# EPA Registration Number 65615 -1 Volume 1

# /\\



# I

## Page s 3 through 56 contain FIFRA registration data and are not included in this copy..**~---~ ~.~~.~.-~------~~--**  

# • •

PROPOSED LABEL

# 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 "",,-,.,., product WIle. they 

## fils! 

# S!IIOll5000T. 

# It 1m**~** 

### 1l!'Y will_ >illY aelM! 

### tryiIlg II> !l't



## .... 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



# •

•

# •

• 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

# •

• • • 

# • • • •


# • • 

# 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 

# .. ,. 

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# .. . • 

# • •



# • •• 

## •



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# .....
, 

# .... • o •



# .. 

# . 7i13.1%

# •

• 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. • •• : •• 

## •• •

# •

• F-I S 001 

### 65615 1 

## ,e ym 

# , . 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

# •



# • . 

# .. ... 

# ., . . 

## 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



### _ .. 

## _--------------

## 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. for 

### b. from Acule Tox. Product and

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



# "

### 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**

## ••**'"~** 

# '0=, nOM. 

### ft Uni:oo Stales 

# o Registration opp**Id-l:.ntjfI~r** Numb!!-r 

# 0 

# EPA Environmental Protection Agency

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

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~ ~----**  

## ------ -- ..... 

## - -_
...

_.



# •

• :'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 

# ...... • •• 

### •**~** 

# ..... . 

# .. ·**~** 

# ... . .... . 

# ... .



# . ... • ••



# ..

• 

## • 

# ...... 

# ·

• 

## • 

# ..

.



# ...

•••• 

### • 

## •• 

# .

# 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 

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### 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, 

## / 

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# '---_--{,A_/vr/ Sheryl Reilly, Ph.D., Chief 

# I Biochemical Pesticides 

## BranFh Biopcsticides and Pollution Prevention 

## Division

# •



# •

• -------- ,-",,--,,'-""'-""-

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!.. 

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# •

•

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. \ ./**"~""** ""-""- 

# -------------------------

# •

• 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'/'" / 

### a**~~7 ~**  

## {--f'L'**~ ~** **1~** Ronald 

### Balk Balk Trust
Enclosures 

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### II> U'I,I/ld**S!~!e~** 

### o Registration opp kk"t1fhor Numtw 

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# EPA Environmental Protection Agency

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


### ; 1 

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### 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.



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### to: EPA Reg. No. 

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### Product Name 

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## Section • III
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# ,**l-~~,~~.",,_,** 

# J

# •

• 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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# 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 

### :;,clf

### dispellsing 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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# .. 

# .

# • 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.**~------**



# ,



# •

• - 

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I I

# "'i~1

SCOOT PRODUCTS GRAND RAPIDS, MI 49507 

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

# ..... , 

# •

EASYTQUSE 

# HOSE-END APPUCATOR

•••• 

## • •

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## ••••• • •••• 

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# ...... • 

# ••

•• 

## •

# •

• 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?

# • 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""-**

# • 

# •

• 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,



# , J;,{**~/(, ~**  

# /i: 

# Ili!**·~SilcW.ReiJlY,** Chk.' PPD Biopesticides and Polhnion Prevention Division (7511 C)

CONCURRENCES
I 

### ,.,,,see • 

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# •

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# •

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# •

# • 

# •

•

• 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

# •

• 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 • ••••• • 

# •• • 

## •


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# •



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# . 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&)

# Ip~~lC

Scoot Mole
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

# td~:: mU$t 

# '!'**~y~,O.** No. ",r It**~y",~** No .• " wgt. elOnt";lUlr P1Ick.go wgt



### , 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·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!~:** 

## wa t 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\,

---- -

### 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.M. 

# '0

, Opp W.ntifl

.. r Number Unl1w 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. 

# ne h , 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 

## wa t • eontairar contairwr Other (Speelivl 

### be submitted 3.1

. 

# o C<lnairuH 1 4 ."",,) ,,""

## ~,~:.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,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,

# ,

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

## Page s 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



# ...

# • 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

## 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." 

# •

•

• • •••••• 

### • 

## • •• • 

## ••

•• •



# . """



## •• • • ••

••••


## •• • • 

## ••

•••• 

## • •• 

## •• •

• •• •• • • • •••••• 

### • •

•• • •••• 

### • 

## •

•••••**--~.-~.-** 

## --_.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!e m ent31: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'.,

# " 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

### Desk Clil;c;e;



## • •• •• •



## • ••

• • • ••• 

### ••• 

## • •••• 

## • •••• • 

## " 

# . • • 

## •

•• •• •••• 

## •• • • •• • 

### ••••• 

## •• • 

## • • • ••••• 

## • •

• • 

## • •••• 

## • •

• •••• 

# • 

# •
Paperwork Reduction Act Notice

!(



# ,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.

# ~~ /J ..-;;::' /I)e. 

## if- 

# cO**~_.~~cL** 

# __ 7

Whito- EPA Q

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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-/"',( 

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# ......... ...............•.

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# .................**'2~ c:r~(c**  

# . ................**~I** 

## :> EPA FOOJl lm-1Al{m I OFFICIAL FtLE COpy

# •

• 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:\ "')"W'**~ PA~ARY**  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"

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### •

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# S Co 01 

# M&LE

EVACUATOR

OIRECTIONS FO« USE '

... .-e1f_

......... "'''''"'','''''_**"'~"".,,-~-"'~** 

## "'***"nl1'l'.:r<w~** fN.o

... ...,.,"", U "'''''**,,_~""'., ,~"'~.,..~..w-"**  

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## .. •

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## ..... _h","_'_-""_"""'''**-~.** APf'lICATfOtl OIRECTIONS: 1i

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## "'

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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

# •

• 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 

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DIRECTIONS FOR USE It ,$ a vCeILI,on cf federll' Lz,.", b uti! !h'!;**p!cjJ~~"'"** () m"N1Cf**mccM.·~W·.1 w~h**  

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...**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' 

### •••• 

## • •••• 

## '---------------------------------------------------------------------------------------'.. 

# .
•••••• 

# • •• • 

## • •••• •• 

## • •

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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}5 ll 

# l,/"
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

# "'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"20016 1111 

### 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:::--" ,'--**~;;;:** 

# - d ' '/"**,'~. ~**  '--**l--~ ~** **/i~ /~t----.** **~j** - - ____ .**~** - I

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### ,{ 5'61;'- I 

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## \_'"~T"",,,T_'n~,T,**T,',"-,'T~:;---** . I,iiiij'--'- 'M'

## ,.d;fll-,,-,-,-,-,.',-,,-=~-,**';;F~r** ;:,

## '.TR~,H'.\ 

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# ,- X**~**

# "t~ 

# , , 

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# "**~**

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# 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 6H3-243·921OI 

### ! 

# I

..

; 1:, " ,-



### r {", c
. 

## ,,,- '., f 

# MOLE ""'REPELLENT



# •

# •

• 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** 

### 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 •• 

## • • 

## •••••• 

## •


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### • ••

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### •••• 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**~-"""----------------------------**

### 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 

# •

# '.

• 

# •
•



# • 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

### 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 

# •

# '.

• 

# •
•



# • --

- - - 

## _._.- -.---- 

## --_ .. 

# _ .. 

# - -_._._-- 

## --.---

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

### 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 

# • 

# •
•



# •I



## • •



# •



# • 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



## • • •••••• •



# ... 

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# .. ., 

# . · 

# ..

... • ••



# .. .

• 

# ·

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# . ••••



# . ... • 

## ••



# .. .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 Oil Tf 

## is IIUSp Grade lt

, 

## 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 '

# • 

# --

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.

# •

• 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.

### 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 

# •

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# -----------------------------------------------------------------~"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

# •
•



# •

• ,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_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

### \



# •

•**---~~~~----------**



# 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 .• • •



# ... ... •• • 

## • ••

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# . , 

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# ... • ••

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# • 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,·.-

..**-~-----------**



### 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

# •

• 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~**

# •



# • 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 ne n 

## 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---**.-----~~~~** ...**---.--~**



### @P3L ENTER LANGUAGE = 

### PCL



# •

•

# •

• 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.

# •



# • 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

### @PJL ENTER LANGUAGE = 

### peL



# •



# •

# \



# •

• 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 

### labor**acc~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= ------------------~-~---** 

# • '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

,**=~~::=?~:~~.**

# ~~ (

.. 

# "

..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-::c 0 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.** 

# ,

,

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

## -------~~---------

# ,



# •

• .--

..**-~**



## 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

# •

• 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

### •



# •



# • .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 determined ll • 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**-~-----.**

# •



# •

• 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

## ,-------- 

# --**~~-- --~** 



# •

• 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 treated ll

, 

## 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

## ,---------- -

---- ----



# •

• 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

# 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

# •

•**~~~~~~~~-~~~~--------**



## 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. Bizzell l 

## 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

## •



# •

• 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. "economical ll j 

### b. 

## IIMoles can dig up 300 

## feet of earth in one night ll ;



## 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 lIeconomical li 

## seems to favorable comparison

9 

## implies an unqualified with "non-economical ll

# •

• 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 provided r 

## 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

# •

•**~-- ~-------------------** 



### Apply SCOOT immediately after the presence of 

### moles is detected or in early spring I 

### Mid

## Summer, 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

### 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

# •

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 --."', 

# . 

# •

•**~'----** 

### , 

# ,

# •

• 

# •

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

# •

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 Ia

### of 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 250 0 for not less than 30 minutes. then cooHng to room temperature. and finally heating while helium is flowing through it at 250 9 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.~/** R s ), 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:;. 

### • •



# .....

• 

# .....**.~** - 

# • •

. 

# -

. 

# . 

# · 

# - .. 

# .-

. . -

I\}aterial Safety Data Sheet U.S. Department 01 Labor 

## ·

# ~ May be used to comply with Occupalional Sa\"ety arid Health /;>.dmininr:uion OSHA's Hazard CommunicaliOfl Standard,**(Non~MandatOTY** Form) 

## ,. 29 CFR t910,12OO. Standard mUS1 be Form Approved 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



### • 

### •

# • •

.**'>':~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

# • •

;



# • WAIVER OF TOXICITY



# •

• ••• 

### • •••• 

### • 

## •• • •• • •• •••• 

### • 

## •••• • • •• • • •••• • ••• 

### • 

## ••

•• • • ••••• 

# . 

# . • • • ••••• 

## • •



## •• • •••• 

### • • 

# . ....

### •



# 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 

# •

. .... 

# . .... • ••••• 

# . 

# .. ..... .. .. 

# .. 

# . ·
..

.... 

# . .... 

# · " 

## ., 

# .

.....

.. 

# .... 

# · "



# .. 

# . . .........



# . .

. .


# . ....

• • 

# ......

### 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

# -------------------

-- ---



# 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 

# .... • •••• 

### • 

## •• • 

# .. 

# . • ••



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# •

• 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

# • 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

### •


## 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



## RonaldL.Balk,President

# ~~ Cleaning Solutions (DBAPesi Solutions) Company Contact: Ronald L. Balk 616-243-0555 4-18-95 

# •

. ...

## --_._-----_.-
- --- 

## -- - ------- --------- - 

## ---_._---------

•



# • 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

# ,

, <



# • // 

# / I", 

# ,

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# ---



# ---**--'-~----** 

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



# -- ------------_._-----

## 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

staff Thank you for your transmittal of 04/24/95. Our 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.



# ----------------------.-

--

## ---------

--



# • 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
... :
• •• 

# . ' 

# . •••• 

## • ••• • 

## ••

•• 

## • 

# . ...... 

# . ., • • • ••••• 

### • •

•• 

## ••••• • • 

# .....

-----------------------------

# 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



# Ronald 1. 

# Balk, President

# ~ Cleaning Solutions (DBA Pest Solutions) 

# Company Contact: Ronald 1. 

# Balk 616·243-0555 4· 

# 18·95 

# •

• 

## ••• 

# • •••• • • 

### ••••• 

### • •• ••• • • •• • • •• • ••••• 

# . . •••• • • 

### • •••• • 

## •••• • • 

## • • 

### •••• 

# • •• 

## •• •



# .... • ••• 

### • ••

" 

# .**--------~. ~---------~** ;., 

# •

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



# •

•

## ----------

--



# •

• 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.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 Nome

# scoor :-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 

### • 

## ••••• 

## • •• • 

## • •••••• 

## • 

## •

•• • 

### •••• 

### • 

## • •••••

## •



# •

• 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 

## • • 

## •

•• •• 

### • 

## •• • •• • 

# · 

# .. • 

## • •••••• • 

## • 

# · 

# .. •• •



# ... • ••• 

### • 

## ••



# .. . .. 

# ...... • 

## •• 

## • • • ••••• 

### • •



# ..

.......

• •


## .. 

# ....

# •

• 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

# •

• 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

# 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.

# •



# • 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.

### 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 

# •



# •

# •

• MAR 24 199" U.S. ENVIRONMENTAL PROTECTION AGENCY Office of Pesticide Programs 

# 'I-/s-I '! S

# f-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

.

# - _.

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:'

... _ .. dSfiirt}on V

- Reactivity Data •



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- Health Huard Data

HUlU'! Ha::a.rc.s (Ae:.Im 1JII(j 0vt:m:1
"'It**S~~gh:;** 

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### 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



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# 5000 sq. ft. 

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# •

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. .::::;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

- C 1s 

### H3,20;t • CH:



### , HO

.**C'$HJ20~** 

### • CH 

## i HO

- C'!:i'H 31 

### 0 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:;;:

## Page s 192 through 193 contain product inert ingredient and source information and are not included in this copyI'.

" 

# ,**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 JV 

### s 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 ltttltblo

### riGI: 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. PaekllVns: ItlItii**storli,~Fr!5etve** in tigilt cclnaiMrs. 

# 1_

........ 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~** 

# """'



# ..



# --**----------------~~.~.~-----~----**

# •

• 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.,-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 We

### formula: <{.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 

# ,

# •

•**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 _._ •• _."

__ "

......**_~~._ ~**  ... "'_, u***'~ ~P"ft'I')'tQMl**  _**~ ......,r~$I=~I.-** **1;liI)!lCf<sJ~~_v,,::~** ..... __ .. _. __ ..**_,-.~.~w­ """"._I~-** **~~ ~,.-...**  

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## !'~.;J**-~** 

# -'1 I**~.,"~O~«IIt«lI!6** I**'''_~~t_l,,,,,,: ~~~~**  

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### _iIII1_~~~1 .1

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### ~**~'::::** 

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# ".J a,..,.., "",

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. P.0888:39 CLEANINGtS0LUTI0HSIIHC.**~-** 

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### Castor Oil 

### 217
{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 '''0



# , f1:!oc nouClia

i ('Icid:**li·napIJlhlll""-mon(l~u1fonic** ncid;

## ~~~~il;~i~j~:;;;:**7·11.1·Jroxy·2·nll[lhrhaTj'Irr!JJJlf()ni~ ~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 B H •

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~**

### 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 O u ,**~'>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.

### 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 'CH l 'iJC

......**r~"** n::lf) .'. 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



# "**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

## • <



# • 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- 

## Solut,'oo' 

## 'DB"**D,,~·** 

## So'u';o','"**-'>'~<ll"~'** ,t,..**~-** :-\,.,!>, 1.! .>.1 

## CompaQ\' Comact: Ronald L 

# Balk 616,2,,3-0;,,·

:'c,

..... _. :**"~'** ,

## 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

# s
- t/-gLf 

# 8 7 0 

# ! (j 

# -/7- <7**~**

# ;e(-ef~**~** Pfu rr: () t)V- 

# f**~** J7 '. f) P'-

# ~ )

. 

# .{;y

# ~**5u/,,--It·~** 

# • 51/1 fJ

# rF~ r: 

# f C-t?-rl-

# ~ C:VP. 

# evck 6fltr ,:::rle 

# It,/''Vw t;-t II',!2-



# •

# •



# •



# • ._ ....



# _ .. _-



### 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

# •

• 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

# •



# • 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

### 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 

# •

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# •



# •

# •

• 

# •

SC 001 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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### ;- r'lr', I\.." 

### J.::.. _.' L. '.J

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### b'::' 0:'.; 

# •

MOLES 

# CAN'T WAlT



# TO MOVE**~al:"ons**



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# ---------------------------------**~** ..**---~~~~~~~~~~~~~-**



### 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

# -------- --

- - ---



### 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

### 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

### 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,

### 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." 

### 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

### , 

# .

. 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

I

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# 20 I ) 8 

# + J"

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# p) 

# s eJ 

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### 5'(y'-'-M-e./

# d~- 

# +-v p-fY\).1 ! 

# vv'lo 

# 1 i£Jr.



# ---------

# ..



# •



# • 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



# -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.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, 1980t -'::Q!J! ! 

### wmbrook Parkway, Rockvd!c. M(L 20852



# •

•

# • 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.•

______ QCT-l·:I-94 1,IED 09:3$**CLEA\~tNG1SOLUTIOHSIII{C.** 616243.1'527 P.04



# •



# , i

, II ,! "**~t 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

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.. 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""""

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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,,~**

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... ,**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

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# ,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

! :



# '!

II 

# • 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. byeate

### gories, 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 defi

### nitely 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

# • 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

,

# •

•**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 45 0 • 

### 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-bk** 

### oi!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 

# !

# •

•

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,Lu te**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 Hydrt tll 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.S ttri k: 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 Uibfitn l

(;AK:lllm5t t ,ua u ; 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'!&&l C4 n t h 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:r Kmaw ; VbCMity.l...::rn-Wie IS«**Su:~mfbt£ .46~'111** 

# ~ IkonJ**!klw~th<>ni** .. m Ch Ion&e CetylPyrldlllh!1I'l CWOOdt: O<x\>u1 c 

### S¢d,"'" Ncr,e;o;y:mlIO

### 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

# • Pharmaceutical Sciences


# •

1985

MACK PUBLISHING COPMANY Easton. Pennsylvania 18042 P. ,



### , I

"{ 

# ,**OCT-l~-9~** WED**09:5~** CLEANltIG1SOLUTICtISlrNC. P. 1 ::- 

# 17TH
EDITION 

# Remington's

AlfONSO 

# 1\ GENNAI\O **Ediror, and**  **Choirmon of**  **the Editorial**  **{)card**

# •

• OCT-19-?4 HED 89:53**CLE"'fHHG1S0LUTIO~ISI** Inc. 6,';2 4 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[';\:

# ,--**~~-~-.--~--------------------** 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 I3 

### N0 2
. 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."

# •

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 ex

### hausted. 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**'----~--.------** ..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 oiLAtiaayInlt'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 de

### tector block ate 

### maintained lit about 

### 300 e

. 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~o** 5- 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 

### "C1N 3 

### 0 4 

### S 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\tiofl**

A: 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 110 0 • 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,,'

# •

•

" , 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 105 0 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.

# •

• 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£lulos t 

### » Microcrystalline Cellulose 

### is purified. 

### pattla!ly depolymerized 

### cellulose prepared by treating alplrJ. 

### cel

### lulose. 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

# •



# • 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-ric

### inoleate 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!HlooOCT- 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-hy

### droxys-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;(' SMIIdardtdtl'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 heat l 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**

### •

• 

# • 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 !

## Page s 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

### NF"XVT 

# t.**~ tu~**  31 :I ttn'l'Dettlure De'\wee,.,

## 65~:l 85". and bccome:s ch:ar on cooling lD "'0 8 : 

### 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, 'nI Y 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 85 6

, 

## 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 30 6 •
. WaEtr. Mtrnod 

### f (92Ii: nGi motetnan**~.O%.** Residue-an ipitiOfl' (2:81): ntll more tl1an Q.2%. 

# -i eary 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'l1rv

### rlcss.l'iry the resioue III 

### vacuum at 

### 60 6 

### 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 po

### wtium 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,

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### 3. ClINICAL IWlI (UIU),

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### C_._st_o_r_01_"1_E_th_O_xy_,_.t_o_d

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### CA_S_#_6_17_9_1_-_12_-_6

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# 4. runc:%IllI ClIIXtc&z.**~** 

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### 9_-_12_-_94

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# (I11III),

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# _______ _
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## II.IYUIiI CIlIIHnIOIII _. 

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# _ .£1& ., _j

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## aco,

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### U.:1

...



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----- ..... 

## -- .. 

## ---------

# (~~! 

# "-

! 

# • i



# . I



# •

•

j

" 

# 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

__

# • 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 j"[',**1l.",,,,I~t\orl~<yol'b~** 

# j**fr~'" """""",_~"'''''I.'''**  

## 'Co**"~"",,.,. ~~"''''** 

-------------------

### •



# •

•

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

# 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 

# •

# , •

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

# 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,**~-,-** "-,."'.., .• '- (.<0**'-~''''-''_** o·**<1''''''-'7r''''-~'i** 0·0:**""~** """""""'>"'9**<~~o~""""'""ent ~'Ja.** **~'1.~)0** ....**~~** ...**-.,~,-,-** ):..**'''\';j';;';'~'-** -,.L '/**_._,-d,~** , •**.:,.,-,C!.~ ~**  0"-,-**~_,~<".IL** "'l!'l:' ..l..

..... ", 1 , "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** 

# , 

# ,



# •

• 

# •

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'. •



# - 

# ... • •• 

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# ..**~** 

# .

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## •••• 

## P"",49**---------~~-~-~-~-~ ~~~** 

### , 

# ,



# •

• 

# • •

MOLE.S 

# CAN'T WAIT

TO MOVE

anc. J 

## gallons



# .......... • 

## •• 

# ·
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# • • • ••••• 

### • • 

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# l

______________**-_-~~_--** 

# __ -

__________________________________**P_~_e_S_(l** ______ _

# 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



# .. .., 

# .... " 

# . •• • 

# • • 

## • ••••• 

### • 

## • • •



# ..

. 

# ..... • • • •

•• •••

# 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 nYoa n 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:

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# l:d~~**I~v"** • 

## • 

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# .

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# .

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## L. BALK 

## 8-17-94 

# "'. "

.. y
..... , , uditions ;uro Whlw.· EPA FIlo Copy m"**------------~------** 

## - "-- 

## • 

# ?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 

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## 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**~** 

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## 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

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## m dds prcl£t. 4. Prtrl.!ct 

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# t

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__ 

## .sECTION 11

. THe eoctfOh Wffit k**(~let.f.d** f",,-

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### !1£t 1£ 

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..... ; "hiIVgbtretf{lfl**~:iffil:'¥i"'. ~l** **!~** h%i:dwt of**~** 4irectiO!'111." Attoch iii eep4rtlu**~** H OOditlorn'lt**~t!i** hi**~_** 

# sEtTum UI 

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6. M'OC+ onty • 

### ••• •

## Page s 282 through 284 contain the product confidential statement of formula and are not included in this copy