EPA Registration

1706-184
- .- - -

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FILE SYMBOL/RE O. / 7tJb C//J.J 

/ I . DESCRIPTOR tfA I ')1.- -

"[ ] 'CHILD RESISTANT PACKAGINd·: [ 

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ACTION CODE 3&8 

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J'NOT APPLICABLE 

REGISTRATION TYPE: ,[ ] CONDITIONAL ] UNCONDITIONAL 

PROPOSED CLASSIFICATION,: [ ] GENERAL [ l' RESTRICTED USE' ' 

DATE'ON APPLICATION EPA RECEIVE DATE PM "RECEIVE 'DATE 

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DATE 

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,[ ] NOT APPLICABLE 

[ ']..JNCORRECT/RESUB 

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DATE 

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STATtlS ________ ~ __________________________ ~~~ ________ ~ 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

Mr. Claude H. Wolf 

Nalco Chemical Company 

One Nalco Center 

Naperville, II 60563 

Dear Mr. Wolf: 

Subject: TX-I0861 

EPA Registration No. 1706-184 

FEB - 1 2001 

Your Resubmission Dated September 14,2000 

This is in reponse to your resubmission of revised label for the subject product. 

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. 

If you have any questions, please call Marianne Clark at (703) 308-6381. 

Robert S. Brennis 

Product Manager (32) 

Regulatory Management Branch II 

Antimicrobial Division (751OC) 

CONCURRENCES 

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EPA Form 1320-1A(119O) OFFICIAL FILE COPY 

Printed on Recycled Paper 

3
NAL.CO CHEMICAL COMPANY 

CINE'. NAt.CO CENTER" NAPERVILLe" 'LL'NOIS 80563-1198 c AREA 630·305-1000 

Mr. Robert Brennis 

U.S. Environmental Protection Agency 

Antimicrobial Division (7510W) 

410 M. StreetS.W. 

Washington, D.C. 20460 

September 14, 2000 

Subject: Registration of Nalco TX~10861 (1706-184) 

Dear Mr. Brennis: 

Thank you for your letter dated August 30, 2000 in which you concur with our suggested precautionary statements 

on the above - referenced registration. I have made these changes and a copy of the label is enclosed. Please note 

that for product stewardship reasons Nalco has retained in the precautionary statements the follOWing phrases: "Do 

not giOt in eyes, on 5kill, or on c1oihing", "Remove and .... 'ash contamh<ated clothing before reuse" and "V,lash 

thoroughly after handling." I have also retained the following phrase, "NOTE TO PHYSICIAN: Probable mucosal 

damage may contraindicate the use of gastric lavage. Measures against circulatory shock, respiratory depression and 

convulsions may be needed." 

Your letter also requested Nalco to upgrade the First Aid Statement to include an instruction to telephone a Poison 

Control Center. 1his is not appropriate for this product. Nalco has its own 7/24 emergency response system and toll 

free number (which appears on the label). Moreover, the product is used in an industrial setting where MSDS's are 

available. Thus, there is no purpose to instructing users to call a PCC to request infonnation on this or any industrial 

antimicrobial fonnulation. 

Similarly, this product is used in an industrial setting that includes training and provisions for addressing all 

chemical exposures, inchlding antimicrobials such as this product. Instructing users to contact a physician for 

treatment advice is unnecessary. It may also lead to poor advice because products are usually referred to by trade 

name or active ingredient with which a physician would not routinely be familiar. Therefore this statement would 

not be appropriate. 

We believe the old standard first aid statements such as shown below and which we would like to add to the product 

label in lieu of your suggested language from PR Notice 2000-3: 

IF IN EYFS: Immediately flush with plenty of water for at least 15 minutes. Seek medical attention. 

IF ON SKIN: Immediately wash with soap and plenty of water. Remove contaminated clothing and wash before reuse. 

Get medical attention if irritation persists. 

IF SWALLOWED: Drink large quantities of water. Do not induce vOmiting. Seek medical attention immediately. 

Finaliy, your letter requ~sied Nalco add thl": gen~ral st&.tement "I fave the product conrei.'1er or label .... itl.", you ·when 

you call a Poison Control Center or doctor or going for treatment" Industrial antimicrobial products such as tItis are 

sold in containers of at least 5 gallons and more frequently in retumable totes of 450 pounds or more. Labels affixed 

to these large containers are designed so that they can not readily be removed. It is not phYSically possible to carry a 

tote to the telephone or treatment location, and it would not be advisable to carry a 5-gallon container. TJiett!fb!e, I 

have included on the label the MSDS statement set forth below. ' '0 , 

, , "Have the product Material Safety Data Sheet (MSDS) with you when calling a doctor or going for treatment:." , , ) ) ., » , 

, " 

Please review this letter and advise me whether I can make the suggested changes to TX-I08tJ1's label. Th'llJt y?') in 

advance for your prompt attention to this matter. lf you have any questions, please feel free to b)llm~t me directly. 

~YOU~' f 

Oaude H. Wolf, MSc., 

Corporate Toxicologist 

CHW/cw 

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';--SUBMISSION BAR CODE # !J.r;so 03 7 

FILE SYMBOL/RE NO, )7(16 -,/f?d ' PM J)3 ACTI ON CODE~_+¥,--,-_ 

, DESCRI PTOR Ii .. 

M PI! ~ ,~~·ffi ' a .J//JJ 7,>1 

'[ J 'CHILD RESIST p'f(~ [ J CERTIFlCA,ION '" ' 

[ J NON-RESIDENTIAL" USE ONLY 

[ J" NOT APPLICABLE ' 

REGISTRATION TYPE: ,[ J CONDITIONAL [ J UNCONDITIONAL 

( PROPOSED CLASSIFICATION,,: [ J GENERAL [ l RESTRICTED USE" ' 

" 

DATE'ON APPLICATION EPA RECEIVE DATE PM ''RECEIVE "DATE 

'METHOD" ciF SUPPORT ' 

- { J "CITE,ALL 

I "J "SELECTIVE".-

[ J NOT SUBMITTED 

[ ".] _NOT .,APPLlCABLE [ r INCORRECT /RESUB 

(, lEVI EW (S) REQUESTED 

CHEMISTRY 

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HED TOX. 

DATA 

PACK # 

DATE 

"SENT 

FORMULATORS'EXEMPTION 

["J"."SUBMITTED ,"" 

[ l"NOT -SUBMITTED 

, [ 1 NOT APPLI CABLE 

[ "J __ INCORRECT /RESUB 

DUE 

DATE 

DATE 

RETURNED 

ENVIRON. FATE 

r------r--~--_r----~------~ 

FISH/WILDLIFE 

OTHER ________ ~ __ __ 

~-----L-------L------L-----~ 

',. STATUS ________ ~ ________________________ ~~ ________ ~ 

AUG 30 2000 , 

, " 

RESPONSE CODS RESPONSE DATE , ~ 

6
UNITED STATES- ENVIRONMENTAL PROTECTION AGENCY 

Mr. Claude H. Wolf 

Nalco Chemical Company 

One Nalco Center 

Naperville, 1160563 

Dear Mr. Wolf: 

Subject: TX-l086l 

EPA Registration No. 1706-184 

Your Amendment Dated May 25, 2000 

AUG 30 2000 

This is in response to your amendment to reconsider the precautionary statements as it 

appears in the Sodium Hypochlorite Standard .. 

Your request to reconsider the precautionary statements as it appears in the Sodium 

Hypochlorite Standard would be acceptable, however, you must submit a proposed label with 

the following comments. 

The precautionary statements should read as follows: 

Precautionary Statements 

Hazards To human and Domestic Animals 

Danger: Corrosive may cause severe skin and eye irritation or chemical bum to broken skin. 

Causes eye damage. Wear safety glasses or goggles and rubber gloves when handling. Avoid 

breathing vapors. Vacate poorly ventilated areas as soon as possible. Do not return until strong 

odors have dissipated. 

Revise the "The Statement of Practical Treatment" per PR Notice 2000-3 dated 

April 11, 2000. 

First Aid Statement 

rfSwallowed: Call poison control center or doctor immediately for treatment advice. 

Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to do 

so by the poison control center or doctor. Do not give anything by mouth to an unconscious 

person. If on skin or clothing: Take off contaminated clothing. Rinse skin immediately with 

plenty afwater for 15-20 mjnutes Call a poison control center or doctor for treatment advice. 

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ePA F,um 1320-1A (1190) Printed on Recycled Paper OFFICIAL FILE COPY 

7
2 

Ifinhaled: Move person to fresh air. Ifperson is not breathing, call 911 or an ambulance then 

give artificial respiration, preferably mouth-ta-mouth if possible. Call a poison control center 

or doctor for further treatment advice. If in eyes: Hold eye open and rinse slowly and gently 

with water for 15-20 minutes. Remove contact lenses, if present, after the first 5 minutes, then 

continue rinsing eye. Call a poison control center Or doctor for treatment advice. 

Please note that the general statement, "Have the product container or label with you when 

calling a poison control center or doctor or going for treatment" should be included at the 

beginning or end of the first aid statements. Also, an emergency telephone number may be 

included at the end of the statement. 

If you have any questions, please call Marianne Clark at (703) 308-6381. 

Robert S. Brennis 

Product Manager (32) 

Regulatory Management Branch II 

Antimicrobial Division (751 ~C) 

8
DP BARCODE, D266597 m{JA CASE, 064909 

SUBMISSION, S580637 

DATA PACKAGE RECORD 

BEAN SHEET 

DATE, 06/08/00 

Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE, REGISTRATION ACTION, 307 FQPA TECH-LBL REV AMD DAT 

CHEMICALS: 013907 Sodium bromide 

014703 Sodium hypochlorite 

ID#, 001706-00184 TX-l0861 

COMPANY, 001706 NALCO CHEMICAL CO. 

PRODUCT MANAGER, 32 ROBERT BRENNIS 

PM TEAM REVIEWER, MARIANNE CLARK 

RECEIVED DATE, 06/01/00 DUE OUT DATE, 

* * * DATA PACKAGE INFORMATION * * * 

DP BARCODE, 266597 EXPEDITE, N 

CHEMICAL: 013907 

DP TYPE: 001 

CSF, 

Sodium bromide 

LABEL, Y 

DATE SENT, 06/08/00 

ROOM, CSl 

ROOM, CSl 

DATE RET. , 

13.6600% 

9.4100% 

6C 

6W44 

1 1 

ASSIGNED TO 

DIV , AD 

BRAN, PSB 

SECT, 9:'l: .. REVR :r 

CONTR, 

DATE 

1 

1 

1 

1 

1 

OUT 

1 

1 

ADMIN DUE DATE, 09/26/00 

NEGOT DATE, / ~/,.Jt/"" 

PROJ DATE, /0//7'16" 

DP BC 

v~ 

1 

1 

1 

* * * DATA REVIEW INSTRUCTIONS * * * 

r"f'~\(? ,---.- " 

~G~ute,'"-Tox: ! Please review the attached label and cover Itr 

in which the registrant is asking EPA to reconsider the 

requirement for adding the text cited in registration letter 

dated 4/27/2000 (copy attached) No specific data was 

submitted with submission 

* * * DATA PACKAGE EVALUATION * * * 

No evaluation is written for this data package 

* * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * * 

BRANCH/sECTION DATE OUT DUE BACK INS CSF 

(fVJ' . 

LABEL 

9
DP BARCODE, D266597 

CASE, 064909 

SUBMISSION, S580637 

DATA PACKAGE RECORD 

BEAN SHEET 

DATE, 06/08/00 

Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE, 

CHEMICALS, 

REGISTRATION 

013907 Sodium 

014703 Sodium 

ACTION, 

bromide 

hypochlorite 

307 FQPA TECH-LBL REV AMD DAT 

ID#, 001706-00184 TX-10861 

COMPANY, 001706 NALCO CHEMICAL CO. 

PRODUCT MANAGER, 32 ROBERT BRENNIS 

PM TEAM REVIEWER, MARIANNE CLARK 

RECEIVED DATE, 06/01/00 DUE OUT DATE, 

703-308-6264 

703-308-6381 

11/28/00 

* * * DATA PACKAGE INFORMATION * * * 

DP BARCODE, 266597 EXPEDITE, N DATE SENT, 06/08/00 

CHEMICAL: 013907 Sodium bromide 

DP TYPE: 001 

CSF, Y LABEL, Y 

ROOM, CS1 

ROOM, CS1 

DATE RET. , 

13. 6600~ 

9.4100% 

/ 

6C 

6W44 

/ 

ASSIGNED TO DATE IN DATE OUT ADMIN DUE DATE, 09/26/00 

DIV , AD / / / / NEGOT DATE: / 

BRAN, 

SECT, 

REVR , 

CONTR, 

DP BC 

PSB / / / / PROJ DATE, / 

CTT / / / / 

/ / / / 

/ / / / 

* * * DATA REVIEW INSTRUCTIONS * * * 

Acute Tax: Please review the attached label and cover Itr 

in which the registrant is asking EPA to reconsider the 

requirement for adding the text cited in registration letter 

dated 4/27/2000 {copy attached) No specific data was 

submitted with submission 

* * * DATA PACKAGE EVALUATION * * * 

No evaluation is written for this data package 

* * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * * 

BRANCH/SECTION DATE OUT DUE BACK INS CSF 

/ 

/ 

LABEL 

10
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASIllNGTON, D.C. 20460 

August 23, 2000 

MEMORANDUM 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Subject: Acute Toxicity Review for EPA Reg. No.: 1706-184/ TX-1086l 

DP Barcode: D266597 

To: 

Case No: 064909 

Robert Brennis, PM 32 

Regulatory Management Branch 

Antimicrobials Division (751 DC) 

From: Ian Blackwell, Biologist ~'iIJ!fl{4~ Efficacy Evaluation Team 

Product Science Branch 

Antimicrobials Division (7510C) 

Through: 

Applicant: 

Karen Hicks, Team Leader 

Chemistry and Toxicology Team 

Product Science Branch 

Antimicrobials Division (7510C) 

Michele E. Wingfield, Chief 

Product Science Branch 

Antimicrobials Division (751 DC) 

Nalco Chemical Co. 

FORMULATION FROM LABEL: 

Active IngredientCs): 

Sodium hypochlorite 

Sodium bromide 

Other Ingredient(s): 

Total: 

% bywt. 

9.41 

13.65 

76.94 

100.00% 

11
BACKGROUND: Nalco Chemical Co. has submitted a rebuttal to a 2/9/2000 PSB/AD acute 

toxicity review. In their letter, Nalco states that they cannot agree with the Precautionary 

Statements prescribed by AD, The letter goes on to state that they prefer to use labeling for 

a 12.5% Sodium hypochlorite product that would be derived from the February, 1986, EPA 

document: Guidance for the Reregistration of Pesticide Products Containing Sodium and 

Calcium Hypochlorite Salts as The Active Ingredient. 

RECOMMENDATIONS: PSB fmdings are: 

Although the 1986 document mentioned above was superseded several years ago by the 

February 1992 EPA RED for Sodium and Calcium Hypochlorite Salts, the 1986 document 

is still referenced for several matters. 

The acute toxicity profile for Reg. No. 1706-184 is currently: 

acute oral toxicity I waived 

acute dermal toxicity I waived 

acute inhalation toxicity I waived 

primary eye irritation I waived 

primary skin irritation I waived 

dermal sensitization I waived 

LABELING: 

PM 32 has informed PSB that the February, 1986, EPA document: "Guidance for the 

Reregistration of Pesticide Products Containing Sodium and Calcium Hypochlorite Salts as 

The Active Ingredient' is still being followed for products containing sodium hypochlorite 

as an active ingredient. Thus, according to the 1986 standard, the precautionary statements 

for this product should state: 

Precautionary Statements: 

DANGER: Corrosive, may cause severe skin and eye irritation or chemical burn to broken 

skin. Causes eye damage. Wear safety glasses or goggles and rubber gloves when handling 

this product. Wash after handling. Avoid breathing vapors. Vacate poorly ventilated areas 

as soon as possible. Do not return until strong odors have dissipated. 

Statements of Practical Treatment: 

12
If Contact with Eyes Occurs: Flush with water for at least 15 minutes. Get prompt medical 

attention. 

*If Contact with Skin Occurs: Wash with plenty soap and water. 

If Swallowed: Drink large quantities of milk or gelatin solution, if these are not available, 

drink large quantities of water. DO NOT give vinegar or other acids. DO NOT induce 

vomiting. Get prompt medical attention. 

*The registrant may choose to add "Contact medical personnel if symptoms persist", but this 

language is optional. 

13
August 23, 2000 

NOTE TO THE PM: 

'This product does not have a sodium hypochlorite percentage of 12.5% as per the 1986 

Registration Guidance package. However, AD is still allowing the use of the labeling from 

that standard for this product. Should the PM Team choose to use standard labeling for this 

product, please refer to the Label Review System for labeling specific to Reg. No. 1706-184. 

14
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15
NALeo CHEMICAL COMPANY 

ONE NALCO CENTER NAPERVILLE 11, UNOIS 60563 1198 Cl AREA 630 305-1000 

Mr. Robert Brennis 

U.S. Environmental Protection Agency 

Antimicrobial Division (7510W) 

410 M. Street S.W. 

Washington, D.C. 20460 

May 25, 2000 

Subject: Registration of Nalco TX-10861 (1706~184) 

D~ar Mr. Brennis: 

Nalco Chemical Company cannot agree vvith the precautionary statement revisions cited in your letter of 

registration for this product. The product contains 9.4% Sodium hypochlorite and approximately 14% 

Sodium bromide. 

Nalco believes the precautionary statements currently on the label already exceed those required for a 

12.5% Sodium hypochlorite product. The Sodium bromide component adds nothing to the product's 

potential hazards. 

We believe the product is properly labeled for a material with high pH (-14). 

The required language for a 12.5% Sodium hypochlorite formulation reads "DANGER: Corrosive. May 

cause severe skin and eye irritation or chemical burns to broken skin. Wear safety glasses or goggles and 

rubber gloves when handling. Avoid breathing vapors. Vacate poorly ventilated areas as soon as 

possible. Do not return until strong odors have dissipated." (Guidance for the Reregistration of Pesticide 

Products Containing Sodium and Calcium Hypochlorite Salts as The ActiVe Ingredient; NTIS Document: PB87-

103222; Feb 1986). The labeling for a corrosive product under ANSI Standard 2129.1-2000 is consistent 

with the precautionary statements currently appearing on our draft label. 

Nalco would consider adding to the precautionary statement the additional text, " ... Avoid breathing 

vapors. Vacate poorly ventilated areas as soon as possible. Do not return until strong odors have 

dissipated." As such appears in the Hypochlorite Generic Standard cited above. 

We request you reconsider the requirement for adding the text cited in the registration letter. 

If you have any questions, please feel free to contact me directly. 

laude H. Wolf, MSc., 

Corporate Toxicologist 

CHW/cw 

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-',-'- SUBMISSION BAR CODE # .s f)? 3!o(!}0 REVIEWE~)o/, C/&..c 

FILE SYMBOL/~9.'NO./~ ~ ,PM 32 YY/N COD, /#7 

,DESCRIPTOR ~~ 1ft b1Z,~ «d/fli 

'[ J 'CHILD RESISTANT PACKAGING: [ J CERTIFICA,ION 

[ J NON-RESIDENTIAL USE ONLY 

[ J' NOT APPLI CABLE ' 

REGISTRATION TYPE: ,[ J CONDITIONAL [ J UNCONDITIONAL 

PROPOSED CLASSIFICATION,: [ J GENERAL [ ] RESTRICTED USE, ' 

DATE'ON APPLICATION EPA RECEIVE DATE PM "RECEIVE 'DATE 

1 (1) /1 0.51(/0 I I tI/ 10;7 100 I 10./1071001 

-METHOD OF SUPPORT , 

[ 1 ,CITE-ALL 

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[ " NOT SUBMITTED 

[ . .] ... NOT .,APPLI CABLE [ r INCORRECT /RESUB 

FORMULAToRS EXEMPTION 

[-]SUBMITTED , 

[ 1 ,NOT 'SUBMITTED 

. [ 1 NOT APPLI CABLE 

[ 'L_INCORR,ECT/RESUB 

l . ~ kl1VI EW (S) REQUESTED DATA 

'PACK # 

DATE 

SENT 

DUE 

DATE 

DATE 

RETURNED 

CHEMISTRY 

EFFICACY· 

TOXICOLOGY .. 

, HED TOX. 

OTHER, ______ ~ ____ _ 

STATUS ______ '" ~ ________________________ ~~ ________ ~ 

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17
, 

US ENVIRONMENTAL PROTECTION AGENCY 

OF-F-ICE OF PESnClOES PROGRAMS 

REGISTRATION DlVISION (T5·757/ 

WASHINGTON. DC 20460 

~OTlCE OF PESTICIDE· ~III:E<OISnUTloN • DIII:EIII:EGISTIII:,o,T.oN 

(Under the Feder .. ' fnliee/icide, Fune1cide, 

and Rodentie~e Acl, .~ I1l7jcnded) 

NAME ANO AODRESS OF REGISTRANT (lnel",d_ ZIP cod_) 

r 

Nalco Chemical Company 

One Nalco Center 

Naperville, n 60563 

L 

€p., RtGISTR,o,TION NO. 

f-J,706-l'il4 

YERM OF ISSUANCE 

1

0,o,T€ O~ ISSU,o,NCt 

WP 27 00"0 r,1 1\ L::UU' 

N,o,ME OF PESTICIDE PROOUCT 

TX-l0861 

NOT~; Chances in t.belinc: (onnull differine: in subsllnee (rom th .. t I . . .ubautted to.nd .ecepted by the Rel:istration DiVision prior to use ot~::ted Itl .conneetion ... ith this reristrltion must be 

produc:tat .... J'$ refer to tbe .. bove U.S. EPA rel:istration number. label In eommeree. In any eorrespondenee on this 

Oa tbe basis of Wormation (urnished by the rel:istrlnt the Ib d· . . the Federal lnsedieide, Funcicide, .nd Rodentieidc Act. ove name pestlclde is hereby Reeistered/Rerell"istered uDder 

A cop), 01 tbe libeline .cccpted in conneetion with this Reeist Ta t· Ion /R erell$trlt1on . . . ts returned here ... ith 

Recistratioo. is in no .... )' to be construed.s.n irn:iorsement or. ov I ci h· • ~~lth .• Dd the enviroomeo.t, the AdminIstr.toc, on his motion maPPC • . t IS product by this ACeney. In order to proteet 

Jeid~ 1D. .ecord,nee wlIh the Aet. The .ceeptuet of any n.~ inYe~:y ~une ~uspend oc.e.nc~1 the recistraUon of. pest. 

Act IS not to be eonstrued IS eivina: the rea:isttlnt a rq-ht t x I . ehon ... Ith the reeatt.t1OD. of. product lUlder Ihis by others_ 0 e e USlVe use o( Ihe name or to its; use if it has; be 

This product is conditionally registered in accordance with FIFRA section en Govcred 

3(c)(7)(A) provided that you: 1. Submit/cite all data required for registration/reregistration of your product 

under FIFRA section 3( c)(5) or 4(a) when the Agency requires all registrants of similiar 

products to submit such data. 

2. Make the labeling changes listed below before you release the product for 

shipment: . a. Add the phrase "EPA Registration No. 1706-1l14" 

• 

h. Restricted Use Classification Recommended. Due to acute oral, acute dermal, acute 

inhalation, eye irritation, dermal irritation toxicity categories. See below. 

SIGNAL WORD: DANGER 

POISON SKULL and CROSSBONES symbol 

c. Precautionary Statements should be revised to read: 

Fatal if swallowed or asorbed through skin or inhaled. Corrosive. Causes irreversible 

eye damage or skin burns. Do not get in eyes, on skin or on clothing. Do not breathe 

spray mist. Wear goggles or face shield. For handling activities, use a NIOSH 

Respirator with an organic vapor (OV) cartridge or canister with any N< P< R, or HE 

prefilter. Wear protective clothing and rubber gloves. Wash hands before eating, 

drinking, chewing gum, using tobacco or using the toilet. Remove contaminated 

clothing and wash clothing before reuse. 

o ATTACHMENT IS APPL.ICA8LE 

'IQNA~ ~ \ OATE 

18
2 

d. Revise Statement ofPratical Treatment to read: 

If Swallowed: Call a poison control center or doctor immediately for treatment advice. 

Have person sip a glass afwater ifable to swallow. Do not induce vomiting unless 

told to by a poison control center or doctor. 

e. If On Skin: Take off contaminated clothing. Rinse skin immediately with plenty of 

water for 15-20 minutes. Call a poison control center or doctor for treatment advice. 

f. If Inhaled: Move person to fresh air. Ifperson is not breathing, call 911 or ambulance, 

then give artificial respiration, preferably mouth-to-mouth, if possible. Call a poison 

control center or doctor for further treatment advice. 

3. 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. 

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 constitutes acceptance of these conditions. 

A stamped copy of the label is enclosed for 

~ 

your records. 

Robert S. Brennis 

Product~anager(32) 

Regulatory Management Branch II 

Antimicrobial Division (751 DC) 

19
----,----

TX-I0861 

Microorganism Control Chemical 

TX-10861 is an effective agent for controlling algal bacterial and fungal slime in condensing and cooling cquipment in which 

recirculating water is used as the cooling media and in reservoirs or ponds that serve as the source of boiler feedwater or cooling 

water. TX-I0861 can also be used to control bacterial, fungal and algal slime in decorative fountains, air washers. and papennill 

influcnt and proccss water systems. 

ACTIVE INGREDlENTS: 

Sodium hypochlorite ........................ " ............................................... 9.41'% 

Sodium bromide .............................................................................. 13.650/0 

INERT INGREDIENTS 76.94% 

Total .............................................................................................. 100.00% 

Total Available bromine = approximately 21.2% (expressed as chlorine = approximately 9.4%) 

KEEP OUT OF REACH OF CHILDREN 

DANGER 

STATEMENT OF PRACTICAL TREATMENT 

IF IN EYES: Immediately flush with plenty of water for at least 15 minutes. Call a physician. 

IF ON SKIN: Immediately wash with soap and plenty of water. Remove contaminated clothil1g and wash before reuse. Get 

medical attention if irritation persists. 

IF SWALLOWED: Drink large quantities of water. Do not induce vomiting. Call a phySician or poison control center 

immediately. 

NOTE TO PHYSICIAN: Probable mucosal damage may contraindicate the use of gastric lavage. Measures against circulatory 

shock, respiratory depression and convulsions may be needed. 

SEE SIDE PANEL FOR ADDITIONAL PRECAUTIONARY STATEMENTS 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

DANGER. CORROSIVE. CAUSES SEVERE EYE AND SKIN INJURY. HARMFUL IF INHALED. HARMFUL 

IF SWALLOWED. Do not get in eyes, on skin or on clothing. Wear goggles or face shield and rubber gloves when handling. 

Remove and wash contaminated clothing before reuse. Wash thoroughly after handling. 

ENVIRONMENTAL HAZARDS 

This pesticide is toxic to fish and aquatic organisms. Do not diSCharge effluent containing this product into lakes, streams, ponds, 

estuaries, oceans, or public waters un\css in accordance with the requirements of a National Pollution Discharge Elimination 

System (NPOES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent 

containing this product to sewer systems without previously notifying the sewage treatment plant authority. For guidance contact 

your State Water Board or Regional Office of EPA. Apply this pesticide only as specified on the label. 

STORAGE AND DlSPOSAL 

STORAGE: Do not contaminate water, food, or feed by storage, disposal or cleaning of equipment. 

PESTICIDE DISPOSAL: Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide, spray mix~ure or 

rinsate is a violation of Federal law. If these wastes cannot be disposed of by use according to label inslructions, c::mtact your 

State Pesticide or Environmental Control Agency, or the Hazardous Waste representative at the nearestiEPA Regiona? OffiCe-for 

guidance. ACGEPT,8D 

with CO}lY..:JNTG 

in EPA Letter Duted: 

20
CONTAINER DISPOSAL 

METAL CONTAINERS: Triple rinse (or equivalent). Then offer for recycling or rcconditioning, puncture and dispose of in a 

sani.tary landfill, or by other procedures approved by State and Local authoritics. 

PLASTIC CONTAINERS; Do not rcuse empty container. Triple rinse (Or equivalent). Then puncture and disposc of in a 

sanitary landfill, or, if allowed by State and Local authorities, by burning. Ifbumed, stay out of smoke. 

DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in a manner inconsistent with its labeling. 

COOLING PONDS, RESERVOIRS AND DECORATIVE FOUNTAINS 

TX·I0861 may be applied at the rescrvoir, pond or fountain inlet or at a location that permits complete diffusion into the water at 

maximum retention timc before reaching the outlet. Sufficient TX-10861 should be fed to maintain a total bromine level of 4.5 . 

9.0 ppm in all parts of the reservoir or pond (two OWlceS per 1000 gallons of water (wt.lvol.) yield 3.2 ppm total bromine). 

INDUSTRIAL & COMMERCIAL RECIRCULATING COOLING WATER SYSTEMS 

TX-\0861 should be applied directly to the cooling water at any section of the system where sufficient mixing will Occur. TX· 

10861 should be applied to the cooling water to provide a total bromine level of 4.5 - 9.0 ppm. TX-\0861 at a dosage of two 

ounces per 1000 gallons of water (wtJvol.) gives a dosage of approximately 3.2 ppm of total bromine, but severnl times that 

dosage may be rcquired to provide a total brominc level of 3.2 ppm throughout the system. The total bromine level should be 

checked with a test kit and additional product applied until a reading of 4.5 - 9.0 ppm is obtained at the bleed-off point. Some 

systems may be maintained in satisfactory biological condition by applying this dosage once pcr day while othcrs will respond 

better to dosages lcss than once per day. 

AIRWASHERS 

(This product may be used only in indWitrial air washers and air washer systems, which have mist-eliminating components.) 

For control of microorganisms in industrial air washer systems add sufficient TX· 10861 to the air washer sump or chill water to 

provide a total bromine level of 4.5 • 9.0 ppm. Badly fouled systems must be cleancd before trcatment is begWl. TX· 10861 at a 

dosage of two ounces per 1000 gallons of water (wt.lvol.) gives a dosage of approximately 3.2 ppm of total bromine, but several 

times that dosagc may be required to provide a total bromine level of3.2 ppm throughout thc system. The total bromine level 

should be checked with a test kit and additional product applied until a reading of 4.5 . 9.0 ppm is obtained at the bleed·nff 

point. Some systems may be maintained in satisfactory biological condition by applying this dosage once per day while others 

will rcspond better to dosages less than oncc per day. 

HEAT TRANSFER SYSTEMS 

(Such as Evaporative Condensers, Hydrostatic Sterilizers and Retorts, Dairy Swcetwater Systems, and Oncc-Through Cooling 

Water Systems) 

TX·10861 should be used at the same appl,ication rates, and in the samc manner as described above. 1t should be added to the 

system at a point of Wliform mixing such as a basin area, ,sump area, or other reservoir or collecting area from which the treatcd 

water will be circulated uniformly throughout the system. 

FOR PULP & PAPER MILL INFLUENT WATER SYSTEMS 

TX-10861 should be apptied to the raw water intake prior to the filter house, economizer, or proccss water. Fced at a dosage 

sufficient to provide a total bromine level of 4.5 - 9.0 ppm. TX-I0861 at a dosage of two ounccs per 1000 gallons Of watcr 

(wt./vo\.) gives a dosage of approximately 3.2 ppm of total brominc, but several times that dosage may bc required to p({l~ide a 

tota.! bromine level of3.2 ppm throughout the system. The total bromine level should be checked with a test kit and additional 

product applied until a reading' of 4.5 - 9.0 ppm is obtained. Some systems may be maintained in satisfactory biological 

condition by applying this dosage. intermittently while others may require a eontinuous application. TX· 10861 may be used in 

pulp and paper influent water systems where the manufacturcd paper or paperboard may be used for food contact purposes. 

FOR PULP & PAPER MILL PROCESS WATER SYSTEMS 

TX·10861 should be added to a paper making system at a point of uniform mixing such as thc beaters, broke chest pump, save· 

all tank, or white watcr taak. Feed at a dosage sufficient to provide a t"fnbbromine Icvel of 4.5 - 9.0 ppm. TX-I086t at a 1'>.'1:' .... £~--'...J 

wit;, CO:.::.::::~T:::; 

in EPA L()ttcr D::.~sd: 

~~?r;: ~1:,2~ '~·~7='~~~_~.:~}~~;t~~ --.' " .'- '''.,~''''~ - " 

21
",---

dosage of two ounces per tOoo gallons of water (wt./vol.) gives a dosage of approximately 3.2 ppm of total bromine, but several 

times that dosage may be required to provide a total bromine level of 3.2 ppm throughout the system. The total bromine level 

should be checked with a test kit and additional product applied until a reading of 4.5 - 9.0 ppm is obtained. Some systems may 

be maintained in satisfactory biological condition by applying this dosage intermittently while others may require a continuous 

application. TX-t0861 may be used in pulp and paper mill process water systems where the manufactured paper or paperboard 

may be used for food contact purposes. 

NOTE: Halogen dosages listed in the various applieations are expressed as bromine. Since most field test kits for oxidizing 

halogens give values in terms of chlorine, simply multiply the reading from the test kit (as chlorine) by 2,25 in order to obtain 

the bromine equivalency listed in these directions. 

EPA REG NO. 1706-

EPA Est. No. 1706-IL-Ol 

NET CONTENTS SHOWN ELSEWHERE ON CONTAINER 

in I:?A Letter D::.:;od: 

22
NALCO CHEMICAL COMPANY 

ONE NALCO CENTER 

Mr. Robert Brennis 

Product Manger (32) 

Antimicrobial Division (7510W) 

U.S. Environmental Protection Agency 

410 M. Street SW 

Washington, D.C. 20460 

January 5, 2000 

,Rft{ 

Subject: Resubmission of Application for Registration Na1co TX~10861 (1706-Rl1t) 

Dear Mr. Brennis: 

Nalco Chemical Company submits this letter in response to your letter dated November 3,1999 in which 

several deficiencies are described. 

The issue regarding an FDA opinion letter in support of the use of this product in the manufacture of 

food contact paper or paperboard remains open. FDA does not issue such letters. The traditional 

approach to "approval" is via listing in the Code of Federal Regulations (CFR). For example, 

21CFR176.300 defines the list of biocide (antimicrobial) active ingredients which may "safely" be 

employed in the manufacture of such products destined for use in the manufacture of food contact 

articles. Paragraph 176.300(d) defines those inert substances that may be utilized to compound end-use 

formulations. A copy of the regulation is enclosed for your use. Additionally, I am resubmitting copies of 

the documentation establishing "approval" for the ingredients in TX-10861 as they apply to food contact 

paper or paperboard. We request that you re-examine the need for such a letter from FDA. 

Regarding the acute toxicology waiver issue, we do not agree with the reviewer that citing 1706-179 is 

unacceptable based on the fact that acute toxicity tests were not submitted for that product. The acute 

"six pack" was waived for that product based on its "similarity" to 1706-171, the sodium bromide 

component notwithstanding since it has no significant impact on the toxicity of the product. 

The currently proposed label forTX-10861 bears the following precautionary statements: 

DANGER. CORROSIVE. CAUSES SEVERE EYE AND SKIN INJURY. HARMFUL IF 

INHALED. HARMFUL IF SWALLOWED. Do not get in eyes, on skin or on clothing. Wear goggles or 

face shield and rubber gloves when handling. Remove and wash contaminated clothing before reuse. 

Wash thoroughly after handling. 

The precautionary statement required for 12.5% Sodium hypochlorite products (from the Reregistration 

Decision documents) states: 

DANGER. CORROSIVE. MAY CAUSE SEVERE EYE AND SKIN IRRITATION OR 

CHEMICAL BURNS TO BROKEN SKIN. Causes eye damage. Wear face shield or goggles and rubber 

gloves when handling this product. . Wash after handling. Avoid breathing vapors. Vacate poorly 

ventilated areas as soon as possible. Do not return until strong odors have dissipated. 

The current label for 1706-171 (95ND141) bears the same precautionary statement as TX-10861. 

23
With regard to the "six-pack" tests for TX-10861, we offer the following comments: 

1. The primary eye and skin irritation tests (81-4 and 81-5) are not required due to 

torrosivity [158.340-(b) note 21. 

2. The dermal toxicity (81-2) is not required due to corrosivity 1158.340-(b) note 2}. 

3. The acute inhalation toxicity test (81-3) is not required since the product does not 

consist of or during normal conditions of use will not result in an inhalable material 

[158.340-(b) note 16]. 

4. The dermal sensitization test is not required since there is no expected repeated 

dermal contact during use. Additionally, the product's corrosivity precludes 

conduct of a meaningful sensitization test. 

Thus, the only test that would conceivably be required would be the acute oral toxicity test (81-1). It 

appears based on the reregistration of sodium and calcium hypochlorite products that 12.5% sodium 

hypochlorite products fall into Category III for acute oral toxicity. 

During reregistration of its 1706-171 product, Nako submitted an acute oral study (no MRlD number was 

assigned). The study was a single dose (5 g/kg) study. Six of the 10 rats administered that dosage died 

during the test period. A copy of that report is included with this letter. Thus the LDsowould be clearly 

within Category Ill. This category requires a "may be harmful if swallowed" statement. Such a 

statement currently appears on the TX10861 label. 

The oral LDsofor 43% Sodium bromide solution is 4200 mg/kg (Organic Halide RED) placing it in 

Category III. We see no reason to suspect any synergistic effect between the bleach and the bromide that 

would change the lethality of the formulated product so significantly as to place it in a higher Category. 

Thus we conclude that there would be nothing gained by subjecting a group or groups of rats to this 

product just to reestablish that its o;allethality would fall into Category III. Consequently? we again 

request that this test be waived. 

I am hopeful that this submission will adequately resolve the two outstanding issues of this application 

for registration and allow for a prompt, successful registration of TX-10861. 

We await a copy of the "stamped accepted" label. If you have any questions, please feel free to contact 

me directly. 

(;}~:I- Corporate Toxicologist 

24
\ 

! 

"-

VOLUME II 

STUDY TITLE 

Acute Oral Toxicity-Albino Rats 

DATA REQUIREMENT 

40CFR158.340 

Guideline: 81-1 

TEST ARTICLE 

Sodium Hypochlorite - Case # 0029 

Product: Nalco Actiplus 2818 

AUTHOR 

sandra M. smith 

American Biogenics Corporation 

Decatur, II 62526 

SUBMITTER 

Nalco Chemical Company 

One Nalco Center 

Naperville, II 60563-1198 

Volume II 

Page 1 of 18 

25
Pages 26-42 *Access to FIFRA health and safety data is restricted under FIFRA section 

10(g)* 
DP BARCODE, D262279 (&PA 

CASE, 064909 

SUBMISSION, S573600 

DATA PACKAGE RECORD 

BEAN SHEET 

* * * CASE/SUBMISSION INFORMATION * * * 

DATE, 01/11/00 

Page 1 of 1 

CASE TYPE, 

CHEMICALS, 

REGISTRATION 

013907 Sodium 

014703 Sodium 

ACTION, 

bromide 

hypochlorite 

187 RESB AmD-OC-MINOR CHG 

ID#, 001706-RIU TX-10861 

COMPANY, 001706 NALCO CHEMICAL CO. 

PRODUCT MANAGER: 32 ROBERT BRENNIS 

PM TEAM REVIEWER: MARIANNE CLARK 

RECEIVED DATE, 01/07/00 DUE OUT DATE, 

703-308-6264 

703-308-6381 

05/06/00 

) * * * DATA PACKAGE INFORMATION * * * 

DP BARCODE, 262279 EXPEDITE, N DATE SENT, 01/11/00 

CHEMICAL: 013907 Sodium bromide 

DP TYPE: 001 

CSF: Y 

ASSIGNED TO DATE IN 

DIV, AD //11/"'''' 

BRAN, PSB I / II / 0 " 

SECT, c;:g:, .J" I. II / II / '" tJ 

REVR ,::IJ,v....."V,(j/."l6.VIC/-n/' CID 

CONTR, I ~~/dO 

DATE 

/ 

/ 

/ 

/ 

/ 

OUT 

/ 

/ 

/ 

/ 

/ 

ADMIN DUE 

NEGOT 

PROJ 

* * * DATA REVIEW INSTRUCTIONS * * * 

13.6600% 

9.4100% 

ROOM, CS1 

ROOM, CS1 

6C 

6W44 

DATE RET., / 

DATE, 04/15/00 

DATE, 'it/., /0'" 

DATE, S !z.2./ 0 '" 

/ 

Acute Tox: Please review the attached cover letter and data 

submitted in reponse to EPA Itr dated 11/3/99. 

* * * DATA PACKAGE EVALUATION * * * 

No evaluation is written for this data package 

* * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * * 

DP Be BRANCH/SECTION DATE OUT DUE BACK INS CSF LABEL 

43
DP BARCODE: D262279 

CASE, 064909 

SUBMISSION, S573600 

DATA PACKAGE RECORD 

BEAN SHEET 

DATE, 01/11/00 

Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE: REGISTRATION ACTION: 187 RESB AmD-OC-MINOR CHG 

CHEMICALS: 013907 Sodium bromide 

014703 Sodium hypochlorite 

ID#, 001706-RIU TX-10861 

COMPANY, 001706 NALCO CHEMICAL CO. 

PRODUCT MANAGER: 32 ROBERT BRENNIS 

PM TEAM REVIEWER: MARIANNE CLARK 

RECEIVED DATE, 01/07/00 DUE OUT DATE, 

703-308-6264 

703-308-6381 

05/06/00 

) * * * DATA PACKAGE INFORMATION * * * 

DP BARCODE: 262279 EXPEDITE: N 

CHEMICAL: 013907 Sodium bromide 

DP TYPE: 001 

CSF, y LABEL, Y 

DATE SENT, 01/11/00 

ROOM, CS1 

ROOM, CS1 

DATE RET. : 

13.6600% 

9.4100% 

6C 

6W44 

/ / 

ASSIGNED TO 

DIV , AD 

BRAN, PSB 

SECT, CTT 

REVR : 

DATE IN DATE OUT ADMIN DUE DATE, 04/15/00 

CONTR: 

) 

DP BC 

/ / / / NEGOT DATE: / 

/ / / / PROJ DATE, / 

/ / / / 

/ / / / 

/ / / / 

* * * DATA REVIEW INSTRUCTIONS * * * 

Acute Tox: Please review the attached cover letter and data 

submitted in reponse to EPA ltr dated 11/3/99. 

* * * DATA PACKAGE EVALUATION * * * 

No evaluation is written for this data package 

* * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * * 

BRANCH/SECTION DATE OUT DUE BACK 

COPT fOR YOOR 

IIiFORMATIGIl 

INS CSF 

/ 

/ 

LABEL 

44
) 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASIITNGTON, D.C. 20460 

February 9, 2000 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

MEMORANDUM 

Subject: Acute Toxicity Review for EPA Reg. No.: 1706-RIU 1 TX-10861 

DP Barcode: D262279 

To: 

From: 

Case No: 064909 

Robert Brennis, PM 321 Marianne Clark 

Regulatory Management Branch 

Antimicrobials Division (751OC) 

Ian Blackwell, Biologist "f2.#iP/cGft{J~~~ Efficacy Evaluation Team ' 

Antimicrobials Division (751 OC) /l: J'iO 

Through: 

Product Science Branch {A:' \" 

Chemistry and Toxicology Team A /VI. . J 0\ rfU Karen Hicks, Team Leader t ~""J / ' l C 

Product Science Branch !/ v J\' 

Antimicrobials Division (7510C); , 

Applicant: 

Michele E. Wingfield, Chief 

Product Science Branch 

Antimicrobials Division (751 OC) 

Nalco Chemical Co. 

FORMULATION FROM LABEL: 

Active Ingredient(s): 

Sodium hypochlorite 

Sodium bromide 

Other Ingredient(s): 

Total: 

% bywt. 

9.41 

13.65 

76.94 

100.00% 

45
) 

I. BACKGROUND: PSB has received a 1/5/2000 letter from the registrant. The subject 

of this review is the portion of that letter that pertains to acute toxicology, or the "sixpack" aftests. The letter states the following: 

1. The primary eye and skin irritation tests are not required due to the corrosivity of the 

product. 

2. The acute dermal toxicity study is not required due to the corrosivity of the product. 

3. The acute inhalation toxicity study is not required since the product does not consist 

of, or during nonnal use, result in an inhalable material. 

4. The dennal sensitization test is not required due to the corrosivity of the product, and 

the corrosivity of the product should preclude any conduct of a useful sensitization 

study. 

The CSF lists the pH of this product as 14. 

II. RECOMMENDATIONS: PSB findings are: 

1. PSB waives the primary eye and skin irritation studies due to the pH of this product 

and probable corrosivity of this product. It has been documented that concentrated 

bases are much more damaging to tissues than are concentrated acids. 

2. PSB waives the acute dermal toxicity study required for 1706-RIU due to the pH of 

the product. 

3. The dermal sensitization study is waived. The reasons are as follows: 

A. The product has a very high pH and is thought to be corrosive. 

B. Users of the product are required to wear protective clothing (chemical resistant 

gloves, etc.) because of the corrosivity of the product. 

C. This product is intended to be used in enclosed recirculating water systems. This 

limits the chance for dermal exposure to this product. 

4. The acute inhalation toxicity study is waived. The reasons are as follows: 

A. The high pH of the product could be severely damaging to the lungs, thereby 

potentially greatly reducing oxygen and CO2 transfer. 

B. The product is intended to be used in enclosed water systems. Thus, the potential 

for inhalation is greatly reduced. 

5. The registrant also indicates that they would like a waiver of the acute oral toxicity 

study because it would be inhmnane to dose animals with a material that has a pH 

over 13. The waiver is granted. In cases like this the product is typically assigned 

toxicity category 1. 

46
The acute toxicity profile for. File Symbol 1706-RIU is currently: 

acute oral toxicity I waived 

acute dennal toxicity I waived 

acute inhalation toxicity I waived 

primary eye irritation I waived 

primary skin irritation I waived 

dennal sensitization I waived 

LABELING: 

Date: 02/09100 LABEL REVIEW SYSTEM Page: I 

ID #: 001706-00184 TX-I0861 

RESTRICTED USE CLASSIFICATION RECOMMENDED: 

Due to acute oral, acute dennal, acute inhalation, eye irritation, dennal irritation toxicity 

categories. 

The PM Team should decide if restricted use classification is necessary or if alternative 

labeling will allay the requirement for restricted use classification. 

SIGNAL WORD: DANGER 

POISON SKULL and CROSSBONES symbol 

PRECAUTIONARY STATEMENTS: 

Fatal if swallowed or absorbed through skin or inhaled. Corrosive. Causes irreversible 

eye damage or skin burns. Do not get in eyes, on skin or on clothing. Do not breathe 

spray mist. Wear goggles or face shield. For handling activities, use aNIOSH respirator 

with an organic vapor (OV) cartridge or canister with any N, P, R, or HE prefilter. Wear 

protective clothing and rubber gloves. Wash hands before eating, drinking, chewing 

gum, using tobacco or using the toilet. Remove contaminated clothing and wash 

clothing before reuse. 

STATEMENT OF PRACTICAL TREATMENT (SOPT): 

IF SWALLOWED: Call a poison control center or doctor immediately for treatment 

advice. Have person sip a glass of water if able to swallow. Do not induce vomiting 

unless told to by a poison control center or doctor. 

47
IF ON SKIN: Take off contaminated clothing. Rinse skin immediately with plenty of 

water for 15-20 minutes. Call a poison control center or doctor for treatment advice. 

IF INHALED: Move person to fresh air. If person is not breathing, call 911 or 

ambulance, then give artificial respiration, preferably mouth-to-mouth, ifpossible. Call 

a poison control center or doctor for further treatment advice. 

IF IN EYES: Hold eye open and rinse slowly and gently with water for 15-20 minutes. 

Remove contact lenses, if present, after the first 5 minutes, then continue rinsing. Call 

poison control center or doctor for treatment advice. 

NOTE TO PHYSICIAN: 

Note to PMlCRMlRegistrant: The proposed label should contain a "Note to Physician." 

The following statements are suggested types of infonnation that may be included, if 

applicable: 

• technical infonnation on symptomatology; 

• use of supportive treatments to maintain life functions; 

• medicine that will counteract the specific physiological effects of the pesticide; 

• company telephone number to specific medical personnel who can provide specialized 

medical advice. 

The following "Note to Physician" statement is required for the subject product: 

NOTE TO PHYSICIAN: Probable mucosal damage may contraindicate the use of gastric 

lavage. 

48
SUBMISSION BAR CODE #!3s t?8S/6 REVIEWER , 

H C /;eel:; 

COPING FORM FOR APPLICATIONS FOR REGISTRATION/AMENDMENTS 

'( ] 'CHILD RESISTANT PACKAGING: ( ] CERTIFICA'.\'ION 

( ] NON-RESIDENTIAL USE ONLY 

( ] NOT APPLICABLE 

REGISTRATION TYPE: ,( ] CONDITIONAL ( UNCONDITIONAL 

PROPOSED CLASSIFICATION: ( ] GENERAL RESTRICTED USE 

DATE 'ON APPLICATION EPA RECEIVE DATE PM "RECEIVE 'DATE 

METHOD OF SllPPORT , 

] CITE-ALL 

] SELECTIVE , 

,] NOT SUBMITTED 

] NOT APPLICABLE 

r INCORRECT /RESUB 

'!REVIEW (S) REQUESTED DATA 

CHEMISTRY 

EFFICACY 

TOXICOLOGY 

, HED TOX. 

ENVIRON, FATE 

, FISH/WILDLIFE 

OTHER ______ _ 

'" 

'PACK # 

j)Jj-'7.5}"1 

DJ. 5155'7 

FORMULAtoRS EXEMPTION 

( .]. SUBMITTED 

( ] NOT SUBMITTED 

, ( ] NOT APPLI CABLE 

( 'L.INCORRECT/RESUB 

DATE 

SENT 

'1 b.oh9 

, I 

qb619 Ci 

I I 

. 

DUE 

DATE 

1//3/60 

1If:! In () I 

DATE 

RETURNED . 

11.27/9'7 

I 

STATUS ___ ~ _____________ ~_~ ____ ~ 

RESPONSE CODE _.J..!=J ..... __ RESPONSE DATE 

49
) 

SYMBOL. 

SURNAME 

OATE 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

Mr. Claude H. Wolf 

Nalco Chemical Company 

One Nalco Center 

Naperville, II 60563 

Dear Mr. Wolf: 

Subject: TX-l0861 ~ .. \v >1"'1'\ 

EPA Registl'flti<>n No. l706-RlU 

Your Resubmission Dated September 9,1999 

NOV 3 1999 

This is in response to your resubmission of waiver request for acute toxicity data 

requirements (Guidelines 81-1 throught 81-6) based on identical formulation of "Nalco 

95ND141 ", EPA Reg. No. 1706-179 with updated Confidential Statement of Formula and 

label. 

Waiver request for acute toxicity data is not acceptable for the following reaSOns: 

The formulation ofTX-10861 is more concentrated (in terms of the active 

ingredient) than 95NDl41. Therefore, EPA Reg. Number 1706-179 and File Symbol 

1706-RIU are not substantially (Toxicologically) similar based on the "double strength" 

version of the other and that acute toxicity data was not submitted for EPA Reg. No. 

1706-179. Thus citing registration number EPA Reg. No. 1706-179 to support file 

symbol l706-RlU is unacceptable. 

You must find some other method of supportjng the acute toxicity data 

requirements for File Symbol 1706-RIU and the precautionary labeling can not be 

recommended at this time. 

The revised Confidential Statement of Formula dated September 9, 1999 is 

acceptable and it agrees with the label. Please note that the certified limits of the active 

ingredient should be calculated on the nominal concentration and not the percent by weight. 

Resubmit a revised Confidential Statement of Fonnula with the correct certified limits for 

the active ingredient. Also, a name and address is required for all suppliers. 

There is not a MRID Number assigned for the submitted product chemistry but 

it satifies Guideline series 61. 

COHCURREHCES - • •••.••.• J~ .••••••••.•••••••••••••••.•• _ ................................... 40 ......... 04 •••••••• ~ ••••••••••••••• ,. ......................................... . 

.................. , ................... r............. r . •• .. • ......................................... ~ ••••.•.• ~ ....................... _ •••••••••••••••••• 

OFFICIAL FILE COPY 

50
2 

Request from FDA an opinion letter for the use of «food grade paper or paperboard 

products" or label should have a disclaimer statement "not for use in manufacture of food 

grade paper." 

Your application can be not be processed until the above materials are cOlTcted. 

If you have any questions, please call Marianne Clark at (703) 308-6381. 

Sincerely yours, 

~$~ Robert S. Brennis 

Product Manager (32) 

Regulatory Management Branch II 

Antimicrobial Division (7510C) 

51
: 

i 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

September 27, 1999 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

MEMORANDUM 

Subject: Acute Toxicity Review for EPA Reg. No.: 1706-RlU / TX-10861 

DP Barcode: D259557 

Case No: 064909 

To: 

From: 

Robert Brennis, PM 32 / Marianne Clark 

Regulatory Management Branch 

Antimicrobials Division (751 OC) ~ 

Ian BlaclcweU, Biologist ~;Cc ril&t 

Through: 

Applicant: 

Efficacy Evaluation Team 

Product Science Branch 

AntiInicrobials Division (7S10C) 

Karen Hicks, Team Leader 

Chemistry and Toxicology Team 

Product Science Branch 

Antimicrobials Division (751 OC) 

Michele E. Wingfield, Chief 

Product Science Branch 

Antimicrobials Division (751 OC) 

Nalco Chemical Company 

FORMULATION FROM LABEL: 

Active Ingredient(s): 

Sodium hypochlorite 

Sodium bromide 

Other Ingredient(s): 

Total: 

% bywt. 

9.41 

13.65 

76.94 

100.00% 

52
BACKGROUND: Nalco Chemical Company requests a waiver from acute toxicity data 

requirements (Guidelines 81-1 through 81-6) fortheir product "TX-1 0861 ". The basis of this 

waiver request is that "the formulation is essentially identical to the registered product Nalco 

95ND 141 (Reg. No. 1706-179). In their 9!9!991etter, the registrants go on to state, "This 

product, TX-10681 is essentially a 'double strength' 95ND141." 

Actually, what Nalco Chemical Company is trying to accomplish is not a waiver of acute 

toxicity studies. Nalco is apparently trying to do, is to have their product TX-10861 declared 

Substantially Similar or Toxicologically Similar to their other product, 95ND141. 

There are a few issues to take into consideration in this similarity request: 

1. The formulation ofTX-10861 is more concentrated (in tenns of active ingredients) than 

95ND 141 is. As such, PSB does not feel that the two products can be found to be 

substantially similar. 

2. "Bridging" of acute toxicity data will not be allowed. Due to the acute toxicity profile of 

95ND 141, bridging will not be allowed from each of the six acute toxicity/irritation 

studies. 

3. When reviewing the registration jacket of Reg. No. 1706-179 and PDMS. It is apparent 

that no acute toxicity data was submitted specifically for Reg. No. 1706-179. 

RECOMMENDATIONS: PSB findings are: 

1. The registrant has not even come close to submitting data sufficient tQ support a data 

waiver. Similarity of File Symbol 1706-RIU to Reg. No. 1706-179 is positively not an 

acceptable reason for a data waiver. 

2. Reg. No. 1706-179 and File Symbol 1706-RIU are not Substantially (Toxicologically) 

Similar. The registrant even states that one product is a "double strength" version of the 

other. The registrants contradict themselves by saying that 1706-RIU is essentially 

identical to 1706-179, and, saying that 1709-179 is double strength 1706-RIU on the 

same page. 

3. There are too many dissimilarities in the formulations of the two products and 

complications with the apparent toxicity categories of 1706-179 for PSB to allow 1706-

179 to be bridged to support 1706-RIU. 

4. What is most important, is that there have been no acute toxicity studies submitted to 

support 1706-179. Thus, there are no acute toxicity studies for 1706-RIU to cite. 

The registrant must find some other method of supporting the acute toxicity data 

53
requirements for File SymboI1706-RlU. Citing Reg. No. 1706-179 to support 1706-RlU is 

unacceptable. 

The acute toxicity profile for reg. no. 1706-NIU is currently: 

acute oral toxicity 

acute dermal toxicity 

acute inhalation toxicity 

primary eye irritation 

primary skin irritation 

dennal sensitization 

LABELING: 

Not received 

Not received 

Not received 

Not received 

Not received 

Not received 

No precautionary labeling can be recommended at this time. 

54
DP BARCODE: D259559 

CASE: 064909 

SUBMISSION, S568516 

DATA PACKAGE RECORD 

BEAN SHEET 

DATE, 09/20/99 

Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE: 

CHEMICALS, 

REGISTRATION 

013907 Sodium 

014703 Sodium 

ACTION: 

bromide 

hypochlorite 

187 RESB AmD-OC-MINOR CHG 

/

''>13.6600% 

9.4100% 

ID#, 001706·RIU TX·I0861 

COMPANY: 001706 NALCO CHEMICAL CO. 

PRODUCT MANAGER, 32 ROBERT BRENNIS 

PM TEAM REVIEWER: MARIANNE CLARK 

RECEIVED DATE, 09/15/99 DUE OUT DATE, 

703·308·6264 

703-308-6381 

01/13/00 

* * * DATA PACKAGE INFORMATION * * * 

'PP BARCODE: 259559 EXPEDITE: N 

CHEMICAL: 013907 Sodium bromide 

DP TYPE: 001 

DATE SENT, 09/20/99 

CSF, Y LABEL, Y 

ASSIGNED TO DATE IN 

DIV , AD 7/..>47'7 

BRAN, PSB '7/02 0/ '7 '1 

SECT, qT '7/,;u/ '7 '7 

REVR , jl(n('{f, '7 POI /e; 1 

CONTR, ~/ 1t...&.f1-<i, / 

DATE 

/ 

/ 

/ 

/ 

/ 

OUT 

/ 

/ 

/ 

/ 

/ 

ADMIN DUE 

NEGOT 

PROJ 

10- 1'1- Cf q * * * DATA REVIEW INSTRUCTIONS * * * 

ROOM: CSl 

ROOM: CSl 

DATE RET., / 

DATE, 12/24/99 

DATE, / / 

DATE, / / 

Product chemistry: Please review the attached, updated CSF, 

label and data resubmitted to support registration of 

subject!s product. 

DP BC 

259557 

* * * DATA PACKAGE EVALUATION * * * 

No evaluation is written for this data package 

* * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * * 

BRANCH/SECTION 

PSB/CTT 

DATE OUT 

09/20/99 

DUE BACK 

12/24/99 

INS 

Y 

CSF 

Y 

6C 

6W44 

/ 

LABEL 

Y 

55
DP BARCODE: D259559 

CASE, 064909 

SUBMISSION: S568516 

DATA PACKAGE RECORD 

BEAN SHEET 

DATE, 09/20/99 

Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE: REGISTRATION 

CHEMICALS: 013907 Sodium 

014703 Sodium 

ACTION: 

bromide 

hypochlorite 

187 RESB AmD-OC-MINOR CHG 

ID#, 001706-RIU TX-10861 

COMPANY, 001706 NALCO CHEMICAL CO. 

PRODUCT MANAGER: 32 ROBERT BRENNIS 

PM TEAM REVIEWER: MARIANNE CLARK 

RECEIVED DATE, 09/15/99 DUE OUT DATE, 

703-308-6264 

703-308-6381 

01/13/00 

* * * DATA PACKAGE INFORMATION * * * 

PP BARCODE, 259559 EXPEDITE, N 

'CHEMICAL: 013907 Sodium bromide 

DP TYPE, 001 

CSF, Y LABEL: 

DATE SENT, 09/20/99 

Y 

ROOM: CS1 

ROOM: CSI 

DATE RET. : 

13.6600% 

9.4100% 

6C 

6W44 

/ / 

ASSIGNED TO 

DIV , AD 

BRAN: PSB 

SECT: CTT 

REVR : 

DATE IN DATE OUT ADMIN DUE DATE, 12/24/99 

CONTR, 

DP BC 

259557 

/ / / / NEGOT DATE, / 

/ / / / PROJ DATE: / 

/ / / / 

/ / / / 

/ / / / 

* * * DATA REVIEW INSTRUCTIONS * * * 

Product chemistry: Please review the attached, updated CSF, 

label and data resubmitted to support registration of 

subject's product. 

* * * DATA PACKAGE EVALUATION * * * 

No evaluation is written for this data package 

* * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * * 

BRANCH/SECTION 

PSB/CTT 

em_. 

IlimMATIIB 

DATE OUT 

09/20/99 

DUE BACK 

12/24/99 

INS 

Y 

coPY ro~ V""R 

Uti 10;1<",., 

CSF 

Y 

/ 

/ 

LABEL 

Y 

56
SUBJECT: PRODUCT CHEMlSTRY REVIEW - Antimicrobials Division 

.. DP .. llarcod'.12:15'1S.2'l··Reg .. No. or file Symbol t70{,~ RILl 

'Manufacturing-Use [ J or End-Use Product [ ~ Case# __ 

TO: {!.4t;, &~ MWkM<A<L a,/I.L 

PM Team No.--", ~"'-_ 

FROM: 

THRU: 

Anna Skapars, Chemist ~ Sk"{f'U'J ID-19 -V9 

Chemistry-Toxicology Team (CTT) 

Efficacy and Science Support Branch (ESSB) 

Karen P. Hicks, CTTeam Leader 

Efficacy and Science" Support Branch 

Antimicrobials Division (751 oc) 

.rhm: Michele E. Wingfield, Branch Chief 

Efficacy and Science Support Branch 

Antimicrobials Division (751 OC) 

Ba,j::J<.oJI.JJum_ci .' . d ' -r, ~ 7r - d 

~ 

0~c-t ,:s. 5-"Mn-<.~~ h,{!,C'UUC-O' 7lrti/]U . ",,,,i/i<.;;f ,pu'~J 

~ ~oM7c2f:' -JrciLJ'71h Of- H1r'J/zttA. 

57
SUBJECT: PRODUCT CHEMISTRY REVIEW - Antimicrobials Division 

DP Barcode D259559 Reg. No. Or File Symbol 1706-RJU 

Manufacturing-Use [lor End-Use Product [Xl Case # 

TO: Robert BrennislMarianne Clark 

PM Team No. 32 

FROM: 

THRU: 

THRU: 

Anna Skapars, Chemist 

Chemistry-Toxicology Team (CTT) 

Product Science Branch (PSB) 

Karen Hicks, Team Leader 

Chemistry/Toxicology Team (CIT) 

Product Science Branch (PSB) 

Michele E. Wingfield, Branch Chief 

Product Science Branch (PSB) 

SUMMARY OF INFORMATION REVIEWED AND FINDINGS 

BACKGROUND: 

Registrant is submitting updated manufacturing process, label and Confidential Statement 

of Fonnula. 

FINDINGS: 

Revised Confidential Statement of Fonnula dated 9/9/99 is in compliance with 40 CFR 

Part 158.175, it agrees with the label and CSF is acceptable. However, please note that 

the certified limits of the active ingredient should be calculated on the nominal 

concentration, not the percent by weight. 

Certified limits for active and inert ingredients comply with 40 CPR Part 158.175 and 

they are acceptable. 

Upgraded manufacturing process, no MRID No. Assigned, is in compliance with 40 CFR 

Part 158.155 through 158.165 and it satisfies product chemistry data for Guideline 

Series 61. 

RECOMMENDATION: 

This formulation is not cleared by FDA for use in manufacture of food grade paper and 

paperboard products. 

58
) 

Please update CSF at next printing to show correct certified limits for the active 

ingredient. 

A name and address is required for all suppliers. Please correct CSF at next printing to 

indicate such. 

For use of this product in manufacture offood grade paper or paperboard products 

registrant should ask FDA for an Opinion letter or label should have disclaimer statement 

''not for use in manufacture of food grade paper". 

59
DP BARCODE, D259557 

CASE, 064909 

SUBMISSION, S568516 

DATA PACKAGE RECORD 

BEAN SHEET 

DATE, 09/20/99 

Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE: REGISTRATION ACTION: 187 RESB AmD-OC-MINOR CHG 

CHEMICALS: 013907 Sodium bromide 

014703 Sodium hypochlorite 

ID#, 001706-RIU TX-10861 

COMPANY: 001706 NALCO CHEMICAL CO. 

PRODUCT MANAGER, 32 ROBERT BRENNIS 

PM TEAM REVIEWER: MARIANNE CLARK 

RECEIVED DATE, 09/15/99 DUE OUT 

703-308-6264 

703-308-6381 

DATE .Ji1l%LJiZj;y'iRiO;:; 

* * * DATA PACKAGE INFORMATION * * * 

DP BARCODE, 259557 EXPEDITE, N 

t~HEMICAL: 013907 

DP TYPE: 001 

Sodium bromide 

CSF, Y LABEL: Y 

DATE SENT, 09/20/99 

ROOM, CS1 

ROOM, CS1 

DATE RET., 

13.6600% 

9.4100% 

6C 

6W44 

/ / 

ASSIGNED TO DATE IN 

DIV : AD 'i /.;Jp/f 1 

DATE 

/ 

/ 

/ 

/ 

/ 

OUT 

/ 

ADMIN DUE DATE: 

NEGOT DATE, 

PROJ DATE, 

12/24/99 

/ / 

BRAN, PSB C; /..) '/ f 7 

SECT, CTT 7/07</ f f 

REVR '1fo.-~ 'l'/dqq CONTR: / / 

/ 

/ 

/ 

/ 

* * * DATA REVIEW INSTRUCTIONS * * * 

Actue Tox: Please review registrant's resubmission for a 

waiver from acute toxicity data. Registrant is citing 

EPA file symbol 1706-179 as being identical label & CSF 

attached. 

* * * DATA PACKAGE EVALUATION * * * 

No evaluation is written for this data package 

* * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * * 

/ / 

DP BC 

259559 

BRANCH/SECTION 

PSB/CTT 

DATE OUT 

09/20/99 

DUE BACK 

12/24/99 

INS 

Y 

CSF 

Y 

LABEL 

Y 

60
DP BARCODE: D259557 

CASE, 064909 

SUBMISSION, S568516 

DATA PACKAGE RECORD 

BEAN SHEET 

DATE, 09/20/99 

Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE: REGISTRATION 

013907 Sodium 

014703 Sodium 

ACTION, 

bromide 

hypochlorite 

187 RESB AmD-OC-MINOR CHG 

CHEMICALS, 

IDff, 001706-RIU TX-I0861 

COMPANY, 001706 NALCO CHEMICAL CO. 

PRODUCT MANAGER, 32 ROBERT BRENNIS 

PM TEAM REVIEWER, MARIANNE CLARK 

RECEIVED DATE, 09/15/99 DUE OUT DATE, 

703-308-6264 

703-308-6381 

01/13/00 

* * * DATA PACKAGE INFORMATION * * * 

DP BARCODE: 259557 EXPEDITE: N 

''CHEMICAL: 013907 Sodium bromide 

DP TYPE: 001 

CSF, y LABEL: 

DATE SENT, 09/20/99 

Y 

ROOM, CSI 

ROOM: CS1 

DATE RET. : 

13.6600%" 

9.4100%" 

6C 

6W44 

/ / 

ASSIGNED TO 

DIV : AD 

BRAN, PSB 

SECT, CTT 

REVR , 

CONTR, 

DATE IN DATE OUT ADMIN DUE DATE: 12/24/99 

DP BC 

259559 

• 

/ / / / NEGOT DATE, 

/ / / / PROJ DATE, 

/ / / / 

/ / / / 

/ / / / 

* * * DATA REVIEW INSTRUCTIONS * * * 

Actue Tox: Please review registrant's resubmission for a 

waiver from acute toxicity data. Registrant is citing 

EPA file symbol 1706-179 as being identical label & CSF 

attached. 

* * * DATA PACKAGE EVALUATION * * * 

No evaluation is written for this data package 

* * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * * 

/ 

/ 

BRANCH/SECTION 

PSB/CTT 

DATE OUT 

09/20/99 

DUE BACK 

12/24/99 

INS 

Y 

CSF 

Y 

/ 

/ 

LABEL 

Y 

61
\ 

NALCO CHeMICAL COMPANY 

Mr. Robert Brennis 

U.S. Environmental Protection Agency 

Antimicrobial Division (7510W) 

410 M. Street SW 

Washington, D.C. 20460 

September 9,1999 

Subject: Resubmission of Application for Registration Nalco TX-10861 (1706-RUI) 

Dear Mr. Brennis: 

Nalco Chemical Company submits this letter in response to your letter dated July 23, 1999 in which you 

define certain deficiencies in the original application. 

We have included the following items in this application: 

1. Amended EPA Form 85704 

2. Updated label with pasteurizer claims deleted 

3. Amended Confidential Appendix (corrected manufacturing procedure) 

4. Documentation to substantiate pulp & papermill use patterns 

Regarding the acute toxicology waiver issue, the cited product should have been 1706-179 (Nalco 

95ND141). This product, TX-10861 is essentially a "double strength" 95ND141. We reiterate the request 

for waiver below. 

Nalco Chemical Company wishes to request a waiver from acute toxidhj data requirements (Guidelines 81-1 

through 81-6) on the basis that the formulation is essentially identical to the registered product Nalco 95ND141 

(Reg. No. 1706~179). The precautionanj statements on the label will be identical to those jor Nalco 95ND141. 

Also, because of the very dose similarity to 1706-179, Na1co Chemical Company believes this application 

should qualify for "expedited review" as a "me-too" product. 

We await a copy of the "stamped accepted" label. If you have any questions, please feel free to contact 

me directly. 

t9~~~ ~;!. Wolf, MSc., <.-... Corporate Toxicologist 

, 

> > , > 

J 'J' 

, , 

", , 

• J" 

, .. ~ .. , , , 

, > , , , , , , • > > 

62
I 

j 

FOOD AND DRUG STATUS 

INGREDIENTS OF 

NALCOI0861 

FOR USE IN PAPERMlLL INFLUENT AND PROCESS WATER SYSTEMS 

INGREDIENT 

Sodium Hypochlorite 

Sodium Bromide 

FDA CITATION 

2ICFR176.170 

FDA Letter up to 22 ppm in water (as Br+ ion) 

GRAS affirmed under 

, " " , , ) , " 

, , " '~j , , 

j ,j' , " " , 

, " " , ," , 

, " " , ." j , 

. ~ '" , . ,, " , , 

63

*Inert ingredient information may be entitled to confidential treatment*
21 CFR Ch.1 (4-1-97 Edition) 

Limitation. 

_n! eel p<ior 10 lhe st\OOl..form- For use only as a fIcx>:;uIanl 0 .. ",,01 and ~rd, 

ing "I*alion In Ih<l maoot",:~~ ~~~ )10 parts per milaOO used al a \<I ..... 001 10 ex"""" "'101' ~ 

~on} 01 innuent wa\i)l'. 

, 

• " ~oyed in the manubcWro 01 

,I- For use or.ly as a~_~~~I ':0 the shOOt.formlng ope<aUon, 01 paper 1.00 p3!lOlll<>OUY ... ,0( 

• 

" " " 

lana 

"'m _. 

,~ "', 

m 

.",.. 

*es al 

leW)or 

,_. 

ooi!W" • 

"" 

100 

Food and Drug Administration, HHS 

Lisl 01 S4Jbstanc:es 

Poiyfo){),clhylvoo (dimolh)'llmlnlo) elhylene )dimclh)'liminio) 

elhyfene didolorid&) produced by reacting oqulmGlar QiJII.I>-

~li... 01 N,N.N.N-iolramelhyfelhy\ene4lamlrKI and 

dichlorelhyl ether 10 )'laid a $CMion 01 Ihe sotid potymer in 

diMi~od water at 25' C with a rcdooad viS<:o.ily 01 no! loss 

lhan 0.15 deci~Ier per (lfam as determined by ASTM melhD(! 

01243-79, "Slaodllfd T8$I Melhod lor .DiMe ScIullO<! Vis· 

cosil)i 01 Vin)'! ChI<)I"Ide Po~me(S." which is ifIco(paralod by 

relll(ellCe. Copies may boo obIairKld Itom lhe American Sod· 

e~ tor TGSting Materials. 1916 Race St., Phi~lphia. PA 

19103, or m"l' boo e..",.,ined al lhe Otfooo 01 Ihe Federal 

Rogi$lll(. 800 Ncrtll Capitot SlrOOl, toW •• su~" 700. WashinaIon. DC 2G400). The totlcwing Iormu~ ~ used lor deletml ..... 

ing rcdOOlld vi=rty:. 

Roducod visaW!y In lerma 01 docil~o'(S per gram.)I-Io)1 

)I-C}. 

where: 

,..SGIution emux time 

t"..Water efflux time 

C-CoJ>Cllnlration 01 sotution In lorms 01 gram. per OOQliler 

Polypropykooo glycol )minimum moloeu!ar weiijllt 1,0(0). 

Potasaium persultate. 

2·Propono;c acid, telomM wilh sodium 2·m!!lh)'!·2·1(I-oxo-2. 

prcpon)'l)amino)·I-propane sultonale and sooiurn pIIosp/liroale (CAS Rug. No. 110224-119-2). 

Ptop)'lGOO glycot oIgInete. 

Prolo;n hydro\y!;ate lrom animal hides or soyboan p<QInin 00 ..... densed wlth oteic and/or slearic add. 

Rapeseed <)ii, sulfated ammonium. pola$Sium. or sodium sa~. 

Ricobrnn 011. sultaled ammonium, ~m, or sodium sail. 

ROllin aOO roon derivatives •..• _ .•.•..•..•.•...•. ., .••. ., .. _ .................... .. 

S<fver chtorlclfK::ollted tilaroium dfoxi<le _ .................................... .. 

Sooium COfboxymethyt guor gum having a minimum visoosi~ 

012,700 oentipoises at 25·C alter 24 nours lIS dOlorminocl 

by RV-seoies Brookfield visoomclO( (or eQIIiwlent) using a 

No. 4 spindle 11120 r.p.m. and uaing p tIlot sampja prepared 

by dissolving 8 grams 01 sodium carbcxymothyl guar gum in 

392 milfimers 01 0.2i>\1fC(!nI-tly-welghl aqueous "","um (>0 

pIlon)'!phenatp soIulfon. 

Sodium dioct)'l wttowc:cinalc. 

Sooium Iormaldehyde wtlo,,),hlI0 ............................................. .. 

Sooium hypocht<llile, 

SocIi"", N-meth)'l-Notc)'ltauralo .•.•...•.•..•...•.• ., ........................... . 

Sodium nibilli ....•.•.•.•.. .,.,., ............. . 

Sodium persuHala. 

Sodium poIyacry;ale • .,.,., ............................................... _" ........ . 

Sodrum poI1~soprDp!!nyIphosphonole) )CAS Reg. No. 118632-

18-1). 

Sodium 'inc po!a$Ei"", poI)l!)hasphaie (CAS Reg. No. 65997-

17-3). 

Spoon oil. wttatod, ammonium, pol.lJ;N/\XIl, or sodium sail. 

Stannous ole,le. 

SteaI)'l·2-lcetytic acid aOO its calcium sa~. 

§176.170 

Limitations 

For uso only 10 imprcMl dry-slrength 01 paper ar.cI poporboard 

aOO 811 .. retllnti<ln IIIld dralnage ald amptoyod plio( KI the 

sh&et..formlng operatlon In IIle marn.lfactur. 01 paper ar.cI paperboard and ~m~ed 10 un at Ii lew! nat Ie exceed 0.1 per_ 

OIInl by weight 01 the fini.hed dry I"'P"'" ond pgpoIboard fibers. 

For usc onf1 11$ a depos.l controt additiVtl omptoyod prior 10 

Ihe shool forming Dp!!raticn In ~ manufacture 01 paper and 

paperboatd and II ale ..... nol 10 o.oood 0.15 perwnI by 

weight ot \he dry paper and poporbonrd 

As fl'<lvidod in § I 78.3871) 01 INs diopter. 

For uso ooIy 81 a pr ..... rvatiVtI iii poI)'!MI' latex u~ at .. 

le';ef nel 10 exooed 22 parIS per million (ba&ed on sItvar Ion 

oollCenll'a~oo) in the dry coating. 

For use onf1 81 a dry-slrength and IotmaIicrHid agent emplo1ed prior 10 the sheel·lorming opcrillion in \he mcnulaolIIte 01 ~ and pcpotboord and used III ° leVtIt not 10 ex_ 

ooed 1% by Wtiighl 01 finished dry poppr or peporboo.vd t!-

000. 

For ~ ont1 as potym(trization co.toIyst. 

For use ooIy II!l an a~I 10 con\rot pUp ab$Orbency and 

pilch contenl in the manufactlJro 01 paper and paporbOIlrd 

prior 10 lno shool·lorming ope<atlon. 

For uso 001)': 

t. At \evefl; nol 10 exccod 02% by weigh! 01 lubricants or r .... 

lease agents appIiocl 01 IB'I'IIlII not 10 cl<CCOd 1 lb. per IQn 01 

finishQd paper or PllPl'rboMl. 

2. As an anticorroIikln ag&l1I at levtils not Ie el<OlOO' 0.2% by 

wCiijllt 01 wax amlll;lO<lll USI!d as !ntcmal sizing In \he manulaclvte 01 ~ and papo<boartI prior 10 the shcel..fonn/ng 

operation. 

For til, only: 

I. As. thickening agent lor nalllril! rubbor latex OOIIlinQ1, proYiOed II is used at a levtil 001 to ClCCCed 2 perwnt by weighl 

01 coating .soIOds. 

2. As • pigmcnl dis;IotsanIln <:OIIIings at a Iovot not 10 excaad 

025 pon;enl by woighI 01 pigm&nI. 

For u.n ooIy in paper mill boilers. 

For use ooIy as a pigmiJn\ dispersatll in coatings al a level no! 

10 exooed I per<:ent by weigh! 01 pig",..,nl. 

191 

64
, (4 DEPARTM.ENT Of HfALTH & HUMAN SERVICES ~ -. , ,/.1- Public Health Servico 

.J<'-e.. ~e't':r . Nil5Ql 

Foot;S anCl Orug Admlni$ttatiet"l 

W.shington OC 20204 

Dr. Lanny Lake 

International Chemical Consultants 

5520 Cherokee Avenue, suite 200 

• Alexandria, VA ~2313 

Dear Dr.. Lake: 

This is in response to your ~etter of November 1, 1990# and 

the subsequent meeting of November 1~, 1990, regarding your 

request for our consideration of SOdium bromide for use as 

a slimicide. You stated in your letter that sodium bromide 

would be used at pulp and paper mills to control algae, 

bacterial, and fungal slime that exist in the various 

process water systems of pulp and paper mills. 

We have reviewed your submission and find that with a 

maximum addition level of 22 parts per million (22 ppm) bromide ion in the process water, th~ bromide ion residua 

in food~coneact paper would be no greater than 1 part per 

billion (ppb), and the dietary exposure to bromide ion 

would be far bel~~ this level. On the basis of your stated 

maximum app1icaeion level of 22 ppm bro~ide.1on in prooess 

water and the minute exposure expected in the diet, we 

conclude that the intended·use of sodium bromide would not 

require a petition to FDA to amend the food additive 

regulations. 

We wane to ~Fhasize that all s1imicid6S must be registered 

with the Environmental Protection Agency (EPA), and that 

under the Federal Insecticide, Fungicide and Rodenticide 

Act (FrFRA) I efficacy data may be required. For more 

information regarding EPA registration procedures, you may call the EPA Hotline at: .20~-382~5~2~ (looal) or 1-800-426-

4791 (long distance). 

sincerely yours, 

AI~BIJ-.l---,;. Alan Rulis, Ph.O. 

Director 

, " " , , , , , 

Division of Food and color 

center for FOod Safety Addieives!~~:~! 

and Applied Nutrition 

" 

, , , J , • . . , ••••• > , , > ", • , 

, " 

" , ')' , 

, " " , ,>, ) 

65
66

*Inert ingredient information may be entitled to confidential treatmen
( 

SUBMISSION BAR CODE #,g!)P/360 REVIEWER II. CltfAJ,G 

FILE SYMBOL.,/ 'R=E~GG~::J~;-:i2~U~iP~M~'-~2:.22~=AC~T~I~O=N~C=O=D=E~j,:f)~6~ ,DESCRIPTOF( _ 

'[ ] 'CHILD RESISTANT PACKAGING: [ ] CERTIFICATION 

[ ] NON-RESIDENTIAL USE ONLY 

[ ] NOT APPLICABLE 

REGISTRATION TYPE: ,[ CONDITIONAL [ UNCONDITIONAL 

PROPOSED CLASSIFICATION,: [ ] GENERAL [ RESTRICTED USE 

DATE'ON APPLICATION EPA RECEIVE DATE PM "RECEIVE 'DATE 

[Of 1 VB 1 qq I 

METHOD <iF SlJPPORT , 

[ ] CITE-ALL 

[ ] SELECTIVE " 

[ ,] NOT SUBMITTED 

[ J_NOTAPPLI,CABLE [ r INCORRECT /RESUB 

1041&71991 , , 

FORMULATORS EXEMPTION 

[]-SUBMITTED 

[ ] NOT SUBMITTED , [ ] NOT APPLI CABLE 

[ '1. INCORRECT/RESUB 

I JEVIEW (S] REQUESTED DATA 

PACK # 

riATE 

SENT 

DUE 

DATE 

DATE 

RETURNED 

, " 

CHEMISTRY 

EFFICACY 

TOXICOLOGY 

HED TOX. 

ENVIRON. FATE 

FISH/WILDLIFE 

OTHER ___ -'-__ _ 

'" 

DJS5'G50 Lf I~ 

DdS5~lj' I L 

I~ 

( 'fr 7{~dr;9 S-/(O iq9 

Iq« 15- f<{ 'ff( 7 'I'! Iqq 

. 

STATUS. __ ---~----_------------------~~--------~ 

RESPONSE CODE ;3 RESPONSE DATE 

'v 

JUL 2. 3 \999.M ' 

67
( , 

) 

I 

SYMBOL. 

SURNAME 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

Mr. Claude H. Wolf 

Nalco Chemical Company 

One Nalco Center 

Naperville, Il60563 

Dear Mr. Wolf: 

Subject: TX-I086 

EPA Registration No. 1706-RIU 

Application Dated April 8, 1999 

. Ill! 2 3 1999 

The application for registration of the subject product is not yet acceptable for 

registration for the following reaSOns. 

The Confidential Statement of Fonnula dated April 8, 1999 is not acceptable. 

Based on your Confidential Statement of Formula the label claim for Sodium bromide 

shouIa be 13.40%. Note that source product for Soditun bromide 

Submit an opinion letter from Food and Drug Admininstration that this product, 

''TX-I0861'' may be safely used in the above uses (Industrial pasteurizers - food and 

beverage) Industrial process pasteurizers; shell egg pasteurizer water system; pulp and 

papennill influent water systems; and pulp and papennill process water systems. All of 

of these uses must be approved by the Food and Drug Administration (FDA). 

EPA File Symbol 1706-RnJ is not substantially similar to EPA Registration 

Number 1706-171 in tenns of acute toxicology. This means that the fonnulations of 

1706-RID and 1706-171 are not similar enough to allow studies conducted on either 

one of these products to be cited to support the acute toxicity (product toxicity) 

requirements for the other product. The main problem is that EPA File Symbol 1706-RIU 

contains 13.66% sodium bromide. According to the label and Confidential Statement of 

Fonnula of Registration No. 1706-171, it does not contain any sodium bromide. Thus, 

the Efficacy Science Support Branch will not allow acute toxicity data developed 

or derjved from Registration Number 1706-171 to be used to support any of the six 

acute toxicity requirements for file symbol 1706-RlU. 

CONCURREHCES 

. ... -.~.:~ ...................................................................... ' ........................................................................ .. 

DATE 

- i ... ;;, ... ~ ........... ~................. ................. . .. ~ ................................... ~ ................. -........ ~ ....................... . 

OPPICIAL PIU:; COPY 

68

*Product ingredient source information may be entitled to confidential treatment*
2 

Your application can not be processed until the above materials are corrected. 

This product may not be lawfully distributed or marketed until it is registered. 

If you have any questions, please call Marianne Clark at (703) 308-6381. 

?~~v~ Robert S. Srennis 

Product Manager (32) 

Regulatory Management Branch II 

Antimicrobial Division (7510C) 

69
DP BARCODE, D255651 

CASE, 064909 

SUBMISSION, S561360 

DATA PACKAGE RECORD 

BEAN SHEET 

* * * CASE/SUBMISSION INFORMATION * * * 

DATE, 04/29/99 

Page 1 of 1 

CASE TYPE: REGISTRATION ACTION: 186 AmD-OC-MINOR CHANGE 

CHEMICALS: 013907 Sodium bromide 

014703 Sodium hypochlorite 

ID#, 001706-RIU TX-10861 

COMPANY, 001706 NALCO CHEMICAL CO. 

PRODUCT MANAGER, 32 ROBERT BRENNIS 

PM TEAM REVIEWER: MARIANNE CLARK 

RECEIVED DATE, 04/16/99 DUE OUT DATE, 

703-308-6264 

703-308-6381 

08/14/99 

* * * DATA PACKAGE INFORMATION * * * 

ROOM, CS1 

ROOM: CSl 

13.6600% 

9.4100% 

6C 

6W44 

~P BARCODE, 255651 EXPEDITE, N 

MEMICAL: 013907 Sodium bromide 

DP TYPE, 001 

DATE SENT, 04/29/99 DATE RET., / / 

ASSIGNED TO 

DIV , AD 

BRAN, EASSB 

SECT: CTT 

REVR c&.--

CONTR, 

CSF, Y LABEL, Y 

DATE 

/ 

/ 

/ 

/ 

/ 

OUT 

/ 

/ 

/ 

/ 

/ 

ADMIN DUE 

NEGOT 

PROJ 

* * * DATA REVIEW INSTRUCTIONS * * * 

DATE, 

DATE, 

DATE, 

08/02/99 

7//1 /q;"( / / 

Acute Tox: Please review registrant's request for a waiver 

from acute toxicity data requirements 

DP BC 

255650 

* * * DATA PACKAGE EVALUATION * * * 

No evaluation is written for this data package 

* * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * * 

BRANCH/SECTION 

EASSB/CTT 

DATE OUT 

04/29/99 

DUE BACK 

08/02/99 

INS 

Y 

CSF 

Y 

LABEL 

Y 

70
DP BARCODE, D255651 

CASE, 064909 

SUBMISSION, S561360 

DATA PACKAGE RECORD 

BEAN SHEET 

DATE, 04/29/99 

Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE, REGISTRATION ACTION, 186 AmD-OC-MINOR CHANGE 

CHEMICALS: 013907 Sodium bromide 

014703 Sodium hypochlorite 

ID#, 001706-RIU TX-I0861 

COMPANY, 001706 NALCO CHEMICAL CO. 

PRODUCT MANAGER, 32 ROBERT BRENNIS 

PM TEAM REVIEWER: MARIANNE CLARK 

RECEIVED DATE, 04/16/99 DUE OUT DATE, 

703-308-6264 

703-308-6381 

08/14/99 

* * * DATA PACKAGE INFORMATION * * * 

~p BARCODE: 255651 EXPEDITE: N 

HEMlCAL: 013907 Sodium bromide 

DATE SENT, 04/29/99 

DP TYPE: 001 

CSP, Y LABEL: Y 

ROOM, CSl 

ROOM, CSl 

DATE RET.: 

13.6600% 

9.4100% 

6C 

6W44 

/ / 

ASSIGNED TO 

DIV : AD 

BRAN, EASSB 

SECT, CTT 

REVR , 

CONTR, 

DATE IN DATE OUT ADMIN DUE DATE, 08/02/99 

DP BC 

255650 

/ / / / NEGOT DATE: / 

/ / / / PROJ DATE, / 

/ / / / 

/ / / / 

/ / / / 

* * * DATA REVIEW INSTRUCTIONS * * * 

Acute Tox: Please review registrantls request for a waiver 

from acute toxicity data requirements 

* * * DATA PACKAGE EVALUATION * * * . No evaluation is written for this data package 

* * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * * 

BRANCH/SECTION 

EASSB/CTT 

DATE OUT 

04/29/99 

DUE BACK 

08/02/99 

INS 

Y 

CSF 

Y 

/ 

/ 

LABEL 

Y 

71
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

July 14, 1999 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

MEMORANDUM: 

Subject: 

To: 

From: 

Through: 

Applicant: 

Similarity Clinic Determination: 1706-RJU / TX-10861 

DP Barcode: D255651 

Case No: 064909 

Robert Brennis, PM 32 / Marianne Clark 

Regulatory Management Branch 

Antimicrobials Division (751 OC) 

AD Similarity Clinic () .iJ /P d d! 

Ian Blackwell UC/lV ~,~ Efficacy and Science Support Branch 

Antimicrobials Division (7510C) 

Michele 

Efficacy 

Wingfield, 

and Science 

Branch 

Support 

Chief 

Branch 

~ ~7~ "0 

Antimicrobials Division (751OC) 

NaIco Chemical Company 

This Similarity Clinic Determination is meant to decide if two or more pesticide products are able 

to cite the same acute toxicity data. In many instances, the data cited was conducted using one of 

the products which is involved in the determination. This Similarity Clinic Determination only 

pertains to acute toxicity studies of end-use products, not to any other types of studies. 

EPA File Symbol 1706-RJU is not felt to be substantially similarto·EPA Reg. No. 1706-171 in 

terms of acute toxicology. This means that the formulations of 1706-RIU and 1706-171 are not 

similar enough to allow studies conducted on either one of these products to be cited to support 

the acute toxicity (product toxicity) requirements for the other product. The main problem is that 

reg. no. 1706-RIU contains 13.66% sodium bromide. According to the label and CSF of reg. no. 

1706-171, it does not contain any sodium bromide whatsoever. Thus, ESSB will not allow acute 

toxicity data developed or derived from reg. no. 1706-171 to be used to support any of the six 

acute toxicity requirements for file symbol 1706-RIU. 

72
I 

DP BARCODE, D255650 

CASE, 064909 

SUBMISSION, S561360 

DATA PACKAGE RECORD 

BEAN SHEET 

DATE, 04/29/99 

Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE, 186 AmD-OC-MINOR CHANGE 

CHEMICALS, 

REGISTRATION 

013907 Sodium 

014703 Sodium 

ACTION, 

bromide 

hypochlorite 

13.6600% 

9.4100% 

ID#, 001706-RIU TX-10861 

COMPANY, 001706 NALCO CHEMICAL CO. 

PRODUCT MANAGER, 32 ROBERT BRENNIS 

PM TEAM REVIEWER, MARIANNE CLARK 

RECEIVED DATE, 04/16/99 DUE OUT DATE, 

703-308-6264 

703-308-6381 

08/14/99 

* * * DATA PACKAGE INFORMATION * * * 

?P BARCODE, 255650 EXPEDITE, N DATE SENT, 04/29/99 

2HEMICAL: 013907 Sodium bromide 

DP TYPE, 001 

CSF, Y LABEL, Y 

ASSIGNED TO DATE IN DATE OUT 

DIV , AD i' /"">/"77 / / 

BRAN, EASSB i'/a"/fc / / 

SECT, CTT Y /3,,/,; / / 

REVR ,/1.scl1M£5 r-/3 /!',r / / 

CONTR, Cnvr.lA./ Lp.o.J / / / 

ADMIN DUE 

NEGOT 

PROJ 

S- /0- q It * * * DATA REVIEW INSTRUCTIONS * * * 

ROOM, CS1 

ROOM, CS1 

DATE RET., / 

DATE, 

DATE, 

DATE, 

08/02/99 

/ / 

/ / 

Product Chemistry: Please review CSF, label and chemistry 

data MRID#s 448082-01 & 02 submitted to support 

registration of subject product 

DP BC 

255651 

* * * DATA PACKAGE EVALUATION * * * 

No evaluation is written for this data package 

* * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * * 

BRANCH/SECTION 

EASSB/CTT 

DATE OUT 

04/29/99 

DUE BACK 

08/02/99 

INS 

Y 

CSF 

Y 

6C 

6W44 

/ 

LABEL 

Y 

73
DP BARCODE: D255650 

CASE, 064909 

SUBMISSION, S561360 

DATA PACKAGE RECORD 

BEAN SHEET 

DATE, 05/04/99 

Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE, REGISTRATION ACTION, 186 AmD-OC-MINOR CHANGE 

CHEMICALS: 013907 Sodium bromide 

014703 Sodium hypochlorite 

ID#, 001706-RIU TX-I0861 

COMPANY, 001706 NALCO CHEMICAL CO. 

PRODUCT MANAGER, 32 ROBERT BRENNIS 

PM TEAM REVIEWER, MARIANNE CLARK 

RECEIVED DATE, 04/16/99 DUE OUT DATE, 

703-308-6264 

703-308-6381 

08/14/99 

* * * DATA PACKAGE INFORMATION * * * 

DP BARCODE: 255650 EXPEDITE: N 

rHEMICAL: 013907 Sodium bromide 

DP TYPE, 001 

CSF, Y LABEL, 

DATE SENT, 04/29/99 

Y 

ROOM, CSI 

ROOM, CSI 

DATE RET. : 

13.6600% 

9.4100% 

6C 

6W44 

/ / 

ASSIGNED TO 

DIV , AD 

BRAN, EASSB 

SECT, CTT 

DATE IN DATE OUT ADMIN DUE DATE, 08/02/99 

) 

REVR , ASKAPARS 

CONTR, 

04/29/99 

04/30/99 

04/30/99 

05/03/99 

/ / 

* * * 

/ 

/ 

/ 

/ 

/ 

DATA REVIEW 

/ NEGOT DATE, 

/ PROJ DATE, 

/ 

/ 

/ 

INSTRUCTIONS * * * 

Product Chemistry: Please review CSF, label and chemistry 

data MRID#s 448082-01 & 02 submitted to support 

registration of subject product 

* * * DATA PACKAGE EVALUATION * * * 

No evaluation is written for this data package 

* * * ADDITIONAL DATA PACKAGES FOR THIS SUBMISSION * * * 

/ 

/ 

DP BC 

255651 

BRANCH/SECTION 

EASSB/CTT 

DATE OUT 

04/29/99 

DUE BACK 

08/02/99 

INS 

Y 

CSF 

Y 

/ 

/ 

LABEL 

Y 

74
SUBJECT: 

TO: 

FROM: 

PRODUCT CHEMISTRY REVIEW - Antimicrobials Division 

DP Barcode D.:lS 5&50 Reg. No. or File Symbol 170" - RJ'tt 

-Manufacturing-Use [ ] or End-Use Product [ vi Case# __ 

/Chi ~~ / MqJu!YMz<, ('.-iOA.k. 

PM Team No. 3;), 7 

Anna Skapars, Chemist 11(7 n CL .5'* atUUi 

Chemistry-Toxicology Team (CIT) I 

Efficacy and Science Support Branch (ESSB) 

5-10- 99 

THRU: Michele E. Wingfield, Branch Chief 

Efficacy and Science Support Branch (ESSB) 

CmcfdM£..t:d ,-&cifi..-~ c>-/ ?Or/JUd&, daZel 4 -?- 99 

15 A"YL ~ej, ""'- "'- 4J I jZ ;:;/1 ;V' ~ '& q (-,;2 CM-t!' it 

It! b1.<.1e1 -iJ-~ a <' crX aA-G. . 

1~v<U.,l ene ~v~ C~<~ZcJ. .&-c2Zj,...J:l Of /;;!'/wL dei:i.ot. Ji -&"-Cf<? ti.c £Jd dQ..h-,,--..f!.rr.- S"ob, '.t.wn.-

.Gumu 'cA. d,,,,,,U ./k." S"C£ k~ tt.(lm<4:it.- /8·.l/tJ %. 

~krZ 1J,. Q.r $.m..", ~L :-01-1<' OU, if: 1= $"" at ~ ~e ~ I d ,.:s %t NtJ70. 

'PlU!v{ci.e..oL t"O c0., or ~ '.s'P.«; d4i; he. HIf'I j) 14.'s f./Jii'tJ8:) - 0/ 

em.cI IfI{.$'O . 0;1 ~ v :' oic" c1c:L... ,-i~n. ~-:" ~ . SUa:. G t,; ":;!.I;;~ 63, TfLi<k d .. t::.. ~'-- .UL ~pt Q-1< ~ UJ/~~40 <;~.e , ~. 

75

*Product ingredient source information may be entitled to confidential treatment*
PRODUCT CHEMISTRY REVIEW 

END-USE PRODUCT [v) MANUFACTURING-USE PRODUCT [ 1 

EPA Reg. No. (or File Symbol No.) 17126- RIl/ 

Registration [v) Reregistration [ 1 

Case No.: 

7):').556S0 

DP Barcode/chemist: IInne>.. Skrall4 

1) 3) 

2) 4) 

1. 

2 • 

3. 

Product Name: TX- (D"s~1 

company: N QttAl (' ~~ Co. 

Type of Submission: New [;] Resubmission [] Alnendment [ ] 

"ME-TOO" [ ) 

Expt Use Permit [ 

Alternate Formulation [ 1 REPACK [ 1 1 Other (Specify) ______________________ __ 

4. CONFIDENTIAL STATEMENT OF FORMULA 

4a. Type of formulation and source registration 

• Non-integrated formulation system 

. Are all TGAIs ·used registered • yes [.1 • no 

Integrated formulation system [ 

4b. 

• If "ME-TOO", specify EPA Req. No. of existinc; 

product: 

Clearance of inerts for non-food or food use: 

Cleared for food use under 40CFR§180.1001: 

• yes [ 1 • no [ 1. If yes: • c [1 • d [ 1 

Cleared for non-food use: . yes [/] 

4c. Physical state of product: cf3..·'t'""~'L 

• e [ 1 

• no [ 1 

4d. The chemical IDSJ analytical information (including 

that for the TGAIs), density, pH, and flammability are 

consistent with that given in GRN 61, 62, and 63-7, 

63-12, and 63-15, respectively. • yes [/J . no [ 1 

76
3 

4e. Dens-ity (or bUlk denslty for solids): at 

4f. pH (if dissolved or dispersed in water) t Itf 

4g. Flash pOint and/or flame extension: None...., 

4h. 

4 i. 

Nes and CLs are acceptable \ 

Active ingredient(s) 

A. Socl{'-tl/Y>'-' li;'fFc),AUiL 

B. Sod<'."",u &;,.;;ffU'dc. 

C. 

D. 

. ( ) . not acceptable ( ) 

NC. LCL UCL 

"1.4/ t,90 I";J.I? 

4j. For products produced by an integrated formulation 

system: 

• All impurities of toxicological significance have 

an UCL: • yes () • no () • not applicable (v1 

• All impurities ~ 0.1% in the product have been 

identif,ied<· yes'( ) '. no () • hot applicable (,.-f 

S. PRODUCT LABEL 

Sa. 

Sb. 

Sc. 

The active ingredients statement (chemical~IDs 

Nes) is consistent with the CSF: • yes [Y] 

The formulation conta.ins one of the following: 

• 10\ or more of a petroleum 

distillate: • yes ( ) 

• 1% or more of methyl alcohol: • yes ( ) 

sodium nitrite at any level: • yes [ J 

· a toxic List 1 inert at any level:- yes [ J 

• arsenic in any form: • yes [ J 

and 

• no ( ) 

• no (~ 

: ~~ \3 

no (v1 

If yes to 

statement 

• yes ( ) 

any of the above, does the inert ingredients 

contains a footnote indicating this? 

• no ( ) • not applicable (J) 

5d. The appropriate warning statement regarding 

flammability or explosive characteristics of the 

product ~re given on the label: 

• yes (/]' • no ( ) • not applicable ( ) 

77
, 

5e. The storagj! __ and-.dis.po,s_a:r~_t-l_st-ru-e_t_i_ons_f-or_ the pesticide 

----and ·container are in compl iance with PR Notice 84 -1 for 

household use products or PR Notice 83-3 for all other 

uses: • yes [v'J • no [ J 

6f. Does the product require an expiration date at Which 

time the NC falls below the teL (based on the one year 

storage stability data or other information): 

• yes [ J • no [v:l 

6. PRODOCT CHEHIS1RY (GRN 61. 62. 631 

6a. Chgmical IDsLManufactureLAnalytical Acce12t ot Mlilll 

Infgrmation Information H2... 

61-1 Chernica~ ID (see Appendix) , A 4'1-&0&;/"01 

61-2a Manufacturing Process2 A 44%08;;-0 

61-2b Formulation Method3, A '-Itt' f{Nf~- Or 

61-3 Discussion of Impurities' A- 44Z08;J-O 

62-1 AnalysisS AliA62-2 Certified Limits 6 . - A -&sF -

62-3 Analytical Method for A1s7 A 'f'f871 111 -o~ 

78
5 

6b. Ph~~icA1LCbem1c~1 ero~ert1~= I tT., nr ~ 

~h =~ l!sl.... ~. 

63-3 n' ,; ~'l State Jlr I L-;"",',f 

63-7 0 ity/u"" n"M.i>v (g/ee) A I/~.t/.'·" ". 

63-12 pH ot • Il- iLt 7if 1-0, 

63-14 ~,,'~'",,''' '~"~M NIp, 1",40"". 

67-15a Flash " .. , ,(' C) 10 A I, n 0, I liu ,n ' .1< 

63-15b ~, .m. Extension /J/{J. 

.,.,. Expl .~.'" tity Ii I M,d ~". I, , -tJI 

63-17 Storage Stability, 

(' dellradation' ot' Als at 

20-30 C tor ~ 1 ~~ 4';~VB''''J 

63-18 Viscosity , T 11 "'f' ,,4' F 

63-19 7!~~~bt~~ty <", I 

.rhM solvents)" 1\ "W I", A, -[)/ 

63-20 corro~tvitY ( ", metals, ""ions) A Ii:~£~>,;. w '~?j'a (J' 

63-21 ni" .::t;k Breakdown v;;i Nh 14. 

Explanaticn,; A • Acc.ptabl.~ N • net acceptable, NA • tecbnically not 

applicabl.; G • data 9ap: U • require. upgrading; W • yaived; E • EPA 

•• timat •• 

FootD91": 1 s •• Confid.ntial appendix A for additional informaticn; Z For 

HP/Er product. produced by an integrated for=ulation .y.t •• ; J For product. 

produced from I TGAI or HP; , May b. yaived unl ••• actual/po.,ible impuritiel 

are of ~o~ CODcern; , ri~e batch analy.i. required for producte produced by an integr.~.c formulation .y.te.; , If different from .tandard ctl recomm.nded 

in 40 CrR 15'.175, this .bould be di.cu •• ed in Confidential Appendix A; 7 

Abbreviate metbod u.ed" a. follovez ga. chromAtography (Ge), infrared (IR), ultraviolet ablorption (UV), nuclear =agnetic re.onance (NKk), etc. ' Pro~ide 

brief de.cription, e.9., color _ yellov er property ~alue, e.9. denlity 1.,25 

g/cc. Unle.1 otberwi.e indicated, thl property sbould b. at 25 C ; t If" 

product i, a water .olution or disper.ion; 10 Not required for aerolol.: 11 

EmulsUi&bll liquid. only; 11 ror end-u •• product. u.ed near electrical . 

• quipment. 

C:C:I J.o~h"'1"" No. oad COIlUal ruo 110,. No. or "ou, Can )1"0.) .750SVtlDtlSll'CUICSe 

"llRu:=th.,io .. n" Ma_t'tTPhC IllicioletDIu.I'Ot10Je)O'e:u:;:a;tCOdo (10,01' aero, Mol. 

<pcrOQCio " 

1 

79
/ 

NALca CHEMICAL COMPANY 

rJ"lc. ":,.,,'.,(; l.:1 "J1FH 

Mr. Robert Brennis 

U.S. Environmental Protection Agency 

Antimicrobial Division (7510W) 

410 M. Street S,W. 

Washington, D.C. 20460 

Subject: Application for Registration Nalco TX-I0861 

Dear Mr. Brennis: 

AprilS, 1999 

. 

1GB 

Nalco Chemical Company seeks to register its product TX~10861. Enclosed please find the 

following items in support of this application: 

I. 

2. 

3. 

4. 

44808201 5. 

44808202 6. 

7. 

Completed EPA Form 8570-1 

Completed EPA Form 8570-4 (in Confidential Appendix) 

Completed EPA form 8570-27 

Six copies of draft product label 

Volume I - Product Chemistry infocmation 

Volume II - Analytical Method for Enforcement 

Confidential Appendix for Volume I (8570-4 and Manufacturing Procedure) 

448082-00 

Nalco Chemical Company wishes to request a waiver from acute toxicity data requirements (Guidelines 81-

1 through 81-6) 011 the basis that the Jonnulation is essentially identical to the registered product Nalco 

ActiPllls 2818 (Reg. No. 1706-171). The precall tionary statements on the label will be idenHcal to those for 

Nalco ActiPlus 2818. 

Also, because of the very close similarity to 1706-171, Nalco Chemical Company believes this 

application could qualify for "expedited review" as a "me-too" product. 

[f you have any questions, please feel free to contact me directly. 

Corporate Toxicologist 

CHW/jh 

APR 2 7 1999 

APR 2 

80
m .ri F A roved, OM 0, 70 . 8- 5 

I&EPA United Statee 

Environmental Protection Agency 

Washington, OC 20460 

~ Registration 

Amendment 

Other 

Application for Pesticide - Section I 

OPP Identifier Number 

~~f~s~ir 

ii, CompenyiProduct Number 

1706-"7( .L. II 

!4, Compuny/product INumol 

I 2;, ErA ~roduct Moneger - / 

i/{flbe.A- Brennls V 

PM' 

3, Proposed Clossificotion 

GJ None 0 Restricted 

TX-1G861 

-5. Name and AddrulIII of Applicont (fneludfl ZIP Codfl/ 

Nalco Chemical Company 

6. Expedited Reveiw. In accordance with FIFRA Section 31c1/3) 

Ib/lil, my p'oduct is similar ot identical in composition and labeling 

One Na to: leo Center 

Napervll Ie, IL 60563 EPA Reg. No. 1706-171 

o Check if mfs fs • n.w eddrflSs Product Name ActlPlu5 2818 

Section - " 

o Amendmenl - Expillin bolow. 

n \ Resubmission in rosponlll to Agency latter dated _______ _ 

o 

o 

[2] 

Final printed lebol. in replonu to 

Agoncy lettor dated 

·Me Too· Application. 

U }Netification - Explain below. Olher - Exploin balow. 

Explanation: Use additional page{sl if necessary. IFor SlIction I and SlIclion 11.1 

ApplicaTion for registratIon ot a new product, a stabilized sodium hypobromite solution. Product combines two 

actlve ingredients wh1=h react in situ to torm the hypobromite (sodium hypochlorite and sodium bromide). 

Section - III 

1. Material Thi. Product WlK a. P.clu,g.d in: 

Child·Resistant Peckeging Unit Pockaging Water Solubla Packeging 2. Type of Conteiner 

Ef" 8'" 8 v .. -

No No §M". Plastic 

No Glass 

• r 'jifiClltion must If ·Yos· No. par If "Yell· No. por Poper 

Unit Packoging wgt. contoiner Pack ega wgl contain., Other ISpecifyl b. j;mittsd 

I. 

3. Locetion of Net Contonte Information 4. Size{'" Retail Conleiner 5. Location of Label airections 

D W Container 

15 ga I and 50 gal Eg On Label 

Label Mini Porta-Feeds 

6. Mannflr in Which label is Affixed to Product ~ Lithogrllph D Other 

Paper r.uod 

Stenci itd 

Section - IV ~ ~ ~ . 1. Conlact Point /Compla,e i'am.s directly below for idflntmceUon of individuel to b. conlected. if necossery, to p,ocus this app£i;if,!ipn./ 

Name Claude H. Wolt, MSc. Title Corporate Toxicologist Telephone NO.llnclude AroaCodll1 

630.305.1453 ~.~~~~ 

, , 

Certification 6. Date /,pplicatidn , 

I cenify thai the stolaments I heve mede on this form and all attachments thereto ere true, accurete end complote. ~ec'efVed , ••• , > , , 

I acknowledge that eny knowfinglly felse or misleeding slelement m",y ba punlsheble by fine or impri.anment or , } fSt'i"mped) •• 

both und,!!~icoble law. >J > "." , , , •• ~ > • 

'S;g,.tU~~1- 3. TItle Corporate Toxicologist -' 

," , -

, .. , , t _.,- ed Neme (J 5. Oate '" , 

Claude H. Wol t, MSc. Aprl I 8 1999 -

-- -

81
( 

) 

448082-01 

VOLUME! 

PRODUCT CHEMISTRY 

40CFR158.190 

DATA REOUIREMENT 

Guidelines 61-1, 61-2(a) (b), 63-2, 63-3, 63-4, 63-14, 63-15, 63-16, 63-17, 63-19, 63-20, 63-21, 

7000,7100, and 7300 

TEST ARTICLE 

TX-I0861 

(Sodium hypochlorite I Sodium bromide) 

AUTHOR 

Anthony W. Dallmier, Ph.D. 

SUBMITTER 

Nalco Chemical Company 

One Nalco Center 

Naperville, IL 60563-1198 

Date: April 8, 1999 

t9/\1~ )1 0 

Volume I Page 1 of II 

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82
STATEMENT OF DATA CONFIDENTIALITY CLAIMS 

Infonnation claimed confidential on the basis of its falling within the scope ofFIFRA section 

lO(d)(I)(A)(B) or (C) has been removed to a confidential appendix and is cited by cross· 

reference number in the body of the volume. 

Sponsor/Submitter: 0JNaiCO Chemical Camp ,Y 

)!;;iPA. L 

Company Agent: ~ -' Claude H. Wolf, MSc. Date: April 8, 1999 

Corporate Toxicologist 

Volume I Page 2 of II 

83
GOOD LABORATORY PRACTICES STATEMENT 

NONE OF THE TESTS DESCRIBED HEREIN WERE CONDUCTED UNDER GLP 

PROCEDURES 

Sponsor/Submitter: 

Company Agent: 

Study Director: 

aIco Chemical C1f //L,~~ . 

uoe H. Wolf, MSc. Date: April 8, 1999 

Corporate Toxicologist 

Anthony W. Dallmier, Ph.D. 

Group Leader 

Volume I Page 3 of II 

84
( 

) 

VOLUME II 

STUDY TITLE 

ANALYTICAL METHOD FOR ENFORCEMENT 

(40CFR158.180) 

DATA REOUIREMENT 

Guideline 62-3 

TEST ARTICLE 

TX-1086J 

(Sodium Hypochlorite / Sodium Bromide) 

AUTHOR 

Anthony W. Dallmier, Ph.D. 

SUBMITTER 

Nalco Chemical Company 

One Nalco Center 

Naperville, Illinois 60563-1198 

Date: April 8, 1999 

ctr 

O\s/ ,<\ 

Volume II Page 1 of 6 

448082-02 

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85
) 

STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS 

No claim of confidentiality is made for any information contained in this study on the basis of its 

falling within the scope ofFIFRA § I O(d)(I)(A)(B), or (C). 

Sponsor: 

Company Agent: 

Nalco Chemical Company 

Claude H. Wolf, MSc. 

Co o,te Toxicologist 

/ j I.' . ,..<.-<d~p"L----

Volume II Page 2 of 6 

Date: April 8, 1999 

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86
GOOD LABORATORY PRACTICES STATEMENT 

NONE OF THE TESTS DESCRlBED HEREIN WERE CONDUCTED UNDER aLP 

PROCEDURES 

Sponsor: 

Company Agent: 

Study Director: 

NaJco Shemicai comp~~Laude iFw~;'~ Corporate Toxicologist 

Anthony W. DaIImier, Ph.D. 

Group Leader 

Date: April 8, 1999 

Date: April 8, 1999 

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Volume II Page 3 of 6 

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87
-

~Tlrtsis:an~ SUbmissiOn.·~) 

~---~---=~~~~~----~' One copy of the PPC diagnosis and one copy of the annotated bibliography are 

/ 

/ 

) 

provided for your files. The PPC has already mailed out the submitter's copies 

of the two documents. 

This is a PAR TlALL Y ACCEPTED I COMPLETELY REJECTEl sd'~;'sioil. 

A copy of the PPC dizgI10sis 2D.d the: 8T1DOt2ie-j bibliography are p:Q\-ije.c. for your 

files. A second copy ,5 provi.ceo for your 1.!....."'-e in c.orresponding \\-::.22 tee C2I2 

submitter. 

i 

L 

88
u.s. ENVIRONMENTAL PROTECTION AGENCY 

Office of Pesticide programs 

NALCO CHEMICAL CO. 

ONE NALCO CENTER 

NAPERVILLE, IL 60563 

Report of Analysis for Compliance with PR Notice 86-5 

Thank you for your transmittal of 04/16/99. 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 

89
90
I 

) 

United States E:1vironmer':JI P~otectlon Agenc'{ 

Office of PestICide Pr09rJr:".s 

Information Resources anc Services Division 

Inform.::!tion Services SrJn,;.' 

SEPA 

ADMINISTRATIVE NOeS).: , 

PM: 3;)- ------~~-----------------------------

CHEMICAL NO.: ________ _ 

The jacket for this action can be 

requested through the JACKETS system, 

91
Administrative 

Materials 

;> 

92
NEW REG~STAT~ON OR "NEW EUP 

I FAST TRACK 1< 

APPL~CAT~ON FOR NEW REG~STRAT~ON 

WITH DATA NO DATA 

In,it. Date 

FEU if -/rk -:9;7'FEU 

Fileroom/JACKETS" Fileroom/JACKETS 

SIG (DATA) PM 

Fileroom/JACKETS 

PM A(}-

REGULAR APPL~CATION FOR NEW APPL~CATION 

OR 

EXPERMENTAL USE PERMIT 

Includes new petition for Tolerance: YES or NO 

WITH DATA NO DATA 

Init. Date 

FEU FEU 

Fileroom/JACKETS Fileroom/JACKETS 

SIG (DATA) PM' ___ _ 

Fileroom/JACKETS 

PM 

0'7 :2. 

Init. Date 

Init. Date 

* Front End processing determined this application qualifies for 

fast track review based of registrants claim of lIme~too". No 

screen for substantial similarity is made by the Front End 

Processing Section. 

93
, 

~/ 

NU>IS 0'-./-1./ Z.1L().\.e..0 --,f{~I(..LJ~. 

No Data .. File Reom -Make Re3.dy 

, E~r • 

(~,N or Inc':' vidual) 

R!!j.e~ted - Fil. Room -Assign Jacket. to Rejected Shelf- . , 

I 

94
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

CLAUDE H, WOLF 

NALCO CHEMICAL CO. 

ONE NALCO CENTER 

NAPERVILLE, IL 60563 

PRODUCT NAME, TX-10861 

04/21/99 

COMPANY NAME, NALCO CHEMICAL CO. 

OPP IDENTIFICATION NUMBER: 260072 

EPA FILE SYMBOL: 1706-RIU 

EPA RECEIPT DATE, 04/16/99 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

SUBJECT: RECEIPT OF APPLICATION FOR A NEW ME-TOO REGISTRATION 

DEAR REGISTRANT: 

The Office of Pesticide Programs has received your application 

for a new 'me-too' registration and it has passed an administrative 

screen for completeness. 

During the initial screen we determined that the application 

appears to qualifiy for fast track review. The package will now be 

forwarded to the Product Manager for review to determine its 

acceptability for fast track status. 

If you have any questions, please contact Robert Brennis, 

Product Manager 32, at (703) -308-6346. 

Sincerely, 

Front End Processing Staff 

Information Services Branch 

Information Resources and Services Division 

Intemat Address (URL) • http://www.apa.gov 

RecyclocllRocyclable. Printed wHIl Vegetable 011 Based Inks on Recycled Pap(H (Minimum 25% Pos!consumer) 

95
&EPA 

Applicant', Name lind Addre55 

Nalco Chemical Company 

One Nal co Center 

Napervllle,ll 60563-1198 

Form Approved. OMB No. 207.0.0060 

United States Environmen/al PrOtection Agencv 

Washington, DC 20460 

Formulator's Exemption Statement 

140 CFR 152.85) 

EPA File SVmbol/Registration Number 

1706 - 7( :z: () 

Product Name 

TX-I0861 

Date of Confidential Stetement of Formulll {EPA Form 8570.4) 

Aprl I 8, 1999 

As an authorized representative of the applicant for registration of the product identified above, I here certify that: 

(1 I This product contains the following active ingredient(sl: 

I) Sodium hypochlorite 

2) Sodium bromide 

""'!) Of these, each active ingredient listed in paragraph (41 is present soley as the result of the use of that active 

"i~redient 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 fA) or (8) below which paragraph applies: 

G](A) An accurate Confidential Statement of Formula (EPA Form 8570~4J 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(8) The Confidential Statement of Formula (CSF) (EPA Form 8570~4J referenced above and on file with the EPA 

',s 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. 

SOUrcB 

Acti"'l1 Ingredient Product Namo Regilltrlltion Number 

Sodium bromide 

Sodium hypochlorite 

Namll and Title Claude H. Woll, MSc. Date 

Corporate Toxicologist Apri 18, 1999 

White - EPA copy 

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96

*Product ingredient source information may be entitled to confidential treatment*
Pages 97-101 *Access to FIFRA health and safety data is restricted under FIFRA section 

10(g)* 
F /1 

} 

NALCO CHEMiCAL COMPANY 

ONE NALCO Cf-.NTER r;: NAPERVILLE lLLlNOIS 60563-1 '88 (J AREA 630 305-1000 

Mr. Robert Brennis 

U.S. Environmental Protection Agency 

Antimicrobial Division (7510W) 

410 M. StreetS.W. 

Washington, D.C. 20460 

Subject: Application for Registration Nalco TX-I0861 

Dear Mr. Brennis: 

AprilS, 1999 

Nalco Chemical Company seeks to register its productTX-10861. Enclosed please find the 

following items in support of this application: 

1. Completed EPA Form 8570-1 

2. Completed EPA Form 8570-4 (in Confidential Appendix) 

3. Completed EPA form 8570-27 

4. Six copies of draft product label 

5. Volume 1- Product Chemistry Information 

6. Volume II - Analytical Method for Enforcement 

7. Confidential Appendix for Volume I (8570-4 and Manufacturing Procedure) 

NaZco Chemical Company wishes to request a waiver from acute toxicitlj data requirements (GlIidelines 81-

1 through 81-6) on the basis that the Jannulation is essentially identical to the registered product Nalco 

ActiPlus 2818 (Reg. No. 1706-171). The precautionanj statements on the label will be identical to those Jar 

Nalco ActiPlus 2818. 

Also, because of the very close similarity to 1706-171, Nalco Chemical Company believes this 

application could qualify for "expedited review" as a "me-too" product. 

If you have any questions, please feel free to contact me directly. 

.C aude H. Wolf, MSc., 

Corporate Toxicologist 

CHW/jh 

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102
~--"~""---,-'-~-'-"-"'------~~"---

103
104
Pages 105-107 *Confidential Statement of Formula may be entitled to confidential treatment* 
108