, 

•• .. • 

o 

•• 

., • 0 

• •• '0 0 o •• 

• •• 

• · •• ..... .. • ~ 

•••• o •• 

.. . 

By natU!:'e of the pt"OQuct, no adverse health ~ffects ace expec'Z.ed. However, all 

industrial ChemicalS: should be handled 'liith caution to avoj>d unnecessary expos~rQ. • 

Continued on next page 

~-"""----------------------------

118
MATERIAL SAFETY DATA SHEET 

Ashland Chemical Co. 

\ 

... 

Page 002 

Date ?rooared: 02/10/95 .' Date Printed. 11/18/95 

I1SDS No: D178552-002.004 

CASTOR OIL USP 

Primary Route(s) of Entry Inhalation. Skin contact. 

4. FIRST AID MEASURES 

Eyes 

Skin 

If symptoms develop, move indiVidual away fron ¢xposure and into :ccsh air. 

Flush eyes gently with water whUe hold-lng eyelids apan:.. If symptoms pe!:sist 

or there is any visual difficulty, Seek medical attention. 

Remove contaminated clothing. Wash exposed acea with soap a~d water. If 

sym9toms"persist, seek medical attention. Launocr clothing before reuse. 

Swallowi ng • 

If swallowed, seek medical attention. If indivi~ual is dLOWSY O!: unconsciOus, 

do not give anythlng by mouth; place ~noividual on the left side with the head 

down. If individual is consciOUS and aler~s ~nduce vomiting by giving syrup of 

ipecac or by gently placing two fingers at the back of the throat. If 

possible, do not teave individual unattended. 

Inhalation 

If symptoms develop, move irrdividual away f~om oxposure and into fresh air. If 

symptoms perSist, seek medical attention. If breathing is difficult, 

administer oxygen. Keep pe~son warm and quiet~ seek immediate medical 

att€'ntion, · .. . Note t~·pnxSlClaos 

No data · · .. , .. . , 

.. . ........ 5. FIRE ./iIGHTmG: MEASURES · ,. 

• 

Flash P,Q'2rtt :u: .• 

555" b. ''It .(290. j c) 

Explosi ve 

• •• Limi t .. ••••• : •. • 

Net il.oplJ].icable . • ,. .... •• Autolg~\~~On Temperature No iitata· · .. Hazardous Products of Combustion 

May form:, acrolein, carDon oioxide and carbon monoxide, vnriou$ hydrocarbons. 

Fire and Explosion Ha2ards 

No special fire hazards are known to be associated with t~iS product. 

Extinguishing Media 

regular foam, water fog, car~on dioxide, dry Chemical. 

Fire Fighting Instructions 

Water or foam may cause frothing Which can be violent and possibly endanger the 

life of the fi~efignter. Wear a se~f-contained breath~ng apparatus with a full 

facepiece operated in the positive pressure demand mode With appropriate 

turn-out gear and chemical rssistant persana~ protective equipoent. Refer to 

the personal protective eqUipment section of this MSCS. 

Continued on next page • 

119
'. 

• 

• 

• 

• 

MATERIAL SAFETY DATA SHEET 

Ashland Chem~cal Co. ?ag~ 003 

Date ?~epa~ed: 02/10/95 

Date Pri~ted: 1:/18/95 

l1SDS No: 0178552~002.0C4 

CASTOR OIL USP 

NFPA Rating 

Not determined 

6. ACCIDENTAL RELEASE MEASURES 

Small Spill Absorb liqUid on vermiculi'~e, floor at:socbent, o!:' other absorbent :nate rial and. 

transfer to hood. 

Large Spill Persons not wearing protec;;.ive equi?ment should be excluded. from area of spill until clear:-up has been ccmpleted. Stop spill at. source, dike area of spill to 

prevent spreading, pump liquid ;;'0 salvage tank. Remaining liquid may be taken 

1..'.p on sand, clay, earth, floor ab50rbentc or oUter absorbent material and 

slloveled into containers. 

7. HANDLING AND STORAGE 

Handling 

8. 

Ey. 

Containers of thiS material Iilay be hazardous when emptied. Since emptied contai"e~s retain product rezidues (vapor, liq~id, and/or SO!id), all haza~d 

precautions given in the data sheet nus~ be observed. 

EXPOSURE CONTROLS/PERSONAL PROTECTION 

Protection 

Wear safety glaszes 

representative. ) 

in compliance w~th OSHA requlatior.s. (Consult 

•••••• · ., · , 

, . •••••• 

, 

.. , " , You·I! safety , 

Skin Protection .. . · ~.... . '. .. . Wea~ ~esistant gloves such 

arms and legs •. 

work ~~hing.~~ve~ing 

••••• , . , , . .. , 

Respiratory Protections ••••• • 

If overexposure has been determined or documented, a N:iOSH/MSHA jotnK~-';. 

approved air supp:Ued ~e$pi~at.ot' is advised in absence of proper enl(t.~nr.u?!ltal 

::;or,trol. OSHA regulation~ also perrni:: O~her NIOSH/MSHA re3pirator$~14.A09~ 

!,;pecified conditions. (See YO'lr t;afety equipme"t supplier.) Engi!".~f~~g or 

administr-ative controls should be i!tplemen~ed to reduce exposure. 

Engineering Controls 

Provide sufficient :nBchar,ical (general and/or lecal eXhaust) ventilation 7..0 

maintain exposllre below level 0: o'le,expcsure {fro:n kTIown, suspected 0:-

apparent adverse effeCtn). 

Exposure Guidelines 

Carr.penen":; 

CASTOR OIL (8001-79-4) 

No exposure limits establiShed 

Continued on next page 

120
MATERIAL SAFETY DATA SHEET 

Ashland Che~ical Co. 

CASTOR OIL USP 

9, PHYSICAL AND CHEMICAL PROPERTIES 

Boiling Point 

(for prOduct) 

Vapor Pressure 

Not applicable 

500.0 F {260.0 c) @ 760 mmHg 

Specific Vapor Density 

tfot applicable 

Specific Gravity .959 @ 77.00 F 

Liquid Density 7.980 Ibs/gal @ 77.00 : 

.959 kg/l @ 25.00 C 

Percent Volatiles 

No data 

Evaporation Rate 

Not apPlicable 

Appearance 

No data 

State 

SIQB.ID • • ••••• 

Physical Form HoMdG~ntous SOLUTION 

•• • 

Color • 

CLSM, .,. • .. • . • 

Odor .p •• 

;io <lata • . .. 

• ••••• 

coiliJ1 1 :MAX 

.. ... ". 

• .. • 

. ..... • • pH • • •••• 

•••• 

,., , •• • 10. STABILITY AND REACTIVITY 

Hazardous Polymerization Product will not undergo ha7~~rdous polymerization. 

Hazardous Decomposition 

Page 004 

Date Prepared: 02/10/95 .' Date ?rinted: 11/18/95 

MSDS No: 0178552-002.004 

• 

• 

• 

May =orffi:, acrolein, caroon dioxide and carbon lwnoxide, various hydrocarbons. 

Chemical Stability Stable. 

Continued on next page • 

121
'. 

• 

• 

• 

• 

--- - - _._.- -.------_ .. _ .. - -_._._-- --.---

MATERIAL SAFETY DATA SHEET 

Ashland Ch~mical Co. 

CASTOR OIL USP 

Incompatibility Avoid contac: with:, strong oxidizing agents. 

11. TOXICOLOGICAL INFORMATION 

12. ECOLOGICAL INFORMATION 

13. DISPOSAL CONSIDERATION 

Waste Management Information 

Page 005 

Date Prepared: 02/10/95 

Date Printed: 1:/18/95 

MSDS No: 0178552-002.004 

Dispose of in accordance l,;ith all applicable local, stat€' and federal 

regulations. 

14. TRANSPORT INFORMATION 

DOT Information - 49 CFR 172.101 

DOT Description: 

NON-REGULATED BY D.O.T. 

Ccr:.t~inc:::'/Mcdc: 55 GAL DRUM/TRUCK PACKAGE 

NOS Component: 

None 

RQ (Reportable Quantity) - 49 CFR 172.101 

No't applicable 

REGULATORY INFORMATION 

•••••• o 0 0 o 0 

o 0 

•••••• 

o 

.. 0 

o 0 0 

o .. 

.. 0 o 0 0 

•••••• • •• o 0 t. 

••••• o 0 

••••• 

tt , 

o 0 0 

.. 0 

o 15. 

us Federal Regulations • t. 

TSCA (Toxic Substances Control Act) Status -.: •• ' 

TSCA (UNITED STATES) The In-.:en'Cional ingn~dients 0;;: tllis produ;'t.U-e listed. 

CERCLA RQ - 40 CPR 302.4 

None 

SARA 302 Components - 40 CFR 355 Appendix A 

None 

Section 311/312 Hazard Class - 40 CFR 370.2 

rnmed.!..ate() Delayed ( ) F!..re() React.:,.ve() 

?ressure ( ) 

SARA 313 Components - 40 CFR 372.65 

No::e 

Continued on next page 

o 0 0 

.. 0 

Sudc.en RE-lease of 

122
MATERIAL SAFETY DATA SHEET 

Ashland C~emical Co. Page 006 

Date Prepared: 02/10/95 .' 

Date Printed: :1/18/95 ~SDS No: 0178552~002.004 CASTOR OIL USP 

International Requlations Inventory Status 

Not determined 

State and Local RegulatiQns California PrOposltlon 65 

none 

16. OTHER INFORMATION 

The information accumulated herein is believed to be accurate but is nat 

warranted to be 'tlhether originating with the company or not. Recipients ar:? 

advised to confirm in .:idvanc'O'. of need that the information is current, 

apPlicable, and sUitable to their circumstances. 

• • • ••••• 

• · .. • .. •• . • 

• · •• .. .. . •• · .. • · .. • 

.. . · •••• " 

••• • •• • · .. 

• ••••• •• • • • 

•••••• 

• .. • 

••••• • • ••••• 

Last page 

• 

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• 

123
I 

• 

• 

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• 

12% Rvnorn S1retC S_t:: 

Gfllrldftilpftb_.M14S5QL 

December 17. 1995 

EPA 

Robert forrest 

Product Manager ( 14) 

Inscc1icide~Rodcnticide Branch 

Registration Dr\'lsion (H7504C) 

Dear Mr. Forrest 

P]c,lse find enclosed the final printed lab;:;];; 

MSDS sheets. 

Regards, 

Cleaning Solutions, Inc, 

•••••• • • • 

• • 

•••••• 

• .. • 

••••• • • ••••• 

T flk:ph0h0 Si6-24"}AjSG5 

1"117 GH1<?4e-2970 

15-1 and 

• • •••••• 

• 

... 

. , . · .. 

• .. ., . · .. ... 

• .. •• . 

• · ., .. . •••• 

. ... • .. •• . 

124
us ENVfflONM£NTAL PROTECTION AGENCY 

OFfICE·O!' PESTIcrn~S PROGRAMS 

RI!GIS'rRA.TrON DMSION (TS-767J 

WASHING 'tON. DC 204GO 

NOTICE OF PESTICII>S' 0 nEGISTF!A-;ION 

. 0 REln: .. ,t;.TF!A~ION 

(Under a,e F"euer{ll fllsccticidl<, F!Jn~l";III€!, 

>lnd Rodcntio::;d~ A~I. ItS /,lw(Jllderi) 

Scoot-Mole Evacuator 

NAME ANO 

L 

Cleaning solutions I. Inc. 

lZS0 Ramons ·st., SE 

Grand Rapids; MI ~9507 

HOTE; CbanECli: in labeling formula dd"fermg Il1 ,;ub.:tan<;c in)"" thai ;lcc"'pl~d in con;lecticn with tbi5 te~i:Hr;fltion muM be 

lliubmifU.d to and lIeeepte:d by the Registralion DJvis.icn prior 10 II!;!! of rile I;\be:! in commen:". in ~ny cor:respondclI";c on thLo: 

pr¢ductalwIlY!1. refer to the :ub.we U.S. EPA n:(1;illtr:uion Ilumbl/!;, 

the! bllsls >of 1mormatiott futl'lishecl by the regi:HHul.l, the 

Federal Im:u~ctlcjde, F\lnp;iCrde, :IInC; ROOf!n:!cldc Ac:, 

nIImed pcstlcide i..-.; hereby Registered/Reregi!;tered uruler 

copy of thc labeling IIceept<!d in c.;lmmct'on witb this Registrl'ltionjReregisulltion i$ returnf!O herewith. 

Ree:istrlltion is in tiD way to be conliuuct! filS JU\ jnd0l"5ement ot apP<"ovl1l <:l this product by thiil heeney. In order to ptotect 

heatth and the "l"lVlcOnment, tbe Ad:::ID.d:ltrator, 011 hi,; motipn, mpy ftt any time SUlipeIld <lr cnncel the ~ell;is1r .. tion 01,. pest. 

kide in accorcl:mc:e wilh the Act. The aeceptlilnce of liny name in conne~tjcn with the registration of !I. proouct om:!!!!r thi$ 

Act is not to fx, "'onl>trD~d ilS li:iving the regi:!:trunt Q. right til exclusive use of the nom..; o~ t<l its UM if it has be"." cQv"'red 

by others. 

This product is unconditionally registered in accordance 

with the Federal Insecticide, Fungicide, and Rodenticide Act 

(FIFRA) section 3(c) (5), for one ye.ar, provided that you: 

submit a revised l'1aterial Safety Data Sheet (I1SDS) for 

Castor oil from your supplier, Acme-Hardesty CO' I Inc., J 

showing the tt#l Castor OilTf is IIUSp Gradelt , before you -of/oF", ,"" 

release the product for shipment:. ,....r~1_-;/f-_1 

B. Make the following labeling changes before you release the 

product for s~ipment: 

v 1. Add u·EPA Reg. No. 6561.5-1" to your labeL 

Establishment Number to your label. 

v 2. "Your use. directions must begin· with: 

DIRECTIONS FOR USE 

Add your EPA 

It is a violation of Federal law to use this product 

in a manner inconsistent with its labeling. 

~TACMMENT 15 APPLICABLE 

EPA 

I ' 

125
• --

2 

J. TO mitigate any possible risks to aquatic organisms I we 

will require the following labeling changes, depending on 

the container size: 

.j • 

a. For the'32 oz. slZe t which we assume is intended for 

outdoor, domestic use only, add the following 

"ENVIRONMENTAL HAZARDS" statement on the Back Panel as 

follows: 

PRECAUTIONARY STATEMENTS 

CAUTION 

KEEP OUT OF REACH OF .CHILDREN 

ENVIRONMENTAL HAZARDS 

Do not apply directly to water. 

J b. For the 64 oz., 128 oz. (1 gal.) rand 5 gal. sizes, 

which we assume is intended for Qutdoor, non-domestic 

use, add the following "ENVIRONMENTAL HAZARDS II 

statement on the Back Panel as 'follows: . 

PRECAU~IONARY STATEMENTS 

CAUTION 

KEEP OUT OF REACH OF CHILDREN 

ENVIRONMENTAL HAZARDS 

Do not apply directly to water, to areas where 

surface water is present or to intertidal areas 

below the mean high water mar~. Do not contaminate 

• 

water when disposihg of equipment washwaters. 1It 

4. Make the following changes to your storage and Disposal 

text, depending on, the container size. 

a. For the 32 oz. size, use the following text: 

STORAGE: 

DISPOSAL; 

STORAGE AND DISPOSAL 

Store only in original container I in 

a dry place inaccessible to children 

and pets. 

Do not reuse empty container. Rinse 

thoroughly. Securely wrap in 

newspaper and discard in trash. 

126
• 

• 

3 

/ b. For the larger sizes, use the following text: 

STORAGE AND DISPOSAL 

Do not contaminant food, feed, or water by 

storage or disposal. 

STORAGE: 

Store only in original container, in a dry place 

inaccessible to children and pets. 

PRODUCT DISPOSAL: 

Wastes resulting from the use of this product 

may be disposed of on site or at an approved 

waste disposal facility . 

CONTAINER DISPOSAL: 

Do not reuse empty container. Rinse thoroughly. 

~ ~ Securely wrap in newspaper and discard in trash. 

\ c.l Within one year of registration, or October 15, 1996, you 

\ ./1 need to .certify to us, in writing, that you have conducted 

~ efficacy studies conforming to the EPA Guidelines for 

conducting mole studies (96-S) and the Good Laboratory 

Practices (GLP) Regulations, 40 CPR 160, and that these 

studies verify the application directions accepted with this 

Notice of Registration. 

Although you are not required to submit these data to the 

Agency for review and validation at the present time, you 

must maintain these studies in the event that the Agency 

needs to review them in the future! either as part of a 

review by the Registration Division or by enforcement 

personnel. If questions arise about the design or conduct 

of the study, please contact us. 

If, by october 15, 1995, you have not 1) satisfed the 

requirement to certify that you have acceptable efficacy, or 

2) have not provided us with an explanation of why you were 

unsuccessful in developing such data and with a request for 

an extension of time (indicating the amount needed) to 

gather additional data, the Agency will automatically cancel 

this registration, effective on that date. 

D. submit one copy of your final printed labeling before you 

release the product for shipment. Refer to the A-79 

Enclosure for a further description of final printed 

labeling. 

127
4 

This registration will be subject to cancellation in 

accordance with FIFRA sec. 6(0) if you do not comply with these 

conditions. Your release for shipment of the product constitutes 

acceptance of these conditions. 

A stamped copy of the label is enclosed for your records. 

Robert A. Forrest 

Product Manager (14) 

Insecticide-Rodenticide Branch 

Registration Division (H7505C) 

Enclosures; 1) Stamped label 

2) A-79 Enclosure 

Peacock 1'lP#6:A: 65615-1. NOT: 305-5407, -6600! 10/5/95 • 

• 

128
•• 

• 

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-----------------------------------------------------------------~" 129
AUG-21-9S MON 11:05 CLEAtfINGISOLUTI8NStlNC. 616Z482976 P. 0 I 

'lonald L Balk 

DATE -........ . 

II',Q$" 

TIME 

• 

• 

, v;,o ,dMBER OF PAGES (INCLUDING THIS PAGE) ____ ~d..~ ___ _ 

FAX • FAX • FAX • FAX • FAX • FAX • FAX • FAX • FAX • FAX • FAX • FAX 

130
• 

• 

• 

• 

,A"O.-'1-95 MON 11 :0>$ CLEAN[HGtS0L(JTI0N$1INC. 616:24S:<;'$'1'6 

Aug1lSt 21, 1995 

EPA 

Robert Forrest 

Product Manager (14) 

Inse.)Ii<ide-ltodenti<:ide Bnmch 

Resistmtion Divisioll.(I:i751l4C) 

Dear Mr. Formt: 

Cleaning Solutions, Inc • 

C;l;m~i,'H Suhrtiom, Ioc. Vl'ill commit to conducting further efficacy tests with an acceptable 

protocol within one- year of ~ lli i!. !'C~.st:;a~f~je f~!' S·UY.;1. . .i\10i'C EVW'':l12iIW rrPA Ftt;;;: 

Sywbol6S61S-R. This is response to your i<tI<r doled August 2, 1995_ 

131
P.01 

Ronald L. Balk 

• 

• 

• 

1250 Ramona 

Grand Rapids 

Mlch!gan 

49607 

Phone 

61&243-0555 

800338·2_ 

RE: 

DATE 

TIME 

TOTAL NUMBER OF PAGES (INCLUDING THIS PAGE) ___ -'-r'2~. _____ _ 

FAX - FAX - FAX - FAX - FAX - FAX - FAX - FAX - FAX - FAX - FAX - FAX 

132
\ 

• 

• 

---~~~~----------

CLEANING SOUJrrONS, INC 

DBA PEST SOLUTIONS, INC 

1250 RA1'vIONA S1, S.E, GIt~"D It-\PlDS. MI -19507 

EPA EST 65615 

EPA REDUCED RISK IN1TIA TIVE 

PRNOTICE 93-9 DATED 7-21·93 

T1t:.\i,{SMm . .\L DATE 4-17-95 

APPLICATION FOR REGISTRATION OF 

SCOOT ;vIOLE EVACUATOR 

..e .• 

• • ... ... •• • • •• 

••• .. ........ .. • •• .. .. .. .. ........ .... ..... .. • • .. .. .... ....... · . ... " .. • • ..... .. 

• •• . ..... , - .. ... • •• •• • 

133
• 

AUG 2 = i995 

D'6cfJI 5"r' 

Cleaning Solutions, Inc. 

1250 Ramona st., SE 

Grand Rapids, MI 49507 

Attention: Mr. Ronald L. Balk 

subject: Scoot Mole Evacuator 

EPA File Symbol 65615-R 

Your sUbmissions of March 20, April 18, and May 4, 

1995 

We have reviewed your revised Confidential statement of 

Formula (CSF), your Material safety Data Sheet (MSDS) I and your 

efficacy data. The results are summarized below. 

I. CSF (March 20. 1995) 

Your revised CSF dated March 20, 1995 is acceptable. 

II. Material Safety Data Sheet (MSDS) 

The MSDS for Castor oil from your supplier, Acme-Hardesty 

Co., Inc., received April 24, 1995, is acceptable, provided that 

you submit a revised one showing the "#1 Castor oil" is "USP 

Graden. 

III. Efficacy Data 

We have reviewed the efficacy data (MRID No. 436422-01) to 

support this product. We have the following comments. 

A. Author of Study 

The author of the study was unclear. On the UTi tIe 

Page", Mr. Balk's name is listed, but on the Good 

Laboratory Practice (GLP) page, Mr. Bizzell's name is 

listed as study Director. Since Mr. Bizzell did most of 

the work, his name should have appeared as the author of 

the stUdy. 

B. Quality of study 

For the past 25 years the Agency has not accepted 

testimonials in place of scientific data to support 

product efficacy. Because of the following observations, 

134
·.-.. -~-----------

2 

we would have to consider this submission to be more of a 

testimonial than a scientific study: 

1. The study falls far short of GLP quality. 

2. "SEGMENT #1" is basically 10 testimonials from one 

individual. 

a. Results were not quantified. 

b. There were no pretreatment activity estimates. 

c. There were no concurrent controls. 

3. The data presented in "SEGMENT #2" are very 

limited. 

a. The text does not appear to include pretreatment 

assessments of rates at which flattened 

subsurface runways are likely to be raised 

again. 

In summary, the efficacy document is not adequate to 

support the claims proposed for this product. 

As indicated in earlier conversations, the Agency has 

published guidelines (copy attached) for conducting field 

efficacy tests for moles. Before attempting to run a 

test with this or other protocol, you should contact Dr. 

William Jacobs at 703-305-6406. If you need someone to 

run these tests, we can provide you with the names of 

persons who are experienced enough to run such tests. 

If yoti commit to conduct the efficacy tests with an 

acceptable protocol within one year of granting a 

• 

registration, then we could conditionally registered this • 

product without efficacy data, assuming you corrected the 

other deficiencies in this letter prior to registration. 

IV. Lal<e ling 

In our April 7, 1995, letter, we provided you with an 

acceptable label for a closely related product, Mole-Mod, EPA 

Reg. No. 64439-1. We provided this label to you so that you 

would know how to develop an acceptable label for your product. 

Although we will provide additional labeling guidance after 

we have reviewed acceptable efficacy data, we are providing you 

with the following comments on specific claims on your proposed 

label that need to be modified or eliminated; As we will note 

from a comparison between the Mole-Med label provided you and 

your.proposed label, none of the problem claims appeared on the 

135
• 

• 

3 

approved Mole-Mad label. The questionable claims include the 

following: 

L You should eliminate the word" "Concentrate" from your 

product name or change it to tlTechnical" since the 

product is 100% castor oil and contains no added inerts. 

2. You retained the original treatment directions on the 

label despite a major formulation change from 21% to 100% 

active ingredient. We will comment on this part of the 

label after we have received acceptable efficacy data. 

3. To repair the proposed label, delete the following 

claims': 

a. IINON-TOXIC"; 

h. tlBIODEGAADABLEt' i 

c. nSAFEIt: 

Claims "a. II , tlb. II, and "C. II are safety claims which 

automatically misbrand pesticides, as indicated in !Q 

gm, SlS6_10 (a) (5)_ 

4. The following claims are questionable and must be deleted 

unless you can provide data which validate them: 

a. Iteconomical ll ; 

The claim tl economical tI seems to implies an 

unqualified claim of favorable comparison with 

IInon-economical" alterna.tive methods that one might 

use to combat moles. Even if such an implication 

is seen as unlikely, there is no attempt to 

indicate how much it costs to use the product per 

average application, per mole or square-foot. 

b. uHoles can d~g up 300 feet of earth in one night"'; 

We question the claim that moles can dig up 300 

feet of earth in one night. It needs to be 

substantiated. If the claim pertains to the length 

of turf that a single mole can raise in 24 hours, 

such a mole is not likely to bring 300 feet of 

earth to the surface in one night or in one 24-hr 

period. 

c. "Moles eat enough food to equal its weight each dayll~ 

136
• 

• 

4 

d. "MOLES CANrT WAIT TO HOVE" (made twice); 

e. "SCOOT MOLl!: evacuator works because moles 

dislike the odor and taste of the product"; 

f. uWhen they first smell SCOOT, they will 

become very active trying to get awayn: 

g. "When they realize that it's all around them, 

they corne to the surface and look for a lawn 

that doesn't smell like SCOOTtfi and 

fo. nMoles usually leave a treated area in ~-2 

weeks after application. Ii 

You need to sUbstantiate with data the claims 

listed under nen through IIfll above, which refer- to 

how the animals react to scoot Mole Evacuator. 

g~ Misleading Graphics 

There are no accounts of moles coming to the 

surface in Mr. Bizzell's testimonials. Unless such 

substantiation is provided, the portion of the 

cartoon illustration which depicts an opened and 

evacuated tunnel must be deleted. 

5. The label must bear a "DIRECTIONS FOR USE" section which 

should be organized as indicated below. 

"DIRECTION'S FOR USE 

It is a violation of Federal law to use this 

product in a manner inconsistent with its 

labeling. 

USE RESTRICTIONS: This product may be used to 

repel eastern moles (Scalopus aguaticus) from 

lawns, ornamental turf, golf courses, and 

athletic fields. 

LOCATING MOLES: The presence· of moles may 

be indicated by a network of surface ridges 

in the turf or'by a series of conical 

mounds of earth pushed up from deep 

burrows. Treat all areas which show signs 

of moles' presence. 

APPLICATION DIRECTIONS: Shake container well 

before using product. Attach garden hose tightly 

to self-dispensing container~ Turn water supply 

on to full pressure, Spray SCOOT MOLE EVACUATOR 

137
--- .-----~~~~ ... ---.--~ 

@P3L ENTER LANGUAGE = PCL 

• 

• 

138
• 

• 

5 

over mole-infested area at a rate of one quart of 

product per 5,000 sq. 'ft. (e.g., a 50-ft by 100-

ft rectangle) . 

Apply SCOOT immediately after the presence of 

moles is detected or in early Spring, Mid-Summer, 

and early Fall if there are moles nearby but not 

on your property." 

Note that the content of the 'tAPPLICATION DlRECTIONS't 

should be adjusted as necessary to accurately portray the 

procedures and treatment rate{s) needed for the product 

as it now is constituted. 

These use directions are tailored to the one-quart 

container, which apparently has a built-in venturi 

system, that is illustrated on your proposed labels. We 

suspect that these directions would not be completely 

appropriate for any of the other container sizes {"64 

oz., 128 oz., 5 gal."} identified on your proposed label 

as we do not expect that self-dispensing, venturi-system 

containers that are one-half gallon or larger in volume 

could be used by typical adult humans with any guarantees 

of reasonable treatment accuracy or comfort. 

Distinct directions (and perhaps a distinct registration) 

would be needed for the larger containers. Such 

directions must include procedures for diluting product 

for use in non-venturi sprayers. If you intend to 

produce your own venturi sprayer for applying this 

product, the use directions on containers of 64 oz. or 

more of SCOOT MOLE EVACUATOR products should indicate how 

to use the product in such application equipment. If the 

product is to be used in Venturi sprayers that you do not 

produce, it might be possible to provide to users general 

guidance regarding how to load the units with the proper 

amount of SCOOT MOLE EVACUATOR to treat areas of various 

sizes. 

Pursuant to Section 5152.105 of Title 40 of the Code of 

Federal Regulations, if the above requested information, or a 

written request for additional time is not submitted to the 

Registration Division within 75 days of the date of the receipt 

of this notice, the application will be administratively 

withdrawn. In that event, any subsequent SUbmission relating to 

the same product must be submitted as a new application. 

139
• 

• 

6 

If you have any questions about this letter, contact Mr. Dan 

Peacock at 703-305-5407 or 305-6600. 

sincerely yours, 

Robert A. Forrest 

Product Manager (14) 

Insecticide-Rodenticide Branch 

Registration Division (H7504C) 

Peacock WP#6:A:\65615-R.AUG:305-5407 t -6600;S/2j95 

140
@PJL ENTER LANGUAGE = peL 

• 

• 

141
\ 

• 

• 

JOJ 

:"":..H: snou!.:! =..e :M.!.!t:::.a.i.nec has no.: been es::.ablished, a 70'\ :eductian in 

a:::~ ... :'=.i' Q,:" da::;aqes cl!e ':.0 1.!se ct dle ::roducc is s~gges"1:ed. 

(21 Test in£armaeion. ?or ~ach scucy, indicate the for:ulaeion, 

loca~on ani: size ot "tes t: -arga.( 5) t a:.d ::..l-te IOOthod, number t rate, ~nd ~equency 0= aoo:!..J.:::acions... ?rovi::ie a' aap of test and cancrol areas, includi:v; t.heir 

=i~er.5Lor.s. ~epo~ all =aw and 5~ary da~ used ~o ~valuate e=fec~ven~$s_ 

:ncl~e ini~r~tion on target and non-target spec~es. Zndica.':.e ~~e cethoa 

4u=,=a~=nale of selectins ~xperioe~~l areas and of assigni~g them to 

:es'e 0= cor.t.::ol ~oups. ?.eport ':.}:G and :;:egree of damage =ein9 ex;>eriencec 

:,y to2S::' anc control areas. ~=-:.lVide clicat:.olog!.cal cat.a for the s~dy 

?erioa. Describe all statistical methods ~sed. 

(3) AC~e?~hle ?ro~ocols. For information en £ield.ef!~ca~I s~dies, 

see 5ec-':'::'on 9 0: re:::erence 12 i:!, ,96-25. References ci.~ed in i 96-3"0 My 

~~ helpful :n developing an acceptable p=o=~col incorporating ~~e tes: 

5~r.carCs ~~s~ibed in ?araqraph (el(21 of dr~s sec~on. 

(a) General. This sec~on presents ~ff~cacy ~ata ~~d ~es~ procedures 

=0= llole =~xica..."ts applied as' hal.!:s and t:u.:usan<:s t.,o uncerqrcund =-.umel.s, 

Targe~ $p¢cies include ~~ eastern mole. Townsend ~ol.el starnose QOle, and 

calitornia ~ole. Submission of efficacy da~ is w~ive~ f~r this $ect~on, 

(~) ACUte and $ubacu~e toxici~y s~di~s. S~bmit ~~e resul.:s of .:oxici=y s=~cii~s ~or each genus of ~ole clalced co ~e cor.~olled by a .:oxican= 

a?pliec as ~ai: or toxicant. ?or a sin~le-dose b~i~, submi= an a~J.:e oral 

~050 .:es=. For a ~l~ple-do$e bait, submit an acu.:e oral ~D50 teS~ and a 

suba.::u<:.-e {S-day) o:al LOSO test. For a fUl!UQan!:, sUbnti.t. an aC'llte inhalation 

~30 =es~. The purpose of ~~e$e s!:udies is to assess ~~e appropriauecess 

0: dosage levels used in subsequent testing. 

(l) ~est standa~d$. Ose animals ~~ac are laboracc~J-r~a~ed or' captured from vil~ en~ronmen~. Use ae least 10 ani~als ;or 

each !osage level. != ex~~al sexing is no.: ?Ossibl-e, determine sex ae ?os~ 

~or~~. cage ~est ani~als i~CivLdually. Observe any changes i~ behavior 

~~~ ~y a!fect e£=icacy. ~bserve gross ?A~~ological cnang~tl !ound ac pest 

~o~~e~ (e.g., h~morrhaqing. *~e~. al~ers, discoloring). !or detailed ce3~ 

s~n=ar~s, co~ul~ =e!~rences 9 and 16 !n § 96-25. 

(2) ':'est ir.!ormac:'an._ ;:nc.i.cate ~,~ species and ori9in of cest , 

~n~=als. Des=~ibe accl~ma~ion ~t animals, labc=a~ory conc~cions (e.g., .:e~?­

e!'a ~~r~, ~t;;.ic:.."':"I, ligh':., ca.:;e size}, 'f!':.c' gross ?a't.."ologica2. changes !"U,"1C 

a<: ?OS~ mo~t:.~:n. Segara':.C: t:\o::=a~i .. y da~ fer each cosage level. Subrn.ie a 

~cse ~2s?O~e ~=ve tor each S?CCi~5 ~la~:ned or im?l~e~ ~1~~ =cm?u~atien 

':!: ~'le s::"'c;e ar.c LDSC 0':" ~50 -... i-=-ll ?i2<s co::.fi::ence l.:..;;U.':s. ':Se2 =e!:e!'oance 

S :..::. ~ S6-,15.} 

{= l ;"2..!lor~~o~! accepca:::ce s-::...taies. .5ub:;"i. ':; t,:"Ie !,;!s~l ':.S of. la.bor3,=~!,: 

a,=::e~ca;:.::~ s~1.!Cies :~r ee.c~ S'e~,-"s =l.~.:..:;)~: :.::: ~e =~~crc!.l~c -"';'~'1 a t:~xi= 

------------------~-~---

142
• 

'04 

~A~::. ~e ?urpose o! these s::udies is to ass~ss ~~e appropria::eness of 

~a~:: :arriers ~$~ in sUbsequen~ testing. 

,:] T~s~ seandares. Use <:he ~ild target genus. Use at leas~ 10 

ace!:: ~ol~s. I~ ext~rnal sexing is no~ possible, determi~e sex at pos~ 

:lOr':.!:!:!/.. caqe o:.es:: a.n.ic.al.s indiVi.dually. Provide a free choice between 

:.:..e :::andidau bait. carrier and the habi!:Uatec die~. Conti;lue recording 

ca:'ly !ocd. consttmP'tio'n Wl~l t.~e ?ercentage of !ood ea 'ten z~li%ez. 

':::mc.:.::'t. la:>ora~ory- acceptance st".u:!.ies wi~'L all candida::e carriers th.a.t :nay 

be ~s-:.eC in ,::-'1e fie1d~ 

t2} Tes~ i~fo~a~on. L~dica~~ ~~e species and origin of 

::e5;:' an.!.=als. Desc::-ibe acclimation o! animals and labora.tory conci.:is.l.ons. 

5U;cl.:.'::·ind.ivioual and summa.!""!' daQ. on all moles, inclucing ::..'1. quantity 

anc percen~ag~ of ,each diet consumed. 

{~) Laboratory ·ef::J.cacy studies. SUbmit the results of a la.borat:ory 

e:!=icacy us~ !or each genus claimed ':.0 be cont.:'olled. The purpose of 

::hue st".:c.ies is to assess the laboratory efficacy of Uie formul.a:tion. 

el) Tes~ s~ndards. Use ~~e Yild target ~enu$ • Use a~ leas:: 10 adult 

:cles !~~ eac~ tesc~ 1£ e~ernal sexing is no~ possible, dete~e sex at 

?O$~ ~or::~m. Use at least 10 adult moles for conc:ols. ~reate~ th~~ 10~ 

eo::~ll 'Cy :'n cont:'o1.s negates t'..'le ::est. For toxi.:: hal::5, provide a f:ee 

c!"!ci:::e Zlet:"..reen ';.~e hab.1;tua::ecl. rati.on (e.g:, fisn-fla. ... orec ca:: food) and ~e 

::~xi::: ~i::. For fu::ti~ants, -:::es't ani:tals individually ~;: an ,ar'ti.!icla.l oole 

ZU=~OW. {S~e reference 17 in § 96-25.) The eX?05ure pe=iod for a singletcse ~t is 3 days. The exposure period for a ~ul~ple-dose ~~~ is LS days. 

The eX?Osure pe=iod for a !unigane is one hou~. Tes:: all fo~ula~ions that 

~ay ~e usee in ~'le !ield. 

(2) Suqges't.eci per~or:nance st.z.ndar~. 'i'~e level of efiicacy ti<.ac 

shoul~ ~ ac~ined for an acceFtable ~es't. has no~ =een es-::.ablisheci. However, 

30\ :uo::o::.ali. '=Y in the tes'C group <lnc no mo!:e ~"lan 10\ 1tlor-::..ali::y in the 

con -'=0:" :;-::,oup is s uqgc·s teo. 

(3) Test kn!Ormation. Identifv ::..~e snecies dnd cri;in of ehe ta=ge~ 

~ani~l$' Oesc:ibe ac~limation of the ani~ls anci laboratory condi~ons. 

-

rot" A =utli.gan~, cescribe ~~e r.iet.l;.od of appli.cd:.l.cn. for a ~ox:ic bai::, provice' 

~ai!y 't.=ea::~c and unt~eatec !ood consumption cao:.a f~r ~ach t~s~ animal and 

species.. ?or each. ani:nal~ indica::e t.'le title 0= oel.l6. Provide summary cla-::..a 

~? sex ~~C species. Schmie a che~cal analys~s or the ::es= ration =or ~~e 

;er=e:1eage 0:: acti,:ve i:ngredient. (See ::eferences 1:! ar.O '\ 4 in § 96-25.) 

{<.). Ac:.ept:able ?ro"-ocols. Ref~r-:!r.ces i 7 and 18 i:: § 96-25 and ot.l'le!"s 

=~:.ec -:.::' ::'''1e § 96-30 :nay be helpful i:: deveioping an ac=e.::t.z.ble f!:;,ot:col 

~~c:r?O~a::~~g ~~e :est stancat"Cs above. Tor ~e~~ccs ~f =hemical ~~alyzis, 

~~,.sl!l,=- ::~=2=ences 13 an'::' 14 in ~ 96-25. 

::he resul::~ c~ field cf:icacy te~~ 

:=r ~a=~ 5?eC~eS =iai:&c ::0 Zle =o~~=~~:ec. ~~e ?ur~ose of ~~eze s~ucies ~a 

, , , 

-, 

:~r.6i ::icns. 

='!::''::::S ~~ ~-':ee ac::ef:::abie :~ .. l= e£::::acy 3::'..;C~~S :0: "'<lcn ;o=ula~o~, 

:-_t::..,cr.:: ?: ~?fl.:.:a~c~, :t~jor =eqior., a:;': :opecies !;la:'r.lec :It'' ~::'i?!iec 1:0 ;e 

, =~~::=?~:~~. 

~~ 

( .. .. " 

143
30S 

{i~) P~e-t=~a~~~nt and ?os~-t=e~t~en~ ?ooula=ion censusing. ~ocat~ 

~o:e-~~=es=erl =~elc$, l~wns, anc o~~e= areas where interference ~y =acs, 

,bgs, or ,,:::.>;.e= <!..."l':'Olals is o.ot an~l.c~?&ted. Usir.g su=fac~ burrows, l.denu"!y 

:l:1~ ::oark ":;:u,!==;)W sys't.el!Ls ::..,ndividuaLly. A single bu==oW' system ·",roule include 

all ~=ter=onnec=~ns su==ace burrows. :n a pe=iod of !ive days, ide~ti=y 20 

aC=l.ve burrow sys~~. ?unch one-inch holes in ~~e roof of edc~ burr~w of a 

:)"(,:,=::0"00' $y~~n. aur~ow sys't.eO',s are ciefined as '"a.c-e.ive .... if holes have be~n 

openf!c ant! plugged a.t leas,:; three times °..ti'::..l;in :::ive days. ~.a.rk .:h.e l.o=ations 

· ... bere :::mr:'O'Js are pu.'lched $0 cllat :::'''2 sace ~unnels can be: punched dtU'inq t."Ie 

:os=_~r£a~e~= phase. As ~ac~ of ~~e 20 active bU~ow sys~ems is locd-e.ed, 

;;:.:;::,;,e:: -:.."12:: so :::.'la.-::. 'clle closest: ac-::~ve :rur=O' ... S1S-::e::l$ ha.ve consecu-::':'ve :-.u:cbers. 

{~iil '!'reaQuent: phase. T!''!!at the cGc-m.:.nberec burrow sy$:te~,-bu= ~ 

~~e ~Vtr. ~umbered burr~ sys~eC$. ~,:::.~~S ~ay, only al=erna.-::.e systemS are 

~=eat~d. ~ea~ in a consistent manne~, ac:~rdinq t9 the dir~c~ons to be 

included on ~~e ?rccuc~ Label. Hai~tain ~tco=ds on ~"1e ~e~~ods of appli~a~ion, 

:oca.~on ar.c'~uan~~7 of ba~~ or f~gar.-::, and ~~e f=eq~ency of application. " 

(::''1) 

::n::=co,.rs !.:':.sur'!.s :..'1a.':. the ~educ::.ion .:..;: t .... 'le numce:- of. ~e -=argot pes'tS in t:-eat:-

~d =u==~s is ~e ~o :::.~e t=ea~ent ~'ld not to o~~~:: !ac=ors. 

( v) ver:"'=.ication 0:: :::.'1e -:::arcet soecies. , ' ~ecause ~~e ~e:::.~~c ot ~ensusing 

1.s ~ i~ci~ec~ or.t, soce live ~=apEing ?efor~ census~ns snou:d =2 aone ~ ve::i::y 

~'l~ speci~s of mole. ~eco:-d ~~e s;ecies ot oo~~ =aptuIec. 

(~) 3u5qe~tec per!o~nce stancia==. T~e level of e£ti=a~l ~~a~ shou~d 

~e a~~in2C ~or an acceptable =est has r.o~ ~een established. However, a 70\ 

~~duc-=.!..on l..n ~ur!"OWl.ng actiVlty 0= :::.'":e ta;:-qet; ?o?l:lat:ion au,e ::0 :;..'1e 'J.se :t 

L~2 ?=oeuc-:: 1.S sug~es=ec. 

(2) '!'es,-::; info!"1':la-::::..on. Repor-:: :;.."'le :--esu,..l..::..s c! all s~llc..ies, :,,~c~l..:di:1S 

:-ay a~~ sucrna:-y data. Sub~~ info=~~.!..on =or each ==eacec bl..:r=c~ sys-::c0 on 

:::.~e ~e~~od and !resuen~i of a?9l~cacion, a~d :::'~2 l~cation, cocpcsi~c~, a:1C 

~an~~y ot bait or =uc.iaant* ?ro~_de a general ~ap shc~.ng ~he n~e~s anc 

ap;roxi~a~e ~oca=ions of punche~ ~Jr.nels, di~en5~~ns ot ~~e bu==ow syst~m£, 

tis~nce ~o ~~e closes= ac~ve bu=r~~ sys~ec, and :;..~e loca~ion of ::=ea~~e~ts. 

:0= ail phases of :::.'1e stl..:cy, incluc~ cllma",=olcgic~l data {daily max~~um anc 

;:".J,..r.i:nu:t: ::er,;p.era:::'1.!=e, an": daily p,::ecl..?l..=at:i..on} t':-om: a local weat:he:- sta'-::;::"cr •• 

~~~~!.~ i:':.=o~a~on on ~or~l.:..=y by species and sex for ~r;e~ anc non-tar~et 

:<.:...1::; 1.:: st:..lcy a..:;eas. :nclude a.!...:' figures used eo calcula-:..e the ,?er:::en=aqe 

~: 2:'::::i:acy. 

(J) Acce?~aole pro",=cccls. Re£e=~nce 17 ~~ § 96-25 and C::.ers ~itec 1.:1 

~ 96-30 ~y be ~el?t1.!l !.n develc?~::g an acce?~ole ?rotocol ~~co=?C=a=~::9 -:::~e 

~es= s~~ciar=s ~esc=~=e~ .!..~ ~a::aq=afh (e}{l) 0= this section. ?ri..o~ :::or.s~:~­

~~~n ~~~~ :::.~e Agen~y or. zuc~ p=otocols ::0 =e ~m~~~yed i..s st~ons.!...y ~ec~nmenCed. 

144
, , 

Record Nvr:nber(s) 

D2162S7 

619{9"Y 7126195 

:DI o:..-r---

• -FILS OR?SG~ NO~ ~6~5~6~1~6~-~RC-_____ -c ______________ ~ __________________ _ 

PErrtrCN oa =. PER'\IT "-'. __________________ _ 

CAT>': ON. == -.-:5.::1.::4/"'9..:5 _________________ _ 

DJ\J3 a: S.,'3:1.L..35ICN 3/20/95. 4/18/95. 5/4/.95' 

, ~ SV~~SSIGN ~~ _6~1~9~1~9~5~ __________ _c ________________________ _ 

=P=<S), "" 5 

iJ..zcrA ~I~ NO(S) ~ 436422-01 

---~~-------------------------

P~'~. NO. __ 14 ___ ~-----------------

??C.:£::iX:f ~.z-S(S} SCOOT MOLE EVACUATOR CONCENTRllTE 

• ~1LSS~UN prv;LOCSZ support claims, get registered 

GiE11ICAL [. FQ?:l'L'UI.IICN lOO't['SP iii Custor Oil 

-------~~---------

145
, 

• 

• 

.--.. -~ 

Efficacy Review: SCOOT MOLE EVACUATOR CONCENTRATE, 65615-R 

Pest Solutions 

Grand Rapids, HI 49507 

200.0 INTRODUCTION 

200.1 ~ 

A 100% USP castor oil end-use technical proposed for Federal 

registration for use to repel unspecified types of moles from 

unspecified sites. 

200.2 BackgrQund Information 

The initial application for Federal registration of this 

product was dated 8/17/94. There have been no prior efficacy 

reviews. 

The package routed for my review includes 

1-

2 • 

3 • 

4 • 

5 • 

6. 

7. 

a letter of 4/18/95 which claims that EPA uhas waived 

all acute toxicity data for USP #1 Castor Oil"i 

photocopies of printed pages Which describe Castor Oil 

and related substances; 

a Material Safety Data Sheet (MSDS) for #1 Castor Oil: 

a proposed label for SCOO~ MOLE EVACUATOR CONCENTRATEi 

a letter of 3/20/95; 

a "TRANSMITTAL COVER FOR 'REGISTRATION APPLICATION''', 

which lists a total of 14 participants in the "Efficacy 

studies for scoot Mole Evacuator"; 

a copy of a IlFAXU transmission of 5/4/95 which refers 

to "GLP with the proper signatures"; 

8. and a compilation of "EFFICACY STUDIES" of the "SCOOT 

MOLE EVACUATORfI. 

Included with the last item is a sheet of paper which 

probably was supplied with the "FAX" transmission of 5/4/95. 

Although that the text on that sheet is cropped on the left 

side of the page, the form appears to claim that the study 

"meets the requirements for 40 CFR Part 160. II As will be 

apparent from the discussions of the "EFFICACY STUDIES", that 

representation almost certainly is false. 

In 1994, EPA registered a product which contains Castor Oil 

and other ingredients and which is claimed to repel moles. 

1 

146
• 

• 

Subsequently, EPA accepted efficacy data submitted for that 

product. This product is arguably a "me-too" to the other 

product, but reportedly consists only of Castor Oil. 

The exact form of Castor oil and the concentration of active 

ingredient used in this product have been cha~ed over its 

brief history as a pending registration application. The 

original Confidential statement of Formula (CSF, dated RS-l7-

94) submitted for this product reportedly contained nCASTOR 

OIL ETHOXYLATE USP CAS #61791-12-6" a.t a nominal 

concentration of 21%. The second and current pending CSF 

(dated "3-20-95") reports the product to be comprised 

entirely of "USP #1 CASTOR OIL CAS # 8001-79-4". The switch 

in product composition apparently was occasioned by the 

applicant's desire to duck as many data requirements as 

possible and the PM Team's ultimately determ.ining that a 

waiver rationale. applied to USP Castor oil could not be 

applied to Castor Oil Ethoxylate because that latter is not 

used as a human drug • 

As the second CSF is dated after the efficacy trials 

reportedly were run, it is possible that the old formulation 

was used for the trials. There is nothing in the efficacy 

volume which addresses the composition of the formulation(s) 

tested other than a copy of a "PROPOSED LABEL" with 100% "US]? 

castor Oil" qlaimed as the product's ingredient. This label 

might have been added to the package ·as an afterthought. 

201.0 DATA SUMMARY 

The full citation for the efficacy volume is given below. 

Balk. R.L. (1995) Sooot Mole Evacuator Containing 100% USP 

Castor oil - Mole Repellent. Unpublished manuscript dated 

3/17/95, Bizzell's Lawn and Care, Sikeston, MO, 53 pp • 

!\RIDt 436422-01 

Although Balk is listed as the author, there is no actual 

report. Rather, the work seems to have been performed by or 

under the direction of David E. Bizzell of Bizzell's Lawn and 

Care. The volume consists mainly of 10 ,sets of four pages 

each which pertain to trials in various places in Missouri 

("SEGXENT '1") and 4 sets of two pages each which pertain to 

assessments of residual mole activity in 10'-X-10' plots 

staked in areas where treatments were made ("SEGMENT #2"). 

Each of the four-page sets begins with a form letter entitled 

"PARTICIPANT INSTRUCTION 

EFFICACY STUDY 

BCOOT MOLB EVACUATOR". 

2 

147
• 

• 

• 

.This letter consists of five sentences arranged into three 

paragraphs. Only the middle paragraph provides any 

instructions to study cooperators, who may have made many of 

the applications and conducted many of the daily 

observations. That paragraph reads: 

ItIn order to preserve the integrity of your 

participation in the application of this product 

the label instructions must be followed exactly. 

Further, it is equally important that your 

observations of the treated area be made as 

indicated. II 

The lias indicated" remark appears to refer to the schedule 

outlined on the observation forms which comprise the seoond 

and third pages of the four-page sets. All that the label 

says about applying the product is included in the 

"DIRECTIONS" paragraph, which reads 

ItDIRECTIONS; Shake well before using. spray SCOOT 

MOLE at rate of one quart per 5000 sq. ft. using 

large sweeping motions. For best results, apply in 

early Spring, Mid-Summer and early rall, or if 

IDoles migrate from your neighborIs yard after they 

first use SCOOT.II 

CUriously I these same applioation directions were on the 

label received on 9/12/94, which claimed the product to be 

1121.00% castor oil USpll, with·almost 5X that concentration 

of active ingredient now being claimed for the product, the 

proposed treatment rate has not been adjusted. 

The observation forms include the name and address of the 

participant, the approximate area that was treated, the dates 

of treatment and each posttreatment observation· (there 

apparently having been no formal pretreatment observations) I 

the time of each posttreatment observation, and areas to 

check off which of the: following descriptions of IIMole 

Activity'l at the. site seemed to be most appropriate: IISame~11 

II Lessn, or "Cannot be determinedll • 

The last page of the four-page sets includes at narrative 

description of the. test results, Bizzell's name, address, and 

signature. The signature appears on a line below the 

following printed 5~atement: 

HI have completed the ten day Observation Chart and 

have· recorded accurately to the best of my knowledge~ Further, I will allow the use of the 

preceding records by Pest Solutions Inc. for their 

own purposes. 1I 

3 

-~-----. 

148
• 

• 

• 

The ten premises treated appeared to include 9 residential 

yards (including Bizzell~s own) and a Little League baseball 

field. Applications dates were between. 3/4/95 and 3/9{95. 

Results, according to the rating scale provided on the form 

pages are summarized in the table below. 

RATING CHECKED POSTTREATMENT ASSESSMENTS DAYS TO 

ACHIEVE 

LOWEST 

RATING 

First 

"Same" 6 o 4-6 

"Less" o 10 

"Cannot be determined" 4 o 4-7 

TOTALS 10 10 4-7 

The. Guidelines (Subdivision G, §96-S) for mole toxicants call 

for 

"thre.e acceptable field efficacy studies for each 

formulation, method of application, major region. 

and species claimed or implied to be controlled." 

For each study, 20 aotive burrow systems are to be monitored 

and treated. While this scope of testing is ambitious, and 

never has been done for any mole toxicant, the level and 

quality of testing reported for SCOOT MOLE EVACUATOR 

CONCENTRATE, which is claimed to be a repellent, does not 

come close to what the guidelines suggest for one test of 'a 

mole toxicant. Bizzell and/or the property owners do not 

seem to have done anything in the SEGMENT #1 series but apply 

product and eye-ball treated are.as. There are rio data or 

accounts presented which pertain to formal pretreatment or 

posttreatment assessments of activity of-specific aepressedand-flagqed subterranean runways. I do not feel that any 

test design which includes no reports of pretreatment 

activity and offers only two qualitative descriptors (plus a 

cop-out) for posttreatment activity is capable of telling us 

very much about the efficacy of the product. No 

quantification of activity is presented on the two middle 

pages. For "same" ratings, my question is "Same as what?" 

For, "Less" ratings" my question is "Less than what?" For 

"Cannot be determined" ratings, my question is "Why not? 

While Bizzell's descriptions all suggest product efficacy, it 

is difficult to believe them in the absence of actual 

pretreatment and posttreatment activity data. Although he 

has sworn that he has completed the activity charts for all 

4 

149
,-------- -- ~~-- --~ 

• 

• 

participants (and from the penmanship, that looks possible), 

it should be noted that the observation times given 

occasionally would have him being in two places at the same 

time if he made the observations himself (e.g., at sites of 

Participants 1 and 7 at 7:00 AM on 3/7/95). For what little 

they might be worth, I present below excerpts from Bizzell/g 

accounts. 

PARTICIPANT 

1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

EXCERPT 

"This lawn took a little longer than some but there 

was activity in lawns around it. But overall it 

worked very well". 

"After 6 dayes (sic] I did not see any more mole 

activity II • 

"I irrigated for a few days and it worked a little 

faster there was excellent control". (Bizzeil/s 

lawn) 

"It was easy to watch the decline-. n (Ball field) 

"The control was normal. II 

II • . . the mole moved to the lawn on the east side 

that had not been treatedll , 

IIWe Had very good control We 

tunnel In The Lawn And Back out. 

more activity In The Lawn.1I 

Had 1 Run 

There Has 

make a 

been no 

" into 

yard 

• very effective. We Had some high activity 

the 7th Day. One run across the corner of the 

but after that we haven/t seen any more ll • 

liThe mole activity moved to the nebors (sic] yard 

the treated lawn has no new activity, II 

"After 6th Day vIe had no acti vi ty in lawn, 

lawn had serrver (sic] mole activity it is now 

free. II 

This 

mole 

Essentially, these accounts represent 10 testimonials from 

one individual. For a while in the 196Q5, the U.S. pesticide 

program accepted 10 testimonials from different people in ~ of a good efficacy study but that practice soon was 

abandoned due to evidence of abuse. The accounts do provide 

occasional references to pretreatment activity, but those are 

not good enough. Assuming that these trials actually were 

run, a person with training in the design of experiments 

(especially efficacy studies) may have been able to obtain 

5 

150
,----------- ---- ----

• 

• 

data sUfficient to support mole claims. Mr. Bizzell did not. 

The two-page sets (IISEGHENT #2") provide some information on 

methods, along with accounts of residual activity for nine 

posttreatment days. 

The procedures reportedly followed were very simple. Four 

individual plots were to be staked and blocked with rope or 

tape. Each was to be a square with 10' sides. Within each 

square, "a hUman foot" was to flatten a small segment of a 

subsurface run. In three of the four cases, the depressed 

segment of the tunnel reportedly was raised on the day after 

treatment but not subsequently. In the fourth case, the no 

posttreatment activity was detected in the tunnel at all. No 

pretreatment monitoring of these tunnels and no concurrent 

monitoring of untreated systems was reported. As moles 

seldom use subsurface runs (used for feeding) every day and 

no control data were collected, it is not absolutely clear 

that the reported results (if genuine) would mean that moles 

were repelled in any or all cases. 

No information was 

"segments" regarding 

presented for either of 

the treatment rates actually 

Bizzell's 

applied. 

As efficacy data for the other castor Oil mole-repellent 

formulation have been accepted, we could decide to let SCOOT 

piggy-back on those data, even though the other product 

contains additional ingredients. I am not very comfortable 

with that approach from an academic perspective. I would 

like to see this product tested appropriately, in its lOOt 

USP #1 Castor Oil rendition. In addition to the many flaws 

in the test information reported by Bizzell, I am concerned 

that the type and concentration of castor Oil in the product 

used by Bizzell were not the same as in the product currently 

being proposed for registration • 

If this product does work, it may do so by making moles feel 

sick and but moles' pairing the feeling with the flavor of 

treated areas. What appears to be a Merck Index page (217) 

reproduced in the jacket for 65615-R includes the following 

text under the heading "Castor 6illl: 

"Slight, somewhat characteristic odor~ 

oil tastes slightly acrid with a 

nauseating after-taste. U 

The crude 

decidedly 

If the perceptions of moles and humans are similar in the 

area of flavor and malaise (and the conditioned food aversion 

mechanism in animals appears to be as conservative across 

animal taxa as any form of learning), the flavor and other 

effects of Castor Oil could indeed be aversive to an animal 

which, in effect, swims through the soil. Whether USP #1 

6 

151
r-

• 

• 

• 

• 

castor oil would have the same effects as crude Castor oil 

may be another matter. 

The label proposed for this product is replete with "false 

and misleading II statements and unsupported (or insupportable) 

claims. The claim "NON-TOXIC" automatically misbrands 

pesticides, according to examples presented in 40 CFR, 

§156.10(a} (5). "BIODEGRADABLE" may well be true, but it 

implies safety. "SIMPLE and SAFE" not only implies safety 

but suggests that any fool can use it. The "HOSE-END 

APPLICATOR II , which would appear to dispense pesticide via a 

venturi pump system is described as "EASY TO USE" (which 

might be the case). The claim " e conomical" is an unqualified 

claim of favorable comparison with alternative methods that 

one might use to combat.moles. 

The label also makes a number of statements regarding the 

behavior of moles. Those which pertain to moles living in 

the absence of the SCOO~ MOLE EVACUATOR CONCENTRATE include 

"Moles can dig up 300 feet of earth in one night"; 

and 

"Moles eat enough food to equal its weight each 

day. II 

The first of these is questionable. It might be accurate if 

the claim pertained to a length of turf raised, but moles do 

not bring 300 feet of earth to the surface in a night or in 

a 24-hr period. 

The claims which refer to the behavior of the animals when 

confronted by the product include 

and 

"MOLES CAN'T WAIT TO MOVE" (made twice); 

"SCOOT MOLE evacuator works because moles dislike 

the odor and taste of the product It ; 

"When they first smell SCOOT, they will become 

very active trying to get away"; 

"When they realize that it's all 

come to the surface and look 

doesn't smell like SCOOT"; 

around 

for a 

them, 

lawn 

they 

that 

"Moles usually leave a treated area in 1-2 weeks 

after application."· 

7 

152
• 

• 

~~~~~~~~-~~~~--------

In line with the "eome to the surface" claim, the left panel 

of the two-panel proposed label depicts a cartoon mole, 

complete with "Waltzing Matilda" tuckerbag and dark shades 

(so we know that it's blind?), walking bipedally in front of 

an opened surface-ridge tunnel. For what they might have 

been worth, Mr. Bizzelll s accounts did not mention any 

evidence of moles coming to the surface in the trials 

conducted in southeastern Missouri in late winter (which is 

not one of the label T s prescribed times for getting "best 

results") . 

Assuming that the product works when used as directed, the 

product's "DIRECTIONS" (quoted above) are rather clear and 

concise. However I there should be a bit more text concerning 

the way to use the "HOSE-END APPLICATOR", and packaging 

arrangement whiCh probably does not apply to the larger 

container sizes mentioned on the proposed label. As noted 

above, it is not clear why one quart/SOaD ff2 remains the 

recommended treatment rate when there has been a nearly fivefold increase in the concentration of the active ingredient. 

While it is possible that Ethoxylated castor Oil has more 

relevant biological activity than USP 11 castor Oil, the 

label received on 9/12/94 claimed the product to be "21% 

castor oil USPII. It is not immediately clear what that 

designation was supposed to mean. 

202.0 CONCLUSIONS 

1. The efficacy report allegedly authored by Mr. Balk appears 

to be largely the work of Mr. Bizzell. Whatever the case, 

the work appears to fall far short of GLP quality and is 

severely lacking in scientific merit. "SEGMENT #1" boils 

down to being 10 testimonials from one individual. 

Results were not quantified. There were no pretreatment 

activity estimates. There were no concurrent controls • 

The data presented in "SEGMENT #2" are very limited and 

appear not to include pretreatment assessments of rates at 

which flattenod subsurface runways are likely to be raised 

again. The efficacy document is not adequate to support 

the claims proposed for this product. 

2. The proposed label completely lacks certain required 

statements, makes false or misleading claims of safety, 

and makes several very questionable claims about the 

behavior of moles, both in the presence and the absence of 

SCOOT MOLE EVACUATOR CONCENTRATE. As the product is 

claimed to be 100% active ingredient, it is a "technical" 

rather than a "concentrate". 

8 

153
• 

• 

• 

3. We are puzzled by your retention of the original treatment 

directions on the label despite a major formulation change 

from 21% to 100% active ingredient. 

4. To repair the proposed label, delete the following claims: 

a. "NON-TOXIC" i 

b. "BIODEGRADABLE"j 

C. "SAFE"; 

d. "SIMPLE"; and 

9. "EASY TO USElI. 

Claims lIa. 1I I lib. II , and IIC. II are safety claims which 

automatically misbrand pesticides, as indicated in 40 eFR, 

S156.10(a) (5) . 

Claims that products are easy to use may well be true in 

a relative sense (for the one-quart container), but may 

create a cavalier attitude on the part of the prospective 

user. 

4. The following claims are questionable and must be deleted 

unless you can provide data which validate them: 

a. "economicalll j 

b. IIMoles can dig up 300 feet of earth in one nightll ; 

c. "Moles eat enough food to equal its weight each 

day"; 

d. IIMOLES CAN'T WAIT TO MOVE" (made twice); 

e. "sCOOT MOLE evacuator works because moles 

dislike the odor and taste of the product!!; 

f. "When they first smell SCOOT, they will 

become very active trying to get away"j 

g. IIWhen they realize that it's all around them, 

they come to the surface and look for a lawn 

that doesn't smell like SCOOT!!; and 

f. lIMoles usually leave a treated area in 1-2 

weeks after application. II 

The claim 

claim of 

lIeconomicalli seems to 

favorable comparison 

9 

implies an unqualified 

with "non-economicalll 

154
• 

• 

alternative methods that one might use to c9mbat moles. 

Even if such an implication is seen as unlikely, the claim 

is gratuitously presented with no attempt at indicating 

how much it costs to use the product at all r let alone on 

a per-mole or square-foot basis. 

We question the claim ("4.b.") that moles can dig up 300 

feet of earth -in one night. While it might be accurate t 

although still unsubstantiated, if the claim pertained to 

the length of turf that a mole can raise in 24 hours, 

moles are not likely to brinq 300 feet of earth to the 

surface in one night or in one 24-hr period. 

The claims which refer to the behavior of the animals when 

confronted by the product are not SUbstantiated by any 

data that we have seen. There are no accounts of moles 

coming to the surface in Mr. Bizzellts testimonials. 

Unless such sUbstantiation is providedr the portion of the 

cartoon illustration which depicts an opened and evacuated 

tunnel must be deleted. 

5. The label must bear a "DIRECTIONS FOR USE" section which 

should be organized as indicated below. 

IIDIRECTIONS FOR USE 

It is· a violation of Federal law to use this 

product in a manner inconsistent with its 

labeling. 

USE RESTRICTIONS: This product may be used to 

repel eastern moles (Scalopus aguaticus) from 

lawns, ornamental turf, golf courses, and 

athletic fields . 

LOCATING MOLES: The presence of moles may 

be indicated by a network of surface 

ridges in the turf or by a series of 

conical mounds of earth pushed up from 

deep burrows. Treat all areas which show 

signs of molest pres~nce~ 

APPLICATION DIRECTIONS: Shake container well 

before using product. Attach garden hose 

tightly to self-dispensing container. Turn 

water supply on to full pressure. Spray SCOOT 

MOLE EVACUATOR over mole-infested area at a rate 

of one quart of product per 5 , 000 sq. ft. (e.g., 

a 50-ft by loo-ft rectangle) . 

10 

155
• 

• 

~-- ~-------------------

Apply SCOOT immediately after the presence of 

moles is detected or in early spring I MidSummer, and early Fall if there are moles nearby 

but not on your property." 

Note that the content of the uAPPLICATION DIRECTIONS" 

should be adjusted as necessary to accurately portray the 

procedures and treatment rate(s) needed for the product as 

it now is constituted. 

These use directions are tailored to the one-quart 

container I which apparently has a built-in Venturi system, 

that is illustrated on your proposed labels. We suspect 

that these directions would not be completely appropriate 

for any of the other container sizes (flG4 oz., 128 oz., 5 

gaL U) identified on your proposed label as we do not 

expect that self-dispensing, Venturi-system containers 

that are one-half gallon or larger in volume could be used 

by typical adult humans with any guarantees of reasonable 

treatment accuracy or comfort. 

Distinct directions (and perhaps a distinct registration) 

would be needed for the larger containers. Such 

directions must include procedures for diluting product 

for use in non-venturi sprayers. If you intend to produce 

your own Venturi sprayer for applying this product, the 

use directions on containers of 64 oz. or more of SCOOT 

MOLE EVACUATOR products should indicate how to use the 

product in such application equipment. If the product is 

to be used in Venturi sprayers that you do not produce, it 

might be possible to provide to users general guidance 

regarding how to load the units with the proper amount of 

SCOOT MOLE EVACUATOR to treat areas of various sizes • 

William W. Jacobs 

Biologist 

Insecticide-Rodenticide Branch 

July 26, 1995 

11 

156
DP BARCODE: D216257 

CASE: 044830 

SUBMISSIOK: 8489471 

DATA PACKAGE RECORD 

BEAN SHEET 

DATE::; 06/09/95 

Page 1 of l 

* * * CASE/SUBMISSION INFORMATION * * * 

cASE TYPE: REGISTRATION ACTION: 010 NEW CHEMICAL SCREENING 

RANKING- : 

CHEMICJU.S: 

o POINTS () 

031608 Castor oil 100.0000' 

ID#: 06561S-R SCOOT HOLE EVACUATOR 

COMPANY; 065615 CLEANING SOLUTIONS INC 

PRODUCT MANAGER! 14 ROBERt FORREST 

PM TEAM REVIEWER: DANIEL PEACOCK 

RECEIVED DATE: 05/04/95 DUE OUT DATE: 

703-305-6600 

703-305-5407 

08{02/95 

* * * DATA PACKAGE INFORMATION * * * 

DP BARCODE: 216257 EXPEDITE: N DA~E SENT: 06/09/95 DATE UT.: 

aiEMICAL: 031608 Castor oil 

~p TYPE: 001 submission Related Data PackagB 

CSF: Y LABEL: Y 

21. 

221 

I I 

ASSIGNED TO DA'TE IN 

I 

DATE OUT 

I I 

ADMIN DUE DATE: 08/08/9. 

• 

:ClIV : RD 

SRAN~ IRB 

SECT~ PMT-14 

REVR: 

CONTR: ~ 

Bill, 

I 

I I 

I I ~/YlfJ5 

I I 

I I 

I I 

7/2</95"- 08T 

I I 

NEGOT DATE: 

PROJ DATE: 

* * * DATA REVIEW INSTRUCTIONS * * * 

Please review the efficacy data (MRID 436422-01) and 

label for Scoot Mo1Q Evacuator • 

I I 

I I 

Originally, the product contained Ethoxylated Castor 

Oil; however, now it contains 100~ castor Oil {USP Grade}_ 

Oan peacock, 305-5407 

* ~ * DATA PACKAGE EVALUATION * * * 

No evaluation is written for this datA pAckage 

* * # ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION W * * 

DP Be BRANCH/SECTION DATE OUT DUE BACK INS OSF LABEL 

157
• 

Treats 

5000 sq. ft. 01 USPCastcrOll •••• 100l1 

NET: 32 FL. oz. (1 QT.) 946 mL ~~g.&~~F 

- addilional sizes 64 oz., 128 oz., 5 gat 

--------

I • 

! . IfIIII1'r I seQ"'-r 

. M(9\LE 

Moles can dig up 300 feet 

of earth in one night 

Moles eat enoiigh food to 

equal its weight each day. 

EVACUATOR NON-TOXIC, 

CONCENTRATE BIODEGRADABLE 

MOLES CAN'T WAIT TO MOVE 

SIMPLE and SAFE ~~g~PUCATOR SCOOT MOLE evacuator _ because 

f1KIies dislik. liIe odor i!ruIl3sla of tile 

product. WIle. they first smtU SCOOT, 

Il1ey wilI_ >IlIY"1ive tJying to get _. WIleuIlley _ that It's aIt ..... d 5000 

-.tIIem,1l1ey """" to liIe _..., 1001< sa.FT •.. 

for a IaWllliIet _'j smell firs SCOOT. 3500 

Motes usually leave treated area in 1~2 i so. FT. 

_ afte, application. llle convenient 2000 

spmy applicatw allows f\Ir easy, eco_ so. FT. 

fll 

caI, __ !aQeofamatobetreated. 500 

'. . SOFTC J OIRECTIOIffi: Shake "",n ber"", using. . . 

. SPIllY SCOOT MOLE.t ,. of 0(18 quart PEST SOLUTIONS ~r 5000 SQ.ll using Ialy. ~g ffiO' GRAND RAPIDS, "'149507 lIOns. for btsl ,es.lts, apply m early . St>M9. MidoSumrner ond early fall, Of il 

1110 .. mi!irato fiom your neigh""" yafIl alter Illey first use SCOOT. • 

CAlmOll: Keep ,l1li or reac~ or cI1Mdr ... 

CONli\INS: l00%<aS!or oil tJSP 

" 

"'~/ <0:.-

-c- f\c 

" 

EPA Est lO000O EPA Reg. lO000O 6 --."', . 

• 

• ~'---- , 

, 

158
• 

• 

• 

282 Cascara / Official Monographs 

Assay solution-Weigh and finely powder not less than 20 

Tablets. Transfer an accuralely weigbed portion of the powder, 

equivalent to about 1.0 g of Cascara Sagrada Extract. to a 100-

mL volumetric flask. Add about 60 mL of 70% alcohol, swirl 

and/or sonicate for 15 to 20 minutes. several times. allow to stand 

overnight. wnieate or swirl for 10 to 15 minutes. dilute with 70% 

alcohol to volume, mix. and filter through suitable filter paper. 

Assay prepIJralion-Prepare as directed in the Assay jor CQS~ 

caro.rid~s under Cascara Sagrada. 

ProccJure---Pipct 20 mL of Assay preparation into a suilable 

flask containing 2 mL of Fern'c chloride solution and 12 mL of 

hydrochloric acid. Proceed as direcled for Procedure in the Assay Jar cascorosides under Cascara Sagrada. beginning with 

"Attach a condenser amnged for refluxing, and heat for 3 hou~." 

except to evaporate a 15.O-mL portion of the <:arbon tctra<:hloride 

solution instead of 20.0 mL Calculate the quantity. in mg. of 

cascarosidcs in the ponion of Tablets taken by thc formula: 

1.667(2.88C)(Aol As), 

in which 2.88 is II composite of the ratio of the molecular weighls 

and assay response factors of casearoside A relative to danthron, 

C is: the coneentration. in Pg per mL, of USP Danthron RS in 

the Standard pNparalion. and At' and As are the absorbances 

of the solutions from the Assay preparation and Ihe Standard 

preparation. respectively. 

Assay for 10tAi hydroxy;mrnnac:ene tkrltalhes-INOTE I-Per· 

form all extractions by shaking vigorously, and allow all phases 

10 separate completely before transferring. Entrainment of agly· cones into Ihe aqueous phase. as indicated by a value of less Iban 

2.6 for the ratio of the absorbance of the final solutian at 515 

nm to that al 440 nm. may lead to false results. NOTE 2-

Throughout this assay, u~ I N sodium hydroxide that is prepared 

without added barium ions as direeled for Volumetric Solmions 

in the s.e-etion ReagMts. fndicators, and SolutiOns.} 

Ferric chleride solution. Stondard preparatIOn. and Assay so- luti()lf-Prepare as dirtcted in the Assay for cascarQsides. 

Assaypreparatior.-Prepareas directed for Assay preparation 

in the Assay fer toral hydroxyanthracelU' den'vatives undcr Cas- caro SaWado. 

Procedure-Pipet 10 mL of Assay preparation into a suitable 

flask conlaining 2 mL of Ferric chloride solution and 12 mL of 

hydrochloric acid. Proceed as directed for Procedure in the Assay fer cascilJ'osides under Cascara Sagrado. beginning with 

"Attach a condenser amtnged for refluxing. and heat for 3 hours," 

exec!?t 10 evaporate a 15.(}.mL portion of the alrbon tetrachloride 

solutton instead of 20.0 mL. Calculate Ihe quantity. in mg. of 

total hydroxyanthrncene derivatives in the portion of Tablets taken 

by the formub.: 

3.333(2.88C)(Au/ As}, 

in which 2.8S u a compo§ite of tbe ratia of the molecular weights 

and uw.y response factors of c.ascaroside A relative to danthron, 

C is the concentration. in !-IS per mL, of USP Danthron RS in 

the Standard preporation. and Au and As are the abrorbancu 

of the solutions from the Assay preparation and the Standard 

preparan"on, respectively. 

Cascara Sagrada Fluidextract 

» Prepare Cas<:ara Sagrada Fluidextract as follows. 

To 1000 g of coarsely ground Cascara Sagrada add 

3000 mLQf bOiling water, mix, and allow to macerate 

in a suitable percolator for 2 hours. Allow the per~ 

colation to proceed at a moderate rate, gradually adding boiling water until the drug is practically ex~ 

hausted of its active principles. Evaporate the 

percolate on a water bath or in a vacuum still to not 

more than 800 mL. cool. add 200 mL of alcohol and, 

• 

if necessary, add sufficient water to make th" D,oM •• 

measure 1000 mL. Mix. 

Packaging and $tantge-P~erve in ti"~;]i,~:':~;f":~~~~~ tainus. and !!Void exposure to direct Sl 

heat. 

Alcohol cOflt~nt., Method I (611): between 18.0% and 

CzH}OH. 

Aromatic Cascara Fluidextract 

)) Prepare Aromatic Cascara Fluidextract 

lows: 

Cascara Sagrada, in very 

coarse powder ..................... . Magnesium Oxide ................... . Suitable sweetening agent(s) ...... . Suitable essential oUsts) ............ . Suitable flavoring agent(s) ......... . Alcohol ............................... . Purified Water. a sufficient 

1000 

120 

200 

quantity, to make .... .... .......... 1000 

Mix the Cascara Sagrada with theM"~nes!'Jm'lJ,; 

ide. "moisten it uniformly with 2000 of 

water, and set it aside in a shallow C()ntainer 

hours, stirring it occasionally. Pack it in a pe,~,la"~" 

and percolate with boiling water until 

exhausted. Evaporate the percolate, at a1 t~:!~r~: not exceeding 100°, to 750 mL. and at 0 

in it the flavoring agent(s). When the 

cooled, add the Alcohol, in which the s';:~~~~ agent(s) and oils have been dissolved, add 

water to make the Aromatic Fluidextract 

1000 mL, and mix. 

Pa<:kagiJlg and sto~Pres.erve in tight. light-rt3isulIl 

tainers, and avoid exposure to dire<:t sunlighl and to 

heat. 

used as the internal 

Castor Oil •••• 

• •••• 

» Castor Oil is the fIxed oil o~,:~P: 

of Ricinus communis Linne (J ~~ph.;~t'~;~,:;::~ It C()ntains no added substances. 

lIIeUls, Method fT (23l): 0.001%. 

Frw fatty Belels {>tOO-The free 

neutralization not more than 3.5 

J volUme of acetic 

159
• 

determined for the alcoholic potas~ 

is the volume, in mt, of 0.5 N alconsumed by the hlank, B is the 

Ihc free·acid titration. IV is the 

l~::~"\{,:t~:~:.t~h;,,',~'l'~',~i'~h~,t~' ~in~~g~,; of Oil used in in mL, consumed in 

t60::md 1M!. 

""",~ (401): between 176 and 182. 

Capsules contain not less than 90.0 

not more than lW.O percent of the Iaof castor oil, calculated from the tests ,a;"~Ii',,~ and Specific gravity. 

in tight containers, preferably 

temperature. 

ciu';'i,;;,;i,nfrared absorption ~ptctrum of a solUlioa .. ~ the contents of Capsules in chloroform to 

40 mg of castor oil per mL. D.l-mm 

used and chloroform being used as m~~~w and minima only at the same waVe-

"';:;'';::':.: preparation of Castor Oil. 

units (90S): mect the requirements. 

the require-

/odfnr 

Emulsion contains not less than 90.0 

not more than 120.0 percent of the laof Castor Oil. 

• 

Official Monographs I Castor 283 

A$SAyIflftrna/ stondord .rofution-tn a I OQ.mL volumetric fl;J.Sk dissolve ahout 1.2 g of di(2-ethylhexyl)phtha];J.te in chloroform, di· 

IUle wilh chloroform to volume, and mix, 

Chromatographic syslem (see Chromarogrophy (62I)-Under Iypical conditions, the instrument is equipped with a flame· 

ionization detector nnd contains a 1.8·m X 4-mm column packed 

with liquid phase G25 on support SI, and conditioned by flushing 

with helium for 2 to 5 mmutes, then hcating wilhout further 

flushing at 2500 for not less than 30 minutes. then cooHng to 

room temperature. and finally heating while helium is flowing 

through it at 2509 for not le~$ tban 60 minutes. During tbe 

chromatogr3phic separation, the column is maintained at 245". 

and the injection port and detector block are maintained at about 

300&. The carrier gas is helium, and its flow rate is ad)usted to 

obtain a peak due to castor oil about 5.5 minutes after mtroduction of the specimen and an intemalstllnd:ud peak about 8 minutes after introduction of the specimen. 

Proudurc-Trunsfer an aeeur~\lely weighed amount of the wellshaken Emulsion. equivalent to about 100 mg of castor oil, to a 

long-neck, round.bottom, 1000mL boiling flask equipped with a 

suitahle reflux condenser connected by a ground-gtass joint. To 

a similar flask transfer about tOO mg of e:l~tor oil, accurntely 

weighed, to provide the standard. Carry out the following steps 

on each: Add 30 mL of a mixture of 300 mL of methanol and 

3.7 mL of sulfuric acid, reflux in a water batb maintained at 75" 

to gOo for 2.5 hours, cool, and rinse down the condenser with 10 

mL of water. Transfer the contents of the flask to n t25-mL 

separator with the aid of 10 roL of waleI'. Rinse the condenser 

and the flask with 25 mL of solvent hexane, and transfer to the 

sep3Tator. Shake the separator for 2 minutes, and draw off the 

aqueous layer into a second t25·mL sep:uator. Add 20 roL of 

solvent hcxnne to the second sepantor, shake for 2 minutes, dis· 

card the aqueous layer, and tran~fer the solvent hexane layer to 

Ihe first separator wilh the aid of 10 mL of solvent hexane. Wash 

the combined extracts with three S·mL portions of water, discarding the ..... llshings. and transfer tbe w.uhed extract to a 125· 

mL conical flask. through a funnel containing anhydrous sodium 

sulfate, willi the aid of 25 mL of solvent heune. Place the flask 

in a hot wo.ter hatll, and evaporate with the aid of a current of 

air to dryness. To the residue add 10.0 mL of intemaf SJondord 

sO/Ulion, and mix until solution is complete. Inject about 5 }!L 

into the gas chromatograph, and measure the heigbts of tho peaks 

due to castor oil and internal standard. Calculate the quaotity, 

in mg, of castor oil in the portion of Emulsion taken by tbe 

fonnul:!.: 

q,(R.~/ Rs), 

in which q, i~ the weighl. in mg, uf castor oit Htkcn for the slnndard, and Rtf and Rs arc the mties of tbe heights of the peak.~ 

due to easlor oil and internal stnndsrd obtained from the Emulsion and the standard, respectively. 

Castor Oil, Hydrogenated-see Castor Oil, 

Hydrogenated NF 

•••• 

• •••• 

Castor Oil, Polyoxyl 35-see Polyoxyl 35 Castot. . Oil NF • .. • 

Castor Oil. Polyoxyl 40 Hydrogenated-see .... Polyoxyl 40 Hydrogenated Castor Oil NF • '.' 

Aromatic Castor Oil 

•• • . ... 

. ". . " 

• 

» Aromatic Castor Oil is Castor 011 containing suit· 

able flavoring agents. It contains not less than 95.0 

percent of castor oil. 

Plleluaging aod storage-Preserve in tisht container:;. 

• • ..... 

..... • 

160
.~ 

-

. - • • . . · - .. . . - .-

I\}aterial Safety Data Sheet U.S. Department 01 Labor · 

May 

OSHA's 

29 CFR 

be used 

Hazard 

t910,12OO. 

to 

CommunicaliOfl 

comply 

Standard 

with 

mUS1 

Standard, 

be 

Occupalional 

(Non~MandatOTY 

Form Approved 

Sa\"ety 

Form) 

arid Health /;>.dmininr:uion 

,. ~ consulled for sp~dlic requirements. OMS No. 1218-0072 ('/is # %001-7'7-"c 

IOENTITY (As Ured on Lo!>cI rmd Usr) 

#1 CASiOR OIL 

i Noor Blank $piK;O$ 81'/1} no: J>(ffmfr:cC, /I e.'lj' lftm is no: app/iC4bIo. C1 00 

inforrnatfoo ;, sva.ilabJe, II'IC spaC(! mut.r 00 matktKi ro irldiCalil thar 

Section I 

WIO ,-ou ,-tU b . Emergor.cy TolcphonQ Numoor 

ACME-HARDESTY CO. ,INC. 215-885-3610 

Marc$Z (~' Street, Cily. SWtfJ, and ZIP Cede) Tol(!phone Numb¢r tor InlormallCll 

626 Ben'amin Fox Pavilion , 215-885-3610 

Oaln Pmpared 

J;NK1NTOWN PA. 10ndO 

Signa!.UfO 01 PrcpatOl fo;xiooalj 

, 

Section II - Hazardous ,lngredientSlldentlty Infonnation 

• OthOf ltmits 

Haulrdous Components (Spccillc Chemicel Identity: Common Namo{s» OSHA PEL ACGIH !LV Recommended % (cpflon81) 

~ 18 

.--------------------------------------- Section ill - PhysicatlChemicat Characteristics 

Bolling Point Speeilic Gravity (HzO .. 1) 

OF Above 450°F 

Vapof Pressure (mm fig.) 

~;~~:~ .~~~~ Moltiog Polo: 

vapor Density (AIR ... t) 

N/A 

--

fButyI Acetate .. 1) 

S J j 9 ht 

Colorless to pale l'pJ]ow yjscous liqrrjrl, cbara~te~i$tir 

Section IV - Fire and explosion Hazard Data 

Exunguistung Madra 

Foam, CO 2 DRY CHEM1CAL 

Special Fife FlQliling Ptoeodures 

Normal DrQcedur-es 

flamtnbl;tle Limns 

Unknown 

• •••• 

• 

•• • •• • odor. .. 

•• t. 

• 

• 

" ..... . .... 

• •• •• • 

en 

n 0< 

"" 

NT r 

."tt, 

• •• • • ....... • i 

• • 

161
• • 

. '>':~i:nv-r~::nyD-I: I~»A_ 

Il1ffApatibmtY (Molerial: to Avoid) 

r'y Occ~ : r X I Co~ __ " A_ wm Not Oo:uf 

'Section VI - Hef:llth Hazard D4Ita 

SKIn? 

Health l-Watds (AClJtG and Chronic) * S)jght local jrrj~ant and allergen; moderate on jngestjon dajJy dose 

as cat~artic 15 to 16 ml. 

,.. Siom and SymptOms 01 Exposum same 

:: 

Medical CO~S ... 

Generally AgI)ttIWIed by Exposure 

* Same 

Emergency and First AId Prooedl..ll'U 

lOl:Al.: WASH WITH SOAP AND WATER: Fl!lSH 

INGESTION; CONSULt M.D •. 

Section vn -- Pmc:autlons for sate HandHng and Use 

Steps to- Bo TBlten in ClI$(t ~ 1$ ~ 01' Spilled 

Norma] procedures 

Waste 0isp0uJ M..nod 

"ACCORDING TO ! OCAI I STAlE AND E;:"DFRAI eEGW~ATIONS 

Precautiom: to Be Ta.klaO in Handling ~ StoMg 

Don 1t subject to excess prolonq~d heating or color will dete~iQrate 

Section VU! - Control Measures 

Norma1 

Mocilanieal (GM~ ~. 1 norma Pf~rw GIovn. 

~eODreoe coated gloveS OIhrtr PlOiaclivO CloWng Of E!'I\.Iipmenl 

NA 

.... 

I Eye ProlbClioo 

Sprayproof safoty glaSSeS or sbi&ld 

162
• • 

; 

• 

WAIVER OF TOXICITY 

• 

• ••• 

• •••• 

• 

•• • 

•• • 

•• 

•••• 

• •••• 

• 

• •• 

• • 

•••• 

• ••• 

• •• •• • 

• ••••• . . • • 

• ••••• • • •• 

• •••• 

• • . .... 

163
• 

April 18, 1995 

Office of Pesticide Programs 

Document Processing Desk 

Room 266A, Crystal !viall 2 

1921 Jefferson Davis Highway 

Arlington, VA 22202 

RE: CFR 40 158.45 Waivers 

• 

Written Request USP Monograph 

iI Whom It May Concern: 

• 

The Agency has waived all acute toxicity data for USP # 1 Castor Oil. See following attachments for USP 

Monograph and MSDS sheets. 

Sincerely Yours, 

Ronald L. Balk 

President 

• . .... 

. .... • ••••• . .. ..... .. .. .. . · .. 

.... 

. .... 

., · " . ..... 

.. .... · .. " . 

. ......... . . 

. . . .... 

• • ...... 

164
1250 Ramona 

. Grand RapIds 

Michigan 

49507 

• 

• 

Phone 

616-243-0555 

8OO·3..~·Z435 

FROM: R Q \\ \3 cd !..( 

DATE 

3:00 p fYJ 

TIME 

TOTAL NUMBER OF PAGES (INCLUDING THIS PAGE) ____ ='--____ _ 

FAX • FAX • FAX • FAX • FAX • FAX • FAX • f'AX • FAX • FAX • FAX • FAX 

165
--------------------- ---

i\prilI8, 1995 

Cleaning Solutions, Inc. 

DBA Pest Solutions 

1250 Ramona St., SE 

GrandRa . 7 

/ , -- A EST. 65615 - f> 

Scoot Mole Evacuator 

• 1. Acute Data 

Toxicily Waiver 

2. ChemistIy Data 

• • 

MSDS for USP 100010 Castor Oil 

USP Monograph for 100% Castor Oil 

3. LabomtOly Practice Statemeut 

4. Study Title Page 

tt. Confidential Statemeut of Formula 

6. Efficacy Data 

Segmeut#1 

Segmeut#2 

7. Labeling 

Proposed Labels 

.... 

• •••• 

• 

.. 

•• • . • •• 

.. " 

• •••• 

• 

• •• 

•• • •••• 

• ••• · " " . 

• ••••• · • " • 

• ••••• 

• • •• . .... 

• • " ... 

166
• 

• 

MAY 15 1995 

U.S. ENVIRONMENTAL PROTECTION AGENCY 

Office of Pesticide programs 

CLEANING SOLUTIONS, INC. 

DBA PEST SOLUTIONS 

1250 RAMONA ST., S.E. 

GRAND RAPIDS, MI 49507 

Report of Analysis for Compliance with PR Notice 86-5 

Thank you for your transmittal of 04/24/95. Our 

has completed a preliminary analysis of the material. 

provided as follows: 

staff 

The results 

Your sUbmittal was found to be in full compliance with 

the standards for submission of data contained in PR 

Notice 86-5. A copy of your bibliography is enclosed, 

annotated with Master Record ID's (MRIDs) assigned to 

each document submitted. Please use these numbers in 

all future references to these documents. Thank you for 

your cooperation. If you have any questions concerning 

this data submission, please raise them with the 

cognizant Product Manager, to whom the data have been 

released . 

are 

167
• 

TRANSlYnTTAL COVER FOR 

"REGISTRATION APPLICATION" 

CLEA1'lING SOLUTIONS, INC. 

DBA PEST SOLllTIONS, INC. 

1250 R.AIVIONA ST., S.E., GRAj'H) RAPIDS, Nil 49507 

EPA EST 65615 

EPA REDUCED RISK INT11ATIVE 

PRNOTICE 93-9 DATED 7-21-93 

TRAl\-!SMITTAL DATE 4-17-95 

APPLICATION FOR REGISTRATION OF 

SCOOT MOLE EVAC[ATOR 

VOLUiYIE 1 Administrative jVlaterials 

Fonns 8570-1, 8570-27, 8570-4, 3540-S 

VOLUME 2 Efficacy Studies for Scoot Mole Evacuator (Guideline No. 96 Series Mole Repellenti 

SEGMEl'lT #1 Y3G Y22Jb I 

168
• 

SEGNlEl\'T #1 (Continued) 

Participant No. 10 

Dale H. White 

201 Kramer 

Sikeston, MO 63801 

EFFICACY STUDY FOR SCOOT MOLE EVACUATOR (Guideline No. 96 Series Mole Repellent) 

SEGMENT #2 

Participant No. I 

Walter Bizzell 

306 Powe", 

Sikeston, MO 63801 

• Participant No.2 

Bill Nace 

312 Powers 

Sikeston, MO 63801 

Participant No~ 3 

Dwight Crader 

109 Green Grier 

Sikeston, MO 6380 I 

Participant No.4 

Chris Caudle 

218 Kinder 

Sikeston, MO 63801 

Cleaning 

Company 

RonaldL.Balk,President 

Solutions 

Contact: Ronald 

(DBAPesi 

L. Balk 

Solutions) 

~~ 

616-243-0555 

4-18-95 

• 

. ... 

169
--_._-----_.-- --- -- - ----------------- ---_._---------

• 

• 

Cleaning Solutions, Inc. 

1250 Ramon;; Srrec(, S.E. 

~~,ldfu!~dt.r;:i ... _~L_~_~ ___ . __ " __ . ______ ,_' ____ ~ _____ . ________________ ~ 

------- --- ---------------------------------------------T~feph;_;;~ 

March 20, 1995 

Office of Pesticide Programs 

Document Processing Desk 

Attn.: Dan Peacock 

Room 266A., Crystal Mall 2 

1921 Jefferson Davis Highway 

Arlington, VA 22202 

Dear Mr. Peacock: 

Fox 616-24a-2976 

436422- fJ;:I]) 

We are respectively resubmitting for an EPA approval of "Scoot Mole Evacuator." This 

submittal we believe complies \vith EPA Reduced Risk and also includes additional Efficacy 

Testing to further comply 'with testing requested. 

If you need any other information, either Dan Lee or myself will be contacting you on 

Wednesday" March 22,1995. Thank you for your help in getting our project through. 

~Y9;Sk .. ', 

,/ 

Ronald 

.... ~~~ L. Balk 

President 

Cleaning Solutions, Inc. 

DBA Pest Solution,> 

cc: DaIlLee 

File 

170
, 

, < 

• 

I", // / , 

O1TIn:::o ;JTJ,.p;$ O'IVIR.O~}-.L PRO'l'"J::CT:rOU )"oOlCY 

orr-XO;: or f'~;tON. P~T:rC:Wl:S J...nl) TOX:rC 36t1!lT}Ji 

•. orrlCl: or pZ;ST1CIJ)t: PROOrv-us . c:r.s 

RVOX3TnbTIon Ol"vxsxon 

InSl.:CTl: C.rDl:;~ lloDrHTICJ;Ot; DAANel 

FACSIMILB RBQOBBT/COV~R S II E E T 

(f{(U( t~ <>l' p ... "t in 1U..(( 11(t;. (I<'I{yl 

SEN D FlL.X '1'0; 

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IUHE: /\OhO,VL j;;Ja-{C' 

OFF, -"'! . ,'_ (; k e:: A" j.~-> -.I r aLiC.-· J, b' ~ _" -

FRO H : 

",'"jo, ~JJ I G' L P6'7A,-,C:::oQ',-"c"",i'-~ ___ _ 

0i";SWN/S;V"O;;, i2]2 L:C i,ELj '£(>1 T fI;',,"-

7 

"";<:0 ;«001' """""", ,_.i:h:::~ f2 n-,2 ,2.,1 ____ _ 

e_,;e (ooZ H,/;-o'l-c_ 0,,0 _, S-!:J !2F __ ;;<:»515 pliJ 

1.:t:l13~R 0,," ?!.G£S (\-.'X111 COVE::;:t S;EZ"n : 2", _______ _ 

S pee i .... 3.,.1 H C1 50 sag e - , , d 

Cw</ I'>-< J 

esc r 

~ 

I 

ibe belo v 

~'d~' ---------------

-------- ---

--'-~---- --------,,--,-----,""'- --- -- ------------_._-----

171
U.S. ENVIRONMENTAL PROTECTION AGENCY 

Office of Pesticide Programs 

CLEANING SOLUTIONS, INC. 

DBA PEST SOLUTIONS 

1250 RAMONA ST., S.E. 

GRAND RAPIDS, MI 49507 

Report of Analysis for Compliance with PR Notice 86-5 

APR 28 1995 

Thank you for your transmittal of 04/24/95. Our staff 

has completed a preliminary analysis of the material. 

provided as follows: 

The results are 

• 

• 

We are unable to accept your data submittal for further 

processing and review/ because of the significant 

deficiencies noted below. It is being returned to you 

for correction. If deficiencies were found which apply 

to your overall submission, they are described 

immediately following this paragraph. If problems are 

found with individual studies, they are described below 

linked to the study identifier found on the enclosed 

copy of your bibliography. 

Rejected study (02) ! 

A statement of compliance or non-compliance with the 

Good Laboratory Practices Standards contained in 40 

CFR160 is required for all studies (except range 

finding studies and supplements to previously submitted 

studies) submitted to EPA. This statement must appear 

as page 3 of all studies, and must be signed and dated 

by the study sponsor, the study submitter, and the 

study director. Please see 40 CFR 160.12 for specific 

guidance. 

The statement of data confidentiality claims must 

appear on page 2 of each study. See pages 6 and 17 of 

PR Notice 86-5~ 

The Good Laboratory Practice Statement should appear on 

page 3 of the stUdy. See page 17 of PR Notice 86-5. 

----------------------.---

172
-----------

• 

TRANS1\UTTAL COVER FOR 

"REGISTR",-TION APPLICA nON" 

CLEA1"i1NG SOUJTIO:';S, INC 

DBA PEST SOLliTIONS, INC 

1250 R.",,'yIONA SL S.E., GRAl'lD R.-'\PlDS. MI49507 

EPA EST 65615 

EPA REDCCED RISK ~lTL"'-TIVE 

PR NOTICE 93-9 DATED 7-21-93 

TRAl'lSMITTAL DATE -+-]7-95 

"-'\PPLlCATION FOR REGISTR."'-TION OF 

SCOOT MOLE EVACU.TOR 

VOLUME 1 Administrative Materials 

Forms 8570-1, 8570-27, 8570-1, 35411-8 

VOLUME 2 Efficacy Studies for Scoot Mole Evacuator (Guideline No. 96 Series Mole Repellent) 

SEGMENTfI!l tZvtY"v-C-C(2) 

Participaoi No.1 

• Caudle 

2m-Kinder 

Sikeston,MO 63801 

Participant No.4 

Sikeston Littie League 

Sikeston Sports Complex 

Sikeston, MO 63801 

Participant ,"0. ~ 

~Jrs LYllIl Dempster 

226 North Kings Hwy. 

Sikeston, MO 63801 

Participant No.2 

Gerald Yeargain 

822 L-adue 

Sikeston, MO 63801 

Participant No.5 

Rick Laplant 

1020 Sikes 

Sikeston, MO 63801 

Participant No.8 

Waller Bizzell 

306 Powers 

Sikeston, :VI0 63801 

Participant No.3 

David Bizzell 

102 Wallace 

Sikeston, MO 63801 

Participant No.6 

Dv.ight Crader 

109 Green Grier 

Sikeston, 110 63801 

Participant No.9 

Bill Nace 

•••• 

• •••• 

• 

•• • •• • • •• 312 Powers •••• 

• 

Sikeston, MO 63801 ... : 

• •• . ' . •••• 

• ••• • •• •• • 

. . ...... ., • • 

• ••••• 

• • 

•• 

••••• 

• • ..... 

-----------------------------

173
SEGMENT #1 (Continued) 

Participant No, !O 

Dale H. White 

201 Kramer 

Sikeston, MO 63801 

EFFICACY STUlW FOR SCOOT MOLE EVACUATOR (Guideline No, 96 Series Mole Repellent) 

SEGMENT #2 

Participant No, I 

Walter Bizzell 

306 Powers 

Sikeston, MO 63801 

!ticipanl No, 2 

BillNace 

312 Powers 

Sikeston, MO 63801 

Participant No, 3 

O"ight Crader 

109 Green Grier 

Sikeston, MO 63801 

Participant No, 4 

Chris Caudle 

218 Kinder 

Sikeston, MO 6380 I 

Cleaning 

Company 

Ronald 1. 

Solutions 

Contact: 

Balk, President 

Ronald 

(DBA Pest 

1. Balk 

Solutions) 

~ 

616·243-0555 

4· 18·95 

• 

• ••• • •••• 

• • ••••• 

• •• 

••• • • 

•• • • •• • ••••• . . •••• • • • •••• • •••• 

• • • • •••• 

• •• •• .... • 

• ••• 

• •• " . 

--------~. ~---------~ 

174
;., 

• 

Treats 

5000 sq. ft. ." USPCast ... 0II .... 100% 

NET: 32 FL. OZ. (1 aT.) 946 mL ~~~~ 

additional sizes 64 oz., 128 oz., 5 gal. 

• 

Moles can dig up 300 feet 

of earth in one night 

Moles eat enough food to 

equal its weight each day. 

NON-TOXIC, 

BIODEGRADABLE 

MOLES CAN'T WAIT TO MOVE 

SIMPLE and SAFE l;:i;~.r,~:rPUCATOR stooT MOlE _lor Wl)rlcs because , _ ... _. mole. dislik. the odor and tlsle of the 

produtl. Wllm1 they fltSt """" SCOOT. 

they will _ VIlfll'ctiw 1f)Iing to Il't 

.-y. WllenIl1ey_llIatifsall ...... d 5000 

.tlle." they <Om< to !he surface and ioo'< SO FT 

for a /awn tllel _t smell I,,. stooT. :JS6o. 

Moles usually"'" treated .... In 1-2 i so. FT. 

weets aU" app!icafuJo. The convenient 2000 _ .ppHcaIor ~ "" easy, "'""""';. so. FT • 

. cal, vMe _ot .... to belrealed. 500 

nn' 

. . SO. FT. r-- J OJRECTIOIIS: SlJaXe welt bef.,. using . . Splay SCOOT MOlE al" of ooe quail 

per 5000 sq. II. usU)g IaJ9II """'IJing m0-

tions. For best results. apply in early 

Spring. Mid-Summer and eaJiy fall, or H 

II1(lJes migrnl. from your nei!jllilonl yard 

afterll1ey first "'" stooT. 

PEST SOLUTIONS 

GRAND RAPIDS, MI 4S5I?7 

CAUTION: Keep 001 of _Ill chilllren. 

COIIfAIN5:100%<as!oroilUSP , 

EPA Est lO000O EPA Reg. #00000 6 

I 

• 

• 

175
------------

• 

• 

WITH DATA 

FEU 

Fileroom/PRDTS 

SIG (DATA) 

NEW REGIS~RA~ION OR NEW BUP 

FAS~ ~RACJC • APPLICA~ION FOR NEW REGISTRATION 

IIQ DATh 

Init. Date 

FEU 

Fileroom/PRDTS 

PM 

FileroomjPRDTS __ _ 

FEU 

FileroomjPRDTS __ _ 

PM 

REGULAR 

APPLICATION FOR NEW REGISTRATION 

or 

EXPERIKENTAL OSE PERKIT 

Init~ Date 

Includes new petition for tolerance: YES or NO 

WITH DATA IIQ PATA Init~ Date Init. 

FEU ~1F Fileroom/PRDTS ' 

'(-" 5 -'IS 

C(~J~.-9r 

FEU 

FileroomjPRDTS __ _ 

SIG (DATA) PM 

Fileroom/PRDTS 

PM L:f.--

Date 

* Front End Processing determined this application qualifies fc~ fa 

track review based on registrants claim of "me-too". No scree- ( 

substantial similarity is made by the Front End. 

176
Form Aporoved. OMS No. ':070·0060. Aoproval Expitll$ ; 1-30·93 

aEPA 

"Aoplicant'3 Nam" and Address 

CLEANING SOLUTICNS, INC. 

1250 RAMONA ST., S.E~ 

GRP.~ RAPIDS, HI 49507 

'Jnllea Slahl$ Envuonmer'ltM Protection AQll11cy 

Washington, DC :Z0460 

Formulator's Exemption Statement 

(40 CFR 152.85J 

EPA File SymbollAlIQlIlltrallon /'JumoOf 

t, '5C 15 -, 

Product Nomescoor :-m:£ EVACUATOR 

Data of Cooiideotiai Statement oi Formula iEPA Form 857Q-.:1.1 

3-20-95 

----------------- As an authorized representative of the applicant for registration of the pr.oduct identified above, I here certify that: 

(1) This product contains the following active ingredient(s): CASTOR OIL 

_2) Of these, each active ingredient listed in paragraph (4) is present solely as the result of the use of that active 

ingredient in the manufacturing, formulation or repackaging of another product which contains that active 

ingredient, which is registered under FIFRA Section 3, is purchased by us from another producer, and is labeled 

for at least each use for which my product is proposed to be labeled. 

(3) Indicate by checking IA) or (S) below which paragraph applies: 

~(A) An accurate Confidential Statement of Formula (EPA Form 857().4j for the above identified product is 

attached to this statement. That formula statement indicate, by company name, registration number, and 

product name, the source of the active ingredient(s) listed in paragraph (1). 

OR 

0(6) The Confidential Statement of Formula (CSF) (EPA Form 8570-4) referenced above and on file with the E?A 

is complete, current, and accurate and contans the information required on the current CSF. 

(4) The following active ingredients in this product qualify for the formulator's exemption_ 

4t,----------------------------------------- Saurc. 

Activo InQredlent ?roduct Nama 

CASTOR OIL USP ill CASTOR OIL 

NUTl'J and Titlo 

RONALD L. BALK, PRES IDENT 

EPA Fonn 8570-27 IRiIV_ 1-9t} 

--------------------~--.. - -- -~ -

3-20-95 

._ .. • •••• 

• 

•• • •• • 

• •• 

•••• 

• •••• 

• 

•• • •••• 

•••• 

• •• 

Yellow - AppliclU'lt <!Opy 

• ••••• 

• •• • • 

•••••• 

• • •• 

• •••• 

• • ••••• 

177
• 

• 

• 

Cleaning Solutions, Inc. 

1250 Ramornl Streit, S.E. 

GnI!td Rapld$, MJ 4V5G7 _ ... m.~_ .... ~ _____ ~~_~_~_~~.~~ ______ ~~_._~~~ __ ~~~~ __ 

TelGphooo Gt6-243-{J555 

FaxG1G-2M!-2976 

March 20,1995 

Office ofpesticide Programs 

Docwnent Processing Desk 

Attn.: Dan Peacock 

Room 266A, Crystal Mall 2 

1921 Jefferson Davis Highway 

Arlington, VA 22202 

Dear Mr. Peacock: 

We are respectively resubmitting for an EPA approval of "Scoot Mole Evacuator." This 

submittal we believe complies with EPA Reduced Risk and also includes additional Efficacv 

!estin~ to further comply with testing requested. ~ 

If you need any other infonnation, either Dan Lee or myself win be contacting you on 

Wednesday. March 22. 1995. Thank you for your help in getting our project through. 

Since~ursl' ~ . 

. /;;;:;/:;:Z/}/~ ~ '. -;¥0~C?"L~fo' 

Ronald L. Balk 

President 

Cleaning Solutions. inc. 

DBA Pest Solutions 

co: Danue 

File 

• • • •• •• 

• 

•• • 

•• • · .. • • •••••• 

• 

• 

· .. •• ... • 

• ••• 

• .. •• . 

.. ...... 

• •• • • 

• ••••• 

• • .. ....... • • .. .... 

178
• 

• 

UNITED STATES ENViRONMENTAL PROTECTION AGENCV 

WASHINGTON. D.C. 20460 

April 25~ 19(}5 

CLEANING SOLUTIONS. tNC 

1250 KAMONS ST., S.¥'. 

GRAND RAPIDS, MI 49507 OfFICE OF 

P~EVEtlTlON, PEtnclCES AND 

TOXIC SOOSTNiCES 

ATTN: RONALD L BALK 

PRODUCT N.1\MB: SCOOT MOtE IWACOATOR 

COMPANY NAME: CLEANING SOLUTIONS. INC. 

OPP IDENTIFICATION NUMBER, 228107 

EPA FILE S'iMBOL, 65615-R 

EPA RECEIPT DATE, 04/24/95 

, 

SUBJECT: RBCBIn OF APPLICATION FOR A NEW REGISTRATION 

DEAR. REGISTRANT, 

The Office of Pest:ic::tde Programs has received your application 

for a new registration and it has passed an administrative 

screen for completeness~ ~ 

The package will now be forwarded to the Product Manager for 

review to determine its acceptability. 

If you have any questions please contact «obert Forest 

P~oduct Manager 14 , at (703)305-6600. 

Sincerely, 

LJt<-<-;-A M N°"-o 

• 

Front End Processing Staff 

Information Services Branch 

program Management and Support Division 

179
• 

• 

FRONT EHR PROCESSING APPLl2AtION INFORMATION CHECE 

PH ,/ 

EPA REGI8~RA~ION ~ER 

STATUS (For a..ndaent.) 

'IXE-TOO" CITlW PRODUO'T' STATUS 

PRAT RECORD CREA~ED 

Active __ _ Cancelled 

Net in ftElF'S __ _ 

Active __ _ Cancelled 

Not in REFS 

180
1;r 

Form A .nVNI. OMS N . 2070-0060. A /I i,.. .. 2·28-95 

Ul'llted States 

Environmental Protection Agency 

WaehiflQtOn;. DC 20400 

- Registration 'I' Of'f' ldenat\er /'rIUI'I'tI:l<Jr ;; ~,;;Z#!. en 

• Amendment • '1l t 51 io!, 1 I Other I' 

Apptication for Pesticide ~ Section I 

S. Nam. and Addt(l5S of Applicant line/uti. ZlP Cod., 

CLEANING SOUirIONS, INC. 

1250 RAMONS ST" S.E. 

GRAND RAPIDS, :1I 49507 

[J Amondmont - ExpIafn blKow. 

firr.~:.~. Pr4f)01I1Jd C1~c,uon 

: X ; Non.. LJi 'R01ItTlcted 

! '---' 

! 6. Expedited Reveiw. In accordance with FIFRA &!ction 3(c)!31 

, lb)(i). my product is similar: or identical in composition and labeling 

ito: I EPA Reg. No. ---------------

! Product Name 

Section -II 

Ii RHubmission in response 1000Agoncy !ottor dated ______ _ 

U Notiffcauan - £xoIain below. 

,-, 

L 

Rnd- printed (abel, in reosonn to'-

Aqo1'lcy lonor dated 

'Mo Too~ App(icllltion. 

! OIMr - Exp/oin below. iZ.J 

Explanation: Uflt lIdditionel pogo lsi it noeassary. iFor $oction I lind Section !LI 

NEW REGISTRATION CPR NOTICE 93-9) ''VOLUNTARY REDUCED PESTICIDES INITIATIVE." 

3. LQ~ation of Not Conlflona !nfomwttion. 

fX1 L.ab.t n ContaiMr 

6. ManMt in Whk-h LobnI is Affixed to Product 

~.ANUAL 

N~. 

RONALD L. BALK 

Section • III· 

j 4. Slmsl Rmai Contallwr 

~2 ax, 64 oz, 128 

QUthograph 

! X 'PftPM nlued 

I i Stoncired 

oz, 

Section· IV 

/ntfe 

, PRESIDENI 

I Z. Type of Centainllr , 

1 

, I I Mow Plastic 

_ t G(eH: 

-I ! Papor to Oth,,. tSp"ci!Y)"HD"",P~E"-____ 1 

5 gal. IS; :t"jRik at-OiiABEr 

'Telephone No. !I~ Artlll C.xIal 

• 

i 616-243-re33 

Certification l s, q,&,fe AppjlcstioG .: 

! coftify that tho statemonUi I hlw" medII- on thia form and ei( a:uaci'lnwnt. thereto aro trlJe, llCC\lnnO and cOf'!'lP1l1te. 'I ~;'fd •••••• 

! 4cl<l'IOwledoe Ihllit any knowllnQlIV faille or misI.ading s,tQ:tom-llnt may b. punishable bv fioe or imprisonment or i •• I~.. ped! ••••••••• 

both under i;)p!leablo (aw. 

I-.~-. S-;"'.c ..... :--'-'M=£..:~=.-;:,-' ;/'--~-::,t:;-{£'-?-, ---!,,-. "'-';-:-eS-i-d-.-n-t ---------1

1 

: : :~:: .. : ... 

.". . ., 4. Typed Nltm. S Oalll I .., 

RONALD L. IlAlX ! ' 3-20-95 I 

EPA'_ 8670-1 In-v. 3--94) Previollll editiom: U8 obsoletlt. 

181
• 

• 

APR 

Cleaning Solutions, Inc. 

1250 Ramons st. 1 SE 

Grand Rapids, MI 49507 

Attention: Mr. Ronald L. Balk 

Subject: scoot Mole Evacuator 

EPA File Symbol 65615-R 

Your letter of March 20, 1995 

Before we can begin our review of the above submission, we 

need the following information: 

I. Forms 

A. Confidential statement of Formula (CSF) 

Submit one (1) copy of a revised CSF showing that your 

product now contains 100% USP Grade Castor Oil. 

B. Data Matrix 

Submit one (1) copy of a data matrix (list) to organize 

the information that you will be submitting, as follows: 

1. Chemistry Data 

If your product only contains 100% USP Grade Castor 

Oil, you need only submit 

a. one (1) copy of the MSDS from your supplier 

showing that it is USP grade and 

b. one (1) copy of the USP Monograph for this 

active. 

Do not format these data. 

2. Acute Data 

If your product only contains 100% USP castor Oil, 

simply submit one (l) of a statement saying that 

the Agency has waived all acute toxicity data for 

100% USP Grade Castor Oil. 

182
2 

3. Efficacy Data 

II. Labeling 

submit three (3} copies of your effectiveness data, 

formatted according to PR Notice 86-5, a copy of 

which you should have. These are the only data 

that you need to format. 

submit three (3) copies of your new proposed labeling for a 

100% USP Grade Castor oil product. This would include the 

label and any printed material accompanying the product or 

referred to on the label. 

Attached is a label for another Castor Oil product for mole 

control, Mole-Med, EPA Reg. No. 64439-1. You may find it 

helpful in revising your label. 

III. Data 

As indicated above, you need only submit efficacy data. For 

the acute toxicity data, you need only submit statement 

saying that the Agency has waived these data. For the 

chemistry data, you need only submit a MSDS and a copy of 

the USP monograph for Castor Oil. 

Pursuant to Section §152.105 of Title 40 of the Code of 

Federal Regulations, if the above requested information, or a 

written request for additional time is not submitted to the 

Registration Division within 75 days of the date of the receipt 

of this notice, the application will be administratively 

withdrawn. In that event, any subsequent submission relating to 

the same product must be submitted as a new application. 

If you have any questions about this letter I contact Mr. Dan 

Peacock at 703-305-5407 or 305-6600. 

Sincerely yours, 

Robert A. Forrest 

Product Manager (14) 

Insecticide-Rodenticide Branch 

Registration Division (H7504C) 

Enclosure: Label for Mole-Hed, EPA Reg. No. 64439-1 

Peacock WP#5:A:\6561S-R.LTR:305-5407,-6600:5/7/95 

• 

• 

183
• 

• 

MAR 24 199" 

U.S. ENVIRONMENTAL PROTECTION AGENCY 

Office of Pesticide Programs 'I-/s-I '! Sf-drt::!'J: 

~~ CLEANING SOLUTIONS, INC. 

1250 RAMONS ST., S.E. 

GRAND RAPIDS, MI 49507 

Report of Analysis for Compliance with PR Notice 86-5 ::;::.. ~;-...,.I'~ . 

Thank you for your transmittal of 03/21/95. Our staff ~ ~ r 

has completed a preliminary analysis of the material. The results are ~ 

provided as follows: 

We are unable to process your submittal because it does 

not meet minimum standards of acceptability. 

Your data must be submitted in accordance with the 

format requirements of PR Notice 86-5. If you need a 

copy of this notice, please call (703)305-5361 or 

(703)305-5363 . 

184
- _. 

tl,l;..ateria! Safety Dala Sheet 

Wlav !:loe' used 10 comolv ""'111'> 

• OSH~'s ka:!:aro CommunICation Stannard. 

2£) e:=R 19'Q.~200. Sianoarc must De 

conSlnted jo~ sq,eciflC reoulrementS. 

Section! 

Adcress (N~'. Slroe!. CIr;', $:am. tlIlO ZJ.I:> Cocci 

626 Ber. .. am~n rC). :;lav-l ion 

: 90.103 

Section /I - Hazardous ,Ingredientsllctenttty Intcnnation 

U.S. Department •Of Labor 

Oct: .... Otll'onal Sl!ieh' and HelilTn AomOnlnral,or. 

{Non_M2m~tory Forml 

;::orm APPfOllo::d 

OMS No. i21S-0072 

Neue' ~ ;::)OC(iS IIUT! rn:;: ~r.'toc II .=,"w nsm !.::; r:c: ~. O! m:> 

onfOtmsoon l! a~ !~ SOlie!:' mu:;! oe mUl'.tK1 Ie ~lI! tnll: 

emer;mnc'" j eJeol'lO>"* Nl,[moe: 

"2:S-88S-3ElC 

;elcollOne N",moe: ~, Irttem".anor. 

213~883-3£:C 

Olue Fruoarcc 

OSHA PE:,. 

eN!::' 

--------------------------------------------- I 

VI!DO( Den:ny {AIR - 1\ 

;Qjn .... j"'~" f"O nai'" " .. j~ow V~S-')I'" 

Seetlon IV - Fire and 5.xotosion Hazard D~..a 

~;:'jre F19rn."11'19 PT~ 

Norm~l :<""oced\,!"es 

~. • 

Nil 

'Ott'C 

~ IaITIIl'Ia!:»f I..1mIU 

vn know:,. 

OSHA 17.t" ~Ol 100:' 

... _ .. d 

185
Sfiirt}on V - Reactivity Data • 

- .-:-~=.:::":'-Til""""="'~"::"::"-;--"":-:"':-'A:::_::------- l--------..,-- fi~~~~~---~---F~------------------------------~-----------------­ " , 

~, IMIIY~ 

p~~~ 'v i W~I .. ~;r~~--~--,----------------------------------------------------------------------­ No: O:::cu: , X 

Section VI - Health Huard Data 

HUlU'! Ha::a.rc.s (Ae:.Im 1JII(j 0vt:m:1 "'It S~~gh:; JOCC', ~"'-;:;an: and c'l"'''Q~C" ]"oor;>·:. "'r ~ng"'~~~Qn r,;<:iy :ins" 

sam", 

::i II~;': 

iNGESTION; CONSUL: M.D. 

Section VJ1 - Precautions for Safe Handling and Use 

WaN ~ M«tnOO 

-p;""""oC!n~NG ":'r ,{) .. ~! 

Section VIII - Control MeestJrtI!S 

M«:I'laI'IlCal ~f'Ur; 

No "rna I 

F-r(»oclNC GlOVes 

NoporoDo -oa~"~ ~l~voe 

:oy~ PrOle(:UO!" 

:C:o'"":'","cO': 

•• 

... _ 186 t 
~---------'-"'-

• 

• 

• 

Treats 

5000 sq. ft. 

• 

'" MOLES 

CAN'T WAIT 

TO MOVE 

NET: 32 FL OZ. (1 QT.j 946 mL c.:.unON: KeF> ,,!,IT OF ~£AC.>; Ol" CHI1..:JRE.'" 

• 

SC001," 

M~LE EVACUATOR 

CONCENTRATE 

SIMPLe. and SAr::: 

SCOOT MOli :MWlor·#Om el!callU 

:'l".om; oak.:! t.'t ceor 11M UJ:I~ CI 1M 

:IOOL'C~ Whu !M~ ilr~: $m!~ SCeD":'. 

t:'ev will MCome YeN actl\'e tIVIII\l W Qi!( 

"m;,'.1'ilW\ tr,ev fUliu Wlr.'S ali UOuM 

L1e~t :To!;' came to ttlt wrtaee am:; IW¥ 

'cr ~!aWn m.t ootsn'\ smt~ j,ke SCOOT M~I!i ~~ua!W :uve UUI!!) ;uu ,r, ,-2 

-«tet:S .rw U101!QIICUL 7he :2I'Nerner.1 

;Cla"'~lct allOw> IJr £1S\'. economl' 

u:. Wloe to'lei'aQt or VU ;0 M trelllC. 

JIflECTIOU$: ShaKe · .. /til ~e:oll USlI'IO. 

SOI'l'( stOOl Mot.: :;1 :lit: C1 ene:m,"l 

o!r:OOO ~ ,. U:Io"'\4 mgt $tlMOIllg mo- :ion:. !ill OUl resu:U. 'OPIY In tam ~Om"4. MkI'Sammtf mo tUN hl:. ~r ,: 

ltMts iTm)fOllt lmm ~OUI nHqM¢(t yuc 

trw lI\I'f hl'Sl usc SCOOT 

CAUTion: Kttll OUI i): rtaer. 1:r t:'.:lOfen 

,:mm.:NS jCQ',', es:oro;! USP 

!",o:es can o:g UD 300 ie!! 

:;: eann In ene mgnt 

·'.10::15 eat enougn 1000 10 

e2ua: its WE!IQm eacn dav. 

NCN·-:-OX1C, 

3!OOEGRAQASLE 

PS.S7 SOLUTIONS 

:li'IANO AI-PIOS. Ml .t9S07 

Page 38 

187
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189
• 

-. 

• 

"------"'~~ ~~~~~~--~--~~~~~~ 

D.C-21-~4 WED 08:33 CLEAN1HG1S0LUTJOj~SlINC. 61~24Z1527 

~"'ICM 

Q' 6-24.,) ... ().5$ 

300-338-20136 

1. --.. ~-:> 

~o __ ...!.r.;,Y..:!Vc~_r~.::....-...:) r~~.::...._-~.:.'~:::.-:.' =--~=:-=-' __ --_\-_A_' _x~ __ -'7.:,0,,3"'--..--',_.2.0"'-"-,,'--·_, -,w_-'--~-;c."l_b_ 

y~ '6, 7 ?:tON: ___ -' ~_-- - -~, h/ ,/ .L~v~_,,: -~:::::.......:.,~""''"''''''~~'--'''''--:::::;:, ____________________ _ 

/1 - , I -------

n ,_-"'W&::;;~""<"'" L' _" -,,~::::::::::':::::;:,{ ), __ J,.(r.:r ~~~;;,L.t.--:O:;;;:!!~:::()='--__ ~ __ _ 

?A.G!S 

-~ .. -... " ~ : ...• ~ - : ...• ' "" ... : " , , , - -

P. (31 

190
• 

• 

PEC-21-'>I4, WED 0ff . .::::;4 CLttAnlNGlsOLUTtONSI tHC. 616.24:E1S27 

Casto, oil 

CAS number: 8001 ·79-4 

Chemical f'lamG: Castor oil 

Synonyms 1 : (1} Ricinus oil 

(2) Ricinolein (glyceride of ricinoleic acid} 

Chemical Structure: 

HO - C1sH3,20;t • CH: , 

HO . C'$HJ20~ • CH 

i 

HO - C'!:i'H310 t • CH2. 

United Statu PharmacopoeJa I Nationai Formulary 

A copy of the full USP monogr<,lph dllscriprion foe CastOf oil , including specifications. is 

Qt1.ached for your reference. 

F1FRA statu. u~d.r 40 CFR Ii 180.1001 (e) 

There is nQ Ustina for r;astof oil under 40 CPR f; 180,1001 {el which regulates 

substances which are exempted from the reQUirements of a toteraoce when used in 

accordance with good agriCUltural practice as an inert {or oct;asionaUy active 1 

ingredient In pesticide formulations: applied to gfOWlt1g crops or to raw agricultural 

commOdities after harvest . 

F1ffiA status under 40 CFR (; 100.1001 (ol 

Casrarol/ {USP! is lis.tcd under 40 CFR is 1S0.1001(el which regulates substtmces 

which are exempted from the requirements of a tolerance when used in accordance 

with good agricutturl!tl practlce a'S an inert (Of occasionally active) ingredient in pesticide 

formulations applied to arumals. Toom are no limits spe.cifically cited fOf this 

slJb:s~nce, however its uso is listed as a cosolvent, 

I ~k !ndgx, 11 th wition ; Merck &. Co. 1989 

l0058C$LDOC 

P.G:;;: 

191
Pages 192 through 193 contain product inert ingredient and source information and are not 

included in this copy
I'. 

" , 

0~.;:;;;5 CLEAN I Nt:: 1 SGLUT I eNS 1 1 He_ 

- "!; '" '= . 616-243152'1 P.ss 

.. "c' 

. _- -', '·;;:f\' \\"'" 

.: ~··:.~~ci <it ~~:~ .',::(",;, :,:-, .. :_ .': ......... _: _:~~, .~I"· ':C" ... ""'U ... ; ::..~ '~-:1.,:r p.:. ~t _. ,k'., • ~,.:- '), ~t;:;t ;::et l:~inutG. 

,·""~J .. r<.u.: ,i'((':"-~"i''-;'" '~;;";J; . ..:.;;;..:.n; :.::- ~:l-:c;·.>l:-:;;'U.e:l:: 

iqf() :~e ps dtrom1tog-rspb. and ..uk,," d!¢ I;hl'Oll'Hltc&flU'l to rull 

.. ~::i ~hc Wi:_nt hu ciutoo. Sin.Warty w)(:tt >!.otl ¢.t:"OIlW.~C£I'tpb. 

tile Imenwr Htmdard lobm·QII. th~ StQndard $"iu:iG'rI. Jolld ~ 

'lOIuuon pr~Jl'l.red a<:!c.Mtl.ifI.a: ~o tM di1«:Uons 1'0{ the rUf fJUP'" 

fU'dii(JIf. wllJmJtlinr \be it.tt!f4! sw;dM11. t'ill inttrfertl1G. pca1:i 

3l'1!: obtt('VeQ, 

Pr«tlfkll-!Jilt¢t abollt 2 uL of me $ta/td4r;! PFlptUfi'llf_ 

into :I. ~uir.ab'.a ltas eb.romwgraph. w Te¢C.Ird tbe ch."OO:Iawsral1l. 

Sir:illll.dy. i.ll.JC'O:~ lbaUt:! ~ of the Ten prl'pt11'Q!iQlt. :lcd record 

IIw eh~tQ;:tvn. C1J.tu1-alc the ~fl.Lltr. In ma. qf edl)'le!le 

QX14e in the: PQnion or Polyox.yl .'.!O Cei01tw!'1 Etilcr takcq by 

~fonnu!a: 

W,rl.'t,t:/Rs), 

ill wll;icll JVs iJ the weight, in m8. of ethylem:: oxi4c ill tbe portion 

of SuZltriarfi sOfulfon taru:n. altd RI/-and RJ' \lft the 1lIrea taliw 

of ttbtioi:Ul; OlW!iII to ,:']urni ,UMaid ill the t:;btoma~ for 

the Tut pnpaN1.tio713nd the $14n#ludpnptlfIJdfim. r~.,p¢a.il'e!)'. 

!be limit ii Q,Ol~, 

FI~ to11fth1.Q •• 1yt!ols--Tt'I1.Jls!a: about 12 g. act:Urltcly 

wd,:kod. to \\ 500.mL sev~tor -=n~n, so m.L of tt!1.yJ i\CC' 

UU'. Add:;SO mL I)( tedium .;h1Gridt selUlWI (29 in 100). wire 

vjgorousJy lor 2 IIili'Illta, and ;..I[ow lG ~cD4rt.~ fill' 15 minutes. 

DN;iA thl! !~. aquwn pbQ$fI. into \\ *Ond 5O(r;nL.W9m.~01'. 

And CXI.l'U<;'t tM ,,~ Iaycr with • ~ SQ.,mL JIOltioa of roo d.i1llD <:hloride satlnioo (19 in !OO). To the QOJnbinor1 3ljUtlOll:S layets "lid SO mL o£ ethyl :aQ¢ttc, 4l!.ake 'YigotOWiIy fot l~, 

a;d. ~]ow IQ scw..";\te ~ before. I>rain the lower, aQ,1iICtl1lS phfif: 

i:rto a dlird SOI).mt sep&rntQf. 'lftd ~cl with. twq so-mL pcftimu or ~hiorolQml. by <lklng fQr 2: D\~I" M~ t/m.t;, i. .... ,. CItlLte tM cac:dWRd ehlorofQfm c.tra.ea 11'1 a t SQ.m.L bc:ab:r (In. 

::t. steam kth, With Ihe aId. of a IUClLm 01 nittO&Cn- to appuent 

dr'FM's. RedJr.5ol'll m ~bout l' ml of clt!orolc:tm. attd It:I.nIht 

10 a J'i1u:r. co1tecruDi the filuata 14 a ISO-mL bea.ket. Rinse the 

fwlnIllAlith smtRI small portfClJ5. of chloroform. lrul el'apotate 

tbro CQttI.billCd flIut.tt and ri~ u Ii=eribed IlboDve. 1JIltil: no 

«iw of chlar-onmu or ethyl atttlltc: iJ petceptibl!', Coal bl it 

~i~~r, ;lfId wei,In the nmit U; 7.5%. 

Orpnie roJuilt biafurioel" ¥.nMd I {467 k mkt$ ths teqllireD1C!'It§. 

Atttq(I pcIymu 1tag1h-Plt.ce m/:' Pclmfyl:;lO CetM~ 1W1« 

ill lI. SO- <ffttet Wh 0Ycntitlbt. in ordtr It) melt it .comPlowb'. 

SMke viprou1ly to ciiminato MY 1iwlbility of ~w-.. rilnl 

gradients within. it. al'ld ~tftt' lOO,tlL to.!. 5· X t8QoJna bigllrttOlution. NMtl !l.mvle tubs. Add 200 ,d.- Qf wboll ltttltbloriGI: by rl1WIIl of a l~at' miCfQ$)'tjngf.. AIiIS' df09$ IJf n~~ 

.tmlthylsll~ U UI intern:Jl :rcfmnot Stand4rd. C;1p me tuba 

tiginJr, 2nd!bAkc thorouSbly. Place tfw tu!:rG- in dle;-.JMlt spec- rtOfm'~f. aM r«Ot4 lUI. N}.Ul $pwtru:o at an apptOpt1a~ RF 

~t 1¢'t't1 and Ii swetp time of ISO ~ per S{lO Hl: (HC 

QU4Ilt.,tw: S~ UNlet Nur.lau MfIFiI!lie RUOlItlMe (7tH n. 

Adjult tM lPewum ampfuu40 ~ tJlat the sl;nai. at 1.1 pp.a'l is 

at iC:I.§t 80% of rull-5cale. R.teotd 1M mt;eral ;l.I'Il3S £tum 1).4 

pptl$ to 2.35 p:pm (At). aM ffQm 2.33 ppm to 4,9 ppm. (rill U Jl 

$'nep time ct 50 w:ond J po::' SOO Hz 'it ali intc,l'Ii pow« !e.v~l 

~Ilc-h th::u the integr.l! of ttw C1ltYWM oxide. pt:V.; I~ l.;C ppm. j$ 

~t leU1 t090 ef full dun htigl\.t.. Do run. ehllnae the pow« levcl 

dvling tIM': iI'II'«p. Rcwrd lite intqn~~;Qd; ~uven1 UIooi. 

ad ca]cutm lAc ""CU£I!' imegnl ,tern. Cal£;u.!.a.u ~b.e ttl,lInW 

of WiyClilylt.ri¢ u.nt~'. ~ per mo,lKU!e tam by ~lte fonnula~ 

II' - 02AlIA, - 3)/4. 

in 1I:l!i.ch :r.! i! th,e totai Dumber or protons in lhe mW1;';Il~ l'40( 

. u:tr--a!ed. by oXYPI\, a~C1'ag¢d. !<.It t1M: e~wl and ~tj}U'j:1 ~, 

j is Ibe fl\ltl'l'oer of oxygm.aGti1l'l~d protons not inductd in the 

o;.:yeth~cnll- IlrUt eou~l, ... it the- np.mbc.r of p~~(l~ in o;liCh ClI:)'. 

(t!ly.iene \ltu.~. 

1t PGI"":':", · .• :· .•• :~,::u :c.nr;;m, :~;.,":,\' >.'. 

rieiool:"::",I-! '::5':::: ::t >!!.1~:-;yl,,~cd :;h..:.:::~i.. \':Ib ':>:=1;:,. 

amounts of POlYEthylene s:lyco.>J ricinQi~at~ :md (i 

corresponding iree glycols. It results- from me r 

action of glvceIol ricinoleate with 3.l:xnlt 35 mruel. edtylen~ oxide. 1_ PaekllVns: ........ ItlItii storli,~Fr!5etve in tigilt cclnaiMrs. 

A: Pb;sclYll3botit 0.1,g iu! mLcfWliter • .e.dd9 mLof's(ld.1t 

chloride wiutl<ln (! m 20). and m::lt In iii. "'am ball:!. Ibe SQIUk o~t$ umnd ill i1 ~m;ltf1l.WIl" bmwun (i,S. ~nd 8;5.· ;ad t 

('Qmcs cit.:lT on cooJ.illl to 4()e, 

Jh Dissol.ve aoout O.le itt It) mL of aic:04Qlic PG~Ul» t 

dtwJd-c IS, bqj! ror .alxll.lt J r.nim.I'tl:$. lad ¢ViJ)Qtttc to d.ryt~ 

.Mi;;: Iht: Jdidue witll: j mL of w::.ter; it ~oh·tC. yitidicJ I de 

$olution. Add it few drQpt of ,mda'! ~«llC aei4: a. WlIiw J! cipi.tal~ is f0mc4. C~ To II, to{l,nlQU (1 ill. 20) add. b~millc 1"$, drGpyrut.: t. 

Imururn: is I!ecolotizm 

Sp;tdnc ~~l' (t4n! betW~cn LtI,s and 1.0&. 

V!m!sitt (9'1.1): betwcm 650 ud. SSO etAtipoi$e£:.t 2S~ ,l! t:;' 

iUary vUwsUnC'let brillg use4. 

AcHl.- (401}: Mt mort tilu 2.G. 

Hyt{Nlxyl'aM (40l): MIWl!till 65 and 8{l, 

IMkto ~ \401 h mWmI as and. ~l'5, 

S:tpeaHiatimJ 18m {<tOt h bGl\YC'M 00 .mi 1$. 

wlU«'.M~h¢I(92!1: 1lI'J~~thuM~. 

:Raidue oa ipiti4e (llli}): !lOt lI:tO'\'e wn 0.3%. 

HaII'Y metals, MethGd 11 (211): O.OOl'iS. 

Orp.vfilttiJe~ McrhtHIJ (dG't>~ ~~f4qti 

m.eIIlS. 

Polyoxyi 40 Hydrogenated Castor Oil 

" Polyoxyl 4() Hydrogenated C .. ror Oil 00"0" 

mainly the trl·hydtolty>t<atat< .m:r of otb""yll,. glyoe,,,~ with ,mailer .".,unll of polyethri<t1e g!:~ 

tri-hyd""'Y'tearale and of tbe cn_dillgf ... ·~ 

ool~. It f($uiu from ltw roaction of &1YtCrol m·b 

droxy.stearatc with a.bout 40 to 4S moks or ethyue 

oxide. 

Po~ altd mlrap-P~e itllight -dJ1It1wrs. 

I6td&UiCfiltloaA! lli.ttoMaboot 0.1 a: 1ft ~ mLOf'4'itcr.:ad49 mt ().HO-Ii> 

.!hl6ridc so!utiontt in 2O}. .a<lltbt.t lit IS "llter bath: 'riluOi!}l 

~I'M' MOW U !Ii tmlJOl'ltUI1! betWeen 70· :"nst u·. 

11: DWOlvo abotn o..llt ill 10 mL o! ll,cQhoJ.~ ~st, 

droJUdo !S. bcil foo :3;mt oJ minutes. arn:l .~.m to drym Mix Ihe ~ with 5 m.L cl w.e.tct: it dllSomt. ~ l.,:{. 

llCiv.tiort. Add a fo;w dwpl: of alaQal a«tic acid: a wrote F 

etpha.tl: is fonmd. 

~~tvN <651): WWtel\:W~ and 10". 

Add fllw!: (401)! not mtU'e than 2tt 

H'$'dxyl'illllft (401;: ~twl:lm 00 al\d &0, 

[0IibM fa!w (401}: not mom ~iI:.tI 2,,0. 

Saponificam ~'ahlf (40L}: betwc:o:(\ 45 !ind. 69, 

Wafer. Method t H'21~: not rM(~ lhll.n 1.0%, 

bsiGue CJl.igDJhOn {lSlj: !lO~ more tltart <1.)% • 

HLm", 111mb. Mtlh~ II \.n!}~ (),OO!IJS. 

O~ 1"<Iia~1. i",puriti"" Mltked J (4ii7>~ tntcU tbarcijU~ 

"""' .. 

--

----------------~~.~.~-----~----

194
• 

• 

VEC-:;;>t-'9-1 W/tD Oa-:36 CLEANIt-lGtS0Ll,)TIONSIIIIC. 6.162431527 P.o.; 

-..... 

,_ .. ~. j".;',:,r. __ .\e.~: _.",", '.;:- -:.,;~ .~::~ '':'~(', ~,~ 

,-,,!!:, . ;",,~Ie,;.rr -=-,~:".":':"_' ,~ •• f~C ;:-··r~~,:.() cj If,e !::QwO::. 

, .... V.jYlll\C:b[ ''''II.I)(N.1 1 ''; £; 'Jl C~sQr .. ';;:"s:,'lLda €;o;u"'~t, 'to ~ ; i;(1. 

~i.. ~'OJ)i.Dl~tl1[; l~k, :~dd ';;OQllt ou mt r:f .';;',(; l!cohllL ~"iil 

.i.!JoJ,;:.r ;onlc(l'::p. ft:l J ~ ::} ':'0 ttli:lIlUS, ~ev~~a! times. a!iaw Ie stand 

o\"tl1'l!p!t. ~k:al[; IX ~""tl! fQl 10 Ie 15 mUlOtC!'. dihllC lVIlh 7u;:::' 

~lc~hQlIQ "'''[\lllt\:, miX. :Ilui fllte. ~llrol.18h n~jlabk fIller paper. 

,iIS4)' pft>pafG~k;rt--Pleput. 3$ (Hret'[cd ItI tbe A:I".nJy jOl' e.:ilj· 

"'am/ldu u.oocr CaK~fa SfJ~aric:. 

P.I"(>«'dUfll"-PP!t 1{1 mL of Allay prepa"':lion in10 ~ iuil;l:illc: 

flaik f;'OOl'a!m1lg.(, mL ~f Frl7ie ';"laFitte seJwitm (IJ1d 12 Jl1L of 

l1.yrlrot:h!01it acid. P;Qe~d u &~~:ed fer Froctdurt in tM As< 

-wY!f)r ct1Xun'lJidu ~el CaufV'{l S(J$f'lJe, IYcSIMillg with 

" Attach-", ctmdel\$~r 3!'r.1l!sed for retlJJJ:l:\,. and ~t fot ] bours." 

u.oell=pt lo.evapm:I.!4:11t! S.O-mL ponion O»tM-eiubol\.lrtn.chloritle 

m1ut:On illslnd of 10.0 mL. C:l-cufate thl: ql.lAl'Ility. in mg. of 

cue:llQ5idtll in Ihe pon~n Cot Tableu uken b11M (oonuJa: 

l.,s67(l,S8c)(Av/ .4::;1-

III whu:/'t t.1I3 is 4 amlJ)Osile Qf th<: ranoOfIhe ~o!ccu!~r ~hq 

m4 UU)' It::lpw'l£C fo:.oetors Qf cat;~ A ",1:ui'll""l0 dsntllfca, 

C ii tl::c ~lnlkli), in 14 pet' :nL of USP OaZ\!bfllll ItS i.n 

the $tQI'ld-.rd pr'fHJUl.hfJJI, ~ Ad and As art the abklrb3.r.c1!!i 

or Ihe sciumw fral]J. the A5!IJ.v I'NpanuiQfl :tnd the Srand.;rd ",~peran'Dn, :~s~ytly, 

. "nay kit tot!! ~dftctlH derifttiY~01lI t-P'ff.. fo~.all extracticm. by shUil1lg 'i1~l,I!;ly. and, 3UoW all phases 

III Hpu:ue oomp!.cttly befort trIUISfcmnt. Bnttt.iumrmt of &;iy-

«U\CII into lhe aq:lI«NI p.!we. as indiealed br. ~ !,!wot H t!tt1'l 

2,-!i f« the ratio 0{ tltC a.lnQl~ Q{ tllo flt:1.I tclutlan at 515 

tUn to that 41 440 _ may ~ tQ tali' .rnulu. Nons 2-

Thl'OltahQUl tAb uuy. use I N tedium A~dt: WI is pupu9:! wilhol.U .Q~d. barium iOllS u mend. (01: VOilintclnc S~IUtDr:: 

in tlJe!aliGn R~ms. IR4itfUQI'S. 4/'fd Sol£lliollJ'.i F~rn'c lhl~dl1 iclIICt.m.$trmdiud puptU(ltlM. aitd M¥Dy sa.-

ilOljqIf-Pt~($ as dm:ctcd in Ibo Astttjl 1m- cuwr(Ridl,. 

&,I1Y prtp6tft~~R u ditetted'for AJ.lay [»'eP.fUduon in Ihc Allay fqr Ictal hydi'oxyd11l1vM'tMt! Jer:'vativy \lid.i:f CM-

(t;/'a,s.dlt. 

hoctiiu"......l'I:ptt 10 mL of AuG)' JlVdratl¢lt into I> ~\li;able 

nul«; conw_;;: mL or F-mfc Mfcrt. $G!wion: and 14 IAl.Il! 

bydroehlOTit 1I.Q4. Pm=d;ls dJrettt4 for PmutllJN. in. tM A~ 

.NJ' /w cJttMl"On'dts WIder CUoMI'Q $tJgruo. be~ wia 

"Autcl;econdMtu ar.anzed fot rdluxing, and heat1ar ~ liours." t!tC~t II) tl'3por:tlc-:l l$.o-mL ~ of the c;rOon tetrachloride 

toiutlQn ircrtc:zd of 20.0 mL. Call;Il]ato th.! t:\uamhy. in ma. 'Of 

IQIIlI bydt'Olt~mbraeeQ& derivative. i"- the port ron ~rTaMm: W:CIl 

oy Ihe fonnu: 

J.331(2.S8C){AI.II AS>, 

lit which 2J.lS is II oompasitc of tho retia «the u.wl«:Wat wciuhtll 

:utd :tYl!.y 'apeak: factors Ilf ell~ A lc:.htLVr:: l6 dantbran. 

c i~ 1&$ <:~tioA. in J.I$ ,0:: mL, of USP Dllntlmm RS in 

IOe- ,st(lMMd pnprmuitm, and Aiu and As "to 'the abaorllilnca 

of'da 'SOiu,tIM5 ffOl:!). lb. Auay pl'el'f<fMllan :&r!4 thr Srtmd<Vd 

'''PQrtnum, m~jYdy. 

Caseara SOl!l'ada Fluidextract 

» PrCl'are Cascara Sacrada Fluidextract as follows. 

To 1000 & of QJ3rse1y gteJUD.d. Cascara S.a.grada add 

3000 mL ot boiling water. mix. and :l,Uo\V to l'!Uu::ecate 

in 3, suitable percolator for 2 hours. .'\.11091 Ute per- colatioo to prQC1:cd at a moderate me. gradually add· 

ing boilint wa.ter until the drug is practicaUy extUlUsted of its acti .... ¢ pfineipies. Ellaporat(: the 

percolate on ;i water bath or itJ a vaCllUlli still to aot 

more than 800 mL. cool, add ·too mL of akobol and. 

P~ch¢Ult: 3m! st!>r"'t;'-?I'!"j't~ .n. 1:e,.'tI. lig!1I.1e.I~tlIl\ 

:~il1er5: ~T.d J"I,)ll) -:-~p" .... r!; iO ~i:ecl SWllighi and 10 . !lt3I. 

,\!c~ ,,,"tent. Jllflhli,J ; (61 J:O ~ 

C!liPH. 

Aromatic Cascara Fluidextract 

» Prepare t\Jomstic Cascara Fluidextract liS 

lows: ' 

Ca~8f;1 Sagrada. in very 

coarse powder .. " ... , ............. , M~nes:ium Oxide ..................•. 

Suitable swe~'tenmg a~l\t(s) '" ... . Suitable ossen,lal ailsl') ............ . Suitable flavoring a.gent(s) ......... . Al<:ohol ............................... . Purified Water. J. sufficient 

quantity, I() roake .............. ,.,. 

Castor Oil 

1000 

1.20 

» Ca~ Oil (s the rtxed oil O;,::~~.~::I~~::f of RicimtS communis Linne \J 

It eontaim no added 3U1''''IlICe.,-

195
DE:C-:::'l_94 I,IEI) 08:1;:7 CL£ANltIC!SOLUTtONSll!4C. 6162431527 

,'; - ','ii,,,' '":;'"".«~" 

.~ .-::L "" ,,::~; ::-;r~/U~.' 

Capsules contain :lot less than 90,0 

mote than 110,0 percent of the la~ 

oil, calculated Ir(}D1 the tests 

and Spffiflc gravity. 

• Ul. ti$ht rontalem. jlrucrably 

Emultion O)ntains not less than W.O 

more than 120.0 percent of the Ja~ 

Castor Oil 

, 

of 

1.:_:,,',,_1~1,' ':0 :~,,,- - ~:::"" ,t..._ '_,1,_' 

_ _ -:.! >c:h"I;:t::wl:phu;-ti):c :;: ::::o~::"I't";. ,:~-

:;,>; wqb. ;::c.QrOI')= \0 "¢i'Jm.:o, "no) :'l1l\, 

Ci,,)ma<"j"<lp.~k' .¥S!I'm ~se.e ChromfJlt):rn1p/lY (6-2) ,j~UI\' 

:er ':In{ll <:;or.¢It1aUs, ~l:e irnWHllCflt'~ e!p.I!FIXO wilh: .3. flJ~­

!~n1Uucq Ceteclor atto ccntal1)~ a l.a·ttl :< +l1lm o;.lumn oat:i;cd. 

with IIqu.id ptwc G25 01\ ~'Pp¢rt SL 2nd C'Or.dltlo~ by tluduns; 

wilb. hciium fIX Z to ~ minut=s, Ib~11 be::'lmg wilbetlt funh-er 

flushint :It 2:SO· for not Jest (hll!l JO milluteli, Ihttl coollilg to 

:-%m {(:m~nre, and finAlly hdtitl$ wb1!e ht:l.tulT\ i1 floWing through it 3t 2SO~ for aot \e1s than 60 mlnlHM. DlJl'ing: lbe (hrcm&~rap1:uC «:(HU~. the cchunn I' rniUlw!'it'd :l.t lotS". 

;)lJ4 the injection port llld de\cCIOf block are rr-.ainuin«l4t a.bo~t 

~OO', n", cuner $" u h-tlium. alla its flow rate is a.djUit«l to 

obtain a ?elk due 10 cut« oil a.l;«Il 5.5 rnUIUI« lIIfler mlt¢due. 

lum of Illc fp«imUi aed.;Jl d!{ema! standard. peal: a!»'.Ir ! minIItts dter Introduction cf 11><; sptc:-iml!!lI.. 

Pl-Oi"tdwt-TunsfetU\ 3,C(Ilfa.te!y w-etth1!d amount of the wcll~ 

slaXen ElmluiOl1. C'<,\!.Uvalel'lt 113 llhcut 100 fll8: of «'liter cil. 10 lI. 

lOOJ_ck. ftllind-bmtOm. iOO-mL bcitin; il:l1k eqillppd with '1 

iu.ltt1.ble ~flux c¢lldotutf ~ by a grQW-glujcinL To 

11; rurular fi:uk IfllMftr .bow: tOO mg of CWOi' 00. !itttunttJy 

weighed. to ~ d~e Jtt1tdw1. CUrr Ollt the followill, SI¢9S 

00 each: Add 10 :rtL of:l mixrure of 100 mt ci' m«baOOl lUx! 

3,7 mL of su!furk At;:I'J, reflux in a WMo;f bath maintained at 15-

1060' {or 2.5 hcut$. IOOOt. lnd ri~ UI1Wtt tM coruknsc with 10 

tilL of wuer, 11"U4l'(1' the I;Otlwnu sf Iho iluk to II, 125.-ulL st~.tM with tbe< aid ollQ mL m WUl1:t. Rime tb. condcnur 

Ud the iWk v.ith 2' I2lL ct SO!VClll h=ne. and u:wfu to tlw ~patatcr Shlli:c lM ~lIt« fer :: mlnloltU • .ud draw off the 

Jrt.ll.ema lJ.yw into a seCond t2S-ml. np&rator. Ad410 mL of 

~(lIVINrt h,¢UJH to the $~ HptntOf. iliake for 2 mUlUtcc. dis· 

carli the aqtI-I!oos layer. and tra/lIf¢t tM wlvmt. Mum: layer \(1 

thdi~I1C~ witb dI. tide( 10 tnL ¢{:ro1va» hex:mc. Wuh 

the (qUlbined OAU'l.OU wl.th thrtc S-C'.I.L portionS of witter. d* ~ the Wlth!afl. &lid tt-aJ:u;f« the '",&shed utr«t 10 It ll$· 

:AA. wa:e&1 twk. throueh l!: fuumU «mWniI1&: anhydrous sodium ~!il!u.. mth thf::ud of 25 mL 0( wivoat ht1'JUl~ PIa« t.be ~ 

ill a tot W4tu bUb\ and t:Vll~te with lhe. 3id of -a eum:1tt 0( 

<Ut to dl')'llm. To wrt1td\tO 1Id41G..O mL 0[ Imcrnttl ~rllnd4ni 

U)/ulicn. a.mt mit un.til ~tlcn is tQI'nplete. Inject aboul 5 ~r.. 

into tla ... cb.roma~p.b.lUId meuun: the ~lrt:$ of tht peak! dl1~ 10 o:utor oil and illlema.! SWldtrd. Ca.!cwate the qutmIty, 

ill me. of eutor oil in tlR; poniort of EmuUiC<1 ralXl1 by Weformula: 

<{.J.,R,JRs). 

'II.!. wbkh q, is the 'h't:tgJ:!t. in- mg. ef carter ci1 ttken for the $W!--

dafl$. and R ... and Rs ate the r:nku of :he hcipu of :.he- peW 

dlOt to ~1.Or oil aoo intctnal ~ ohtllMd ftOOl the Emut- ~ion and Ihe su.n<h.«l. mpteUrdy. 

Castor Oil, Hydro~tcd-sE'e Castor OU, 

HydrogelUted NF 

Castor on, Polyoxyi 35-see PolyoK]1 35 Castor 

Oil NF 

Cmor QU. Polyoxyl40 Hydrogenated-see 

Polyoxyl 40 Hydrogenated Castor Oil NF 

Aromatic Castor Oil 

» Aromatic Castor OU is C;l$tOt' Oil oont4iDing 5Uit~ 

able flavoring ag~nts. It contains l10t IdS tbart 95.0 

percent of ca~tor ou. 

P#ekatiAt Vld no:r.n~Prc!ef\'1!! m l!!lhl C,ootltU'ler" 

P.07 

1 

, 

196
• 

• 

DEC_~t_94 WED ea:38 CLEAN!NCtSOLUTIONSIINC. 

1 J : 38 

~ .. m ... nt. of .. t91<t111Ul«t. 

(a.) An excl"nl>t'o" ft4rt> a. ~oltrll,nce 

tb.;!J~ In gn.tll-ttl! whet". it. apPQan thAt. 

tb.-t WW 1t1l.!1.!1U,V {If th, pII~tkid", 

chl'Jll1o",l ll': or en .. 1, rAW 4~culhu .... l 

c¢'!'l'mw.Hti'!:~ for whl(~n !t h lllfootul 

under conwtionlll of llU1 eu.:r1!ntly p<"e. 

vaihnr cr ptor>Csed W!it 11lIlOl:V¢ hO ha;:-

,,-.-0. to tb_ P\.llJhc heu.n. 

(t, Wh'J'l"i "lIPtieu to f:\l"0W!:ljJ" cro))" 111 

a.eeormCE with. 1'!cxY! ~{e.'lltur .. \ 

praetlct, the foUowtl'ig- pet;ticide cherm· 

cQ.lf. l.rt! txempt fT"Om the rtQutromO"nr 

or .. tol"ta.l'IJ;~: 

(.!) Tht [OltowillC OO~t corowund$: 

Bo.t\1uux l'l"'4XUttt. copper Mt!tate. 

PUle oo~ ea.t'bon&'a' {:naJu::h1~,_ 

OODPIlr ny<!roxl.df.. eopper-!ullt nuli-· 

tUN4, «)ppet" hnolAat$. 4QP~r olti .. te. 

cotlntt oX)'chio1"lde, eo;p« IIU.U.~ 

DUtc. cCItper sulf_te monohydtl-to. eo.,.. 

P'lr cu(Cate P'!!l.tt.hydn.~, (~liJl"" 

R , • . , 

2.:H.\lJ;l!;rboXl Ifll(Ji!. 

{:I, Pe~olO:\lm 1;1113, 

(4} P!~r0ltyl b",t;Q".;ld~. 

(0) (Reet:'1l!;1) 

(6) N·Prcpyl b<:t~1J 

n> ?YOII:th:J.fU a:-.! pru:~nrlr:.:; 

(el R'=lter,'J~e or d.er!}!: ,,~ cube !'oet~ 

($)R)I',,"m;).. 

uo) $ ... b.d!l!~. 

7'hftt P'l<;.tlo'dn Me r,c~ '!;x'tltlPted intn 

thti roQ.ulrcmmt Of a. toierl!"l';:e when 

I\.DDlltG to II!. crop t'.!. ;ht time of or a!ti>r 

hlU"vnt. 

(C) !\uidues Of ~he lcllowlnc =~ 

nAU AN l!x:~mpt>:t! !ten-. ta~ "«l;1.Ur(!-

mtnt of a. tolerancw wb.el'l ua« l~ n.c- c:ordl.net V;lt}, food arf1~:Ut\ltd );>fM:-

tice ;v; inl':l't {or Q<;;.<:.u1ol'lally $.CtjvC) in· 

rrred1e.rn.s in pcs:!c!de fOrmUu.UQM "' ... 

tllttd. to j):"roWII'!e' cropa \>t t-(l u,w .... 1· 

c.tll:)ltal commod.l.;.1t1- Lltor harvest: 

I ""' i 

~ _ t_« f,;'h, __ 41':11 _._ •• _." __ " ...... _~~._ ~ ... 

"'_, 

~P"ft'I')'tQMl 

u _ *'~ ~ 

......,r~$I=~I.-

1;liI)!lCf<sJ~~_v,,::~ ..... __ .. _. __ .. 

_,-.~.~w­

""""._I~-

~~ ~,.-... 

I~.....c,~ --

wtt«r*~~UI-W_ 

- I>'< 

~~-.­

~~.~~..., ,...;w.."f4Ijt~l __ 

","3_. 

~. {C..-t;.ol'''''fI~i$< ;P1r _. __ .. _-. ".... ~ 

!'~.;J ~.,"~O~«IIt«lI!6 -~ -'1 I I '''_~~t_l,,,,,,: 

~ 

~~~~ ...... ~~~I~~1M 1·····-_·_···.· I "-"\ Co 

_iIII1_~~~1 .1 .... _ .. .....,.,.... ~ " IN'" 

_ 1M"l .... r4 • .....,... €i.': _ t, 

_"'''~~Woo. I . ~ tCrC.~ I<h.Io .,..,t .. ~. QII. l ___ ._.,._. I ~_~ 

fYr,.'-.".,~~~.j I 

~ ~':::: .. _._._._ .... _.I __ ~r_"'_'""_'~_'~ ".J a,..,.., "", ..... , ero_ . 

P.08 

197
88:39 CLEANINGtS0LUTI0HSIIHC. ~- --- _."' -_. --- ----... -.~-.,. -" _. --. --

kd:~,""''"Y''''''''__ I ' ~_""v"""""'~l 

~ "" .. "". d ......... ~ .. """ ..-.1'>f"""'!I""' 

~"-"'" "" .... ,."" .... -.... ~~~ ...... ~-. """' ....... ~,- ~I "".~ ~'.H .. "' . ....,'" .. ~ II"~ "".: __ ri~"'u~'"""¥J,:y,..""",,,~ , 

.. ~ "">~Wt 't?'OI _ _ "" I \\9'''t.~_t <_, i><,,~,t1 """'~ 

~~,C<~_ . ~:, 1.!>T~~""~~""fl- ) 

~.!.~.!:~~~l 

R, p, HSt.E.-'t. 

I ~=~-".-----'-- --"=----",- '''''1 ~"'''''''''- ,o",~.", --"., ""'''''00-" 

I 

1 

'<'Iam,lty;w.,l}V_ "'M"'~ '" I~'~ l ... 30-N~..rt~~""!$o ~.~I 

CI~<J~<""'~".""'" 1"_ otr¢ ........ ~,~_,~'" 

Prj Ve4v!! ""'" .. ~ ~111\1«, 

~~v.LJ;Dt"'v..l'Jr$&l '_'4"'~'1 n 

~~~*_ ----'-~::::::::--:::::::.= f 

=:,,~-:-~ ,. --·'-_-::-~·=:~·:.1 

==.~- ,:::::::=:.=~~~:-:-~::~~ I :~:: 

'ICh.""",~ " .. _._" "" .... "' -----" I "'~=-, """.«- -. ~""'·_"i'KI<"~~9~" 

, ..... .,_. ~'IiI ,;""",,_ JI'¢!~ ''''_;:.-,' 

" ." ""_..- -- ""'" ..,.,. ....".,""""'" .,_. "''''~t<_'M'~rnl,.(>j)i~ 

"'-'~-~'" ~-,,~ 

I 

_ ~ ~. """"""'"'. _1'NI 1 .......... 

~~"", . W<I~...w,_, 

, _. ~ . ! ~."", """*' tAl'l ..--#\ ~....mv",,'" • ""'~ 

~ __ '" ... _.""' __ I t.-!~~, -<"-'-~"~-' I So ... _ --. . _.h ..... e.e •••••• _ _ ld<; ¢'Iff'l._' .... 'l1."'-.~ ... ~'""""~. $eI>t~ ___ , 

""'~-

.. "-...... ~- ... ~-.- ~~ 

$a/-<:! h __ ~_" "''''"",,~. c=.""". 

~-.:~:~:~:~~.::::=,::,::::: I S= O¢i"'''''~CI_~''- i 

"I~-~'''''--

I ,_"_._.~_ .. ~_, .. __ .I A-'~~ .. --.. -"~; ~ ""!I¢.Nl!_. '" ____ ~ .... ,_.""... 0-... ... _._ ..... -... ~ ... .. _, .. _"~ ... _ ._.. !It'""'''~''''''''' • ____ .~. __ ,.__ 00> 

____ . " _____ ~. __ ."_,"' Cc. 

::~~:--::~.:'-:'::~:~::::::"~~-:::~' ! :::'~~'!::t:'''' ....... "-'-1"--

__ ". ____ • 5e<d ""_" "'""' .... 

<36 

P.O'S> 

;""""" ""'''' .. ,. u~~ .......... ·· -- ." .. ~-,-",~" 

::.t. .... ~~ •. .,.."...","'W ... t'v .. ·,·( 

~ ..... , .-_.,,---.-.- .~,,- -.. _" .. c.._ oj I'«'-:''''''''''''''«l:; 

wn~· ... '"I'_l ___ ~. 

~~ 

• {;o<--""t .... 

~,.~ . ..-:wYA _.,,""_ ... _ •• 

c·", .. oJ """' __ '"" 

~,,--, 

«<~~ "'~.-'-"-'----

w_'" " .... ,, ____ ... _ '-__ . ~#'~ - ... -.-, ....... _-----.. 

e""' ....... ' ____ ..• _. ___ , __ ._._. 

C .... "" ".,", , 

w._'<'>. 

:".t-« __ ... , • . _. ___ .. _ .. ___ ._ _ 

~'*""'~-. ~~ t C 

'11;1'$ l;"""""""' ..... ,_ (C.o.s ~< ko. HI' 

IQ-J': "'CO,., ...... ~ __ ._._._ .... ,_ .. , ______ ... iMw _ _ .".,,_ ''". ___ .. _ .. ~" .... '". P+wtI'WllI"' __ q._, ~cl~4q.,.,_ 

~T'tcrc,,)~~~~ 

198
• 

• 

DEC-21-94 HED 02:-10 CLEAHIHG1$QLUTtOHSltHC . . -.-_ .. __ .... -_ .. ---- ---_ .. -....... -.. ... -" . -.. . -_ .. _------'.' 

: 

! 

I 

-I 

~ 

~------, ..•. _--_.- ~_ 

..... _._._-----",- -"-,-,~-, .. :tfCFl'tt~_ 

R.f' ll$&EA 

finO.l0tH 

-"'----------I .> " .. ~_.,~ .•• ___ eo.."'JI_~ 

~ ..-. ~ ,,,,,",_. ,~ : ~ •.. -.. - .. ---.- --- ,-0 __ " ___ " ___ \s..--.~.~~-

~ 

~,o)~"""""" 

."j''''''.'~ .. -·--~·-'-'--··l~··-~N~ 

.~ C!I.-.~ - "-.-______ .. --.. -~-, . _,,_ .. ____ . ___ ,~ __ 'lid.; '*"""._ ~~"'_ CIIrMr 

~ O"Nl'oIW ~ 

.---. 

__ __ .---,- • __ . &:<O!~_, 

~ 

~iI* ___ .,,~_._~._ ~_, _____ .. _.~. Do. ~/iII_._ .• ~ _. ________ • __ . _____ ._._., __ .I~...__.~'fMl 

~_ .... ____ . ___ ._ _'·_·ISIH~_at!Io<. OIII.,.(Iol.·., .... " ___ ~ _________ ~~ 

0;tIM"...,.._._, _______ ,, __ ,_~ __ &tw~_ 

C:II8.~_, ________ . ____________ ..• 1)0. 

__ -_____ ~ ______ ...... "< __ ~ __ ,. &>oe-'IIII"W ~_ ._~~_~_____ 0.. 

tl/ot!'dI~ __ ·,,_· ________ I_·~,,·_~_·_ ~ __ o.-__ .. ___ 

__ . 

~~~.--,----.. --~.".. ~~ 

~0iI ___ .... ~~ ___ -'"_.~ ____ ~. __ ~. 

Qw="i ........ _.~n>21CFlt '''l.IiM'''IJMO!IIr_"~~ ~t#.~ ...... 

(.'"'=, tlS--l;- '>U<' .... ~ICA&I'!iIo,No-l~lI-- _._. __ , __ . __ ~"!~ _, __ """*. _ ~ 

c..- ~~·----~-,--i ___ .___ . . . ._ .... _-._.- __ . ___ ~~~~6fI\"i. SIIW~_. 

f;)-,.! _ ... ~ ~ """'.-oiI _~ ______ .......... 

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{I 93-11). Solubh: in rncthltnol, Cth31l01, ~cetoue, acetic u>::i\l, 

chloroform, etller a:1<1 1;Icnzcn..,. 

Hydrochloride, Cz4HUNO ... HCt.RtO, minute 

from nleohol -+- methvl ethyt ketone + elhcr 

mp 220". • m:o l'SC: SU Ca.~saidine, 

¢rystals 

(1:1 :4). 

Cassamine. CuHuNOs; mol wt 433.57. C 69.25%, 

]19,07%.1" 3.23%, 0 111.45%. ExtrllcteQ front the b;:!rk uf 

Erytf-,ropMelflll f{uitwcr.sc G. Don., ugumitu}l'Iu. 1l01tl: 

El1'gd, Tonticllr, HeJv. Chlnt. Acta 32, 21M (1949'). Struc. 

ture! Arya, Engel, ibid. 44, {650 (1961). 

"'\:HI'.{l(){'"Zr.l{l~('~IS)l! 

r.lIJ 

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~~~~il;~i~j~:;;;: i ('Icid: 7·11.1·Jroxy·2·nll[lhrhaTj'Irr!JJJlf()ni~ li·napIJlhlll""-mon(l~u1fonic ncid; ~cirf; acid F; F A~:d. Cl~H.04S; mot \"[ • H 3 . .riO'ij" 0 2854%, S 14.:J,fi%. j>r"pn; , /1l.'r, 20, 14;:fl (t887); G(~U, J. Cl,cm. 

, 

o{ Cauia fistula L. (CalTiartor.arl.'!!s fistltla [L.l Pel·s.), 

L:guminOSOf!. "abir. Uppcr egypt, E. India; cultiv~tcd ill 

Jropic.al Amcrica und A{nc:~. emU/ft. St{! CMsi;l Pulp. 

MID esc: &i' Cas.~ia Pulp. 

Cassin Pulp. The pulp frDm the ripe froi[ of Gusla 

fiswla L .. Legllml1tosa~. 

AhT10.~' black. viscid mass; swcctish. UlltC. ConstTt. Hl'droxl'm\lthylanthf<lquinone~. ~mm. tlllll1io. '1IUllminoids, 

about 60% sUGilt'S. :!.lED CSE: Has "«m uSed as la,,!u.ivc. 

Cashmm. ChelUlut. Leav~s o{ Castanea d"nllltll. (Manl!.) 

tlorkh., Fagm:eac. collceted in Sept~mbcr and October. 

}JubU. Southern Europe. TlleTc <'1rc Jwrdly' any chc5Inm 

tre.:s left in the U.S. Consrit. Tnnnin, gum, ~Ibumin. rcsin. MED USE: Formerly in p'-"t'b,,',.';i~. 

Ot~1c1:\mllrin. C.HuO~; mnl \,·t n020. C 63,51%, 

H 8.29%, 0 28.2Q%, Front Ciwd« "recta Turp.· (c. nicbo/$oui Ho<:>k.), Stltlaroubllce{lc. lsoln .and Slruenlre 

work: Dosnlan, J. Cllen!. Snr.. 121, 969 on:!.}. t2:!, 2{1i 

0923}. Par':lT1.i.lp~ t:t aT., C.A. 39, 2~EB (194S); Miki, i/Jid. 

41.2715 09:53). Geissman, ChafldokuT, J. Or/{. Chenl, 26, 

1217 (l96I), 

Bittt:r nl-cdlcs. mp 267-269°, Soluble in alcohol, hoc water. ~tf.n t:sr.: H"l been med a& ~m>!bicic>!. 

Castle's Jntdn~ic Fnctor. rntrinsic f:lClor. Mol ..... t ~bollt 

1500. OOCUlS in normal !l:u~tric juice, but is deficient ill Imricnt~ wjtll ]'kfniciou.~ afl<!rnia. Contain~ 9.2% N, 11.1% 

ho;:xo$;lmiuc, 3.4% methylp¢nto~e a.q fucoJ:e, 15.4% r~ducinJ: 

C'iugar (l~ "Iuco~c. 1.4% tr),ptop!l:\n. Consjdet~u as a muco- r.rotein. rn clillic.1l tests a diminish>!..! eKcretion of vitamin 

D •• iu tl'e fl"<;c5 is takcn (lsevidcncc of i:"llri:nief:l.:tor :I..-tivit>·; 

Ina) be pfepd from hng nllll:OSi\; C.utlc, Alii, J. M~d. Sri, 

178,748 (1929); C.1Sth.·, Towmcnd. ibid. 7M; Cu~tlc, Tuwn;;-

,!nd, Heath, ibid. 180. )OS (1930)~ Latu~r. Uuyky, CnK. 

McEvlI}·-Flowc,. R..~iIlC, Brit. ,\f,'d. J, 1953. 1, 467: LM:.:r, M"E~uy-Do\\!e, Riochem. J. 55, XXiI[ (t;;53); 01"ss. Boyd. 

Rubinste:n, Svia:ab, Scir.n~e 115, 101 (I%2j: Hcinl.; Welch. 

S.:I1:1rl', Meachrun, P:usuff, Tnllf~. AS$nt', Am, PIIYs. 65', 2{4 (1;;:5~); C~l1elldl!.r, Turnhull, Wilkisaka, Hrir • • ikd. J. 19S4, 

i, 10; L:lllteT, :\ferJ'ills, Raine. UlU~a 266, 1.491 (1954); 

Daum, FC(lCf!1Ulll. U.S. pat. 2.912,]VO (1959 10 Eli Li!ly); 

Alfllo,ur &. Co .• Brit. V:lt. 791,186 (1958). Puri!ic..1noll: 

Rob-buls, U.S. paL 3,008,817 {1961 to Armour &: Co.}, 

Polemic ngainsl existencc (If int:-itlsic f~;;:tor by r. G. H"\!atncote imd r. S. Mooney: Drug Tmrir. News (Jtme 2, 1958), 

P 42. 1'roce~ for pr~pt!rinG au.cmcnUlIivc intrinYoic {actor 

conCCJllmtc: bllenbogen, Hawkins, U.S. ;t:l.L 3,020,204 (1962 

to Am. Cyan:lmid}. 1soln of mucoiu~ willI hi/:h i:mhlsicf:leto! .:lctivity (rom the p,asnic mucosa of II1.'UI n:lU pip.: 

Fait1Drd, Pribill:!, Po~th,.it, physil,l. Clm~. 3:'.1, tOO {tS'''Z}, 

COJIIJllcrdal prcpn~ rm: '_''>IL'tlly nlMkcl,'d in c()mbinati():1 

wim vit.1nlin B,~, <".ft .. G'rsrrhlma. 

MED U!m: Vi~nJill Bu witit Iml'imic Fnctol' Coucentr~tc, 

Sce Vitamin BH • 

C.;{stor OJ!, Ricinu;;..,il ;nil of Pnlmn Cllri~lj; t(l:1!;;~ntun!;an 

oil. Fixcd oil obtaillc.d by cold·pres!lin~ Ih~ ~~cJs or Riciulrl' 

comnwnls L., Euphorbiareeac. Tri;:1:r'c¢ridc of fatl)' ncid~. 

p,,1tY ncirl eotllpositi':l11 i.~ apprm: ricinnici= &7%, <:!Icic 1%, lin,,!~i~ 3%. Plltntitic 2<';;'. stellC'ic 1%. am; dill"uroxystearie 

trace amuunL,,: nindtr jlt al., I. Am. oil (''/rCIIl, Soc. 39, 

5013 (1962). Review und hlbJfoHrap.b)': Alldcr:.Qn. J, Pllilip· 

pin" 1'lIlIrm, .-1nllC. 42, 5_1(; (19551; Dom'nglJl:r. ~I aT 

J. ChNI/. edit ... 29, 446 (1952). 

Pale )'cl1ow, \i5COllii .:lil. Slit,:ht, ;w:n~whal dHlraderi~lic 

ouor. The crude oil t:lSleS sli),lilily .:lui'" willI n d~cidecll)' 

aaus~ating ;Irler·tastc. Has excdlent keepi:lg qualities. dO~5 

aot tum ram:i'] unless 5tlb-jccted t<:> ex..-egive he<'1L Dextro· 

nll!\lory (undilin sodium light). dg:~ 11.%1-0.963. Wcight 

oftecludcll.! grillle~: 8.1 ro8.9 j.'toundsper g:ll1oll. lit" IA73-

t.477. '1? 1.466-1.473. Soliuifi"~llt -IO'IU -!S". Viseo~it}' 

at 25' = (i-a poises, al30 ~P:1.'~s~J tiS U:±- t (GardnerHoldt Seal,,), FIllSh pi o';4!5°F (230"C): ifmit,ion tentp ~4l)'1-' 

(449'e). SurfaCe ten"il>n al :;!Q< = 39.0 ~.yn~s.l"m, ,,1 80~ = 3:5,2 dynes/em. Acid. vaiu~ <4. S"p"!1.ificaliQ!1 vahle 

116 187. Iodine value (Wi~') S 1-91. R~k:'~rl-Meissi vah)~ 

<:0.5. Polcmke <luluc <O,~. Acetyl \'~Iuc 11l4-t50. Hy_ 

droxyl v:ltuc Hil-t61}. M'$dl.1" wilh absnlJltc ~lh';'\HOI. 

mClhanol, cthcr, chlQfofollrl, glacial JCCli: lIcid. Dinoh'cs 

iu it~ Ulvn vo! of pctr ellier Of 95% (,leD]:O!. Does not 

'Ilisso!"'¢ to alW ~XI~t'Il in num~r,~t 0';, \ll1tc;-<; mixed wit~ 210
218 

'IImlh~r v<!gellllll", oil, \"'-hell h~:tl~d 10 300' fur ~n'cral 

h(lur~ it polym~rizcs anu Ixcumcs misdblc wilh min"ral 0.:1. 

us,,: Slarting r;!W material fur many ba,i~ illduslnal 

cllcmicals; chid rLlW material for the procuction or ~(1)aci;; 

;lcid which h;'\ basic in~rcdicnl in the pruduc(iDlt of Sl'lllilclk 

rc!tins alld fibers; as lubric<1111 in mcUI dl"ac\'ing, nl~cllillc 

Illbricntion <tno 2-cydc engine fuds, in ilydranl'c I1llid~, 

lubb<:r preservatives and nlold lollric:lIlts; constiUlcnl nC 

cmb;!imlng fillid~: iTl !l(Hlp mnDuf; 10 illlp~n cmolliclU ,mc lubri;::anl propc'rlics to cosmetic prepns; ;,s Tlllkc~'-rcd oil 

(sulfated castor oil) for dyeing anI! finishi!!.\:. le):liics; "$ 

dehydratelt caSlor oil in alky~5, reSIIIOU, copolymers, I'afnisllcs, oil·ba~~d paint~, ~namcl~, calk~ al,d pUII!':s; :IS 

blo\\'lt oil (oxidized oil) for plll-\Iicir.ill£ oildolh, :'rt"id~1 

lc:ltitcr, "oulcd f:;thrics, :;tnd l:!cqucr5, la pkislicil.c ro,in in 

tllc rn:lnuf of $tick~' n}'-p:l~r, fo. l!itrocdllllo~;e amI .(imilar 

';O;jting sysll.'lTIs, hot mells. dUllliC.lling 1"ld ~'Icn,::il i'lks. ;:1I111e~iu~s :lnd I,nn;'::!'ll!:; in pr~pll n!' U.Tdh<1:1c ;lOlym~~s, 

N(D I:~F; lnlern. :I~ ciltll~r(lc: mp,e;IIly ,"s "molllenL 

{)().Ie: Or<11 15-60 ml: topically 5--10',:- uinlment. vrr tI~E: Mild pllrJptic'c for most <Jnin' .. ,"" hut tI"r"'i~bk 

in .. dult hor~e~, Diln\l~l in yonnS( ;lI<im;"lI,;, '~I'lll'kIllCaled 

I;'illl ,,"' .. rm cncma..,; dIe.;ti"e in '1r<;<1lnl~1l1 "I' intntlfl!ll 

obsln,ctiun cau~cd hy rctention of Ihe ,n~COl1iUnl ill I"nll\ 

amI "alvc,.;. Soolliin/l: .. pplicatiolt whcn o.!roppcd i'1\o Iho 

eye :I\"t"r rcmol'<11 offor"ign ballic." Dos,,: roal5 ~IIlJ c~"",,.t: 

60-90 rol; cattlc: 500-1000 ml: shccp :md s\dne: 60-120 m!; dog~: 4-60 ml. 

Castor Oil, Bydror.cDlllt'(l. Optll,c',lx; Ca~lon~"x. "lnl 

wt aboot 932. A hard, Whil\' "':1).(, ,np 8ri,"",~8<. Iudinc 

number (Wii"') <5,0, E):In:mdy ins,,1 ill w«(cr '''1<1 in lile morc C(HllnlQll urG~nic solc·--:nt~. 

lI~fc: III wa(er-rcpcllcnt eo:,lings, ..:nlldIC5, ,llocpoli,I:. 

c-:'rc<lI1 paper, oilltnlcnLI and cosmdics; for imprC!,lnali"l: 

p"per, wllod. cinlh; for d~clric~l clllld<'llS~r ,mpr"gn,lli0l!; ,'.< !'oli~ itl\1ric<1",(; "'; ;I pr('.~'lllrc IlhJI,~ rd~a,e azo:nt i" Il,'~ 

I11;II1llf 01' fHfl1l..:d pla5tics and rlli>!Jer !,:(HI(h. 

C(ll(ll:t~". C:1ptrasc (Iron, hodn,- li"c'); Opti<l;o,ce. 

f.1l7yrn,'s ""'Ilidl rramok rcactions i:l"ol,,' 'I' IIlc f.kCO'l~;"1 

nl" Il~'(!,o1'e" p~rn.~idc to 11·;tlc,· allli o-xyt:c. r\IIIl(IUllh wid"l" 

,!i5tdbutcd :lIun,lg anilllal,. pb'I!';, I\~\'i,:ri~ ;111.1 f'lngi. 

catala5,-;: in m"lllmali:II1 !JC\'r ;lIld 1,10011 .,~.; heclt 1110·,t 

intcnsi,'dy,tudiccl. All c~LII.1se" sn fM bll"\cil ""lll~1!: fOlll' 

hematin WO\lp;; 0'1 I. prot"in clilit all <1pproxim:\I~ nl'll "I 

of 240,000, Redell': P. Nicholls, G, Ie SdlO'lh~"ll" 

"Clt;\I:.SC.c" in P. D, Boy"r, H. L<1rdy, K / ... Iyrb;iek. The 

F.n:.l'u,rs ~ol. S (Acad<!lnie I'r~s", Ncvr Ynrl:, 19(3), pp 141-

225. 130"inc h .. palocaru(a:t!, a Icrnl for clwl"s,~ vhl~'Il~,j 

from ""0. W[I.', rcpnrred III lower ~crum clllllc~tcrol; Iho: 

;lCI"'C fnrnl W~~ fonn,\ 10 <".ml~hl (I ci1ulytic i1lllOllIlt of 

:LInc (O.32<;~,); A7.arnolT. Curran, J, Lah. & CHn. N,·d. 60, 

856 (1962). cf, LJllorte cr .. I., 11irn'hwl. Plr"t'fu,lcOl. 11, 6,0 

(1962). l~ltln; fmlll tn:lmll1alian k.J1' .. hog!, $hecp. c-illll~) 

li~',-,r, :IIld kidlleys, Lnlli, CW<111aURIl, U.S. ~'''1. 2.1((3,179 

(1955 to Armour &. Co.); from calf or bed livcr, l,;,pnr(( 

d al.. lar. cil., Sehro~d~r er al., Diod,,'fII, lJiopl'1'5, A<'Ia 58, 

bl I (196'2); from b~d lic'cr, Dan, U.S. (':n. 2,992,1('7 \i961 

10 Clu. Han~Il'~ ).<lb. JIlC.); fWD! A,pcrglllus rlig('f, F~m;nl 

er al .• U.S- pal. 3.102,081 (1963 III l\'lil".~ L:,b,. IllC.), 

Sirncillral :Imjy of bo~illc-I"'er ,::at:tIJ.W: Sdlrocdcr i"I 01., 

luc. cit. 

l)SF; In "olll\lillat:on wilh glu:05e nxidasc, for tre:1l,u':nl 

of fOlld \l'r<tppc!'$ 10 prevcnt oxidative detcriDr~tioll nf fo"d: 

Sal'Ctl, Scutt, U.S. PilI. 2,165,233 (\956 to Be'l L Silr~lt}. 

C:I Inl i n, I -1lJ'Jm),y-.5-o.-w-5fl-p)"fida[J ,2 -u) phcm)):a~ "l(' )-ca,ho;rylic QciJ," 1-lIy<.lmx}'-1-carbol\,u·5H-pyriJo[\2·aJphc'nQl\illin-5 -ow:; I-IIYlI!(l.~~'- SU- Ilyrklo[3. :!.-.. JI 1\1 C:1 OXaf ill5-IIn",)-c<1rbosyli:; <ldJ. C,~ll~N~Os; mol Wt 30~.~·1. 

C 62.34'.:<'. n 2,(,2';',., N 9.090;;;, 0 2S.<J5',:;,. \'r'P'~: I-J;ii. 

Jal'. ~",\. 1782t'(1) (10 Chi<:u Urtl); M"'lId~,,·lttr"l!: en ,I. e.A, 5:5, !14')4c (1961). 

J)a,k Ilr;n,gc' puwd~r, >Je~ ~47 243'. ~Itn l)S~: Shm,', th(rJp',:ulie ~'-li"ily ill ,;,,\;,r,,~\~. 

CrYS!.11< :-rOr;l lllctl,anol --';. clhyl ~c~I;""'~"b";::~';~';~;;';';; ["Jfj-~ - 184' (,; ~ OKI ill fllclll.~noIJ. ! 

cI!nnol: 2(,{1 nt" (lilt, 4.27); in sndinrll hydrnxide: 

(In? ,4.35). Soluhk ir. 'C"~\"r, "knlllll; slighl!y sol ;,~,W. dllorofilrnl, ..-111,-,., 

Hc'X~<l"CI.11", C'4Iil,O'I, ~ryda\$ !'rom elhanol, 141.~O, ["J;;" ~ IO{o" t~ 0.75 in ~hl,\roforlll/. 

Mel",'1 ~I!,,~r, C:;.II 2I Ou , ~'>s:ll~ I"rlll1l ?\,~ lilt 

0(; 

, 

/0.'. /011 

, r 

,il-Fc'nn, ,w~,li~c i'nJnl "',~I<Ol' -T ac~li~ ~cil~. mp 

Slit:ln\r Sill ill ,',01" w;'I~r, ether, h'l i:1 hOI l~llICr, 

,:bcial JC~jic a~id, ;'c'Cto"~; p"Jc(l.;:~II~' inSlJ1 in 

chlnrofor,,\, ",O:lr ';Ihcr. 

d·Fllrr:I, Ilc ..... iln "on) ""IICI' .,- "~dk ;,cioJ, 1)'\1' 

1,5-177' ,,'J-,'~n .IHhyer. (':YIn +-I(,'to +1::>.4" (ill 

I-f'orm, nc~d\"s ffllm W<l(,;' -'c. ;,-::,'Iic ~'c·id. mp 

175 177-' ,l'h,-" 'HlhYllr. raln ~ I ~)l" (in wal"r). 

':~I': I" dyeing ;IIllllannl:lg, ~!tl' \,n: ASI,i".\"1I1 "lr',CI in Ilj'''I'I1o.':I. 

Nccdl~ 

Ab~orpli, 

C:Hiterllnirr::11 It, 

of <1lliw," 

lillns cll: 

P. D. BI 

(AC,ujc'll 

.:A'; 

~19~ HyJroly; 

aili:lcmt 

Bi;;p},)',<. 

19 (I ~ 1(,: 

Iltroml-i, 

pur,·cil. 

211
920 Ribosome 

lto!atcd !I.$ ll;\ $111[, ll;lcfU~O.j>.HlhO. l!cx~$"n"l 

fl1ate:o fmtn water. Spil.r'IIWY $01 in cold watcr. Red~c~~ 

F~hling's soln. 

Diffc:""'tiation b~tw<!en rilw~c_5-phIlJphate and rioo.~·3· phMphate by mcam of the orc,nol-pento!c reaclioll: At. 

(m.um, Umbrdt, J. Blol. Oem. 167, 36!) (1941). 

Ribosome. The activc unit ill fI'lllfl'lm;1llall pnllcu' ~rnth'" 

tI$. Rlbowmes arc small ~pl!Crical particles. nboul 250 A in 

diltmetcr. which are made up of RNA and protein mo!ec~t($. 

Alwn.H prcllCnt in chUiten. TIle clu;ter, tcrmo;d 11 ''pDf) ... 

SCfflC," u~ulI!ly contlliru Ii,,¢ rii}o9(lmct, but tom~timt~ four or $.:. Thc pol,YUIn\'C i~ hcld toWtlho;r by one Ol' mW'c RSA 

molecules. nleTe il; evidellce that this RNA '5 nres1Xn/:er 

RNA. Tbe prob~bility c;.;;nz tlull. ribOllomn move along lh" 

meumger RNA chain while CIISlIlICd in thc prOCCM of Ulfg pt'oteiru. aCC(lrding to in~tr~ctiolU of the mcU<mger RNA. 

Rrf: J. Watl.Cf, A. Rich, ell"",. & Eng. N€ws41, no.ll, I' 41 

[Fcb. 25. 19(3). 

o·Rlbulow. ~t")'rhro-rf!"tt.do#; 1r1lIloUOJc; 0,c'7t"ro.2· 

ketopcntose. Csll .~O:; mot wt 150.13. C «ttlO7~, H 6.71%, 

0.53.299,;. FOrollllion by d~<)mpn of 2-!;:elo-D·gl\tc\lUlC ac.d: Hal! rr al., lJim:hcm. J. 60, 271 (1955); plCl'n from 

D.Arabillose: GI'l.IlI .. ~~r, Rcieh,tdll, ffcw. Chi,,~ ACfd HI, Ml) 

(1915). 

H!una" Tv:ricfJy; Inw,:stion may e;l.~~e 't2~Jieij, vomiting bemonl.'",ic ltu\!Ocmerilis. !t<:Jl"tic lind rcmll dama!:'c: 

c<>::\'u/J;lon$, eonm. hypot~maon, rC$pirMofY ll~pr<;l>Slon, 

death. ~ 

Ricinotcic Add. d·12·Hydroxy.ds·9·octad«:cnoic acid· 

<i'·12_hydro)(),0Ieic acid. CuHuOs; 111111 wt 2')8".45. CHI: 

tcHI),CH(OH)CH.ClJ.=CH(CHs)7COOH: C 72.43%. 

II 11,48%, ° 16.08%. Neutralization ~al~e t81.9S; iodinc ,·al~c 8~.05. Founll primM;ly in oit. from the seed:; of 

Rkfnus 5PP, EupOOrbla.;-(at. Castor oil contains. 80-85% ~icinclcic adll,VlYScIILll$ Ilf':JlTy~~l\ln rmhr;-1t:1mon, Fotty Adds (New York, 1948. l' !S9). 

SttuctUn!: Goldooool, lJcr. 27, 3121 (1&94). 

Liquid. d~r .• 0.940; mp +5.5'; bpu 145'. [al~~ +6.67'; 

!"')t; +7.15 (c ,.. ~ ;n acc(ouc). nB 1.4716. Sol~ble in 

akobol, ~cetnne. ctlU!l', chloroform (r/. the rolubi!!ties of castor cit). 

Acid $ulnltc; rlchwlslll/lnk (1<:11/, Cl.» .. O.S, ohtained b~ thc 'l.ction of chl"rO$~lfo"ic add. Vi~coU!l brOWII liq w.th weak hl~e {\on,.ccllcc. Soluble 111 wa.a (about 10%) Sol~h!C ill alcohot, .;-ther. chloroform. . lIH.: II' t,,;(tito;' fln;shi~g; MO!ctimc~ a:!de-d to Turkcy red 

(1;1, dry·cluuill& soaN. MW l'~E: Ha~ been uud in cOUlr~ccptivejd.lim. 

?,lCl! 

00 

I ,= 

I ,~ 

Rifllmide. N,N-Din/o>'1rijomycin B "midr; rlf.;uuydro D 

,j,cthyb,u.illc; rifon.vcin fI N,N.dtcth/llUlide. CuH ... I N:O .. : mol wt 810:95. C 63.69%, 1 7.21%. N 3.46%, . ° 1~.657p. Prcpn: Beh:. pat. 632,770 1!%) to Lep<=ut I S.p,A.), CA. 61. 4161ib (1964); Seminal., J. Md. eke",. 7, I 5% 119(4). '.,!. I 

~,oo t I'~ C'l~ 

.I

! 'W~ '<.,,~~''''' Sw«t syrup. r"'I}: +16· (water). 

o-~itrophen}"lby<.lmlone. C.,H •• NsOc, flat ydlow I1cedl.1 

from abs alcohol, mp 16S-169S. {",m -40' (~ = 0.32 ;,: 

mcthanol). 

Diphosphate, C~H .. OuPz. I'rcpll from D·ribt>~,,·5-

phor;plmte; Horccker rt al., B/IXhem. l'upllroriol!$ 6, llJ 

I}",I J,r I ~'I;";:(){)yV on u(l Y 'CHl 

n::lf) 'iJC .'. ...... r~" f ,~ '" (~Jf 

(195&). . 

Ricin. A t(l~C pcotcin bol~tc<i from C1!.:l\or !Jell:' (Rid",,. S<1~gllfn~lIs L.. Enpftwbwce/1l'): Sti!1mnrk, Arb. Plwrmak.)"",r. 

DnrpM 18S9, 59; O~borne it 01" Am. J, Physio). 14,259 

O905j1; Cr:!i8 fl.ol .. US. p1lL 3,060,16~ ,<1962 HJ .U,S. Dept. Army. Scpllrllllcn and p:optrhet of H';-lIf 0: hlugUlo rr ~I., 

J. BilXh~m. (Tokyo) 55, 58111964), 56, 31S (1964). Pll7tia!!y purilkd (cry~(}ricin hM high hemliggiLuiuatiag or pr(l{wfytic 'l(;tivity llt acfdition '0 tll~kin·. PurifIClltion of 

ricin by chrom~togt"phy and SUMq\lftll crystn (10m cold 

O.OO5M rho$ph1lte butfer, pH 6.5, IP'<et cryst rlc;1I D shOWn to Ix! 11 bomogrno\l$ ~ub5ta.rn;¢. -Ricin D (mol wt about 6.00 

X 10·) Ius no hcn~WUtinlltiUg. protcolftie. 01 nOli· ~p\!¢Hk llrotciu coagulating activilY. MLD l.p. in micc lit 

4.8 .hrs •. o.oot '" of ricin D nilrog:<:n and 0.r12.8 ,," of Cl ~de 

ncm rutrogM. per &ram body Wt. .v~[:. As ehernical v.;arfar.c ar-lll, Cmi, ~. al .• loc. cit. 

R,,:m .§ a protophu.ttuc pOlS(>II. mo~t c-/Tocu"c whcn givcn is. or inhaled as /inc pllrtielcs. 

RIcinine. J ,2.nllmiro--I-rNtho:o'.I-methyl-2-ox<)";C<)li"". . nifrifc; ricidinc. c.fhN.O%; lllol w' 164.16. C 53.53%, ·1 

H 4.91,%, N 17.0;%l.0 19.4'1%. From ~s ~nd leavc~ or. llle eastor pLmt. I<lcinm CCffl1l1Ih1f!: L. !:;uplwrbliucac. I 

Extrac,""on prcptdUfc-.: SoUch"", firr:.. 51. 673 1191S}. S"nth<!~ll\ ~t:lrung w.th poly=izlIhon of cyanuacc:yl I 

chlQridc: $<;:hro<>ter ~r ",t.lkr. 65", 432 11932). Biosynth~l~: 

Waner. Henderson, J. Biol. Chfm. 236, 1186 (1961); E,,=y I 

Prinms. needltJ; from ate, mp 201':;~. SublimC$ lit 170-130" 

under 20 mm Ilrd'~ Sparingly:wl io w.;tler, 1I1cobol, 

chloroform, cther. Nctltra!.o litmw. D(}<:$ not form salts 

with acids. 

I I !. ' 

,.,.: "~y~ o_+,._J., iK'1zf{'Hc~lt~)~ 

, " 

Yellow·orangc pp: . .::rv$till(iuxl from bclllene + h""mTIc. 

No ddinitc mp, bet;,,,; to zoflen at 140", nlcit5 comp!ctdy 

lit 170' (eec). [aiH -41L7" (c '" 0.4 in methauol), U1u-a· 

viole: ~p<ClrUJ11 in phowhntc buffer (pH 7.:;8): 222. 302, 

and 421 to!' (. 4;!.!PO. 2.0,770, lind 16,200). UtD USl';: AntumefllblllL 

Rifamydn. Rifumydu. Antibiotic aolllt«! from tlic 

fennentation broth$ of Str£l'tDm~a mtdituMIIKi: S('nti ~t 1>1 .. Allil'bioticr A,,""a! 1959-1960, p 262. Among rifMllY' 

cln,., rifamycin 11, O. S.;)nd SV tire tl!emot<!studied rMmNn 

CiJrOnt210gTilphic ~llldi¢S 011 t~lUItforTIUlti411 p<"oduc\$ of 

rifa,nydu 8: Sen~i ('t 01 .. J. e;"'NI'I<1W,. S. 51? 09(0) 

Prtpn of rifamycin B Ilcri~s: Se..,ti '" al .. U.S, fmC 3,313,804 

(1961 to Lcpetit). Ampd'onl<:lrie titration or rifam'lCin B. 

O. S aod SV: GaUo er 01 .• PdrmtJCo (Pookt), Ed. Sel. 17. 

66$ {1962). Strt)f!IW"C: Prc1og, PUTC Appl. Chelf!. 7, 551 

0%3).; Chf,w:>thuapb: 7. 133 (1%:;): Oppohct €l 01., £~pmc/1l1a 20~ 336 (1964)., Review, i>:cl~dil1$ Ri.famycin B, 

C, P, E, 0, S, SV. lIlId X: P. 5<1fl5l, A Fan'..,lv Of New 

ArH\cjolicS, Tbe Rifamye;ns" in ll. GaUo lInll L Sanl!!- nmn~ • Ra"",.;-h Pro£uss it, Orgtmlc-BlDloglro( do U .. di("/mll Ch~mlsrry wI. 1 (Soc ida Edit()rilll~ f'atmllu\ltica Mibno 

Jtaly, 19M). 1'1' 337··'Ul. ., 

tr~n>r~nal'''~ 

in M). ,~'dj~ .olt!. 

COMul1 rhe cross irulcx luforc using tlUs !itcrion 

RiJlil.m. 

NOu; I 

o ZIU;4 

Id"C l6!: 

tion mn. 

m!' {E~; 

Sol\lmJit 

(J.44""1" 

cthy al 0.OO5~{. 

mg/ks: 

Ri,flln 

NOu; 

o 29.i: 

IS, n8 

(d« 16 

mM<ul 

273,3' 

inwl i' 

with r, 

!light!l 

iro~cl " 

Ri.{il 

695.78 

liou po S~n$J. 

cry,m 

;n mc 

pH. 

Inrr 

"J,~ NH 

412 (1 

OTUHf 

mcth. 

7.3; : 

Sligh 

~oln; 

LO., 

m~~ 

",0 

o :!r 

U",· 

Pmc 

acct. 

2Ui. 

S 

C;II I 

Our 

" 

212
r------------------~~~--~ 

• 

• 

U.S. ENVIRONMENTAL PROTECTION AGENCY 

Office of Pesticide Programs 

CLEANING SOLUTIONS, INC. 

1250 RAMONS ST., S.E. 

GRAND RAPIDS, MI 49507 

Report of Analysis for Compliance with PR Notice 86-5 

Thank you for your transmittal of 09/12/94. Our 

has completed a preliminary analysis of the material. 

provided as follows: 

staff 

The results 

We are unable to process your submittal because it does 

not meet minimum standards of acceptability. 

Your data must be submitted in accordance with the 

format requirements of PR Notice 86-5. If you need a 

copy of this notice, please call (703)305-5361 or 

(703)305-5363 • 

are 

213
• 

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i 

TR4.NS]'vHTTAL COVER FOR 

"REGISTR4.TION APPLICATION" 

CLEA.,,\ING SOLUTiONS, INC. 

DBA PEST SOLUTIONS, INC. 

1250 RAMONA ST., S.E., GRA .. l'ID RAPIDS, MI 49507 

EPA EST 65615 

EPA REDUCED RISK INITIATIVE 

PR NOTICE 93-9 DATED 7-21-93 

TRAl\lSMITT AL DATE 9-8-94 

APPLICATiON FOR REGISTRATiON OF 

SCOOT MOLE EVACUATOR 

EFFICACY STUDY FOR SCOOT MOLE EVACUATOR 

Participant No.1 

John Little 

5941 144th st. 

Holland, MI 49424 

~icipant No.4 

Ronald 1. Balk 

Participant No.2 

DanR Lee 

7010 Silver Lake 

Rockford. ]\'[[ 49341 

Participant No.3 

Phil Walcott 

2455 Lemplighter 

Jenison. MI 49428 

Participant No.6 

Robert Holineyer 

3440 Eastern Ave. N.E. 

Grand Rapids. MI 49505 

Participant No.5 

Harry Moore 

3875 - 4 Mile M 

Grand Rapids, MI 49504 

6965 Cimarron Dr., SE 

Grand Rapids, MI 49548 

Ronald 1. Balk. President 

Participant No, 7 

Jeff Middleton 

5634 Pear Ave .. 

Croton, MI 49349 

~~-;:V~//~' /0P' ~.~",t-/£:!:%'- ___ 4:~>;:;:;' . l ~ "'~, __ 

('1"''''';0-

-'>'~<ll"~' Solut,'oo' 'DB" D,,~· So'u';o','" ,t,.. ~- :-\,.,!>, 1.! .>.1 

CompaQ\' Comact: Ronald L Balk 616,2,,3-0;,,· 

:'c, ..... _. : "~' , 

214
Section 1 Transmittal Document" """",,,,,,,, ",,,,,,,,,,,,, """""", "" .. """",,,,,,,,,,,,,,, "'"'''''''' 1-10 

Transmittal Cover .......... " ............. " .......... "............................................................................ 1 

lndex"""""."""""".""""""."."""."."""."."""", .. """."""".""'''''''''''''''''''''''''''''''''''''''''''' 2 

EPA Form 8570-1 ", "".,,,,,,,,,.,,., """"."""""., ".", "." """ """,,,.,,,,, """" """".,,,,,,,, """" """ 3-4 

EPA Fonn 8570-27 ."", "". """" """""""""'''''''' """.".""""". """".".""""." ."".""""""".,, 5-6 

EPA Form 8570-4 ".""", """'" """"""""". """"""""""." """"""""", """""""" """". """". 7 -8 

EPA Fonn 3540-8 ,,,,,,,,,,,,,,,,, """"",,""'" ."." """"."""""""""".""""""". ",,,,, """" """""" 9 -1 0 

Section 2 Scoot Mole Efficacy Stodies 

Scoot Mole Efficacy Studies""""""""".""""""".""""""."""".""." """ "". , ", ". """""""" .1-25 

jFion 3 Product Chemistrv """""""""""""" "". "". """ ,,,,, """". """", """""."" """""" 11-42 

'If'!l' CFR 158,155 Product Composition"""""""".""""""." ,,,, """""""". """""",." ."""" ."" 11-12 

40 CFR 158.160 Description of Materials Used to Produce ProducL""""""""""""""" ... .13-14 

40 CFR 158.162 Description of Production Process"" """""""""""" """". """""""" """., .15-18 

40 CFR 158.165 Description of Formulation Process"""""."" """""""". """""" .. """""" . .19-21 

40 CFR 158.167 Discussion ofFonnation oflmpurities ".""" .. """.""""."""""".""""""",,22-23 

40 CFR 158.170 Preliminary Analysis""" .. ". """.""".""""""""""""""""""".""""""""".24-25 

40 CFR 158.175 Certified Limits "."". """""""."."""""""""""""""" .. """" """""""'"'' ",,26-27 

40 CFR 158.180 Enforcement Analytical Method"""""""""""""""" """"""""".""""."",,28-29 

... 40 CFR 158.190 Phvsical and Chemical Characteristics """".""""""""""""."""""" .. """.30-31 ' . , 

~DS Sheets""""""""""""""""""""""""""""" "" .. " .. """""""" """""""""""""""""" . .3 2-42 

Section 4 Confidentiality Claim.""""""""""""."""""""",,,,,,,,,,,,,,,,,,,,,,,,,,,.,,,,,,.,,,,,,,,,,,,.4 3-44 

Statement of No Data Confidentiality Claim"". "" .. """"., """"""""". """"""." """""""""" 44 

Section 5 Miscellaneous". , """""""". "" , "". """ , """" """"""". """'''''''''" "" "". , """, """.4 5 -4 7 

Name Change Letter of b;p lanatiOiL.."" """"".""""" """,,,,,,, """"". "". "".",,,,, """",,,,,,,,,.46 

40 CFR 158.45 Request for Waiv,r ofT oxicoicg\, ".""""""" """"".""" """" """"". "." "". 47 

215
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• 

216
• 

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• 

._ .... _ .. _-

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

October 17, 1994 

OF;=/CEOF 

"flnr;lHiOK PES11C0ES 

MW ~OXK::: suaST;\hCES 

MEMORANDUM 

Su""BJECT: Scoot Mole Evacuator 

EPA File Symbol 656l5-R 

FROM: 

Screening of New Chemical (Ethoxylated Castor Oil) 

Request for Additional Information from Registr&nt 

Dan pear1{]!~Ologist PM Team ~ !} / rr Insect~ ide-Rodenticide Branch (H-750SC) 

TO: Rot: Balk, registrant '.<..Y'>(.J 

Consultant to Registrant 

I requested that the registrant submit the following so that 

we could determine if the data waivers for Castor Oil would also 

apply to Ethoxylated Castor Oil, the active in Scoot Mole. 

1. Additional information about ~he usP Monog~aph that would 

explain the purpose of the listing of an active ingredient 

as a asp flJonograph. 

2. Listings for Ethoxyla~ed Castor Oil in FDA Regulations, such 

GRAS listing and sections allowing the active in food, feed, 

or medicines . 

3. A comparison of the chemistry and manufacturing process for 

Castor Oil and Ethoxylated Custor Oil 

Peacock WF#5:A:65G15A.R:305-5407,-6600:10/17/94 

217
• 

• 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

October 17, 1994 

OFFIC<:OfPlllVLNnON. PFSTICOi?S 

A ';0 TOXIC !i:-'gS: ... .;;C;:~ 

l<1jEMQRANTIUM 

SUBJECT: 

PRoto! : 

Scoot I<ljole Evacuator 

EPA File Symbol 65615-R 

Screening of New Chemical {Etnoxylated Castor 

and ReqtlCsL for New Active Ingredient Code 

Dan peacoH~ logist 

PM Team 1 

lnsectic'; e- denticide Branch (H-7505C) 

TO; Clare Grubbs, Head 

Document Management; Section 

Information Services Branch (R-7502C) 

Oil) 

Please screen this application as one containing the new 

active ingredient, Ethoxylated Castor Oil (CAS No. 61791-12-6) 

and provide me with a new active ingredient code. 

On August 22, 1994, the"Pront End Processing Staff (FEPS) 

1) sent the applicant a "RECEIPT OF APPLICATION FOR A NEW 

REGISTRATION!', acknowledging the new registration and the 

completeness of the administrative screen and 2) sent the product 

to PM 21, which is incorrectly listed in our computer records as 

the team handing Castor Oil (CAS No. 8001-79-4) . 

Because of the delay in processing this application for a 

new active, I am requesting that you expedite the rest of the 

administrative screening process for this product. 

On the next page, I have listed a number or reasons tolhy the 

Program did not recognize this application as containing a new 

active and have suggested actions that may help us to identify 

such new actives in the future. I have forwarded this memorandum 

and attachment to Ms. Rita Kumar, who will be working On the 

Quality Action Team (QAT) to revise the administrative screening 

process. 

Attachment 

cc,: Rita KUmar 

218
• 

• 

2 

Attachment 

SUBJECT: Scoot Mole Evacuator 

EPA File Symbol 65615-R 

Screening of New Chemical (Ethoxylated Castor Oil) 

and Request for New Active Ingredient Code 

FROM: Dan pe~ 

Reasons why the Program did not determine during the 

administrative screen that this application contained a new 

active 

1. On the application form, the registrant did not identify 

this application as containing a new active ingredient, only 

as one containing a new registration. 

2. The FERS did not recognize that, on the application, the 

registrant qualified the I'new registration rt as being 

eligible for PR Notice 93-9, Voluntary Reduced[-Risk) 

Pesticide Initiative, which currently only applies to new 

actives. 

3. The registrant did not follow PR Notice 86 -4 I which lists 

the need to submit certain things like a transmittal 

document, list of data requirements, and how they are being 

satisfied. 

4. 

5. 

The registrant listed the active both as Castor Oill an old 

active l and Ethoxylated Castor Oi1 1 a new active .. 

The FERS did not check the CAS number provided on the 

Confidential Statement of Formula (CSF) , which would in 

indicated that this active was new. 

6. The registrant did not specify that this application was a 

me-too and did not submit a data matrix. In addition, the 

registrant did not submit a Certification Statement. These 

two facts should have been grounds for failure of the 

screen. 

7. Efficacy data was submitted but was not screened. 

8. There is no screening form in the jacket although the 

outgoing letter said that one had been performed. 

9. The registrant did not specify the product manager 

219
3 

Suggestion for better identifying new actives during the 

administrative screening process 

1. When talking to potential registrants (especially 

inexperienced one), who may be submitting applications for 

new actives, emphasize the following: 

a. encourage the registrant to call before sending in the 

application so that the registrant is submitting the 

basic elements of a new chemical application 

b. tell registrant to follow PR Notice 86-4, including 

putting the words llNEW ACTIVE INGREDIENT" throughout the e 

package 

c. tell registrant to call in two weeks after submission to 

insure that we received the application 

d. tell registrant to put the correct PM on the application 

form 

2. The PEFS should look mere carefully at, consult with the PM 

team and REFS, and document with a screening form, when the 

following show up on an application: 

a. conflicting active ingredient names (REFS should be 

checked. ) 

b. non me-too's without data matrix, chemistry and acute 

toxicity data 

c. references to PR Notice 93-9 

d. application forms without product manager numbers or 

names 

e. no certification forms 

Peacock WP#5:A:6561S.R!305-5407,-6600:10/17/94 

• 

220
• 

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1, 

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221

*Inert ingredient information may be entitled to confidential treatment*
• 

• 

222
• 

• 

• 

SC001 

I M&LE 

EVACUATOR 

CONCENTRATE 

• 

Moles can dig uo 300 feet 

of earth in one night. 

Moles eat enough food to 

equal its weignt eacn cay. 

NON-TOXIC, 

BIODEGRADABLE 

MOLES CAN'T WAIT TO MOVE 

SIMPLE and SAFE 

SCOOT MOLE evacuator VlOItS oecause 

moles aislike the ooor and taSte oi the 

oroouct When they firs! smell SCOOT. 

:ney wlil oecome very active trying to get 

E.ASY 70 USE 60:1 

HCSE·~ND APoUCATOR 

away, When they realize that Its all arouna 50CC 

mem, they com's to the surtace ana lOOK 

tor a lawn tnat doesn't sm,llllke SCOOT. 

MOles usualiv leave trealBO area in i-2 

weeKs aner aOPliCatlOn. :ne ;;onveniem 

soray aoolicator allows tar easy, accnoml· 

cal. Wloe coverage or area to oe :mateo. 

DIRECTIONS: ShaKe well aaTOre uSing. $oray SCOOT MOLE 51 ;ale oi one auart 

per 5000 sa. i uSing large sweeOlng mo' 

tions. ror oest reSuits. aooly In early 

Sorine;, Mia-Summer and eany Fall. or iT 

moles migrate irom 'four neignoors yam 

aner they first use SCOOT. 

CAUTION: Keen Gut of reacn oi :::n[idrer.. 

:!JNTAINS: 2:.00% castor Oil US? 

79.00% ;ner. ingreaiems 

:?A oSL #00000 ,?A ~eg. #00000 

peST SOLUTIONS 

GRAND RAPIDS, Ml 49507 

6 

~----------------------------~ .. ...... 

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223
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~' M,\ C) f'J~ ;- r'lr', I\.." J.::.. _.' L. '.J ... ,,! 

b'::' 0:'.; 

• 

MOLES 

CAN'T WAlT 

TO MOVE 

~al:"ons 

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---------------------------------

225
~ .. ---~~~~~~~~~~~~~-

10/17/94 Reference Files System 

• 

• 

Chemistry Data Report 

Active Ingredient Code: 31604 

Full Chemical Name: 

Hydrogenated castor oil 

Reregistration Case No.: 4097 

Case Name: 

Vegetable and flower oils 

Toxicology Caswell Nr. : 

CAS Number: 

Product Manager: 

Review Manager: 

OeM Compliance Manager: 

Chemical Name Type: 

Type Synonymous Name 

486A 

8001-78-3 

14 Robert A. Forrest 

VIRGINIA DIETRICH 

Report Chemical Name 

R CAS Reg. No. 8001-78-3 

S Castor oil, hydrogenated 

Page: 1 

FIF~\ 88 List: D 

226
----------- - ---

10/17/94 Reference Files System 

• 

• 

Chemistry Data Report 

Active Ingredient Code: 31604 

Full Chemical Name: 

Hydrogenated castor oil 

Reregistration Case No.: 4097 

Case Name: 

Vegetable and flower oils 

Toxicology Caswell Nr. : 

CAS Number: 

Product Manager: 

Review Manager: 

OeM Compliance i"'lanager: 

Chemical Name Type: 

Type Synonymous Name 

486A 

8001-78-3 

14 Robert A. Forrest 

VIRGINIA DIETRICH 

Report Chemical Name 

R CAS Reg. No. 8001-78-3 

S Castor oil, hydrogenated 

Page: 1 

FIFRA 88 List: D 

227
10/l7/94 REFERENCE FILES SYSTEM PAGE 1 

NON-ACTIVE PRODUCTS CONTAINING THE ACTIVE INGREDIENT 031604 

PERCENT IDENT. NO. 

01. 0500 1621-12 

03.0000 5602-37 

• 

• 

Hydrogenated castor oil 

FORN 

STATUS CODE PRODUCT NAME 

c 19 

c 10 

TREE TANGLEFQOT PRESSURIZED FO~~ULA 

(NON-POISONOUS) 

HUB STATES BIRD REPELLENT 

228
10/17/94 Reference Files System 

• 

• 

Chemistry Data Report 

Active Ingredient Code: 31608 

Full Chemical Name: 

Castor oil 

Reregistration Case No. : 

Case Name: 

Toxicology Caswell Nr.: 

CAS Number: 

Product Manager: 

Review Manager: 

OeM Compliance Manager: 

Chemical Name Type: 

Type Synonymous Name 

165B 

8001-79-4 

2-1---steve---Robbins"'-- If;'-

Report Chemical Name 

R CAS Reg. No. 8001-79-4 

S oil of ~icinus 

s Ricinus oil 

Page: 1 

FIFRA 88 List: 

" f /'~-'L7 

, : ",." -:-, 

i, 

229
10/17/94 REFERENCE FILES SYSTEM PAGE 1 

: 

CHEMISTRY DATA BY NAME 

FOR STRING 'CASTOR OIL' 

PC CODE CHEMICAL N~~ 

-------~----------------------------------------------------------------------

31608 

32604 

79093 

• 

• 

Ca.stor oil 

Castor oil, hydrogenated 

Castor oil, sulfated, sodium salt 

230
." 

10/17/94 Chemical Comment PAGE 1 

:: 

• 

• 

User ID:: DPEACOCK 

pC Code: 31608 

Chemical Name: Castor 011 

Comment: 

Comment Date: 10/17/94 

Steve Robbins {PM 21} is listed as the Product Manager for Castor 

Oil. The correct Product Manager is Robert ~orrest, PM 14. 

Please change all of your records. 

Dan Peacock, 305-5407, reviewer for Castor OIl 

231
, . 

. 10/24/94 REFERENCE ~ILES _. SY STEM 

CHEMISTRY DATA BY NAME 

FOR STRING 'CASTOR' 

PAGE 1 

PC CODE CHEMICAL NAME 

- -- - -

31608 

220201 

31604 

79093 

• 

• 

Castor oil 

Castor oil 

Castor oil' 

Castor oil; 

~tdhOXYlated (~~ INDEX NAME) 

Y rogenated 

sulfated, sodium salt 

,Fa I C() 1>./ ~r ~ 

/) Ui> /o/:Le/9<f LiJ 1- h~ 

r;;. N?-N'/ C~_.~J 0-4j;::.( 0. r [I'rd 

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( 12 G 20 I ) 

8 + J" ~ 1''1 r J;i-j (yvb~ (tv'! 

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d~- +-v p-fY\).1 ! vv'lo 1 i£Jr. 

--------- 232
.. 

• 

• 

OCT-19-94 WE!) '119::5~ CLEANINGlSBLUTleNS1IHC. 6162431'$;27 

RonaidL B~k 

1250 Aamona 

Grand Raptds 

Mlehigan 

49507 

' .......... . 

7 

'?,OH'~~ !fA (?6lA ~ 

Rt,--",~",,"~~,--¢ =cl2:=:' :l:-L!h,-""w=-~~~' ~L-__ _ 

;';., :: - ; ,-... 

p.et 

- 233
OCT-19-94 WEn 09:33 CLEANIHG1S0LUTION$llNC. 6162431527 F'.02 

CI,;nil'lg Solutions, Ine. 

October 19, 1994 

Mr.llM I'oacooi:: 

l'ursuanl to our conversation on Monday of this -k, reganting the 'Scat Mole' prod1lC~ I'm enclosing copies of 

the cover pages ofUSP XXI and NFXVI along with copies of ill C''"-'tor Oil official USP Monogmphs. 

Enclosed also are CQIlies of the cover pages ofRemiDgton's Plwmaceutical Sciences and renees within 

reganting Castor Oil. I'm certain that you are aware Remington's is "the' manufacturing bible . 

• dditiooally, per our covmation the ditfem>ee beiwcen the 'Mole Med' product and "Scal Mole' il thet in 

"Mole Med' Castor Oil is added to1he formula MOng with an emulilm.r (surfactant) and then water is added for 

a homogenu. final formola. The l'olyoxyl40 HydrngODlltod Castor Oil, however, is USP Castor Oil willi the 

emulilifier aJready added 00 thai when added with waler fonnll an immediate stabla final formula. 

While both haw an official USP Monograph there is. decided advantage in using Hydrogenated Castor Oil. 

Th.io advantage is thelless emulsifier is necessary to produce a stable hoo!ogenus (mal formula wilh 'Scat Mole' 

than with 'Mole Med'. 

FUrther, tha bull: of all Castor Oil used is inoo<pomted into cosmtlics as an emollient. 

While when COIll\l&!in& Castor Oil and Hydrogellalad Castor Oil, Castor Oil could be "sed internally as a laxative 

~ -.nslly as an emolli~ while Hydrngenated Callor could only be .. oo extemally as an emollient. 

A, an example NADAll-55S OIl animal topiOO wound prepmtioo rontains IB ingredients. Castor Oil USP 

appem in the I!l'C'ltest quan1i1y. It'. function is thet ofan emollient. 

This ~ for thi, JlUIllOSe is inelevant because beth final formulas oould only be used topieo1ly as .. 

emollient and neither intemally. 

J bepe that !his has helped with 1he clarity thet you requeslod 1he other day. 

lfyou require any fwfber information pl_ feel ftoo 10 oontact me. 

234
OCT-19-94 WED 09:34 CLEA~~114GIS8LUTr0NSIIHC. 61&2431527 P.O~ 

THE PHARMACOPEIA OF THE 

UNITED STATES OF AMERICA 

NF 

THE NATIONAL FORMULARY 

By authority of the United SlaleS Pharmacopeial Carmen/lOll, Inc., 

meeting at Washington, D, C, April 17-19, 1980 

235
t -'::Q!J! ! wmbrook Parkway, Rockvd!c. M(L 20852 

• 

• 

236
• 

The United States 

Pharmacopeia 

TWENTY-FIRST REVISION 

Official/rom January 1, 1985 

The National 

• Formulary 

SIXTEENTH EDITION 

Ojficia/from January 1, 1985 

United Stales Pharmacopeial Convention. Inc. 

237
• ______ QCT-l·:I-94 1,IED 09:3$ CLEA\~tNG1SOLUTIOHSIII{C. 616243.1'527 P.04 

• 

, 

i 

, 

II 

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l~ ,; Ul'ualJy ~rr«t~ ocvtmi$htw ",ith;n I'> W.i'J1t B.~yl Pt,,",,~ l!li tb lin U~n. ThI'J mikl&nd Jf«:ti"" aollwWo 4 t./l.~ m«tlffil~H} 

u(itfacwrv dtJP~'tl$ pf the bewd, obvilltJJlf tnt new fer Iln -enrnu: f'mp\cyw term of eMOIIf:l ~wU Tht tJW.tm~I't witb roap:W:= o.1Ik 

Side ~crt(t..ar, tW'JaJJy l:it\ut~ ro4W<>mirn!.l('l'ilro~ iMllin\led uu (hydro~tde in U·.t'Vtfft:n«¢( w~U!r! pUIp,Lam rIM )tnd,~ ronmtufll'-' 

of tht' ~"p!Msiiory m4}' C1I~ rlM'ul tuit!otim::, ThN~ &U, 00 wn- ~nd...ak~ lb, Jn~pr.nticn mw~ pru..u\;>lft, lNlrtK"t..r\y in W", Ft""M~ tf Va ~tl(: ~Nt>"" -u:. rm"'-4 The c~tlu.rti~ KU"hy I. Al'W tr!~m:h-«Iwr'~ to Iht \.>!!f of blUNidyl, .. .:ctpt {Of' !I.E! Ilcut~ ftt.!,g,ul kUl'ned lJ#~ S w'ii. ;:Ld"!lY_"'!;;~;I..'> mL. alJl.i(jm~n_ 

Dw.t_Orlll, 10 \0 311 nI&:; urn;:i, (lr"llIn1 'ntal, 10 me; ,,'ual, .___-....---~~ 

~di(1\nf,rea(lI,8tatlm~.NttnlOtn~:"r"I,O.s:DU;/kg\jtllmtl ~ Cattlclon 

mblil~~ IJ«;,-/n!<)ffflalioll. rh lH)tciltW(fl' busk U!bltt~\tng.;;: Th. flted vi! ot.(.aintd fmm 1he~ of Rlcl1'i.(;, WI>'I"'tl"'} Ltn."l~ Mt uk~ Wlthm 1 nO\illl-fter me't"stion efantildd1.n mtlk. t (Fl'-m Euph<'!1'bw(cc,,1 

DOS4#C Forru--S"ppooiw.WM.: HI wg; T .. bl~u, Eut.rn: Cw.· Pnpuatio .. -By =1d. <I1pns!;<';I1'> and su%eqlWnt. cl~'f~alt(m 

{, mg. of the oil b).< h"",L It ~b thieDy w glyuridn of ncmclw:. .. nd 

lwrici:Jokie w.d.~ 'The purgative IIntoll hAl b«n altdtn..l,d to 11>-

I G,cl:nl;¢ rici:wltin in the ttttMlt.,.\t.lkltwl<#c add MUlzPl'OOUMd. 

The _tktClltain twQ. ~tll""p!ct. finn, it Vf.ry ~ tJ!iwnUl UW 

S-crtd I»rk Cht!!fm: D~;Bur·!xrr,~ Bitt., &rl<. I mg- U!;.kpe~ (HJ. and ~;ntn",. A }Xiiw~ but O,2·dihydl'o·'·mtil':o:<y·l·meth.\'I·2·C>lou'c;:,tinonitlilo) ~ of 1M prWtru:e <jf 

Thew-itd WI< "f Rho"""" ... pur;;ht~l'1<: Dt uFldcll'J tf'amRhI1 !:hUt w~e ll,llatMcet;, tht l-MtbJ Me defirulfly t*1;mnWL 

1,>3·D,hydrolylUll.hnlq~ j117.tO.2J C"HtOJ (2.:0.21). 

P~wp.-Flcm. mthrw:r.~ II:l dffcribad in tM f}':II~ 

of Il.mhraU:.. p4t:~ 78U. Iu ch$f:ll.tOt.! fU\lclaN cleWy ~.*mblft tilt 

D!lthtllQuinonl" den~t\"'n whlth ~t UI Jl~tc ~mb'rulllOO m 

tUC&n; $$ft&d4 aIld. the olhv ,rciuwt ;lyftlAide UtbortKi. 

D«etipl~ .. -QIMl~"-eol",~ cr:l"~ fWwdu, ~ 10 lllhfunt 

u about 1~' a.rul. ",cit! ~~ 100' a.ed 197" 

Sltlu",iUty-l tit>" 10.000 sL wsw, 2100 tnL 1Ik7lwl. SO mL ehl~ 

fQfn\, ¢W mL tthtt 

Usm-Allllt'llhrs-quiOOllt OulV'alive"",th Ihttarne rneciatlt!B'I of 

4~lim a~ other dr"&,~ 'II. th;~ ffmJP' II 1$ II. [(>1<1\1,,.,. which p.<cd\h.~f 

It!. wft 0: t!:'lUirolH stooLm (; to' 8 W,;un P,,,,,,netd 114m,n,ttlttl.,!:; 

me), mull to Ultlpo!'>Ity brO'Nllhh &1Mnt!jjf cfth.. mu;;#a I=lllll¢tr; 

O'AI). Tl~ drug .. ho&~ in Il~ m.i!\( ofnUI$'n!\,IDothenV'd =,-

(lU$e «tu..nattt llit nUH.ng mbnt. DIIln\hrou i.ehmh.,IN in tn~ 

I,lll:1t and imparts .. )wti<ilIb wlw tQ(ltk&l~ tJrme Uh.u nM ,ail'!~ 

wil.l~ etct'PUlUce m c!lnK:ru roWlem<-. hul t'!-~ t!lainly ,n vtltdw,· medki,,~ 

DMe-Unwl. MI>', 11<11<11. 31..5 to IS!) """J> "';lb '"" <1M hwr *1 ... , 

t~N"!l1: m\'(L! (Il,rd'e" i> ",12 ,,('~r.< 0) "!(,.,,,,~·h"l1 .. ;;bll dv-

~t:~ Fo:rm~-'';'~bl<:,c,' ~-;~ ""d ~f, "'~. 1,.;'1"',0 ";" ,,,;,.111' 

mL. 

\ 

'1 

'< 

, 

·It :\ 

1· 

, 

.1 

I 

, 

, 

, 

I 

, 

I 

238
WED 09;~6 CLEAN1NGlSBLUTf@HStINC. 

nr.teripU/i,,_)'~ whm, "'MTh'~, ~t"'l\£t U'lWihlt'l!n1 D~li<I will!. • {.irtl, (ha1«(U:<m.w,..u...; f.~e ff{lm ,.ad<'!;')': Plflting n.DZti 

I!:" to 1j5"', lpfdfl( iU .. ~ty .ixll.lt {j.~. 

Soll)bil\1y-1M<llu~ in ... 1lWr. l~~ toIublo-m .,cld IlIwIwl; ~ 

alcohol diw:>!n. the- Cttctk&cid Vld • pc.>tUQIl .. hh .. mytlOll. 'fIbJ.thue ~QlUItjt\ltDtt.ofwhlk ""aI" CIl'Olph!td)' aoIubJ.f mtble<'(lf",,,,,. ~th~r.!oM 

flUd Mid V{lWlkovib; parriYlI\lll,lbio i,., told btlUtMtb6 wId .... btm Gi. 

t\l!rld~; con<>plltoly KlluJm. in ~ J,iqlJ.il! •• 1 VJwt ~~. 

URI-A .tlff,t>.tn_ IiIfht in Melly F,p.mllilru; slJch B~ t"Uate1. 

JI$IWtl, 1U'Id oilttl'M.tlU. 

YellOw Walt 

BttTI\'U; Vtlk,wBuawa!:. 

,!'ho purified I'J,u ft«1; th1-lwllf)'t'Ol;nb r:ilbe be+, Ap~ rmUi/er" 

LiImf (Fa=. Apidcc). 

COOttitvtUUo-A D\U;t\tl"V or WH lubitahffi!. ~lJ I'lyrKU\. in· 

IGillbta in buili1It WlW IHld r:oWlimin; d1iafiy of myric)'j poillleitatt 

(~liCl(H31<hll and lnyfK),14k.mol. l~Ut-,Oltl; lID cctin {)t 

(ffl1l,e Kid !CnH6~1, formwl)t o:alltd urin wIl..flt ~ only m 

~ U:I;D aboolbent is WleU. here to denote tilt watet'lIb-- $O"frnna 'Of emu:bri.fy1tli propertit:!! of t.Mw ba%$ amd nQt. to 

d9Cfihl! tMir .aCUM OD the akin.. 'l'hooo bl!LCll~. wtnetimes. 

called (>mulsi/i.abk- Quwnent 00se.E, are gellually anhydroUlt 

Nbtwleoo: which havt the prcpnty <If abtclbing (l\mul$iIYin¥) 

«maideraWe quantities. of wiltel and nili rttainillg thcir o.intm~m~lib: ccmieWMY. PNfl{lflltiolU of tlW 'type do not 

contain W.Ilttr Q a co.t:npo1iBtH of their buie fomula, but if 

waw is illCofponned. when and u. dwroo. a water·w·oU 

emulsion tettIlu. The ~ official producb.fall mm this 

category, 

'~Lanolln 

W'l'QI Fat USP XV{;R..tmod WIIIIl Fit 

r-ol~ t./t&t OOG~ not RlO!'f! dlU 0.2:1)% cf II'ltW. 

CoutitublU-CoAI41ns tht.t.reHIli ~~I (Cnlt.~OH~..,d 

o;l;)'("holtTtfl'Vl "~JJ u. triktpvr.llllUld abphAtll! Al~~ A!m;t 

'1'fo oftlw~ lite ~_ iu th= '"" et.!ll:.e, tho TftI:I,lI.irnWrQQt;1.I.fl"iq: 

u ntm oUh, f~ f*llY acidr. Cllrntll.lWe, t'(<vt;~. fa'1'~C, 

kul4polmlric:". rr.yrU~. I\1'Id palmitU: adU. Some of tbwt acids artlwnd 1m.. Tl» _ultiIymg and ~rrl«tioM 11f~cfu> .,11 aile 

til- thII ~j8 that an found in tM ~fiAhle frllction wbtA 

lanolin. it tmmd \Yuh.albll. (;OQstinnillll.Pll'ffi'UmI~ly qne-l$tf 

of thizi fl'ltCtJoa IIDd known ,~ Jan"!,,, 41cOiJilU. tnt .I. net b~· 

pcONd of (hol.tsrflf"td (~). hmcfrerrlll$'lt). ehtJitslfi1tOl (dihydn.. 

tiwluruol) 11"), IIIrtoffr7'IU (2'M • .and .. ariou .. f>thl!~ skabolt ~4K), 

~~BJI'~tbeh.tt.ymaw. (''''l1r,o£>b~hOIII 

tha "W061 of tht :thtt-p. This nwulll WQOl f,,~ wnw;.,n .btrot a.M, u( 

en. fatty &cid • .nod f..uy &eid Klmi of thokJr","" 41ldf'.ltbe h4btt 

Illoolwk. The~~_th.iulpmtMtCQnstituMU 

tntl:, ~ ~ th&h in II. pmifitd futm. mlllY ~.tav. bHn 

pn impllW $-tll-M:. wh\(:h 111 d.l.MoIv~ by boilin+ llkeh':»' but i!Ij'jI!.4l.t.~~. 

ou~ Q(I caclin;; {31 urciein. which UnWr1& diMOt~«l. iI\ tb!': «old al. 

tohal.ic liquid. Thi, Illttm" u; Pt<lbll"bly 4I:>W:ture of fatty Idd!. 

PrcoplU'atioo_YdlQW ..... u. it to liat\!lM -W"Cfttiotl ~ bt.e5. I( \$ 

obu,mxi CQ tbt" l~~ ~w~ by rim. ~bruaetin: u,f" ll.MtY from tn.!. 

OJllIbe by thaving ofttbe tmh oftb, ,ells. draining,lIlld thext pbcint; 

thtm ill =~~~ '!'hl!'~)t ill. tflpldly whirled out, watM ffi addt<l. 

and thf wax is ibm"QUgbly and "Iu.iilly dc&lWd; it·;" then mdwd ,nd 

ittli!ll!d. aqd urn iolGmold!l to cool 1I.t!d hal"dtn. 

Dcteripm. .. -y~;., trQyI.-mw-r. I<Ojid too"itP6lI qHNr:.lt,lIocl, 

!)'lin odm' • .arui It t&i1lt, dltlNcwi~ie: LUI~; .. hen wid. ,II, romwhat 

Mit~ and when kcktB it))'I"6I!Al$. dull, reellla:, ~IM 1'1'«-

wn; ~ phd:IIof_ ~ hoetdtbe !wtd;Iptdtk.flllvityAOOut 0.96;; 

1Mlu. bet ....... iii' lWd ~W. 

SalubiJity-1Ilwlublt i .. wtoW; SJlWiI!l toldble in C?ld: .kt!lw1; 

(:G!(olpltulv whdIk .itI ~hlorofl)ml. ~r.~ ~&Od vuw,:dt em; p.tttl." 

lOl.ubie ifi«ld btn.Hj)t arui euboln d"ulC!ok;~t>I.t.olyd1b1e in timt" 

liquhi. &to lbcut 30". 

\fu&-A \t1lI~nin6 ...,t. m UUIIny llharola«!uUea\ pnpl1latiom 

and mJrt'ditn( cl many jlolithee. 

h is; (inally o:t1a$d with Ketone-lind tht- .soM1"I~ w~utnt)y 

UPiWI.t.W. by distllU>ti.", AnhydtcuJhulliliD d.tItlJl'll h'orol;umlJ1\ in 

thqt the fotmH oonLillt"m practkally 110 _U!r. 

DMtrit»inJ_Ydlqw. to:lIl~Ww, WlctUOU$ Da$~ hIIvmt I ~U¢hl. 

d:.a....cta.ictie od¢l'; lJIf:ks hat ... " u~ _ltd 4!!", 

BoIuhllioty--lNdublcIDIW>ItI", WI. mu. 'Nitbwt~t.ion aith.boul 

IWk't Il8 ~t ormw; IJMI'inJiy wlubie III ooJd a1rohl'l. m<m! ;WI1lb1t 

in hf,t..I~;I«:eli tclllbh'ln riM: .mt~. 

U",-Mt irI;m!i~t. of oinlmMlta,. t';~ly ,.ben &n I.QUW\l$ 

liquid if w- be IrtCWJllXiim.\. It givva 10 di:&tit:cti~ quality 'IiO th~ 

ointJ&ent. ~4~fll4Cth"e ~uand n;1lill~ 

~ ~jrorDl CODIi~y flU tho. qintme#t 1Wd.:;MIIt clltllatie eondi. 

titm;. HowtVi\'(', anhydrous UmoUn bY been omi1ttG from f<IAAY ~~ on tm: HCO~boo fA dtntultclocil!uwho have f<rulld 

tlu.t many patiuu. UD tlllt~flc to-un, v,nima.1 WIU.. 

Qolutcrol ............... , .. " ... . 81...,~J Akobo1 ......... " •.. , •. Whi~W,tp. ................... . 'W'lUtt PeU'OlaW.. .. ....... _ .• ". . ..... -...... , 

~t<\IIk. . ._ ............................. . 

,.. 

", '" .... ",." 

UN$--A prouctivt end twtr.·a~Wbk CluU'tMllt ~'t. It will 

a~b au.r;:1! IUlIU:ruM",r 1!l#lI!~ <If aq~ ~u~ of~1l: 

1I"Il~ flU'Bll.in.t: ........ ter.Q.'<'Jt ')1'tt(>f-~. See Oinrln<lnu 

(pegt 1&'131. 

dtvWd. .b De oltbee<! ~ ~ WlXllfat u trwlw.a withw..t.k.t..I:k.t.H. 

Ututlponifled ftta.oo emu.lslO!1' celltrifuttd to $tc:\lnUn 11'4. 

<0Ilap- ~utioa, ftom whkb.. 0Cl ,~, II hi}'l)t of putially pur 

9i'OOI mMPUa1G. 'l"hi& product» tw:thu pul"itled bY ~ it f!'i 

C:IIIki.umcl.k.ridIlu,dtJ"u,.dthyQrllw-dbYMlonWithumbktdlimtl.\..: ____ -

EmuklOO OJitltment bases !lIe actua!.h'tanholid tmultiiont 

1'heJepnperatioN ea.n bedjOOtd i.nwtwogrwpson tiu! bimis 

of emWc1Ol'o ty:p!l: lUL'lulsion ointmen.t hIIM Wlllel-lD-I.)n (wID) 

type and emuaion cintmelDl l>41a' oll-iu·w~ltr IoIw) type. 

B~ of both t:fpi!3 will permit the incorporatlOb of some- additioDal aJnOOllt$cfwatqr without MlJcin~ the consistency 

of tho bas~ below tha1 o! a ooft cuam. H>:lwcver. only oilro-water emUlS;OD ointment b&es Cllh be tcadily «,moved 

from the $kin Illd clotmnpJith water.. Water·in oil ttnulaions 

ll.r\! btttet €.l1lol.liu1.l$ and pro\.«t.ant$ than Me oil·ln·WateT 

emubions. WalAlr·in.oi! Cl.lluJsj(m~ ClI:n til!' dil\.1ted with 

cih. 

p.es 

i 

, I 

! : 

'! 

I 

239
I 

• 

OCT-19-94 WED e9 

Preface to NF XVI 

The National Form\1lary 1\1 publhhed together with 

the United States Pharmacopeia til a stngle v(l1ume. as 

a consequence of tbe acqu.isition. by the USP Convention, of the Nalional formulary ifl 1975. from its 

inilial publication in 1888 as. a sister compendium tathe 

Pharmacopeia (see HisrOl'Y oj rh~ Nalional rOrJnufary. 

page 1518) through the years to its 1975 edition, the Nf 

bad been published by the American Pharmaceulical 

Association. 

In tbe 1980 publications, the scope of both USP and 

NF was changed, the P'harm.aoo~la being limited to 

drug subsUlnces and dl»age forMs., and the National 

FOrmulary being Iimi[ed to pharmaceutic ingredienb. 

Where a" anicle is used as both a therapeuticagtllt and 

a pharmaceutic ingredient. it i$. indudcd in USP, with 

a cross·reference from NF to that USP monograph, 

solely for the convenience of the user of the compendia. 

Wbile USP and Nf continue 3$ twodistinCl official 

wmpendia. the eonsolidation bas enabled the elimination (If II: large amount Qf duplication of lelll, and it 

is f-e.ll.sibl~ and convenient to make el':.tensive w;:e of 

cross-references from NF to US'? with regard to Genera .. Notices and Requirements~ General Chapters; 

ReagenlS, IndicatQr5, and Solutions; and Reference 

Tables. In addition. 3 combinJ;:d :index to USf' XXI 

and Nf XVI facilitates reference to tbe.oontentsofthe 

respective oompendia. 

A tabulation or pharmaceutic ingredients. byeategories, is included in the $ection. Re/tren.ct Tables (see 

USP XXI, page 1491). Most of these ar-ricles are 

recognimi in NF XVI. although a numbe.ofthem are 

the subjects of USP XX I monographs. Where lIIn article is. recogmled in the USP and aiso is classiliwas 

a pharmaceu(ic ingredient. NF includes.a margina! cross·r~fetem:;c to that title .. (or the convenience of the 

user of the compendia. Mso for convenience. USP 

XXI itlcludes marginal cross·references to alJ monographs in Nf XV!. 

tandllrds and Tests Although it is-the goal of the 

National Fon'llulary to provide monograph$eventually 

for aU pharma.ceutic ingredients used in drug dosage 

forms .. p.recedlffice i$. s:i~o t(.l those used in formulattoll$ 

for which there are Approved New DrtlZ Applications. 

and indiC31ions of widespread lise, and Which are administered systtlnicaUy. 

In general, N F articles are defined so as. tQ characterize: their composition 3S closely as possiblo:, by providing tmS and stating. limits, either In tne monograph 

de~nition explicitly or by reference to required 10.-

bellng. 

Many articl~ used in foods, cosmetics, organic 

synthesis, and even various commercial .fations. airo 

are used liS- pharmaceutic excipients. Specifications 

for such anides developed in laboratories in those in· 

dustries reflect tbe history of thos~ materials. and Ittus 

may differ from the usual pharmaceutical standaRh 

and letts. It has been deemed appropriate to adapt 

these in some cases for N F monographs. or increasing importance is the proliferati.on of 

polymeric products useful as excipienls. Anticipating 

the need fo.r further monographs for such articl!S, the 

chain lenlph of which may vary. some titles. e.g., 

NQnoxynol 10. include a number todenQte tnQre definitely the chemical structure of the anic:le. The use of 

famUy monographs. appears also to be of value in that 

these define closely releted polym~rs of various 

kind~. 

Credits-As with any group effort. the weight of 

responsibility for succe:;.s in producing the National 

Formulary falls more heavily on some than on others. 

Thus, while the Revision Committee 3S a whole (see 

page viii) served as the elected agent of the USP Con_ 

vention in producing this compendium. great credil is 

due the host of those not (In the Revision Commlttce 

who contributed nelpfully OUI of a sense of public: service and thereby ,greatly ¢nbancc<1 the C:ornmiuee"s eff~livene.ss (see page xiv) . Foremost "recognition belongs to Dr. Ralph F. 

Shangraw. who $erved as Chairman of the Suboom. 

mittee Ihat wa$ dirOC:tly responsible for mosl of the 

content of the National Formulary. HIS tborougb 

examination of Inc issues concerning ingredienls and 

his careful atl1:ntion to the detailS of the tests and 

specifk;:uions hr:rein have led to the many addilions and improvemen(:~. 

FOr further information regarding cot'ltributors 10 the 

compendiat revision program, see the PrefacE' to USP 

XX!. 

" 

" 

• 

j 

240
• 

C L (: fH~ I HC 1 S 01., U;T~'~O~N;;-;S~';-;':'~' C:-.--:":,~~~~~~---· ••••••••• I ., 61624315Z, 

USPXXI 

Cnn~n: If tUOWl5n or tan Ie while, tOO.tSt to fine powder. Is 

practlcaU" odorJc~ and h,,& II mUClbginous taste, Soluble in 

w;ner lit i tcmperatur~ (If aboul 80-, formifl& a visoous, du.r cr $liEhlly~nttolutl(>r1 that flow) readily, DISF<flUln water 

mOte readily i(ftr~t m.:>iHcllw "'nl'! akohol. sl)'cenn. or a S:llU' 

r .. ncd ~IUliCf\ of SI)<;-fQ!;C in waler. 

Whjt~ crymHinc wax lnwJubk in 

m most CQ!!1Jl'IOn org,lIm;.:toh'cnu 

Sttrile Cd'uoDn $odlllfn: Wlute t<) off·whitt, P."<1ctlC4fiy Q<;\Orlett, tr)'~llllim: jXlwd~r. or wllitc to off·wb1\c roll1lllavlll£ the chul'letc,iStie appearlln~ of prOOuw. prc~re<l by frUlc-<lrYll'lJ. 

Frwy roluble in w;uer. in nhnc TS. and in ~Xlflm' roJuu •• m~; 

very$li;)\tJ)' wlub-lc ina!eohol: pt'ar;t,call), m;:clubk ill chlorofClflll 

lIr.o 1n rthtr. 

CcUulo$t A«la]t: FUIC. 'Amtc powder or fr«.l1owitlt pellel$. 

AVl1il~bk: m a ral'ltt of ~iJcm;lt~; ind acetyl C(mt(;nt'; Hlgr. v~ity, whieh ren~ts high m,ol«ullr weIght. decmas t{)lu· 

bJlilYlllghliy, High a(;elyl eQlllenteeUu.!ote 3.~I;'ltc~ generally ru,7C more Jimrt~ solubcln v in commonly \.1$00 wprlle $olvellt~ 

tbtn low acetyl CQntent eeliulost 3.utatet. 001 art more Wl.ubk 

In metbyJclll:.ehlono\:. AU \\C1:tylwntcnl cdluk4e acel"tt:sale 1tt~ubk in aloobol an<! in W$tl':; SIllubk m d)(lx<lfle lind 1n cli· 

metbylimmlnlidc . 

Mlerott'ymlliM ~Ilulo«:: Fine, white, odotle$~, en'1taliinc ~. It comtltsof free.fkwtlng, tronfilmm p?-nicluilut rna" 

t>e cornptem:4 into nl[·Wndmg t"bku; wbich dmnltgr:llc rapldl~' 

10 water Itl$clubl:e in water, in diiule~nds, and in m~tot!~nJc 

:Wlvellts; practlc§ily mrolublc m .oc:hum hyclrC):ide sOlution (I 

11)20). 

Mkr«rymlflot CtlIu!o$t and C'rWltyrnclhytcellulll'$t Sod{Iffil; 

Ta~ltI« •• odorle>$. Willte IO' off·whlte. I;OOrlt 10 line po ... der. SwelJ~ in wMer, producing. when disperud, a white, uvaqou 

di$pusion or tel Is ill$oIubJe in mgallic ~venu. <lila in dllllU add~. 

Oxkfu!fll C,lhdool!; II) the f()tro cf gauze or lInt. Is Sllghllv offwMe 111 color. 1$ ~CidJ.;; to the tute. aM hUll-SUght, cMrl'CdOct« 

Il1!Oluble in "'~Itr and ill acids; $o~ubk 11' dilule iI)kali«. 

OxiGiud: R~:tfC\t~: A krnl faJxil:. lU\lldly in the form 

of MedIc strips SH~hJJy Qff~w1me:, navme II. ~Ilgbl odor. In· 

soluble m 'A~ter and m dilute acilb; wlubl" in dilule .ldl:.;ltC5. 

Powdtnd Crl~: WhIte. ooorl~ ~ut>$!anot:, tOlUl$linl,1 of fl· bft'u~ panleles. winch /'IU)' br;coolj)fested IfltOMlr.bmding laOk!. 

Ihat dlsin\cgrale I<lpidly in waler It exim III ~;'IflQU$ !!l.l!lt~. 

e);hibttmg dqtte> offutelltss ran&in,;: froll) lI. frw·fiowlnt: dcntt' 

p¢wdcr to a coaNt. flllff}. mln-n<:fWmt materIaL lnsoluble 10 

waler, m<ldute .leH.is, and 10 ~arJy all err-lime t*"eng; ~1J8hll\' 

soluble in sodium hydrOlld~ rollluQn (I In 20) • 

Ce:~ Aefbift' Phlf>.lAt;:; frtt.flowmJ; "hite pcwder M"y ha~e '4 tlight (l(k)r 0\ ilt'e\,C acid. \n~I\>"'lc IPo "';lilt' lil:)Q ,1\::.1 

COho); soluble-,n ~cetone a~d In d;(\x~nc 

C~L.~bl' Whll.: I" (llr.W~llt_.t'rr$lJHm" po· .. d~r Sjl~hll;' 

, ...... t>j,; ," w,,'~r, pr"<::I".;,tl, ,,,,..>!,,b!~ '" "I~"h"i. In ~hit'mfnrm and ,n elh~r 

Reference Tables I l)escr'ptiotl and Solubility 14&7 

Sttrilt Cl!pll&lolhln Sodium.: Wh,l" II:> off·willte. practi<:all;- odcrl~~, eryst~Jine powdct. fteely wlubk in Wl'lt;~, it: IlIlln~ 

IS. and in dC~\fose Ccluliom. iru.oluble In most orlJn,,- sol· 

~t'nt<; 

St~rikC~ Sodium: Whue to off·whllt eryslaUlne poW{\tr, 

odorl~ Ol' fwnnt a ,llgtil OOOt Vety ~ol\!ble Iii WAler; inrolubk In f!}¢$l {lrglltl1c w/'1lelllS. 

Ct'phnu!iM; WhIte tooff·whitc. nymJJinz powder. Sparingly 

$O!ubk HI watcr. very wthtly v.>luble in alcolwl itlId m chklrofMn, 

pr~ct)dJl}' Hlwl\lblt II) ether 

CetClSltlIrylAltoltQl: Unctu¢lIS. ""bue n~kt:t Of !l'rlInuks, h3VUljt a fainl, chllf3cter~tlC odor. and ;II bland, mild UHtc, lnIolllulc 

in water; soluble in #lcohol alld l!l ether. 

Ctt)l AIrobol; UnctUO\l.5, wh1\e fbkes, granules,CUbe$, or Cll$ti!lp. 

Has a fa.lnt chatactemtl<:OOol w a bland. mild lute. lMQIubk 

itt w-a.lct; zolubtelt1-2!eobol and in rther, the roIubilJly i[K:rc.a5ing 

wilh :lUllt1Crea1~ in t~mper;\\ure. 

Cetyl Uteu Wax-: Whne 10 off·whJle, wme.what 1tatl.~lucent 

Oaku, h~"ing II. er),!utlhne struCl\!fI:: and a pearly I,"ler whcn 

caked. Has Jl fainl mr .and 3. bland, mild tlUtc, free ft\!!l1 rill1-

ddny. and hM a specifiegllwity of about 0.83 3130". lMOlllble In water; :wluble III 00i1H'l& aloohcl, in tlner. in <;bloro!'oril" and In fixed and \'ol~tile oils; 3l!!l'luly ::;O!ijbJe in cuM solvent l1e~lI.11t: 

llfll.ctieally insoluble In wlu alrobol. 

CuyJpyridinltlm CbJcmk: Whne powdtf, having .1 diSht, characteristic odor. Very ~lubk In waler. In llkohol. and In <:hlt>-

roform. $Iighlly oolubie lA benune and In nhu 

CdylJryridWltlfl Chloride Topial &»uti&a: Clear liqllld. h 

rolorlea ul'lkn i! cclor h2$ been added: hasan arom.,lhe«kn'-lI{Jo 

3. biller UnIt 

ACfh~lwCh:lrct»ll; Fln(, black, odork~~, tMteJ~$ p""'der, frtt 

from grill)' matter 

Qtn-ry Juke: Clear IiqUJd, havmg:m IlfOmalic-. chilral.'tm$!>:COOO; aoo a ~our Ullie. Is affected by light. Tltt cokn' of freshly pre- ~led Cherry Juice j; red to rWcilSh ounge. 

Chlonl Mydn:tt: Cclorkss, transparertt, Of .... rute ~uls haVlIl£ 

an aromatic, pellet~ting. and s.!l!1:h:l)' acrid <Xk»'. and a t!Jrhtl: 

buer, c;uuic taue. Melt~ at about 55"'. and slowlyvolailh2t'$ 

.....hen n~ tOllir_, Very wlublt in wattrl1nQ inohveoil, free]; 

wlublc In ,kehol, m chloroform, and ill ether. 

C~1: Of(.whlle,$ligbtly ilMlulu po-,wkr. Vcr,! ~hgbtl) 

solubli: 1ll water: freely roIuhle in ar,elone; ~Oiuble In dllult al+ 

l>.~lL 

Ol<l~I¢ol: nfl;=:, whne to gfllyl~h wbJle or yt:Uowlsh ",hile. 

Ileedlt·like crystalS Of t'IOOl[ilU;d platCi. lt~ $<lIUlio"~ are prae, 

llUlIy neutral to lJlmu~. Is reuonabl~ Hilble m l'lC~lntl or mooerately aeid S1,)IUUOfl$ .. Il~ aJ.cQbol whu~n i$ dC>:h'Of(ltlltOJry 

lind Itt dhy! acetatc IQlu\lOO 1$ k~QrOlaJQf)' 511gl11l:o sclubk In walel, frccl}' oolubk In akohcl. in propykne glye«. in lI.telorno, 

and In ull)'! ae<t:dt. 

ChltrrampMHlccl Palrclute; Fine. ",hIt>!. UIlC1UOU,. erym!llme 

?"wdoer. halii"!, II faml -ex:br and a bl<lna. mild taste hso!uck 

In W')lt:r. fr<':~ly soluble in :l.cetone and in chl«ofwm: rollick U'I 

;:lhu: ipanngly wlubk m ,,1C(rh<,:.!: «ery &llthll~' rolubk 111 solvent h~:>;:lrlc 

SIt'll'" (:hk>QmpMmccl$oditiffi &K-cina{('; liS-In yclioR t»""'dtr 

F'leely ll)iuble in W;tler and 10 alrohol 

C'hffl-I"('}cli:t; .. ~ H:rdtcchmidt: WhIte. cry~t;tII;M p<.>wdtr, whier 

IS odorlu~ ¢r almo.<l od<>rlt'~> Mdg llt :liMt 22~~ Fn:th 

:rohible 111 walet and in d,lcrofOtm.$CllJ\m in akobo!; l',aCllCtlll\. 

lmolu\)k 10 ethH Md HI b-fnl~11t_ . 

~rtpo"idC: Yd:o". pr..c',ca.lI~ <'X.k\f;c,",_ ery\t.Jil~~' lX'"dv 

h ,eh.,thVC H,) ~unh~hl M~II~ ~l Jtmul ~4(\' I r,'v!ubk 'n ""I," 

.,r"(!rlnth 50lubk 1)\ ,hlor..,form :II'lU In ,,1.,1111.;1 

p.l)? 

I 

1 , 

241
• 

• 

OCT~19-"'4 WED 09:4'5 CLEANIHCISOLUTIOHStIHC. P.08 

USPXXI 

Pol~oJ(yJ 2t)Cl!cto!>it'lllyl EtMr: uUffi-coJom:!. waxy, unClUm.!~ 

man, melting. wben he-aled, to a elta; ortNIn.$\'; ye\Jow llq\ud, 

Soluble in water. in Alcohol. ted in .. ~tolle;inwllleJe til wl>'ent 

hex1l.ne, 

Waxy, white to light tan solid. It o-:lOfJe:; 

odor. Scllilile Ul W1I.IU. in akohcl, in tther, 

and III acetone; IlUoluble in mineral oil and in \'tsetabk od~. 

Polyoxyl SO Stearate. Soft, qeun·CQ\otoo. WMV oolld. nanng a faint, fat-like odor. Meltz at about 450 • Sohihle in water ttld 

in it0PfGpyJ aloolrol 

rol1pmpy~ -GJyrol:: Ch:u, eolwlen or practi,ally ooIQI1~. 

vI~sliquid. Soll1blc in \\'ate;;and in lu~h «ganic wlvcnl~:t~ 

aliphatIc ketones and alrohol~ l/lsoluble In cIne; and ll'l m(tjt 

eJipbatie hydrocarbom . 

Pclytotbate:W:- Lemon to amber hquid havmg a famt cbant'.;. 

tenst~ odor. Soluble hl. water, in :kooo\, ill. ethyl aC'!ta1e. in 

natbanol. and i)'l diourte; i~!iOluble UI mmnal OIL 

PoI)'$Od,!ttr 40:: Yt"llow liquid havillt a faint, duaetuistic odor. 

Soluble- In Wattr and in aloo~I; in§Oiuble in miner-lll oil and In 

vtltetablc oils. 

Potymh.t(: 60:. l.enwn· to orange·colof1:'(\., oily liquid ~ ~mi·gtl 

haYing a faitH, characteristIC ooor. Solul;>le In wattr. in tlhyl 

attute, and J)IlolUt"Ilt:; iMOluW.:: 1:1 mine:-alml and in vt'!~t:J-bkoi!s_ 

PoI~te 80: Lemon- 10 ambr-r.colored, oily liquid having a faint, eh.uacterutic odor and " warm, Sl}ffiewhat biuer tute_ 

Very soluble in water. ptOduting an odorless and prlletiullr 

ool.otlt$$. solution; ,muhlein IIkohoi .TId in ethyl aoeutc; llWJlubk 

In mmenl oil, 

Polytro.:ri4¢: White, cty~taJli!le powdet, haYing a characteristic 

odor. Practicallr i/l$.oluble in waiN and in chlor"form: \.¢luNe 

in methanol and m lI(:1::tooe. 

PoIftlQ)l AttUtt Pbtltllhm: FrCQ-fiowing- wlute powucr. May 

haVu.!litht odor of .a~lI¢iG. lOOl:llubk In WIlW, in mctnykM 

ctIlocide. and In chloroform: scfuble in rMthano! and in al· 

CQhol. 

P6IpmyJ Al~: Whitt: to crea:m·co!orcl £:ranule~, or white to 

ereluu<¢!«edrowder. hodorku Fmly wil.lbkl/1 'YlHer lit room kmptf1l.Iure S9IUtion may b..: dft<.:tro mort" rapidlY <!I 

romev.'hat higher temptralure!, 

Stdfurattd Potuk: frrC!uJar, liver_brown picw;- wben freshly 

mack.. clansinz loa greMimytllow. Has lin cdor of hydrogen 

sulrMkand II biittt •• <:rid.and alkalme tme, and dCCOffipo1-U on ellp.)Sun: to air. A solution (I In 10) 1$ light brown in color Jlnd 

i$. alkaline to L.tmuf.. FtMly wlublo:'1'1 'tJater, \!1N~Uy kavmg a llit:ht rc:sidut. Alto-nol dbsolves o:'tly the sulftdes. 

P"otamrm Ac:uatf'! Coto-rk$s, monoeht"llO: rnY3Ia!,. or while. Cf)'lu.Uit"ll~ }X>'A-..iu ,h;wing 11. u.line and )\ightly a!ka-hlll: taste. h odorlt$~. or has i\ fairlt a«tou~ odor, DeliquC.l;Ci!'$ on ellpo$!lre 

to nwln all". VelY wlub!.e III WlIl«; freety $oluble In lI.irohoJ. 

~ ~k: CbI{)I"ieJs. tt;;lMp.1ttUt, mO(lO(;hnlO: pn.m~ 

()I" u a whil~. {!raliular !'¢wdcr. h '\Xl.orkM. a.nd IS nabk in air Ic~ .ol ... u,",~ M~ neu,ral or lIJk",hn!!; to pMno/phlilaiem TS 

Fr«h tclulUe In waler: p-~eu"llll:-- IMoJ..b'<i '" "kOMi 

f1iHJ!JWm (,fiW{m; C(l!{lt\~13, ElOTipted. prbfm\.tH.', QJ CUPIC JI 

CI";,"",k, cr ",hil". 2'"""",1:11 !X''''der, h oo{lfln~. h::l~:: saline t.;l~k. 

R-rferenN Tabir.! I [k§cnption and Solubility 1411 

am! is!table In air. hUQlt;tlOOJ ne n~ulu.l 10 litrnuJ fr«!y ~olubk in v.:a,ler and eYen more :Kllubk in bY.lins WMer; :rwolubk 

in alcohol. 

P<iW-l;jut:l Citrate: Transparem crystals or white. granular 

j3Qwdel. IsodC>l'leu, hilS:'; ecclit"lg. ahne lute. And 15 delKjues-

\:'en! wl!-ef'! u.pooed to mollt 1Hr. Fleelr roluble in water; almost 

Inwh .. ble In e:lroMI. 

f'OW6iumCI~(e; "lute to yeUowish: wltite.ery:n.al!lfI~pqwdcr 

or granu](:s. h odOllt:$~, MS a sil£htly blnt! taste, and IS ~Ulbl.e 

in ;!jl, ltswll,ltions are slightly alkaline to lmma. Fm:ly w!uhle In Wltn; p,actlcally Inro1ubh: In dehydrated altohcl, III ether, In 

\x:nzeM. and in chloroform. 

PGtUl1l1m H)'61'oxl6t; Wllil e or practically White, fUkd mU-K:S, or sma!.! pelletl. OJ" fbkcs, or IIlCh, Of other fOtlhl' Is hard and 

bnttle lind ,lwwsc CT)'st-aUine fricture. Exposed t1) all'. It rap¥.!l), 

l1b1orbs ~rbo~ diox.lde and mo-~lIrt. and. dcliquCttu_ Fruly 

wluhle in wam, in $k.ohOl,lt.nd 111 gJ~: veryrolvbk: ill. boiling 

akoh¢!' 

roanililm iodide: Hu.;lu:dral cr~ta~ ritner trll.nSparcllt and co\orles~ or $~what opaqut and whne, or a whm:, granular 

powd(f h !hlhtly hyEfO$«!plc. 111 roill-tions are neutral (If 

:!lb!t~ to litmw_ Verv.w1uNe in wal~r and r;\'en mill<: !O!uble 

til bolllng wata-; freely'wIIlNe In gl~ntl; soluble in alcohoL 

p~ I~ Om!~: Cle1lr, eclorless, odlJ(less liquid. 

having a dmracterutlC. ~trootly $:thy taSte. bnwtrnl ()f alkall:'!e 

to htm~, Specific gravilY i! about 1.70 

Putamgm Mct.phosphtt: White. QdorleYl pm.-d<!ct. In~olubJc 

in water: roIuble III dilule lo-iullOM of sodIUm saIl'> 

Pt:fteuium P~BAte: Dark purp!e crvsuk. :llml;!$t cPllqu~ 

by tr",nsmitttd I.Igbt and of a blue mtuJiic Juster by reflected 

htht. Its cclor l$ tomctime} modifl«i by,... d3rk br<.1ll«~li~c 

ltPP.¢'lta1\:ce_ Is stable in all Soluble in wllter. freely soluble 111 

lxlding w:.ter. 

Momobasic Potassium Phosphate: Colorless cr)'$Ials or while. 

&nnUlar(H cry$t.allinc poW<kt, hodorku,lIndn5Ubk inltH. 

The pH (If a solution (! In 100) 1$ abO\ll4.:' Freely rolubl!e Ht 

""liter: )X'actieally inf.(lluble In aloohnL 

f>~ ~ TartnUt": CokN-kss C'l)'SLlbOf white,o}'luIlIIl( 

powder. rulVlng a COOling, salineustt As it emo~ulightly 

III WlUm. dry illr. theerystab a.re ct"tcno:>at«l with a white pow. 

deI. freely rolllblc in water. practictlJy Inso.luble In .ak:obcl. 

Pouuium Sorimte; White cryst::th or powder, hllnng a ehara" 

leritticodor, Mcltf At about 270~, WIth deolnrpo€!ttOtl Ff'Mly mub!t in wllter: wluble in akohcL 

~: Whlte to ¢tea,rnywbite powder, haltlnt:a bllll o®r. Is 

hygl<.nl:QPlc. Soluble m water, III aloObol. and in ehloroform; 

Insoluble in ether 

l>~fodiM: Yell~l~h wown. lI.motp-hoo). pow,jel, haVIng 

a $ligJIl, c/lltaeteri5tjc odor, Irs w:lUlloll I~ aeld 10 litmus. 

M-IuNe in waler and in aloob{)l: p-rOtcucally iMOluble in ehl«¢-

form.in carbon letu.-ehl¢fide, in elher.m tOI~ent heXlr.e. and ir. a~IOi\¢< 

Pl)liOoce-lodiM Topk31 A«OfOl S&llrtioo: The liquid cblliinw 

fro!)). Povid¢n.e·lootne Topical AU%-Gl Solutwn I!- tnnlp:uCnl. 

Ilavio$ 11 t'ed-di~b brown color 

Praidoxi¥¢ Cw.»-ide: WillI .. to p:ilk·yello .... , (Cryltalhne powdtt 

h odorle% and is nable in au, freely soluM .. lJl. "'Mel. 

Slffile ftuJioo.x.ime Chlarkk: White to pale·yellow. cr~mdhne 

j)Qwder 1$ odrules~ and ;$ Hable in all_ Fr«:ly $< .. (u\.>k In 

W~lcr 

PnllW)(rM HydrocbJori4e: Wtlltt: to practically Whllt, cnmlhne 

Nwdu. h;!~H"P; 11 nU'l1binr IHll!' M$\\' h~~ ~ $E~bt arCIn;)I,e 

,,om Tht pH (lr a !OIUll{Jfl 0 I:; 1(0) ,~:o:I»u\ .:,) r r~~h wi· 

"Nf 'rl "'.1ller and III 31lmbo!: $OJubl~ m chhno(vnn: nn ~l;fhlh' ~()lllblt HI elh!;t. 

1 

j 

i 

! 

242
• 

• 

i 

. 

I 

f 

J 

j 

~ 

OCT-19-94 WED 09 :49 CLE'H1rNG1SB!"'UT!'~NS1 ~·HC. P.09 

Pbarmaceutic Ingre<lltntS 

GtiU .. t .nd/'lr AI'IluiWoe fl.Cfllt 

calciu/tl S,Lute 

Maln~iumSlljC:ilIC 

SUw.:n O, ... ~,de, C¢II\l!<l~l 

Tak 

H~tut 

Glyulln 

Pn:>I''ilCM Glyrol 

_ 

SQrbitcl .... Larwlin 

l.,,~ill. Anhydttlu, 

Oi~t~t. HYllrophil~ 

O;ntm¢nt,. W!tite 

01l;lme1lt. Yeij(lw 

Pciydhyw( G)ycol Oilltm.1\t 

Petto!ttum 

i>~rt.bt\lm. H~drop!lilie 

Petroli-WI!\. Wbitf. 

Reu: WatCf Ointment 

SQulllanc 

P!uIkizv 

Cul;noOi) 

Dr .. «tylattd M¢(IOfily~ndtll 

D)~YI Plnh.l3;te 

Glyocnn MCII¢-_mJ o;.aC':;tylated MonOJlycerid~ 

f'o/y<thrlfne (1)'((11 

I'fC?1~ Glyod" 

Trll=m 

PctyfMf M~. IEWlltibk 

CtlllllC$$ A«tilte 

""-''''- ""hoi Akohol. Dtlu.t~ 

AmylUle Hydrttll 

lknlyllkl'il¢$tll 

!1Ut)I"'~ 

Cilrt>on Tet~k4'idt 

Ch)<)rofqrm 

CIIrn Oil 

Cou¢mttdO.l 

GlyC1:tll'l 

I ropi'QIlyl Aledwl 

Mtth)1 Ale\l\lol 

r.1ctbylwt Ch!cridt 

M«hy) lWbtIWI Kc!~ 

MiMtlIOi) 

!>eal)l.n 011 {>-olyedl)kMGly~ 

PclyptoPi'kll~ Glyroi 

PropyJeM! G)~OI 

~mtOil 

Water fOf 1,*;tIeJ'I 

Wattt for In.l«-tiW1.Sttrik: 

Wa..e! (or lrriCilticn. 5t~rilc 

W"IU.Pllrif>L'4 

....... Cdl ulcu. p.:r-..d<=<i 

C~r«>O.l 

Stl~ Ea.t~h, j>"rili«i 

~~Dtc~ 

i1anum Hydr{!xl<if: i.,me 

Soda Lime 

~~&£i;;) Cetyl Alrohol 

CetYl &t¢n Wa>t 

Paamn It!»,,, 

Stnryll\!rohol 

Wv.. e",llis![Jlng 

W~~. Wkt~ 

\VJJ,_ Ye!l ... ..-

:»ptmitory Bti'!' 

Cow;!, iMt(f 

","lr(:thyl~"e Oty'::ol 

S\el!tMiIIIt awi/Of Viv:,wty·iltttn'tint 

A .... ' 

AUG3 

Ag:r 

Ahl.ll1ic Acid 

A.lunl,>1Um MoM1ttea!Ale 

IX-lltOll1tC 

lkllwnlte Magm_ 

C.IOOl/t¢r 934 

CarooO\ymtthytcelluJ,m Cak,urn 

Carool()'"lrn:thykcllulllK Sud,I'm Cu1x>,,'!m~thykettubv, Sodium 12 

C;'!I!~lieeJ'l3n 

Cell\l:lt%. Mjtloo:-t)st,vllm-. and 

C;uWtyrl'.ethyl~lluk«Sodi~m 

Gd~tin 

Gu&r (;lIm 

o"x.uou t;.'tI"i"101H 

Ft",\<)\e 

\i;)/.,~j,n 

Lac:o;:.", 

Iltallll1wl 

$orbit;;! 

Slt~1o 

5t'l.r<;h, P:vgthtinizcl 

SUC1<fl;>! 

Sugar. C~Pfd~ibh.­

$ua'lr. C()!tl<:<::t«mcr'l 

Tabkt Di§mt~ .. t 

Altlnr:;A~ 

C:eUIl!¢t~. :'lit!'1Xry~latb~e 

CrOlUr~ll"te S<xliul(\ 

CI~1*'wmie 

P;,ltcrill" }'o-uui\lnt 

Sedt"m Stardl GlyC<l!~t.: 

Stu~h 

Star~!I. Presehl.!ill-w:d 

Ta\>hl l.oo/MCa;nuk Uibfitnl 

(;AK:lllm5tt ,uau; 

r.ht,OC$mm Stctrilte 

Hydro>;y~t~Y) C-dl\l~ 

H ydr w;yptr.>py) Ct;llclllU; 

H)'tlr(Myprupyl Mdhyl«tl~ (Ne<:_ 

U08;2006:29"lO) 

MlIgMllllm AIIlminwn S,I,Qte 

~ffth1ItdJIlI,," 

M;Mrnl Oil, L,ght 

f'c1~thyl(M aly-cl)] 

Steii1r1: J<,,.!d 

fal,. ~- -_..... V!gct~bl(: Oil. Hrdl\l;:cn:t:nI 

Zir,1;--Sl«Tat! 

Pc;:ti" 

F\lly-"nyf AitQiwl 

PQ"Id¢r<c 

Sillea Gd 

Silicoo D,o;.;idc. Ccllcidal 

SodiWllAlgllH'IC 

T'!&&lC4nth 

X&m,hanGo;r.ll'l 

Swffir.lbtA;ut A~patUlme 

{X"tn.t<3 

D~m~ 

OcXtlVK Excipo~"1 

Frllctc«: 

M~nnitcl 

S3.cdt~l)n 

$lI.«:II:II1I' Ca1Cl(jtl1 

SII-" .. ;huin S.,di"m 

Scrbitcl 

S.:nbit¢l Sd\lI;CII 

SugH.ccm~ible 

Sugar, Cc!lfertmMf', 

S;=p 

Tabkf bid« Aca~'~ 

AllJnic Al:td 

(:llrlxN;ymttbylcdIU10%-' $odium 

Cc)l~lcg, Mkrxrr~talI,/)C 

!!tkyl«ltukl&¢ 

Gelat," 

GILX:OU. LlIi\lid 

T~A:W 

O~t~ 

Glyctrin 

~1allnttcl 

p-ou.~m Chloride 

~~--~umCMmde 

V_ItFLA vOJtEll AND jOlt SWEE-l1!:t-tO 

ACilcm Sjrup 

~ArCfru.!«: Elixir _-- 6tn~1I.tdthyde Elixir, Comtl¢\ll1d 

ChmySynl1' 

CIX~5yrcp 

E:irxbctyon S),I"!,. ArQm:ltlC 

hc-alcobciiC Eli:>;l! 

Omngc Flow4 Wattt 

O!uge Syrup 

I'1:ppemlirrt Watn 

Sm'b,wISdutlm:t 

Syrol' 

Telll Ba!n.rn 5~t\19 

OlRAC1~OlJS 

CerttO,' 

CmW%(ed Oil 

Eth~;Oluu: 

lw-;tfO?>1 My!illa"" 

Iwpfw,:>yll'alnnt'ttc 

Mil1e!'"~IOll 

Mlncral Oil. Light 

OlivcOll 

Ouar(f\l.", 

Hydr<ll~prapy! MethylcellulCSi'> (NOJ. 

211JS; 29%;29lC) 

Methylcclll'i<W: 

f'U.llut Oil 

f'mlcOI! 

Se$~mcoOil 

$'1ylxali Oil 

$quill;!{I': 

PiWtlWm! 

Sw...:b. p,tt;dati:lizr;d 

Syfl'P 

1':tJrltt ucl/or;~DtWtM 

C<'Ik,UIll CMk$1atc 

CJK:1UIll f'lImliha.t .. VlbM1C 

C,,Jei\1l1' PhCCflIu.tr;. Tlibuit 

Czleillt:'! S",lfatc 

Ceil\.>UM, Mitf(>CIpUUi:'<~ 

Cdlulon, l'owdettd 

~1""ltl 

S1c1UU; S<hlilifll Ch)Qo&:> JFlj«>ue .... B4~ttn<><!~t)C 

W2kr ret III/eCtiw!. B:et:rKmaw; 

~ 

VbCMity.l...::rn-Wie IS« Su:~mfbt£ .46~'111 

IkonJ 

!klw~th<>ni .. m Ch Ion&e 

CetylPyrldlllh!1I'l CWOOdt: 

O<x\>u1c S¢d,"'" 

Ncr,e;o;y:mlIO 

243
USPXX/ 

• 

• 

R(/erfn.ce TableJ" I Pbrmactutlc 111j!ftdtents 

P.,lyoxyJ 20 C~t~!e.)tr! £th~. 

Poly.:u) I .m Stetra\c 

ro:y~t>tbJt~ 20 

f'alJlllDlbito: 40 

Polysorbate 6(; 

FoI)'!oOtb~!e :so 

Sodhlm ~~r}tSut("'t~ 

Sj]1t;.'\~n Mt>nDl!!lltlV! 

&Jr!:Hl~n M<>~<)Cbo~Lt 

SOrl;>it;)n Monopahmlate 

SatblUII MOl'f~LeH1:'" 

TY!"~~PQi 

1493 

244
• Pharmaceutical 

Sciences 

• 

1985 

MACK PUBLISHING COPMANY 

Easton. Pennsylvania 18042 

P. , 

, 

I 

"{ 

, 

245
OCT-l~-9~ WED 09:5~ CLEANltIG1SOLUTICtISlrNC. P. 1 ::-

17TH 

EDITION 

Remington's 

AlfONSO 1\ GENNAI\O 

Ediror, and Choirmon 

of the Editorial {)card 

246
• 

• 

OCT-19-?4 HED 89:53 CLE"'fHHG1S0LUTIO~ISI Inc. 6,';24 31'52, P. t:5 

US? XXI OJlicial Monographs I Arnilorid¢ 35 

Amikacin Sulfate Injection 

C.IH~)N~O".2H,sO.. 781.75 

o-Stteptamlr>e, O· 3·amlno- 3-deo:l Y'n- D-SJuI;OVYlano})!· 

( J ~6) -0.\ 6-a onno-6·!;\cOX.Y·"'·D-g!uCOPYI II !IC~)'J. 

(J -4) J-N ~(4·afllmo.1.hy<110)(Y· t _oxobutyl)·2·dtnxy., 

{S}-. wlhle (I.1J ($a.h}. 

0·3-Al'!'Jlno-3-eeoxy ·o:-O-gll,lcopyraoosy!( 1 -4).0·16.;; mino. 

6-deoxy-a.o-glu£OPyt11nosyl( 1-6) J ./'i)·(4·amino-L-2· bydI1nybl,ltYfy!)·.:-dro~Y-L,sl~ptamHle sulh!.le ! I :2) 

fj9831·jJ·5J 

» Amikacin Sulfate Injection is a slcrile sohuion of 

Arnikacin in Water fot Injection prepared with the ~ud 

of Sulfuric Acid and containIng suitable buffers and 

prescrvath-es. II contains 001 less than 90.0 percent and 

not more than 120.0 percent of the labeled amQunt (If 

amikactn (C12H41N~O!). 

Paekaglnc imd fi.(~ Pr«<en-e In smgk-ill,)$¢ ru- in mull Ipterd.O'U 

containers. prcfelltb!y of Type I or Type III ghs~. 

Rcl~ ~rd-·USP Amika<irn Rt/aUlu Sfandatd·-Do oot 

dry ~fote I,Ulflj. 

Idcrrtif~tiofI~Di!ulc it Wilh water to obtain a 10luhon oonUhlin& 

6 mg per mt. the mulung $O!utioo lesponO$ tothe IdmtifldltlOft 

tf'J1 under Amiko(/IT 

Pyrog«'!-When diluted. if ntcC>$8ry, "'hh Slerik: Wllttr for in· 

JectlQfl tQ- a roncentrlltio;) of 25 rog of amikacin per mL, 11 rr.ee1l Ihe 

requiu:m'"...nu 0( the Pyrogtll Ttst (15!). the t~1 00..1: beIng: t.O mt 

pel kg 

s.rety·~Di!utelltl a~~\lrately meuuloo volunteor Amlkaol'lSul· 

fOu injrtliCrl with. $Iuik sa!me TS to obtain a SOlution ront:unu'Ig 

1.2 Ing of tlmlkacll1 rer mL. and priXu.:l u dilccto:d III rlw: It.1t fOI 

SafelJ ulldet Amik(lruL 

pH (791). belw¢tn3.5 and 5.5. 

Othtl reqllllrt\ltWflt~-lt meets the requilement~ ur,du Injuliotu 

m. 

A$U,,-PloceeQ with Amik.acm Su!fale In}«tlon as (ilf«"(oo uodel 

AnfiblOtics-MitfOOiaf A!$ays (8 l i. WIns an aXUI.lte!y measured 

vo!ume of inJeclion diluted qutlnfnallvdy wilh water to ob\;Utl a 

Tf'JI Diill/ioll having 11 concentrallon auurn."<I to In «tual to the 

meiJHl;O dose leve! of the Standiir<L 

Amiloride Hydrocbloride 

<;1Yr'<~rot>'!!&~ - ..l..01 . ..r.t • ~,..~(> '" """~. C!H~c\N,0. Hel. 2H 10 302, l1 

Pynzinecal bo.\~mldc, 3,5-diamino' N ·(ami.fU)iminomclh yl).(;. 

,hlol", mOllQhydlooh!oodedihydl;lHc. 

t>'.Amldmo·3.5·dlamin(»6.ch!olOpyrai!ineeal\ro~lImide 

monobydro<:hlolide dihydl3tt: I f744(J-SJ-41_ 

» Amiloride Hydrochloride contains nollt"SS Ihan 98.0 

percenl and not mQre than 101,0 percent of 

C~H~ClN?O. HCl. calculated on the dried basis, 

Pat/ .. glng and SIOlllgr--PI':!I¢rve ir. wd!·e!~ C()ntaiMr:;. 

RfftffltCt' ,tand.nI_VSP Ami/Dride HydfCCllforiJe Rt/efM« 

SumtilJrd-Dry lI\;:: Pltl~UfC not exce~ding 5 mm of ma{;UI~' 0.: lOO~ fN :; hO\lts befofle U!IfI{, 

l6rntifical}m,-

A: The mh~rcU ab$orption speclrum of a minel11 oil dispersion 

of II ahiha fl/a~lma 001]'.\11 tht Mmc wavclenglh$.on Ihal of" 

s:mi!lIl. undptd, pl(p3lanon (If uSP AruiJ",ide Hydroch!C/Jde 

RS 

S; Prqr.:r.: "n aql.l,:olJ$ tQltlhC!'> haVIng a known COllccntl31><m 

uf ,dnu) bOf) ~~.;.[ dntilolide hyd,¢(;blOflcie pt'l nlL and dllulc 

'lu.tnl\lJll"d" .<flO $tcpwlS~ wllh DIN bydrncnlolie ;leI':! 100\,)l:1In 

" wIllI"",,! n.,'<'IO;.' ,. ':>JII!;j!!l!r.i!,,:lIl of ;loou~'" () PI'; IXI mL lhe (Ii· 

lr.!v"')<:1 .1t>"'·rll~U~ ~pcctlum ur tn ... ,Olull(m W pI tpiUed p hibib 

mJx,,'<l~ .,in,: uun;mJ <lllht ~~mc w:tvelrnglh~ a~ lhJl "I to 51m,[;n 

wlutl,m or USP Amilolide H.~dr<X'hlond~ RS. CQlwomllanlly 

qlUsUleC, and lhe ft$pettl'c lttsolphvlllt~, clIleu!3Ied 0:) the ,Ii ltd 

. buis. #-t the wavei<::utlh -(if maximum lIb;orbln,e,; aOOul 361 nm 

do nOl diff~r by 11"1Ot(: than) 0%-. 

C It rupcrnd$ t~ the tests for eMond" {! 91) 

AeWit) ·-OI~so1ve l.O g III 100 mL cf it mi)';tul c or IIltlhano\ :11110 

w~rcr \I : O. and lil1il;le wiln 0.1 0 F tochum hyUm:tHit. (j~lelmining 

the end-poinl poh:;ntlcmelticaHy- nOl mOlt tnan 0.30 mL I~ IC' 

'lUlled (o- 1%3S Hel) 

Leuondry~ {731 )-Drv it at a premne not t:l;ceedmg 5 mmof 

mtfCUI} at 100" [01 3 houts' It lo~& UlwtCn I \.0% and 13.O%of 

ils welgbt. 

knkhe l,Xl: ignition '.2& I), OOt mOlt th3D 0 I%-. 

Htlt\! 1IMUlk., Mtlhod {f <VI)' 0.00';% 

Chrmmllotnlpbic purlt~_ 

$li:mdard pr<.'pardtio!ls-Plepuc a f('rits of w!ulh:m,< A. B. C 

D, £. and F. of US? Amibnde Hydrlkhlo-ride RS lfIl1l1U:o:nac of 

metnan<JllI,oo ~h!oro[Ofm {4: I J havtng coocentJaliom of 4000, 40. 

20,3.4, and 2 PS -p<"r mL 1e1P«1ivcly. 

Tj!sl prrfU1~~n'Oti·-Prepari: a rolv.ticn of AutilQflrle Hydtochloride in a mulure or metl',:t!to! and cb!ororolm (4:!) havmg 11 

coocentt3tion of 4 mi pel mL 

ProutlUrf·-Ot;;I; sUitable lhin-!a}er chrcu13tograpbk pbte (~ 

Chrol?UllOgrophy (621»), (:;)lted wit!! a Q,25·mm Iaytl of chlOmatct;!aphle $ill~. tel and j:'f'l"'loosly w$$h-ed wIth m.ethal'lOL bep· 

arateJy ~PCI S-,uL portiont of Sta1f!lard Pf(poNllWru A. B, C. D, 

E, and Fand the Tnt Pr(pwr1(Wtl. DIY the ~p<'}lS with a meam of mllogen. and d""elop the elllortUtoglllffi$ in II wb,tnt ~ys.t(n1 

consisting of IdubyrJrofuran ami J N lImfMlHUlfl hydro:ude () ~ :2) 

until tbe &clvrnt flont ha~ nKrn:d about thl et·foulth$ Mlne length 

cf 1M ptal<:'. RII{l1{We lhe plal~ hom t~ cioc!opi(lg ehambel. mal}; 

the $<lwei'll hoot. allow to Ilir.dt}. and txanunc (hc platt under 

fonS-w,tvtknsth ullranIXet !igh!. tht R{value cl' the PlIn(JpJll q:« 

obtaiMd ftQITI th~ T~.Jt pnfNlramm cwruponds to thil ObtaltH:d 

flomSlandlUd pnperatfon A. tslltnalt lhe !eveb or «elY ad(htltlm! 

$pots o\»trved tn the chromatogr;un of tm: Te!-l preporoll(Jft b~ 

oomp,ariwn I'o'lla the princij)JI l~S in the chromatQElamS of 

Srandard pftptJfa.liotU8,C.D.E,andF: the $um cline iJittmlU~ 

~f My additional spou obJ!;!V«i IS nm I!reat(1 Ihan lhal of the 

pnnciplI! Sp!)l obtl~jned from Srr;.ndard pftptJftlllonBleqlJivalelll 

to 1%). 

A"lly_DI$Wlv~ ebout 450 m{: of Amiloridc Hy,hochknide. ac· 

curately weIghed. in 100 mLof glawl aCdtc aCId. add 10 fill of 

mercurIc aC'ctate- TS and f 5 mL or dtoxant. tina mlr. Add crystal 

viQle1 TS. and Ull:ll-¢ with 0.1 N ptlch!{IIle add VS 10 g blue end, 

pqinl- Pedorru a bhtnk determlnat(oh, and rnak!' any nccuuly 

COfI~-ticll, Each mL orO.1 N pef{;hlonc aeid u tQuiv~lenl to 26.61 

mge! C(,HtCfN:rO. Hel 

Atniloride Hydrochloride Tablets 

» Amiloride Hydrochloride Tablets contam not ies.s 

than 90.0 percent and not mOf!;; Ihan 110.0 percent of 

the labeled amount of C&HliC1N,O He!. 

PlIcka!;ing "M sto-llt!t-PttiCrvt In "'dl·clo~ed COnlillflet5 

Rcftttn« ,taurd--U;SP Affllfortdt- HJ'drochfomit Rt!"rf:llU 

Slondard-Dlyotl l) PIQ.t:Ute nol e-)(cetOin& 5 mm Dr m~ICUIY 11:1 

looe f()! J hours Ixfore lI~IOS. 

ldflofif.cationA; The- Ict.:-ntlOn tlme.:.f the m~)er pe:!;k '" lke dtl00l3l0SlQm 

obuined hom th.., AJ'say pr(panl/lO!ll:!)lfespow.h to. that obumed 

bom the Srflflaard prcparaliQIf 

B: T rilntfel an amounl of fmtly g/{)I.lhd TabletS. equlV~knt 10 

S rna of amllwide h}'1lnxhlorme. to a 2j-mL voIumellte fh~k. add 

methanol to ..-olume, tl'Il.\,.IIlld fillt! _ Se~I(Hely .app!)' to ~L "ach 

of the nltr~le and li Slandard <;.ollitlOO of USf' II.mlbnde HydlO· 

chloride RS ill m(thnool coLt3ming (} 2 m~_pcl mL.loa Ihm-!l,-n 

cnromliloglillphk plare t~c Chr(lmalcp':uph}-" {621 ) I e()3lro .... Hh 

;a 0.25·mm !aytl of chron\lIlOgraphK ~Ihea fcl mixlllre. DevtlQP 

IIx: chrO:T1J.tog<":lft1 in a soh'UIt Wllem I;OIt$J'Ht>).' of l~tr/!.h~~fur1'~ 

and) IV ;,mmOrll<lf''-, hy(jro"id~ t2::': II ,,,withe '"<It.·eM (rOlll llJf 

movcd <1001,11 Ihrt;·f~rl h" of lh~ icntlh of the pl:ue Rt:It1Q"t 1i1( 

fllale If"", tne d,,'cic!nn,· e"~lll\:'er "IHJr) unG C\;lfHln",- u,ukr 

~h"tI.wft'''h:"gl h ,,11, -,V,,;kl l'1h~ ,he it, v..:t!u~ 01 1 he Pllfitl[';\: 

247
,-- ~~-~-.--~--------------------

OCT-19-9·' l,ncD 09:'57 CLltnNlHG1SQLUTIOHSllrtC. P. 1 <1 

41) ,\minQCllpr.)ic f 0}/1(1(11 1,f"'!>llfrrl!'iJ' 

Aminoraproic Add 

C~H,,~O, I)lli 

HnJnQlc ~cld. !j'JmH\Q-

;;·'\m,n<Jh",.o;:lno,e ~t"j 

» ;\minocaprov; ACid ~ont,t1ns not less lhall 98.5 

pcr('t'nt and not more than 100.5 perctot of CijH.13NQ;!, 

'::jlculat<':d on lite anhydrous baSIS. 

P.;cuging :and $I(lrage·_ ?r(strVe l(llillht ';On!allleK. 

Rtf«fll.ce standard_US!' .4mllloroproJ .. Awi Ref"NM~ Srun 

dard-Dryal [OS" [or}O mtntHe'J btfore lltll!~. 

Idwlifiealion-Thl; lnrulled al!sorplion ~p«lrlim of ~ pot.u~lum 

bromic\! dispe-r~oo Qi' il. prevl\lu~ly dr~;l.1 IO:;~ to( }O minules. 

~Mlib!ts mUHUli only at Ibi!: ~ame wavdenglhl:l.~ Ihatof a 5imilat 

ptcpl1tkm (If USP' J\tnlfl;XjprotC Add RS. 

Wllkr, Mcrhod I (?ll); nOI mote Ihan 0 5% 

RtsioQ<l om i~mti!)n (~S Ii: 'lQ-t more thln 0 i % 

Htayy rMlals, Mtt/Jod If {231}. 0.00;;'%. 

o\my-l'nw;fer .tixlut 500 mg of AmiJKqprOtC ACId, act\!raldy 

wdjb«:I. IQa beaker, add 100 mL of gJilelal a«!licuid_ he3.11/<::ill!Y 10~ feet wlUliO!l,and eool ·\dd IOdlopso(nl in500so[ullOf/O( 

cryst:tl violCI lit ebJ01<GbenzCJ'lt:. il-nd tit~te \\,Ith 0.1 N ~l~nlolle 

.J.dd;1\ dio~aJ'le VS 10 It blue end·pOlnt. Pel rm m Q bb.nl: delermi-

!\aIlOr!. and make My (l«"esury CQlrecuOll. Ea(it mL of o. t N 

perehlWlc 3,c,d 1~"'-1Ulvaltnt to I:; \2 mg or C,Hl~NO!. 

Aminocaproic Acid Injection 

It Aminocaproic Acid Injection is a sterile ${llurion of 

Aminocaptolc Acid in Waler for Jnjection. It contaiu$ 

!lOl less lhan 95.0 percent and not more than 1.07.$ 

percent of the labeled amount of C(,HI~NOl' 

Paoogitlg:tlid SIQr.ag~_Pre~tve in ~in8Ie-do~ or mul!iple.do1e 

coltlai1l:tr$. preftrobly of Type I gIJ-SS_ 

Rt'rUfll(V Handa«i-USP .-1mvll)('I!pr»{(" Acid Rt/ntlKe Siand.ud_ Dry:ll [OS~ fot 1.0 mmute~ bz{ore U!;lng 

Idtftt1ne:llloq-r.tl.\.2 mL of tnjt{;tion. added dlOpwiSi:, Wilh 100 

mLor lIcelOM, rapidly :l:t(n-mg the m~~IUle "'~lh a Va.» rod 10 m1$u«: ,;ry~(alli~u.Nn. Alrow the tl1ixt\!te 10 $uod ror 15 minllle& . .lfl:d 

filt~tlhtour:h a mcdium'pofosity, slnHrcd·glu$ hUer. Wasn Ihc 

cry$1:r~ wilh Z5 mt.. ufllc.:!ont. upp\y varou11I 10 u-mOVI! the w-I~'Cnt. 

dlyat 105~ for 30mlnut~:lI'IdeQ'Ji; thO::lnlciuewoblaim:dre-

~PQl1d!; 10 Ihe ld~1fIlJicanolf /(Sl under .. ·4!tn/!!Xaprou: Add. 

Pyrotm~AmlnOC::ljlfoic Aeld Inje~tlOn. dIluted, If nect15l!IY. >\.llh 

WAler for il'lJ(cw;>n to ~ oo~cnt(illk>n of 2X! mg p.<r mL. mecl~ the 

r~ulremellu oflhe fVrQIO'I Test {I:; I J, the tnt dose !l<-in~ I mL 

p<r kg 

pH (191}' ~t"'cC'n60Md"i_6 

Olh(r rtqUifl:flWftl$-lt m'::-cls Ihe rcqlllrCrn~!1l~ Ulldtr IntN:w,J4S 

(I) 

AS~y- Tnun(er an uceun.tcly measured volume 0( Amll'!OC<\prok 

A\;:d Inp::cuon. «jul'valent tQ 500 rng or amm<J<;tlprOlC "'\;ld, 10 .. 

b.::Iktr. add 100 mt.. of gladal acelk add. ml~. J.nd prOCted as <:Ii, 

,...CleO in lhe A_Uov u<i4:r Am'tlfXopro.c A .. ,J_ beS,IMlng wilh "Add 

10 d~?1H or J. [ in 500 wluhon "r ~rY"ilal .'Okl in chlorob(n. ~erle 

Aminocoproic Acid Syrup 

11 Ami"ocaprOl~ Acid Syrup conlJiflS not k:>5 IIk1n 

95.0 percent J.nd not more than 1 !5.0 petcent of the 

Lll;ekd amount '1f C6HDNO~. 

P:I;cueing "nd ~ol:l.gl1-PI<:::~~lve li1' tight com;l.'nCl'$. 

R"r('lalcf' stambrd-USP Amiflo<:a-proic Arid R(J .. reri~'" Slan.-

IIMII-Dry,lI 105$ for 30 mlflUIc.1 beloH' uSing. 

USP Ul 

ldtnhfi<lIliOl1 ~t.~ ",:X",I I '! <}{ "m·",.·'h~n~". "!t,n l"lt"'~tly _,~d,~ 

,IHCf.,·,·j,v"",Il:.',-n7(n;: ~.1lt,)rh:~c'h,,,,,,,, ~e-,;n) ''',Ih ~b<~,-,\ :0 'Ill 

.,!, ~ ,'\ h~drocld""e .,c,d "',, I (Xl"ll L t;.." kr O~,'~n' "nu J',,''''N 

Int "'<.lr~~chlvn( ",,·,d. ",no '~",h the cnln "ilh five H).nd •. """iiI)'" 

'll -ktller. cteLanllng unci tJm:,lrding thc liquid (QIIOW1~!t ."Id, W;a~illn&. Plac" Iht w~h«i r<:>-'n ,n ;J. gta~s-slopp<:red. 115-ml 

can!C:l! llisk, ..!Mi add a ~olume or Syrup, cqUlval(nl to aooul 250 

mg or ~mlnOC:.:lprOll) ;J.Cld." r,d 10 rn L of water In'>tll Ihe s\opper 

In thc n;.~k. Mid ~hajo;c by m .. "hanicJI mcan$ (or 30 mlflUln. 

Tr,lfi~rer Ihe man ~Iurry lOll. medium-porosity. 'Inltrw·,llI$$ fuor,eI, 

"'a!n WIth aboul 100 mL or ";l.1tr. <:rp!y suclion 10 fI!ta,J.1l<.! d=rd 

lilt "'3.5hln8:. !'1~(1; a lOO-ml beaker under Ih~ Slem cflhe funnel. 

add 10 mL of I IV hydrO{ftloric ;:;cid 10 Ih;: .6;,." slir fur 4 ro ;. 

nl1nUlc~, <Inti Dhtr by :applYl-:lg ~UCII"!1. {;v~pI'Irale Ihe filllMC (In 

a steam b~1.h 10 drYlleu. dr;.' ~I 10," for I hour. :ln4 ewl: the r<:~' 

idll~ $0 obl~ined It'JNn(j, 10 Ihe M(lfflfi;:al/cn rut v.n4\':r ,-l""troeopr01e And 

pH (19t) belwcen 6.1 and 6 6 

A_y-Transfer:.l.n lie<:ur~leli' measured ve'lIm::-of Ammoc~ptOlc 

ACId Syrup, ",quI~ak-nt 10 .. bolll 250 mg 9f aMlwxaprlM' aCld.!Q 

~ 250·ml b«ker.:add SO rol of tlaC1;l1 "celli: aCId. tnIX.:lnd pr-oc«::d a3 dlN:ettd In the ,1f$UY utWer AmuwcQ'.urofc Ae,'d, b<:gillning with .• Add 10 drops or a I in 500l'Ohnlan of crystal Violet In ehlo~(l· 

rene:' 

Aminocaproic Acid Tablets 

» Aminocaproic Acid Tablets conlain nolless lhan 

95.0 percent and not more than 105.0 percent of the 

labeled amount of Cf)H I3N02. 

Pad.lllin{lllmi Sttn"!l:t-Ptesuve in lIght omraincr$, 

Rtf««t«: Stam.nl-USP AmCrnxapr(>Je And Reft'rtru:< Smn. 

dard -Dry at 105-~ ror 30 minules berore using:. 

ldeaurlUtioo-TrillJfate.2 Tllblcts with 10 mt. ofwatef, and filter 11110 100 mL of jettone. SWIrl the mll',lure. and allow 10 su_oo r",{ 

!5 minoln HI compicle <:tysuUiz;uion. Filler Ihw!lgh a mi:' 

dium·pormtty. lillleOO'gJan friter. and wuh Ihr Cly!lab wun 2'5 

mL Qf act'lcne. Apply vacuum 10 remove Ihe $Ql.\'tnt, then dry at 

10:;" for 30 minules, ar.d t<X?I: Ihe tc~idue w oblamed ropar.{h 

1'1 th" fdt'nl,1lca1ir>f/ r4~t onder AmltllXilpn;i .. Add 

~{711}~ 

Medium; water: 990 mL 

Apparatus [ 100 Ipm. 

Timt,' 45 m\nule~. 

pH? 5 wawbuff"r-Dinoll'e (, 1115 gofbmtc ncidand 7930 

i{ of polassium clllOlide 1n about lOOOmL ofw!!..£(. add 60 mL of 

I.il N mium hydl'l)xid<:, and. mix. Difl.lle wl\h waler 10 1000 mL 

mm, \1M \ldd 1.0 N sodium hydroxide. If nc!Xssary. 10 lIrljlln 10.1 

pHof9.5±01 

Stamiard pnportJtron-/)b;uAw ar. a\:C11taltly 'j!."'i~Md qll3J1\ny 

orUS? Ar.Jn~prok A .. 1rl RS In waler. andciilutequanutau~tl~ 

wllh waitt 10 oblain a $Olulion haHng a kno"'n C(>(leentration of 

;J.!)<)!I\ 0 5 mg pn ruL 

hcu:dUr("-ln{l) Ihr<:e ~ep.rale 5!).m.L ~clumo:tri<: flub pipel 

(<1:) I (nl ora filtered portio::: oflherollllwn undn 1~1. (b) I mL 

of the SrandtJrtf preparcriOfl. /l,M (c) I m/.- of walu 10 pr(Wille a 

hl.tl1k. Add 20.0 ml of pH 9.5 /}Qrau buff(/' ami 3.0 mL of freshly 

ptepar~ jJ-l1;lpfllhoquitwne-4-wdlumsulfooaleroMion{Jln SOOI 

to eneh, ~v ... rI to mix. ilnd ?l-;!.ee Ine 3 f!\lsl<;s m.;1 I'IMcr blUh nUill'lI:l.ined ~t a lempotr.l\ure of <i5 ± 5" JM 45 mlnUln. Cool. dill.llc 

caeh with waler 10 volume. and !1m:, (fflermll'le the IlmC\l!1t of 

(~HoNOl di5SOhed rrom ~blorb:!.I'\;I;$, '!It lh~ wavelenglh or 

maxImum lbl:Qrb:II'l~ a111OO1l1 460 nm. cll1am«! rrem the Wil ml"lion 'n eQmpan!OO with Ihose ... b(,ained from Ihe SU.I\dlrd wllJlion. \l$lng lhe blal'lK. 10 set Ihe Inm umen\. 

To!nan.fu-N\lt I~s ~han 15% (0) or llie il!olxlcd umO<Jnt of 

(~KllNO:- ;~ diswlved In 45 IUlnl'to:$ 

U.-»f«mity of d<»:l!;:it lt~lt~ (905)' meel lfte rcqum::mcnl~ 

A~say- WeIgh :;nd finely IlOwdet 1WllC$5 Ihan 20 AmJ~prole 

ACid Tlibkl~ TrJ.Mftr nn :J.cc.:!ur.llely weq;.bed portlQI'l of Ihe 

p"",dn, cqlll~illenl 10 .llNul 500 mg of l\m~nOCJProlC acid. I(l' a 

beaku,:I<id about \00 rnt.. of glaeil-I :u:etl(l;lQd.l1ell &e1llty IOdfro 

WlutiM. mId rocl. P\(KCed as dirCCled in the A:say under Aml-

!!«'a17"Ql(' And. ~ginnlflZ wnh .. Add 10 drops or J. I it\ 5OOro!lIllQ!l 

of cry~I"1 ~Klle-I in ebiCfob¢I'ltenc." 

248
• 

i' 

f 

i 

I 

i 

, . 

• 

. , . , 

! I 

~_f; 

--_._---------------

OCT-t9-94 NED to:Ot CLEONINCtSOLuTtelf$lINC. P. t s 

uS? \.\1 i I):> CMW:lI'";t I iJ/jiri(1i _!'dvfJoSmphs 

;' "~to (lr<'fMf(1.r{rm-rrcpllrc co, d,,~ .. f,,-u tv. i,,_,u, /"nl"~"I'''-'t 

." :11.' f!-'<f' /<" I",,,f i<.'ilN,J\' ''''lh~,,,,<,Jt'' ,I, "I <1/11 <::f I.tnJer C,H,"'w 

y"",udl) 

P'''f"Ju,,.-Pir<:[ 10m L t,l" .-ina r ,"'({7i1".:I!'Wf IntO 0. suJlJb1e ~1:nk >.:()nt;limng 2 mL of FUN,' .;hio"d;t !Olulrt)fJ and l1 mL or 

hydf«hJorl~ aou, Pnxcea ~~ U;ltetro te.- fNxxdure m th'l: Auay 

lor Nlf(arO$fdn undcl Ca$<:ara Sn;:n:da. il(ginrung. \,.ith "AttJ.ch 

,l \.'Ondenstr MtMlg.{{! rot rdlu~\ln&. and he.lt ({lr J hours," t'~CtPt 

10 n::poratc;! t 5.0-mL IXlfUOO 'Gfthe carbon teU;tch],;ride wltttioll 

,nHead of ~O.O mL C.ltcut:m: ~hc 'il:Hllltrty, rn mg, of tOla! hydroxyanthl:!;\."tnl: ,jerl"all'<:~ in tIlt' portl(»\ <}fT .!bktJ; takl:D by the 

:01 mub 3 333t2 gBC)t,1viAs). in whlth ::'.88 rs n <.'(lmp<l5lte of the 

r;ltro of the ml'lloeutJr ""eighl.1' aod .l1$a), rnpofl1ie f>ll.:tOrl or e;:;:s' 

e-arOSltic A reJ;l;tive to uanlhr<m. C.s tb.e C<)ncenlr;l;tiOri. rt! J.tg r-er 

mt.. of US? Danthwn RS In lheSlaudani p~{ldrl1f(O", Mid Au a.nd 

liS Jre the abWrwlltt:$ of the solutIOns from the A'HGY pNpiJr,lriOfi ~nd the StGrrdaM p!'tpnNlJI'on, respetli~dy 

Cascara Sagrada Fluidextract 

» Prepafe Ca~ara Sagrada FlutdCrarac! as foUows, 

To 1000 g of coanely ground Cascara Sagrada add 

3000 roL of boiling Water, ffiJX" and aHoY> to mal."erate 

in a suitable percolator for 2 hours. Allow the perco· 

lation 10 proceed at a moderate rate. gradually adding 

boiling water until the drug is practically e;r;hausted of 

itS active pnnciples. evaporate the percolate on a 

water bath or in a vacuum still to not more than 800 

mL. cool. add 200 mL of alcohol and. if necessary. add 

sufficient water to make the ploduct measure 1000 mL 

Mix. 

Packa;il!t ad ~Pre:>erve illliJ.nt. !itht·ral~lant mntamas, 

anU li\'Otd \:Jtpi»Q;((: to 4itt:ct $Unlig!'!t and to eXCC$sive he:lt. 

Akolwtrontent. Merhod f ({i! I); between I1LO% and 20,0%0£ C]H~OH. 

Aromatic Cascara Fluidextract 

» Prepare Aromatfc Cascara Fluidextract as follows. 

Cascara Sagrada 1 in very coarse 

powder ...... ,. 

Magnesium Oxide 

Pure Glvcvrrhiza Extract 

Sacchar·ill· ... , .. _ 

Anise Oil ... < ••• , • , • 

Coriander Oil 

Methyl Salicylate 

Alcohol "" .. " 

Purified Water, a sufficient 

1000 g 

120 g 

40 g 

2 g 

0.65 ruL 

O.J5fttL 

OJ tuL 

200 fill 

quantity, to make ........ Hloo ml 

Mix the Casc:lfa Sagrada with the- Magnestum 

Oxide. moisten it uniformly with 2000 mL of boiling 

water, and set it aside in a shallow container fo, 48 

hours, stirring it occasionally. Pack tt in;1 percolalor. 

and pen.:olate with ooiffllg Watet unti! lhe drug is exhausted. Evaporate the percola!e, at a temperature not ~x'ceeding 100<1, to 750 mL. and at Oilce dissolvc in it th~ 

PuteGlycytritil.l. Extract. When the liquid has cooled, 

:ldd the Alcohol. in which the Saccharin, Melhyl Sali • 

cylate. and oils liavc been diss.olved, finally add sufficient W(lter to make the Aromatic Fluidextraci meaSllre 

1000 mL. and mix. 

p~~ lI.nO ~flmIlr:t'"-f'~C'M:n"t: lfl tighl, !ighl "r<:si~\i:\.nt cI)tlloiner$, .. md ;rvom e;O:P'QSurc to-diree. ~U!lligh! and to e!:C\':s~i~·e /)1;a'-

.\t",bllt ~<J<ll,",d {6, t , ~Cl,"C,,"1 I Wf, .wl! :2O"t v' ,::t t ,01 r ,k' 

:,rm,,-,nl b.¥ rf", gd>,hl(mj ,-hrd"'''l,';!ruph:<; m~1h,-,d ." 1,'." '" '"'' 

u~ed;\~ rhe '~te",al <llnCard, 

Castor Oil 

n Caslor Oil is: the fixed oil obt;Jineo from the seed of 

Ricirlto ('Omo/l(ftrs tinr\e (Fam. Euphorbiacc-ae) 

Packllgmc ,and uerac<:'-Pr~cr"e JI1 l,&hl <:oilw;ner~. :tnd :\rOlo e!:j)Q~ure to C1W:$$jye tle;:!l. 

SP«'lfic &fality {Sol t)· !.>W'JC\:.iI 0.957 and 0.961. 

Dtitinctw. frl)m _t olher frxci oi15-!t rS ()nl~ {»Hly ro!ubk III 

ro!vem heA01(t!! (distinction from moSI OIher fjxrd OIJJ}, but Jl yrehh :: dcr !;quid wllh .1!l t:qlU! volume of akohcl (jordgu fixtd /..'1ls} 

Huty _tilb. MnhOti If i 2J 1) ~ O.OO!%. 

Fr« fatty adds {40!}~The rt«: fatty lI~lds m 10 i fequire for 

neutra!izatioo Ilot mote t};sn 3.5 mL (If 0.10 N sodium hy· 

drOXid¢. 

Jftd(ol.}l llldtk-Trllfl.).fer Z S. aCCtlr-.!.leJy weighed. 10 a gJa~$-

51orperci. 250-ml.-("oote:l! Oalk. add ~,(l mL of a fre,h!y prtparcd 

ttu:\turc of I ~o!unwd acetic anhydtk!e 3nd J voJum($of py(wi,-,t-. 

l-OO SWlJ! to mc..:, Cl)Ilnttl the flask tOil reflux ,.O/H.Ienx:-r, and htlt 

00 3 neam bath fer 1 hoor. Add 10 mL of water IluO'Jgh thee9fl. 

denxr, ~wi;llQ mix, /)mn en a stc-am both for an arlditKlllal 10 

mmutu.and allow 10 cool to r-OOm temperatute. AdI:I throus:h tM: 

rondenur I:; mL of nOfnul butyl zleOOcl th!).1 pn:"lo\l~!y hM been 

neutralized to phtnolpltlhakm, remove the conden«:r, alld w;nit 

the up«thc«>nd.enu:;r and the $Waofth<: fluk. "'Jlh lU) additional 

10 mL of IlwUa!iZeG IW{Jnaj butyl alcohol. AIM I mt.. ofplKnol. 

pltth:l!cin TS.;t1'ld tiltate with 0 51'1 a!eofulEc poumum h~'UtOllioe 

VS to lI. flint pink end-point. ru-folm a: blank determtnauon on Ii S O-mL portitm of the aceti..: anhydridt~pY!Jdinc mixture To 

detennlne the amout!1 of free ;led rn the CMtOf Oil, weigh attu, 

ratdy 10 £ illlo a 2~Q.mL conieal fluk.add 10 mL;)f pyridine that 

prevlOus!y has Mil neutraliud to pheMlpht~!tio, $ .... rr! 10 mr:t,. 

add' I mL ofphcnolphtlulcil'l TS, and titratlt wtth 0.5 .v ako!wli.; 

po!:aulum hyorot.lde vS (1):1 !:amt pink cnd,polnt. ('akub,te the 

hydroxyl value by the fOlmula 56-.!NIA + (BW/DJ - C1/W. in 

which N is the oormality determined or the akoho!ie poW$tUI'tl 

hycira;o:mc :ohlllon. A is Ih(" Valllmt'. in mt.. a/.O,s N llk"obolic po. 

ta1$ium bydroxide cnnsumtd by ti\¢ blIl.(!K. B is the vol.utru:, m rnL. C~nllllT!Cd Jl! Ihe free-acid tiJr3.tien, W i5 tM we-ight, m g, of Od 

taken. D is the \'idgal, in g. uf0:1 US«! in the ff«'>aod tma.llO!!. i!'ld 

C h the volume. il\ mL, cOIl$um<ed In the t&!f\p!~ HI~3.tl(ln. The 

hydroxyl value l~ between 160 lind !65. 

Iodine ~alue (401); \x:tween 83 and SS 

S-apOnifkalieft YIlWlt {401 >: l:ctwetll! 76 and 182 

Castor Oil Capsules 

» Castor Oil Capsules contain not less than 90.0 percent attd flot more than! ]0,0 percent of the labded 

amount of C3StO! 011. calculated from the test;; for 

Weighr varia lion and Spec.fic gm(liry. 

P'"claging and $tOTlllp'~Pn::~lVC m tlghl (OIIn,mer!. ;:lder;)bly 

.H ccntroJkd 100M temp<:raturt, 

l<kntifiutiOfl-The ,nfrlired ~I»orptron $pectrum vf J ~tut:on 

~fer:'>ared by dih.)tvrng the contents (If Capsules in o:/)Iotolcrm 10 l rorn:<:nrntioo 1)( abour 40 me <lfcastol OI! per mL D I-mm rodium 

chtcride utb l!cmg u}<.d Jl1d cnlolclorm belliS (J~cd , ... llle blank • 

exhibit$ ffill),lma am.! mrnrffia "nty at tIM: !amt Wayel¢ntl tIS 3.~ ttl:lt 

of a l!lni!ar p;'t?3.ratiOfl of Cll~wr 0\1. 

UnifmmJt.r6f ~q: .. 00115 (905)' meet t~ requrfcments. 

Other «qIli{~m~The contcnt$ ofCapzulc:; meet the leqUll(:" 

ment~ Qf lhe t~t$ fvr Sp«ijie gl'lf':rl,r. HydN1.1:},1 <·aflll'. loJi.'!" 

(N/illt. ;': nd $cflt'lli/icmltJft J:!l2fr,~ IInder C CJf!)r Orl 

'----~--.------.. 

249
J 

I 

\ 

• 

OCT-19-94 l.u;oD 10:05 CLEAHIHG!SOLUTtQI-lSIINC. >['!6243.1'$27 

IlSPXXf 

. Castor Oil Emulsion 

» Castor Oil Emulsion contains nOl less than 90.0 

pen:tnt and not more limn 120.0 pcreenl of the labeled 

amount of CaSior OiL 

PACkaging am;! 5ton;I:'-Prncrv,= In (Ighl containers. 

ibtificaUoo-Shakc ",elL and place about 10 mL In "II lZ5-mL 

separator. Add IOmL of I IV hydroch!ork add and abm,1! 20mL 

of soh'em hexane Sh:kt vigorously fer 2 1<:' J minutes, allow the 

Illyen to Stfniu.tc. disl.':ard the aq\leo~ 'PhtSc, lind filter the upper 

13ycr th(ou~h anhydrous sodium sult.lIe i(lto a smOl.H ~akc; 

EyaporJH~ tbe ro\vent oll;l steam ~!h, lInd to the IcsidllC add J 10 

2 drOp$ ofnMunc acid: :. ted color HlUIQ.les the pretence OfCltiIOr 

oiL 

AtiaayInlt'l'1Ia! $i4ndGfd SoiulrOfl-Jp D JDO-mL volumetric fjMK cli.- SQi\~ a\):)ut !.2 g of di(2.cthylhexy!} ph!haJate In chloroform, dllu!t 

with chloroform to volume. lIf1d mix. 

ChnmI(ltotNJprnc system ('$«' ClvtmUJlogriJphy (611 } ,-Under 

typical condltioM. the instrument IS tqUlppd With a fiam,,·jnniUilO1\ dd~tQr and-contains a I.8-m X 4<mm column pitcke,j with 

liquid phase 025 on $Upport S1, aoo oonditloo(o by fluihing with 

helium for 1 to $ millutes. then heating wIthout furth~r Or.uhlng.at 

2,509 for not ku thiln 30mmuto. then cooling to room temperature. 

and finally heatint wbile helium is. nowins thropgh ilat 2S0· fot 

not ten rhan 60 minute$ Durinl} the cbromalographic %p3t3tiC'f;. 

the ~1umn is malnuinw at 245" .and the (Iljcctlon pon and detector block ate maintained lit about 300e. The camet gas is belium, and its flow rtle i'adju~ted toobtail'1-l> peak dpe to C4st()1' oil 

about 5.5 mil'lutesbfict mtroouctioo of the specImen and un mternal 

$tandard pea): about 8 minutes after introduction of the spec· i~n. 

Pfoudw!.'-Transfcr an a~uratdy welsh«) amount of the 

well·shaken Castor Oil Emulsion. equlva!ent !O aboul 100 m& of 

cutor oil, to a long-nec);., round-bottom, 1OO·mL boiling fiuk 

equipPed with a tuitablt reflux condfMer connected by a SlOu~· 

gla$j. JOint, To a sl.Imlar Oa~k traMfecr about 100 mg of (1tstor 011. 

aceuratdy weighed. til provid~ the ~talX4rd urry out the fol· 

lOWIng steps on each. Add 3(1 mL of a mi,lturc of 300 mL of 

methanol and 3.1 mL (If $ulfllflC: acid. reflux !n a water Imtn 

·malllt3.med 3! 75" !O SO" fOl 25 boun. cool. lind rin~e down the 

condellW with II} mL of water, Transfer the COnlen!s orthe flask 

10 a I 25-mL ~eparator with the ai>! of 10 mL of .... "t!er. RinK the 

-condcnzcr and the fiadt Wllh 25 roL of roIvent MUM, and tTilnsfer 

!O tnesepaTtw. Shake tht-St:ptrator for 2: minute" and draw off 

the aqueous layer- into 1\ ~ 125-mL separator. Add 20 mL of 

rotvuIt hex3.(te to tbe: ~d stpaU.lQt. sl\3ke for 2 mmutes,.tltscaro 

the aqueous layer. and tramfer the solvent hexane layer 10 the fitst 

.$epaf3!ot with tbe .id or)(l roL ofrotvem bexant Wash tbe 

comblnw extracts wilh thn::e S-mL portklns of wllt(:f, di~Qrdlll& 

the wuI'UI'l$$, artd tramfer the w~hw extract to a 12~mL oo1ueal 

Oask. through a funnet conlainm.e .:anhydrous slXl!um sulfate. WIth 

the aid or2~ mL of solvent bexane Place the flask III II h01 Wa!er 

bath. and evapatat~ with the aid of a curren! of IIlr wdryn.:n. Tothe residuell.dd 10.0 mL of Jillrrna( S!(mdard Jq/Ulion, and mll>; until 

~oluti<ln (s wffiplete-. Inje.;t QOOu! ~ pL in!o the gas chromato61apk 

and measure the hei8hu of !he pe3k$ due- IO castor oil anc intcroai 

nandard. Calculate the quanmy. III mg, 01 c!!S!or oil ill the p!)rti'M 

oLEmulswn taken by the fOIOlUla qA'f..,,/Rs). il) which '1, 1$ tM: 

.... elght. ill mg. of «stO! oil taken for thoe starnbrd. and RA And Rs 

are!ile ratios of the heightS of the pea!\sdue tOC!l$tor oil afld illtetn21 

zUnihrd obtained from tbe Em\lb:on 3nd !ht sllndud. res~­

tiv<::!y 

Castor Oil, Hydrogenated-:;C(, Caslor OIl, 

Hydrogcnaled NF 

Castor Oil, Po1yoxyI35-sel' PoIYQ;;yl 35 Castor Oil 

r-;r 

Castor Oil. PoJvox~'1 411 HvdTt)genttteO-5;;'(' PolyQ/iY1 

40 Hydhlg..:n:uLc \..,[:-'I<)r 0,; '- i 

Official Monographs I C'ffad()r 169 

Aromatic Costor Oil 

» Prepare Aromalic Cast(lr Oil as follows. 

Gnnamon Od 

Clove Oil 

Saccharin 

Vanillin .. 

Alcohol ._....... . ..... . 

Castor Oil, ;; sufficienl quanrilY, 10 

). mL 

mL 

0.5 g 

I g 

30 mL 

make !OOO mL 

Dissolve the volalile oils arnJ lile solids in the Alcoho!, 

add the CaslOr Oil. and mix. 

Pllclorgll1& and stt]rag~-Pre~t'rve m ught <XIn!:linen. 

Aloolro! conknt. Muhod I {51 If: belWUil 2.0% ano 4.0% of 

ClH~OH. 

Cefaclor 

,~ 

~ Q.". ~~Cl 

fi ... I .. _-.k -' . ".0 \':::2' I tI ~ ~ -. CI,HI~C!NlOtS.HI0 38S.82 

5.Thia.l.aubicyClo(4.2:0joct.2.cne-Z-carboxylic acid. 7-

[{aminop~rlll.cetYI)aminoJ·3·ebloro.g..oxo-, 

motlohynrate, {6R-(6a.18(R·JJJ .. (6R.7 R)-1-[(R)' 2~Arru:ft(» 2·phenylat:ttamido H"",h.lcr~,E·o~o5-tr,ia.I.;u:.lbit:yc1o {4.2.0 jOl.:t-2 ·ene-2·earbo~yh\: aCl.d 

monohydrate. 

3 ·Ch!oro-7 -D-{ 2-pheny Iglyclflll.mido)-3-ceph~m-4·catbo.'l; rllc 

aCId monohYdrate 170J56-03.5\. 

AnhydrQus 3£1.81 SJ994·i3-J. 

»- Cefaclor has a potency of nOt [ess than 860 JAg and 

nOI more than 1050,ug of C n H I"C1N30 4S per mg. 

Pllcbginz anti $torage-Pre~crve in ! Ight contaloe~, 

Rderfll« s~fd-USr C .. fador Rt:Jm!flfc Srandard-Do not 

dry bdore U}lIlg. 

ld~ntifieli\tioflA: The mfrarcd a~orp1loo ~pe.:lrtlm of a Olloullt oil dl5pt'Ulon 

of It exhibits ma;xlnu. anly at the :.ame wavelengths as !ila! of 3 

titnl1at prepaTJlUon ofUSP Ct'faelcr RS . B: P!llet a suitabte !hm·\ayer chromatosraphi~ pale {set' 

Chromllwgfaphy (621}) ccatQ(l Witb.a 0 2S-mm layer of bindv· 

ffee silica gcllo II chamber con!!umnS 11 mtX!ur" of n-hexane and 

!ctrnde...""ilile {9!i :5} Ioadcpth. of abou.! I cm, alloW the sojVtn! fronr 

to move the length of the plate. remove the plate from the cllamt>tr, 

and allow the w1¥'ent tOeVaponite 0" this pbte. spa! 20 #L each 

of a wlution of Cefae!or in water ront:llfilng.2 mg p¢r mL 10m! a llmiJarly prepared S!l\rtdaro SofUUOll of US? Ctfac!ot RS. Allow 

the $~U; 10 dry. and deveklp the ehionutogram HI a $olve!lt synem 

CtWlsUngofO.t M Ciui;: aClo. 9,1. M dibaslC$\1diumpltosphat~.and 

a I !n t~ .solution of nmhydnn In acetOne (60.4(J: LS) uut-Ii Ihe 

solYtnt front ha~ moved abQ\.!t three·fctuths of the kngth of the 

platc Remove the plate frem thl;: deve\oJ)!ng chamber. mark the 

ro/vcnt front, dry the pl!te for 10 minu!es:1I 1100 • and c:tamine the 

chroma!ogrorn: the R, value of the pnncipat 'flO! obu.in«i from 

the t~t ~O)Ullcn corrO:pOl1ds to that eb!iII'ltted frum !ilt Sund31d 

WhltlM. 

Cry!>ullinit)' {695}: mttlS !he rcquirenY.ntS. 

pH {79t)· betwecn 3,0 and 4.5. In an aquoou~ ~uspeMio;l con· 

taming 25 mg per mL 

Water. Me!n,cd I {921}' belween },O% and 8,0%. 20 mL of" 

mlxture of Qrbon tctraeblo(;cit:-. enlOftlform, lind mtthli!'l6! (2. '2'! J 

bemg u~cd in place of mt!hJnoi It! !hc !l!I;!:!IQIl n:s~el 

Aul'!"-

S!/mdard p'-q'araU(T,,-Dl~~oive .:. $uH>Jble yU~f<!HY (If \)SP 

Cd'llclOf RS, lIcclJr .. i<!h w(,gn.:o. In BuJJt:; ,'" .; I Yo, "'hv>pha,,' 

250
• 

• 

" , 

OC T - 1 9 - '? 4 WE l) ! 0 : 08 C L £ AH I tlG 1 SOL U;T~'~O~'~' S~'-'~N~C:-, --:-:--:-:-:--:---------------- 61~2~3152T P.t? 

l~"l'.r, 

~s;,u-- '\""~" «,",,,r.ll,'j; .1L,<>ul ~00 ,l1g, pr~";,)u}l)'" ,,(,0:4 ,11 

!20" fgr'" hOlJt'. H.111~I<::r :0:.; ,u,t .. t>k eCfi1"-I~~r. :;nd dl~Wlve ltl 150 

nIL "r '~~lcr <on!.lln'n~ : ml d"dilutt<l hydrochlorIc tie,a Add 

ii onL "I .....".!i"m ilydm~,d" TS :;nd JOO me of hvdroxy nlphthO! 

blue lI:ldl<::W;\1. J<ld lltr;!tt ','<In 1)05 ,If di;cQlum tlhyl~!1td;· 

.'mln<:!e~('Jzcet:!te V$ COlli Ihe wlulion II citep blue In N!ot. &;.ch 

<nL <If O,OS M d::odivm elhyJtnedi:lm,tk:'!e<ra;}u!a!e JS (qUiY~ len! 

to 10.9! rna of C,fl \nCJ.Q~, )ll,)t ku tll;!11 Sl8% IS f')uf.d. 

Lun;HI drY'rI,g' OJ 1) _ Dry i I :\t 12f}e (or 4 hours: illO';cs n.:-- [WW) 15.0'Ji, .:tr.d :30,1)';. of iu werght. 

--11'11111 ~~,\dd pl\~nolphtha!<:;n ts to 10 ml~ of:l. I \n 20 wlulltm. 

Jf>'.! r,n'ale with/} 10 tv wdju1I1 h~IJf!,\,,,iJe: tim more thl.n 0.$0 mL 

I~ required 10 produce a pHlk (olor. 

If til".\' N~r<lls (Rc~Stnl tut)-Di$$"lve ) Z 1/'1 1.~ ml of diluted 

bydrochlc.rwaqd, dilute W\tl! W<lICr 10 40 mL, ",nd add 10 mL Qf 

hydr¢i~n ,ulfilk TS: .lny brown eelor pfHduted IS Mt \liIrket Ihan 

Ihal 'J'f a eoolrol tontalning 0.02 mg of added PI> «)'002%). 

UaIIf(JII<N111nd afkafi .t41(r-~1r>; t g with 40 mL af w;:,tct. 

~arefu I)' ;).Q.d > mt,. Clfh,-drQ¢r,\Qric ;l(;ld. h-(al dIe ~utiol'l, brn) fur 

I minute, ami add (;1pldly 40 mL of oXJlic<lelu 1$ Add immediately to the Warnt lnlXlu(l!: 2 drer.> of mdhyl red 1'5. then add :un· roonlll. TS drop\>!M;, from a bu\tl, until th-: mbmHt t$ jU5t al\;J.line. 

Cool to (oom Itmperarute.. \ranlfer !Q .. I OO·nJL EI a\!\lJ.tetl e)limkr. 

dilule whh "'liter tl) 100 mL mix.::tnd allow to~lamf for'; hOlm (If 

<YtefrughL fih~r.llod !tafl$fer 10 a pll'otinunHflm 50 tnL oftheeiear 

filtnl1e, lowhlf:h bas beenadded 0 51l1LoI sUlfune ae\d. f;VlPOlatc 

the mlxtute on a ~ttam b-lth to a small hulk. C;uc[ully herd ¢\ocr 

a free n~mf!' to dr:o-ne'>$. and conllnue hU!il'lg 10 compkli! d1xomposill(!n il;nd ",,!atilmlllon of llmmOllium s\\lh, Finally '!pile the 

re$ldue O1t 800 ± Z5~ for 15 mllluJey lht reslQue wtllh!!1')t mort 

lhan 5 m>'lll%l 

Vclotfl!' janr c(ui-Sor lOOUI ~,OO mf; 'hilh I rnL of ~l$lfurjc 

~(:,d, Jnd warm, I he loi:tlure do-es nOI (mil al'liJdor!Jf ,01"lilt faltv 

'l(:ld ' 

Calcium Nitrt~. C3tNO)hAH:0--:n6.1S-U~t ACS rc::.gel'l! 

gr.11e. 

Odd-um PllntG1hm"I_U~ Caln~m f'o/!!"rh"nJt .. (liSP 

monograph) -

Cakiwn P-alltotMlIlille. Dt ... lf'O..-lia CddYm P(ff:(O(hCI'lnte 

\ USP m¢"og.ravh). 

CAlcium Sl1lfale. CaSO .... 1H20~ln.17-Uu ACS rtagem 

traM. 

C1kiwn Sulfate'. Anhydroo" CASO .. -136.14-11 N-nforrns 10 

Iht rtqlolltemt'ntS of ;ht ACS I~U fl,)l thloridc, magnesium and 

11kall ~lts.,1M heavy merills undf!'r ACS reagent gl':lde Catc;um 

Sulfate. 

LNS 01/. rgrHrtOlf-IJlllte I g. accurately wd&hed. at 500 ± 25" 

10 e»n$laJ)t welshL ,r loon nOI mor~ Ibn 2_0% of ir~ v.e.)!!hl 

C.mphor-U~e CmNpn()r i USP mOnograph). 

dl.1B-C:II~ulfonit Acid. C loH:60.,5-nl.2'1-Whitf!' to 

"ff-while, ct)1t1Js Of powder. 1$ ojXlcally Inaeli~t_ 

Mtfnngro"f( (7JI L deC(lmpo~.aboul 199". 

Cltpryl Atcohol (l·Oaanfll). CH.l(CH,hCHOHCHl13\l.13-Clcar. eolc--!lC$s. oily llqmd. ha~'mg a pungent. lrOtl1aH( 

00Qr. !n$\i!uhle- HI water. Mltdtile "'"h O1WOOOI. with bentt"e, and 

wub ether Sro:;Jfi~ gr:lVity. alXlut 9 82. 

OC1/illg ""!'ng" lReilsenl I«n)-Not I(;H Ihan 9<;% diSlill bt:tween 11.!!~and 131§. 

R,,/r-cC(1l!!!/lfdn {Stl} betw;:en iA2A"l1d 1.426at2{)" 

Rlts,due en rt-ap<N<lItan- EVllJ'O'".:ne 11 mL 0n a $learn in.th. Jlmi 

dry II at 15(l~ fer 2lw\1rS' Ihe re!ooue ",elrh~ not m<ue Ihan LO mg 

to.ol~l· 

Wara_~'IJ~ 5 mL wl1l1 20 mL ~1 so-i'<-:nt aeu.ne: the mi..:\ure i~ d<!.lr. 

Q.r!xnJ Dlo,[ee-U~e Cot~n Dro.nde IUS? mOl1ot\Tdph). 

Carixln DW~I" lklc-.::tor T",1w- A ru~c ~t:j\lt1i glas, tube ro 

dcslglll::ci th!!.t g,h m2y be ;xmed through ft, JOO ronmlnwg ;uilabk 

I'SP tXt 

,,!f,N\};n;: fiher-. :In! '''l'f'9rl r,h...j,., I." \h., ""-,,,,,11'" indr:1""'; "'''' 

d'i,I,,j ·,;okt. 

':"0712--, -'\. liulla!)l" <.lc\e.;:lor lat.: Ih,,\ "'lnj"rn'" hj Ibe fl"-'Mtr~p" 

,p«:fiC1l.\!on i~ av,nluhle Irem ;-",1!1vn'-ill)t~q;tr. Inc. JO! PJr)::"''l'r 

V,tw Dllve. Pl11>bur2h. P.:!. IS~05;!S Rderenct: .... \In'tx:r Cil 

30M I. MeMunng. Range 0.D2 10 0.30%. Tube having coll'JH100$ 

olher Ihan IhOi.:" speC1fl~d in Ihe m(lflQ!rllpli n\<,>, ~ u~~\i in J.(C<:lrdance .... i1h tho: ~ttH"'n tttnkd 1"r1$ mid Apays 11\ Ih~ Gnu-Ntl 

,VOH«(J. 

Ci$r~ .. i)h..,lf\dt, CS~-'76.13- Uv .. ACS re-&g.<:nt gradc-. 

Carben: plsulfiw. Chrom;tl\)gfJlpeic- U.i.e a suitable glade. 

Carbtilt MOrKIxWt-Th-ttCto:H TuIX-A fus<:-~t3.l~d !\Luf. lub.e Xl 

deIgned that eu- rtllY be pa$«d IlIr()tjgll it ... nd <:()(!I~l1Ung Suitable 

aborting filters .tl,d wppon media {or the indica{on: ,odine jJ(:nl. 

o~ide and selenl\lffi dioxldt: 11:1111 <:hrcmle :u:id and pnO$phoflc 

ltld. 

~OT!~-A suitJ.hledelC'Cl(U tube Ihat ~fonm to Ibe monograph ,;:«d'1czmon 1$ llval\!ab{e from ;\lat!oJ1.;.1 Draeger. !n.: .. 4()1 Pukway 

View OM'>'e. PiH5bulgh. Pa 15lM u Reierer.«: N\lmbet cn 

156{JI. M«if.uring Range 5 to 1 ~O ppm. Tube$ having c1)(ldiW;ms 

atha thalli h()$e sp«iJi,d in Ihe lUOncgaph may be utcd in a«:lJtdarK<! wIth Ihe ~eCII{)n enlllkd T'esrer ami ASJGY' ill. Ihe Gtnual 

NorlaL 

C.arb"", Ttrflldrkuldt .. CO~-15J.S2-lJ$e ,'\C5 re,,&enl 

t rade_ 

COlrborMle-:\htfl)1 SiliecfW- L:~e it $uila.bk grade.' 

C:lorlwx.yl.t~ ISodiuJP Forml Catitm-txchanc.e R~i4 IS(}. t ..... 

lOO-mtshl--See Carro"·"xtnang,, RUin. Carooxylolr lSad/uJ!1-

fC:<f'nl) \50- to 100·1I1(sl.). 

CarOOl\r_1byl ce/hda.*--U!e::. 1uilabk gr1lUc. 

Cakin~t _WhM or shghtly lelia"'. odor!e;.$. granulU ~·(,-dtr. 

In$Oluble in "":liler \lnu in ether tI(1J.IUI so!n:nt$: re,u$I:Y c!15wlvo:d 

by lImmont:t TS and by tol\lllo1'\$ of alkali h),dtC);.ides, usually 

re(lnlng iI. cloudy SQluhon. 

R .. siaue-rm. igntllOIl tR~egenl te$I)-lgnite '2 g: the l"e1idlb'¢ 

wtlShs net m(\{l: lhan 20 rog (1.0%-). 

Loss 0(1 df}1I1t (1}1 i-D~y It "I 1050 10 eOfl~la.nt weight: it 

tmn flot morl!: tll411 (O.O'?", of ItS wtlghl. . 

Alkaflm'ty-Shake I g "11h 20 niL ef .... ater f\1>( 10 minult$.a.nd:." 

ml'!r' th(; fillral!; IS not allll1hne 10 red litmus INIjXr 

SQlub£t l1<b$taF.rts- When the filUl;tc (rom the Alkalinlry ttit. 

is evaP<l'r<He<j and drie<l at )05~. lhe residu( weighs 110117lOre thalT 

I rne(O.l%-). 

F<I(S-DiHolve I g i:\ a ml.\ture of \0 nlLofwlter and S mid" 

alcoholic ammonia rs, <lrtd shake-out wdh two 20-01L pottionsoP 

wlvtnt hexane. E"apor;tIC tho: he:tane::\1 11 low lemperaturt, and· 

dry al 80~' Ihe weight Qf the roidue Q>:C nQ! tl\et-¢d 5 mi', 

(O.S%). 

NUNl.'" Wnl .. nr. M('fhod / {J61 ) _Iktwetn ! 5.2% and 16.O'k· 

ofN is ,cunJ, on Ihe anhydrous w;sis , 

Where Vil:lmln·[rte e;:~tm ;J;.leql$lred. u~e Q5eio Ih;JI hu ~lY. 

tenikm:l f(<<: from lhe fat-wl.ublt. ,<\lilIDU\S by rofltlllUOU, tl\tnctmn' 

wilh hot 31cohal for 43- houu fOllow(d by :lir·!:!rYlng 10 remOVt; til¢' 

~<:>l'tnL 

10 :JUt 

in .:tlu:r, '" ,,,,,.,, 

, ' 

C!1tlnn .... Mhli!tgt R.mn-Ut~ a $uluble gr:ll;!c. 't) 

C;'llw.~xekante R6m, ClItl7¢xybtt ($w.Illlm Form) (50-

(OO-!)W}hl-_ U~e a s\Oltlble grade. i I 

Ct<ri_eMb.tllge R~i.n. :\-tetbl:!er~tk C:u-l,""yl;t Add __ t.!!l\I ~uil,J.bk gJade. 

251
• 

• 

OCT-l?-94 I<IED t8:t2 CLEAHlI4GlSOLIJTrOI~SlIHC. 6. t 62'1 "51527 

Hydrogeuated Castor Oll 

» HydrQgef1<'1tt:d Ctstor Oil IS refined. bleached. hydrogenated. and deodorized Castor OiL consisting 

mainly Qf the Iriglycf:(ide of hyoroxyslearic acid. 

P:lcbging and 'i't<jrag;e-Prrserve in hghl con(3ir;er~. 30d ,1"010:/ 

t~posure 10 e~=lve heat. 

\ldtrlllttance. C/(m J (74t). \>etw«n OY' and 8W' 

Hea.y~ta.l$.Mrf;'Qd!l{2JI) 0.00 l%.. 

Ftflt f:uty acid, (401)-Weig.l! Grruratety 20 g :nlo1. <.;I;!nlcd I1Mk> 

mell en a ~Icam balh. ad<;! 75 mL of hut .alCOllollh:u PI"";:vlou~lv ha1 

betn l)Culrahzcd wllh 0.1 N st>dl~m tI)"dr(l)tidc \0 pntMlphthaleln 

TS. swirl, and add I mL of pMnolphlhakln TS T,trAle with 0.1 

N 500ium hydroJUUC V5, ~wirlin8 vtgorou$ly, unltl the uohllrorl rc- >"ItaiM raifltly pinkal\o:r being s.h.tk(tl tot 6O~: not Il"IOrt ltuf! 

Ii 0 r.)l otO.! N ~ooiutn hydf(wd; IS r<quired. 

Hyd(Q)I,yl lll_ The hydro)tyl \>alue IS between I S411.nd 162, dtttrmJJ"!cd as dirtcted In Ihe t~t for H~dIQ:r:y1 t'ailu uflder Carrol" 

011. 

l(ldhtt ll11ut i :tQl)' oot 1Mrt than ;. 

SaPMificatin talll>t (4Q1): bttWet11 116 and 1&2. 

Caslor Oil .. Polyoxyl3S-su Polyoxyl J.5 CaS-for Oil 

C.a.lItor on. Polyoxy140 Hydrogenated-sec PQlyoxyl 

40 Hydrogenaled Castor Oil 

Microcrystalline Cellulose 

Cellulose. 

Cc£lulost 

» Microcrystalline Cellulose is purified. pattla!ly depolymerized cellulose prepared by treating alplrJ. cellulose. oblalned as a fUlp f(om fibrous piant material, 

wijh mIneral acids. t confains not less than 97.0 per~ 

cenl and not more than 102,0 percenl of ceJlulose. cal· 

culaled on the dried basis. 

P:ld.lISiRg If" Sfou.gt-Pnnrve in well..;lowd container;. 

hnntiliatiu-Dclermlne t!l.e paf\J.cle ~Ile by w:vmg 20 8 for ~ 

minules 0:) an al! jel ~me equipped ..,Ih II. ~~n h.:a"lng j7-j..Cm ~",ngs. If mott than 5% IS reL1in-cd OIl the ~ef«n. mi:>: 30 II of 

MICr.xr),slarJilW Ctllume v.ill! 210 mL of w:uer: olh~r;\o·ise. ITU..\ 

4$ & "',lh 2S~ mL Qf"'al<;r. Perform the mllUn& In Ii biVHp«Q (18,000 rpm} power blender foI'.5 minutes. Tran:!ler 100 ruL of 

(M dispe:rsi¢n to a 100 m.L arldU:ttW 0'linll¢r. an¢ alk>w"\O uar4 

for J how); a while. DpOQut". bubble-free di.spE:mon. whlen dOC-!! 

n;:.t form .. ~o~maU!nt liquid :11.1 1M surface. isoblained 

pH (791 r -Shake about)" With 40 roL ef .... atu fur ),0 mm\ilts. 

;lOd c.:nlnfuge: lhe pH ofllw'lIp¢:rn1l13t1t [/quid I~ Oct ..... un 5.S lind 

7 (I fe, Ihe trades of MiHocfystdJine Ccll<o:lore Ihal h1VC i\; skve 

fract!1;l1'lJrcal-cr t!tan S% ret!uned CtI the 37·J.un screen, and belWtef! 

5.0 tlnd '.0 for thegnon "'llh Ie» than 5% retained on tbe 37·jt;"J"! ~qcen. 

1.Ms~4rying (7~1 )-Dry II M lQ5~ for j hwrs: il ~nm mille; 

!han 5.O"k of Its w-elghl. 

RE$i<.hn 00 19niti>m (!Bl): tW! mote lh.an 0.1%. 

\\'Mu-:wIWle SlilbztlMts--Shake 5,0 S wilh i'lb<;rllt SO m.L of WIlI-er 

for 10 minl/les, niter through filter p3.per lWhlllmM No. 4t 01 

(qIHvalent) Inlo a tared btakl!r. ~vapmlile 00 a stt"am bath to dry- r~~$, aoo dry ill 1()5-e for I hOur: !lot I7Nr~ IhM $.0 ma to. !6%-) of 

r<:1idue I~ uba;n~ fer :he grtd~ Ihat n;\Vc a ~I("\'e frael/oll more <I'~n 5% ",u<'nliM 0(1 ,b~ 31.,...., xrc ... n, wh"", nol tn<X<:; lhan 12.0 

mg to 24%) (If t~~,dut:,~ o;Millll1;d for Ihegl.l!.dn that bave a ~I~e 

fl1!cti<m /)01 m<lre chan 5% n:tenIKlf! Olt rhe 3i-.um !'Cr-ten. 

yp YV! 

lk~t!~lal,.,I!("ri")fifl (2}li ",1;0;'-0 

~I~.(h- To 20 onL t.'( Ihe d"p~";""~ <.01 \1,crlXr~q:lH'r,.: (";!I,lw"" 

vl!u,n<c if! 11:< idrnrtjlrdifi)tl ,'(J/ ;;CO;l few elwt'o d ;t.>dille TS. J.n<.i 

m'~ nQ pu.plish \).1"" II)r bill" (..>I<)r'~ pl~'<"luced 

A~o;ay- T r;)'flskr aOOu\ l;;~:ng. of :--'1Ier¢l":r'f~I~liine CdlulO$t. ~<;. 

ttualdy "'~ls/1;ed.:o ~ JOO·ml conl-cal flJ~k wnh Itlt"ald >If :lCOtlI 

.1:5 mL of W1l1er, Add ~O 0 mLoI'0.5.V p<AanwJ7l1:1; .... lJl'OnI:lt<! m'~. 

~:u-ef,,!li' add 100 mL of $u!£uf1c aCld.;lm.! h~t r:!pldly 10 lMCllllet1t 

t'OIJint. Remoy<; from h<;~t. alloW' 10 SliHtd;1t room temperalure 

for IS minute$. cool in a Waltl bath, and lr!lMfertoJ: HQ..mLvol-

\lmtlrk fluk. Di!ule wilh ~;H<;r almou 10 volume, -coello) :'S ... 

o;hlule Wilh wJ.ler 10 volume. alKll11(?( 1\trate;1 5()·mL olhquot "<ttl 

f).l 1'1 fCllOus ammonium ~ulfar~ vS. u$ins 2 ef 3 dlops of tlrth'J" 

phenantnrollne TS u th¢ Ifldica-Ior. f><;rform a blally. deltnllin;l.· 

tlon, and nOle th¢ dlfferer,q; In volume$. required. Euh mL of lhe 

djff(I"1lOCC HI. vcl\l~ of 0.1 r'V rerrou~ amlTWlllum !ulfaleCiflJllmW 

is ¢quiv:lenl !o 0.615 mg ofeclluJO$e In IIx: portion ljlflU«lli e<o 

om:·fiflh or the ~pttjmtn wcighed fOr ttlt Anay}. 

Microcrystalline Cellulose and 

Carboxymethylcellulose Sodium 

» Microcrystalline Cellulose and Carboxyntethyl~ 

cellulose Sodi.um is a COlloid-forming, altrited mixlure 

of Microcrystallfne Cdlu{o<;e and CzrooxymethyJcel· 

lulos.e Sodlum. It contains not leS51han 75.0 percenl 

and nOI more Ihan 125.0 percent of the labeled amount 

of carboxymethylcellulose sodium, ca!cuJ:ned on the 

dried basis. The Vlscoslly of ils aqueous dispersion of 

percent by weight stated on the label is not less than 

60.0 percent and not more than 140.0 percent of Ihat 

stated on Ihe labd in centipoises. 

P3ci:.lItint and st:orsge-PrfieIYC In llthl oonI2Irt~r5. WJ(t Irl a dry 

place. alld. ;!.vcid u.p<JSure to <;;>,«:»Ive be'll. 

ubdinl;-Labd jllo indicale Ihe pe-rcenuge ronttfll 'Jf cart>o:\y. 

methylrel!IJIOS¢ $Odium and lhe vISCOSIly of Ihe dl5pcrw;m In Willer 

Df the cHiSt);"!,t<&! weight ~re(nlllg<; ~mPQliI0l'1. 

lduttilicsmmA: M;:\ (, g wuh jOlJ mL or ....... ler in a bkmlo ilt 15,OOO.-pm for 

5 millules: a wt\in:, op3.que, bubble·free !jiSt¢r'MflIS proriuUQ 

which doe~!W1 )ettj,;: tln ~Iar.dirlll: . .8: Add ~vetill drop&DrtM d~n obume-J in Jd,!nr(/kcrfoll 

It!r A to a .wh.aioo ofalIJlIllnumchlotiQe (I in 10): eAch drop fornls a while. opaque gJ.01:l\Il(: wtn<::h 'tIoes nol 4\$ptrse nn standing. 

C: Add J. tnt. mioolltl: TS to the d~P':'rsioo. oblalne<J ,n Idtr.· 

trJkiJ.lian r(Sf A: flO blue Of purplish blue color l$ p,Muo:<i. 

Vi$(:mjty 1.91ll-Determine the a.mount;'f of MKIQ(:r),$1lI1hne 

Cellule&e lind. C,;roo.>:yrn~lhykellulo~c Sodium needw 10 ~re 

600 g 0)1' 2 !uiubk di$pel~on. eal-eutalc4 Ol'l tile dried. b;nh. 

Trarufcr an a.c¢llrllleiy weigh-e"c amOlll'l1 of WUtr 10 a lOOO-mL 

blender b<:twl lJeain $Iirring wilh an IS,OOO.pm blender;l.l a re- duced s~ oblatnro by adju}til'lg tile vollage to 30 veils by mean% 

of" :u,IJb/e ltJ;l'I$(otmcr, a!ld Immedlltely add Ibe accl1ri11ely w~ghW t'Oft:tlO of MierQ(:tyn:.Uine CeUulou and Cat!lo1tym,:h. 

ylcdulote Sodium. tai:ina are ttl avoid ccnl:ictlOg the ~idn of lhe 

bow! With Ihe-powder. ('¢(I[illue stirring 111 ilih speed for 15 ~ds 

follo'lli rig the additioll of the ~er, then incrn$'; the trafl$(otmtr 

SeIIlMa 10 lIS vol", <liM miX for -; minutes. 3CCYratdy um<d. at 

t8,OOO rpm. Stop tlw blender. 1l.nO lower tht ilppropnAte spindle 

of a suitable roUti<)flal visC()$:melet inlo lhe dfspenltln. Thirty ~ornis afler Ct'u41itln ill ml:>:lIlg, :;1011 Ih<:: w&c~une!<r, and determltlc tM: V(S«l$lly using the apprOpr1alt 51'Ifldle In Qbtlbrt;;. xale 

fUding: U1:twten 10% lltHl 90% of full.scale III a ~p«d of 20 rpm. 

Delermine the !eate readillt 3fler JO seecnds of rOlalion. am:! caleulale the ~ity. if! c¢nhP'li5~, by MultiplYing Ih¢ ~Je rwruiing 

by the ron-stant for Ihespindle IJ..S;O at 10 rpm. 

pH {191}. bct,.<;en 6.0 and S.O, de!ctm;nco. On tM diW~n'Ort 

prepart4 ill Ih.c I~I for Vlscruliy. 

p. t B 

252
• 

• 

tt6:24">:t5:27 P. t 9 I)CT 19 <:>4 . WEn jg:t? CLEANtHG1S0l.,.UT12HSiUiC • 

Polyoxyl 20 Cctosteary! Ether 

»Polyo~yl 20 CetQ$tearyl Elher is <t mtxture of 

mMo.cetosteary[ tmixed hexadecyl and QCladecyl) 

etllers of mixed polyoxyethylcne diols, the averati;e 

polymer length being equivalent to not le$s ,han 17.2 

:url not more than 25.0 oxycthylcne units. 

Pzb.\!.t~ ~fId s.rO ..... I'''-PlQ;ePle in liEnr eQntdml:r~. il\ a ¢WI 

p"" 

R..tn«.'l!JUJd4rd-USP Pofyoxyi2aC.:rosrearyi £Ihrf Refu" 

MU Sral'ldard. 

lemtlfl('1llNm-lf1 ;nfrarc;j a.bwrpHofl spectrum, obtamed by 

~~lIinl a. capilbry film Q( It bctween sodium chlonde pb.t~, 

<:1.bbiu muima 0111)' al 1M Jllme wavtlengtbla3 lhat or A similar 

prq»ra.uon of USP PoiY0ll.yi 20 Cetwtellryl Etber RS, 

pH {191,. ~tw~en 4,5 and 7.5. ~kttrolincJ in a wluuOll. (I in 

W*". '''' AftthtJd I (911,: not mere lh~r1I.()'Jt.. 

ReHw qn tCRitiou-Wdgh aocurately "bout 25 g into 11 tared 

4O<IL porcelain Cr\Icibk. and heat In COOUct Wlth:til" uotil it igllilt$ 

spc!fttancourty. orean be It-nlted wiru4 gl¢wlrtg 5plint. Allow the 

nux: to go O\lt. p!~ce the crucibk tn it mu1Th!: furnace with the door 

pwyopen unit! thcC$rwn u oon~m¢d, clOSe the Ifwt, and hut ~t 10J ± 100'" fOf I hwr. Cool ilt It dmcatOf", wcigh, AooaIw.latr; 

thtPCfWItate of relidue. If the alOOUnt so obuinod tJ«Wb 1),4%. 

,1@1flthClltuntilecMUtnl weight is allai1l«l: the Itmit i1 04%. 

,t"f!IffIk.Mtthod!f(211)· 2 ppm. 

H""Y /Dthlk, MtrhCtli If {2JI}· 0.002% 

Atil1"IJvt {401}: flOt more than OOS. 

H!*ox)"11JlJIfe {40I}: belWun 42 and 60. 

S~tutioev.l~ 1401,; not mot<! tlln2. 

Fnr~)"_vymb-Transfer lltoout 12 !1,UO!"r.ttejy oI/(lShod. 

to. wo:.mL lep7lralOf" ~Cfttaininl 50 mL of tth,l ;tecu.t<:. Add 50 

mL<)f wJtum chlonde rollllion (29 in I 00,. $ha~ vigorously fet 

"2 nMUItl. and allow to $Cprarl! lor 15 mim,ltell. Dr-un lhe lower, J.~ pl!1I.)C. UllO a ~Qfld 500.mL !epara(M, and Cl'..trtltt the u~ b.ye with .t u-«md 5(}.rnL portl¢11 of sodium chloride solutIOn 

(21m 1(0), To the cmnbined dqUew~ Ja,en .add SO mL of ethyl 

;u:a:::ue, shake VlgQl'OU!ly ror 2 mtnut6. and aUow to sc.p;:uare as l>!:kre. Dr.atn the lvwtr. aqUl:QU!l phaw illto u thiro 500-mL separlllll)t. and extract with two 5O-mL per1JotU {)f ehlot<>fOfm. by 

1nllill! for 2 minut'!l ~dl tilrtc. Evapw:ue tbe oombill'td cillorafwm t.)I;trntts in a I SO-mt iJukcr Of! it)tam bath. with the ud 

oflnttam of mtrogen, tcal'ptrent drynm. Redissolve In aboul 

lS_\" of ehiorofOfm, and uansfcl 10.1. fill¢(. QOIl«ting the tlltr;uc 

tn a 1 SO-ml. beaker. Rinse t~ funn.:! wilh $eVenl small portl'1m 

oftbloro(Ofm. and evaporate the oombifl(:d filtrate and rir&in&s, J~ (w:;ribW abovc. unIt! no O'ltlf 01 ehlMQ(crIn 0( (thyl acetate is 

Il'tIftpubie. COOl Itt 3. UOlcatOl', and weigh: Ihe !lnrir IS 7.5'%-, 

F"m~tb~frot <lxhlfhrtrflal !ranJ<l!'ii IQIllrivtt-Prep:ut a rollltiOl1 COfIllinlrtS 100 

'l'Ig« ",.bulyl tl'>}¢(IOe tn each 0"11.. of ehhrobt:l'IV!nt. StOle in;l HeW,. el{$!:U eontatnC!', Prepare frah weekly. 

Stondard !ofllrio-t-[NoTIi'-Ethyltll .. Glade: i~ to?;le and 

!1aamabk. Prq:.are tlta ~utfu<1 in a well·ventilated!wOO. u,ing 

gtert tare.] Plaee 250 roLof ehloroben:rene in a tlllI~·sloppertd. 

;)I)O.FtlL e1Jl11'C:11 na'S\(. Bubble etnykmeo'lde thlough the thlOf<r ~.tt a f'tl<lIdeatl: ratefor::tbout:m aunllltt, itmrt the Moppet, 

:.InC:'ltore prote>:lC'd from heat. Pipet 25 roL of 0.5 N alcohclic 

n:ri'«hll;>rie acid $010.11>00, prepared by muunJt 45 mL 0( bydro' ~h~ atW With J liter of a.koMI. it'llo a 500·mL C>JOteal flask 

.::oclt'llng 41) 8 of maSM3ium ehlQnde he.o:ah~dral!:, Shake lhe 

mi.rure 10 eff«t aturatiofL Pipet Jl) mL ,,(tbe elllYltN.! OXide 

"clitIOn into thee fla~k, arid add 20 d~{)f broffi(X"rqoJ green 'IS. 

If t1c solutIOn 1$ nIX yellQw (aek!) at tttl) poiOI. add an additional 

voIJme, aCClJrittely meuurW, of O.S N aknlmlic hydrochlot!c 1Cid 

10 Iivr. an: el\e~) of ;lbour 10 mL. Re<;ani lhe 117(011 ~o{umc ofO.S 

N;4vhQIk; Ityarochloritlleld uddttJ. lMtrt tile ~ropptr in tIM: fl.uk. 

JI\(b,iklw to :<.land f« 30 mtnul£l!. Titrate lhe e:::l:eea a~ld with 0,5 

,v :l\:~holic jXl'lusium hydro;l.ide VS. Perform a blank tl1C<It:on. ~1lJ 10.{f mL of ehIOl'cb/:Ii.t;ent: iMtnd of ethylene o..:i4¢ roluoon. 

~ 1M ~lllW loul vol\lm;- cfO.5 N alcoholiC hy<Jux:h!'Jrie ilek1. 

"rtdllOle l!l~ diffcrtllct: In volllmt"$ ~Ulfi:d. Each ml of the differmce m voh .. tmi <l'f 05 N alcoblie potasSium hyrlrQ1lide COfl-

,'yF XVI 

""'id "~,"UI¥"I"nl '" 22.02 "'!;; we ."hylc"~ 'Hide. C,Heulale lhe 

cOfl¢efltratil.'r;. in mg per mL of tlh~1eM ,nice ,n lb~ Sf{};ndar(/ 

s.)ful";"I. Sl!lr.ciard'<!'<' &ily 

Standafd preporallQ.1-TrRil,fer Jboat 5 g Qf USP Pclyo,yl2Q 

CttOSltat')'1 Ether RS to" ~ull"b!e Zbl! Mltleof ;tboul6Q-mL calMeltt, and add 10 mL of ehlwoOentel'le. nile!l), 50 ;.<LQ( III/tmci 

:;randard !oluri(}tl, and ~f!lICCUr«ttl)' mruured volume of SratlliOfd 

J{>/url";;m e(>nt~inlrlg aboot 0.5 m; of «lhylene o,«Ie. Imat" 

mt8rKtie !tirnnll b.:tr. Cilp lhe ooule lightly, and mr untll Mmegendty is ~lr;lirted. 

Ttsr P"l'f'lrctiQII-Tram(er ""bo,H 5 g of ?olyo1lyl 20 Cel.r 

~lea!)'1 Ether. ao;uralciy wtithed.:Q a ~uitlble gJl$& boItk of thout 

6().rnL >:3plleilY, and add 10 mL of tnlorcknZ:llne and SO ilL le· 

euratd), ma.sur«l. of ttm:maf sralllirmi :;oiuliOn. Insert a magnetic $hmng bar. cap thl; bonle llghlly, 2m:! Ulr unlil ~lI':lty 

isatu/ne'd. 

Cftromarogf'aphi\' sySle'f>\:-Undtr tYp1eal conditions. the tn· 

st(Ult!(llt ISeqllippe,j wltha n3m~·iontUhO<ldet«tO/'. 3,M wm.ains .1 1.8·m X )·mm (aD, st~inless steel column patted witb $3. 1M: 

irtj«:rw port al\d<kted,<)f Week are ffi.1intai.wd at about 210~ :lind 

2)0'". relpeo;tlvely • .and the coIumn;at about 160". Helium is uwl 

~ tm: carr~r~' at a flow rate: of 66 ruL per minutl!". 

Illttrf;:rtMc ,herk-Init"C1 3, ~ultable vo!.um of eb.i<lr«>enl«lC 

onto lhe gu ~hrcmatt1£:rapb • .tnd 3](010' lhe ch((lmllognlm to run unlil l~ w1vent hu eIuted Sonul:uly In)«t:md cblonulozraph 

the Il'lttfl!(Ji slandard scituia.1, the Sr41l<i.ard :oluriOl<. and a $0' 

luuon P,rep:t:m:i atOJrding 10 th~ diroctions for til<: Tm ~rtDfl . but omitting thc tnternal stl'lnd<lrd. No Interrering peaks-llre obServed. Proudu~-In;xt alxwt 2;.:L m theSra/ldaro prepcratl()ll IM{) a $uttab!<: &!I~ ~broillatot"rh, and teCQ!"d the chromatogram. 

Similarly. inJeCt about 1,1(L \") lhe Trsr pf"f'pi1roJion. and r«Ol'd the 

ehro,'T! ... togram. Ca.kul3te tm:quantity. in mg.ohtllyk:n¢~lde 

in th¢ portiooci' PclY01.,120Cetooe4.ryl f.lhtf Uk,l:n by the formu!A 

Ws{RtIRsJ, if! wh((:!t IVs it the ~lght. in mi, erethylene a,i,je 

in t~ pcttion of Srarnlard :QlurifNt takffl, ami Ru ami R.s;'lf't the 

_(tt ratiOiS of ethyler,e olltde 10 intCfn3-1 Jtarniard in rhe duomalO> 

J,f"IUm fmthe Ttsr prtparanOllll00 lft¢ $ratl.dard f'N'paru(lor:. no· 

!(X:ctlvely. TheHmit·isO.OJ<:%. 

AH'"'i¢ petrin« IcftiTh-Phiee the PI.'I)1.u:yI1O Cttc;tellryl film 

in: il 50'" waler ~th (7,1:rnighr.. in orou to melt It compittdy, Shlke ~ISOltusly 10 (limilUt¢ any pO%lbr!lty of f1"!cl«u!::.r wciglHgtadiello. 

wilhin ii, and tfln~fer 200 JJ.L to a S· x ISO·mm hlgh·ruolullOft 

NMR ample tube. Add 200 I"l. of carboo t~tlnd'llorlde by muM 

of lI. l(pa!3{( micrmynnge. Add 5 drcps or tflrllmttllyl$llane a~ 

an internAl rdelence standard. C:p Ibe tube tIghtly. and 'haie 

tlwroua:bly. P1Qet: tbe lUbe in the NMR spectrometer. and f'('l;"(.IfQ 

the NMR. sp¢ClrUl\1at an approprlatr; RF POWN' I~el ;iM II $w«p 

lime (If 250 w»ndJ pt'r 500 Hz {lee QUdfirartl'e Jam~ umf« til>-

,·(ftU Mag/fttlr RtJOtU1/Ut t 761}). ACljult Ihres~m amplitude 

ro lb,lll the SiSllalllt 1.1 Cpm ~ <II Ie.ru:t 8{)% of ,ull !Cale. R«ord 

lhe ifl,t¢uallHe.u from .4 ppm 10) ;LJ.S ppm (Al).and (rOOI 23$ 

ppm to 4.') ppm ~A2) at a s ..... eep tim!: of SO seomd~ pet S:OO HZlJt ~n Integral powtr Itl""l 5uch lh:;u the integral ofth~ erhykrn: o,,,<le 

peak at 3.!i ppm i$ al ltaH !l1Yfo.or fuU ¢ha.n height. t>o tm("llan~ 

If,¢ powu level dUllng lllc ~wU? R~ the Il\1eeral of ",ell p¢"lIk 

~ev~nJ limo. and QkulJ.te lhe avcrage integral art;1, CJlculatf 

llle numberof !)xyelhvlene ttnlU. n. ~r molcwle by rhc formu!ll: '" 

'" {J:!A~Al - 311",;~ wbidl 32b lhe.totsl nttmbc.l'o/pwtOM in 

the mclecuk not aeti"'3".ttd by oJ(~&en . .3.YCntg«l for the «:t~1 ar:d 

11et!.ryl rAdical$. 3 is the rtumber of "xygen·aetl~ated pr()ton~ not 

im:llldcd in tm: oll)'ctbylene tlmt eount. and 4: is lh~ numlxr of 

protons rn elleh m:yethyltne unit 

Polyoxy! 35 Castor Oil 

» Polyoxyl 35 Castor Oil COnta1tl5 mainly the ai-ricinoleate ester of ethoxylated glycerol. with smaller 

amounts of polyclhylene glycol ricinoleate and the 

correspondin$ free glycols. it fC$lIi1S from the reactIOn 

of glycerol nClnoleate with :tbout 35 moles of ethylene 

oJtide. 

PllCktigHtc mid sro~e'"- Prtsen-e 'n rignl CCnlAiners. 

Idtmlf'katiOO-

.-\: Di»ohe~bol.ll 0 ! g on I mLcl"water,:.dd 9 mLof.ooium 

chlonde SOlation i I tn '<1)1, ~I'.rl htat in a "'3'.H buh: ttN:":KlI!Hloo 

253
OCT- 19-94 WED 10::::0 CLEAt-ll riC t SCLUT t 0llS1 t I.e • 

• 

NFxvt 

~,lI<rb,(! 41 IlICffiP'!f;!.IU":; WIWC"" (,$" and 6S~. Jet! b\::t-Olr.t5 

clQr on«'Olillp, 10 40· 

8: Dls.whe about 0.1 & in ]0 mL of alcQlloh" pot;ll;Hium hy· 

orol\Mk TS, boil fwaboul 3 fmnute£, ana: cv:J.porat.e to drynru Mn 

1m: re$idlle .... tlll S mL of Wallt!" il olssolves, )'lddtll,f.1I Ckllf 5<}h .. · 

11OtI. Add ~ few drop, of glatt::!;] autic acid' ;: ..... hlle pndpiu.le n formed. 

C: To a wlllflO!l {! in 20) add I>romine TS. d(cpwlSe: Iilc 

b!Qrlllm: i~ d«Q]oflzea 

SpKifrc ,utily (841)' \x:twe;:n 1.05 lind 1.06. 

Vlswslry (9)1)' be!w~n 650 and 850 centlpotses at 25".1/. c.ap· 

Hlary v~$itmtcr beill& UsW 

WAtn.Mrr;lOd J (921): 1\01 mere than 3.0% 

R~1tt on ipltian {2!!i); flOt mere tha!'! 0.3'&. 

Hu.t,!PI«~M"lh04fl <2Hj' 0.00]% 

Acid tahw (40t)' MI nwre~han 2.0 

Hydroxyl ~Iut (401 i. Wtw«n 65 and SQ. ""-

lo4int fahle {401 J, ~twCi;n 25 ;1nd 35. '\ 

Sttpoolf"railon tll~ {<lOt). belw~n (jlJ and 1:. 

\-;:OXYI 40 Hydrogenated Castor Oil 

" Polyoxyl 40 Hydrogenated Castor Oil conlai 

mainly the td-hydroxystearate ester of ethoxylat 

glycerol, with smaller amollnts of polyethylene glyco 

tri-hydroxyslearaH: and of the corresponding fre(: Slycoh.. It results ftom the reaction of glycerol tri-hydroxys-tearate WIth about 40 to 45 moles of ethylene 

oxide. 

P.c~:lmI :;!w&&c-Prcsuve m \llhl e\'lt\l3lnt"n 

Idtaill'icatmA: [)iliwlte~bQ\lIO,1 gin I mLofwltcr,add<)rnLufrodtum 

chloride Y.llullOO t I Ir. ~O), ar4 heat in il wuer bat};: tm: wiullon 

bccOlmS turbirl $.1 a temperature bet"'ttn 10· and 85", I fk [)'»o1;'c a!xrut 0.1 g Hi- 10 mL of :!lrobo-Itc PCI;\$Sl\!.DI h)" 

I dww1e IS. boil fOf aboot.3 mil'lulel, and evaporale lo(!ryllt$. MIX 

Iton. Add a few dro~ of tlaei:1 aCetIC acid' ;It whItt:. pr«:ipnat 1'1 rorrm:.d. 

'\ Ih~ re!:duc wilh oS mL or water: it dimolvcs. yleldtng J: clcar wlu· 

(~INIz ttl'ltpt"r&llIrt ((lSI)' !x:twCl:lI 11)~ a.nd 3D· 

'\ W,ttt,Mrlhodlt92I); notm¢l"et?un){):%. 

Rnidw on iRftitioa (281): tlot morc Ib~n OJ%, 

, Heary mtta-b. MNhod 11 (131 j; 0,001% 

• \fddt-aj~(401). notmo/cthan2.0. 

lI)'dt':Il .. ~ll'Chllt (40])' \)(twetn 61) ami go 

oolMv-alut(401) !')l)tmarcthan1,Q 

"."",iflcaffcn 11IIft {..tOI). btl""'ecn 45 ~r}d 69. /1 

Polyoxy 4O'St<~r.!!t:.e _~~// f'oly{oxy-I ,2~lharlwlyl). o-hydro-Io. ... hydrvxy·, ocud~~!1o;!tt 

Po1yC:lh}l~nt &lyea! fflCnootn.nlt 19004-99·.'1. 

» Palyoxyl 40 Stearate i~ a mIxture of the mono-esters 

and dj+esters of Stearic Add or Punficd Slearic Acid 

with mIxed polyoxyethylene dials. the averAge polymet Ie~gth being ~quivaleut to abOUI 40 oxyethylene 

Unlu" 

Packag:1nz aM Mor.q:t-?rntne.n \lght COOlamer~ 

Rut1tll« stlUld.rd-USP Polroxyl.:a SleerS/1: R.f'ftrt:/tl;(' SMIIdard 

tdtl'ltiticam:mA,: The l!lITdrtd ~bmrl>tiQfl ~pccln .. m of " fnti'ler~l ,"'I QI~pef,i,-,n 

of i! t)\hibll~ r."l(\JIl/t1" Qll\~ .It th: Nm( wtlvtkfl.\'Jh-> ;l< ;h.,l (I .1 

SImIlar pn.j>II.I311<Jn or uS? P<lh0x,1 40 ;:'Ie;trlto;- £I.::' 

8: TrlMltrabol.il3iJl wOl'rOUIlO-b011t'''' ~I~i·t,,!. );.1" ::1rl(j 

"dd caUllCtsh wtllt "'IMnt'. ~;,v fill or ako!;ci 11M 7 "' ~ \,f 1")1.1--

Qfficia[ Monographs / Polyoxyl 159) 

$t1,lm hytlro;o(le. Cl;>fll'lect;:; 1t1llabk conderu:er \0 th", fla!ll;, and 

reflux fer 2 hOll-n;. Trlln:Jcr the h<)\ t-i.p:mifiQuon mixturt tG 3 

2000·mL rtparator wI,h Ihe aid or 250 mL ofboihng water, cau· tictluly ncutralize wilh a ffi!:durt or -=qual "GI\lme~ or sulrum: acid 

and watcr. Wling the lil)lumc U!ed. and add a 10% eJ;(e~~ of Ihe 

dliule lIeld Add Mother 250 tnL of t>cilmz waler lind 250 mL of 

hOI aloohol. Cautlotuly add 250 mL- of ~ .. ent !texan;, murt ~ 

p¢1~th)'lene Mapper m lhe ,ep,mI\Of, shake thonw/l.hly. am! aHowthe llIyer1; 11;> $epu;u(;. iramrel tb~ tQw(;r layer \Q 'l M<Qffi1. preheated 2(!OO.,mL stpata\or. C)l.traci in tllesame tn:umer WIth anothcr 

250-mL portion of rolvcnt henne, and discllt1i Ihc lOWer, aqu~~ 

layer Wa$h the combirte'd huant rotulicm WIth two IOO·mL 

portions of 11 mi~lu:reQf tqWl.I vclurM$cf a.kvhel and Woller, tllll~fer 

the hnan-e :olulioo to l!. beaker. ~a~ue Q(l1!. $learn bath to dry· 

r.t!4, dry the midue in \'iltUl.lm at GO for I hOOr,and n'Xll~ tm a-cid 

value ($« Far! and Ff.ud Ol ft (401) l, 0.5 S of (hI' fatty ~dds s\.' 

obl.:unt\:! b¢iog 1I1.t-d, I;; Qell>'«n ISll ~nd 212. and Ihe :«lme vallie 

is not more Ihln 5-. 

C~&q temptrAlun (651): ix:twcdl :n° and ':1~ 

W.ttr, Melhod f tnt)· not mOi<rthan 3J}%. 

AI1MIk. MtthfJd 1 \2tl )-Pnparc the T~sr PrqwflrWII u fcl!&\>l; 

Mix 1.0gO!I( wilh }go{amixturcofequal Pirbofpowdercd po. 

lamum mtr&IC lind sodium carOOnlll¢. Add themiJltUfe.IO$maU 

fKJfhO!l$, 10 II. platinum crllcibleat re<1 heatl andalJowlhe ruction 

10 CeaK. ExttaCt Ihe cooled r"eMdue by bmling It vnlh 20 mL or;! 

N $ulrunc acid, oocllhe scl\l\mn, arid filter. Wash tm: r~;:due ""Ih 

20 mt or wattt, and evaporate the rotnbmcd filUdt\': and ..... ubing 

to rumes.Q[ ~ulrGr tno:uce-· the m!d\le,dmw{11WJ lfi 5 mL or "'OI.I,r, 

meeu th¢ f«!ummCIlt$ or Ihc IC$t The Ilrnlt tt 3 ppm. 

Ht1I'fy IMltls.. Mdh<1li If UH) 0.001%. 

Add ttiut {40I)' l\Olmoreth.tn:. 

HydroJ>yl valll\' {401 ). belwt(1) 25- and 4{} 

SapMff'tell.tioa val« <40J): !ntwt<;n 25 and 35. 

f'r-ee P<lfyothykm- glycols-Tramf~r lI.\xlut 6 g. lIocurately "'t"l,ghW, 

to a ~mL npdr3.tOf «muining. 50 mL or etb)"1 acmtc. Diaoh't 

rompl«dy, tMn add 50 mt of sodIum chl¢tide$C1l1t1On (29 in 1(0). 

shakevipotlsl~ for 2 tninut~ and alJ?wto~te rm 15 nunUIU 

If Kparatioo h; Incomplete, wdull)" insert the r.cj>iUaIO!' ~nto the 

",tIl Of a Skam balh f\.'f short \lim: inteMib. R~lllm techmque 

as many tH1'!1:"5 f\~ n=r y to easu re the cmnpiele ~rallCfl of the 

IWQ phMet Coo!, and draft\: tbe- lowel, OIqUOOUJ, pb:aK tntOl! seoond 

50(1·mL R'~f3I¢!, and ~!\Ullet the upper layer wIth 2.M(."Ql1U ${j·ml 

pontOn of wO'tum cl\londe tolulion (29m IOO) Rcpeat tM ltP~· 

I'll Iter. 3S berCl'C, includms rflt Sleum I,-o,!.lh t('<:hn«llle lo~nhJlflCt" 

ccmpl-ele kparatJoo. To th'l' oombllltd aqUQOlls !aym add ~ ml 

of ethylllCttate, shake vIgOTo\!.~ly fQt 2 mIMICS. :and allol" tOKP' 

ante IU ~fQt¢. Drain the lowCl. IIquOOU$ pha.se inlo.a Ihmj 

500·mL s¢p;!.utor, and exlract II with two 5O-mL oortlom of 

ehlcrofw-m, by ~bllklrl8 for 2 minules each !tim RepeJit tne wum bath I«:hniquc to et\iure (omp!ete up$,ratlOO. Evaporal(; the 

et>rnl,nl'ttd chlorQformtxtra(:U Hi- II ISO-mL bQker o-ttll slum bath, 

with t~ ;lid or a $ut~m cf nllr~n. IQ 3pj")<arcnt drytlw;. Redl$-

wive ill aboul 15 ntL or chluroform. ant! rramftr to a ftllC!". eol. 

!(clitlg thc flItratt In a I ${J·ml ~ktr. runn t~ fllnn1':1 wlIh 

~tvera! $!'laU potllons of chloroform, and tVJlpgr.1te the rombtlK'd 

fil1raleand nnZltlp. 3sdw:nbed a\xwt, \:nlll 00 od<:lf of chlmofOftr> 

or elh~llIcelale h perceptible. J)ry In vawum al 6(1~ fOf I hour 

Coo! tn a desiecalOr, and wtiZh- fiCll~! Ihan 11'% an1J n« l'OOl't 

Ihan 270/., of fret polyethylene £Iyeoh tS found 

Poly"xyl 50 Stearate 

PClyloJl),'.1 ,1.(,lnancdt),ll. ",.( I.o:>:oexudetyl),w.hydro~y-. 

Poi)"tlh)'!e!\t gly«>1 mO~~$t~tatt 19004-99,31 

» POlyoxyl 50 Stearate is :I mixture of the monOSIt"d-

(ate and distearate esters {If mIxed pol;-oxyethykne 

cliols and the corresponding irec d~ol$ ihe average 

polymer length I'S cquivd~;11 to :lNUI 500xycthylene 

unll~ 

P"Cklilf:l~and nora!!,,_p,;;,er,e;n II!,hl ~.ml",,,,,r--. 

Rtftrttt(C' $tllndanl-us f' f',,/: C\ If 5{l St,.,Ofal,. R,./dl·w r 5:rru, 

d~rd 

254
*Inert ingredient information may be entitled to confidential treatment*
• 

• 

• oEPA 

U. S. ENVIRONMEN7AL PRQTEC710N AGSNCY 

APPUCATION FOR REGlS"ffiAll0N OF P='Sl1CIDE· PRODUCING ESTABUSHMENT 

(SeCilON 7. FEDERAl... INSECTICIDE. FiJNGIC:O=-, AND RODENnCiDE AC7, 

AS AMENDED. 92 StOll B29) 

NOTE: READ AU JNSTRUCTlON$ 8!E~ORE COMP!.E71NG. 

A. ! 

24.3-05:..5 

EPA 

~E ES7ABUSHMENTS ASSIGN=;) NUMBERS ABOVE USE 

HAVE BEEN REGISTe:RE:> IN ACC::JROANC2 WITH ONLY' 

SEC71CN -; F!FRA AS AM!:NOEC 

i 90 , 

I ! 

256
Pages 257 through 266 contain product inert ingredient and source information and are not 

included in this copy
I 

40 CFR 158.170 

Preliminary Analysis 

• • 

USP Grade Active. No Technical Grade of Active Ingredient Contained in the Product. 

"See USP Monogrnph. 

• 

• 

Page 25 

267
NF"XVT t. ~ tu~ 31 :I ttn'l'Dettlure De'\wee,., 65~:l 85". and bccome:s 

ch:ar on cooling lD "'08 : 

at Diswlve; 300U! fr,! g In I D m L or 3.ieohoiic OOlasJlUm h~· 

droxlcle TS. nail rot abotl: J mHlutC$. ;l,no ev:an0r3.ICIOOry!l$. ,\<fix 

tnc n:siduc W1til $ mL.. Clf wale.-: It dlMOivo. YIelding. a CJr:ar 501U· 

tiOIl. Adc a few droc:> of JiaCial aet:.UC a(:;lc.~ ::. wilitc !)f~pl~e 

li: r1Jrmca.. 

C; To a sojutlon \ j In 2[J-} :lOG bron'llne 75. oT-()pwi~e: IRe 

!m;!.nllne IS CI:C01OOl.«k 

Spedlie gr:I'I'ity {S4t): Dclwccn 1.0"5 :!ono :.06. 

VISC:CIIID 1911:: bcrween 650 ano aso .c:ntitlOlSCS 2. :::~o. a caomat'y' vlSeoslmetltr beillQ: UCC. ' 

W.mr. Mi!uloti; (911): not more than ::.0%. 

RCJidut.on ipiutm {:lSll: IlOI moretban 0.3%. 

H.", rn«tal5. Ml!lhod I1 i:::3.): 0.001%, 

Acid ltiuc (401 >: not mor!: 1han :'0. 

HyGroxyJ val,.. (4(i\): between 63 and 80. 

l~vajlH:- {.wI): DctWeen 25 :and 35. 

SapaaUica.Doo Yalue- (4tll); bctw=n 60 and'" S. 

,.'. - - '-'~- ~.--~,~--. --', .------~-.~., 

PolY(lxyl 40 Hydrog<mated Castor Oil \ 

., })-,Polyoxyl 40 Hydrog.enated Castor Oil contains \ 

EJ,'nIY the ~ri~hydroxyste3.rate ester of ethoxyiated. \ 

oL with smailer amounts of 'Doiyetnytene giycoi \ 

~ ~hydroxys~ar~re an~ of th: :;~rr=po~ding free, giy- I 

eoiS. It resWts Ifom tne fl;acuon or glycerol m-tl~­

droxystearate with about 40 10 .15 moh:s oi elhyiene ' 

oxid~. 

PKUgUte ami: ROratt-Pret::~ in ti!irlt conuunen;. 

Idlll1iflCllliono'\! DissolvcaboutO.1 'I!: in I mL ofwatet.add 9' mLof500iurn I 

chloride$OtuUOfJ < I in 2m~ and- heat In a wat~ bath: tbesoiutlon 

bceol'ru:s: tutOici It a temDC'l"allu·e between jOlt and 856, I 

B:. DiSS®'e l100ut 0:1 i in 10 mL oj aleonolie 1'OtASSiwn h,!~ , 

oroxide. 1"$. boil for aooul.l mtnutcs.amieva.ooralCto drvnt:S$.. M»: I 

Ihe tdil:iuewitl!. S mL {)f wattm it oissoive&. j'ieldmg a clear SOIUlion. Add a f~ drops of ~a.aa1 acctic ace.: a wntte weQprt:3.te i 

is formro, . I 

COllfWllIg tetliDttalllrt' (65 D: between 2V" and 306 • . 

WaEtr. Mtrnod f (92Ii: nGi motetnan ~.O%. 

Residue-an ipitiOfl' (2:81): ntll more tl1an Q.2%. 

-ieary metIIJs. M~iwD.· JJ <:31): 0.001 %. 

:iO vailat' (401): not more man :;.0. 

ydNXyl YD.i.,. <4Ot l: betWCCII 60 and. SQ. 

lodinr'l"llilw 1.401}; ·nOl more t/l,Ul :;;"0. 

SalWlllifics.tion. WI*, \.:.0 l ) : betWeen 4 Sand 69. 

P olyoxyl 40 Stearate 

Polyi oxy~ 1.:: -ctnancdiyll. a·iI~dro-<u-i1:o'(.\rcx,!·. ac-.:aeeanoo.te. 

Poiye::nYlene gJyeoi monO$I~ale j9DG4-99.J], 

»0 Polvoxvl4{) Stearate is a mixture of the mono·esters 

anc di:.esiers.of SJeo.nc AClo or ?u.dned Stearic Acid 

with ml~ed poiy.oxyetnyjene ciiois. :h:: average poiymer 

lensth ·oemg equivaiem ~o acou: ..;.0 oxyetrtyjcne 

units. 

Packa1int sod: 111)~ "PteSl!:!"Ve In tiSIH eorltainets. 

Rei_ell: St8Jldl.~{./S? PO/YOXV/ .doD Src!'tlratt Rt/ennrt: Sr.an· 

.rlard. 

IOtfttillt::2.tionA: Tile Inimrod l10s0tollon $~!'\1m of a mInerai oH dIGDe'mOll 

oj it exhiolts m;luama clni .... 3.1 Ille ~am-r: ..... avc:len#t!1S as tmn 01 a :umilar 1)reaaranol'1 of US'? P"OlvO)[v! ~ S{-c;$1':lHe ::t$. 

B: i'n1t!si"e~ aOOlll j.D e 10 a'rouiHI-oonam . .500·mL 11:t5i:. ~o 

add QutioUSI"Y, 'WIth IT1ixm'~, ~50 mr.. il( :J.leono~ :J.f'lD -;.$ "Oi OOta~· 

Ofj'icial M_graph, (Polyoxyl '59, V T'l 1i.J.-

~lum bWirQ)r.ide. ConncPa'suitabie condcnKr to 1M: nask:. and 

reilux ror: hours.. T~an$i'e:' the not sapomiit::J.uon mIxture 10 1;; 

2000vmL 51Ct)llrnlor wllil the :uCi of :50 mL ofboiiin1!; water. QQ. 

110USlY neut;':l,jiz.e wltil iI. nmaurc or eqUAl VOlumt:l$ 01 suifl.lrn.: lleld 

and water. nonn!! ~ne- volume uscci.. and aad 2. Iocr.. elect$. of the 

ciiluleacld. Add anolher!SO mL of boning water am: ~SO rnLof 

not 31COl'lOl. Cauuol1SlyaQO ZSG mL of SOlllenl henne. tn$Crt a 

:xuyeutYlene SlotJpCr In the- ~Cgar.tl.Ot. ihake Ulorou!-hiy. and 30110\01· 

tile: 11I.Ym 10 $e;lanlte. T tansier tnt: lowlCr l,-yertO a :le¢Cnd. :nre· 

neatcd 1QOO...mL leDal'Utc:'. ~tTll.ct in tnesante: manru::,wlm anO!.h~ 

:..5D-mL comon oi :>oivenl h~a.ne. anC dlSCarc tne iowe~. aoueous iayc:'. Was.n thc comointG .nexane soiutlolls Wlln IWO lw..mJ.. 

OOr1l0n5 of a mi;tlure oi CCluaJ Y{liumcsof 2lCQiIoIand wau~t. Q1I.n$.ler 

Inc nexa!le: lioiullon 10 a Oea.kcr. evaOOTate on It susm oatil to'l1rvrlcss.l'iry the resioue III vacuum at 606 for I bour. a.na COOl: Ute acid ~aluc Isee fars 4nd Fixed Diu (401 )). 0.5 ;g of Ine fan:.- Mlds.so 

(JOlamca being used. i~ belween ; 88 anO 2;:" aM tile lotitne vaiue 

IS nol more tlUln 5. 

Congaiiag t-tmperatun' < 6S~ >: Oe.tw~n .H<;" anD 47-. 

Wa1er. M tritcuJ I <921); not more thlUl .l.O%. 

Arsenic. M ~lhod 1 (2~ 1 }-?rc:mre the T ur PrrptlTalil;Jtt 2S follows: 

Mix t.O &: oii! with) g of aminureoi equal caruoipowoered powtium nI tnne and $Odium c:&l'oonate... i\dd tile mtXwre. in smail 

portIons. loa piatinum -cruciblea'\. rcd.hClL"t • .a.na. allow tnc r=action tQ~e. Extract the coolt<i residue f)y boiiine it WIth 20 mJ... of:l: 

N sulfunc acid...:ool Ule :sotuuan.. ami fillet'. Wuh tM. remue wili:! 

2G mL. of wa.ler. and eYl'DOfaTC Tllc'ctImbin.:li filtrate am: wasning 

to iume:! oi sui fur Inoxide:: the T'eSidue. QiuoiYeci il': S mL of Watc:-, 

meeu the rcqulremc:ntsof the tr:$t. The iimn l:S;i ppm. 

H • .ymet.ai$..Ml!.lirodlJ {23I): O.OOl"i, 

Acid ... IIMtI40I); notmoretnan:' 

Hy<iroxyj ujue, (401): bet\tlecn 2S afld 40. 

Sc~rll::llrioa we {4(l1): 'oetwecn 2S and 3S. 

rree-~II!:IM"-giyctlis--Transfr::'" atlC»u 6 g. accuratelY weighed. 

to a S~mJ.. .s~lot eor!wning SO mL. oi cthylaeeta:a:: Di:ssolvc- coml)ietl:i~·. :hen add 50 mL of sodiumclUotidt solution {29 in 1 DO}, ~ha:ke vi!OTOusiy for 2 tl'UflUu:s. and allOW10 se»aratc for I $ mInUl~. 

If separatIon is inc::omplet~ c:areiuily Insert tite .Jeparator Into the 

wejJ of a steal'tl earn for-snort urne mter"la1s.. Rcoca.t this: t.ochruouc as many umes as neces.sary It;H!",uce the compielc separallol\ of inc 

IWO onases. Cool • .a.ru2 dram me iowe:". aoueous. pnuc: into uccxmd 

5OQ..m L.. Seuar.tltlr. and extract the upper layer with a scc:ona jo.m.L ~TtlOn oj sodium enlonde SOlution (29 in 100). Re:ceat the Kloa~ 

ration ~ ·oefore. inCluding [n!!'.: $t~rrJ I.\II.th tl!.ehmquc: 10 enilance 

eomoiete separ:ation. To ttl!:' combined aqumw: l3ycn aoo Sf} mt... or e-lhyi..aC:ClI1e. ~im.kc vigoroUSly ior :2 minuteS. anD alll)W to scpo. 

Il.ral¢ as oeiore, vrain Ihc lowt":'. aoueous pnase into 1. third 

500-mL scnaraurr. and extrael it wi'\.h IWO :SO-mL TJ()n.IOli~ of 

~~~h~I~:;~~id~~ :=n~=':n.Rc~~:!~~ comblMQ chioroform e"tnlCU In 2. I !{}.mL 0caKCl" on 11. steam b&tn. 

wnh Inc Olio of a Sll'e:am of nttr02er' •• IO a~rern cirvne:u.. R<CCiis· 

s.ol"e III aOO ... ~ ~ S mt.. of <:hloroimm. and: lrnnsi=r to a r.ltcr, eol. 

'u:cung Ine filtl"3.te III a ISD-mL .oca.kc:. Rinse Ine iunnel wilb 

ScVcN:1 small portiOns of chI01'()iotm.ltl4 ~a?Orate rneeomoineci 

ffitnu.e anc rin~lnt1.. as ~oco. aoove. untii no -coor of eblOl'Olotm or ethYl acetate Ii QC'l"C!!Plible. Dry in V1I.CtJ!.Uf.I AI 6~ for! hour. 

Cool in a Oeslcca.tO"r. ana WCl!:.It! no! less Iha.n 179& ano no~ mOR: 

than :7% of ir-C¢ oolyetbYlene ~lyC01S IS iouno. 

Polyoxyl 50 Stearate 

POlyl O~Y~ 1':'¢lhancdiyl t. (H ·,·oxooct.ao~I}-(,I.l<oh'tIQro)!.y·, 

P-olyett!yiene g]yeol mOIlQste:aratc (900,,·99.)\, 

» Poiyoxyl 50 Stear::ae is a mixture of tne monos;:ea~ 

rate and ciisteD.iate esters of mlxec poiyoxyethyiene 

dlois ano the ciJ"rTcsoondin£ rre::: diols, The (lye:-a2e 

~oiymer length i~ eq'uivlllen! to about 50 o~yemYlene 

unIts. 

PIClUI'ltint lim!- $lOr&.'2t-- PN:Se~c in l!!thl CO!lEtnner.;. 

RejerenCl!' st2nd.r6~':'/S.P ."01i'.?x~'1 So SltQrtHt i?t;.ltrtllrt Sum· 

Clarti, 

268
, 

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-.1I" .... ***l11** ...... ****** ..... " ... ti ......... *****.f.f, I:i>~~ 

-k ~ c.". '{J! __ 

C F '1/... "1M. t;, 0," 

1. na S1l!IIOt./UG 10. (1RII), __ :6S~6~1:5-~R:.... __ ..::==:::::::===~::._ 

1. fOT.DJollClf l'IItmGIr lIII. (IRII), ________ -: _______ -...,' .• 

3. ClINICAL IWlI (UIU), __ C_._st_o_r_01_"1_E_th_O_xy_,_.t_o_d ___ CA_S_#_6_17_9_1_-_12_-_6 _____ _ 

4. runc:%IllI ClIIXtc&z. ~ <_l, __ 2_20_2_0_' ______ '-_____ _ 

,. _1II:f _ (UIIlI),~,..;;C"'OO"T ... ':;;!O;,:L:::E-'EV=A:L.U;,:A;,:T;;:;OR;;........,.....,--__ -_--__ _ 

t. l'OI (_> V 7. l'OI ~ III'I~U (111),_1.'-''*="--___ _ e. DoUlI 0' 1IQIt:n' ~ •. _ .. __ 9_-_12_-_94 _____________ _ 

ll. I11III UVIlIIIU (I11III), _______ ._ .._. ____ ~, _______ _ 

14. I11III II.IYUIiI CIlIIHnIOIII _. (I11III),_.....,=;-;:==-="."..,='"""'"""=..-__ _ (iii _~c _ .£1& ., _j 

•. U. IIICOIlI _wg (Ell) 

,--------------------------

Dl.h of Ca,.·rq,l -IIt· _______ _ 

~ ~~:'.:::::::::::::::.:- _101 .. 6 Co aco, _______ _ 

o 

D lIItJ.M1 

--_ 

('De'11 5sU.:1 ... 

an .. , ... ) 

-----..... --.. ---------

269
(~~! "-

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rfli'f 

CHEMICAL NAME/PESTICIDE CHEMICAL CODE (PCC) 

REQUEST FORM" 

REQlIESl'OR NAME: LUcy J TRAINOR 

TEL.:UJljI 305 6972 ORG.: ISB/PHSD ItlY.J1:~flKI 

CSF ATTACHED: 

REQUEST DATE,j!!.EO,fr 

ROOM: 266 MAIL CODE: 7504C' 

xxxk) YES H CSF l$ attached complete rtefil A and the cnemial Dame ill Item B. 

o NO :rr CSF is not attached wmplde Items A. f&rough C. 

A. INFORMATION REQUIRED: 

VCWI.&ttt1uM1 ~ 

o Provide peC 2Dd ToIer:lbct! EKemption Status Fot" FQOd .. Uu Inl1!rt lhgrediel1t(s} 

a Provide pce ror Non~Food Use Inert Ingrediecbt (s) 

Cl l'ronde PC'C fur Active higt'l:dient(s) 

o Provide peC ror Dye 

o Determine iC Fl'::lgranee is Acoeptahie (011" Use ih Fonnulalion OO~.rOH~~):' ________________________________________ __ 

B.INGREDIEN'rlNFORMATlON: 

lagrediebt No. 1: 

a..m. N ... " OJ:;; 7fi[ 0 I. L 

ETHOX'(Ul __ 72 

Tnde Name: 

Inpdient No.3: 

C. PESTlcmE PRODUCT INFORMATION: 

Oem. Name: 

CAS Reg. No.: 

Ingredient No. 4: 

Chew. Name: 

Trade Name; 

CAS Reg. No.: 

EPA Reg.. Nt)../FiJe Symbol: 65615-R ProductN'a~ 

Rtptral1t: CLEANING SOLufIONS 1 lNC 

SCOOT MOLE EVACUATOR j 

Faod·U,. Pesticid" 0 YES 0 NO 

f Pen:eqt in FOf'ID.ub.uon (.For Fragf:lllcrJD~5 only): 

"Once completed, this Conn "may be entitled to treatment as CBI under section 10 of FIFRA. If so~ a red Fll 

CSI cover should be affixed to the reaue ... t (firm ann fhl> ~ ................. f. h ... .,... .. n""~ .......... ""~~ __ 1 __ 

270
• 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

October 17, 1994 

0"; IC': co 

?R8-'UfftJlI. ?(Snclo":s 

.t>;;J TOXIC $03$,M<C(S 

MEMORF...ND1JM. 

Su~JECT: Scoot Mole Evacuator 

BPA File Symbol 65615-R 

Screeni~g of New Chemical (Ethoxylated Castor Oil) 

and Request for NeH Active Ingredient Code 

Dan peacoci'r~ff;' logist PM Team 14.:<"£ 

Insecticu'/e- ,'denticide Branch (H-7S0SC) 

FROM: 

70: Clare Grubbs, Head Documen~ Management Section 

Information Services Branch (E-7502C) 

please screen this application as one containi~g the new 

active ingredient, Ethoxy1ated Castor Oil (CAS No. 61791-12-6) 

and provide me with a new active ingredien~ code. 

On August: 22, 1994, the Front End processing Staff {FEPS; 

I} sent the applicant a IIRECEIPT OF APPLICATION FOR A NEvi 

REGISTRATION", acknowledging the r.~w registration and the 

comoleteness of the administrative screen and 2) sent the product 

to PM 21, which is incorrectly listed in our computer records as ~he team handing Castor Oil (CAS No. 8001-79-4). 

~ Because of the delay in processing this applicacion for a 

new active, I am requesting that you expedite the rest of the 

administrative screening process for this product. 

On the next page, r have listed a number of reasons why the 

Program did not recognize this application as containing a new 

active and have suggested actions that may help us to identify 

such new actives in the future. I have forwarded this memorandum 

and attachment to Ms. Rita Kumar, who will be working on the 

Quality Action Team (QAT) to revise the administrative screening 

process. 

Attachment 

cc: Rita Kumar 

I 

fr~'" j"[', 1l.",,,,I~t\orl~<yol'b~ """""",_~"'''''I.''' j 'Co "~"",,.,. ~~"'''' 

-------------------

271
• 

• 

• 

L .. 

2 

Attachment 

SUBJECT: Scoot Mole Evacuator 

EPA File Symbol 65615-R 

FROM, 

Screening of NeVI Chemical (Ethoxylated Castor Oill 

and Request for New Active Ingredient Code 

Dan pe7~;;iJjp . ..../ ;/7-"/-

Reasons why the Program did not determine during the 

administrative screen that this application contained a new 

active 

On the application form, the registrant did not identify 

this application as containing a new active ingredient, only 

as one containing a new registration. 

2. The FERS did not recognize that, on the application, the 

registrant qualified the "new registration" as being 

eligible for PR Notice 93-9, Voluntary Reduced[-RiskJ 

Pesticide Initiative, which currently only applies to new 

actives. 

3. The registrant did not follow PR Notice 86-4, which lists 

the need to submit certain things like a transmittal 

document, list of data requirements, and how they are being 

satisfied. 

4. The registrant listed the active both as Castor Oil, an old 

active, and Ethoxylated Castor Oil. a new active .. 

5. The FERS did not check the CAS number provided on the 

Confidential Statement of Formula (CSF) , which would in 

indicated that this active was new. 

6. The registrant did not specify that this application was a 

me-too and did not submit a data matrix. In addition, the 

registrant did not submit a Certification Statement. These 

two facts should have been grounds for failure of the 

screen. 

7. Efficacy data was submitted but was not screened. 

8. There is no screening form in the jacket although the 

outgoing letter said that one had been performed. 

9. The registrant did not specify the product manager 

272
L 

3 

Suggestion for better identifying new actives during the 

administrative screening process 

1. When talking to potential registrants (especially 

inexperienced one}, who may be submitting applications for 

new actives, emphasize the following: 

a. encourage the registrant to call before sending in the 

application so that the registrant is submitting the 

basic elements of a new chemical application 

b. tell registrant to follow PR Notice 86-4, including 

putting the words IINEW ACTIVE INGREDIENT" throughout the a 

package 

c. tell registrant to call in two weeks after submission to 

insure that we received the application 

d. tell registrant to put the correct PM on the application 

form 

2. The FEFS should look more carefully at, consult Wlcn the PM 

team and REFS, and document with a screening form, when the 

follo'l'ling show up on an application: 

a. conflicting active ingredient names (REFS should be 

checked. ) 

b. non me-too's without data matrix, chemistry and acute 

toxicity data 

c. references ~o PR Notice 93-9 

d. application forms without product manager numbers or 

names 

e. no certification forms 

Peacock WP#5:A:65615.R:30S-5407,-6600:10/17/94 

• 

273
, 

• 

UNITED STATES Ei'lVIRDNMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

CLtANIll'G SOl .. UTIONS, INC 

ATtN: RONALD L. BALK 

1250 RAMONS ST., S.E. 

GRAND RAPIDS) HI q9507 

August 22, 1994 

PRODUCT NAME ~ SCOOT MOLE EVACUATOR 

COMPANY NAME: CL£I;.NING SOLUtIONS. INC. 

opp IDENTIFICATION NUMBER: 215.61 

EPA FILl! SYMBOL: _ D5615-R 

EPA RECEIPT DATE: 08/19/94 

OFFlCiEOF 

MevemlON. JlESnCIDfS AND 

TOXIC SUBSTANCES 

SUBJECT: RECEIPT OF APPLICATION FOR A NEW REGISTRATION 

DEAR REGISTRANT: , 

The Office of Pesticide Programs has received your application 

for a new registration and it has passed an administrative sc~e~n for completeness. 

The package will now be forwarded to the Product Manager for 

review to determine its acceptability. 

If yO\ have any questions please contact St~ve Robbins, .Acting 

Product Mana 21 " at (703}305-6900. 

Sincerely, 

J/ ;{~ FrO~d Processing Staff 

Information Services Branch 

Program Management and Support Division 

274
I 

I 

(::"~i\:l;M; sm.UT'[{);<:S', l};C, 

1\','1',"; :m~·;ALT; ,,, nll.1.:C 

~?'i"") "A~'DXS- SL, ~,?;, 

,~:"M';:') :;,\;'U)f::, rH 1;95(0:' 

o'nCfor 

i'Rl;Vf':-n leN. i'tsnCIOf;" N;O 

70XICSUilSfANCES 

Tne Office of ?estici:i<:!. 9;:cg:ca.'TS i rec!2ived your reques<: far a 

('J"iill')&.ny ..-:t'~il1bt'?~ ! Cn.Sl:;:"U,utor nun>1:::er. T:,o company nu.:wer <::ssigned __ ,,~ , . c <. ___ K!."";LJ _.,. _____ < __ _ 

Ym; ill:e :t'cq;.l1.n"d Co )Jot.i,~v ;:::l·e Agency of any chancre in 112L"'l18 ox: 

;;'Cc~;:2S~. A~:, r;~c1";'le.se$ for (:;'-:';";'9'2 of COITlp;;:.ny 11<'l.F.ti.? and/or address, 

~'1.~)0 ~-,- .... 

"-,."'.., ~~ ... -.,~,-,- .• '- (.<0 ):.. '''\';j';;';'~'- '-~''''-''_ o· -,.L <1''''''-'7r''''-~'i '/ _._,-d,~ , • .:,.,-,C!.~ 0·0: ~ 0"-,- ""~ """""""'>"'9 

~_,~<".IL "'l!'l:' <~~o~""""'""ent ..l.. ..... ", 1 , ~'Ja. "I' "-

be ,:l=Y<1rl~;- id2i1t:ifiec on yOur corrl,.rt11i-eiS lett'orhead. .l'~ll reqnests 

::;e<,c, ::0 ;:;-:: c,!<;::nt -,-.:) tIlle', Zc:lj.o'J,':";;:g: 

;)ocmcnl: J??:oC02-SSi:t':'d De3;{' (CORDR) 

Of-;;ie:s; of: P€:8ticid.e ?;;:og-;:-ar.:s - E7504C 

1.; • s. Znvi;;:';'JYl:,1(~;)t<:l ?rotect;ion Agency 

"1(}1 ',\1 Si:=-8'::~: St; 

j',,~_.~ P;CO(~l~cts ;',U~1':: 

~,1-",:' ~;";1.?.n'.-: .:;nd./ O~": ~:al;Pi , 

p'";:;r:J.c.l:'l;:, pro,';'..1cc,,; ,,::~:;, 

St:..;:Ji-"'c,<="::. 2;:car,,::r'.. (:,,\:: ~-;'C-2-; 

~ '-.~"-~ '_>_'0· ... _ . 

I'I': :t2!:::~S;:0:::.'~d with t.1"ie 

to'-.""i;',:':' " .. :,;fi instr0.ctiol~S 

:.>-:: ob=::.;d~'l:£s 0)[ c;;;lling 

.=-J2~2:',(,:~. 

,;, -; :':. ':~~.':-" :;'::r , -". /'> ~ j 

\-,'{ . ~./.,:- ,:;..--'" 

l:("or~': ?;';-;_G. 

Agency prior to 

for regist"-!:ring 

'c.he Rs::gistl"ation 

.!::r;:;:OTtfG..'C:'on Sc!Vici2~} Bralich 

?:.::cgnl:Th i-ea.'~:,S0n;(2i1t arld S'-lpport Division 

;1~C")el.('dI;Mt:yd8~ I~ 

-r"n,"~ \"f'(~ ~1l;:;'"""~I~~ ~~ P""'" I~~( 

""_"'~'",« '1!",,~(5l1"J; ~ffl1"W 

275
, 

, 

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• 

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ISGOO't 

M&LE 

EVACUATOR 

CONCENTP,ATE 

• 

MOles can dig uo 300 feet 

oj eal1l1 in one night. ~ -

Moles eat enough food 10 

equal rts weigni each day. 

NON-TOXIC, 

BIOOEGRADABLE 

MOLES CAN'T WAIT TO MOVE 

SIMPLE and SAFE 

SCOOT MOLE evacuator workS nocause 

mOles dislike ""te odor and taste of Ina 

product. When theV firs! smell SCOOT. 

tll~! wiil aeeame very active llYln9 10 gel 

away. When they reafize tnat it's all around 

them, they come tD the surtace ant! JOCK 

for a lawn trial Qoesrl't smell like SCOOT. 

MOles usuallv ieave treatetl area In 1*2 

wee1(s :mer aopliC3tiar.. The convenient: 

spray appncalOr alloViS for easy. economi' 

cal, wille .coverage or area to oe msteo. 

DIRECTIONS: Shake well before ,sing. 

Soray SCOOT MOLE at fal' of on. auan 

per 5000 SQ. tt. uSing ~rge sweeping mo· 

tions. ror oest jesuits. ap'Oly in 2anv 

Soring, Mid-Summe-r ana eimy Fall. or if 

mOles migrate from your neigntlOls yard 

after tIley first use SCOOT. 

~AUT!oN: Keep om at reacn c! ::niitifer" 

CONTAINS; 2.1.00% Castor aillJS? 

79.00% inen ingrealems 

:?A "s:. ;<00000 :?~ Reg. ><lOOOO 

EASY TO USC: 60:1 

HCSE·SNO A?P~ICA'TOR 

II iii 

5000 

so. "'. I 

35CO 6 seL F:. \ 

2000 

SQ .. =7. 

500 

sa. F":". '-____ -' 

PEST SOLUTIONS 

GRANO RAPIDS. MI 49507 

6 , ,. ,-----------_____________________________ -:J'. • - ... • •• , .. . . 

. "'.... 

• • • • .' .. ..... 

, . .... • • .. 

, . 

.. • ..... • 

• 

•• • •• • · .. 

• · ., " .. ~ . . ..... 

• •••• 

P"",49 

---------~~-~-~-~-~ ~~~ 

276
, 

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• 

• • 

MOLE.S 

CAN'T WAIT 

TO MOVE 

anc. J gallons 

.......... 

• •• · ., • • 

• ••••• 

• • • • •• .. ........ • • • • ....... 

• •• •• • •••• 

• ... • • ..... • 

.. . ., . · .. 

• 

. ·, .. . ...... 

•••• • •••• l 

______________ -_-~~_--__ -__________________________________ P_~_e_S_(l ______ _ 277
*Product ingredient source information may be entitled 

to confidential treatment*
L 

4erwork Reduction Act Not. 

The public reporting burden for this collecrlon of information is estimated to average 1.5 

hours per response, including familiarization with the form, organizing the necessary 

information~ and completing the form. Send any comments regarding the burden estimate 

or any other aspect of this collection of infonnation. including suggestions for reducing this 

burden to: 

and to 

" · " . · " • 

• • •••• •• 

• 

•• • . " ." .. 

• 

•• • • • • •••• 

. ~ .. • •••• 

Chief, Infonnation Policy Branch, PM-223 

U.S. Environmenlltl Protection Agency 

401 M Street, S. W. 

Washlngton, DC 20460 

Office of Mruugement and Budget 

Paperwork Reduction Project (207(}(J()6() 

Washington, DC 20503 

.. .., .... " . •• • • • 

• ••••• 

• • 

• .. • 

. ..... • • • • •• ••• 

279
oEPA United States 

Environmental Protection Agency 

Washington, DC 20460 

i ,for 

, 

-

[I: Registration 

Amendment 

j Other 

I I 

: 2. EPA Product Manager 

i RONALD J" BALK 

i 3;, PropO$oo Ctossification 

" :. E:J None LJ RliliitrictGd 

4. CompanylProduct (Namel ' PM# ,., 

~~~, ~";,~m.~"!:! ~dd~'~ ".:,,,"~ AI':~f~''''~~Ap~'fn''~i'~"'~",~I;;In~'~/U~d.;ZZI;P~C;O~d;'');--'~ --'----t;;6.~EE:.;,P~.~di' ~C~!~~dIR~.V:.~j:w;.~, o~a:c;;';O(lrdl;mc:e with FIFRA Section 31c)(3~ CLEANING SOLUTIONS, INC. (h)(i), my prodlJct is: similar or identical in composition and l<:1befing 

1250 RAt-l)NS ST., S.E. to, 

GRAND RAPIDS, MI 49507 EPA Reg. No., 

o Ch(}ck if this is 11 mfW (Jddress tName 

, - II 

Amendmont· Explain billow. Finn! printBd Irtb,:d~ in rop!Jom:e to 

ResubMi!llliOfl in ,.;ui:llons!'I to Agon<ry letter dotud ______ _ 

[J 

o Agetll:Y lotter datlKi -----, ________ 1 

nMe Teo" At.'pJieotion. 

fiJ Ol110f - Explain below. 

-;;;;;;;;;~~;;;:::;;~~:;~; ,,- (Expl Uso lIdditionm pIIgo(s) il nIlCG"OI.ry. (For ,ection I lind Section IU 

N!'Itifiea-Uoll - Explmn bolow. 

NEW IlEGISTRATION (PR NOTICE 93-9) ''VOLlJ'NTARY REDUCED PESTICIDES INITIATIVE." 

,~ur~----------------~ 

must If nyosn No. j>t:r 

Unit PIICkll>lirl'lJ wgt. Ctln~inllr 

0< co ,I, Io<H 1?1? ~ 

~or Soluble P.ackogl/lg 

X ::-

If nYoan 

P..,kaolt Wilt 

2. Typo of Cantainaf 

~::~c Glaall 

Paper 

Other (Specify).!.! HD"'-PE"--____ I 

IIXI "":;' No< n 

4. Siml.1 Rmen Container 

~2 oz 64 oz, 128 oz, 5 gal. 

16. Mantlllr in Whlcl1l.al;lol is Affi)(od to Ploduct D Other 

MA,~UAL 

I -IV 

Title ,,' 

Certification •• :., 'i:e· . . ! oortify that tho II'hllllmont;: I h<!V'u mada (HI this form III'Id olilattllchmonts thortlto arc true, accurate and ;' • ROC~~ •• 

I aCknowhtdOll1 hilt any knowlingllv falaa or IT!iGlol3dinu statement may ba ptlnish.oble bV finc or imprisol'lmcnt 01..... (9taMped} 

both Ilnder applicabltJ law. • 1: _ 

l:d~~ I~v" . • • • , . ..... . 

... .. • •••• 

15.0atlil 

L. BALK 8-17-94 

"'. " .. y ..... , , uditions ;uro Whlw.· EPA FIlo Copy 

m" 

280
------------~------ - "--

• 

?ilPt-& I!EOOitH!III 1\!:1" !MIYEr 

~1!"r!!l~~£~!!i""~f!J!!"f!;~;¥fSdrti( Iftif ~I EM' thi" ,»llu;tkn of li1fo.r~tilf! if; wtiJrnt¢d 10 1 ptf rtrWftt¢" hwtrt£thm$$ _'d\.jng ¢1;it,t Jeta Ml/$'CM,. ;W!§tiwdh;! lIffl 

tAA OOt4 net:64, vrl 1;11 M'd rwiwh'10 t'iw aXim:titin 0f iM~ti&",_ ~tt t;m1lrdif\j ttt€< ~ 

wtl!mte m" ¥flY Otf;-0f QffR1;t of COH0Cll<A"! of bf_t{i;ID, 1rn::hrl!na ~tjont fiX ,.e6xir'$ thh: burden, to Cdef, 

l"f_ttm Poticy IJr&'\Ch, P#<223, \)/L EmJn:t'm1!imt&l PnAu;tirn MPM:"h un M Street, sti" !JQQ-dr;gtw-, OC 2;)fhJ; 1lfld to thfl 

Office of !M_tien &~:} ltfJ0.!ll'itory Ilff&lrt, Offlco of ~ 1InIi ~i. tloo.hll¥lhm, DC 205Q3, 

IN"SJBUtT!OS$. This ferm IS to tv? lllted for- ;mU ~UC&?'f'll"OO fw fWlLl Nl9hltt&t!m. %'ld 1.Wt' t¢'tesi.:;trlJltl~< ~t. 

r«AtulMlon, to ~ikDtl0n£ for MtHk!ltiom., fiMill print. t.HWJ'~ ~htratiO!\. &tc. tn ~ to pn:x:eu «l 

~\kilt'Wl {Of'" e IWM r\lJglstrl'ltlcn s£:Q!jtti!!d Qf\ tide t~ th fM.tMn& mtltt\et !!'!J$l U:C~ tbe i!ff'UC!lticn~ 

1. CertHkt.tfon with RMpBtt to CiutlM of 1Wt:n (E¥l fNm ~2'9). tlf nl!il ",.x~ted by 40 ern 152.81 (b) (4}1; 

2. C«lf'ioo-;tiat St&tewmt of fiU'iiUta {EPA Fom t511J-U; 

5. FOrmJletol"t Ex~tion Stlltl!\llllent (£?A f$Oll as11)-m;' 

4. five copies of «aft labet II'(!; 

S. lhf"M copin of br¥ datil ~itted; 

6. AutMr)zlltlm letter are ~j~e; 

7. Miltrfce$ wlwre appticsbte~ 

Sl.!b:!Ihsfoo of Lw.elfng • UlbeUI'(! tnoutd f'int be ~h:too {n the ~ cf draft I.abel§ "hit aU l$PUcatiGM fO(' 00\1 

regietratjW'!. SIJCh drdt llrlals limy 1m fn tiw fom of ~ tabat teat <m tV;; )t 11 lnciJ ~ f%' a lW'lC.loJp of tM p-~ 

tal. If prepilred liS a lItJ(;tup, It Wwcld be ~tna:t«i in va.i& 4I!IJ!i!f $$ W iacHit~t~ Rt~ in an 3.5 x 11 incl! Ht~. 

lW?k:up labels significantly s&lItt(!r than a.5 x 11 it'cll¢$ ilIihwW' bit ~~ en as x 11 inch piI$liW fer £t.biIMlen. 

Stb!iiiUllon of bata ~ Vatll tti.lmftted in ~t r;4 thh; ~iefl;irw; lWZt be- ~uoo Itl ~ with Pi IWtfce 86,5. 

spttlfIC INSTRUCTIONS: f'lC1!!HI raW the imtr.M:tflXl$ Bst1!d h$l@!' bcicr-e CJ:l!!!Ptetil'l® this nwtication. fint 

detarnlne the type of rW;1st"tlltion ectlerl. Hsted in stock. A. fw- mdcl!; Fll.Ve ~lttine thIs nwllcstiOl'l. for 

~ticatf6rni ;ukmitt«1 If> t&1r\¢Ctkm tilth IftM ~it-tt'@tlon $Cti<W$~ Soeti_ 1$ nI, M'id iV _t be etl!ll'plete-G by tlw 

ll(:ptleMt. for apptiC!ltiCf'"% s~itted in c~tlon with ~ Nl'ifilttn!tioo .&o;:ti_. re~;:"i_, ootlficeti_, 

re-rC9istrflti1)n$, He" S«tlcns 1, ll, tnd IV _t be ~rted by tim *flPHamt. 

g{~ A - Check the ~!"cpd$tl' action i,y $itch y;ru ${'¢ m&mittlng this fen&. 

SECTIOO I - Thl5 1i<!t'tioo $%t b0 o:mpictf$-3" _ ~jewt%. ftt aH ~i$tnthm KtlGGS. 

'. ~~t ~. If>un }"0c« ~~, if _ Ma. bem -*'i~ by EPA. mis m.lSib"M' _y hilVC b.w!n .$$slgl:Wd 

to y;ru IJ§ g U$'fc r0;)l:;trmt, fj distr!but<l? or 00 l:!I'1_twthfuwl:nL H ~ pr~t h reghtered, lMert the P~t 

2. 

--

rEA Pr-«M:;t ~ - If K,""lC"%0, fin in tiw _ gd R1 rnmbe- of tlw: ES f'nx:!uct ~r. 

3. l'~ Cl_ifi;:JI!t1cn • $p&:'ify the cl_lfiat'iM m dds prcl£t. 

4. Prtrl.!ct mmw- Enter the Ui&9lete ('.£Me of titi1- twaticilk 00 'it wilt :;;:;;,:;;,,011; tm 11!l;vL ,hit flW"l _t be 

srmcifl<;; to this FW,xt enly. >:)0 of ,,~ h nBt pwwitted ~ f of tln MWre c~, Dt'Mt inchi'Je 

Mff brU'ld ,-- IH c~ tiM 

~ 

• 

5, ~ d'cl ~ of ~'ia!rtt Yb< _ 6f U;<; 11m &r ~ gd lIEhll"M$ ~ in?3I% ~jc&tlcn h tM V fim 

tit W14§ the regist!"ntion wiH L0 1%*%;' If 'fiAt 4i"'t 4Cdf1@ 'lh!::clwt1 ct krltlfhc-r 7$1 M&t m.i:mit oo,'<",n''''h +tOO 

fhat fWtty to ect Tor trroo h I'Itgi.(trd!im !lWtiAii'$~ kJ ~\tilf2 rwt rgidif1@ in tm.ft©1 Sbtei\i umt fUn'!; &1 

mAN:w\tw SJMt f¢tldir"$ !n th0 un;tw $U;Lt&. t<' _t f'fW ~ In tiH F$®,:'tt1:&dm _tttW2. 1M r~ znd ttlll!plHQ I1$Hlr'J 

liddf®U- of DAh an Ii81fit !!!!\Xt iUY~ Uti::; ~UC$dei'L 

6. F.l'p4H;w!tevI$l rHM liUtJon:; tel::; (R{ ptw'. f'fW ~ted rf4i_ of ~iutivw {{ff renhtn!tf00, e ~~tf 

to t-:dsttnq regi;;tnttivw, rbt ~r0 "lm,lu- y j~:t!1:;b; .. 'it ~ pe::;tizlw ptr'-m\u;tti rut lYre U$f'~tly r~~1!te~ with, t 

nl0 EPA. 10 order {IX ;pph;;:lHlcn tv be ei>:;pbie 1f%' ~a:U:f '(00 WiSt Dt. vitTi the evA Ihm,.,tr5u«, 

Ml.ffil!x;r U'ld pf'u.!-xt 1_ th¢ rVW,xt Yffi' beti~ 1% $1:iwl'toc t" 0i! fd(ntj~$l He 'f'X¥ Yi-"" ptGduct _t w 

$lwllst cr i0mticlll in beth fornAbt!cn wv.! t£W;hm __ 

.sECTION 11 . THe eoctfOh Wffit k (~let.f.d f",,- .. H llrWUcathw£ ~Hed to ~ trw nt;tJ:4trtrticn (;l"y of $ CW'Nffitiy • 

r""i1f't,!",-iN prvL¢t (~t), kw ;;. n.w.hdt%izm in ~ t~ Sin ~ htttw, £8' RQ-1.H!cgt!Of\$ to tM A'f1l!!f'Cf. ftX ttl", 

~l$$!i:jft of flr.,4\ ;uintro l:ilietif1@, fry;- reN\'@l"ust'i<x; mvJ fiM' lEi{ ~ Mthm t.fwt pet'bltl& to g u:a·~LilSl 

~. This £cctlm III !1£t 1£ 2t: ~ 19(' #I I'mi ~lc&ti&t tw ft$I!b:twtiut. 

1" ~Joct: rA' ~_iut ~ t:%Wk too ~k4bte bl,ccl: JW'id pvmrt& tlw ~ tat€{' &t# if ~~ilit*~ Pro-ohm ii brief 

eJtp(MWt!oo of 1fu;, ~(!I) fo,~ tfw mimriUP101'l, mrd! m; "'tlw ~tfsn of 4 site, plffit w unp (~if'l)"; 8~ tm 

tmf!d®ntial $tntt=eflt. M fOf"lllUt,!l by ..... ; "hiIVgbtretf{lfl ~:iffil:'¥i"'. ~l !~ h%i:dwt of ~ 4irectiO!'111." Attoch iii eep4rtlu ~ H OOditlorn'lt ~t!i hi ~_ 

sEtTum UI {Pactaglnt and emtiiMr ln~tiool - Th1$ Scat!cn _1: 00 ~etw f« -lilt $f!p{lcrticm 

zl.lblltittedo'",oCOfTlIU:t:ien With nw r~'i$tr-etiQfj or- ~lc*€ _dau£$~ 

1. Type·_·~i,,;~k il1m- ~iQte Mod:. if ytNif" ~ wUllm ~ in t!w i.m:tiU'ltv:.i pw:J;:3g1r,g types. 

!ndic#tt tM aiu-on:n. iooiv!dwl peciwb MId ~ $II<'W ~H ~'l~~ 

2~ Twm of ~H cddInet ~ Indfcste t:)'p€ of rW!"Iteil'l$l" in Wild. ~ twill be ~N.. 

3. ~~q(!Set ~ - Specify tM net Cwttent:s- ef aU retsil ~trnm> fOf' }'(l!W ~. 

4. $1_ .. ) et~f~~if\iM' ~ Spe<;fiy tM: ret «t¥ter<ts ef aU nrtaH. ~irnm> f« 'f'W4!t ~t:. 

5. lc'dit __ (be ~i_ - IndJC$te the tonti_·of the _ directi_ f« v«E ~. 

6. ~J&.&idt loA-! i# $ffil!ll!!d"to ~ ~ hdicat& tM ~ ~t tw¢l is;({~ to r%t;e-H =tl:d~. "1"1' ••• 

• • 

geTl" IX {~ point} ~ This secHOi'! _t be; ~OJ!'Pbt=l k>r aU ~'h:;({i_ ffW aeebtrb:tioo ectlam. I.e., 

new ~ba: ,*"iatNlitien. rMUbai$$i()f'l, "'mP-too." ~i$trati_v ett:~ 

l'S'- W'.."~lenatory. 6. M'OC+ onty • 

••• • 

281
Pages 282 through 284 contain the product confidential statement of formula and are not 

included in this copy