EPA Registration Jacket 73304‐1
1

Tox QuikSheete 

ProdnctName: iVld.ole· 3-B41ric; IU1J TC?0 EPA File SymboVReg. #: 73'301-1 

A.I.: i ",Mlt-3 -1:>t,;,TI11v ilt?I'd label Signal Word: \NiitrVli~ NIV11C orPCCodc 

Acute Toxicity ToxCat. pptiona,1 Information* 

'f es IS U H b h Lnca , S ourca (DaR, c.& BRAD) 

Oral Toxicity/ Pathogenicity vlJ2I1V tli' Cirolc¥ 2.4fUD 

EP (TGAIJAI Iqq5 I~~VI'I Dermal Toxicity/ Pathogenicity ~a1Vep EP (::O~ AI 

, ! 

"Inhalation! Pulmonary Toxicity , wtllV~ EP {TGW AI 

Primary Dermal Initationl IV EP fG~AI Pathogenicity 

Primary Eye Irritation! /I EP (fGAI)AI 

Pathogenicity 

Hypersensitivity elrclo One EP (fG~ AI t. ' ii 

(" h. ~ 

'-' Ttl1\1 " 

Comments: 

, . . . . . 

Today's Date: 5 Dec- 05" . 

Last Name, First Initial: DUjtJ?!:Y?'iJ . .M.. 

"',,, .. 
2

) 

; I&!J f ~ 

MATERIAL TO BE ADDED TO JACKET 

REG# 1330'1-! 

Description: 

7U~/) £J..I018ILITj' 

check all that apply 

0 new stamped accepted label (I) 

(I) 

:::! 

Q. 

0 new CSF 8' 

(") 

0 notification (ij 

(") 

Instructions: 

Attach this sheet to the top of ALL material sent to the file room (both loose paper and 

new material in jackets). This sheet will be imaged; a clear description will aid in 

finding material in the e-jacket. Remove staples from all material. If returning loose 

paper then hold together with a binder or paper clip. CSFs should be placed in the 

CSF folder (if returning jacket) or covered with a red CBI sheet (if returning loose 

paper). Material to be returned to file room should be place in the appropriate bin. 

Reviewer's 

Name: 

Phone: 

Date: 

lJffJ) 
3

NOTE TO: 

FROM: 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

Indole-3 Butyric Acid (IBA) File 

Arnet Jones, Agronomist, EFGWB 

OFFICE OF 

PESTICIDES ANOTOXIC 

SUBSTANCES 

SUBJECT: RED Eligibility 

Today a rneet'lng was held to discuss the RED for indole-3 butyric acid. 

Among the issues discussed were recent registrations for terrestrial crop uses 

for IBA. Originally EEB had indicated that no data were required because only 

greenhouse uses were registered. 

Recently, however, there were two registrations for terrestrial crop uses tor 

IBA. It is registered for broadcast application (including aerial) to several field 

crops. EEB requires four studies for these new registered uses, but the 

studies were not submitted (see copy of R. Petrie's memo which is attached). 

It is doubtful, therefore, that the RED can be produced since EEB apparently 

will require the four studies. (The RED process cannot go forward if major 

data requirements are not satisfied.) 

It was decided that the RED for IBA would be delayed pending a final 

determination from EEB as to whether these data are required. Partic·pants in 

the meeting were advised not to take any further action on their portion of the 

RED until contacted by SRRD. 

IBA has been classified as a biochemical pesticide. As a biochemical, there 

are nO environmental fate data requirements unless adverse effects to 

nontarget organisms are shown in EEB Tier I testing. Also, prior to IBA's 

classification as a biochemical pesticide, EFGWB did not object to a request 

for a low volume/minor use waiver of the environmental fate data -- hydrolysis 

(161-1), photolysis in water (161-2), aerobic soil metabolism (162-1), 

leaching/adsorption/desorption (163-1), and terrestrial field dissipation (164-1) 

-- which had been requested in the DCI of June 28, 1988. EFGWB agreed to 

the waiver of the environmental fate data provided that neither EFED/EEB nor 

HED/TOX need these data. 

@ Printed on Recycled Paper 
4

MEMO TO THE FILES: 

SUBJECT: INDOLEBUTYRIC ACID (IBA) REGISTRATION STANDARD 

DATA REQUIREMENTS FOR OUTDOOR-AGRICULTURAL USES. 

THE EEB HAS RECLASSIFIED IBA AS A BIOLOGICAL COMPOUND, 

THEREFORE, THE EEB HAS NO DATA REQUIREMENTS FOR THE INDOOR ROOTING 

COMPOUND USES OF IBA. 

BASED ON THE CROP AND TURF USES ON THE ACTIVE LABEL NO. 

9779-313, THE FOLLOWING DATA ARE REQUIRED TO BE SUBMITTED: 

1.) 154-6 AVIAN ACUTE ORAL (BOBWHITE OR MALLARD) 

2.) 154-7 AVIAN DIETARY (BOBWHITE OR MALLARD) 

3.) 154-8 FRESHWATER FISH LC50 (RAINBOW TROUT) 

4.) 154-9 FRESHWATER INVERTEBRATE LC50 (Daphnia magna) 

THE 154-10 NON-TARGET PLANT STUDY PREVIOUSLY CITED AS 

REQUIRED IN A MEMO FROM A. RISPIN TO J. ELLENBURGER (no date) IS 

NOT REQUIRED BECAUSE IBA IS A NATURALLY OCCURRING PLANT HORMONE AND 

IS APPLIED AT SUCH LOW APPLICATION RATES PER ACRE (0.00015# 

AI/ACRE). IF OFF-TARGET DRIFT WERE TO OCCUR, IT IS EXPECTED THAT 

ONLY A SLIGHT STIMULATORY GROWTH RESPONSE WOULD OCCUR TO NONTARGET PLANT SPECIES. 

RICHARD C. PETRIE, AGRONOMIST 

'~-444fl"e' 

.~/ I~j~ Co. ~--t~-' _5//3. ~/0· '11 

EEB/EFED/OPP 

CM-2, RM 815-J, 557-7358 

IIIIW ~!I~ 11M 1I1I1 111m III .... " ................ ~ 
5

Crop Booster plus 12-8-8 

with hormones 

ACTIVE INGREDIENTS •••••••••••.••••.•••• -•.••••••••• 

Gibbe~llic acid ••••••.•••.•.•••••• . D.0000625% 

Indol- -;tyric acid ..•••••••.•••••••• 6.0000625% 

INERT I REDIENTS •••••••••••••••.••••• f ........ ~ .. 

GUARANTEED ANALYSIS (Fertilizer) 

12-8-8 

Total Nitrogen (N) ••••••••••.•••••••••••••••••••••••••.•.•.••.•• 12.00% 

Urea Nitrogen •.••..••••••.••.•.••••••• 8.93% 

Ammonium orthophosphate •••.••••••.•••• 2.67% 

Ammonium thiosulfate •••••••••••••••••• 0.40% 

Available Phosphoric Acid (P205) ............................... . 

Soluble potash(K20) ••••••••••.•••••••••••••••.•••••••••••••••••• 

Chlorine-not more than ••••••.•••••••••••••..••••••••..•••••••••• 

Sulfur (S) (!=ombined) .••••.••••••••••••••.••••••••••••.••••••.•• 

Boron (B) ••••••.•.•.•••••••••••••••••••••• ' •.••••••••••• , •••••••• 

Copper (Cu) (chelated) ..•••••..••.•••••••••.•.•••••••••••••••.•• 

Iroti (Fe) (chelated) ••••••••••.••.••.••••••.•.••••••••.••.••.••• 

Manganese (Mn) (chelated) •••••••••••••••••••.••••••••.•.••..•••• 

Zinc (Zn) (chelated) ••••.•••••••••.••••••••••••••••••••••.•.•••• 

8.00% 

8.00% 

6.00% 

1.00% 

0.02% 

0.05% 

0.10% 

0.05% 

0.05% 

Derived from urea, ammonium orthophosphate, ammonium thiosulfate, 

muriate of potash, sodium borate, copper EDTA, iron HEDTA, manganese 

EDTA and zinc EDTA. 

ACCEPl'ED 

with COMMENTS 

in EPA Lrlier Dated: 

FEf3 ' i ml \..h"l~r the Fecizral ir.secticide. 

Fungicide, and RO':"nticide Act 

as amended, for the pesticide 

re~er~ider EPA Reg. No. 11, -1[3 

IF INHALED: 

IF ON SKIN: 

IF IN EYES: 

persists. 

STOP - READ LABEL BEFORE USING. 

KEEP OUT OF REACH OF CHILDREN 

CAUTION 

STATEMENT OF PRACTICAL TREATMENT 

Remove victim to fresh air and apply re~piration if indicaced. 

Remove contaminated clothing and wash with soap and water. 

Flush with plenty of water. Get medical attentioa if irr~:3~ion 

See additional PRECAUTIONARY STATEMENTS below. 

EPA Reg. No. 9779- EPA Est. No. 977~--

Manufactured For 

RIVERSIDE/TERRA CORPORATION 

Terra Centre, 600 Fourth Street, sioux City, Iowa 51101 

Riverside Serves Agriculture. Agriculture· Serves Everyone. 

NET CONTENTS 1 GAL. 

NET WT. 10.2 LBS. 
6

GENERAL INFORMATION 

Crop Booster Plus 12-8-8 is a combination of plant growth hormones and foliar 

fertilizer, formulated to stimulate seedling vigor, flower and fruit set, and to 

increase crop yields. All recommendations are for foliar (broadcast) applications unless otherwise stated. This product contains 8 oz. of formulated plant 

growth hormones per gallon. 

PREPARATION AND APPLICATION OF SPRAY SOLUTIONS 

Fill spray tank half full with clean water. Start agitation. If compatibility 

problems are suspected, add an approved compatibility agent at labeled rates. 

Shake Crop Booster plus 12-8-8 well and pour directly from the container into 

the partially filled spray tank. Add the rest of the water. Provide agitation 

during mixing and application to maintain a uniform suspension. 

..... Cro Booster Plus 12-8-8 may be applied either uipment. When 

,./ applied alone or Wl.t 0 l.ar fertilizer, use an ap non-l.onic surfactant to 

enhance the wetting and spreading characteristics of the spray solution. When 

used with other pesticides, follow the label requirements of the pesticide used. 

FIELD CROPS 

COTTON: 'For early season vigor, broadcast 2-1 qt. applications at cotyledon to 

5-leaf stage 7-14 days apart (optional). Apply 2 qts. per acre at matchhead 

square. Broadcast an additional application of 2 qts. per acre at first bloom. 

GRAIN SORGHUM (MILO): Apply 2 qts. per acre at the 2-6 leaf stage. Use additional registered hormone product as directed on the specific label. 

PEANUTS: Broadcast 2 qts. per acre at initial pegging. Use additional 

registered hormone product as directed on its label. 

RICE: Make one application of 2 qts. per acre at the 2-5 leaf stage. Add 

labelled rate of an approved hormone product. 

SOYBEANS: Apply 2 qts. per acre at first sign of bloom. Use additional 

regist'ered hormone product as directed on the specific label. 

VEGETABLE CROPS 

BEANS (Green. Lima, Pinto. Blackeye, Mung): Broadcast 2 qts. per acre &L Zirst 

bloom. Use additional registered hormone and follow the labeL :r~411iremer.Ll:i of 

the hormone used. 

BROCCOLI, CABBAGE, CAULIFLOWER, BRUSSELS SPROUTS: Spray 1 qt. ~er'acre a~.2 

weeks post-transplant or at 4-5 leaf stage. Follow with a second ,applic,oqun of 

1 qt. 2 weeks later. Use additional registered hormone product as direcr,ed on 

its label. 

CUCUMBERS. SQUASH: Apply 1 1/2 qts. per acre at the 2-4 leaf stage. Fc:!ow 

with an application of 1 1/2 qts. at early bloom. Repeat applications uf :'qt. 

per acre at 7-21 day intervals. 
7

I 

LETTUCE. SPINACH, TURNIL, MUSTARD GREENS: Make an over-Lne-top application of 1 

qt. per acre at the 2-5 leaf stage. For spinach and greens, apply 1 qt. per 

acre after each cutting. Use additional registered hormone product as directed 

on the specific label. 

MELONS (Cantaloupes, Honeydews, 

first sign of running and again 

mone product as directed on the 

Watermelons): 

2 weeks later. 

specific label. 

Apply 1 1/2 qts. per acre at 

Use additional registered horPEPPERS: Apply 1 qt. per acre 2 weeks after transplanting. Follow with a 1 qt. 

application at early bloom. Continue treatments of 1/2 to 1 qt. per acre every 

7-21 days. Use additional registered hormone product as directed on the specific label. 

TOMATOES: 

If machine-harvested: Apply 2 qts. per acre at early bloom. Use additional 

registered hormone product as directed on the specific label. 

If hand-picked: Apply 1 qt. 

qt. per acre 3 weeks later. 

per acre 3 weeks after transplant; follow with I 

Spray 1/2 qt. per acre every 7-21 days. 

SOD, LAWNS, TURF AND ORNAMENTALS 

SHRUBS (Established): Apply 1/2 qt. in 2 gallons of water two to three times 

per year. Spray to point of run-off. 

TURF (Immediately after laying): Apply I qt. per 5,000 square feet and water 

in. Thirty days later, make a second application of I qt. per 5,000 square feet 

and water in. 

SOD: During initial sad production (4-6 weeks prior to harvest), apply 2 

qts/acre. Add additional registered hormone product as directed on the specific label. For growth enhancement after harvest, apply 2 qts/acre. Repeat 

application 6 weeks later. 

LAWNS (Established): Apply 1 pint per 5,000 square feet. 

NOTICE~ Seller warrants that the product conforms to its chemical description 

and is reasonably fit for the purposes stated on the label when used in accordance with directions under normal conditions of use, but neither this warranty 

nor any other warranty of merchantability or fitness for a particular rurpose, 

express or implied, extends to the use of this product contrary to label 

instructions, or under abnormal conditions, or under conditio~~ ti0~ rea~~nJbly 

foreseeable to Seller and Buyer assumes the risk of any such use. 
8

PRECAUTIONARY STATEMENTS 

CAUTION 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

Avoid contact with skin, eyes, or clothing. Wash hands thoroughly after 

handling. Wash all clothing with soap and water before reuse. 

ENVIRONMENTAL HAZARDS 

Do not apply directly to water. Do not apply when weather conditions favor 

drift from treated areas. Do not apply where runoff is likely to occur. Do not 

contaminate water when disposing of equipment washwaters. 

DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in a manner inconsistent 

with its labeling. 

Do not apply this product through any type of irrigation system. 

RE-ENTRY STATEMENT 

Do not enter treated areas without protective clothing until sprays have dried. 

Because certain states may require more restrictive re-entry intervals for 

various crops treated with this product, consult your State Department of 

Agriculture for further information. 

VSTORAGE AND DISPOSAL 

DO NOT CONTAMINATE WATER, FOOD, OR FEED BY STORAGE OR DISPOSAL. 

v'STORAGE 

Do not store below 40°F. Store out of direct sunlight. Handle in accordance 

with information given under PRECAUTIONARY STATEMENTS. In the event of spillage 

or leakage, soak up material with absorbent clay, sand, sawdust, or other absorbent material. Scrape up and dispose of in accordance with information given 

under DISPOSAL. Repackage and relabel useable product in a sound container. In 

case of fire or other emergency, report at once by toll-free telephone to 

800-424-9300. 

/ 

~ESTICIDE DISPOSAL: Wastes resulting from the use of this product may be disposed of on site or at an approved waste disposal facility. 

LI~ONTAINER DISPOSAL: For one gallon plastic containers-or larger, triple rinse 

(or equivalent). Then offer for recycling or reconditioning, ry~ punctu~~ and 

dispose of in a sanitary landfill, or incineration, or, if allo~ec by state and 

local authorities, by burning. If burned, stay out of smoke. For con~aicers 

less than one gallon, wrap in newspaper after emptying and dispose in h~~5ehold. 

trash. 
9

SYMBOL .... 

SURNAME .... 

DATE .... 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

N. Bhushan Mandava, Ph.D. 

for Reactimex S.A. de C.V. 

Mandava Associates 

1730 M St., NW, Suite 906 

Washington, DC 20036-4510 

JUL 2 6 2005 

J'll+t&! 8'!5 

uw 

CONTAINS CONFIDENTIAL BUSINESS INFORMATION 

RE: Updated Label and CSF submission 

Indole-3-Butyric Acid 

EPA Reg. No. 73304-1 

Dear Dr. Mandava: 

The amendment referred to above, submitted in connection with registration under 

FIFRA section 3(c)(5), is unacceptable. The deficiencies are as follows: 

(1) Confidential Statement of Fonnula rcSF): 

The proposed eSF, dated 7 Mar 2006 differs substanitially from the previously approved 

CSF dated 7 May 1993. Bulk density for the active ingredient is reported as .25gm1ml on 

the 1993 CSF, with a pH level of "Not Applicable". The 2006 CSF lists those ingredient 

characteristics as .508 gmlml and 4.0-4.1 pH, respectively. 

While the Certificate of Analysis indicates the product is the same chemical, BPPD has 

concluded that the updated active ingredient is significantly different from the previous 

one and the requirements of 40 CPR § 158.162 Description of Production Process, as 

well as 40 CFR § 158.690 Physical! Chemical Characteristics must be submitted on the 

new fonnulation. 

(2) Label Review: 

Our records indicate that toxicology data testing was waived, and conditionally required 

the product label to specify its intended use for fonnulation of plant rooting preparations 

only. You must revise your label to state its use limitations, or submit the previously 

waived toxicity data to support broadcast use of the product. 

Your application will be kept active for a period of75 days to give you an opportunity to 

correct the listed deficiencies. If you find that you need more time to complete the requirements, 

you should request an extension and commit yourself to satisfy the deficiencies within a 

reasonable stated period of time. If this procedure is not followed, the Agency may 

admInIstratively WIthdraw your apphcahon~~ conslaerafion ana rehre HilS file wlffiout 

I turther notic . :.0 rl'r.il.}.a.c. ora~£eJ2im me policy est .bllshoo by P Notice 75-4 of August 2 ..................... ····r'~i.y .. ..................... ..................... .. ................... ..................... . ..................... 

. .. ~~ . ..................... ···,jM1~i··· ..................... ..................... ..................... ..................... . ..................... 

? 2.-~ /0<. 

EPA Form 1320-1A (1/90) Printed on Recycled Paplff OFFICIAL FILE COPY 
10

1975. After that) you will have to submit a complete new application should you wish to pursue 

the amendment to the registration of your product after the application has been withdrawn. 

Please contact Mari Duggard, (703-308-0028; duggard.mari@epa.gov) with any questions you 

may have regarding this action. 

Sincerely, 

cn"~tl() . I} She;-K.Lteilly,! :;;;}hief 

Biochemical Pesticides Branch 

Biopesticides and Pollution 

Prevention Division (7511P) 
11

Plaue reed (MtN - M on ,..,.,.a hero ~m ~ ,"m>, Form Approved. OMB No_ 2070.()()8( mir .. 2-28-95 

United States ~ Registration OPP Identifier Number 

&EPA Environmental Protection Agency Amendment 

Wa9hington. DC 20460 Other 

Application for Pesticide - Section I 

I. CompanyfProduct Number 2. EPA Produot Manoger 3. ProPesed Clessification 

73304-1 Sheryl Reily, Chief 0 Nono o Rastricted 

4. CompanylProduct INemo) PM. 

Reoar Weed and Feed Biochemicals Peslicides Branch 

5. Name and Address of Applicant (lncludoZ/P Codo{ 6. Expedited Reveiw. In accordance with FIFRA Section 3{c){3) 

Reactimex S.A DE C.V. (bJlil, my product is similar or identical in composition and labeling 

to: , 

c/o MandavaAssociates, 1730 M Street, NW, # 906 

EPA Reg. No. Washington, D,C, 20036 D Chock ff this is s nsw oddross Product Name 

Section - II 

El Amendment - Explain below. U Finel printed labals in repsonso to 

Agoncy latter doted 

0 Resubmission in responso to Agancy lettor detod D "Me Too" Application. 

LJ Notilicotion - Explain below. D Other - Explain bolow. 

Explanation: Use additionol pego(s) if nocossary. IFor soction I and Soction 11.1 

Update CSF and amend label. 

Section - III 

1. Material Thi. Product W~I Be Packaged In: 

Child-Re~jstant PackeQing Unit Packaging Wator Solublo Peckaging 2. Type of Contoiner 

Bv"' Er" El V., 

N. N. N. ~M'''' Plastic 

Glass 

'isrtification mUgt If "Yes" No. por If "Yes" No. per Papor 

Unit Packaging wgt. conteiner Packege wgt containor Othar (Specify) &I~/ guhmitttJd I 

3. location of Net Contenta Informetion 4. Sines) Retail Container 5. location of labol Oiroctions 

L label U Container l::::::l 

6. Mannar in Which labal is Affixed to Product U lithogroph 0 Othor 

Paper PeIUOd 

Stonci 8d 

Section - IV , " " , j , " j 

1. Contect Point {Camploto ilof1l$ diroct/y below for idontiffcatfon of individual to bo centtlcted, if nOco$stlry, to proCf}$$ this BpjJ(ic'JtfiJjI.J 

"' " Name Titlo J,~eD,hona No. Itnclude Aree Code) , Maclhu Mandava Agent for Reactimex SA de C.V. , (20~) 223-1124 > , " 

Certification > , , » ) , , 6~ Oete Applicetion 

I certify that tha stataments I heve modo on thi$ form and all Qttechments thereto Qro true, eccureto ond cjo~pJe}e. " ) Rob~'l&d ) ) j j 

I Mknowlodga thot any knowlinglly falsa or misleading statemant may ba punishablo by fine or imprisot\ll1ont;or , _(Stamped) both undar applicable low. ' , " , , ., ~ ).' 

3. TItle , 2. Signature ' j , ) 

17 IJll~t£---- Agenlfor Reacllmex SA de C.V. ),' , , , , J ' " 

4. Typed Name 5. Date 

Madhu Mandava March 7, 2006 

, , " EPA Form e570 , " , IRov. 3 94) ProV'lous edItions are obsolote. 
12

MANDAVA ASSOCIATES 

CONSULTANTS IN SCIENCE. TECHNOLOGY AND REGULATORY AFFAIRS 

1730 M STREET, N. W., SUITE 906, WASHINGTON, IX 20036-4510 

Telephone: (202)-223-142411147 . Fax: (202)-223-0141 . E-MAIL: Mfl1U'bwa@tOmpuKen>e.com 

Hand Delivered 

Dr. Sheryl ReillY, Chief 

Biochemical Pesticides Branch 

Biopesticides and Pollution Prevention Division 

Office of Pesticide Programs (7504C) 

U.S. Environmental Protection Agency 

c/o Document Processing Desk (AMEND) 

1801 South Bell Street 

Crystal Man 2, Room 266A 

Arlington, V A 22202 

Subject: REACTIMEX S.A. DE C.V. 

March 8, 2006 

Indole-3-Butyric Acid, EPA Registration No. 73304-1 

Dear Dr. Reilly: 

On behalf ofREACTIMEX S.A. DE C. V., we are submitting an updated CSF (2 copies) 

and draft amended labels (5 copies) for Indole-3-Butyric Acid, EPA Registration No. 73304-1, 

as per Barbara Mandula's request. 

Please note that we are providing a Certificate of Analysis for the basis of updating the 

CSF, since the registrant does not possess the data that was transferred to them at the time of 

the registration and data rights transfer approval. 

If you should have any questions, please contact us at (202) 223-1747 or by E-Mail at 

Mandava@Compuserve.com. 

Enclosures 

NBM/mm 

cc: David Fernandez 

Sincerely, 

N ' ~t-..- Mb~~~", , 

" " 

N. Bhushan Ma~d,,:'" Ph. D. ' 

Agent for Reacthnex 'S.A. 'Ce CN. , " , " , 
Page 13-*FIFRA registration data may be entitled to confidential treatment*
Pages 14-15-*Confidential Statement of Formula may be entitled to con
16

INDOLE-3-BUTYRIC ACID TECHNICAL 

Plant Growth Regulator for Formulation Use Only 

ACTIVE INGREDIENT: 

Indole-3-Butyric Acid 

OTHER INGREDIENTS : 

TOTAL : 

KEEP OUT OF REACH OF CHILDREN 

9~, 3,%, 

, 1: 7,% 

100:0% , 

WARNING 

See [Side] [Back] Panel For Additional Precautions 

FIRST AID 

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. 

IF ON SKIN OR CLOTHING: • Take off contaminated 

clothing. 

• Rinse skin immediately with 

plenty of water for 15 to 

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 an ambulance, 

then give artificial 

respiration, preferably by 

mouth-to-mouth, if possible. 

") , 

") ) 

• Call a poison control center 

or doctor for further 

treatment advice. 
17

IF SWALLOWED: • Call a poison control center 

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. 

EMERGENCY TELEPHONE NUMBERS: Have the product container or 

label with you when calling a poison control center or 

doctor, or going for treatment. You may also contact: 

• (800) 424-9300 CHEMTREC (transportation and spills) 

• (800 ) 832-HELP (4357) (human health) 

• (800) 345-4735 ASPCA (animal health) 

EPA Reg. No. 73304 1 

NET CONTENTS: 1 KG 

EPA Est. No. 73304-MEX 001 

Manufactured For; 

REACTIMEX, S.A. DE C.V. 

Av. Industrias l200~C pte. 

Bellavista, Monterrey N.L. Mexico 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS AND DOMESTIC ANIMALS 

WARNING 

or 

Causes substantial but temporary eye injury. Do not get in eyes, on 

skin or on clothing. Wear goggles, face shield or safety glasses. 

Avoid inhalation of dust. Wash thoroughly with soap and water after 

handling and; before drinking. Remove contaminated clothing and 

wash clothing before reuse. Read and understand the Material Safety 

Data Sheet for additional information before working with this 

product. 

ENVIRONMENTAL HAZARDS 

Do not discharge effluent containing this active ingredient into 

lakes, streams, ponds, estuaries, oceans, or public waters unless 

this product is specifically identified and addressed in an NPDES 

permit. Do not discharge effluent containing this product to systems 

wi thout previously notifying the sewage treatment plant authori ty. 

For guidance contact your State Water Board or Regional Office of 

the EPA. 
18

DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in a manner 

inconsistent with its labeling. 

This chemical may be used only for the formulation of products 

containing indole-3-butyric acid intended for: 

(1) The Following Use(s) 

Terrestrial, Food Uses On: Barley (cereal grain), Beans 

(blackeyed peas, southern peas, dry, lima, navy, & snap), Broccoli, 

Brussels Sprouts, Cabbage, Cauliflower, Citrus Fruits, Cotton, Corn 

(field, sweet) (cereal grain), Cucumbers, Lettuce, Melons, Mustard 

Cabbage (pakshoi), Mustard (leafy/stem crop), Oats (cereal grain), 

Onion, Onion (green), Peanuts, Peas, Peppers, Potatoes 

(white/irish), Rice, Rye (cereal grain), Sorghum, Soybeans, Spinach, 

Squash (summer/winter/zucchini), strawberries, Sugar Beets {sugar 

crop), Sugarcane (sugar crop), Tomatoes, Turnips, Wheat (cereal 

grain) 

Terrestrial, Non-Food Uses On: Ornamental Herbaceous Plants, ~o2r~n~am=e~n~t~a~1c=-tw~o~O~d~Y~~S~h2r2Cub""s::-'~a~n~di-'v~i~n~e;;;'s, Ornamental and/ or Shade Trees, 

Golf Course Turf (greens, tees, fairways & rough), Ornamental Lawns 

& Turf 

(2) Uses for which the U. S. EPA has accepted 

and lor citations of data that the formulator 

support of registration; 

and 

the required da ta 

has submitted in 

(3) Uses for experimental purposes that are in compliance with u.S. 

EPA requirements. 

Formulators are responsible for obtaining EPA registrations for 

their formulated products. 

STORAGE AND D~SPOSAL 

Do not contaminate water, food or feed by storage or disposal. 

PESTICIDE STORAGE: Store product in original container away 

from other pesticides, fertilizers and feedstuffs. 

PESTICIDE DISPOSAL: Wastes resulting from use of this product may 

be disposed of on site or at an approved waste disposal facility. 

CONTAINER DISPOSAL: Completely empty liner by shaking and tapping 

sides and bottom to loosen clinging particles. Then dispose of 

liner in a sanitary landfill or by incineration if allowed by 

state and local authorities. If drum is contaminated and cannot be 

reused, dispose of in same manner. 
19

CONDITIONS OF SALE AND LIMITED WARRANTY: 

The Directions For Use of this product reflects the opinion of experts based on field use and 

tests. The directions are believed to be reliable and should be followed carefully. However, it 

is impossible to eliminate all risks inherently associated with use of this product. Crop injury, 

ineffectiveness or other unintended consequences may result because of such factors as 

weather conditions, presence of other materials, or use of the product in a manner 

inconsistent with its labeling, all of which are beyond the control of REACTIMEX, S.A. DE 

C.V. (REACTIMEX) or the SELLER. All such risks shall be assumed by the Buyer. 

REACTIMEX warrants that this product conforms to the chemical description on the label 

and is reasonably fit for the purposes referred to in the Directions For Use, subject to the 

inherent risks, referred to above. 

REACTIMEX MAKES NO OTHER EXPRESS OR IMPLIED WARRANTY OF FITNESS OR 

MERCHANTABILITY OR ANY OTHER EXPRESS OR IMPLIED WARRANTY. TO THE 

EXTENT PERMITIED BY LAW, REACTIMEX AND THE SELLER DISCLAIM ANY 

LIABILITY FOR CONSEQUENTIAL, SPECIAL OR INDIRECT DAMAGES RESULTING 

FROM THE USE OR HANDLING OF THIS PRODUCT. REACTIMEX and the SELLER offer 

this product, and the Buyer and User accept it, subject to the foregoing Conditions of Sale 

and Warranty which may be varied only by agreement in writing signed by a duly authorized 

representative of REACTIMEX. 
Pages 20-21-*Confidential Statement of Formula may be entitled to con
22

U.S, ENVIRONMENTAL PROTECTION AGENCY 

Office of Pesticide Programs 

Biopeslicides and Pollution Prevenlion Division (751 IC) 

1200 Pennsylvania Avenue NW 

Washington, DC 20460 

NOTICE OF PESTICIDE: 

_ Registration 

l Reregistration 

(under FIFRA, as amended) 

Name and Address ofRegistrantlinclude ZIP Code): 

Reactimex, S.A. De C.V. 

clo Mandava Associates 

1730 M. Street, N.W. 

Suite 906 

Washington, D.C. 20036-4510 

EPA Reg, NUJt1b.cr. Date oftssu:mce: 

73304-1 06/24/05 

Tenn oftssuance: Unconditional 

Indole 3 BUlyric Acid 

from that accepted in connection with this registration must be submitted to and accepJed by thc 

Division prior to use of the label in cornrnerce, In any correspondence on this product always referJo the 

On the basis ofinforrnation furnished by the registrant, the above named pesticide is hereby registered/reregistered under the Federal Insecticide, 

Fungicide and Rodenticide Act. 

Registration is in no way to be construed as an endorsement or recommendation of this product by the Agency. In order to protect health and the 

environment, the Administrator, on his motion. may at any time suspend or cancel the registration ofa pesticide in accordance with the Act. The 

acceptance of any name in connection with the registration ofa product under this Aet is not to be construed as giving the registrant a right to 

exclusive use of the name or to its use if it has been covered by others. 

Based on the Reregistration Eligibility Document (RED), EPA has reregistered the product listed 

above. The last accepted label dated 05/1311993 meets the requirements RED. This action is taken 

under the authority of section 4(g)(2)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act, 

as amended. Reregistration under this section does not eliminate the need for continual 

reassessment of pesticides. EPA may require submission of data at any time to maintain 

registration of your product. 

Signature of Approving Officiat: Date: 
23

• 

lei SYNTEXi 

NET 1 KILOGRAM· 

(2.2 LB.) 

INDOLE - 3 - BUTYRIC ACID 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

ACTIVE INGAEDIENT, 

Indo)a·3-ElutylicAcid. 

INERT INGREDIENTS. 

. .......... min.97% 

. ........... max,3% 

CPA Rop No <W7~1 EPA E>' No' 4247:\.'-1)( I 

KEEP OUT OFREACH OF CHILDAEH 

PRECAUTIONARV STATEMENTS 

H"'ZAHDS TO IiUMANS 

"-NO DOMESTIC "-NIMA~S 

VJARNING 

c."s"," su!»!",,".1 bu, "'mpoloty eyo ;ni"<Y. Do ,,,Of 

gel iII.yos, on ,~it) Of on etolhing. We.fqOjlgl ••. I."" 

<I\;ald .f ..,Iory glou",_ "',oEd WI'''Ii,," 01 d"". 

W.sh Ih.f.Ughty ""'h '".p .np w.'.r .11., h<md~ng 

,nd !>.)I.f ••• ""11 Of .'''Iong. Romo"o Con'.ml""od 

c",'hlng belu,g mu, •. A •• d .nd UMO"",,"P Ih. 

M.,.,iol Salely 0 ... SIlo.' I.f .dd,tion.1 inl.,ma"gn 

ootOf. working ""'h Ih;, P'Od",,!. 

STATEMENT OF 

PRACTICAL TREATMENT 

lI;n oyco: Hold 0)<>1000 ope" aM lru,h WIIh • " •• dy. 

gon'", w •• m.' IV.'" lor IS m'nul'~. Ge' moole.' 

.~onl'.n. II.w.ll."..,o: Drin~ !'fOm~Uy .'.'go quO')_ 

1ity 01 m;I),_ 09U wlI'lo. 01 goloun •• Iu''''n. or II ,ho.o 

.,. no' .vOlIoblo. 100g~ qua,,,,,,,. 01 w.'", A,,>d 

a!cOO,", G" mo<J>C.Ol .Mnlion. 

ENVIROIiMENT IiAZARDS 

D. "'" m,eha'l.le ;nlo Iol<a •• ", •• m •• pooos 0' publ;,: 

".10" unle ...... ceo'd""'" -.;th .nN~OES po,mi', 

Fo' guloon"" eonlilC! yo", ,og;""ol .1I,e. 01 'he I.'P A. 

DIRECTIONS FOR USE 

,,;. a ,".Ioloon 01 Fod.,a"." to u,,"!hi> ~ro<Iuct;n. 

mOnnor ;<>="'''''''' ,,<ttl I .. 1.I>o~nu 

This eh""'~ m'7 1>0 uoo<l .nl)' I", th<> lo,mulalion 01 

• pl.nt ,ooUng P"F"".U"". FOffnul.,oro uoinu Wo 

p,od<Jct "0 "',pon""ol,,, 00,.",1"11 EPA ,.-g;,u.tlO" 

10, Ihoi' lo,mul.,oo P,od"ct •. 

r------'-

STORAGE AND DISPOSAL 

STOIlAGE: Sto,. P'O<ioJd;'" 00il1fW "",taJM' ""I)'. 

.w.y I,om olhor F><"icid8 •• '0<;;,,.,. 1<>0<1" I .. d, 

OIS~OSA~' Do no' "",,'.mln". W."". 1<>0<1 ., lo.d 

by ,!Q'''BO .rdl.po'.1. W.$!" '.,u~lng Imm IhO u'o 

01 ,h;, pioduct m.y b. o"po,od 01 on .~o 0' .1 on 

.~p,",od wa$lO di.po •• llaOl;Iy. 

C.mp"'oly om p'y ~ne' ~ .ha',n 9 .nd la ~pin 9 SKI •• 

.nd oottom '0 I"",.n 0I"'9'09 ~."'elo •. Empty ,,,,,i· 

dU. ,n,o man"'.e'"'i"ll "'l"ipmonl. 0"'1""0 ,".ny 

".,t. ,.,"'uo •• , .~p,.pria'uly """"inod w."o 

O .. posollae",tio •• ='~'<\jj ,. EPA ,~ul.'",n •• 1 040 

C,F.R. 2iiiU., O"G, Thon d[opo.o 01 ~n",;n 0 •• n".'Y 

laMhll <II oy ;"ein.,.ti"" 0 .11o"ed oy ,,,,, •• nd local 

II d,um ;, con'omloo.,<1 .... p "",",0' bo ,.u,oo. d"~O$& 01 in II,. ,am. m.nn.,. 

SYNTEX, S,A. de C.V. DIVISION QUIMICA 

• 0 .. 

o 

APARTADQ POSTAL 517, CUERNAVACA, MOR. MEXICO " v ~ 

" 0 

o " •• .0 

. .. " . ·.0 . 

• 

• ~. o. 

, 

••• 0. 0 

• • 

•••••• 

• • .. • ••••• 

• • •• •• 
24

Note to File: 

73304-1 

Our letter of3/24/95 indicates that for this fonnulating use product, the 4 ecological 

effects studies referenced in the 8/92 RED remain outstanding. This is inconsistent with 

the findings ofthe 5/21190 EFED review done by Zig Vaituzis. That review carefully 

states that root cutting uses qualifY for the data waiver. but broadcast turf applications do 

not. The label clearly states that this product is for the formulation of a plant rooting 

preparation. 

The label submitted 5/13/93 has the updated eye irritation wording (tox. II). 

This product has therefore completed the requirements for reregistration. 

fbl0vfs 

Phil Hutton 
25

) 

) 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

January 12, 2001 

Dr. Bhushan Mandava 

Mandave Associates, Agent for 

Reactimex, S.D. De C.V. 

1730 M Street, N.W., Suite 906 

Washington, DC 20036-4510 

Dear Dr. Mandava: 

CHICEQF 

PREVENTK;:t4, PEST(;IDES AND 

TOXiC SWSTANCES 

Subject: Transfer of Pesticide Registration and Data From 

Company Number 42473 to Company Number 73304 

Pursuant to your request in your letter and transfer 

agreement of November 27, 2000, we have approved the transfer of 

the following registration and data from Syntexr S.A. De C.V. 

Division Quimica, company number 42473, to Reactimexr S.D. De 

C.V., company number 73304. 

The effective date of these changes is the date of this 

letter. 

Registered Products 

Indole-3-Butyric Acid 

Old EPA 

Reg. No. 

42473-1 

New EPA 

Reg. No. 

73304-1 

You should indicate the new company designation, new EPA 

Registration Number and new Establishment Number (if it has 

changed) on the labeling at the next printing which should occur 

no later than 18 months after the effective date of this 

transfer. After 18 months, any product released for shipment 

must bear the new Registration Number and Establishment Number. 

If you intend to use the labels which currently appear on the 

transferor's product after the effective date of the transfer, 

but within the 18 month grace period, you must maintain complete 

and accurate records which identify by batch number, lot number, 

or other suitable description the quantities of such produc~ 

bearing the transferor's label. Each container or package 

bearing the transferor's label which is released after the 

effec~ive date of product registration transfer, must be clearly 

and accurately marked with the batch number, lot number or other 

descriptive designation used to identify the product in your 

records. 

Supplemental distribution agreements of registered products 
26

) 

) 

2 

do not transfer with the Section 3 registration. It is your 

responsibility as the registrant to notify any and all 

supplemental distributors of the transferred product{s) of this 

transfer agreement. If you wish to enter into supplemental 

distribution agreements of your product(s) under this new 

registration, the form UNotice of Supplemental Distribution of a 

Registered Pesticide Product, If EPA Form 8570-5, must be submitted 

to the Agency for each supplemental distributorship. 

You are required to contact your local EPA Regional Office 

to determine what effect this transfer of pesticide registrations 

has on the pesticide production establishment registration. 

It will not be necessary to submit labeling for review if 

the only changes are in the company designation and the EPA 

Registration Number. Other changes in the product and/or 

labeling may require EPA review and approval prior to initiation. 

In any correspondence on these products always refer to the U.S. 

EPA Registration Number listed above. 

The transferred registration will have the same status under 

the Federal Insecticide, Fungicide and Rodenticide Act, as 

amended, 7 USC 136 et seq., as it had prior to the approval of 

this transfer. 

When registrations are transferred from one company to a 

second company, all restrictions, data requirements, conditions 

{suspensions}, and deadlines existing on the registrations are 

transferred with the registrations. The new company is 

responsible for adhering to or complying with all such 

restrictions, etc. on the acquired products. 

In regard to deadlines, the transferee company is 

responsible for submitting all required data according to the 

schedules already established for the acquired products. Failure 

to do so will result in the issuance of a Notice of Intent to 

Suspend. Requests from transferee companies for additional time 

to submit, because they acquired the registration(s} after the 

3 (c) (2) (B) request was issued will not be granted. If a 

transferee company has other valid reasons for delays in the 

testing which were clearly outside of their control, then such 

requests for time extensions will be considered in accordance 

with the established procedures. Transfers occurring while a 

3 (c) (2) (B) request is being issued or during the 90-day response 

time are subject to the same conditions expressed above. 

Registration is in no way to be construed as an endorsement 

or approval of these products by the Agency. In order to protect 

health and the environment, the Administrator, on his motion, may 

at any time suspend or cancel the registration of a pesticide in 

accordance with FIFRA. 
27

3 

Furthermore, the transfer of the subject registrations is 

approved under the condition that the annual maintenance fee 

obligation has been fully satisfied. The marginal maintenance 

fee is determined based solely on the total number of active 

section 3 and section 24(c) registrations held by the transferor. 

If the annual maintenance fee has not been fully satisfied, the 

transferee and transferor will be notified to comply within a 

specified time period or the affected registrations may be 

canceled. 

The Agency acknowledges it has received a request for data 

transfer dated November 271 2000 to transfer data ownership from 

the transferor to the transferee. The data transfer is effective 

the date of this letter. After this date Reactimex, S.A.de C.V. 

will be considered the data owner. This action will not 

automatically reflect on the Data Submitters List. If you want 

\ to be added to the Data Submitters List, you must submit a 

request to: 

Document Processing Desk (DSL) 

Office of Pesticide Programs (7504C) 

U.S. Environmental Protection Agency 

Ariel Rios Building 

1200 Pennsylvania Avenue, NW 

Washington, DC 20460 

By copy of 

these changes. 

approval please 

this letter we are 'informing the transferor of 

If you have any questions about this transfer 

contact me at (703) 305-6474. 

~f1~:.1d jJ~~,- Donna G. Parker 

Information Management Specialist 

Information Services Branch 

Information Resources & Services Div. (7504C) 

cc: Ms. Debby Halliday 

D. Halliday & Co., Inc., Agent for 

Syntex, S.A. De C.V.Division Quimica 

3803 Luneta Lane 

Fallbrook, CA 92028 
28

) 

J 

1El~©[i!I®@~~©~@]®@ @Ilil@] 

!FI©OO\Yl~a©1lil 

!FI1i'@W®llilfrO©1lil 

[Q)OWO@O@1lil 

NUMBER OF PAGES: 2 

TO: Name: Stacy Grigsby 

Address: FODIOPP 

FROM: 

MESSAGE: 

CM2 Room 1116 

Crystal City, VA 

Phone: (703) 305-7410 FAX Phone: (703)-305-5884 

Name: Shanaz Bacchus, Chemist 

US Environmental Protection Agency . . 

Office of Pesticide Programs 

Biopesticides & Pollution Prevention Division (7501W) 

401 M St, S.W., Washington, D.C. 20460 

Phone: (703) 308-8097 (FAX 703-308-7026) 

Email: Bacchus.shanaz@epamail.epa.gov 

Attached is a copy of the registered label on file for EPA Reg. If 

you have any further questiQns, do not hesitate to call. 
29

, 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON. D.C. 20460 

Ms. Deborah Halliday 

Halliday and company 

3803 Luneta Lane 

Fallbrook, CA 92028 

MAR 24 1995 

OFFICE OF PREVENTION, 

PESTICIDES AND TOXIC 

SUBSTANCES 

) Dear Ms. Halliday: 

SUBJECT: syntex Corporation 

Indole-3-Butyric Acid 

EPA Reg. No: 42473-1 

Submission Dated February 14, 1995 

We have completed review of the additional data for the eye 

irritation study submitted by you to support the reregistration 

of the subject product. 

1. The eye irritation study is now acceptable as Core 

Guideline data and based on these data Toxicity category II for 

eye irritation has been assigned to this product. The acute 

toxicity profile for this product is as follows: 

Acute oral toxicity 

Acute dermal toxicity 

Acute inhalation toxicity 

Primary eye irritation 

Primary dermal irritation 

Dermal sensitization 

waived 

waived 

waived 

II guideline 

IV guideline 

waived 

2. The last accepted label dated 10/24/90 that we have on 

file has, signal word "Caution" and general precautionary 

statements for toxicity category III and IV. Please submit 

revised labeling with signal word "Warning", and precautionary 

statements and statement of practical treatment for toxicity 

category II for eye irritation. 

3. Although the product specific data requirements are 

fully addressed now, you have failed to address the generic data 

requirements. As we infqrmed you in our letter dated Nov. 18, 

1993, your product is a technical grade pure 'form active 

ingredient used for manufacturing purposes only, and you do not 

qualify for formulators exemption, you must address the generic 
30

data requirements. As indicated in Attachment C of the 

Reregistration Eligibility Document, four basic ecotoxicity 

studies (Guideline Numbers 154B-6 thru -9) are being required as 

confirmatory data for this chemical. 

Please respond within 30 days from the date of this letter 

addressing the deficincies listed above. Questions regarding 

this letter should be directed to the Regulatory Action Leader, 

Rita Kumar at (703) 308-8709. 

Sincerely, 

j{o;c--~ 0 ...... -' Janet L. Andersen oOY Acting Director 

Biopesticides and Pollution 

Prevention Division (7501W) 
31

I D. HALLIDAY & CO. 

April 7, 1995 

Ms. Rita Kumar 

Environmental Protection Agency 

Biopesticides and Pollution Prevention Division (750 I W) 

Document Processing Desk (7502C) 

Crystal Mall #2 

Inl Jefferson Davis Highway 

Arlington, VA 22202 

Ref: Indole· 3-butyric Acid 

Dear Rita: 

\ 

3803 Luneta Lane Fallbrook, CA 92028 

619/728·2893 FAX 619(723·8590 

As we discussed on the phone today, I am enclosing our letter of December 7, 1992, to 

Ruby Whiters concerning the Ecotoxicity testing requirements for IBA and my notes on 

her telephoned response. I am also enclosing the letter from the EPA waiving the Eco 

tests for nursery uses of IBA and the current label in lise for this product. 

I believe my previous letter adequately explains our position on additional eco-testing. 

Please let me know if you have any questions. 

Thank you for your consideration of this matter. 

Cordially, 

&l{v;IDzmAr-.-'\f/~~7<f Deborah Hallidav 
32

OPTIONAL FORM 99 (7-00) 

FAX TRANSMITTAL JH of p1I!)es'" I 

lei SYNTEXI 

'.om :Sr.""", "", &C ",Ls 

'" .. ··703~30g-go'f7 

GENERAL SERVICES ADMINISTRATION 

NET 1 KILOGRAM· 

(2.2 LB.) 

INDOLE - 3 - BUTYRIC ACID 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

"CTIVE INGREDIENT: 

Indolc-3.8u1yr1c Acid. ... mln.97% 

INERTINGREOIENTS ... . ....... mn •. 3% 

KEEP OUTOFREACH OFCHILDREN 

PR~CAUnONART STATEM£NTS 

IlAZAROS TO NUMANS 

ANO OOM~$TIC ANIMALS 

WARNING Ca· .... s "ub,lanu.1 bu, ',",po,"!)' .yo i"iu",. Do nol 

g¢llneye,.. on 'kin '" o<Iclo'hing. Woa,gog910 •• lac. 

,hiold 0' •• Ioty gl"""o •. Avoid inhol.l",n 01 du'1. 

Wosh \h.o,oughly with 'oap .nd wa'., .ole' hondr'"9 

and bolo,. ¢'';n9 0' drlnking. Romo,,> ""o"""","lod 

""'Ihing bolo,o ,0U'O. R.3" and und=1>nd thO 

MatM~1 SaIolyOal. Sheo!!o, .MI~onollnlo'mollo<l 

0010'" wol1<;"g with th;. p,OduCT. 

STATEMENT OF 

PRACTICAL TAEATM£NT 

II i·' ey~o: Ilo~ oyellds opon .nd llush wi'h •• I •• dy. 

90(111<> 'Mam 01 ""I", 10' 15 minu,os. Got m¢dH:el 

nllonUon. II .wallowod: O~n~ p,omplly a t;,'ge quan· 

'ity 01 mil~. "00 whao. 0/ ~olalin ,olul;on. 0' il those 

afa not ov ... blt). large Quan,ijl.s 01 w ... ,. AvoiO 

01""'01. Got m.docal.!ten';oo. 

~ll'IIRO'NMENT HAZAROS 

Oonot<f .. cliargo into 1.~o •• 'I' •• m'. pooo' 0' publio 

wo'." unlo .. in =,dance with an NPO~S po'ma. 

Fo' 9udance oOntaC! you, '''9ion.1 011"=0 o! tho EPA. 

DIRECTIONS FOR USE 

I", ° viol.,on 01 Fodefall.w '0 u,. ,hi, p,oduolln. 

""nno' ""'>n","on, w,'h I,. ,.ool'ng 

Thi. ehOmlo.1 "'oy bo uoed onlylo, lila 10'mul.I;On 01 

• planl 'oollng p,ep.,a,",n. F<nmulo.lOr' U"'"'9 1M. 

»I<><IvOl Oro m,ponsibl. 10' obtolnino EP A '''Ili.ltal;''n 

10' Ihw 1o'",ula'o<I prOduol,. 

STORAGE AND DISPOSAL 

STORAGE: S,o,. prodUeI in aOg",ol """'''"'0' only. 

aW'yl'om otll., 11<>'-' 'ertlli"",,!<><>d odo.d. 

OISPOSAL: 0.. .... 1""" .. "'ilI .... W"'O'. lOOi1 o,lood 

byslo,"II. ",disposal Wa .......... ullin91rom Ihouoe 

01 this p,od"", moy be di&p"$<!<1 01 0<1 .~o 0' 01 an 

0P»lov.d wa,,~ diopo.>! loony. 

Com p""oly empty line, by SIlokin9 '00 lolpping .... , 

and w"om '0 Io¢>en dinyll1\! po~lcte •. Empty 'esi· 

du~ in'o ",.nuloolu,;"q oqulpm.nl. 01'1>0$0 o! any 

wo.le , •• <dvo. "I app,opriatoly pormiliOd w.<to 

d"~ .. llol,"li~o. ac",,<dlng '0 ~PA ,e~ul'l;ons "140 

C.F.R. 200 e"oQ. n,on d"po,o o! lino, oa $Afti .... '" 

landlill Ot ~y ",onofatlon ~ allOlWd bY'I"'a ondto.::.l 

'U'ho"'i ••. 

II drum .. C<lntaminalold and o'nnol bo (&u.od. 

di,po.o olift 1M ,amo m""n.,. 

SYNTEX, S.A. de C. V. DIVISION QUIMICA 

APARTADO POSTAL 517, CUERNAVACA, MOR. MEXICO 

L-tBEL 
33

SYNTEX,IPTM R2/R3 

SVNTEX DISCOVERY RESEARCH 

DIVISION Of SYNTEX (U.S.A.) INC. 

34ell HillVIEW AVF.N\,JE, P.O. BOX lot1SCl 

PALO ALTO, CALIFORNIA !U303 

February 14, 1995 

Ms. O. Halliday 

O. Halliday & Co., Inc. 

3803 Lunata Lane 

Fallbrook, CA 92028 

ID'415-496-3506 FEB 14'95 

(415) M;'·I>O~() 

fAX {~15) 406-350e 

DRUG t;.\lALUATION 

IN.."ITITUTE or PATHOLOGY. TOXICOLOGy, ANt:! METABOLISM 

Rs: Eye irritation study wi(h Indole BUlyric: acid in rabbits (Synlex Study 16·B~aO·1160B·XX·OO-EY·LL[EHJ) 

Dear Ms. D. Halliday, 

Following instillation aftha 10$1 formUlation, the eyelids were held closed for 1 second after instillation. 

The ayes wer!) not subsequently washed. Excep( lor the normal physiologic tsar processes. it may be 

concluded that the study was conducted with leaving the test material il11act in contact with 1ha eyes for at 

D:h~U~~lA-h-~~ ~pa~~mai1hY Director of Toxioology 

Syntax Research 

Telephone: (415) 855-5580 

IPTMJA-7131 -1.1249 

'" , , , ) , 

" 

" 

, tt " , 

" , 

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, , 

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34

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i " 

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-"":;,1"" 

Z'069 410 589 

Receipt for 

~ Certified Mail 

""'''cU.''-''' -"""'" """ 

No Insurance Coverage Provided 

Do not use for International Mail 

(See Reverse) 

S"nr ,~ 

S"eo, 'i'''' "''' 

PO 51"'" "nd ZIP Cod" 

Po;oago 

Cer"lwd Fee 

SPCC,,: De,,"er" Foo 

ROSI"Cled Dellvory Fee 

::ll Rewrn Rec.,p' Sh.w.n9 

0> 10 Whom & 0~10 Oel,"",06 

s::. R"w," Roee,pt Showing 10 Whom, 

e DOle, and Addr.ss",,'" Address 

:::::! • TOTAL PO'lage 

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" 
35

." ) 

\ 

CERTIFIED MAIL 

Ms. Deborah Halliday 

Halliday & Company 

3803 Luneta Lane 

Fallbrook, CA 9202~ 

Dear Ms. Halliday: 

FEB 1 1995 

SUBJECT: Indole-3-Butyric Acid 

EPA Reg. No. 42473-1 

Time Extension for Correcting Deficiencies in Eye 

Irritation study 

Your letters dated 12/25/94 and 01/27/95 

As you requested in your letters, an administrative 

extension has been granted until February 28, 1995 for the 

submittal of data correcting the deficiencies in the eye 

irritation study'Which was submitted to support reregistration of 

the subject product. In granting this extension, it should be 

clearly understood that these data must be submitted by this date 

and that no additional time extension will be granted for the 

completion of -these guideline requirements. 

Questions regarding our decision for this time extension 

should be directed to the Regulatory Action Leader for Indole 

Butyric Acid" Ms. Rita Kumar at (703) 308-8709. 

Sincerely, 

~~~esticides ~:::~e~~ector and Pollution 

Prevention Division (7501W) 
36

) 

D. HALLIDAY & CO. 

3803 Luneta Lane Fallbrook, CA 92028 

619/728·2893 FAX 619/723-8590 

December 25, 1994 

Ms. Cynthia Giles-Parker, Product Manager (22) 

Fungicide-Herbicide Branch, Registration Division (H7505C) 

United States Environmental Protection Agency 

Crystal Mall, Bldg #2 

1921 Jefferson Davis Highway 

Arlington, VA 22202 

Reference: Indole-3-Butyric Acid 

EPA Reg. No. 42473-1 

Re: Deficiencies in Eye Irritation Studies 

Dear Ms. Giles-Parker: 

In response to the letter from Connie B. Welch of Nov 29, 1994, we would like to request 

additional time to present the letter of certification which was requested, We will be 

unable to comply with the 30 day response time due to the Christmas and New Year's 

holidays. We would like to have an additiona130 days, unti129 January to obtain and 

send the letter to you. 

, , , , 

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37

) 

~1-27-1995 04:11PM FROM TO 17033081825 P.0l 

I 

D. HALLIDAY & CO. 

January 27, 1995 

Ms. Cynthia GiJos-Parker, Product Managcr (22) 

Fungicide-Herbicide Branch. Registration Divisio.Q. (H750SC) 

United States Environmental Protection Agency 

Crystal Mall, Bldg #2 

1921 Jefferson Davis Highway' 

Arlington, VA 22202 

Referenc~: Indolc~3~Butyric Acid 

EPA Reg. No. 42473-1 

Re: Deficiencies-ih Eye Irritation Studies 

Dear Ms. Giles-Parker: 

3803 Lunela Lane Fallbrook, CA 92028 

619n28-2893 FAX 619n23~8590 

We have not yct reci;ived the nece~.sary information from Syntex. We would like to 

request a 30 day extension to provide you with that information. Thank you for your 

consideration. 

Cordially, ULI l\.Y 

Deborah Halliday 

TOTAL P.01 
38

D. HALLIDAY & CO. 

January 27.1995 

Ms. Cynthia Giles-Parker. Product Manager (22) 

Fungicide-Herbicide Branch, Registration Division (H7505C) 

United States Environmental Protection Agency 

Crystal Mall. Bldg #2 

1921 Jefferson Davis Highway 

Arlington, VA 22202 

Reference: Indole-3-Butyric Acid 

EPA Reg. No. 42473-1 

Re: Deficiencies in Eye Irritation Studies 

Dear Ms. Giles-Parker: 

3803 Luneta Lane Fallbrook, CA 92028 

619m8-2893 FAX 619m3-8590 

We have not yet received the necessary information from Syntex. We would like to 

request a 30 day extension to provide you with that infOlmation. Thank you for your 

consideration. 

Deborah Halliday 

> > , > 

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• ••••• . . , > > •• 

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39
40

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41

CERTIFiED MAiL 

Deborah Halliday 

D. Halliday & Company 

3803 Luneta Lane 

Fallbrook, CA 92028 

Dear Ms. Halliday: 

Subject: IBA RED 8-Month Response - EPA Reg. No. 42473-1 

Data Waiver Request - Dermal Sensitization 

Combined Acute Dermal Tox & Dermal Irritation studies 

Acute Dermal Tox Study 

MRID # 424837-01 & 425339-01 

Your Letters Dated May 19, 1992 & Sept. 11, 1992 

Eye Irritation & Dermal Irritation Studies 

MRID #s 418630-01 & -02 

The Agency has reviewed the subject data (MRID 418630-01) as 

part of your 8-month response to the IBA RED, and has determined 

that it is deficient at this time. A discussion of these 

deficiencies can be found in the enclosed letter. 

within thirty (30) days of receipt of this letter you must 

address the deficiencies noted in the enclosed letter. If you are 

unable to remedy these deficiencies within the 30 day limit, you 

must inform the Agency within this time frame as to how and when 

you will remedy the deficiencies. If additional time is required, 

submi t a detailed explanation of why the additional time is 

necessary. Failure to adequately respond within 30 days of receipt 

of this letter may result in the issuance of a Notice Of Intent To 

Suspend (NOITS) your product. 

If you have any questions, please call Cynthia Giles-Parker 

(PM 22) of my staff on (703) 305-5540. 

Enclosure 

Sincerely, 

Connie B. Welch, Acting Deputy Chief 

Fungicide-Herbicide Branch 

Registration Division (7505C) 
42

~I SYNTE><I 

NET i KILOGRAM 

(2.2 LB.) 

INDOLE - 3 • BUTYRIC ACID 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

I,CTIVE INGREDI ENTIndc!;,.3.But)lflC Acid 

!/fERl INGREDIENTS 

EPA Rog No 42473 t 

.... ,.", .... , .. mln. 97% 

,,, .. , ".,.,,,,,.max.3% 

'I KEEP OlfTOF REACH OF CH!LOREN 

I PR~CAUTIONARY STATEMENTS 

I A~~Z;~~~~~C H~~~~~S 

I C,"50, 'Ub.IM! ~t~~~~ry~yO ;"iury. 00 oot 

I 

ge, ;n. yoo. Of) ok;n Of on elo1l\ll\y. We., gogglo •• laoo 

ohiolrl or solOt~ gl~sses Amid ,nhoi,"on 01 du,l 

Wooh thoroughly "';,h $Oop ond WOlef aller ho",Wng 

~rd polo", ooting or df;nfung. Remove ctlo'omlnatod 

I 

cloth og bolore feu'c. Rood .nd understood tho 

t1olon.1 Sole')' Oota Shoe' lo( oddltionol,n\orm,,;on 

bel"'" wod"ng with th;. pr4d"CI. 

, STATEMEfIT OF 

, PRACTICAL TREATMENT 

I I '" eyeo: Hold oyclido open and flush "';'h • '"'Oldy. I ~Cf,'1e .treom 01 wole, 10' 15 ",inule •. GOI m.,.;Iie«l 

·1 """nlion, II owo!owcd; D"M Pfomplly • I.,.go duan· 

,ny 01 ",ilk. o~g wh;,o. Of gol.I'n .olu~on, 0' ;I!hoo. 

10'0 cot ouo~:ml~, I .. so duontl"oo ot WOlOf. Auold 

olcohol, G<1 mcdi",,1 atoenlion, 

ENYIRONMENT HAZARDS 

Do no' olOch'fge ;nb loke" ""oams, pond, Of publ,c 

, ... ","" unloo. in ~=do.nco w"z, an NPO~S perm.t. 

F Of guidon"" contact yo Uf Ill'lJfonol oiliee 4 f Ihe EPA, 

DIRECTIONS FOR USE 

It i, 3 Uiol,oon 01 Fcdomllow 10 u"" this Pfoduc< ;n • 

",~nn", ;noon""IOnl wilh ", I.boling 

ThO. ohomic>.lm~y p~ Usa<! onlytofth. tor",u!>';"n 01 

o pEont fOOting ",epomtl"". FOfmutolofS u,,;ng "'"' 

",oduct a<efo.pon"plo tOf opt"nino ~PA to~;'katiOn 

lor .,,'" 10ffTluioiod Pfoduc". 

STORAGE AND DISPOSAL 

STORAG~: Store Pfoduc<;n Oflg;nal c4nto;n", only. 

awoyf",", othof p",tiei<lo" to,..".,. food Of I.od, 

DISPOSAL: Do nol eon\O.m;n~IO w~tOf, food 0' f~od 

P'I s""agoofdlSposol Woste,,,,sultin~ tromtho u •• 

ollh1s PloduCI maybo d;'po.od of on .ito 0' at On 

apPiovod waslo di'posal facility. 

Completely .",pty ~nof by .h oking and tapping .idos 

and bottom", leo«>n elingLflg p01liele •. ~mply '0,1· 

duo ;n'" manulac,unng edulpmen,- OISPM& 01 ""y 

""'''0 fo,;duo. at appfOpo;aloly ~m'llOd w .. to 

dlSpoool taciuo"" oCCOfd;n~ '0 EPA f"9ulo~ons at 4(1 

C,F ,R. 2S0 ot ""d. Thon d~po", of liner;n • ,0n;''''I' 

londtlll Of by ;nClnOfa"on If allowod by sto'" aM local 

tl drum ;0 oon"mln~'oo and oonnot p~ ,ou.od. 

4i,po"o olin Ihe .. 010 ",ann." 

SYNTEX, S.A. de G.V. DIVISION QUIMIGA 

APARTADO POSTAL 517, CUERNAVACA, MOR. MEXICO 
43

) 

SYM80t. 

nATE 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

CERTIFIED MAIL 

Deborah Halliday 

D. Halliday & Company 

3803 Luneta Lane 

Fallbrook, CA 92028 

Dear Ms. Halliday: 

28 ' 

Subject: IBA RED 8-Month Response - EPA Reg. No. 42473-1 

Data waiver Request - Dermal Sensitization 

Combined Acute Dermal Tox & Dermal Irritation Studies 

Acute Dermal Tox Study 

MRID # 424837-01 & 425339-01 

Your Letters Dated May 19, 1992 & Sept. 11, 1992 

Eye Irritation & Dermal Irritation Studies 

MRID #5 418630-01 & -02 

The Agency has determined that all acute toxicity data have 

been waived except the primary eye and primary dermal studies. 

The eye irritation study (MRID 418630-01) is classified as 

supplementary. This study can be upgraded to guideline provided 

that you submit a written statement verifying that the contact time 

was 24 hours. If such confirmation is made the tox category II can 

be assigned. The primary dermal irritation study (MRID # 418630-

02) is classified as guideline. No revisions to your precautionary 

labeling are required at this time. 

The acute toxicity profile of the subject product, based on 

the foregoing, is as follows: 

acute oral toxicity 

acute dermal toxicity 

acute inhalation toxicity 

primary eye irritation 

primary dermal irritation 

dermal sensitization 

WAIVED 

WAIVED 

WAIVED 

IV 

WAIVED 

SUPPLEMENTARY 

GUIDELINE 

For your information, the Agency reviewed the subject data for 

this product and has determined the following: 

Acute dermal and primary skin irritation data cannot be used 

to satisfy the requirement for a dermal sensitization study. The 

EPA Form 132<>-11\ (l.W) 
44

) 

irritation resulting from one exposure to a material, while the 

dermal sensitization study is designed to identify materials which 

have the capability of producing an allergic reaction. Dermal 

sensitization studies require repeated exposures followed by a rest 

period or time interval which allows the test animal's immune 

system time to respond to the test material. After its rest 

period, the test animals are then exposed to the test material. An 

allergic response would be indicated by skin irritation scores in 

the test group that are more severe than skin irritation scores in 

a naive group which has only received one exposure to the test 

material. 

The acute dermal toxicity study, MRID 424837-01, is classified 

as supplementary data and cannot be upgraded. The study failed to 

follow the subdivision F guideline requirement that at least ten 

animals (5 males and 5 females) be used at each dose level. 

Additionally, the exposure areas were intentionally abraded before 

testing. 

The acute dermal toxicity study, MRID 425339-01, is classified 

as supplementary and cannot be upgraded. The study failed to 

follow the subdivision F guideline requirement that at least 10 

animals (5 males and 5 females) be used at each dose level. The 

skin of the test animals was abraded prior to exposure to the test 

material. Additionally, the weights of the four test animals were 

not measured at the beginning of the study, as required by the 

guidelines. The dose level of the test material applied to the 

animals should have been 2.0 gjkg of body weight for a limit test. 

The Agency doubts the size of the exposure areas used, as surface 

area of the test animals is often determined by the weight of the 

animals. 

Please submit the information requested to upgrade the eye 

irritation study (MRID 418630-01). 

Sincerely Yours, 

/5) 

Cynthia Giles-Parker 

Product Manager (22) 

Fungicide-Herbicide Branch 

Registration Division (7505C) 
45

NOTE TO THE FILE 

CONV. BIOCHEM. 

GRN GRN TITLE OF STUDY RESULTS/REVIEW DATE 

81-1 152-10 ACUTE ORAL WAIVED 2/24/93 

81-2 152-11 ACUTE DERMAL WAIVED 2/24/93 

81-3 152-12 ACUTE INHALATION WAIVED 2/24/93 

81-4 152-13 PRIMARY EYE G 1/14/92 

G 6/28/93 

S 8/9/94 

81-5 152-14 PRIMARY DERMAL G 1/14/92 

G 6/28/93 

G 8/9/94 

81-6 152 -15 DERM. SENS./HYPERSENS. WAIVED 3/10/93* 

WAIVED 8/9/94 

152-16 HYPERSENS. INCIDENTS WAIVED 3/10/93* 

WAIVED 8/9/94 

* LARRY CULLEN LETTER GRANTED WAIVER 
46

, ) 

F/vt .. z. 'lC'r-~k~o~>&s Pa~ k_ 

!C"'''~ 2. Z r UNITED STATES ENVIRONMENTAL PROTE 

WASHINGTON, D.C. 20460 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

MEMORANDUM: 

Subject: EPA Reg. No./File Symbol: 42473-1/ Indole-3-Butyric 

From: 

To: 

Thru: 

Acid 

Ian Blackwell, Biologist tiiJ!3 /, ~;/13 Precautionary Review section 1~ Registration support Branch 

Registration Division (H7505W) 

Cynthia Giles-Parker, PM 22 

Fungicide-Herbicide Branch 

Registration Division (H7505C) ~ 

Thomas C. Ellwanger, Section H d ,~\/..e· Precautionary Review section e1}la CY~U • .v.\'~\)J I, "I"'" 

~ ~ 

Registration Support Branch:1 !.J{1-" 

Registration Division (H7505W) 

Applicant: Syntex, s.A. de C.V. 

Division Quimica 

Apartado Postal 517 

Cuernavaca, Mar. Mexico 

FORMULATION FROM LABEL: 

Active Ingredient(s} :: 

Indole-3-Butyric Acid 

Inert Ingredient(s): 

Total: 

% by wt. 

min. 97% 

max. 3% 

100% 

Recycled/Recyclable 

Printed with Soy/Canal" Ink on paper that 

contains lit lens! 50% recycled flbl!r 
47

BACKGROUND: syntex has requested a data waiver for the dermal 

sensitization study of "Indole-3-Butyric Acid". The registrant 

states that a dermal sensitization study should not be necessary 

because of the dermal toxicity and irritation studies that have 

already been submitted and because of the dermal toxicity studies 

that were submitted as part of this submission. The submission 

includes a combined acute dermal toxicity and dermal irritation 

study, volume 1 (MRID #424837-01), and an acute dermal toxicity 

study, volume 2 (MRID #425339-01). 

PRS previously denied the registrant a data waiver for the 

dermal sensitization study of this product on 1/14/92. PRS 

reviewed the primary eye and skin irritation studies on 1/14/92, 

the results of that review are: 

primary eye irritation 

primary skin irritation 

II 

IV 

guideline 

guideline 

Data waivers were granted for the acute oral, dermal and 

inhalation toxicity studies by the Health Effects Division (memo by 

Robert Zendzian, 6/5/89). 

RECOMMENDATIONS: 

1. The registrant must cite or submit a dermal sensitization study 

to support the registration of EPA reg. no. 42473-1. Acute 

dermal and primary skin irritation data cannot be used to 

satisfy the requirement for a dermal sensitization study as each 

study serves a different purpose. The acute dermal toxicity 

study is designed to assess the systemic toxicity of a pesticide 

resulting from one exposure. The primary skin irritation study 

is designed to measure the degree of skin irritation resulting 

from one exposure to a material, while the dermal sensitization 

study is designed to identify materials which have the 

capability of producing an allergic reaction. 

Dermal sensitization studies require repeated exposures (an 

induction phase) followed by a rest period or time interval 

which allows the test animal's immune system time to respond to 

the test material. After this rest period, the test animals are 

then exposed (challenged) to the test material. Skin irritation 

is scored, and an allergic response would be indicated by skin 

irritation scores in the test group that are more severe than 

skin irritation scores in a naive group which has only received 

one exposure to the test material. 

2. The acute dermal toxicity study, MRID number 424837-01, is 

classified as supplementary data and cannot be upgraded. This 

study is graded supplementary for the following reasons: 

a. The test used only 2 males and 2 females. According to the 

subdivision F guidelines, §81-2 (c) (h) (1) (iv), at least 10 

animals (5 males and 5 females) should be used at each dose 

level. 
48

b. The exposure areas were (intentionally) abraded before 

testing. 

3. The acute dermal toxicity study, MRID number 425339-01, is 

classified as supplementary data and cannot be upgraded. This 

study is classified as supplementary data because of the 

following deficiencies: 

a. The test used only 2 males and 2 females. According to the 

subdivision F guidelines, §81-2 (c) (h) (1) (iv), at least 10 

animals (5 males and 5 females) should be used at each dose 

level. 

b. The weights of the test animals, at the beginning of the 

study, were not measured. This does not follow Subdivision 

guidelines. 

c. The doses of test material applied were reported to be 3.89, 

3.83, 5.76, and 6.51 g/kg of body weight. If the lab was 

attempting to do a limit test, the doses should have been 2.0 

g/kg. 

d. The weight of the test animal is often used to determine the 

surface area of the test animal. PRS doubts the size of the 

exposure areas used. 

e. The skin of the test animals was abraded prior to exposure to 

the test material. 

The acute toxicity profile of 42473-01 is currently: 

acute oral toxicity WAIVED 

WAIVED 

WAIVED 

acute dermal toxicity 

acute inhalation toxicity 

primary eye irritation 

primary skin irritation 

dermal sensitization 

II 

IV 

REQUESTED 

guideline 

guideline 

) LABELING: 

As there has been no change in the acute 

this product since the 1/14/92 PRS review, 

mendations will be made at this time. 

toxicity profile of 

no labeling recom-
49

DATA REVIEW FOR ACUTE DERMAL TOXICITY TESTING (§81-2) 

Product Manager: 22 Reviewer: Ian Blackwell 

MRID No.: 425339-01 Report Date: 4/13/93 

Report No.: 16-B-80-11608-XX-OO-O-EY-LL 

Testing Laboratory: Syntex Research Dept. of Toxicology and 

Pathology 

Author(s): Duane Hallesy, Ph.D. 

Quality Assurance (40 CFR §160.12): Included 

Test Material: Indolebutyric acid (lot 35584-27B) 

Species: 

Weight: 

Source: 

summary: 

rat 

Not specified 

Charles River 

Age: not specified 

Breeding Laboratory 

1. LD" (mg/kg): Males = 

Females = 

Combined ~ 

2. The estimated LDso is 

3. Tox. category: Classification: supplementary 

Procedure (Deviation From §81-2): ~ Weights and ages of test animals were not recorded. 

RActual doses of test material were 3.89, 3.83, 5.76 and 6.51 

g/Kg. 

aSkin of the test animals was abraded using a needle. 

~How were dimensions of exposure (~ 10% of surface) area determined without knowing weight of test animals? ~Only 2 males and 2 females were used. 

Results: 

Reported Mortality 

(NUMBER KILLED/NUMBER TESTED) 

DOSAGE (g/kg) Males Females Combined 

3.83 0/1 0/1 

3.89 0;1 0/1 

5.76 0/1 0/1 

6.51 0/1 0/1 

Signs of toxicity: No skin irritation was seen. Red nasal 

discharge, ocular discharge, slight facial swelling, 

Gross Necropsy Findings: No gross necropsies were conducted. 
50

DATA REVIEW FOR ACUTE DERMAL TOXICITY TESTING (§81-2) 

product Manager: 22 

MRID NO.: 424837-1 

Reviewer: Ian Blackwell 

Report Date: 7/7/80 

Report No.: RS 11608-XX-OO-O-SK-TX (EH) 

Testing Laboratory: Syntex Research Dept. of Toxicology and 

Pathology 

Author(s): Duane Hallesy, Ph.D. 

Quality Assurance (40 CFR §160.12): Included 

Test Material: RS 1160a-XX-oo-o, Lot# 1. 

species: New Zealand White rabbit 

Weight: 3396 to 3770 9 Age: young adult 

Source: Nitabell Rabittry, Hayward, CA 

summary: 

1. The estimated LDso is 

2. Tex. Category: Classification: supplementary 

Procedure (Deviation From §81-2): 

"The backs of the test animals were abraded using an 18 gauge 

needle. 

wOnly two males and two females were used. 

Resul.ts: 

Reported Mortality 

(NUMBER KILLED/NUMBER TESTED) 

DOSAGE 

Males Females Combined 

2000 mq/kg 0/2 0/2 0/4 

signs of toxicity: Runny eyes, scabbing and anorexia. 

Gross Necropsy Findings: 

eye, red foci in lung and 

Skin encrustations, 

gastric hair ball. 

moist skin around 
51

ACUTE TOX ONE-LINER 

1. PC CODE: 046701 

2. CURRENT DATE: June 24, 1993 

3. TEST MATERIAL: Indole-3-butyric acid EPA; reg. no. 42473-1 

Study/Species/Lab/ 

Study#/Date 

acute dermal toxicity 

rabbit / syntex 

Research / RS 11608-

XX-OO-O-SK-TX (EH) / 

'7-7-80 

acute dermal toxicity 

rat / Syntex Research 

16-B-80-11608-XX-OOO-EY-LL / 4-13-93 

Core Grade Key: 

G = Guideline 

M = Minimum 

S = supplementary 

MRID No. Results 

424837-1 

425339-01 

Tax. Core 

Cat. Grade 

suppl 

ement 

ary 

suppl 

ement 

ary 
52

( 

r~1 SYNTE>( I 

• 

NET 1 KILOGRAM 

(2.2 LB.) 

INDOLE-3 -- BUTYRIC ACID 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

ACTIVE INGREDIENT: 

Indole-3-Butyric Acid ... ; ...... : ........... min. 97% 

INERT INGREDIENTS ..................... max. 3% 

EPA Rag. No. 42473-1 EPA Est. No: 42473·MX·t 

KEEP OUT OF REACH OF CHILDREN 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS 

AND DOMESTIC ANIMALS 

WARNING! 

Causes substantial but temporary eye injury, Do not 

get in eyes, on skin or on clothing. Wear goggles, 

face shield or safety glasses. Avoid Inhalation ,of 

dust. Wash thoroughly with soap and water after 

handling and before eating or drinking. Remove 

contaminated clothing and wash contaminated 

clothing before reuse. 

STATEMENT OF PRACTICAL 

TREATMENT 

tf In Eyes: Hold eyeJlds open and flush with a 

steady, genUe stream of water for 15 minutes. Get 

medical attention. 

If Swallowed: Drink promptly a large quantity of 

milk, egg white, or gelatin solution, or if these are not 

available, large quantities of water. Avoid Alcohol. 

Get medical attention. 

ENVIRONMENT HAZARbS 

Do not discharge into lakes, streams, ponds Of public 

waters' unless In accordance with an NPDES pennit. 

For guidance contact your regional office of the EPA. 

DIRECTIONS FOR USE 

It is a violation of Federal taw to use this product in 

a manner inconSistent with its labeling~ 

This chemical may be used only for the formulation 

of a plant rooting preparation. Formulators using 

this. product are responsible for obtaining EPA 

registratlon for their formulated products. 

STORAGE AND DISPOSAL 

STORAGE: Store product in original container 

only, away from other pesticides, fertilizer, food or 

feed. 

DISPOSAL: Do not contaminate water, food or 

feed by storage or disposal. Wastes resulting 

from the use of this product may be disposed of 

on site or at an approved ·Na~t~ disposar facility. 

.. c < 

Completely empty liner by sn3kingC an: ·lapping 

sides and bottom to 100S911 clingttlQ ~Cj~.rticles. 

Empty residue Into manu:a:c~uring "equ'lpment. 

Dispose of any waste r~&ldues at ,app~oprlately 

permitted waste dispos!3.1 facilities 'C'H'{lldlng to 

EPA regulations at 40 C.F.R. 260 ~t ~e1: Then 

dispose of liner in a sanitary landfill or by 

incineration if allowed by state and local < 

authorities. If drum Is· contaminated and cannot 

be' reused, dispose of In the same manner. . 

SYNrEX, S.A.de C.V. DIVISION QUIMICA 

APARTADO'POSTAL517, CUERNAVACA, MOR.· MEXICO 
53

DP BARCODE: D187215 

CASE: 041238 DATA PACKAGE RECORD DATE: 01/26/' 

SUBMISSION: 5434085 BEAN SHEET Page 1 of J 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE: ACTION: 360 ACTN INI BY AGY-REG & AMN 

CHEMICALS: 

~g:~~~~~~ON QUIMICA 

PRODUCT MANAGER: 22~ARKER 703-305-5540 

PM TEAM REVIEWER: ... M: ....• 2 703-305-7801 

RECEIVED DATE: 10/28/92 DUE OUT DATE: 02/15/93 

* * * DATA PACKAGE INFORMATION * * * 

DP BARCODE: 187215 

CHEMICAL: 046701 lEA 

EXPEDITE: N DATE SENT: 

DP TYPE: 001 SUbmission Related 

ADMIN DUE DATE: 04/06/93 

ASSIGNED TO DATE IN 

DIV : RD / / 

BRAN: RSB / / 

SECT: _S / / 

REVR:···· // 

CONTR: / / 

Data Package 

CSF: Y 

DATE OUT 

/ / 

/ / 

/ / 

/ / 

/ / 

* * * DATA REVIEW INSTRUCTIONS * * * 

ROOM: CM2 

ROOM: CM2 

DATE RET.: 

LABEL: Y 

PLEASE REVIEW THE ACCOMPANYING DATA PACKAGE (WAIVER 

REQUESTS) FOR THE ACUTE DERMAL TOXICITY TESTS FOR lEA. THE 

REGISTRANT FEELS THAT THERE IS NO SIGNIFICANT DATA TO BE 

GAINED FROM CONDUCTING SENSITIZATION STUDIES. WHAT EFFECTS 

WILL THIS HAVE ON THE lEA RED THAT WAS ISSUED ON SEPTEMBER 

10, 1992:-"YOUR COMMENTS ARE GREATLY APPRECIATED. MANY 

THANKS ... 

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

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

97.000C 

229 

265 

/ / 
54

B. Human Health Assessment 

1. Toxico\QiY Data 

The Agency has waived all data requirements on the active ingredient because of the 

expected, extremely low exposures to those involved in the use of products coniaining 

IBA and due to the negligible dietary exposures expected from the use of IBA on food 

and feed crops. IBA is exempt from tolerances of residues on crops (40 CPR 180.1099). 

All registered products are formulated with IBA in low percentages of IBA, from 0.0004 

to 4.5, and are applied in ultra-low quantities, up to 7 mg active ingredient/acre/crop 

season, for the crop uses. Use of products for the ornamental plant propagation use also 

results in low applicator exposure to IBA. 

Additionally, these products have low acute toxicity,as suggested from data of at 

least one fonnulated product (Toxicity Gamgories m and IV, no dermal irritation, and 

moderate eye irritation, perhaps from another active or an inert ingredient in the product 

fonnulation.) As discussed in other sections of this document, the Agency is requiring 

registrants to submit new, or reference, existing acute toxicology and chemistry studies 

for each product. 

2. OccQllational and ReSidential Exposure 

There is potential for occupational exposure to rnA during dipping and 

transplanting activities and mixing, loading and spraying activities. However, since the 

Agency does not have concerns about any toxicological endpoints, the Agency has not 

required exposure data. The Agency has no significant exposure concerns other than 

appropriate label precautions for eye protection for mixers, loaders, and applicators. For 

pesticide products in Toxicity Category II for primary eye irritation, the following 

protective eyewear are required: goggles; face shield; or safety with glasses with front, 

brow, and temple protection. 

1 MRID #s 41661402, 41661403, 41661404, 41661406 

5 
55

D. HALLIDAY & CO. 

September 11, 1992 

Cynthia L. Giles-Parker 

Product Manager (22)' 

Fungicide-Herbicide Branch 

Regist,CI tion Division (H7505C) 

Dea, Ms. Giles-Parke" 

Subject: Dermal Sensi ti::::ation Studies 

Synte>: COrpOration 

. Indole-3-Butyric Acid 

EPA Registration ~lumber 42473-1 

3803 LunCla L,\nc Fallbrook. CA 92028 

619/728-2893 FAX 6 !9n23-8590 

Telex' 181734 

Please find enclosed the cot-rected studies submitted 

as: 

\)olume 1 ,_. Acute Dermal effects of 

vlhen tested on the" skin 

Indole Butyric Acid 

of rabbits. L/z4;5310/ 

Volume 2 - Acute Dermal To}(icity o'f Indole ButYric, Acid 'f2~33'(J I 

when tested on the ,at. 

Than~ YOLl, 

~~a::!:~' D. Halliday & CD. 
56

O. HALLIDAY & CO. 

}i-i03 !.IIIlCW L,llle Filllhrook, CA 92028 

May 19. 1992 

Ms. Cynthia Giles-Parker, Product Manager (22) 

Fungicide-Herbicide Branch, Registration Division (H7505C) 

United States Environmental Protection Agency 

Crystal Mall. Bldg #2 

1921 Jefferson Davis Highway 

Arlington. VA 22202 

Reference: Indole-3-Butyric Acid 

EPA Reg. No. 42473-1 

Re: Dermal Sensitization Study 

Dear Ms. Giles-Parker: 

619/721-:-2X93 FAX 619n23-8590 

Telex 181734 

In respons~ to your letter of Jan 28, 1992, we would once again like to request that the 

dennal sensitization studies be waived. We are submitting, in support of this request, two 

acute dennaI toxicity tests done to OSHA or IRLG protocols. These tests were more 

-rigorous than the dennal sensitivity test previously submitted. The test animals in these 

studies also had no observable reaction in Indole butyric acid. 

We still feel that no significant new data is likely to be gained from sensitization studies. 

We further feel that the tests already submitted establish sufficiently the dermal safety of 

this product. As the purpose of these studies was to establish the labeling requirements 

for the product, we feel those goals are accomplished with the tests we are submitting and 

the previously submitted data. We feel the requirement of additional testing imposes an 

unreasonable hardship on our company to no particular purpose for a low volume, minor 

use product. 

Thank you for your consideration of this matter. Please also note revisea label enci<:'fed . • 
57

D. HALLIDAY & CO. 

3803 Luneta Lane Fallbrook, CA 92028 

619m8·2893 FAX 619m3·8590 

Enviromeni.:i'll Protection Agency 

Of·ficE of Pesticide Pr-ogr2l.IDs 

401 t4 St.reet SW 

i.oJashing-ton" Due. 20460 

October 25" 19T.:': 

De,oif Mr-. Leonard Cole, 

Please find enclosed "=he D2ta su::)pO!-ting guide-line 

r-equirements for the ren:gistr2T.ion of 1ndo12-3-

Butyric Acid. 

The n"quired data has been submitted on the 2ppropriate 

E.PA submittal fon!). 

Please let us know if there is any fUrther informEltioc-, 

that yo<-\ n=quin=,. 

Thank You" 

()~ /ld&.daA-{ 

Debot-ah Halliday /" 

D. Halliday & Co. 

>"),, 

, " 

»>,,) 

" > > ) 

" 

" , , J , > 

, , ), ,. > 
58

"-

DATA REOUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPP

PRODUCT NAME, 

Indole-3-Butyric Acid * 2" EPA REG.NO./FILE SYMBOL, 42473-1 3. FORMUL]:I"TOR,' S EXEMPT

SELECTt:o,': , 

APPLICANT'S (COMPANY) 

lDRESS, 

NAME AND YES : : NO'X 

""-'--'-' , 

Syntex Corporation 

P.O. Box 517 

Cuernavaca, Mor. Mexico 10 22 93 Indol.e- 3-:BtrGyri:C Ac

MONTH DAY YEAR 

40 CFR Part 158 - I 

DATA REOUIREM= __ " ____ i 9. SOURCE OF DATA SATUlfYING REOUIREMENT 

., 8b. 9a. 9b. 9c. 9d. 

Name of Test Submitted Date Submitted certificate 

ine by Submitted by another of perrnisefer- Applicant person/firm s'lon (P) or 

nee (give name) Offer to 

umber Pay (OTP) 

enclosed: 

indi.cate 

ge. 

Public 

Literature 

__ 

L 

_________________ 

L 

_______ 

ection 

58.190 PRODUCT CHEMISTRY 5/11/89 

& 

9f

N.A

Wa

oth

(e

61-1 Identi ty of I Yes 7/20/90 

inqredi ents t_ 

Statement of Yes 7/20/90 " 

composition 

51-2 

.,-. 

Discussion of 

of Yes 7/20/90 II 

lnaredlents 

5.- 3 

62-1 l Preliminary [ 4/11/e9 & I analYsis _______ 1 Yes 7/20/90 

Certification Of 7/20/"" " 

limits L-__ __ __ V __ "-____________ JL ______________ i-________ JL __

52-2 

----------- I 

-- Analytical method I Yes 7/20/90 II 

for enforcement I 52-3 

limits : I Ii I ! 

53-2 Color I _1. __ 

53-3 Physical State Yes " 53-4 Odor Yes ,(/20790 If 

-X"Registration for use in formulation of agricultural rooting compound only. 
59

Syntex Corporation 

P.O. Box 517 

Cuernavaca, Mer. Mexico 

1 CFR Part 158 - I 

DATA REQUIREMENT LISTING FOR THE SELECTIVE OF SUP

Indole-3-Butyric Ac

'vATA RJ';Q]HRENENTS i 9" SQURCE OF DATASATI SFYING REQUIRE11EN'I' 

L IISb. Ilga. 11gb. IlgC. 19d. [ge. 19f

lide- IName of Test ISubmittedl Date ISubmitted [Certificate IPublic IN.A

Lne \ I by ISubmittedlbyanother of Permis- ILitera- \Wa

Applicant: Iperson/firm sian (P) or lture lot

1ce I: (give name) Offer to: (e

lIflber : I Pay (OTP) : 

58.190 PRODUCT CHEMISTRY 

(continued) 

I : enclosed:: 

: : indicate: 

__ L____ i LIIPII or JlOTplJ i 

Yes 4/11/89 

& 

7/20/90 

53-5 point 

2-."' 6 \Boiling point Yes -1 .,------ ---

)''.:r- I iDensity, bulk I 

2.1-

"3-

,3-11 

density I or Yes I 

specific qravi.t'l i I SQ1ubilitY Yes II , 

I Vapor Yes 7720/90 II 

: Octano1/water 

Ipartition Yes 7/20/90" 

I coefficient 

:; 12 I H Yes II 

13 Yes 7720790 

)J 14 :Oxidizing/reducing: : : 

Lf '" ","on L,·. I I I 

I ___ L__ I, 
60

OAT!\. REOUIREHENT LISTING FOR THE SELECTIVE METHOD Of SU

1. PRODUCT NAME' : 2. REG. NO ./fILE SYMBOL, 

Indole- 3-Butyr1c Acid \ 

3. FORNULATOR'S 

SELECTED, 

YES": 

EXEM

5. APPLICANT'S (COMPANY) NAME AND] 42473-1 

WDRESS; ] 

NO "

-

7. NANE OF )\1::TIVE 

Syntex Corporation i REGISTRATION DATED: 

P.O. Box 517 \ 

Cuernavaca, Mor. Mexico 1 10 22 93 Indol.e-3-BUty::-le- hb

i MONTH DAY YEAR - >. .-

3. 40 eFR Part 15S - f 

DATA REQUIREMENTS SQURCE OF DATA SATISFYING REOUIREMENT 

3a. ISb. 19a. 19b. 9c. 9d, 1,ge. \9

;uide- :Name of Test ISubmitted: Date Submitted Certificate IPublic IN

l: : by ISubmitted by another of Permis- \Litera- :W

: :App1icant: person/firm sion (P) or Iture :o: l: (give name) Offer to: : (e

\ \: Pay (OTP) \ : 

, " 1 ed' I I 

I I I enc os. I I 

I I I . d· t' , 

I I I I In lca e I I 

'---

___ 

I L_ _: P_"_Qr __ l : 

. . I I I I I 

)ectlon I I I I I 

.5 S . 190 II PRODUCT CHEN I STRY: I II I 

, ( . I I I I 

I contInued) I I I I 

I I I I I 

I I I I I 

I . . I I I I

-L_f 1ammab 1 II tv _ __ 1-.. _I 

63-16 i Explodabilit·· 63-17 (StoraGe stability Yes 7/20/g0 63-1S lviscositv-- --- 

1 j---.- ----.--.--.---.---- .. -,- "N 

63- 9 ,MISClbllltv , _____ , __ -'-- 

€ 20 lCorrosion 

"---- I Characteristics 

63-21 \Dielectric break 

I down vol.t..a...qe 
61

SAMPLE HATRIX FORMAT - DATA LISTING FOR Ttl. ,,>ELF;CTIVI! HmIOO 

PRODUCT NAME: 2. EPA REG.NO./FILE SYMBOL: 3. FORMULATOR'S EXEM

Hndole 3-Butyric Acid SELECTED: 

APPLICANT'S (COMPANY) NAME AND 42473-1 YES NO 

ADDRESS: c; .: -

Syntex Corporation 6. APPLICATION FOR 7. NAME ACTl'VE INJ

P.O. Box 517 REGISTRATION DATED: ,,' ''- :, 

Cuernavaca, Mor. Mexico -

__ 

22 93 Indole-3-Butyric 

-=-;;;==-,.-:c=-=-____ r-__ 0111 ::: < :': 

4 0 CFR Part 158 _ !.!!llLL . : " DATA EOUTI'EMENTS 19. SOURCE OF DATA SATISFYING REOUJRRHENT ., , 

• 8b. 9a. 9b. .9c. 9d. ge. 9f

. ide- Name of Test Submitted Date submitted Certificate Public N.A

.1, by Submitted by another of Perolis- Litera- Wa

,f'er- Applicant person/firm sian (P) or ture oth

Ice (give name) Offer to (eX

,mber Pay (OTP) 

enclosed: 

indioate 

or "OTPIM 

;8.340 TOXICOLOGY 

(continued) 

81-1 Acute Oral, toxit W

___ -I-;,-::ra t :. 

81-2 Acute dermal W

_ to_xil:'i ty_, rabbit a

8 1 _3 W

81-4 :priI!lary. eye .. 

___ -II_'=.rr1t-at10n It _1-____ -11-_

81-5 1?riIpar:y. dermal 

1rr1ta"t-i.on 

81-6 sensiti- W

zat10n 

6-32 
62

) 

) 

IIJ 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MAR / 0 /993 

CERTIFIED MAIL 

Ms. Deborah Halliday 

D. Halliday & Co. 

3801 Luneta Lane 

Fallbrook, CA 92028 

Dear Ms. Halliday: 

OFFiCE OF 

PESTICIDES AND TOXIC 

SUBSTANCES 

Subject: Data Waiver Determinations in Response to the Indole~3~ 

Butyric Acid (lEA) Reregistration Eligibility 

Document (RED) 

Indole-3-Butyric Acid 

EPA Reg. No. 42473-1 

The Agency has reviewed data waiver requests made by 

registrants submitting 90-day responses to the lBA RED. Based 

on these reviews, we have made the fOllowing decisions that apply 

to your product: 

1. The Dermal sensitization Study, GRN 152-15 

and the Hypersensitivity Incidents, GRN 152-

16 are not required. 

Sincerely, 

\~awrence E. Culleen 

l--1cting Director R~gistration Division (H7505C) 

~ Printed on Recvcled Pacer 
63

, 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM: 

Subject: 

To: 

EPA Reg. No.: 42473-1 l .... l 

Van M. Seabaugh 6~ M, ~~, Precautionary Review Section 

Registration Support Branch 

Registration Division (7505W) 

Cynthia Giles-Parker (PM 22) 

Fungicide-Herbicide Br. 

Registration Division (7505C) 

Label (5-13-93) Information 

OfFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Active Ingredient: Indole-3-butyric acid •...•••...••••• 97% 

Inert Ingredients: .................................... ---.J..! 

100.0% 

Applicant: Syntex, S.A. De C.V. Division Quimica 

Background Information: 

The assignment sheet to the PRS says,"Please review the 

accompanying data package (product specific data) submitted in 

support of the re-registration of the above mentioned product. A 

battery of six acute is not included with this package. All acute 

toxicology data have been waive except primary eye irritation, 

and primary skin irritation." 

Summary: 

Summary information is presented (Table 1). 

RecycledIRecyciable 

PrlllIed with SoylCanola Ink on ~ \hal 

contains at loast 50% rocycled mw 
64

2 

Table 1 . Summary Information . Acute Toxicity MRID Toxicity Classification 

Test Category 

Eye Irritation 418630-01 -- Supplementary. 

(§81-4) Study can be 

upgraded to 

guideline with 

written statement by the 

registrant to 

the Agency 

that the 

contact time 

was 24 hours. 

with the 

statement, a 

toxicity 

category II 

can be 

assigned. 

Dermal 418630-02 IV; P.I.I.= Guideline 

Irritation 0.0 

(§81-5) 

DATA REVIEW FOR ACUTE EYE IRRITATION TESTING (§81-4) 

Product Manager: Cynthia Giles-Parker 

Reviewer: Van M. Seabaugh 6~S ~.-4.AJ.( 

MRID NO.: 418630-01 

Title of Report: Primary Eye Irritation Study (Draize Procedure) 

In Rabbits With Indolebutyric Acid 

Report Date: 5-30-80 

Performing Laboratory: syntex Research, Palo Alto, California 

Report No.: 16-B-11608-XX-00-0-EY-LL (EH) 

Author(s): E. segre, L.Thunen, F.J. Murray. 

Species: New Zealand Rabbit 

Sex: 3 d, 3 9 

Weight: 2070-3942 grams. Age: Not specified. 

source: Nitabell Rabbitry, Hayward, CA. 

Dosage: 100 mg. 

Test Material:lndolebutyric acid eRS 11608-XX-00-0} 

Quality Assurance (40 CFR §160.12): Statement submitted. 

Summary: 

1. Toxicity category: Not assigned. If the registrant 
65

3 

states in writing to the Agency that the contact time was 24 

hours, then a toxicity category (II) can be assigned. 

2. Classification: Supplementary. The report does not list 

the exposure time. Was the test conducted to allow a 24-hr 

contact time? The study can be upgraded to guideline if the 

registrant submits in writing to Cynthia Giles-Parker (Program 

Manager) that the study was conducted allowing a 24-hr contact 

time for the test material. 

procedure: One hundred milligrams was instilled into the 

conjunctival sac of the right eye of each rabbit (3 males, 3 

females). The lids were held together for 1 second and released 

before returning the animals to their cages. The contralateral 

eye (left) of each rabbit served as a control 

Results (Table 2): 

Table 2: Summary Of Observations 

(number "positivell/number tested) 

Observations Hour Days 

1 1 2 3 7 14 21 

Cornea Opacity 0/6 6/6 6/6 5/6 4/6 4/6 -

Iris 4/6 5/6 4/6 3/6 1/6 0/6 -

Conjunctivae 

Redness 0/6 2/6 2/6 1/6 0/6 0/6 - Chemosis 0/6 2/6 1/6 0/6 0/6 0/6 - Discharge 0/6 5/6 4/6 4/6 0/6 0/6 -

comments: The control eye of rabbit #201 exhibited 1 opacity at 

day 7, but not at any of the other observations. Otherwise, there 

were no significant listings other than those noted in the above 

table. 

DATA REVIEW FOR SKIN IRRITATION TESTING (§81-5) 

product Manager: Cynthia Giles-Parker 

Reviewer:. Van M. Seabaugh bl'r1> ¥ .. A.Ai.f 

MRID No.: 418630-02 

Report Date: 6-2-80 
66

4 

Title of Report: Primary Skin Irritation Test of Indolebutyric 

Acid (RS 1160S-XX-OO-O) Using Rabbits. 

Performing Laboratory: syntex Research, Palo Alto, CA 

Report No.: 15-B-SO-1160S-XX-OO-O-SK-LL (EH) 

Author(s): Duane Hallesy 

Species: New Zealand rabbits 

Age: Not specified. 

Sex: 3 d, 3 9. 

weight: 2922-3760 

Source: Nitabell Rabbitry, Hayward, CA 

Dosage: 0.5 grams 

Test Material: Indolebutyric Acid (lot #1160S-XX-OO-O) 

Quality Assurance (40 CFR §160.12): 

Summary: 

1. The primary Irritation Index = 0.0 

2. Toxioity Category: IV 

3. Classification: Guideline 

Procedure: 

stated: "On the day before treatment the backs of the 

rabbits were clipped. The clipped skin was divided into 4 

quadrants each approximately 4 square inches. The right front and 

left rear areas were lightly abraded by making 4 epidermal 

incisions in a IItic-tac-toell pattern with an 18 gauge needle. 

Test material was applied to all four sites. Following 

application of .5 grams of indolebutyric acid mixed with .8 cc 

distilled water, all sites were covered with gauze patches held 

in place for 24 hours. After removal of the dressings, the skin 

sites were scored for erythema and edema using a scale of 0-4 for 

each parameter. The skin was then washed with water. Scoring of 

the test sites was repeated at 72 hours and 7 days after dosing. 1I 

The protocol (page 11) indicates ••• "the test materials (0.5 

grams) are introduced under a 1.5 inch 12-ply gauze patch which 

is secured in place by two 1/2 x 4 inch strips of adhesive tape 

in the form of an X.II "The trunk of each animals is loosely 

wrapped with an impervious material, such as a rubberized cloth, 

for an exposure period of 24 hours. (The impervious wrap should 

be applied in such a manner that the palm of the analyst's hand 

can be easily placed between the wrap and the animal's back.)" 
67

r 

5 

Results: 

The report indicated scores of all zeros [except for grade 1 

for rabbit #205 (right rear abraded test site); rabbit #202 

(right front abraded test site; scored "1")] for the 24, 72, and 

7 days observations. Primary irritation index equals 0.0 (based 

on non-abraded test sites). 

Speoial comments: 

1. The EPA guideline for dermal irritation (§81-5) lists a 

contact time of 4-hours. The contact time in the present study 

(MRID 418630-02) was for 24 hours. The Agency considers the 24 

hour contact time a more severe test, and the study is acceptable 

for the registration of this product. with the use of a 4 hour 

contact time, it is less stressful and allows the animals not to 

be placed into stocks. Several references in the literature 

indicates basically no difference for regulatory purposes for 4 

verses 24 hour contact times. 

2. The EPA guideline for dermal irritation (§81-5) lists 

the usage of non-abraded skin test sites. In the present study 

(MRID 418630-02) abraded and non-abraded test sites were used. 

The data are acceptable to help register this product. Several 

references in the literature indicates basically no difference 

for regulatory purposes for abraded verses non-abraded test 

sites. 
68

6 

ACUTE TOXICITY ONE-LINER 

1. PC CODE: SHA 046701; Indole-3-butyric acid 

2. CURRENT DATE: 8-9-94 

3. TEST MATERIAL: Indole-3-butyric acid; EPA Reg. No. 42473-1 

Study/Species/Lab/ MRID No. Tox- Core Grade 

Study#/Date Results icity 

category 

Eve irritation 4l8630-01 Observed post -- supplementary; 

)31-4) /New Zealand exposure: can be upgraded 

Ibbi t/Syntex opacity to 7 to guideline with 

Research, Palo days; iritis to statement to the 

Alto, CA/16-B- 7 days: grades 2 PM that the 

l1608-XX-00-0-EY- or above for exposure time was 

LL/5-30-80. conjunctivae to 24 hours. Then, a 

3rd day. toxicity category 

II can be 

assigned. 

Dermal irritation 418630-02 P.!'!. = 0.0 IV Guideline 

(§81-5)/New Zealand 

rabbit/Syntex 

Research, Palo 

Alto, Ca/15-B-80-

11608-XX-0-SK-LL 

(EH)/6-2-80. 

) 

-
69

OP BARCODE: D192182 

CASE: 041238 

SUBMISSION: 8440832 

DATA PACKAGE RECORD 

BEAN SHEET 

DATE: 06/11/9 

Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE:~REGISTRATION 

CHEMICALS:,~046701 IBA 

. ACTION: 674 8 MNTH RESP~PROD SPC DATA--' 

97.0000 

ID#: "Q,4.24"7:HT6001 INDOLE-3-BUTYRIC ACID 

COMPANY: 042473 SYNTEX, S.A. DE C.V. DIVISON QUIMICA 

PRODUCT MANAGER: 22 .1(.]NTHIAGILES .. 7PARKER 703-305-5540 ROOM: CM2 229 

PM TEAM REVIEWER: ~QNARD COLE. 703-305-7801 ROOM: CM2 265 

RECEIVED DATE: 05/13/93 DUE OUT DATE: 11/09/93 

* * * DATA PACKAGE INFORMATION * * * 

DP BARCODE: 192182 

,CHEMICAL: 046701 IBA 

EXPEDITE: N 

';op TYPE~ 001 Submission Related 

ADMIN DUE DATE: 09/09/93 

ASSIGNED TO DATE IN 

DIV : RD / / 

BRAN: RSB / / 

SECT: "J'RS" / / 

REVR "'" / / 

CONTR: / / 

Data Package 

CSF: Y 

DATE OUT 

/ / 

/ / 

/ / 

/ / 

/ / 

* * * DATA REVIEW INSTRUCTIONS * * * 

~->' '-,%!r-?""~ -~-~~,_~ __ _ 

_ ~REREGISTRATION** 

DATE RET.: 

LABEL: Y 

PLEASE REVIEW THE ACCOMPANYING DATA PACKAGE (PRODUCT 

SPECIFIC DATA) SUBMITTED IN SUPPORT OF THE RE-REGISTRATION 

OF THE ABOVE MENTIONED PRODUCT. A BATTERY OF SIX ACUTES IS 

NOT INCLUDED WITH THIS PACKAGE. ALL ACUTE TOXICOLOGY DATA 

HAVE BEEN WAIVED EXCEPT PRIMARY EYE IRRITATION, AND PRIMARY 

SKIN IRRITATION. THE MRID #S FOR THE AFOREMENTIONED ARE 

41863001 AND 41863002. YOUR COMMENTS ARE GREATLY 

APPRJ>CIATED. MANY THANKS ... 

DP BC 

192183 

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

BRANCH/SECTION 

RSB/PCRS 

DATE OUT 

06/11/93 

DUE BACK 

09/09/93 

INS 

Y 

CSF 

Y 

LABEL 

Y 

/ / 
70

SYM80L 

C"TE 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

CERTIFIED MAIL 

Deborah Halliday 

D. Halliday & Company 

3803 Luneta Lane 

Fallbrook, California 92028 

Dear Ms. Halliday: 

Subject: Indole-3-Butyric Acid 

Reg. No. 42473-1 

Re: Reregistration 

NOV I 8 ioen I,'v~ 

Your submission dated October 25, 1993 

The Data Requirement Listing for the Selective Method of 

Support submitted in connection with registration under section 

4(g) of the Federal Insecticide, Fungicide, Rodenticide Act, as 

amended, has been received, and the data listing is incomplete for 

the following reason: 

Although you have listed the product specific data 

requirements on the data listing, you have failed to 

include the generic data requirements. Your product is 

a technical grade pure form active ingredient or a 

manufacturing use product; therefore, you must include on 

the data listing the generic data requirements. Also 

this product does not qualify for formulators exemption. 

Please submit a revised data listing which includes the 

generic data requirements to the Agency within fifteen (15) days of 

the receipt of this letter. Please note that the Notice of Intent 

to Suspend your product's registration will remain in effect, until 

the above mentioned information is received. 

Sincerely, 

Cynthia Giles-Parker 

Product Manger (22) 

Fungicide-Herbicide Branch 

Registration Division (7505C) 

COHCURR!NC:!S 

1f.e.~ .. ~ ............................................................................................................................. . (;01% ··;i·Tt~?:;:;··· ................. ................. . ......... ~...... ................. ................. .................. .. ............. .. 

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71

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! 

ATTACHMENT II 

Micro Flo Co. (63079-1); NOITS for failure to comply with 8 month 

response, i. e. failure to satisfy Product Chemistry Guideline 

requirement nos. lS1B-IO through 16, and 151B17{a,b,c,f,i,k,1,m,n,ol, Acute ToxicOlogy Guideline requirement 

nos. 152B-IO through 16; failure to submit any of the proper 

administrative forms. 
80

) 

) 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

ocr 8 1993 

CERTIFIED MAIL 

Return Receipt Requested 

SYNTEX, S.A. DE C.V. DIVISON QUIMICA 

D. HALLIDAY & COMPANY, INC (AGENT) 

3803 LUNETA LANE 

FALLBROOK, CA 92028 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TQXICSUBSTANCeS 

Subject: Suspension of Registration of Pesticide Product(s) 

Containing Indole-3-Butyric Acid for Failure to 

Comply with the Indole-3-Butyric Acid section 4 

Phase 5 Reregistration Eligibility Document Data 

Call-In Notice dated September 10, 1992. 

Dear Sir/Madam: 

This letter gives you notice that the pesticide product 

registrations listed in Attachment I will be suspended 30 days 

from your receipt of this letter unless you take steps within 

that time to prevent this Notice from automatically becoming a 

final and effective order of suspension. The Agency's authority 

for suspending the registrations of your products is section 

3(c) (2) (B) of the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). Upon becoming a final and effective 

order of suspension, any violation of the order will be an 

unlawful act under Section 12(a)(2)(J) of FIFRA. 

You are receiving this Notice of Intent to Suspend because you 

have failed to comply with the terms of the Phase 5 Reregistration 

Eligibility Document Data Call-In Notice imposed pursuant to 

Section 4(g) (2) (B) and Section 3(c)(2)(B) of FIFRA. 

The specific basis for issuance of this Notice is stated in the 

Explanatory Appendix (Attachment III) to this Notice. The affected 

product(s) and the requirement(s) which you failed to satisfy are 

listed and described in the following three attachments: 

Attachment I 

Attachment II 

Attachment III 

Suspension Report - product List 

Suspension Report - Requirement List 

suspension Report - Explanatory Appendix 

W RecycledIRecyclable T)." J:"\ Prlnled with $oylCllnoJI Jnk on plIpeI Uta! 

'0<;7 oonWIIS It IOIIIt 50% recycted Itber 
81

) 

) 

- 2 -

The suspension of the registration of each product listed in 

Attachment I will become final unless at least one of the 

following actions is completed. 

1. You may avoid suspension under this Notice if you or another 

person adversely affected by this Notice properly request a 

hearing within 30 days of your receipt of this Notice. If you 

request a hearing, it will be conducted in accordance with the 

requirements of Section 6(d) of FIFRA and the Agency's Procedural 

Regulations in 40 CFR Part 164. 

section 3(0)(2) (B), however, provides that the only allowable 

issues which may be addressed at the hearing are whether you have 

failed to take the actions which are the bases of this Notice and 

whether the Agency's decision regarding the disposition of 

existing stocks is consistent with FIFRA. Therefore, no 

substantive allegation or legal argument concerning other issues, 

including but not limited to the Agency's original decision to 

require the submission of data or other information, the need for 

or utility of any of the required data or other information or 

deadlines imposed, and the risks and benefits associated with 

continued registration of the affected product, may be considered 

in the proceeding. The Administrative Law Judge shall by order 

dismiss any objections which have no bearing on the allowable 

issues which may be considered in the proceeding. 

section 3(0)(2) (B) (iv) of FIFRA provides that any hearing must 

be held and a determination issued within 75 days after receipt 

of a hearing request. This 75-day period may not be extended 

unless all parties in the proceeding stipulate to such an 

extension. If a hearing is properly requested, the Agency will 

issue a final order at the conclusion of the hearing governing 

the suspension of your product(s). 

A request for a hearing pursuant to this Notice must 1) include 

specific objections which pertain to the allowable issues which 

may be heard at the hearing, 2) identify the registrations for 

which a hearing is requested, and 3) set forth all necessary 

supporting facts pertaining to any of the objections which you 

have identified in your request for a hearing. If a hearing is 

requested by any person other than the registrant, that person 

must also state specifically why he asserts that he would be 

adversely affected by the suspension action described in this 

Notice. Three copies of the request must be submitted to: 

Hearing Clerk, A-110 

u.s. Environmental Protection Agency 

401 M street, SW 

Washington, DC 20460 
82

- 3 -

and an additional copy should be sent to the signatory listed 

below. The request must be received by the Hearing Clerk by the 

30th day from your receipt of this Notice in order to be legally 

effective. The 3D-day time limit is established by FIFRA and 

cannot be extended for any reason. Failure to meet the 30-day 

time limit will result in automatic suspension of your 

registration(s) by operation of law and, under such 

circumstances, the suspension of the registration for your 

affected product(s) will be final and effective at the close of 

business 30 days after your receipt of this Notice and will not 

be subject to further administrative review. 

The Agency's Rules of Practice at 40 CFR 164.7 forbid anyone who 

may take part in deciding this case, at any stage of the 

proceeding, from discussing the merits of the proceeding ~ parte 

with any party or with any person who has been connected with the 

preparation or presentation of the proceeding as an advocate or 

in any investigative or expert capacity, or with any of their 

representatives. Accordingly, the following EPA offices, and the 

staffs thereof, are designated as judicial staff to perform the 

judicial function of EPA in any administrative hearings on this 

Notice of Intent to Suspend: the Office of the Administrative Law 

Judges, the Office of the Judicial Officer, the Administrator, 

the Deputy Administrator, and the members of the staff in the 

immediate offices of the Administrator and Deputy Administrator. 

None of the persons designated as the judicial staff shall have 

any ex parte communication with trial staff or any other 

interested person not employed by EPA on the merits of any of the 

issues involved in this proceeding, without fully complying with 

the applicable regulations. 

2. You may also avoid suspension if, within 30 days of your 

receipt of this Notice, the Agency determines that you have taken 

appropriate steps to comply with the section 4 Phase 5 Reregistration 

Eligibility Document Data Call-In Notice requirements. In order to 

avoid suspension under this option, you must satisfactorily comply 

with Attachment II, Requirement List, for each product by submitting 

all required supporting data/information described in Attachment II 

and in the Explanatory Appendix (Attachment III) to the following 

address (preferably by certified mail): 

Office of Compliance Monitoring (EN-342) 

Laboratory Data Integrity Assurance Division 

u.s. Environmental Protection Agency 

401 M street, SW 

Washington, DC 20460 
83

) 

- 4 -

For you to avoid automatic suspension under this Notice the 

Agency must also determine within the applicable 30-day period 

that you have satisfied the requirements that are the bases of 

this Notice and so notify you in writing. You should submit the 

necessary data/information as quickly as possible for there to be 

any chance the Agency will be able to make the necessary 

determination in time to avoid suspension of your product(s). 

The suspension of the registration(s) of your companyts 

product(s) pursuant to this Notice will be rescinded when the 

Agency determines you have complied fully with the requirements 

which were the bases of this Notice. Such compliance may only be 

achieved by submission of the data/information described in the 

attachments to the signatory below. 

Your product will remain suspended, however, until the Agency 

determines you are in compliance with the ,requirements which are 

the bases of this Notice and so informs you in writing. 

After the suspension becomes final and effective, the registrant 

subject to this Notice, including all supplemental registrants of 

product(s) listed in Attachment I, may not legally distribute, 

sell, use, offer for sale, hold for sale, ship, deliver for 

shipment, or receive and (having so received) deliver or offer to 

deliver, to any person, the product(s) listed in Attachment I. 

Persons other than the registrant subject to this Notice, as 

defined in the preceding sentence, may continue to distribute, 

sell, use, offer for sale, hold for sale, ship, deliver for 

shipment, or receive and (having so received) deliver or offer to 

deliver, to any person, the product(s) listed in Attachment I. 

Nothing in this Notice authorizes any person to distribute, sell, 

use, offer for sale, hold for sale, ship, deliver for shipment, 

or receive and (having so received) deliver or offer to deliver, 

to any person, the product(s) listed in Attachment ~ in any 

manner which would have been unlawful prior to the suspension. 

If the registration(s) of your product(s) listed in Attachment I 

are currently suspended as a result of failure to comply with 

another Section 4 Data Requirements Notice or Section 3(c) (2) (B) 

Data Call-In Notice, this Notice, when it becomes a final and 

effective order of suspension, will be in addition to any 

eXisting suspension, i.e., all requirements which are the bases 

of the suspension must be satisfied before the registration will 

be reinstated. 
84

1 

- 5 -

You are reminded that it is your responsibility as the basic 

registrant to notify all supplementary registered distributors of 

your basic registered product that this suspension action also 

applies to their supplementary registered products and that you 

may be held liable for violations committed by your distributors. 

If you have any questions about the requirements and procedures 

set forth in this suspension notice or in the subject Section 4 

Phase 5 Reregistration Eligibility Document Data Call-In 

Notice, please contact stephen L. Brozena at (703) 308-8267. 

Attachments: 

Sincerely yours, 

Michael M. Stahl, Director 

Office of Compliance Monitoring 

Attachment 

Attachment 

Attachment 

I - Product List 

II - Requirement List 

III - Explanatory Appendix 

bee: Culleen/Opp 

Barolo/OPP 

Ross/OGC 

Dull/OCM 

Brozena/OCM 
85

- 5 -

You are reminded that it is your responsibility as the basic 

registrant to notify all supplementary registered distributors of 

your basic registered product that this suspension action also 

applies to their supplementary registered products and that you 

may be held liable for violations committed by your distributors. 

If you have any questions about the requirements and procedures 

set forth in this suspension notice or in the subject section 4 

Phase 5 Reregistration Eligibility Document Data Call-In 

Notice, please contact stephen L. Brozena at (703) 308-8267. 

Attachments: 

Attachment I 

Attachment II 

Attachment III 

Sincerely yours, 

- Product List - Requirement List - Explanatory Appendix 

, Director 

iance Monitoring 
86

ATTACHMENT I SUSPENSION REPORT - PRODUCT LIST 

SYNTEX, S.A. DE C.V. DIVISON QUIMICA 

PAGE: 1 

EPA Registration Product Name 

Number 

42473-1 INDOLE-3-BUTYRIC ACID 

) 
87

ATTACHMENT II SUSPENSION REPORT - REQUIREMENT LIST 

SYNTEX, S.A. DE C.V. DIVISON QUIMICA 

PAGE: 1 

Guideline Requirement Name original 

Reference No. Due Date 

**** 

1# 

### 

1#11 

151-10 

151-11 

151-12 

151-13 

151-15 

151-16 

151-17 

152-13 

152-14 

Confidential statement of Formula (CSF) Form 

certification Form: Data Citation 

Certification Form: Offer to Cost Share 

Certification Form: Data Compensation 

Product Identity 

Manufacturing Process 

Discussion of Formation of Impurities 

Analysis of Samples 

certification of Limits 

Analytical Methods 

Physical and Chemical Properties 

primary Eye Irritation - Tier I 

Primary Dermal Irritation - Tier I 

05/10/93 

05/10/93 

05/10/93 

05/10/93 

05/10/93 

05/10/93 

05/10/93 

05/10/93 

05/10/93 

05/10/93 

05/10/93 

05/10/93 

05/10/93 
88

ATTACHMENT III SUSPENSION REPORT - EXPLANATORY APPENDIX 

This Explanatory Appendix provides a discussion of the basis 

for the Notice of Intent to Suspend issued herewith. 

On September 10, 1992, EPA issued the Phase 5 Reregistration 

Data Requirements Notice imposed pursuant to section 4 of FIFRA 

which required registrants of products containing Indole-3-Butyric 

Acid to develop and submit certain data. These data were determined 

to be necessary to satisfy reregistration data requirements of 

Section 4(g)(2)(B) of FIFRA. 

The Indole-3-Butyric Acid Phase 5 Reregistration Oata 

Requirements Notice dated September 10, 1992, required each affected 

registrant to submit materials relating to the election of the 

options to address each of the data requirements. That submission 

was required to be received by the Agency within 90 days of the 

registrant's receipt of the Notice. In that response you elected to 

cite data submitted by other registrants and stated that you would 

make offers to pay others for the required data. The Notice further 

required that data or appropriate administrative forms be submitted 

by deadlines noted for the subject data requirements on Attachment 

II. These deadlines have passed and to date the Agency has not 

received from you either adequate data or appropriate administrative 

forms to satisfy these data requirements. Because you have failed 

to provide an appropriate or adequate response within the time 

provide for data requirements listed on Attachment II, the Agency is 

issuing this Notice of Intent to Suspend. 
89

) 

) 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

CERTIFIED MAIL 

Ms. Deborah Halliday 

D. Halliday & Co. 

3801 Luneta Lane 

Fallbrook, CA 92028 

Dear Ms. Halliday: 

199'3 

OFFICE OF 

PESTICIDES ANOTOXIC 

SUBSTANCES 

Subject: Data Waiver Determinations in Response to the Indole-3-

Butyric Acid (lBA) Reregistration Eligibility 

Document (RED) 

Indole-3-Butyric Acid 

EPA Reg. No. 42473-1 

The Agency has reviewed data waiver requests made by 

registrants submitting 90-day responses to the lBA RED. Based 

on these reviews, we have made the fOllowing decisions that apply 

to your product: 

1. The Dermal sensitization Study, GRN 152-15 

and the Hypersensitivity Incidents, GRN 152-

16 are not required. 

Sincerely, 

'\sJawrence E. Culleen 

Acting Director 

R~gistration Division (H7505C) 

r!.lJi Printed on Recycled Paper 
90

l 

caNfiDENi/AL 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

FEB 2 A 1993 

OFF"ICE OF 

PESTICIO€S ANO TOXIC SUBSTANCES 

MEMORANDUM 

Subject: Response To Requested Review Of Data Waiver Responses 

For Indole-3-B.utyric Acid (IBA); Reregistration Eligibility Document (RED), Case No. 2330 (EPA Reg. Nos. 572-333 

thru 572-339, 869-60, 5332-10, 42473-1, 63310-8 1 64388-1). 

From: 

Cynthia Giles-Parker (PM 22) 

Fungicide-Herbicide Br. 

Registration Division .(H7505C) 

Van M. Seabaugh b~$ Precautionary Review section 

Registration Division (H7505C) 

Thru: 

l 

Thomas Ellwan~er, Jr.. . ~ / , C. ~-ri Head, Precautlonary ReVlew Sectlo~ 

Registration Division (H7505C) 

Summary (Recommendations) 

PRS Batching Acute Toxicity Data waivers 

EPA Reg. No. In IEA RED Granted Not Granted 

572-333 Table I, Batch 2 X 

572-334 Table II (no batch) X 

572-335 Table I, Batch 2 X 

572-336 Table I, Batch 1 X 

572-337 Table I, Batch 1 X 

572-338 Table I, Batch 1 X 

572-339 Table I, Batch 1 X 

869-60 Table II (no batch) X 

5332-10 Table II (no batch) X 

42473-1 Table II (no batch) X • 63310-8 Table II (no batch) X 

• 64388-1 Table II (no batch) X 

A wavier request is unnecessary, not justifiedl and denied. 

The studies (7) have been submitted to the Agency (see pages 

5 and 6 of this memo). 

Discussion 

According to the memo (Cynthia Gyles-Parker to Tom Ellwanger; 

received 2-8-93), several waivers were granted for acute toxicity 
91

CON FI D!:.J/1IAL 

2 

studies prior to issuance of the RED for IBA. It is stated in the 

memo that registrants have raised the issue that data should not be 

required because of previously granted waivers. The PRS believes 

the mentioned waivers were for generic data only, and are not 

applicable to end-use products. 

According to the IBA RED, the Agency has decided that the 

products are biochemical pesticides. Therefore, the acute toxicology data requirements for these end-use products [40 CFR, 

§158.690 (e)] are guideline references 152-10 (oral toxicity); 152-

11 (dermal toxicity); 152-12 (inhalation toxicity); 152-13 (eye 

irritation) ; 152-14 (dermal irritation) ; 152-15 (hypersensitivity). 

Rockland Corporation (EPA Reg. Nos. 572-333 thru 572-339) 

Per letter (Judith Lemm to EPA Document Processing Desk; 12-9-

92), the eye and dermal irritation toxicity data cited for EPA Reg. 

Nos. 572-333 thru 572-339) are MRID Nos. 418630-01/-02. Response 

(PRS): The microfiche copies of 418630-01 (eye irritation test) and 

418630-02 (skin irritation test) were retrieved, and determined to 

be for IBA (technical). These data for a technical (straight chemical) cannot be used for these end-use products (mixed chemicals) • 

The Agency still needs data for eye and skin irritation testing for 

these products. 

Rockland Corp. requested a waiver for oral and dermal 

toxicity. 

statement (Rockland) 

"We find the request for additional product specific data in 

direct conflict to the RED background information in your correspondence. The previously granted low volume use waiver, low 

toxicity of the chemical that resulted in its reclassification to 

a biochemical pesticide and the reaction from the professional 

growers expressing a definite need for continuation of products 

containing IBA contribute to our decision to request a waiver for 

development of additional data." 

"Our products are labeled for and sold to professional nursery men only and are used in such diluted amounts that exposure is 

minimal. Our products would not be found in any area other than a 

professional grower's business where an awareness of safety precautions and the need to follow label directions would certainly be 

prevalent. The precautionary statements on our labels include the 

use of goggles, clean rubber gloves and protective clothing when 

handling these products." 

"It is evident that our volume of distribution is not conducive to justify addition(sic) data development." 
92

(!oNFIDt:/VT/AL3 

Response (PRS) 

We recommend that the waiver be denied. The lBA RED (pp. 5) 

talks about rBA (technical material). No oral and dermal toxicity 

data were presented for these end-use products (mixture of chemicals), and are still required as requested in our hatching document for lBA products. In general, toxicity data for a straight 

chemical cannot be applied to a product containing mixed chemicals. 

We cannot recommend labeling if we have no acute toxicity data on 

which to base that labeling. Comment (Ellwanger): Appropriate 

labeling is required regardless of knowledge of customers or their 

financial considerations. 

statement (Rockland): 

Rockland Corp. says that the Pesticide Assessment GuidelinesSubdivision M [§152-10 (inhalation) and §152-15 (hypersensitivity)] 

) are not applicable. 

Response (PRS): We disagree, and still request the information 

as stated in the IBA RED batching document. No scientific rationale 

was presented to justify granting waivers. 

Green Light Co. (EPA Reg. No. 869-60) 

Per letter [Jeff Leudke to Document Processing Desk (RED/RD/ 

PM22); 12-1-92], a waiver is requested for acute toxicity data 

submission. 

statement: (Green Light Co.): 

Syntex has additional data, or is in the process of generating 

additional toxicity data for IBA. IBA is very similar in structure 

to indole acetic acid, a naturally occurring auxin. EPA Reg. No. 

869-60 is not labeled for use on food crops, and of no residual 

concern for hUman consumption. It is not sprayed so there is no 

potential exposure from drift. It is applied at a very dilute rate 

(0.0004% lBA in product diluted further by application rate of 3 

1/2 tablespoons of product per one gallon of water). There is 

sUfficient data already generated on IBA. 

Response (PRS) 

Syntex has presented data to the Agency for rBA (straight 

chemical), but we have not seen any data for this end-use product 

(EPA Reg. No. 869-60; mixture of chemicals). IBA constitutes only 

.01% of this product. The registration jacket contains none of the 

required acute toxicity data (guidelines 152-10 thru 152-15), and 

we need the data. The presented information for the requested 

waiver of acute toxicity data is not sufficient to grant a waiver. 

The FRS contacted HED (John Whalen and John Redden) on 2-16-93 

regarding inhalation data waiver requirements for IBA products 
93

) 

{!tJIVr;OEIVTIAL 

4 

whose usage indicates dipping and not spraying. HED indicated that 

these types of products should be tested for inhalation toxicity 

even though the use pattern does not include any atomization. 

Playtabbs Products, Division Of Tango Industries, Ltd. (EPA Reg. 

No. 5332-10) 

Per letter (Edward Hartman to Document Processing Desk 

(Red/Rd/PM-22; 12-7-92), a waiver of all data was requested. 

statements (Flaytabbs Products): II 1) IBA is an innocuous 

chemical. 2) EPA has classified it as a biochemical. 3) Syntex has 

agreed to supply necessary studies. 4) Very low use experience. 5) 

Our product is not used on food crops. 6) Our product is not 

sprayed. 7) Our product does not 'drift'." 

Response (PRS): We recbmmend the waiver be denied. We still 

need acute toxicity data for guidelines 152-10 thru 152-15, because 

of the following information: 1) Acute toxicity from a technical 

product (straight chemical) and an end-use product (mixture of 

chemicals) may differ due to several things including II inert II 

ingredients, percentage of the technical ingredient in the formulated product, absorption, excretion, etc. 2) Unless waived by the 

Agency, acute toxicity data are required on all products including 

biochemical formulations. 3) Syntex's agreement is irrelevant to 

Playtabbs situation, because the data supported for Syntex's 

technical product (straight chemical) cannot be used for EPA Reg. 

No. 5332-10 (different formulation). The formulation of EPA Reg. 

No. 5332-10 was not found by EPA to be identical or substantially 

similar to other registered BT products. 4) The registrant is 

required to have the product properly labeled to help protect human 

health. The following Playtabb Products' statements do not relieve 

the registrant of that responsibility: 1) Low use volume; 2) Nonspray application; 3) Non-drift; 4) Uses on non-food crops. The PRS 

contacted HED (John Whalen and John Redden) on 2-16-93 regarding 

inhalation data waiver requirements for end-use products containing 

lBA whose usage indicates dipping and not spraying. HED indicated 

that these types of products should be tested for inhalation toxicity even though the use pattern does not include any atomization. 

D. Halliday & Co. (EPA Reg. No. 42473-1) 

Per letter (From Debroah Halliday to cynthia Gi1es~Parker; 12-

7-92), it says the following: 
94

) 

Pesticide 

_§l52-10 

_§l52-11 

_§l52-12 

_§l52-15 

5 

Assessment Guidelines - Subdivision M 

Acute Oral Toxicity: Previously waived. 

Acute Dermal Toxicity: Previously waived. 

Acute Inhalation: Previously waived. 

Dermal Sensitization: Waiver has been 

previously requested for sensitization and 

hypersensitivity studies • .. The product is a manufacturing use technical (TGAI), 

and not registered for end-use at this time. 

Question (Leonard Cole; PM Team 22): What about eye 

irritation? Is everything waived? 

Response (PRS): Listed in the Code of Federal Regulations 

(40 CFR; §158.690), are the toxicity data requirements. An eye 

irritation study (§152-13) is required for manufacturing use and 

end-use products unless the material is corrosive to the skin or 

has a pH <2 or >11.5 (such a product can be classified Toxicity 

category I based on potential eye and dermal irritation effects). 

According to the EPA IBA RED (page 5), HED waived the acute toxicity data requirements for IBA (technical). EPA Reg. No. 42473-1 is 

IBA (technical). Based on HED's decision on IBA (technical), we 

recommend granting a waiver for acute toxicity data. HED should be 

asked to provide labeling for this product, because they said that 

they have sufficient data. Studies reviewed in the PRS on 42473-1 

indicate the following: 1) Eye irritation (Toxicity Category II, 

guideline classification); 2) Dermal irritation (Toxicity category 

IV, guideline classification). (:..n..-I-. P (hJ 

Hortus USA Corp. (EPA Reg. No. 63310-8) 

Per letter (Joel Kroin to Cynthia Giles-Parker; 12-18-92), 

a waiver is requested for acute toxicity data. However, they 

provide no rationale for that request. The registration jacket for 

this product was checked on 2-11-93, and data were received and 

evaluated by EPA as follows: 

Acute Toxicity Test 

Oral toxicity 

Dermal toxicity 

Inhalation toxicity 

Eye irritation 

Dermal irritation 

llypersensitivity 

Toxicity 

Category 

IV 

III 

III 

III 

IV 

Classification 

Guideline 

Guideline 

Guideline 

Guideline 

Guideline 

Supplementary • 

An additional hypersensitivity 

Agency, and will be reviewed. 

study was submi tted to the 

A waiver request is unnecessary, not justified, and we 

recommend that it be denied. 
95

· -. 

6 

Astoria-Pacific. Inc, (EPA Reg. No. 64388-1) 

Per letter (Raymond Pavitt to Cynthia Giles-Parker; 12-21-92), 

a waiver of data submission is requested for acute inhalation 

testing. 

statement (Astoria-Pacific. Inc.) 

An inhalation toxicity data waiver is requested for this 

product, because it is inappropriate for this product. The product 

does not consist of an inhalable material. Under conditions of use, 

this product will not result in an inhalable material. The product 

is a liquid and therefore not applicable to inhalation studies. 

Response (PRS) 

The rationale presented by Astoria-Pacific, Inc. is not 

sufficient to grant a waiver. No other information (scientific 

rationale) was presented to us for our consideration. Therefore, we 

recommend to deny the request for an inhalation study. An inhalation test can be conducted on a liquid product. The PRS contacted 

HED (John Whalen and John Redden) on 2-16-93 regarding inhalation 

data waiver requirements for end-use products containing IBA whose 

usage indicates dipping and not spraying. HED indicated that these 

types of products should be tested for inhalation toxicity even 

though the use pattern does not include any atomization. 
96

, 

! 

) 

I~I SYNTEK I 

NET 1 KILOGRAM 

(2.2 LB.) 

INDOLE - 3 - BUTYRIC ACID 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

AC1NEINGREDIENT, 

indclo·3·8uty!ic ACid. 

INERT INGREDIENTS, 

.mi~. 97% 

_ .. max.3% 

, KEEPOUTOF REACH OFCH1LOAEN 

PRECAUTIONARY STATEt,!€HTS 

IlAZAFlO$ TO IlUMAHS 

AND DOMESnC ANIMALS 

WARNING 

C,","" "b'tantial hUI tomporOf)' """ IniU'l" Do "'" 

II"llneyos, on.klno< on clo!hing, W~o, g09Qi<>s. f."" wield 0' •• I<>Iy gI05"". Avoid ;nhal.fion 01 do.l 

Wosh tI<l<oUOhty with ooop and w.\of .fler haod~"!I 

and bolo,o eafing Of d,.,king. RamoY<! oon!.m'nowd 

elo!hing bolo,. """0. Road and onderstand !ho 

Ma!e,iaI S.fol)' Data Sheet 10' <KIdl!i""ol iOlomlolLOn 

~fo!O '"'"""'9 wfth!his PfoduC!. 

ST .... TEMENT OF 

PRACTICAL rnEATMEHT 

II In eye" Hold o)/",doo!>"o and IluOh with a .taody. 

genllo 51"""" 01 wa!er fo' 15 mino!"'. Go! modie.1 

.~.n!ion. If 'W'llow<>d: Dfln~ prompUy alo,ua quon· 

till' 01 m~K. eqg wh", 0' gelo~n 'oIution, Of ~ Ih.,o 

.re no! auallol>l .. 1'<11" Goanlilio' 01 w.lo,_ .... void 

oleohol. Ge! m<KIi<nl o!\efllion. 

EIiVIROHMEHT HAZ .... ROS 

Do no! diOOha!ge 'nlO loke'. suoam'.I"'0ds Of public 

W.IB", unl." io acCO,dant<! w~h an NPOES ""rm~. 

Fo' 90id;)tlCOc<>n13ct yOO! ,oaional ollico of tho EP ..... 

DIRECTIONS FOR USE 

111'0 "';ol'llon of FcdC!ollaw to u,o !hIS ploduCI ;n a 

moMo< ;"""",;",,"! wilh lis lobol",9 

Thlo cIlcmiOill may be u$O<l ooly \0, Iho formula"on 01 

o ploOf rooting prop,,'liOn, FO!muOIlo," ",,,,g thi. 

ploducl"6 ,",pon,;W. for obWning EPA 'o~i$!f.lion 

\of 'hoi' formul.ted 1"00"01'_ 

STORAGE AND DISPOSAL 

STORAGE: Slo,. p«>dUClIn origin:>! contain.' ontv. .w.y f,om o!ho, pe .. tcidoo. fMi!tzCf.!oW or f •• d. 

OISPOS .... l: 00 no! oontammalO ".10,. I<>od 0' 1000 

by slOl auo 01 d', !>"sol. W aO\O, moulting fiom tho u'o 

of 1l"Os p",doo! may bo di,!>" .. d 01 00 ,ilO 0' a! an 

opp!oved ".,IC dio!>",al !acility. 

ComFlo!elyempl)'ioo, by .haking and!oWlng .i<le, 

Iin<I bo~"",!o i<>c .. n oIi09ing paniclo,. Empty 'o,i· 

du!' iOlo matlulacwn09 <>qo;pmon!. D"po,q 01 aoy 

wa.W ,"""0"" il! app'op,lololy p<>'m~lod w .. !~ 

dlSpOOoll"';,I",. acco!ding 10 EP .... rodol""on. a! 4U 

C.F.R. 260 e!.oq. Tt>on dlopo,o o! lino' m ~ .aniWy 

landfill 0' by indno,a!ion il o~owed bYsta\o and IoCOI 

ou\hOriIi<! •. 

If d,om I. oon!.mln.wd ond caMO! bo ,,,o,,,d. 

d"'"" .. o! in !ho ... me m'n""'. 

SYNTEJ(, S.A. de C.V. DIVISION QUIMICA 

APARTADO POSTAL 517, CUERNAVACA, MOR. MEXICO , 

" , 

" , 
97

I$t SYNTE>( 1 

NET 1 KILOGRAM 

(2.2 LB.) 

INDOLE - 3 - BUTYRIC ACID 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

ACTIVE nmREDIENT: 

;"dciG-3-Bu,yr", Acid._ 

:!:Effi mGREDIENTS, 

_, ..... ,.,_,_.mtn. 97% 

__ ,.,., ... , ____ m" •. 3% 

KEEPOUT OF REACH OF CHILOREN 

PAECAlfTlOtlAAY STATEMENTS 

NAZARDS TO NUMANS 

AtlO DOM~STIC ANIMALS 

WARNING Couseo ,ubstanli.l&ut 'omP<".ry oyo in~ry. Do not 

getin oyos, 00 ,l<inorondothi"ll_ WO"goggles, t.oo 

.h,old or saloly glasses_ AvoJd Inhora,;"n 01 du'" 

lVosh thoroughly wilh ,o.p and WO!~f al'er haJ>d~ng 

.nd boloro o."ng Of d,ink,ng, flomo'}O <=II.min,t"" 

I

c;.thing b~loro muso, Reod and utldorSl.nd ,ho 

",.leri.15,(ol)' D.t. Shoot tor addilional'"torm.~on 

ooIGf!) wor,ina w"h tIIi. prodUCf, 

I STATEMENT DF 

PRACTICAL TAEATM~NT 

II ," eyo., Nold eyalid' open arid liush with. OIe.dy. 

i '? $!re.m 01 water I.r 15 minutes, Ge' modie.1 

lon. II ",,.llowed: D"nk promp'ly a I.rg~ quon· 

"'f of mil;(. egg wh'"".f geia"n s.lulion, or;1 tIIo'. 

ore not aUa,l<>b(O, lorge qu.nl,t,os ot w.lor. Avoid 

o!cchol Gel mod,col a~onUon. 

~NVIRDNMENT NAZARDS 

Da cot dPchargo in:o lalIes •• ue.m,. po ods .r public 

~'":o''' unloss In ."""'rdan"" wilh an NPDES pormit 

F," go;O.nee cont.ct y.ur moionai ollie<> of 'ho EPA. 

.DIRECTIONS FOR USE 

I, IS , ",ol"llon 01 Foderol-Iow to uso this produ", ill a 

maOo"r IneonsiSlen! with il> taboUng 

This chomlc.1 moy bo ".ed only tor I .. to,mul.,io" 01 

a ptolnl m.'"'g prop.,."",,_ Fo,mule,,,,. u.ing this p,Oduc' are re,;xlnOibIO lor obtaining EPA fOg ~t'otion 

lor their lo,mutatod product" 

STORAGE AND DiSPOSAL 

STDRAGE: Storo dr.duo, iII o"glno1 cent:lJn.f .nly, 

away lrom o\hef peSiioidoo, lortilizef. tood or tood. 

DISPOSAL: O¢ not cootamln.,. wa'or. load Of 1.0><1 

by ,tor.go ordlSpos.1. W"-'too",.ul~ng trom th."",o 

ollh" product m.y ba d"pe...o 01 on oilo or at an 

apPf.Ued wosle disposailaeililY, 

Com plotoly .mpl)' linof by .hok,ng .nd lapp,ng "do. 

.tId bonom fo 1<).50n clinging paniclo" Empty ra,~ 

due ,nto m.nutactuflng equipment o,sp •• o 01 any 

waol. fe,iduu .t oppr.pflaloly pormillod wasl. 

di.po •• 11.,c,I,"os a""",rding '0 EPA regula".n. af40 

C.F.R. 260 ot .od, Then dispese olliner m a son~.ry 

10ndl,II Of by ioonef"'ion it ailoWlld bys"" •• nd Ioca:' I 

.u1ho';';05, 

II drum is cont.mlnatod ond C.MOt be f""wd 

dl$po.o 01 in 'he .omo m.nner, • 

SYNTEX, S.A. de C.V. DIVISION QUIMICA 

APARTADO POSTAL 517, CUERNAVACA, MOR. MEXICO 

I~I SYNTE>< I 

NET 1 KILOGRAM· 

(2.2 LB.) 

INDOLE - 3 - BUTYRIC ACID 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

A(;TIVi'c INGREDIENT: 

1:,riah-3.8utyfic Aold, 

HERT INGREDIENTS, 

........ __ ,min. 97% 

" ....... ",max, 3% 

Cp.' Rog flo 42473-t EPA E" No' 4247:J~~X t 

KEEP OUT OFREACH OFCH!LDREN 

PRECAUnONARY STATEMENTS 

NAZARDS TO NUMANS 

AND DOMESTIC ANIMALS 

WARNING c,,;,~, oobOl.oti.1 but 'amperory eyo iniury. O¢ not 

got'" oyo;, On 5kin Of on cJ.th",g. WOOf s<'ggloo. loco I oh'otd Cr salol)' 9""""5, Av~,d Inhol.tion 01 dU'I. 

, 'No," '"~[¢ughly w"h 5¢.p ond WO",f .llof hand~ng I "od oolccc ca"og or drinking. RomoUo cen,.mlnatod 

le!o'O>;1 oolore re"oo, Ro.d and uodorsl.nd 1110 

Ma:o,ial salal)' DOl. Shoot lor odd";.n.1 inlorm.tloo 

;"'Iom \',O[I:,"g w,m this produot. 

STATEM~NT OF 

PRACTICAL TR~ATMENT 

'I '" o)'a,' Held ey<>lid. open ""d I~,h with. ,taody, 

I

YO,;o ""am 01 water tor r5 minute" Go, m~ioal 

""o",,,,~ ii ow"'Iowa<!: Dr;n, Pfomptly .I.rge qu.n_ 

"'",. ot o;,lk. og9 wh,lo. Of go!."n ,olulion. or il tho"" 

'''e no' ava,lable, I.rs~ quon",;o5 01 W.lor, Al'Old 

,: __ oh,,' Got m04;""I.ttontion, 

ENVIROltMENT IiAZARDS 

I ;;~ 0"' dloch'rge 'nlo laka" ,."0""", »Onre or public i ,,"'ors unlo,s in .c",rd'ne<> wilh .n NPD~S pormi', I CN "danoo ",nlMt yOUf region.I.Uice 01 ,he ~PA. 

DIRECTIONS FOR USE 

II " a v,.I.tion 01 FedOf"llaw 10 UsO- this product iII a 

mon""r in",no"tan' with ~.I.benng 

T/1i. d",micaJ m&y be us.d only 1of !he 10rm,lo""n 01 

a pl.nt footing pJ<Ipor.tion. FO/mu~,o,. USing rhi' 

pfoduct ar~ rospen,ibl& tor obraining EPA fegl51[ali¢n 

tor tIIoif !O/mula~ produc ... 

STORAGE AND DISPOSAL 

STORAGE: Store product in 00(/II.1 cefllal""f ""Iy, away 1r.m other poslicidll5. r"rUtzof. load or lood, 

OISPOSAL: Do not contom;nat. water, 100d.oftood 

by 'IOrag' Of disposal. W.stes ro.u~ing Irom Ihou,"" 

01 ,hi. product may b~ d"'pe •• d 01 on "I<> .r at an 

approved Was'O dl$pa,,,; 1"",~I)'. 

Complotoly 0 mp ty linaf by shoi< Ing and tappiill! .,doo 

.tId bOMm 10 Iooocn ol'ng!-,g p.r~clo., Emply re.i. 

due into m""ul.onIOng ~quipmont. D«»O"" ot .ny 

1'1'''0 rooidue. 0' approp"a,oly porm,tred W."te 

d;'pe,aI10OlI,tloO acrordmg t. ~PA r.aublion. at 4a 

C.F,R. 26aet ,ed, Thon dIOpooc ollinof In a '.nitary 

(ondmlor by mciIlo,."on il .llowud bY''''te ar>J ~ 

.utllon,,,,o, 

It drum" panlO-m,na,od and ""nnot be mu,~. 

di,pe", ot iII tha samo matlner. 

SYNTEX, S.A. de C.V. DIVISION QUIMICA APARTAnopn~TA1 <;17 (,11!:D~''''f",...A .............. ,,.~~ 

[~I SYNTEXI 

NET 1 KILOGRA 

(2.2 LB.) 

INDOLE - 3 - BUTYRIC ACID 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

ACTIVE INGREDIENT' 

Indol".3.8ulYf", AcId """"" __ , ......... min, 97% 

INERT INGREDIENTS, ,maX, 3% 

EPA Reg N. dZ473 t EPA E5i No: 4~47:).MX t 

KEEP OUT OF REACH OF CHILDREN 

PRECAUTIONARY STATEMENTS 

NAlAADS 10 NUMANS 

AND ODMESTIC ANIMALS 

WARNING Cau.es .ub'''a"ijal but tamP<'r""f.ye Iniury. Do n.t 

g'" iII 0Y.',on.,inoron clothiill!. Weofg~gl"'.I.co 

.hleld or salol)' gto,.o •. Al'O,d mhelalion oj duSi. 

Wa.h 'harougNy wi,h ""OP .nd WIllor .ltaf h.nd~ng 

and belore o.ting or dflnl<ing. Romov~ o.ntami,"".d 

clorhing bo10rG feuSO. R •• d atld und."t.nd tho 

Mal.ri.1 SalGty D3", Sheot I.f odd"",n$! !-,J""",.,.,. bolora w.f<Jng witll tIIi. pr.duct. 

STATEM~NT OF 

PRACTICAL TREATMENT 

It iII eyoo: N.W oyelid. open .nd tlusll with. ,to.dy, 

gende "ro.", of wa'Of lor t5 minu,o" Gol m~,cal 

anon~on. ~ swal~wod, Dfin, promd'iy. f4rge qu.n_ 

IiI)' ot m'lk. egg whila. or gelat'n >oluton, or il tIIo,e 

.ro n.t .vail:>ble, I.,go qu.n""os .1 wa'er, Alt(>id 

.Icohol, Got "'04icol ,non"on. 

ENVIRONMENT NAZAADS 

Do not d;,oha'll e into 10,,,.. otream" p<>ndo .f IXJ b~c 

1'101.[$ unless in ."".rd.Me w"h an NPDES po"",~ 

FOf9UldoMe cont",:! yeUf iagi¢no1 off,co ot til. EPA. 

DIRECTIONS FOR USE 

II i. a Ulola,,"" ot F<!<Ior.llaw to us. this product 

m.nnor incon'"''''nt with il< I,bolina 

Th;, chemi<:.1 m.y bO u""" only lor tho tormulobo 

a plont rooting prop",&tl.n, Formul.to", uoing 

produci "'0 rospMSiblo lor obtaining EPA regi.". 

tof ,heir tormtJlofCd pfO<!uru. 

STORAGE AND DISPOSAL 

STORAGE: S,oro pro<lU<:1ln o"ginal centalnef on 

.way 1rom Olhef po.lioldo., tM'''or. load Of 100r 

DIS~OSAL: 00 nol contamin.1O wator. I.od or to, 

bY'I.fogaofd~»O,"I, W"",o. r""ulliill!lrom!he u, 

01 tIIis pred"ot""'y be disp •• ed oj on .i"'.f Of f 

.pprol'Od mote ",pe,.11,c"ly. 

Complo:olye"'ply linef bYShol<ing.n<! IO-ppiIlg old, 

""d bOf1.m to Iooocn cf'n!)ing p.nklo •. Empl)' fe, 

du~ 1010 manulaclunng .q"pm.nt. Dispose oJ '" 

1'1."0 ro'idues at .pprop"aloly parmilled wao 

d;opooaI1'''','ie' a=d;ng '0 EPA rogulatlon. a" 

C.F.R. 26a e' ""q, Thon '"'P<"a otl;n.f in a 0"';1. 

I.ndl;! or by molneranon ;1.lkowad by ... ", and Ioc 

ou,ho,,~ ••. 

It drum is conlomin.1e<i .nd ""nno' Ix> reu .. , 

disposo .lln Iho sam. mannof, 

SYNTEX, S.A. de C.V. DIVISION QUlMICA 

APARTADO POSTAL 517, CUERNAVACA, MOR. MEXICO 

I~I SYNTE>< I 

NET 1 KILOGRAM 

(2.2 LB.) 

INDOLE - 3 - BUTYRIQ ACID 

PLANT GROWTH REGUL.¢.;r,OR . 

FOR FORMULATION US::? ONLY: 

ACTIVE INGREDIENT 

1r>d<>1<>.J·8uJync Acld, 

INERT INGREDIENTS , .. 

, .... min, 97% 

...... ;"ax,3% 

KEEPOUTOF REACH OFCHILOREN 

PRECAUTIONAflY STATEM~NTS 

NAZAflDS TO HUMANS 

AND DDMESTIC ANIMALS 

WARNING Cau.e& sub.fCntio1 b<rl IOmpo<a!}' .ye Irlury. 00 n.1 

got in 0)1<", on .kln or on clothing. Weaf goggle.>. laoo 

sIIiold Of sa10ty gla ..... A~d lMalaltOn ot duo~ 

W.s11 thoroughly w,th w'p and wo\Of aftor hand,ng 

and belowea'ing Of drinlliill!. Rem_ conl.mmated 

ctotiling b.k>r. feU5e, Road and undorstand tIIo 

Matori~1 Salely D.la Sho.t1", .dd,liono1 mto"".lion 

b.k>fO w.r'iIlg wilh this producl. 

STATEM~NT OF 

~RACTICAL TREATM~ffT 

II in oyeo: Nold .yobM. opon .nd tlu.h .. th 0 sready. 

aontle .ue~m 01 woter lof t5 minU"", Got m.di<:ol 

a~ontion. 11 ow.Uowod: Drink promptly a tar!!" quan· 

"I)' 01 mil~. egg wh~o. Of g.I.lin ,olutl"". Of ~ tho" 

ore not av."obl~, I"'Qo qu",,""O" 01 wa'Of, AUofd 

alcohol, Gef medicol Mon~on_ 

ENUIRONM~NT NAlAflDS 

00 nol dl>ch"'~a inlO Iak~'. olf •• mo, peodO.f pub~o 

wotO" unl.,. In =rdanO<! wilh.n NPDES pormit. 

Forgu,danco cenlaol)l<'uf r.gionalollioo ot tho EPA. 

• DIRECTIONS ~OR USE 

It i. a viotal,on 01 Fellcral 1<1"'10 u'o thi>'pfoJuCt '" a 

mannef iIlconsis,;!nt w,lh ilS labeling ,~) 

• Th .. ch.m 1",,1 mi./ be U.'od ",o1y tor tho lormul".l<)n 01 

a plont rooUng prapol.I.on. 'Formulo,,,,s,u51ng thl$ 

PfOduct "'. f .. """"ble'~f "''''',flIng ~pA(""b"o!inil lor 'hoir tormul':od p'.duO!s, 

• 

r---~~-"--.- '; STORAG~ AND DISPD~I.L 

STORAGE: St.re pici!uct ",'\>~ginal C<ItII.'""r ""Iy. away 1rom O'hOf pootioide .. 1eruli,ef. loed Of leod, 

Dls~OSAL: 00 n.t """I.minale wotar, too-d or tMd 

bystOf"!!O ",di,posal WaotO$[".uWllIJlfOm tho u.a 

01 ,hi. product moy be d«posed of on .i'. or at an 

app'"""d was", dJsposall.c'ity, 

Gomplorely.mply 'nof by.h.lIi"ll.tId 'applng ,Wo. 

and bottom to Ioooan e'nglng partidos, Empty fO"-

duo inlo m.nulocturing <>qulpmenl. D«pe'o ot .ny 

w ... t. reo1dua. a' appropfi.tely permittoo waote 

d'opoooll.elliti •• a<:cording to ~PA fogul.ti.n. al 40 

C,F,R. 200 a' ""q, Then di,po"," 01 nner ,n a $o.niIO!)l 

l.ndl,11 or by In"'''''r.lion il anow<><! by '10-10 and local 

~ulhoritios, 

~ drum ;. OOnlom,natad .nd o.nn.1 be roused, 

diOj>O'" 01 in tho """'. m""".f. 

SYNTEX, S.A. de C.V. DIVISION OUIMICA APARTAOO POSTAL 517. CUERNAVACA MOR MI=)(lr.n 
98

1 

} 

D. HALLIDAY & CO. 

3803 Luneta Lane Fallbrook, CA 92028 

6191728-2893 FAX 6191723-8590 

December 7, 1992 

Ms. Cynthia Giles-Parker, Product Manager (22) 

Fungicide-Herbicide Branch, Registration Division (H7505C) 

United States Environmental Protection Agency 

Crystal Mall, Bldg #2 

1921 Jefferson Davis Highway 

Arlington, VA 22202 

Reference: Indole-3-Butyric Acid 

EPA Reg. No. 42473-1 

Re: Request for waiver of data requirements 

Dear Ms. Giles-Parker: 

We are enclosing a Data Call-In Response form and Requirements Status and Registrant's 

Response to comply with our 90 day reregistration response. On the latter document, we 

have requested data waivers on some requirements. Our reasons follow: 

152B-1O Acute Oral Toxicity Previously waived. Please see attachment #1 

152B-ll 

152B-12 

Acute Dermal Toxicity Previously waived. Please see attachment #I 

152B-15 

152B-16 

Acute Inhalation Previously waived. Please see attachment #1 

Dermal Sensitization 

Hypersensitivity 

Incidents 

Waiver has been previously requested for 

sensitization and hypersensitivity studies. 

We are awaiting a response at this time. 

Please note that our product is the manufacturing use technical (TGAr). It is not 

registered for end use at this time. A document received with this data call-in identified 

our product as a liquid formulation. This is not correct. It is a crystaline powder and is 

not formulated in any way. 

Thank you for your assistance. Please contact us if you have any questions. 

Cordially, 

~0<-!M'tfU1 Deborah Halliday 

DHldw 

Enclosures (3) 

, , , , , , 

, , , , , 

, , >;,;" 

, , 

, , 

, , 

, , , , , , , 

, , " 

, " 

· , " , , >' , 

, J;' , 

, '3, 

· " · . ,., ;, 
99

,-.. _, 

_ 

united States Environmental Protection Agency 

Washington, D. C. 20460 

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE 

INSTRUCTIONS: Please t)lpe or prinT in ink. Please read carefully the attached instructions and supply !Ill" information requested o't!)l)"

Use addiTional sheet(s) if necessary. 

1_ Company name and Address 

D.HALLIDAY & CO 

AGENT FOR: SYNTEX t S.A. DE C.V. DIVI 

3803 LUNETA LANE 

FALLBROOK CA 92028 

4. Guidel ine 15. Study Title Requirement 

, ... ," 

Prod Ch ..... - Bioch_ieal 

151B-10 Product identity 

IS1B-11 Manufacturing procesS (1) IS1B-12 Oiscussion of formation of (2) 

ununtentional ingrdients 

lS1B-13 Analysis of sflnllles ,/ (3) lS1B-1S Certification of limits 

lSlB-16 Analytical methods 111) 

151B-17 (a) Color (12) 151B-17 (b) Physical state 

151B-17(C) <>Jo, (12) 

151B-17 (f) Oens i ty ",/ 

151B-17(i) pH' (6) 

151B-17(k) flalmlilbility 

151B-17(1) Storage stability '" (13) 

lSlB-17(m) Viscosity [8) 

10. Certification 

2. Case II and Name 

2330 Indole-3-butyric acid 

EPA Reg. No. 42473-1 

g 6. Use 7. test 6 Pattern Substance 

! 

ABCDEFGHIJKLMNO MP/EP ABCDEFGHIJKLMNO MP /EP 

ABCDEFGHIJKLMNO MP /EP ABCDEFGHIJKLMNO MP /EP 

ABCDEFGHIJKLMNO MPjEP 

ABCDEFGHIJKLMNO MP /EP ABCDEFGHIJKLMNO MP /EP 

ABCDEFGHIJKLMNO MP /EP 

ABCDEFGHIJKLMNO MP /EP ABCDEFGHIJKLMNO MPjEP 

ABCDEFGHIJKLMNO MP /EP ABCDEFGHIJKLMNO MP /EP ABCDEFGHIJKLMNO MP /EP ABCDEFGHIJKLMNO MP /EP 

3. D

P

ID

11. Oalc 

I certify that the statements made on this form and attachments are 

1 acknowledge that any knowingly false or misleading stateme may be 

or b9th under applicable law. /....

Signature and Title of Company's Authorized Representative 

; 12. Name of COOfJally Contact ----- 13. P)lone 

De bD""- I--I",! LJ"'-j CI'l
100

United States Environmental Protection Agency 

Washington, D. C. 20460 

REQUIREMENTS STATUS AND REGIS'I'RANT'S RESPbNSE 

INSTII:UCTIONS: Please type or print in ink. Plellse read carefully the attllched instructions and supply the information requested 011 th

Use additional sheet(s) if necessary. 

1. COIIpany name and Address 

D'HALLIDAY & CO 

AGENT FOR: SYNTEX, S.A. DE C.V. DIVI 3803 LUNETA LANE 

FALLBROOK CA 92028 

4. Guideline 

lI:equi rement 

"""", 

5. Study Title 

2. Case # and Name 

2330 Indole-3-butyric acid 

EPA Reg. No. 42473-1 

Progress 6 Reports 6. Use Pattern 7. Test Substllnce 

3. 

P

1 1 2 3 

1 151B-17 (n) Miscibility / _(9) ABCDEFGHIJKLMNO MPjEP 

151B-17 (0) Corrosion chllrllcteristics ABCDEFGHIJKLMNO MPjEP 152B-10 152B-11 152B-12 152B-13 

152B-14 

152B-15 152B-16 

Aeute Toxic - Biochemical 

Acute oral toxicity 

Acute dermal toxicity Acute inhallltion 

Primary eye irritation Primary dermal irritation 

Oermal sensitizlItion 

Hypersensitivity incidents 

(1) 

0,2) 

(3) 

m 

(1,2) (4) (5) 

ABCOEFGHIJKLMNO 

ABCDEFGHIJKLMNO 

ABCDEFGHIJKLMNO ABCDEFGHIJKLMNO ABCDEFGHIJKLMNO ABCDEFGHIJKLMNO ABCDEFGHIJKLMNO 

MPjEP 

MPjEP MPjEP 

MPjEP MP/EP MPjEP 

[ 

__ L_L_i_ Oille 

(full text of ce,tification 15 on page one). /;;.? 7":2-- 

" .. ----- 
101 -" 

United Environmental "" -, 

states Protection Agency - , - 

Washington, D. C. 20460 - - 

- - 

--' 

DATA CALL-IN RESPONSE 

INSTRUCTIONS: Please type or print in Please read carefully the attached instructions 1II'1d supply the information requested on 

Use additional sheet(s) if necessary. , 

-

__ _.

1. COI!'iPilIny nfl!lle and Address 2. Case 11 and NiIIOO 3. Date 

D.HALLIDAY & CO 2330 Indole-3-butyric acid PRO

AGENT FOR: SYNTEX, S.A. DE C.V. DIVI 

3803 LUNETA LANE 

FALLBROOK CA 92028 

4. EPA product 5. I wish to 6. G.mer ic Data 7. Product Specific Data Registration cancel this 60. I am claimimg 8 GeneriC 6b. I agree to satisfy Generic la. My product is a MUP and 

product regis- Data becouse I Dato requin!lllents os indicated I agree to satisfy the HUP 

tration vol un- obtain the aetive ingredient on the attached form entitled requirements on the attached 

tarity. from the source EPA regis- "Requirements Status and form entitled "Requirements 

tration number listed below. Registrant's Response." Status and Registrant's 

Response." 

42473-1 N.A. N.A. 71-.s 

8. Certification 9. ODte 

I o.,tlfy th't tho ,t.t.,.,t, .... '" thl' f". ,nd ,II ,tt,oh"'.t, •. I ,",00","". thot ,.y ,."I.,ly "',," m;,'"d;"" "",m1''' by'-.' d,_.t 

or both under applicable law. (r A P 

Si<;:lnature and Title of Coopany's Representutive V 

Il--,-k CJ 11. Phone Num

GI'l/J
102
103

\ 

iLLIDAY & CO. 

3803 Lunem Lane Fallbrook, CA 92028 

619/728-2893 FAX 619(723-8590 

December 7, 1992 

Ms. Cynthia Giles-Parker, Product Manager (22) 

Fungicide-Herbicide Branch, Registration Division (H7S05C) 

United States Environmental Protection Agency 

Crystal Mall, Bldg #2 

1921 Jefferson Davis Highway 

Arlington, VA 22202 

Reference: Indole-3-Butyric Acid 

EPA Reg. No. 42473-1 

Re: Request for waiver of data requirements 

Dear Ms. Giles-Parker: 

We are enclosing a Data Call-In Response form and Requirements Status and Registrant's 

Response to comply with our 90 day reregistration response. On the latter document, we 

have requested data waivers on some requirements. OUf reasons follow: 

152B-IO Acute Oral Toxicity Previously waived. Please see attachment #1 

152B-II 

152B-12 

Acute Dermal Toxicity Previously waived. Please see attachment #1 

Acute Inhalation Previously waived. Please see attachment #1 

f 152B_15 ~\'- Dermal Sensitization 

o 

l152B-16 r1J'Hypersensitivi ty 

Incidents 

Waiver has been previously requested for 

sensitization and hypersensitivity studies. 

We are awaiting a response at this time. 

Please note that our product is the manufacturing use technical (TGAI). It is not 

registered for end use at this time. A document received with this data caB-in identified 

our product as a liquid formulation. This is not correct. It is a crystaline powder and is 

not formulated in any way. 

Thank you for your assistance. Please contact us if you have any questions. " ., 

DHldw 

Enclosures (3) 

". ~ .. , . 

. . . ... 

, ..... 

· 

· ., .. . · . " . 
104

} 

1- " 

'''-' 

United states Environmental I?rotection Agency 

Washington, D. C. 20460 

REQUIREMENTS STATUS AND S RESPONSE 

; • 

fNSTRUCTlOIIS: Plcase type or print in ink. P\case read carefully the attached instructions and supply the inFor"mtion requcsted 0,1 this 

Use lIdditiDnll1 sheet(s) it necessllry_ . ' 

I. nllme lind Address 2. Case II and Name 3. Dat

D'HALLIDAY & CO 2330 d 1 b " "d AGENT FOR: SYNTEX, S.A. DE C.V. DIVl In a e-3- utyr2c aC2 PR

3803 LUNETA LANE 10

FALLBROOK CA 92028 _ EPA Reg. No. 42473-1 

I.. Guideline 5. Study Title g Progress 6. Use 7. Test 

Requi rement l Reports Pattcrn Substance 

lIurber C 

o I 2 3 

, 

151B-17 (n) HiscibiHty ,(9) ABCDEFGHIJKLMNO MPjEP 

151B-17 (0) Corrosion choracteristics ABCDEFGHIJKLMNO M¥'jEP 

Acute Toxic - Biochemical 

152B-10 Acute orlll toxicity (1) ABCOEFGHIJKU1NO MPjEP 152B-11 AcuTe dermal toxicity (1,2) ABCDEFGHIJKLMNO MPjEP 

1528-12 Acute inhllllltion (3) ABCDEFGHIJKLMNO MPjEP 

152B-13 Primary eye irritation (2) ABCDEFGHIJKLMNO MPjEP 152B-14 Primary derma \ irritation (1,2):/ ABCDEFGIUJKLMNOMPjEP 152B-15 Oermal sensitizlltion (I.) ABCDEFGHIJKLMNO MPjEP 152B-16 Hypersensitivity incidents (5) ABCDEFGHIJKLMNO 

'<"::: -

____ 

=:1 0"" / _
105

ATTACHMENT I 

UNITED STATES ENVIRONMENTAL PROTECTION AG.NCY 

WASHINGTON, D,C. 20460 

II i

'

, 

" 

007637 

Indole-3-butyric Acid I I.!:::M ik>lume!Minor Use Rsql'est fur Data Waiver 

~ay Ellenbergerr, PM Team 50 

Sepecial Review anl Rer<gistration Nvisi,;>, (H7509C) 

/~~7 .--?~ ______ Fobert p. Zendzian Ph.D., ' ... ;:--.~ :;;;,::: 

Actin; Heoil, Rev Sec I ~~ __ _ 

Toxicology Branch I 

Health eJ;fects Division (H7509C) 

11l.'<OUGH: Edwin Bcrid 

Actin; Chief 

Toxicology Branch I 

Willi Z21\ Burni!l:lT\ 

Deputy Director 

Health Effects Division 

Compound; Indole~3-butyric Acid 

R<gistrant, N/A 

Acti9n RegUested 

Tax Glen #499 

MRID #N!A 

Registration #802-149 

Tox Project #9-1509A 

In resfOnse to a data call in notice on Indole-3-butryic Acid (lEA) 1 several 

t'egistrants have re:J.l..lest.e:1 &ta waivers basad in lew volurne/minor u.se. Toxicology 

data requirerrents fur the teclmical rrataria! as statoo in the CCI are; 

81-1 Acute oral - Ret 

81-2 Acute darrral - Rabbit 

81-3 Acute inhalation - Ret 

Reco!l11>mdation 

82- 3 9O-day deIn1al - Rabbi t 

84-2 Mutagenicity Batter:,' 

ToxiC01~ r~n::1s that t..'1e data waiver be grante5. IEA. is used. sP;lcHically ali a rootlngTent tor ~cry cuttings. Use concent:rat!btr"L'1 the 6.."1d use pt-odo.lct 

is 0.004%. T'ne h:me affier pro:iuct. is fb:onulated as a fOwder and rold in fbi:.' 

packages of 0.4 to :2 ounces. The green hoose product is formulata::1 as a liquid in 

water arrl sold, only to o:mrrercial users, in conWners up to one gallon in size. 

Expo.sure to the user, even the ccmnercial user, is expected to be minute. 

One kilcgram or the ibnnulate:1 product contai!)S only 4 miligrams of lEA.. 
106

Page of 

Un,ted States EnVironmental Protect,on Agency 

Washington, DC 20460 Form Approved 

oEPA Certification with Respect to 

Citation of Data 

OMS No. 2070·0060 

Apprm'al expirt·s 9·30·90 

Appl,car.t's Name and Address 

Syntex Corporation 

P.O. Box 517 

Cuernavaca r Mor. Mexico 

EPA File Symbol/Reg,strat,on Number 

42473-1 

Product Name 

Indole-3-Butyric Acid 

Date of Applicat,on 

May 6, 1993 

I. This application is supported by all data submitted or cited in the application. 

I n addition. if cite-all options are indicated, this application is supported by all 

data in the Agency's files that concern the properties or effects of this product or 

of any other product that is identical or substantially similar, and that is one of 

the types of data that would be required to be submitted if this application 

sought the initial registration of a product of identical or similar composition 

and intended uses under the data requirements in effect on the date of approval 

of this application. 

2. I certify that, for each study cited in support of this application for registration that is an exclusive use study, I am the original data submitter, or have 

obtained the written permission of the original data submitter to cite that study. 

3. I certify that, for each study cited in support of this application for registration that is not an exclusive use study: 

I am the original data submitter; or I have obtained the written permission 

of the origipal data submitter to cite that study~ or 

I have notified in writing the companies who have submitted data I have 

cited to support this application and have offered to: (a) Pay compensation 

for those data in accordance with section 3(c)( I)(D) and 3(c)(2)(D) of the 

Federal Insecticide, Fungicide and Rodenticide Act; and (b) Commence 

negotiations to determine which data are subject to the compensation' 1 '

requirement of FIFRA and the amount and terms of compensation due,> ", 

if any. The companies I have notified are: (Check one) ., ,,' ; 

o All companies listed on the Pesticide Data Submitters List for all , 

active ingredients contained in my product (cite-all method or cite-ag" , , , 

option under Selective Method). (Also sign the General Offer to Pa.y' , ; 

Statement below.) , . " " , 

I1D Those companies who have submittted the studies which I have cited " 

(Selective method), " :,' 

~~~-cnc---c>r--o---~-,--~-----o~----~~~~~~--~----------~~~~-- Name and Title lce res. Dattj 

Deborah Halliday 5-6-93 

General Offer to Pa. ereby offer and agree to pay compensation to other 

persons, with reg 0 the approval of this application, to the extent required 

by FIFRA sec. 3(c)(I)(D) and 3(c){2){D). 

5-6-93 vice Pres. Date 

Deborah, Halliday 

EPA Form 8570.29 17.9&t 

... ~ . , , , , 

> •• ~ •• , , 

> ••• , • , , ., .' 
107

1 

oEPA 

Appllcant"s Name and Address 

United States Environmental Protection Agency 

Washington, DC 20460 

Certification with Respect to 

Citation of Data 

page of 

Form Approved 

OMB No. 20iO-0060 

ApprO\·al expir~s 9-30·90 

EPA File Symbol/Reglslriltlon Number 

42473-1 

Syntex Corporation 

P.O. Box 517 Product Name 

Cuernavaca, Mor. Mexico Indole-3-Butyric Acid 

Dale oj Application 

May 6, 1993 

I. This application is supported by all data submitted or cited in the application. 

In addition, if cite-all options are indicated, this application is supported by all 

data in the Agency's files that concern the properties or effects of this prod uct or 

of any other product that is identical or substantially similar, and that is one of 

the types of data that would be required to be submitted if this application 

sought the initial registration of a product of identical or similar composition 

and intended uses under the data requirements in effect on the date of approval 

of this application. 

2. I certify that, for each study cited in support of this application for registration that is an exclusive use study, I am the original data submitter, or have 

obtained the written permission of the original data submitter to cite that study. 

3. I certify that, for each study cited in support of this application for registration that is not an exclusive use study: 

I am the or~ginal data submitter; or I have obtained the written permission 

of the orig4nal data submitter to cite that study; or 

• 

I have notified in writing the companies who have submitted data I have 

cited to suwort this application and have offered to: (a) Pay compensation 

for those data in accordance with section 3(c)( I )(D) and 3(c)(2)(D) of the 

Federal Insecticide, Fungicide and Rodenticide Act; and (b) Commence 

negotiations to determine which data are subject to the compensation':' 

requirement of FIFRA and the amount and terms of compensation due,> "> 

if any. The companies I have notified are: (Check one) ',» ; 

o All companies listed on the Pesticide Data Submitters List for all , 

active ingredients contained in my product (cite-all method or cite-ail' , , , , 

option under Selective Method). (Also sign the General Offer to Pay,> , ; 

Statement below.) , , J ), 

[] Those companies who have submittted the studies which I have cited ) , 

(Selective method). ) , : , , ' 

and Title Oate 

Halliday/Vice 5-6-93 

offer and agree to pay compensation to other 

approval of this application, to the extent required 

and 3(c)(2)(D). 

and Title 

Deborah. Halliday/Vice 5-6-93 

, ... , , , ., , 
108

D. HALLIDAY & CO~ 

Enviromental Protection Agency 

Fl.uigicide-Herbic:ide Branch 

Product Management Team # 22 

-Room "266A Crystal Mall 2 

1921'. ·Jefferson Davis Highway 

Ar 1 ingt.on, VA 22202 

May 6, 19n< 

Dear 'Cynthia- Giles-Parker 

of, Indole-3-Butyric Acid. 

3803 Luneta Lane Fallbrook, CA 92028 

619/728-2893 FAX 619/723-8590 

All. data that t1aS been submittecJ is citr-,ld ill a;ubmitt2l1 

by EPA. identifier rlLlntbel"s. 

Cordj.ally-, 

Deborah. Hf'l Hday 

D ,'Hal·liday & CO , 

, 

, 

, 

, 

,. 

" 

.. 

• " 

, 

" , 

, » , , , 

, , • 

· , • 

" 

. 

.. ~ , ... , , • 

• • · ,. ~ " • • " · , , ~ , ,,~ . • ~ , 

• ~ • > •• 

• • " , .. ,;, , • • " " 
109

D. HALLIDAY & CO. 

3803 Luneta Lane Fallbrook; CA 92028 

619/728-2893 FAX 619!723-8590 . 

Page of 

NAME i\ND ADDRESS OF AF'PLI CliNT. 

PRODUCT NUMBER. 

PRODUCT NAME: 

. ~ . 

r;.lynt:~,'>r COI"por',,,ition 

P.o. EJOH :~.i7 

Cuernacaca, Mer. Me>:icc 

[ndole-3-Butyric Acid 

-""""".....,-----,----_._-_._-_._----_. __ ._---

DATA SUPPORTING GUIDELINE Hio(1UIREMENTS FOr, THE 

REREGISTRATION OF INlJDLE-:'(--BlJTYf'<lC ACID 

GUIDEl;.!NE 

CITATION 

TI TLI, or' ,rn.l1J Y CHAT!DN 

156.6,9_0 Produc t Chemis try ________ ... _____________ ._._. _____ _ 

_ 151-l,0-

151-11 

Product Identity 

1.51-12 ,PiSCLlssion 01' Fonll"at:ion 

151~.1'5:" , Certification cd L..imi tf:;; - -, . "-', -",,:,--:.' 151'-_1~- _, - Analytical Method . ,', -"-,',.', 

_ 151-'-17(a) 

151-17.(b) 

Color 

Physit;=al State 

Odor 

15,~:'~,t(!J) ~ 'Vapor Pressun;> . -"'-'"'/, 

151:"i7( i ) pH .,." . 

C I !<rJ 4.1 ::"'<B4401 

C 11<Cl 41 '':\[':)440:1 

C1I(IJ 415B44C11 

[;11<0 4.15E=J4402 

CIKD 41584402 

CII>:O 4151:-)4402 

CIIW 415fJ4403 

CH:O 41'584403 

CIKO 4i:5!:-)4403 

CII<O 41~\84,403 

CII-:O 4.1 :~84403 

Clim 41584403 

CH:fJ 41:184403 

CJKC3 4158440~~ 

C 11<0 41584403 

, 

, " 

, .. ~ . ,, , , " , , , , , , , - , ',~'~" , , 

, " - , > , , " 

, " " , , , . ~ ~ , , , , 

" " -, , , " , H , 

, , " ~ ~', ", , , , ~ >, " , 

" )'J. 
110

D. HALLIDAY & CO. 

- 3803 Luneta Lane Fallbrook; CA 92028 

6191728-2893 FAX 6191723-8590 -

Page . of 

NAMEf\ND ADDRESS OF APPLICANT. 

PRODUCT NUMBER, 

PRODUCT NAME, 

Synte>: Corpc:>r"t:1tion 

P.O. 'Bo}: ~517 

Cuarnacaca~ Mor. Mexico 

Indcle-3-Butyric Acid 

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

. DATA SUPPORTING GUIDELINE REGIUIREI1ENTS FOr, THE 

. REREGISTRATION OF INDDLE-·3-.. 11Ul"YFdC ACID 

GUIDEL.INE 

CITATION 

TITLE DF ,lTUlJY CIH\TIDN 

158. 6,~OProd"c t Chemi s t ry __________________________________ _ 

.15+-,10 . 

151-11 

151-12 

Prodl.,lc;:t Identity 

Manufac::tur'ing PI""OC;'?SS 

,Discussion t,f FOI'"m,,\ tJCH1 

Anal ysi~ 0'/: Si::,unpl r;.\~~ 

. 151'-17(a) Color 

15,l-,17(h) 

151M 17(i) 

: ,"" ; 

"',, .. ' :-.,' : . .' 

Vapor Pressui'"f-? 

pH 

CIl<lJ 4.15F:l44Cll 

C1KiJ 

C I l(jJ 

CII<O 4.15fJ440.2 

CI K(J 41584402 

C:II(O 41584402 

Cll<O 4.1584403 

ell(13 41584403 

Cll<O 41584403 

CIKO 41584,403 

CII<O 41584403 

CII<(I 

4.15l~4403 

C 11([J 41584403 

.. .. " 

.. 

j' ; ~ 

'" , 

" .. 

.. .. , .:" , " .. 

, .. , ;, ); 

.. " 

", , 

.. , , " ". 

.. .... , , , . , 

> , > • > , 
111

U U,S. GOVERNMENT PRINTING OFFICE: r990·267·630 

&EPA Application for Pesticide: 145733 

D. Halliday & CQ. 

3803. Luneta Lane 

Failb't'oOk., CA. 9'202.8 

6 1993 

FOR 

2 a GilesParker 

Syntex Corporation 

P.O. Box 517 

Cuernavaca, Mar. Mexico 

Indole-3-Butyric Acid 

RE-REGISTRATION 

No 

per container I P,,,k,,,, w"I,h! No. per container Pap~r 

Ja~;a;;;;;o""itC~'"""'"'Om"';;;j;f.S~;jiffirtaiiioOiiiiiii1=-__ L _____ L ____ -l_-J Othor F~P,6Ci~). ;-. 

Uthograph 

Paper glued 

II 

I 

o Other (Sp(Jcify) 

1. Contact Point (Complete items directly below for identification of individual to b(J 

Deborah Halliday 

Vice President 

D. Halliday & CO 

-2893 

Certification 

this form and all attachments thereto aro true, aCCtJrato, ·and 

falso or mIsleading statement may be punishable by fine' or 

Vice President 

, , " , , , , , 

" 

II 
112

" 

I~I SYNTEXI 

NET 1 KILOGRAM· 

(2.2 LB.) 

INDOLE - 3 - BUTYRIC ACID 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

ACTIVE INGREDIENT: 

Indole-a-Bulyt'" Acid. . ... , ... " ... ,mln. 97% 

INERT INGREDIENTS , ................ ,maX. 3% 

GPA Rop. No 42473·' EPA ES1. No, 4247a.MX-t 

KEEP OUTOF REACH OFCHILOREN 

PRECAUTIONRRY STATEMENTS 

HAZAflO$ TO HUMRNS 

ANO OOMES-TIC ANIMALS 

WARNING 

C,",., sub'I""".r but 10m pot.,y eye "n{"'Y' 00 nol 

pot In ej"'. on ,kin or on elolhin~ _Woo, goggle,. !aco 

,hlold or ,.re,y pl.,.." A"old inhalil.lion 01 eu". 

w •• ~ Iho,oughly ""Ill ,oap and walo, oU~, hatlel;n~ 

.nd belo,u o.bng 0' drinking, R"m,,"e contamlOOIed 

,"olhing 1>010'0 ,0U,e, Road one unde,,,and Iha 

Matn"al Sof"ly OOia Sheet tor .de~l""allnIO''''.,''on 

I><>I0re l"""klM wilh !hi> ",o1UOI. 

STATEMENT OF 

pRACTICAL TREATMENT 

If m "1"'" Hold e)l<i;d' of<'n and nU'" whh a .... ey. 

g01'l~o ",.,Im o! water fo, fS m;nUlO •. GOI modi""l 

a"Onlfon. U ,w.llowqe: 0,;"" promplly a la,go qUM· 

"'1of mik. ogg whllll. 0, gelalln ,o!ulion. 0' I! !ho'e 

"'0 not .u.iloble, lo'go qUMIiI'., o! "'OIor. Avaid 

a"'o~ol GO! me<ilcal anontion. 

EHYfRONMENT HAZARDS 

00 nol e;,Ch'f!)e inlO loko., >lream •• pone, 0' publio 

WO!ors unle .. ;n ocroroao"" ",i" an NPDES F"'mll. 

Fo, puidanCil conlactycu, ,og;onal ollieo 01 tho EPA. 

DIRECTIONS FOR USE 

~ j5 a u~'ljon of Focer.llaw 1<> u •• ,h .. produ'" in 0 

m.Mo, m""n,I.lon, \Vi,h j" labolOlg 

Thl, ",,".,1001 may b. ",.d ooly I.r tho !omIur.lion 01 

• pl.n, fO<IH,,!/ PI' .... ,.,;"o. Formuilil." "'"'9 ,n", 

prod"ol", ,._n.,blo lor ob'ainjn~ EPA tog;,"a~"" 

I,r tho~ I.,mulole<! prod"""_ 

STORAGE AND DISPOSAL 

STORAGE: SIOlO p,odUCI in ."Io.!inal COnlaiM' 0tI1y. 

away I,,,,,, olM' 1"'.1lddo" 'e",ruzo,. food 0, !<>ee. 

DISPOSAL: 00 no! ""ntam;nal<> W.'.f. lood or !~od 

by "o,age 0' di,,,,,,al. Wa"o' 'o,ul!mg!""" IhiI 0>0 

ollhi, preduOl may bo di'posed 01 On ,;10 0' o! an 

'pb,oued waslo di'po>ollaol",y. 

Cornplololy emply 1m., by .h.>lng ane !'ppinG ';Co. 

ane bottom 10 Ioo,on e~n9lng pamela •. Emply ,,,,I· 

duo inlO manulaOlu,ing oqu'P",onl. O<'f'l" 01 MY 

wa". 'o,ieu.' al 0PP'09,IOtoly I"'fmittoa ",a"& 

e"po,al 1061,1'" occo,ding 10 EPA ,apulaUM. al4G 

CF ,R. Z6P 0' 'oq. Thon d'rSpo,o 01 ',no, 10 ~ >lInlla,), 

landlill 0' by inelno,allon ;1 .ijowad by "010 ond local 

.Ulh",lIio" 

II dru", I. conlaminal"" ane CIlnnOI bo ,ou,od, 

dtop""o 01 in Iho •• m. mannO'. 

SYNTEX, SA de C.V. DIVISION aUIMICA 

APARTAOO POSTAL 517, CUERNAVACA, MOR. MEXICO 

, , >, , , , , 

" , . , . " , , , >' >. 
113

I~I SYNTEX I 

NET 1 KILOGRAM· 

(2.2 LB.) 

INDOLE - 3 - BUTYRIC ACID 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

AC1W,,'NGREOIENT: 

'ndofe.3·Bulyt;c Acid. ", .. , ____ ,._.,m"'- 97% 

INERT INGREDIENTS. _,. "mO'_ 3% 

~1'Afi'9 No 4&)3.1 <PAE-' . No-.24nMX·' 

KEEP OUT OF REACH OF CHILDREN 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS 

AND DOMESTIC ANIMALS 

WARNING 

Coo,n. sub"",".' bUllempOl0'Y eyo iniory. Do nol 

901", O}'i>S,on ";n ofondolh;ng. Wear g09gle.,I.co 

oh;"W 0, .alo'Y 9"".'_ A"oi<l ;nhal."on 01 do"_ 

Wash Iho'oughfy wllh $<lOP'oo w.tot .Uo, haod~"g 

aod b<>1o'Q c,,~,~ 0' dliokm~, Romovc coo'aml",,'od 

clo'hif19 bOlO'O ,0",C, Ro.d aod "odo""""d ",0 

I~ atoriol S ,'oly 0 OIa Shcollo' .d d",onal iolo,m."on 

bolo," """kind With 'hi'!"odu"" 

STATEMENT OF 

PRACTICAL Tl1EATMENT 

II in c)<lS: Hold e)'<lid. opon .00 lIu'h w'l,h a Slo.dT. 

gonllo s"~am 01 1'1"0' 10' fS mio",o., Gcl mcdi~ 

att"oUon, If 'w.~oW<ld' O'iol< j>fompUy a "'90 quon· 

lityol m~ ego wh~o, 01 gelotin so~lioo. 0'" Ihe.e 

• ,0 001 aU.iIoblo, '''90 qu.nlll;'. of \VOl", Avoid 

,"",hot Gcl medico.l.n"o,l<>o. 

ENVIRONMENT HAZARDS 

00 nol If """,,,,go iolo ""e., SI, oamo. ""nd-, 0' du!)lie 

watels unlo" ,n =d.""" Wilh dO NPQES p.'m~, 

Fo' oui<!at>co con""" ~UI ro~i""., oillea ollho EPA. 

DIRECTIONS FOR USE 

II,," v,oI.'loool F,><lef.11Iaw '0 U,e ,h;, ~"'<f"C11T1 a 

m"oncr ",c,",,,,,"o' ""h ," labol;r19 

Th" o!>Ornlcol may bo uoed only 141 tho lormul.50n 01 

o ,"an' ,oo,iog proparal"o. F",",uIM01' "''''D Ihi, 

plod"", .rel.,pO<l.ibfo for obl"nmg EPA l"1J~".Uon 

1001h~ir formulol<>d producl •. 

STORAGE AND DISPOSAL 

STORA,GE: 810m p,odl>Clln <>rig"" """1"",,, ""'y, 

aw.y I",m olhOl "".licid." 'o<til"." food 01 fli.d. 

DISPOSAL: 00 not ",nl.mi,..,. ""'let. ,'''''' OIlood 

by ''0' ago 0' di.po'OI. W ..... 'o.u~I"lI"om ",Q u •• 

01 "'" produc' may bO d"'P<'.ed 01 00 .10."..'.0 

0pp,ouod Wa". di.jl<I>af '''''''-'Y' 

Complo,otyomptyl",c,by .hokioo and "p,ind ,>do, 

.nd bottom '0100$00 0I"'9i"9 po~icla •. E",ply m", 

duo io'o m.nul.C1u,it!1 oqu;pmMI. OitlpoS<l 01 on~ 

wa"e lOsiduo, 01 app'OPlIOI.'~ porml".d 1'1." • 

di.po",1 fo""ltio •• c<:<>11lngl<> EP A ,ogul.r<on. '140 

C,F.R. 26001 ,eq. ThOn di"P"'o ollio., in 4 ,.nito'l' 

"OdRI 0' by ",<ioo,.I",n ~ allowed by stol. aod local 

aU1holili~" 

II d'Um is con'amlnaled ond """001 b<l "",sed. 

di."""" of in 10" sam. "'aM",. 

SYNTEX, SA d. C. V. DIVISION QUIMICA 

APARTAOO POSTAL 517, CUERNAVACA, MOR. MEXICO 

. 

" 

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,,", 
114

Page of 

United States Environmental Protection Agency 

Washington. DC 20460 Forrtl Approved 

oEPA Certification with Respect to 

Citation of Data 

0/;18 No, .:mO·0060 

Apprm'JI expires 9·30·')0 

Appilcanl"s Name and Address 

Syntex Corporation 

P.O. Box 517 

Cuernavaca r Mor. Mexico 

EPA Flte Symbol/Reglstrallon Number 

42473-1 

Product Name 

Indole-3-Butyric Acid 

Date of AppliCation 

May 6 r 1993 

1. This application is supported by aU data submitted or cited in the application. 

In addition. if ciIe~all oplions are indicated, this application is supported by all 

data in the Agency's files that concern the properties or effects of this product or 

of any other product that is identical or substantially similar, and thaI is one of 

the types of data that would be required to be submitted if Ihis application 

sought the initial registration of a prod uct of identical or similar composition 

and intended uses under the data requirements in effect on the date of approval 

of this application. 

2. 1 certify that. for each study cited in support of Ihis application for registra~ 

tion that is an exclusive use study, I am the original data submitter, or have 

obtained the written permission of the original data submitter to cite that study. 

3. I certify that, for each study cited in support of this application for registration that is not an exclusive use study: 

I am the orjginal data submitter; or I have obtained the written permission 

of the orig~al data submitter to cite that study; or 

I have notified in writing the companies who have submitted data I have 

cited to sUNlOrt this application and have offered to: (a) Pay compensation 

for those data in accordance with section 3(c)( I)(D) and 3(c)(2)(D) of the 

Federal Insecticide, Fungicide and Rodenticide Act; and (b) Commence 

negotiations to determine which data are subject to the compensation 

requirement of FIFRA and the amount and terms of compensation due, 

if any. The companies I have notified are: (Check one) 

o All companies listed on the Pesticide Data Submitters List for all 

active ingredients contained in my product (cite-all method or cite-all 

option under Selective MethOd). (Also sign the General Offer to Pay 

Statement below.) . 

~ Those companies who have submittted the studies which I have cited 

(Selective method). 

Form 8570-29 17·8&1 

Halliday 5-6-93 

offer and agree to pay compensation to other 

aDoroval of this application, to the extent required 

3(c)(2)(D). 

and I Vice Pres. 5-6-93 

, 

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115

Page of 

UnF!ed Slates Envlronmen!al Pro!ectlon Agency 

WaShlng!on. DC 20460 Form Apf'rov~d 

oEPA Certification with Respect to 

Citation of Data 

OMS No. ;mO-0060 

.-\pprrJ\"~t expires 9-30-90 

Appllcan(s Name and Address 

Syntex Corporation 

P.O. Box 517 

Cuernavaca, Mor. Mexico 

EPA File Symbol/RegFstra!ion Number 

42473-1 

Product Name 

Indole-3-Butyric Acid 

Da!e of AppllcatFon 

May 6, 1993 

I. This application is supported by all data submitted or cited in the application. 

In addition, if cite-all options are indicated, this application is supported by all 

data in the Agency's files that concern the properties or effects of this product or 

of any other product that is identical or substantially similar, and that is one of 

the types of data that would be required to be submitted if this application 

sought the initial registration of a product of identical or similar composition 

and intended uses under the data requirements in effect on the date of approval 

of this application. 

2. I certify that, for each study cited in support of this application for registration that is an exclusive use study, I am the original data submitter, or have 

obtained the written permission of the original data submitter to cite that study. 

3.1 certify that, for each study cited in support of this application for registration that is not an exclusive use study: 

I am the original data submitter~ or I have obtained the written permission 

of the orig~al data submitter to cite that study; or 

I have notified in writing the companies who have submitted data I have 

cited to support this application and have offered to: Ca) Pay compensation 

for those data in accordance with section 3(c)( 1)(D) and 3( c)(2)(D) of the 

Federal Insecticide, Fungicide and Rodenticide Act; and (b) Commence 

negotiations to determine which data are subject to the compensation 

requirement of FIFRA and the amount and terms of compensation due, 

if any. The companies I have notified are: (Check one) 

o All companies listed on the Pesticide Data Submitters List for all 

active ingredients contained in my product (cite-all method or cite-all 

option under Selective Method). (Also sign the General Offer to Pay 

Statement below.) , 

IKJ Those companies who have submittted the studies which I have cited 

(Selective method). 

Halliday 5-6-93 

offer and agree to pay compensation to other 

of this application, to the extent required 

and Title Vice Pres. 

ida 

5-6-93 

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116

) 

D. HALLIDAY & CO. 

- 3803 Luneta Lane Fallbrook; CA 92028 

619/728-2893 FAX 619/723-8590 -

Page I of 

NAME AND ADDRESS OF APPLI CANT. 

PRODUCT NUMBER, 

PRODUCT NAME, 

Syntfi.~,>: GOy"pr.wi,ttion 

P"O. Ben: !'H7 

Cuernacac8~ Mer. Mexico 

Indole-3-Butyric Acid 

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

DATA SUPPORTING CllJlDELINE 1',EGllJIREI"IENTS f"Of, THE 

REREGISTRATION OF IN01.>LE-·3--[;IJTYFiIC ACID 

IlLilDEl.INE 

CITATION 

T.l "I'Ll, OF tl'rUDY CITATION 

158 "690 Prod LIe t Chemi 5 t ry __________________________________ • ______ . 

.151-10 PI'"oduct lcJeni:i. ty C.ll< [) 41.:5EI4401 

1.51-11 Manufacturi.ng PI··{JC,8S~::, [;11<n 41 :'iE"JII40l 

151-12 , Discl.\s!SJ.cm cd' Fonn,,-, tion CIl<D 41~)E\4401 

15j,-13 An,,\l ysi.s 0'1' f3i,1mp;[ E')~:; C 11m 41 '5(034402 

.151-:1 B: Cel'"ti f il:: a ti.rm o'f L..i.mi t~~ C.lKO 4i5F34402 

151-16 Analyt.ical Methocl CII«() 415fJ4402 

.l.51-17(a) Color- CH:lJ 4.1584403 

151"'17(b) Physi~~al Stah:> CH:O 41 :58440~~ 

.151-17(0) Odor- CH~C'J 41 ~~\8440:::'; 

151-17(d) Melting Point CII<D 415(14403 

151-17(e) Boiling C.lKrJ 4.1. ~1B44(l3 

151-17(f) Density ClI<O 415[.:.l440::J; 

151-:I,7(g)_ .SolLlbility CII((J 415194403 

151-J,7(h) Vo1pOlr' Pr-eS51.1I"!:;.' elK[] 4.1. ~lfJ440::', 

151-17(i) pH C! I<D 41 ~~l34403 

, 

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• " , ~~.~~~ 

• , , •• , 

, """ · . , 

~ .. • , · . ~ .. • , • , 

" " · ~ .... 

• • " , " • • , ~ •• * ~ ~ 

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117

GW.!DELINE 

CITATION 

J.51-17(J) 

151-17(p) 

TITLE OF STUDY UEIE:: PATTEI::':N 

St.abi 1 t.i Y CI!<C) 

Octan'olJWatel'" pc.'tl'""i:i.ti(m 

CITATIDN 

4:1. 3~J4403 

15S.690 TOX I COLOl,Y ___ ._._ ••• _ ••...•....•.•. : ...•...•.•...• _ ....•...•. _ .•..•. _._._ ........•..•. 

152-11 CIi«J 

152-11 ACLlte Dermal Waived 

152-12 ACL1te Inhal.:,d.:ion C I I<Cl ~~a.i.verj 

152-13 CII<D 41fJb3001 

152 ...... 14 Primary Skin Irrit~tiol1 C1I<U /.). J.lJb3002 

CII<D 

152-16 Hypel'"'sensi ti vi ty C 11<ll ~Jai ved 

152-19 Mutagenicity C :lI<O 

152-:2'1 CII<O W,:i\.lved 

152-23 Teratogenicity C1I<O 

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118

! 

$YaOL 

SfJfUfAMIt 

OATE 

UNJTED STATES ENVJRONMENT .... L P."WTECTION AGENC'( 

/ 

M E M 0 RAN DUM 

SUBJECT: Notice of Intent to Suspend Registration of Indole-3-

Butyric Acid Products for Fai lure to Respond to the 

Indo le- 3-Butyric Ac id Rereg istrat ion El ig ibi 1 i ty Document 

(IBA RED) as Required under FIFRA Section 3(c) (2) (8) 

FROM: Frank T. Sanders, Chief 

Fungicide-Herbicide Branch 

Registration Division (H7505C) 

.TO: Robert P. Zisa, chief 

program support and Compliance Referral Branch 

Office of Compliance Monitoring (EN-342) . . 

The Fungicide-Herbicide Branch ,(FHB) requests "that a 

3{c){2){B) Notice of Intent to Suspend (NOITS) be issued to those 

registrants of Indole-3-Butyric Acid products tha~ did not respond 

to the required 8 month Data Call-In (DCI) Notice in the IBA RED. 

The RED was issued September 10, 1992, and the 8 month DCI due date 

was May 10, 1993. Certified mail receipt cards (green cards) were 

received from all registrants who were mailed the RED. 

The IBA RED required that registrants of pesticide products 

containing Indole-3-Butyric Acid meet certain data requirements to 

maintain continued registration of their product{s). The 8 month 

response consists of administrative forms and all outstanding 

product specific data that the registrants committed to submitting. 

Failure to adequately respond to 8 month response is basis for the 

Agency to issue a NOITS. 

FHB requests J{c) (2) (B) NOITS be issued to the registrants 

listed below because they did not respond to the May 10, 1993 8 

month due date for Submitting data. 

Attachment 

CONCtllttlIHCaS 

-t'F;,J;r· Iftz:r;/"r .................. _._-.-.. ----.......... ................... ........ _ ........ .. _ ... -........ 

'Iq;~'t:::;, r:i;t::3" ................. .. __ ........ . ............. _. ................ ...-.......... - .................. 

ePA ...... ,oic ,. ('100) ! / ,.,.,., - /&qt:IId ,.,., OPFICIAL FILE COPY 
119

Attachment I 

Plantabbs products (5332-10); NOITS for failure to comply with 8 

month response, i.e. failure to satisfy Product Chemistry Guideline 

requirement nos. 151B-IO through 16, and 151B17(a,b,C,f,i,k,1,m,n,o), Acute Toxicology Guideline requirement 

nos. 152B-IO through 16; failure to submit any of the proper 

administrative forms. 

Brooker Chemical Corporation (8281-1,2,3,4,5,6,7); NOITS for 

failure to comply with 8 month response and Failure of the 

registrant (Voluntary purchasing Group) to whom they (Brooker) have 

tendered an offer to share in the cost of developing data to 

fulfill the commitment to develop and submit the data as required 

by the RED Notice; for failure to satisfy Product Chemistry 

Guideline requirement nos. 151B-IO through 16, and 151B17(a,b,c,f,i,k,1,m,n,0), Acute Toxicology Guideline requirement 

nos. 152B-IO through 16; failure to submit any of the proper 

administrative forms. 

Rockland Corporation (572-333,334,335,336,337, 338, 339); 

for failure to submit proper administrative materials, 

Application for Registration, Five (5) copies' of revised 

labeling and data matrix listin~MRID numbers. 

NOITS 

i. e. 

draft 

National Research & Chemical Company (42198-6); NOITS for failure 

to submit proper administrative materials, i.e. Application for 

Registration, Five (5) copies of revised draft labeling, data 

matrix listing MRID numbers, and certification with Respect to 

Citation of Data. 

Syntex. S.A. de C.V. Chemical Division (42473-1); NOITS for f&ilure 

to sUbmit proper administrative materials, i.e. Data matrix listing 

MRID numbers. 

Voluntary purchasing GrQup (7401-343); "NOITS for failUre to comply 

with 8 month response, i.e. Product Chemistry 151S-10 through 16, 

and 151B-17(a,b,c,f,i,k,1,m,n,o), Acute Toxicology Guideline 

requirement nos. 152B-IO through 16; failure to submit any of the 

proper administrative forms. Failure of the registrant to whom 

they (Voluntary Purchasing Group) have tendered an offer to share 

in the cost of developing data to fUlfill the commitment to develop 

and submit the data as required by the RED Notice. 

Earth Science Products (43905-1); NOITS for failure to submit 

proper administrative forms, i.e. Data Matrix listing MRID numbers. 

Bartus USA Corp. (63310-8); NOITS for failure to submit proper 

administrative forms, i.e. Application for . Registration, 

certification with Respect to citation of Data Form, Data Matrix 

listing MRID numbers. 
120

ATTACHMENT II 

Micro Flo 9o~ (63079-1); NOITS for failure to comply with 8 month 

response, i. e. fai lure to satisfY Product Chemistry Guideline 

requirement nos. 1518-10 through 16, and 1518-

17(a,b,c,f,i,k,l,ffi,n,o), Acute Toxicology Guideline requirement 

nos. 1528-10 through 16; failure to submit any of the proper 

administrative forms. 
121

) 

D. HALLIDAY & CO~ 

Enviromentc\l Protec::tit:m Agency 

FW1gicide-Herbicide Branch 

Prodl.\ct Management Team "* 22 

Room 'Z66A Crystal l"1al1 2 

1921 ·Jefferson Davis Highway 

Arlington ~ VA 22202 

May 6·, 199:~ 

Dear Cynthia Giles-Parker 

3803 Lunela Lane Fallbrook. CA 92028 

619/728-2893 FAX 619(723-8590 

All data that has been submitted is c.:itc;!d in ~~t.lblltitt.al 

by EPA ident.i f ier' rll..\mb~;;ol"s. 

Cordially, 

Deborah H.~lliday 

D. Hal·1 id':IY & CO 

, 

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122

Please 

Application for Pesticide: 

May 6", "1993 

D. Halliday &.,Cg. 

,3803. _LuI'!~ta ,Lan,e,,)_ 

Fallbrook, CA 9202;8 

k 

RE-REGISTRATION 

lithograph 

145733 

GilesSyP:teJ;C Corporation 

P.O'. Box 517 

cuernavaca',"Mor. Mexico 

" -: 

• 

• •• • 

• • 

• 

• 

• 

,-, n. Label Paper glued • .. 

~~~~'a" . 

material ... ". ... • •• 

1. Contact Point (Complete items .. 0 ~ ~ .. " : 

OS " .. 

Deborah Halliday 

Vice President 

Deborah Hallida 

i i 

D. Halliday ·&"CO 

893 

CertIfIcation , . this form and all attachments thereto are true, accurate,: i£hd' 

false or misleading statement maybe punishable by fine'or , , . 

Vice President 

May 6, 1993 

.. 

Ii' 
123

Paperwork Reduction Act Notice and Instructions 

I 

I 

I 

i I 

j 

I I 

I 

," , 

"" 

Paperwork Reduction Act Notice 

Public reporting burden [or this collection of information iscs[i11l~[cd 

[0 avcr;lgc of 0.85 hours per response, inc!11lling time for reviewing 

instructions, searching existing data sources, gatHering and maintainiHS the data needed, and COm]lieting and rCllicwitlg the cullcctinllllf 

infurmatlon. Send comments rcg .. rding the burden c:<aimlllc or auy 

11lher aspect of this collection of information, including sugzcstion~ 

fur reducing this burden, to C]Jicf, Infornw!ion Policy Brnnch, I'M223, U.S. Environmental Protectio)1 Agency, 401 M Street, SW, Washington. DC 20460; and to the Omce of Information and Rcgubtory 

Affairs, Office of Management and Budgct, Wa.~hington, DC 20503. 

Instructions 

General 

1Ili~ fnrm is to be used for all applie;uion.~ for!lcw amI a1l1emled rcgistration~ for pesticide products. 

In order to process an application for new registration submitted on 

thi~ form. the following mmerial n1U.~t accompany the applicatioo: 

I. Offer to Pay Statement (EPA Form 8570-Z7, ·28, .29). (If 

not exempted by 40 CPR 162.9~1(b),) 

2 Conlidentlal Statement of Fonnula (EPA Fornt857o-4). 

3. Five ropies of draft labeling. 

4. TIlree eopics of any data ~ubmitted. 

Subl1lis.~ion of I.nbc!ing • l ... 1bcJing should first be :mbmitted in the 

form of draft labels with an application.~ for ncw regL~tratlon. Such 

draft labels may be in the form of typed label text on B 1/2 x 11 inch 

paper or as a mockup of the proposed label. If prepared as a lUockup 

it should be constructed in suel1 a way as to facilitate storage' in an B 

1/2 x 11 Inch IiIe. Mockup labeL~ sign(fieantly smaller than 8 In x 11 

inches should be mounted on B 1/2x II inch paper for submission. 

Submission of Data. Data submitted in support of tl1is applie~tion 

must be submitted in accordance with PR Notice 86·5. 

Specific 

Please read thc Instructions l\sted below before complcting this application. First determine the type of regl~tration action, Hsted In Block 

A • for which you arc submitting this application. For applications 

submitted In connection with New Registration actions, Section I, III, 

and IV Mu..~t be completed by the applicant. For applications submitted in c'rnneetion with amended registration actio)\s, Section I, II, amI 

IV ml~')t,Pc'J:omplcted by the applicant. 

nIOI'k:A ~ ~i1~ek the appropriate aetlnn for which you arc submitting 

thl~ form. 

Scdlo)l~t·:IJljS Section must be completed for both Registration and 

Amended Registration actions. 

1~ f,':on"lpnoy/I'ro!Iuct Number _ Insert your company number, If 

, 'on'e'hns been assigned. TItis number may itave been assigned 

to you as a basic rcglstrant, a distributor, or as an estabOsh-

"nlent,. If application is for an amcndment, in..'lCrt the registra-

, ,tido-,riumher oC the product, 

4; I}at,; '; Fil[ in the appropriate date. 

1. 'rrMuet Manager - If known, fill in thc name and nuttthcr of 

the Product Manager. 

4. Proposed ClnssIricntion • Specify the proposed classification 

for this product. 

5. Nnmc nnd Address of Appllcunt • 11te name of the "firm or 

person and address shown In your application is the person or 

finn to whom registration will be Issued. If you arc acting In 

behalf of another party, you must submit authoriz.ltion fr0111 

titat l13rty to act for them in regL~tration matters. 

I EPA Form 8570-1 (Rev. 9-88) 

I 

, 

I 

An applie~m nut rC$iding in thc United St:lte~ must have an 

authoril.cd agent re~iding in thc Unitcd States to act for titcm 

in all regi~tratinn m~tters. '!llt name and complete mailing 

address of sneh ~n ~gcl1t nHlst aceom(1any titis application, 

11, I'rodnet Nnme • Entcr the enlnpletc prndnet ntl1nc of titis pesticide ~sit will "PI)Carlm the !Jile!. '1 lIe nrune ~tust be spedfic 

to this prodllct only. Duplicmimlnf na111C:; is n!)[ pernlitted 

mnong 11rOd(let3 nf the ~"!11e company. Do not include any 

brand nahle or c011111any linc de~ign~tlons. 

Amendment Infnnllation 

Scction !! • 11tis Section ww;t be completcd for :111 applications submitted in connection with Antended Registration. 

1. Subject of Amendmcnt • Check the appropriate block, and 

provide a brief explanation of the purpo:>e(s) for the amend· 

111ent, such as: "the ndditioH of n site, l)Cst, or crop"; "to 

ch.mge inert ingredient"; "gcnerall:lbcJ revisio!ls ofllrecautionary statements," etc. 

Pnclrnging nnd Contniner Infonnation 

Scction III .1111s Section must be completed for aU applications sub· 

mitted in connection with New Registration, 

I. Type of I'uclrnging. Check the appropriate block ifyollr product will be packaged in titc indkatcd packaging types. Indi· 

eate the size of the individual packets and number per rctail 

container. 

2. Ty~ of Rctn!! Contn(lIcr· Indicate typc of cunt~iner in which 

product wiI[ be marketed. 

3. Locution of Net Contcnts - Specify the net contcnt.'> of all retail 

containers for your product. 

4. Size(s) of Retn!! Contulner • SI)Ceify the )let eontcnt.'> of all 

retail containers for your product. 

5, Locution of US(' Dircctlons. Indicate the 11)Cation of tlte USC 

directions for your product. 

6, Manner In which label Is nffixed to product - Indicate tite 

method product labeting is attached to retail container, 

Contnt:1 ruint 

Sectloo IV • 111is Section must be completed for all Registratilm and 

Amended Registration applications. 

1·5. Self-eXJllanatory. 

6. EPA Usc Only, 
124

, , 

Kim Janikowski 

D. Halliday & Co. 

3803 Luneta Lane 

Fallbrook, CA 92028 

Dear Ms. Janikowski: 

I 

Subject: Dermal Sensitization Studies 

Syntex Corporation 

Indole-3-Butyric- Acid 

EPA Reg. No. 42473~1 

The dermal sensitization study sUbmitted in connection witp 

registration under the Federal Insecticide, Fungicide, and 

Rodenticide Ac~, as amended, has been received and volume 1 of the 

study has been given the MRID *42483701. Volume 2 of the study has 

been rejected for the fOllowing reason: 

1. A statement of compliance or non-compliance 

with the Good Laboratory Practices Standards 

contained in 40 CFR 160 is required for all 

studies (except range finding studies and 

supplements to previously submitted studies) 

submitted to EPA. This statement must appear 

as page 3 of all studies, and must be signed~, 

Cl,ng_ .. QC!ted .9Y_ ... J:.he study sponsor, the study 

submitted, and the study director. Please see 

40 CFR 160.12 for specific guidance. 

enclosure 

Sincerely, 

Cynthia GileS~Parker 

Product Manager (22) 

Fungicide-Herbicide Branch 

Registration Division (H7505C) 

CONCURRENCES 

SYMBOL Li7%c 

.p ........ / . .................................. .. ::::A"' fit~f;~;; ..................................................................... " ................................. . 

EPA F 0'"' 132Of-l (12-70) OFFICIAL FILE COpy 
125

SYNTEX CORP. 

u.s. ENVIRONMENTAL PROTECTION AGENCY 

Office of Pesticide programs 

C/O D. HALLIDAY & CO. 

3803 LUNETA LANE 

FALLBROOK, CA 92028 

Report of Analysis for Compliance with PR Notice 86-5 

Thank you for your transmittal of 09/22/92. Our staff 

has completed a preliminary analysis of the material. The results are 

provided as follows: 

Your data submittal was found to be partially in 

compliance with the standards for submission of data 

contained in PR Notice 86-5, with the exceptions noted 

below. A copy of your transmittal bibliography is 

enclosed, annotated with the Master Record ID's (MRIDs) 

assigned to each document accepted. Please use these 

numbers in all future references to these documents. 

If deficiencies were found which apply to individual 

accepted studies, they are listed below following the 

applicable MRID. Any document which has been assigned a 

MRID has been accepted under PR Notice 86-5. If any 

comments related to a MRID appear on this report, they 

are provided for your information and reference when 

preparing future submissions. Some individual documents 

were not acceptable, and all copies are being returned 

to you for correction for the reasons indicated below. 

These rejected studies have been assigned separate 

identification numbers which are annotated on both the 

enclosed bibliography and the rejected document labels. 

The rejected studies and their deficiencies are 

described below. 

Rejected study (02] : 

A statement of compliance or non-compliance with the 

Good Laboratory Practices Standards contained in 40 

CFR160 is required for all studies (except range 

finding studies and supplements to previously sUbmitted 

studies) submitted to EPA. This statement must appear 

as page 3 of all studies, and must be signed and dated 

by the study sponsor, the study submitter, and the 

study director. Please see 40 CFR 160.12 for specific 

guidance. 
126

D. HALLIDAY & CO. 424837- 'P¢ 

September 11, 1992 

Cynthia L. Giles-Parker 

Product Manager (22) 

FLingicide-Herbicidt:'2 Branch 

Registration Division (H7";::)O"::,C) 

Dear Ms. Giles-Parker, 

Subj eet: Dermal Sensitization Studies 

Synte>: Corporation 

Indole-3-Butyric Acid 

EPA Registration t>lLtmber- 42473-1 

38()3 Lllncta Lane Fallbrook, CA 92028 

619/728-2893 FAX 619n23-8590 

Telex 181734 

Please find enclosed t.he r.:orr-ected studies submitted 

as: 

Volume 1 _. Acute Dermal effects of Indole Butyric Acid 

when tested on the ski.n of rabbits. L-/Z4f310! 

Volume 2 - Acute Dermal To}:icity of 

when tested Dn the r-at. 

Indole Butyric Acid fZ.e.j-ec.rc-:'0 

(02-) 

Thank You, 

~~a::!:~' D. Halliday & CO. 
127

'D. HALLIDAY & CO. 

May 19. 1992 

3N03 LUIlCla Lillie Fallbrook, CA 92028 

619!72R-2W)3 FAX 619/723-8590 

Telex I R 1734 

Ms. Cynthia Giles-Parker. Product Manager (22) 

Fungicide-Herbicide Branch, Registration Division (H7505C) 

United States Environmental Protection Agency 

Crystal Mall. Bldg #2 

1921 Jefferson Davis Highway 

Arlington. VA 22202 

Reference: Indole-3-Butyric Acid 

EPA Reg. No. 42473-1 

Re: Dennal Sensitization Study 

Dear Ms. GHes~Parker: 

In response to your letter of Jan 28, 1992, we would once again like to request that the 

dennal sensitization studies be waived. We are submitting, in support of this request, two 

acute dennal toxicity tests done to OSHA or IRLG protocols. These tests were more 

rigorous than the dennal s'ensitivity test previously submitted. The test animals in these 

studies also had no observable reaction in Indole butyric acid. 

We still feel that no significant new data is likely to be gained from sensitization studies. 

We further feel that the tests already submitted establish sufficiently the dennal safety of 

this product. As the purpose of these studies was to establish the labeling requirements 

for the product, we feel those goals are accomplished with the tests we are submitting and 

the previously submitted data. We feel the requirement of additional testing imposes an 

unreasonable hardship on our company to no particular purpose for a low volume, minor 

use product. 

Thank you for your consideration of this matter. Please also note revisea label encl('fed. 
128

--~" ;.iJ·.~J PM : _ .'. ..J-. 

!1£MORANDUM 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTQ."I DC 20460 

SUBJECT: Classification of Indole-3-Butyric Ad.d as a Biochemical 

Pesticide (Caswell ~499) 

FROM: 

THROUGH: 

Robert Taylor/Angela Barnes (PM-25) 

Registration Division (H750SC) 

J. Thomas M~Clintock, Ph .D. i Microbiologist ".', .<.\~ "1:\ 17CP 

Science Analysis and Coordination \' \ \ '5:\!"-. 

Health Effects Division (H7509C) \ 

Reto Engler/ ph.D., Chief 

Science Analysis and Coordination 

Health Effects Division (H7509C) 

\ 

/~HL , ACTION REQUESTED: SACB and the opp Biotechnology Workgroup were 

asked to classify ~ndole-3-butyd.c acid (IBA) as a conventional 

chemical or biochemical pesticide. In a recent correspondence (see 

attached memorandum from J. T. McClintock to R. Taylor) the regist'Cant 

was ~Sked to submit inforroation ve~ifying the natur&l occurrence of 

the subject compound ~n plant s. prior to a response from the 

registrant, SACE and the OPP Biotechnology Workgroup recommends that 

this memorandum supercedes our review of 2/23/90, J, T. McClintock. 

DISCUSSION CONCLUSION; The current definition of a biochemical 

pest c e s etes t at "In order for synthesized pesticides to be 

considered as biochemical pestic~des, they must be structurally 

s Lmi lar, and funct ionally ident ie·el, to a nat urally occurr i ng bi 0-

chemical pesticide." No evidence was presented by the registrant 

on the natural occurrence of lBA in plants. 

Following extensive review and discussion, SACB and the opp Biotechnology Workgroup have considered an alternative approach fot the 

classification of lBA as a biochemical pesticide. Several naturally 

occurring plant growth compounds have been identified Which display 

activity resembling auxin (indoleacetic acid - lAA), a plant growth 

regUlator. Such plant compounds, whieh are intermedtate metabolites 

produced during the synthesis of IAA from tryptopha:1, are indole 

acetamide, indoleacetaldehyde, and i.ndolepyruvic acid. I'l'hen applied 

to auxin-deficient plant tissue these cOmpounds are thought to be 

converted to IAA before they are effective. IBA is a synthetic auxin 

that structurally resembles not only IAA but all of the intermediate 

metabolites. Consequently, since IBA is sufficiently similar to the 

Chemical structure: and functionqlly equivalent to naturally occurri:1g 

au:dns We believe that lEA should be classified as a biocnelOiical 

pesti~ide. 
129

D. HALLIDAY & CO. 

December 7, 1992 

Ms. Ruby Whiters, Chemical Review Manager 

Accelerated Reregistration Branch (H7508W) 

3803 Luneta Lane Fallbrook, CA 92028 

619m3-2893 FAX 619m3-8590 

Special Review and Reregistration Division (RED/SRRD/4099) 

Office of Pesticide Programs 

U.S. Environmental Protection Agency 

401 M Street, S.W. 

Washington, D.C. 20460 

Reference: Indole-3-Butyric Acid 

EPA Reg. No. 42473-1 

Re: Request for waiver of data requirements 

Dear Ms. Whiters: 

We are enclosing a Reregistration Phase 2 Response Workshee.t and Requirements Status 

and Registrant's Response to comply with our 90 day reregistration response. On the 

latter document, we have requested data waivers or "option 9" indicating non-support of 

the indicated use pattern. 

Our intent is to supply IBA to manufacturers of rooting hormone liquids and powders for 

horticultural use, which are to be utilized as pre-planting dips under controlled, indoor 

conditions. Within these recognized use patterns there is no exposure of birds or aquatic 

organisms to the product. Therefore ecological effects would not be an issue. This is 

also the opinion cited by the EEB in determining previously that ecological effects data 

would not be necessary where only these uses are involved. (See attachment I). 

The ecological effects data appears to be required in order to support two terrestrial uses 

of IBA. Out of all the companies producing IBA formulations in the United States, only 

two companies are producing products to be used in a tenestrial manner - i.e. by 

broadcast, sprinkling on turf or soil, or spraying on crops or plants in the open field. 

Although the use is very low (7 gm per acre according to the RED document), it seems to 

be felt that ecological effects data should be available to confirm that these uses do not 

cause any harm to the environment. While we feel strongly that the level of anticipated 

exposure by these routes is so low as to not present a risk, we would be willing to prohibit 

these uses atom product altogether, unless the formulators themselves are willing to 

generate the necessary data. 

These two formulators, Plant Growth Formulations Inc., and Riverside/Terra 

Corporation, are not customers of our company. We do not know where they acquire 

their IBA, or if it is even produced by Syntex. We feel it places an unreasonable burden 
130

Ms. Ruby Whiters, Chemical Review Manager 

EPA 

04107/95 

P.2 

on our company to require that we should provide data for uses which we do not support 

and for manufacturers who do not even purchase our product. The cost of this testing 

will be very high. The quotations we have received so far are prohibitive from an 

economic standpoint. I am very concerned that the availability ofIBA to the US nursery 

industry could be jeopardized, simply to support two uses of the product that are outside 

the mainstream and far less important than its use as a rooting hormone. 

As I am sure you are aware, less than 1000 kgs ofIBA are sold into the US every year. It 

is, however, critically important to the nursery industry and many small growers would 

not survive without it. TIns ext.\~mely low volu,"ne has t\"O effects - it makes exp(!nsive 

testing very difficult to support, but it also makes the risk to the environment very 

minimal. The RED also indicates that the biochemical nature ofIBA and its other 

characteristics make it very unlikely that it might pose an undue risk to the environment. 

Another rational for requiring ecological effects testing might be to assess the risk in the 

event of an accidental spill. We control the shipping of all Syntex IBA in the US. It is 

shipped in 1 kg sealed plastic cans and is further packaged in double poly bags inside the 

cans. The cans are shipped only in boxes, with the maximum box lot being 4 kgs. The 

chances of a major accidental spill are therefore non-existent. The technical grade crystal 

is also non-soluble in water, which lessens even further the chance of accidental 

environmental contamination. 

We urge you to reconsider the requirement that our company or Syntex provide 

ecological testing. The expense is a major problem and the normal use patterns do not 

create the type of exposure these tests are designed to evaluate. We ask that you 

consider restrictive labelling to limit the pennitted use patterns rather than requiring these 

very costly tests. 

Thank you for your assistance. Pi~ase cari,act us i[you have any questions. 

Cordially, 

r;mJLf",

L

1?aifLf-..-// 

~tili Halliday 

DHldw 

Enclosures (1) 
131

D. HALLIDAY & CO. 424837- '1J<P 

Septembe~ 11~ 1992 

Cynthia L. Giles-Parksl~ 

Product Manager (22)· 

FLlngicide-Herbicidt':.> Branch 

Registration Division (H7;;,05C) 

Dear Ms. Giles-Parker~ 

Subject: Dermal SensitizF.'Ition Studies 

Synte>: Corporation 

Indole-3-Butyric Acid 

EPA Registration Number 42473--} 

3803 Luncta Lane Fallbrook, CA 92028 

619n28-2893 FAX61~m23-8590 

Telex 181734 

Please find enclosed the ccwrect.eo studies submi tted 

as: 

'Volume 1 - Acute Dermal effects of Indole Butyric Acid 

when tested on the skin of r-abblts. L/Ztff310/ 

Volume 2 Acute Dermal Toxicity o·f 

~'1hen tested on the r-at. 

Indole Butyric Acid IZqec.76'-0 

(02-) 

Thank YOLl, 

~~a::!:~' D. Halliday & CO. 
132

I). HALLIDAY & CO. 

3~(j3 LUIlCia LUlle Fllllbr<X'lk, CA 9202R 

May 19. 1992 

Ms. Cynthia Giles-Parker, Product Manager (22) 

Fungicide-Herbicide Branch, Registration Division (H7505C) 

United States Environmental Protection Agency 

Crystal Mall, Bldg #2 

1921 Jefferson Davis Highway 

Arlington. VA 22202 

Reference: Indole-.3-Butyric Acid 

EPA Reg. No. 42473-1 

Re: Dermal Sensitization Study 

Dear Ms. Giles-Parker: 

6! 91728-2893 FAX 6191723-8590 

Telex lX!734 

In response to your letter of Jan 28, 1992, we would once again like to request that the 

dennal sensitization studies be waived. We are submitting, in support of this request, two 

acute dermal toxicity tests done to OSHA or IRLG protocols. These tests were more 

-rigorous than the deona! sensitivity test previously submitted. The test animals in these 

studies also had no observable reaction in Indole butyric acid. 

We still feel that no significant new data is likely to be gained from sensitization studies. 

We further feel that the tests already submitted establish sufficiently the demlal safety of 

this prod1lct. As the purpose of these studies was to establish the labeling requirements 

for the product, we feel those goals are accomplished with the tests we are submitting and 

the previously submitted data. We feel the requirement of additional testing imposes an 

unreasonable hardship on our company to no particular purpose for a low volume, minor 

use product. 

Thank you for your consideration of this matter. Please also note reviseo label enc10fed. 
133

-

.. 

SYMBOL 

SURNAME 

DATI!: 

UNITED STArES ENV1RONloIENTA!. PROTECTION AGENCY 

- ,41> • 'F -

Deborah Halliday 

D. Halliday & Co, 

3803 Luneta Lane 

Fallbrook, California 92028 

Dear Ms. Halliday~ 

,)\J. "'N 3 0 !99? 

Subject: Dermal Sensitization Studies and Label 

syntex Corporation 

Indole-3-Butyric Acid 

EPA Registration Number 42473-1 

Your Submission Dated May 19, 1992 

The subject dermal sensitization studies have been rejected. 

Please see the enclosed Report of Analysis for Compliance with PR 

Notice 86-5. 

We are returning the two studies so that they may be corrected 

and resubmitted. 

If you have any questions or need additional information, 

please contact me at (703) 305-5540. 

Enclosures 

SincerelYI 

Cynthia L. Giles-Parker 

Product Manager (22) 

Fungicide-Herbicide Branch 

Registration Division (H7505C) 

CONCURRENCES 

.. «.!.?~~.r..~ .......................................... : ............................................................................... . o j..t/ /./(/7 ••••••• J .......... ......................................................................................................................... . 

(;'"r,r L 

EPA FG,m 1320·1 (12.70) OFFICIAL FILE COPY 
134

/ 

U.S. ENVIRONMENTAL PROTECTION AGENCY 

Office of Pesticide Programs 

SYNTEX CORP. 

c/o D. HALLIDAY & CO. 

3803 LUNETA LANE 

FALLBROOK, CA 92028 

Report of Analysis for Compliance with PR Notice 86-5 

Thank you for your transmittal of OS/26/92. Our 

has completed a preliminary analysis of the material. 

provided as follows: 

staff 

The results 

We are unable to accept your data submittal for further 

processing and review, because of the significant 

deficiencies noted below. It is being returned to you 

for correction. If deficiencies were found which apply 

to your overall submission, they are described 

immediately following this paragraph. If problems are 

found with individual studies, they are described below 

linked to the study identifier found on the enclosed 

copy of your bibliography. 

* You provided fewer than the required three complete 

copies of submitted data. 

Rejected study [OlJ : 

You must include one of the two acceptable statements 

of data confidentiality claims under FIFRA section 

10(d) (1) (A) 1 (B), or (C) as the second element in each 

study. The language of two alternative forms of the 

statement of Data Confidentiality Claims 1 shown in 

Attachment 3 of PR Notice 86-5 1 cannot be altered. See 

pages 8 and 13 of the Notice. 

* Studies must be continuously paginated from the 

title page through the end of the study and all 

appendices--except for the Confidential Attachment of 

Supplemental Statement of Confidentiality Claims l if 

present--even when the study is large enough to span 

more than one physical volume. 

Rejected study [02J : 

You must include one of the two acceptable statements 

of data confidentiality claims under FIFRA section 

10(d) (1) (A) 1 (B) 1 or (C) as the second element in each 

study. The language of two alternative forms of the 

statement of Data Confidentiality Claimsl shown in 

are 
135

Attachment 3 of PR Notice 86-5, cannot be altered. See 

pages 8 and 13 of the Notice. 

A statement of compliance or non-compliance with the 

Good Laboratory Practices Standards contained in 40 

CFR160 is required for all studies (except range 

finding studies and supplements to previously submitted 

studies) submitted to EPA. This statement must appear 

as page 3 of all studies! and must be signed apd dated 

by the study sponsor, the study submitter, and the 

study director. Please see 40 CFR 160.12 for specific 

guidance. 

* Studies must be continuously paginated from the 

title page through the end of the study and all 

appendices--except for the Confidential Attachment of 

Supplemental Statement of Confidentiality Claims, if 

present--even when the study is large enough to span 

more than one physical volume. 
136

D., HALLIDAY & CO. 

FC,t£.;T 1:0- 1) 

(.a\1 

i,~? 12: ;Ecl" c: ,-) 

(qz..) 

May 19. 1992 

3803 LuncHl Lane Fallbrook, CA 92028 

61Sl/nS-2SSl3 FAX 619n23-S590 

Telex lS1734 

Ms. Cynthia Giles-Parker, Product Manager (22) 

FungicideMHerbicide Branch, Registration Division (H7S05C) 

United States Environmental Protection Agency 

Crystal Mall. Bldg #2 

1921 Jefferson Davis Highway 

Arlington. VA 22202 

Reference: Indole-3-Butyric Acid 

EPA Reg. No. 42473-1 

Re: Dermal Sensitization Study 

Dear Ms. Giles-Parker: 

In response to your letter of Jan 28, ] 992, we would once again like to request that the 

dennal sensitization studies be waived. We are submitting, in support ofthi5 request, two 

acute dermal toxicity tests done to OSHA or IRLG protocols. These tests were more 

-rigorous than the dennal sensitivity test previously submitted. The test animals in these 

studies also had no observable reaction in Indole butyric acid. 

We still feel that no significant new data is likely to be gained from sensitization studies. 

We further feel that the tests already submitted establish sufficiently the dermal safety of 

tbis product. As the purpose of these studies was to establish the labeling requirements 

for the product, we feel those goals are accomplished witb the tests we are submitting and 

the previously submitted data. We feel the requirement of additional testing imposes an 

unreasonable hardship on our company to no particular purpose for a low volume, minor 

use product. 

Thank you for your consideration of this matter. Please also note reviseo label enc10f'ed. 
137

ECT 

ST D'E 
138

This is an accepted submission. One COpy of the pPC diagnosis and 

one of the annotated bibliography are provided for your files. 

The PPC has already mail~d out the submi~ter's copies of the 

t .... a documents. 

Th isis ~ p~rtJ..~lly dCCOL?tedbctd sub\niS:!:'ion. A CCPY 0= ~~'! ;!iagnosi:i and <.)f the annm::ated. b1.bliography (if applicable) .are 

pr-:>vided fer year filt:5~ A ::;econo copy 1.5 provided f<Jr ~our Il$~ 

corresponding .... itt t!!~ C.!l.~~ :::::.~it~er. 

!.n 
139

SYNTEX CORP. 

u.s. ENVIRONMENTAL PROTECTION AGENCY 

Office of Pesticide Programs 

C/O D. HALLIDAY & CO. 

3803 LUNETA LANE 

FALLBROOK, CA 92028 

Report of Analysis for Compliance with PR Notice 86-5 

Thank you for your transmittal of OS/26/92. Our staff 

has completed a preliminary analysis of the material. The results are 

provided as follows: 

We are unable to accept your data submittal for further 

processing and review, because of the significant 

deficiencies noted below. It is being returned to you 

for correction. If deficiencies were found which apply 

to your overall submission, they are described 

immediately following this paragraph. If problems are 

found with individual studies, they are described below 

linked to the study identifier found on the enclosed 

copy of your bibliography. 

* You provided fewer than the required three complete 

copies of submitted data. 

Rejected study [01] : 

You must include one of the two acceptable statements 

of data confidentiality claims under FIFRA section 

10 (d) (1) (A), (B), or (C) as the second element in each 

study. The language of two alternative forms of the 

Statement of Data Confidentiality Claims, shown in 

Attachment 3 of PR Notice 86-5, cannot be altered. See 

pages 8 and 13 of the Notice. 

* Studies must be continuously paginated from the 

title page through the end of the study and all 

appendices--except for the Confidential Attachment of 

Supplemental statement of Confidentiality claims, if 

present--even when the study is large enough to span 

more than one physical volume. 

Rejected study [02) : 

You must include one of the two acceptable statements 

of data confidentiality claims under FIFRA section 

10(d} (1) (A), (B), or (C) as the second element in each 

study. The language of two alternative forms of the 

Statement of Data Confidentiality Claims, shown in 
140

Attachment 3 of PR Notice 86-5, cannot be altered. See 

pages 8 and 13 of the Notice. 

A statement of compliance or non-compliance with the 

Good Laboratory Practices Standards contained in 40 

CFR160 is required for all studies (except range 

finding studies and supplements to previously submitted 

studies) submitted to EPA. This statement must appear 

as page 3 of all studies, and must be signed and dated 

by the study sponsor, the study submitter, and the 

study director. Please see 40 CFR 160.12 for specific 

guidance. 

* Studies must be continuously paginated from the 

title page through the end of the study and all 

appendices--except for the Confidential Attachment of 

Supplemental Statement of Confidentiality Claims, if 

present--even when the study is large enough to span 

more than one physical volume. 
141

D. H.ALLIDAY & CO. 

Reit£-re:-O 

ca'i 

e It iE'",,,, () 

(<\,2-) 

3803 LunCla Lane Fallbrook, CA 92028 

6191728·2893 FAX 6191723-8590 

Telex 181734 

May 19, 1992 

Ms. Cynthia Giles-Parker, Product Manager (22) 

Fungicide-Herbicide Branch, Registration Division (H7S05C) 

United States Environmental Protection Agency 

Crystal Mall, Bldg #2 

1921 Jefferson Davis Highway 

Arlington. VA 22202 

Reference: Indole-3-Butyric Acid 

EPA Reg. No. 42473-1 

Re: Dermal Sensitization Study 

Dear Ms. Giles-Parker: 

In response to your letter of Jan 28, 1992, we would once again like to request that the 

dennal sensitization studies be waived. We are submitting, in support of this request, two 

acute dennal toxicity tests done to OSHA or IRLG protocols. These tests were more 

ngorous than the dermal sensitivity test previously submitted. The test animals in these 

studies also had no observable reaction in Indole butyric acid. 

We still feel that no significant new data is likely to be gained from sensitization studies. 

We further feel that the tests already submitted establish sufficiently the dermal safety of 

this product. As the purpose of these studies was to establish the labeling requirements 

for the product, we feel those goals are accomplished with the tests we are submitting and 

the previously submitted data. We feel the requirement of additional testing imposes an 

unreasonable hardship on our company to no particular purpose for a low volume, minor 

use product. ' ; ~ ~ , , , , . ,") 

, " ) " , Thank you for your consideration ofthis matter. Please also note revised label'enclo~,ed., ">~'> " 

2) ~C»\<..- 01!<rv-r..J. loy.:,C\\'-j C/b \ncL.o 

Oh 0'1" IZ o-X... 

') ')' , , 

, , , " l , , " , 

, 
142

rei SYNTEXI 

• 

NET 1 KILOGRAM 

(2.2 LB.) 

INDOLE-3 - BUTYRIC ACID 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

ACTIVE INGREDIENT: 

Indole·3·Bulyric Acid ...................... min. 97% 

INERT INGREDIENTS ..................... max. 3% 

EPA Reg. No. 42473-1 EPA Est. No: 42473·MX·1 

KEEP OUT OF REACH OF CHILDREN 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS 

AND DOMESTIC ANIMALS 

WARNING! 

Causes substantial but temporary eye injury. Do not 

get in eyes, on skin or on clothing. Wear goggles, 

face shield or safety glasses. Avoid inhalation of 

dust. Wash thoroughly with soap and water after 

handling and before eating or drinking. Remove 

contaminated clothing and wash contaminated 

clothing before reuse. 

STATEMENT OF PRACTICAL 

TREATMENT 

If In Eyes: Hold eyelids open and flush with a 

steady, gentle stream of water for 15 minutes. Gel 

medical attention. 

tf Swallowed: Drink promptly a large quantity of 

milk, egg white, or gelatin solution, or if these are not 

available, large quantities of water. Avoid Alcohol. 

Get medical attention. 

ENVIRONMENT HAZARDS 

00 nol discharge into lakes, streams, ponds o~ public 

waters' unless In accordancev~ith an NPOES permit. 

For guidance contact your regional office of the EPA. 

DIRECTIONS FOR USE 

It is a violation of Federal ,law to use this product in 

a manner inconsistent with its labeling. 

This chemical may be used only for the formulalion 

of a plant rooting preparation. Formulators using 

this product are responsible for obtaining EPA 

registration for their formulated products. 

STORAGE AND DISPOSAL 

STORAGE: Store product in original container 

only, away from other pesticides, fertilizer, food or 

feed. 

DISPOSAL: Do not contaminate weter, food or 

feed by storage or disposal. Wastes resulting 

from the use of this product may be 'di~~bsed of 

on site or at an approved Ylagt'~ disposat facility. , , » , 

Completely empty liner OY: sn~king: ahe. lapping 

sides and bottom to loosen' clinging j:!flrticles. 

Empty residUe Into manu!aejuring >e~urpt;Jent. 

Dispose of any waste residues at ?PPIPpnately 

permitJed waste disposal facilities "'ac!GQI'dlng to 

EPA regulations at 40 C.F.R. 260 ~t,~eq; Then 

dispose of liner in a sanitary landl!1I or by 

incineration if allowed by state and local 

authorities. If drum is contaminated and cannot 

be' reused, dispose of in the same manner. 

SYNiEX, S.A. de C.V. DIVISION QUIMICA 

APARTADO'POSTAL 517, CUERNAVACA, MOR. MEXICO 
143

UN !TED STATES ENVIRONMENTAL PROTECTION AGENCY 

J/lN 28 1992 

Deborah Halliday 

D. Halliday & Co. 

3803 Luneta Lane 

Fallbrook, CA 92028 

Subject: Indole-3-Butyric Acid 

EPA Reg. No. 42473-1 

Re: Acute Toxicology Studies 

Your submission dated April 29, 1991 

The reviews of the above mentioned studies 

connection with registration under the Federal 

Fungicide, and Rodenticide Act, as amended, have been 

the following are the Agency's comments: 

submi tted in 

Insecticide, 

completed and 

ACUTE TOXICOLOGY COMMENTS 

1. The primary eye irritation and p~imary dermal 

irritation studies are graded guideline data a.na 

are acceptable to support the registration of 

the subject product. 

2. The request for a waiver of the dermal 

sensitization study is denied. A dermal 

sensitization study must be submitted. The 

laboratory's basis for the waiver that no 

irritation was observed in the primary skin 

irritation study does not rule out the 

possibility of irritation caused by 

sensi tization from repeated ."exposur~,. 

3. The signal word is "WARNING" based on the 

primary eye irritation study. 

LABELING COMMENTS 

1. Please revise the signal word "CAUTION" to 

read "WARNING". 

2. Please remove the heading "Health Hazard 

Info:r;mation" and the two statements 

immediately following this heading. 

COHCURR!HCES :::::e:! .. ~~Q ................................................... +4 •••• -................................................................... . 

O,TE "~ ··i/i:71i:iz· C············· ............................................................................ _ ........................... . 

EPA Fonn 1320.1 (12.'701 
144

.• 

3. 

-2-

Please revise your Precautionary Statements to 

read: "Causes sUbstantial but temporary eye 

injury. Do not get in eyes "'. on skiJ;l. or on 

clothing. : .. Wear goggles, face shield or safety 

glasses. Avoid inhalation of dust. Wash 

thoroughly with soap and water after handling 

and before eating or drinking. Remove 

contaminated clothing and wash contaminated 

clothing before reuse. 

4. Please revise the Statements of Practical 

Treatment to read: "If In Eyes: Hold eyelids 

open and flush with a steady, gentle stream of 

water for 15 minutes. Get medical attention." 

"If Swallowed: Drink promptly a large 

quantity of milk, egg white, or gelatin 

solution, or if these are not available, large 

quantities of water. A\i''OID. hl:;CGUOB-'{1 Get 

medical attention." Avo; d AiCUl kll tr 

Sincerely, 

Cynthia Giles-Parker 

Product Manager (22) 

Fungicide-Herbicide Branch 

Registration Division (H7505C) 
145

U.S. ENVIRONMENTAL PROTECTION AGENCY 

Office of Pesticide Programs 

SYNTEX CORP. 

C/O D. HALLIDAY & CO. 

3803 LUNETA LANE 

FALLBROOK, CA 92028 

MAY O"i 1991 

Report of Analysis for Compliance with PR Notice 86-5 

Thank you for your transmittal of 04/30/91. Our staff 

has completed a preliminary analysis of the material. The results are 

provided as follows: 

Your submittal was found to be substantially in 

compliance with the standards for sUbmission of data 

contained in PR Notice 86-5, with the exception(s) 

noted below. A copy of your bibliography is enclosed, 

annotated with the Master Record ID's (MRIDS) assigned 

to each document submitted. Please use these numbers in 

all future references to these documents, and correct 

the noted exception(s) in future data submittals. If 

deficiencies were found which apply to your overall 

submission, they are described following this 

paragraph. If the deficiencies apply to specific 

studies, they are listed below fOllowing the applicable 

identification number or MRID. Thank you for your 

cooperation. Any document which has been assigned a 

MRID has been accepted under PR Notice 86-5. If any 

comments related to a MRID appear on this report, they 

are provided for your information and reference when 

preparing future submissions. If you have any questions 

concerning this data submission, please raise them with 

the cognizant Product Manager, to whom the data have 

been released. 

In the future, please indicate the volume number (e.g. 

volume x of y) on the title page of each study in your 

submission. These volume numbers should correspond to 

the bibliography in your transmittal listing. 
146

D. HALLIDAY & CO. 

Robert J. Taylor 

Product Manager (25) 

Fungicide-Herbicide Branch 

Registration Division (H7505C) 

us Environmental Protection Agency 

Crystal Mall, Bldg #2 

1921 Jefferson Davis Highway 

Arlington, VA 22202 

3803 LunCla Lane Fallbrook, CA 92028 

619/728~2893 FAX 619n23-8590 

Telex 181734 

April 29, 1991 

Reference: Conditional Registration #42473-1 

Dear Bob: 

We are submitting the enclosed studies in response to item 

#3 of our coriditional registration for Indole-3-Butyric 

Acid. 

These studies are submitted on behalf of: 

Syntex Corporation, S.A. de C.V. 

P.O. Box 517 

Cuernavaca, Morelos 

MEXICO 

The studies we are submitting are the following: 

Volume 1 - Guideline 81-4, "Primary Eye Irritation study 

(Draise procedure) in Rabbits with Indole Butyric 

1ls/boOI Acid." 

Volume 2 - Guideline 81-5, "Primary Skin Irritation Test of 

Ii <':/ Indole Butyric Acid Using Rabbits." 

71 ",,3002-

We would like to request that the hypersensitivity studies 

be waived. Based on the fact that the results of the skin 

irritation tests were negative, we feel that 

hypersensitivity studies will not yield significant new 

information. Therefore, we request that the studies here 

submitted should be considered sUfficient to complete the 

precautionary labelling review. 

Please contact us if you have any questions or comments. 

Thank you for your continued assistance. 

Cordially, 

D. HALLIDAY & CO INC. 

~M~~ Vice President 

Company contact 
147

'I '. 

_. HALLIDAY & CO. 

Robert J. Taylor 

Product Manager (25) 

Fungicide-Herbicide Branch 

Registration Division (H7505C) 

3803 Luocta Laoe Fallbrook, CA 92028 

6191728-2893 FAX 6191723-8590 

Telex 181734 

us Environmental Protection Agency 

Crystal Mall, Bldg #2 

April 29, 1.991 

1921 Jefferson Davis Highway 

Arlington, VA 22202 

Reference: Conditional Registration #42473-1. 418630-00 

Dear Bob: / 

We are submitting the enclosed studies in response to item 

#3 of our conditional registration for Indole-3-Butyric 

Acid. 

These studies are submitted on behalf of: 

Syntex Corporation, S.A. de C.V. 

P.O. Box 517 

cuernavaca, Morelos 

MEXICO 

The studies we are submitting are the following: 

Volume 1. - Guideline 81.-4, IIPrimary Eye Irritation study 

(Draise Procedure) in Rabbits with Indole Butyric 

J-\ \ '6.~O ~D( Acid." 

Volume 2 - Guideline 81-5, "Primary Skin Irritation Test of 

Indole Butyric Acid using Rabbits." 

'--j I '1,60-0)--

We would like to request that the hypersensitivity studies 

be waived. Based on the fact that the results of the skin 

irritation tests were negative, we feel that 

hypersensitivity studies will not yield significant new 

information. Therefore, we request that the studies here 

,",,;' submitted should be considered sufficient to complete the 

precautionary labelling review. 

Please contact us if you have any questions or comments. 

Thank you for your continued assistance. 

, " 

, " " , , , " , " > 

, " , " > 

" " 
148

DP BARCODE: D167505 

CASE: 041238 DATA PACKAGE RECORD DATE: 08/12/9J 

SUBMISSION: S400778 BEAN SHEET Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE: REGISTRATION ACTION: 570 CON REG FLW~UP DAT REQ RD 

CHEMICALS: 046 701 ;"'Indol,e'~3-butyric acid 97.0000~ 

ID*: 042473~0000l.INDOLE~3~BUTYRIC ACID 

COMPANY: 042473 SYNTEX, S.A. DE C.V. DIVISON QUIMICA 

PRODUCT MANAGER: 22 CYNTHIA GILES~PARKER 703~557~8540 ROOM: CM2 251 

PM TEAM REVIEWER: LEONARD COLE 703~557~1526 ROOM: CM2 253 

RECEIVED DATE: 04/30/91 DUE OUT DATE: 08/18/91 

* * * DATA PACKAGE INFORMATION * * * 

DP BARCODE: 167505 EXPEDITE: N DATE SENT: 08/12/91 DATE RET.: 

,CHEMICAL: 046701 Indole"-3-butyric acid 

OP TYPE: 001 Submission Related Data Package 

ADMIN DUE DATE: 10/21/91 CSF: Y LABEL: Y 

ASSIGNED TO DATE IN DATE OUT 

DIV : RD / / / / 

BRAN: RSB / / / / 

SECT: PRS / / / / 

REVR: // // 

CONTR: / / / / 

* * * DATA REVIEW INSTRUCTIONS * * * 

PLEASE REVIEW ACCOMPANYING DATA PACKAGE IN SUPPORT OF 

REGISTRATION FOR THE ABOVE MENTIONED PRODUCT. THE 

REGISTRANT HAS SUBMITTED THIS DATA AS A FOLLOW-UP TO 

CONDITIONAL REGISTRATION. INCLUDED ARE PRIMARY EYE 

IRRITATION, AND PRIMARY SKIN IRRITATION WITH MRID *s 418630~01, AND 02 RESPECTIVELY. THE REGISTRANT IS 

REQUESTING THAT THE HYPERSENSITIVITY STUDIES BE WAIVED BASED 

ON THE FACT THAT THE RESULTS OF THE SKIN IRRITATION TESTS 

WERE NEGATIVE. YOUR COMMENTS ARE GREATLY APPRECIATED. MANY 

THANKS ... 

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

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

/ / 
149

MEMORANDUM 

SUBJECT: 

FROM: 

TO: 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

EPA Reg. No./File Symbol 42473-01 / Indole-3-butyric acid 

Ian Blackwell J6!zf II/tlt/ 

Precautionary Review Section ' 

Registration Support Branch ~ Ilr~/9L Registration Division (H7505C) 

Cynthia Giles-Parker PM 22 

Fungicide-Herbicide Branch 

Registration Division (H7505C) 

APPLICANT: Syntex Corporation C/O D. Halliday & Co. 

3802 Luneta Lane 

Fallbrook, CA 92028 

FORMULATION FROM LABEL: 

Active Ingredient(s): 

Indole-3-Butyric Acid 

% by wt. 

min. 97.0 

I nert I ngredi ents:..................... max,;,._.::3 __ _ 

Total 100.0% 

Printed on Recycled Paper 
150

BACKGROUND: The applicant, Syntex Corporation, has submitted primary 

eye irritation and primary dermal irritation studies in support of the 

product Indole-3-butyric acid. The studies were conducted by Syntex Researchls Department of Toxicology and Pathology. The MRID numbers 

are 418630 -01 and -02. The applicant requests that the dermal 

sensitization study be waived. Data waivers were granted for the 

acute oral, dermal and inhalation toxicity studies by Health Effects 

Division (memo by Robert Zendzian, 6/5/89). 

REC DMM END A Tl ONS: 

1. The primary eye irritation and primary dermal irritation studies 

are graded guideline data and are acceptable to support the registration of the product. 

2. The request for a waiver of the dermal sensitization study is 

denied. A dermal sensitization study must be submitted. The 

laboratory1s basis for the waiver that no irritation was observed 

in the primary skin irritation study does not rule out the possi- bility of irritation caused by sensitization from repeated exposure. 

3. The signal word is "WARNING" based on the primary eye irritation 

stu dy. 

LABELING: 

1. Revise the signal word from "CAUTION" to "WARNING". 

2. The statement "Health Hazard Information" and the two lines 

following it should be removed. 

3. The Precautionary Statements should be revised to: 

"Causes substantial but temporary eye injury. Do not get in eyes, 

on skin or on clothing. Wear goggles, face shield or safety 

glasses. Avoid inhalation of dust. Wash thoroughly with soap and 

water after handling and before eating or drinking. Remove contaminated clothing and wash contaminated clothing before reuse. 

4. The Statements of Practical Treatment should be revised to: 

"If In Eyes: streamg~ater Hold eyelids open for 15 mi nutes. 

and flush with a steadt, Get medical attention.' gentle 

"If Swallowed: Drink promptly a large quantity of milk, egg white,OR 

gelatin solution, or, if these are not available, large quantities of water. V Get medical attention," 

AWlb ALWHOL. 
151

DATA REVIEW FOR 

PRIMARY EYE IRRITATION TESTING (§81-4) 

Product Manager (PM): 22 

Reviewer: Ian O. Black~w~eTl~l--

MRID No: 418630-01 Report No.: RS 11608-XX-00-0 Report Date: 5/30/BO 

Testing Laboratory: 

Author(s): 

Syntex Research Department of Toxcology and 

Path 0 10 gt Duane Aal esy, Ph.D. 

Species: New Zealand Albino rabbit Sex: 3 males + 3 females 

Source: Nitabell Rabbitry 

Age: Not specified Weight: 2.07 to 3.94 kg 

Test Material: Indolebutyric acid 

Dosage: 100m9 (0.19) into right eye 

Batch #1 

Quality Assurance (40 CFR §160.12): Included 

Summary: 

Toxicity Category: II 

Classification: core---~g7.u'i·d~e~l'i~n·e 

Procedure (Oeviation From §81-4): 

Results: 

lubservatlons (number r'pos1tiVe"/nUm5er 

Itested. 

HOUr!Oays 

1 I 12 j3 I 4 II 11. 121 

Cornea 0/6 6/6 6/6 5/6 --- 4/6 0/6 --- Iris 4/6 5/6 4/6 3 6 --- 1/6 /6 --- L.onJunCtlVae 

Redness 0/6 2/6 2/6 0/6 --- 0/6 0/6 --- emOS1S 'I' ~/b ~/b lib --- 'b --- ]SC ar e , --- ---
152

DATA REVIEW FOR 

DERMAL IRRITATION TESTING (§Bl-5) 

Product Manager (PM): 22 

Reviewer: Ian D. BlacKWeTl 

MRID No.: 418630-02 Report Date: 6/2/BO 

Report No.: RS 1160B-XX-OO-0 

Testing laboratory: Syntex Research Department of Toxicology and 

Pathology Author( s): Duane Ha1iesy Ph.D. 

Species: 

Age : 

Wei ght: 

Source : 

New Zealand White rabbits 

Not specified 2.922 to 3.760 grams Nitabell Rabbitry 

Test Material: indolebutyric acid, Lot 1160B-XX-OO-0 

Dosage: 0.5 grams 

Quality Assurance (40 CFR §160.l2): Included 

Summary: Toxicity Category: IV 

Classification: core - Guideline 

Procedure (Deviations From §81-5): 

Test material was app1ied to abraded and intact test sites. 

Results: 'Observations were made at 24 hours, 72 hours and 7 days. 

There was no irritation observed at any of the intact test sites. 
153

Tox Chern No. ____________ __ File Last Updated ______ __ Curre

Study/Anirnal/Lab/Date 

Primary eye irritation I 

RS 11608-XX-00-0 1 

rabbit 1 Syntex 

Research Department of 

Toxicology and 

Pathologyl 5-30-80 

Primary skin irrit./ 

RS 11608-XX-00-0 1 

rabbit 1 Syntex 

Research Department 

Toxicology and Pathologyl 6-2-80 

of 

I 

Material 

Indole-3-butyric aCidl 

..... 100% 

EPA 

Accession 

Number 

418630-01 

418630-02 

Results: 

LD50, LC50, etc. 

Corneal opacificatio

iritis, redness and 

chemosis. Clear by 

14 . 

No dermal irritation 

observed. 
154

1~I5YNTEX I 

NET 1 KILOGRAM 

( 1

(2.2 LB.) 

ID z'/lD 

INDOLE - 3 - BUTYRIC ACID 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

ACTIVE INGREDIENT: 

Indole-3-Butyric Acid ...................... min. 97% 

INERT INGREDIENTS .................... max. 3% 

EPA Reg. No. 42473-1 EPA Est. No: 42473-MX-t 

KEEP OUT OF REACH OF CHILDREN 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS 

AND DOMESTIC ANIMALS 

CAUTION! 

HEALTH HAZARD INFORMATION 

1. Harmful if swallowed. 

2. Eye and mucous membrane irritant. 

Do not get in eyes, on skin or on clothing. Wash 

thoroughly wilh soap and water after handling and 

before eating or smoking. Avoid inhalation of dust and 

con1amination of food and feed. Remove and wash 

contaminated clothing before reuse. Read and 

understand the Material Safety Data Sheet for 

addilional information before working with this product. 

STATEMENT OF 

PRACTICAL TREATMENT 

In case of contact with eyes, immediately flush with 

plenty of water and contact medical personnel. II 

swallowed, drink moderate amount 01 water and 

contact medical personnel. 

ENVIRONMENT HAZARDS 

Do not discharge into lakes, streams, ponds or public 

waters unless in accordance with an NPDES permit. 

For guidance contact your regional office of the EPA. 

DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in 

a manner inconsistent with its labeling. 

This chemical may be used only for the formulation 

of a plant rooting preparation. Formulators using 

this product are responsible for obtaining EPA 

registration for their formulated products. 

STORAGE AND DISPOSAL 

STORAGE: Store product in original container 

only, away from other pesticides, fertilizer, food or 

feed. 

DISPOSAL: Do not contaminate water, food or 

feed by storage or disposal. Wastes resulting 

from the use of this product may be disposed of 

on site or at an approved waste disposal facility. 

Completely empty liner by shaking and tapping 

sides and bottom to loosen clinging particles. 

Empty residue into manufacturing equipment. 

Dispose of any waste residues at appropriately 

permitted waste disposal facilities according to 

EPA regulations at 40 C.F.R. 260 et seq. Then 

dispose of liner in a sanitary landfill or by 

incineration if allowed by state and local 

authorities. If drum is contamlnated and cannot 

be reused, dispose of in the same manner. 

SYNTEX, S.A. de C. V. DIVISION QUIMICA 

APARTADO POSTAL 517, CUERNAVACA, MOR. MEXICO 
155

) 

) 

SYMBOL. 

SURNAME 

DA.TE 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

D. Halliday & Co. 

Agent for: Syntex Corporation 

3803 Luneta Lane 

Fallbrook, CA 92028 

Dear Ms. Halliday: 

Subject: Indole-3-butyric Acid 

EPA Registration No. 42473-1 

Re: Additional Stability Information 

Your letter dated November 28, 1990 

JAN 31 199\ 

You have requested an additional 4 to 6 months to submit the 

additional stability information requested by the Agency. This 

information is due July 3D, 1991. For additional information on 

requirements and protocols please contact the National Techrtical 

Information Service, 5285 Port Royal Road, Springfield, VA 22161 

(telephone: 703-487-4650) for a copy of the Pesticide Assessment 

Guidelines. 

Sincerely, 

Robert J. Taylor 

Product Manager (25) 

Fungicide-Herbicide Branch 

Registration Division (H7505C) 

COKCURRI!NCES 

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

EPA Form 1320-1A (1190) Print~d 1M R~cyc/~d Paper OFFICIAL. FILE Copy 
156

D. HALLIDAY & CO. 

Robert Taylor 

Product Manager (2S) 

Fungicide-Herbicide Branch 

Registration Division (H7505C) 

us Environmental Protection Agency 

Crystal Mall, Bldg #2 

1921 Jefferson Davis Highway 

Arlington, VA 22202 

No-....-ambar 23, 199.0 

3803 Lunl3ta Lane Fallbrook, CA 92028 

6191728-2893 FAX 6191723-8590 

Telex 181734 

Reference! Indole-3-butyric Acid #42473-1 

Dear Bob: 

As we discussed on the phone, it will not be possible to 

meet the November 30 deadline for submission of additional 

stability information. I am advised by Syntex that this 

will require a minimum of 4 to 6 months depending upon the 

required protocol. 

Would you please let us know if there is a particular 

protocol we need to follow? We will then analyse the 

situation and give you a more exact date for completion and 

submission of the data. 

'rhank you very much for your assistance. 

Cor.dially, 

r- IIALL~II)AY %&~ co /. / // 

/ ." . ! j _ • / I i 

!/ '/'-f/l J4t} , .~tc#t. Deborah ~liday 

'~ ( ) " , , . 
157

TO '1703312)87026 P.01 

: ,. " 'I 

~ ... ..". 

(~ UNITED STATES ENVIRONM~NTAt. PROTECTION AGENOY 

WASHINGTON. tJC ao4S0 

/J. f/ f\ cR; ~ k IA r11cJvr -

MAY Z 1 1990 

.. ""' .. 

""'nCIOat ~~ 

TOX!O'U~.'J{tCi 

MEMORANDUM . ,,-.. Stll!Jl>CT: Request for !;ontar\!et Data Waiver. for C~rrently Registered Indole-3-b~tyric Acid Uees 

FROM. lIi\! vaituzi., Microbiologist , J"1' t4~' .¢y'ro Ecologioal Effects l!ranch (H7S07-C) t 

Environmental Fate and Effects Divis 

THRt): Raymond W. Matheny, !lead section 1 \ I '/"I, II~ Ecological Effects Branoh 7507-C) v..,.,_r;:VJJ ~/IZ.,/a~ 

Environmental Fate and ~f Divi.ion'v~ g( ,(~ 

James W,. Akerman, Chief, 

Ecological Effects Sranch ( 

Enviromnentall'ate .. nd Eff 

TO. Ruby Whiter. (PM-50) 

A,.1«.1JI. 

507-C) 

U Division 

Generic Chemical Support Reregistration Division (H7508C) 

BACKGROUND. - .r 

IndOlll-3-butyr!c acid (.IllA), .. synthetic auxin st:~ucturally 

re.9mbl~ng the naturally occurring auxin indole aC$tio acid, 

hal boan registered ,as a chemical witll low volum~/minor use 

<lata waiver", Following extensive review the opp has 

clOooifiecl (ISA), as a biochemical. 

118 a result of FUM 'S8 data call-in, the companies marketing 

I2A haVe requu'ted that, the avian, freshwater 'fiahand 

lnvortebrate testing requirementobe waived forth. 

reregiatration o~ IBA as a biochemical. ,,.. -.'~" 

DISCUSIHON 

•• 

ISA i. a-plant growth llormone used to stimulate plant cuttings 

to produce healthy root. in container grown orn'ament-al plant 

crops. It i, applied to pl~nts 1~ & very ~ilute form (O.lt to 

0.6,) in a powder or liquid form by dipping of cuttingt prior to planting in pote or' flats. Most growere oan treat 

between one ahd two million cuttings with one kilogram of 

technical grade tBA. 

. ':' 

., .... 
158

. -. • I • :; "I' _ '" • _"T r ,'1 

Page 2 

ATTACHMENT I 

-2-

Plant propagation takes place in enclosed, controlled areas. 

Aftar rooting the cuttings are transplanted and placed in 

pots either in greenhouses or outdoors. Since IBA is absorbed 

by the plant cutting within 24 hours the amount of residue 

coming in contact with the environment is negligible. Technical 

grade rSA is shipped in sealed 1 kg plastic containers and 

the potential of environmental contamination through an 

accidental spill is very low. 

CONCLUSION. 

EEB concludes that the environmental exposure to the plant 

root growth hormone IBA from the treatment of plant cuttings '. is negligible. This essentially amounts to a greenhouse use 

pattern. As a result no ecological effects data are required 

for the reregistration of lEA for plant root treatments in 

the nursery industry. 

In order to make a risk assessment for use patterns other than 

nursery llp l ant-cuttings-dip-method,l (e.g, lawn spray) EEB needs 

the following data; 

Guidelines 

Reference 

Numberr 

154-6 

154-7 

154-8 

154-9 

154-10 

Kind. of Data Required: 

Avian Acute Oral (bobwhite quail or mallard) 

Avian Dietary (bobwhite quail or mallard) 

Freshwater Fish LCSO (rainbow trout) 

Freshwater Invertebrate LCSO (Daphnia magna) 

Nontarget Plant Studies 
159
160

I~I SYNTEX I 

NET 1 KILOGRAM 

I 1

(2.2 LB.) 

/D-2-19D 

INDOLE - 3 - BUTYRIC ACID 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

ACTIVE INGREDIENT: 

Indole-3-Butyric Acid ...................... min. 97% 

INERT INGREDIENTS .................... max. 3% 

EPA Reg. No. 42473-1 EPA Est. No: 42473-MX-1 

KEEP OUT OF REACH OF CHILDREN 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS 

AND DOMESTIC ANIMALS 

CAUTION! 

HEALTH HAZARD INFORMATION 

1. Harmful if swallowed. 

2. Eye and mucous membrane irritant. 

Do not get in eyes, on skin or on clothing. Wash 

thoroughly with soap and water after handling and 

before eating or smoking. Avoid inhalation of dust and 

contamination of food and feed. Remove and wash 

contaminated clothing before reuse. Read and 

understand the Material Safety Data Sheet for 

additional information before working wnh this product. 

STATEMENT OF 

PRACTICAL TREATMENT 

In case of contact with eyes, immediately flush with 

plenty of water and contact medical personnel. It 

swallowed, drink moderate amount of water and 

contact medical personnel. 

ENVIRONMENT HAZARDS 

Do not discharge into lakes, streams, ponds or public 

waters unless in accordance with an NPDES permit. 

For guidance contact your regional office of the EPA. 

DIRECTIONS FOR USE 

It is a violation of Federal law to use this product in 

a manner inconsistent with its labeling. 

This chemical may be used only for the formulation 

of a plant rooting preparation. Formulators using 

this product are responsible for obtaining EPA 

registration for their formulated products. 

STORAGE AND DISPOSAL 

STORAGE: Store product in original container 

only, away from other pesticides, fertilizer, food or 

feed. 

DISPOSAL: Do not contaminate water, food or 

feed by storage or disposal. Wastes resulting 

from the use of this product may be disposed of 

on site or at an approved waste disposal facility. 

Completely empty liner by shaking and tapping 

sides and bottom to loosen clinging particles. 

Empty residue into manufacturing equipment. 

Dispose of any waste residues at appropriately 

permitted waste disposal facilities according to 

EPA regulations at 40 C.F.R. 260 et seq. Then 

dispose of liner in a sanitary landfill or by 

incineration if allowed by state and local 

authorities. If drum is contaminated and cannot 

be reused, dispose of in the same manner. 

SYNTEX, S.A. de C.V. DIVISION QUI MICA 

APARTADOPOSTAL 517, CUERNAVACA, MOR. MEXICO 
161

) 

" EPA REGISTRATION NO. 

US ENVIRONMENTAL 

OFFICE OF pESTICIDES 

PROTECTION 

PROGRAMS 

AGENCY 42473-1 r DOCTOF2s~t~90 REGISTRATION DIVISION (TS·767) TERM OF ISSUANCE 

WASHlNGTDN. DC 20460, CmmITIONAL 

NOTICE OF PESTICIDE, o REGISTRATION NAME OF PESTICIDE PR(jDUCT 

o RERE:c;iSTRATION 

(Under the Federal-Insecticide, Fungicide, 

and Rodenticide Act, as amended) Indole-3-Butyric Acid 

NAME ANO AOORESS OF REGISTRANT (Ihcillde ZIP cod,,) 

r -, 

Syntex Cor.poration 

P.O. Box 517 

CU0rnavacD, !'lor. Nf~}(ico 

L .J 

~OTE: Changes in labeling formula differing in substance from that accepted in connection with this' registration must be 

submitted to and accepted by the Registration Division prior to use of the label in commerce. In any correspondence on this 

product always refer to the above U.S. EPA registration number. 

On the basis ot information furnished by the registrant, the above named pesticide is hereby RegisteredJReregistered under 

the Federal Insecticide, Fungicide, and Rodenticide Act. 

A copy of the labeling accepted in connection with this Registration/Reregistration is re,turned herewith. 

Registration is in no way to be construed as an indorsement or approval of this product by this Agency. In order to protect 

healt,h and the, environment, the Administrator, on his motion, may at any time suspend or-cancel the registration of a pesticide. in accordance with the Act. The acceptance of any name in connection with the registration of a product under this 

Act'is not to be construed as giving the registrant a right to exclusive use of the name Or to its use if it has been covered 

by 9therS. 

This product is conai tionally registereo in accordance 'ditb FIPRA 

sec. 3 (el (7) {AI provided that you: 

l.fjubmi t and/or Cl_2 " c -11 data requ ir~(; for registration/ o __ ~ 

reregistration of your product nnd6-r FIF'RZI. sec. 3 {el (51 Hh',"D the Agency 

- requires aU rE'~gistr2lnts of similar products to submit sncll data. 

L. l"i2:l!:e tilE: ~.ebelin'J cl'13nges listed belm'l befon'O you release the product fo:: 

shipmen t: 

Add the phrase! "EPA Registr-:rtion Ho. 1"2473.-1 If to your J."c-e1. before you 

release the product for: shipment:. 

Change the "InstrucUon for Formulation II heading to read HDirections for 

Use ll • 

3.Submit primary eye irritat.ion l primary den;\al irritation, and hypersensi bvi tj 

studies by AprH JO, 1991. Dati':! in the Agency's file conce!"ning these studie" 

performed IdJth the t8cnnic8.1 is sketchy or lacking, therefoL2 these studies 

needed to cotlplHe tb:::: 

C'" 

D/\TA1cHMENT IS A~P\"ICAit~" 

SIG~ 

! Tta OF ASPOy\NG O(~.tA\" ,j 11!,; U _ - ,_ 

EPA Fo on 8SYO.& (Rev: 5-1&1 

I i i I 

U 

precau tionary labeling rev.i.evr. 

" 

/) " 0 I D'j'b/t2(/:/c; 0 

PREVIOUs EOITION MAV aE USED UNTIL. SUPPL.V Is EXHAUST~O. , 

arE 
162

UNITED STATES ENVIRONMENT;t.L PROTECTION AGENCY 

4. Submit additional information on stability, Guideline 

Reference Number (GRN) 63-J.3. This information must 

include a discussion of the sensitivity of the active 

ingredient to metal ions and metal, stability at normal and 

elevated temperatures, and sensitivity to sunlight. Please 

submit this information by November 3D, 1990. 

5. Submit five (5) copies 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 sec. 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. 

Enclosure 

"" l J ; S,ln~~11ly \ 1 \ I I \'L~\LvJ\.A C ~V\.·VIW 

.. Robert J. Taylor 

Product Manager (25) 

Fungicide-Herbicide Branch 

Registration Division (H7505C) 

CONCURRI!NCES 

. 
163

ACCEPTEb 

v:itb co)"nlEl'ITS 

in EPA Letter D"teu: lei SYNTEX I 

INDOLE 

NET 1 KILOGRAM 

(2.2 LB.) 

PLANT GROWTH REGULATOR 

FOR FORMULATION USE ONLY 

ACTIVE INGREDIENT: 

Indole·3·Butyric Acid ...................... min. 97% 

INERT INGREDIENTS .................... max. 3% 

EPA Reg. No. XXXX EPA Est. No: 42473·MX·l 

KEEP OUT OF REACH OF CHILDREN 

PRECAUTIONARY STATEMENTS 

HAZARDS TO HUMANS 

AND DOMESTIC ANIMALS 

CAUTION! 

HEALTH HAZARD INFORMATION 

1. Harmful if swallowed. 

2. Eye and mucous membrane irritant. 

Do not get in eyes, on skin or on clothing. Wash 

thoroughly with soap and water after handling and 

before eating or smoking. Avoid inhalation of dust and 

contamination of food and feed. Remove and wash 

contaminated clothing before reuse. Read and 

understand the Material Safety Data Sheet tor 

additional information before working with this product. 

STATEMENT OF 

PRACTICAL TREATMENT 

In case of contact with eyes, immediately flush with 

plenty of water and contact medical personnel. If 

swallowed, drink moderate amount of water and 

contact medical personnel. 

ENVIRONMENT HAZARDS 

Do not discharge into lakes, streams, ponds or public 

waters unless in accordance with an NPDES permit. 

For guidance contact your regional office ot the EPA. 

INSTRUCTIONS FOR FORMULATION 

It is a violation" of Federal law to use this product in 

a manner inconsistent with its labeling. 

This chemical may be used only for the formulation 

of a plant rooting preparation. Formulators using 

this product are responsible for obtaining EPA 

registration for their formulated products. 

STORAGE AND DISPOSAL 

STORAGE: Store product in original container 

only, away from other pesticides, fertilizer, food or 

feed. 

DISPOSAL: Do not contaminate water, food or 

feed by storage or disposal. Wastes resulting 

from the use of this product may be disposed of 

on site or at an approved waste disposal facility. 

Completely empty liner by shakio9 end tapping 

sides and bottom to :0(.0:->13,' clinGir,G particles. 

Empty residue into rr.anufacturing equipment. 

Dispose of any waste rE.sidues at o.fjpropriately 

permitted waste disposal f,C[cilitiE'f acr,ording to 

EPA regulations at 40CrR. 260 et 33q. Then 

dispose of liner in ('I. :-;qrlitary lalldfill or by 

incineration if allowed by st3.t3 c:.nd local 

authorities. If drum is contaminatAd qnd cannot 

be reused, dispose of in the same m3:1:1er. 

SYNTEX, S.A. DIVISION QUIMICA 

APARTADO POSTAL 517, CUERNAVACA, MOR. MEXICO 
164

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFnCE OF PESTICIOES ANO TOXIC SUBSTANCES 

According to 

Toxicology Branch 

Inhalation studies 

October 23, 1990 

a memo dated 7/10/90 from Robert 

(TB), the Acute Oral, Acute Dermal 

have been waived for technical IBA. 

Zendzian, 

and Acute 

Review of technical IBA by the Precautionary Review Section 

(PRS) indicates that primary eye irritation, primary dermal 

irritation and hypersensitivity studies are needed (see memo signed 

by T. Ellwanger on 10/5/90). A complete precautionary labeling 

review cannot be conducted until these studies are received and 

reviewed. Therefore PRS is unable to advise FHB on the appropriate 

signal word and precautionary labeling statements. 

In a telephone conversation with Ruby Whiters, Special Review 

and Reregistration Division (SRRD) on 10/23/90, it was confirmed 

that the primary eye irritation, primary dermal irritation, and 

hypersensitivity studies were not required under the Data Call-In 

(DCI) for technical IBA according to R. Zendzian. 

Cynthia Giles-Parker 
165

DP BARCODE: D155510 

CASE: 041238 

SUBMISSION: S381728 

DATA PACKAGE RECORD 

BEAN SHEET 

DATE: 09/10/90 

Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE: REGISTRATION ACTION: NEW PRODUCT - OLD CHEMICAL MINOR CHANGE 

CHEMICAL: 046701 Indole-3-butyric acid 

ID#: 042473-R INDOLE-3-BUTYRIC ACID 

COMPANY: 042473 CHEM.DIV.KM4 CARR FED.CUERNVACA CUATLA 

PRODUCT MANAGER: 25 ROBERT TAYLOR 703-557-1800 ROOM: CM-2 245 

PM TEAM REVIEWER: CYNTHIA GILES- PARKER 703-557-0705 ROOM: CM-2 251 

RECEIVED DATE: 07/27/90 DUE OUT DATE: 02/02/91 

* * * DATA PACKAGE INFORMATION * * * 

DP BARCODE: 155510 EXPEDITE: 

OP TYPE: 001 Submission Related 

",MIN DUE DATE: 02/07/91 , ASSIGNED TO DATE IN 

DIV:RD // 

BRAN: RSB / / 

SECT: PRS / / 

Y DATE SENT: 09/10/90 

Data Package 

CSF: Y 

ASSIGNED TO 

REVR : 

CONTR: 

DATE RET.: 

LABEL: Y 

DATE IN 

/ / 

/ / 

* * * DATA PACKAGE REVIEW INSTRUCTIONS * * * 

Please review application to register technical IBA. If 

this product is registered, this will be the only source of 

lBA registered in the USs 

According to the attached memos acute toxicology data was 

waived for the data call in notices. Does this mean that 

the acute toxicology data is not needed for registration of 

this product. 

Please review the labels and if possoble, determine which 

label statements are appropriate for this product. 

FHB will be requesting an expedited review of this product 

in order that the registrant may make the growing season if 

this product is approved for registration. 

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

DP BC 

155508 

BRANCH 

RSB 

DATE OUT 

09/10/90 

DUE BACK 

02/07/91 

INS 

Y 

CSF 

Y 

LABEL 

Y 

/ / 
166

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

PI;STICIDES ANO TOXIC SUDSTANCI;S 

MEMORANDUM 

SUBJECT: 

FROM: 

TO: 

Sheila A. Moats, Ph.D. Jt: \ ~ 10 (5/'10 Precautionary Review Section ~ 

Registration Support Branch 

Registration Division (H75-05C) 

__ --,~-'"C":'>'jyf-"""1Jc,-L'7/:" c...=--ii'G'c.=--f-?-"a4=.I~=>-cT' "-;;=--;c: (PM .tS") - UJ1 / c .. i OJ e.... - fVl.-.k, ,-c../d e /*J.- (!,.-n ~ Registrat'on Divislon H75-05C 

APPLICANT: _S=yn'{-Uf.. 9. If. J)iV/SfOh a/..l-/rn/ca-

-11 ;) p!YI-fa._d Q 'Pes ;-<>-[.5-/ '7 

Cl-<-e-Ln<>->, <LCO--, Mod. 1!LQ$.Jc-o • 

FORMULATION FROM LABEL: 

Active Ingredient(s): 

·;;f~ndD& "" :3-

Inert Ingredient(s): 

Total 

% by wt. 

-'I::LcQ 

3'·0 

100.0% 
167

. , 

: ~ 

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S?YI:J'f-re-?t. :;-',!l CA!i!,¥:or'r g.J. U,"'J}.I's:LQ.kh._ 

"ClYf oRe e.d ~d)- Z"e 71's hw£,'" '1 ad -;;;",d" to- $" ;3~-f"fhJ ",,'/).g/d 

7 . .£ ) ,,-P./, .. v-t En'o,,:o7/.- J("';t"-/'!Jif<Y>- (/[""'j No If tl.i.f 1.3 -If .. __ " 

__ .JY12._'±~'.!---r~.b~,L..!8_0.!?~_.£~_~i'."?.!.::/t,,=s'._c. _______ _ 

__:k n gQ'&- ~0>..<d:"I-/!f:.s.._,!,,=£cL4..[-.:kAd.2..kL_h_?!?<,CL-f!!J~':' 'Q.'-"'!.Y 

~;,{'t~,-~I '~8 0<.- ~h. e.YrJ-.l~a.-L -1l&2..~~_..I1J.1.)l.':. '2:!.t2..J,.Mo/iJ1J~1t).aJJ...S...¥g'.Q-ft-lAoJ "~'1-.$ 

_1;;[l'- 0 ee /w.$ ~f~ c-Lo.s"';d.i'~.?d_:f-I2ILI>d._~_.i2iQ&~..'''-''''C t, 

~~&'ic/; ¥J&~)<'ri'20.LD~"h o!"'TLi,""'22-2~'-'J--j/~; h~,-:""--t;=€J!J"" FE.' .v' 

..f:ii t1 e,~ pA if0-.f f M 70..""l:'2 $'Q.-d-q,.:I-"dj~/Wf ;}eLL!.?' 9C'J-: __ _ 

__ 2 a-:-t c<.-_Jl!dQ:/ V~l-§ ~ Q-).~- _~~s.l..-!J..c..'jA-£L ___ t~L-6~_.k:..J3..J1._t~_~_isdJ.. 

t",*J..&.-!2'J' u~<Ji"'~ ~ d Mm..4_±~-£di.'2!:> __ J'.t,",d~'!?c£ , 

_-d-C~~.iQ---E::-__ m.fb1X)~d-.U_D2_~;LCL:yjiij/~i];!?~j~--.L 

JJJ:1 ~1LrY1--.2.:J:L,p oflL,ll_D j,~t1~_DJi:k=ioJ:L,~J<-"h£c:l~y 

_J3'~~&~-&1LFlj~_~_~~ ___ ~~_?--~_l~ _________________ _ 

________ ~T)"''''-2'dr~' ~7 

""-",,,,---...!h. 15€.-- AQg-aC1di6' j,'/e-.- C""O_!':!:.....c..U!::l1._-'~:~ __ .-._,_ I tr - --:; _tJ.&#~b_T.L<-dy-"l.j-..L~A -fs!)&02 =.ed...t.cu;?k.;1k_t'l='!..6.0L"""d 

I'" <,clue I- is ,.rIce-I-c;:'y 0-)- 1..0'"<:0£-,, '74--~-i-",~-,=1'{ "'~_Ck.~;,,~,l" OJ,! 

~~~ ;'I:.._~~o.o~L"2..~ S A..HiL..c.A..~j-~ __ .9:::£.-£;d22dp,::~,_~?_ 

~L1A< ,tiJrJ!f-Y'cdrf'-" _~~c'd .... Ii',,!s -#:C'k...<i?d<<2S.M_'V-,~d-_1",=-s f:...~'2!~ f~o~ 

-..itrt a-f) ~-.-.2_~ d t'o/-!~€Jt.l G_L~_~ ,S>g:E:f.\D_~~_l s :2 _=!...~~_L!:L!:_~?: 

-.I1-.p<J/ m ~+g.7&:._~~a.rf/:pA-a fu.-cIJ;t/ @~J2&L!:n(L2j_dc?""-?!::--irYL!3--L 

-ihZl:l.hJ:/ () tL stcyLy ~ Y:- 0--_ A jiJ.t:<--l-S'e.tlJY-' i:iJ!.;"fr:-~~b±cl¥ _____ _ 

L ",<hd;~ , ___________________ _ 

__ ~Sd-Q on-jJ~hz.... _ __J2!2~~rJ.S;,...h cul1-L@~6""'_l.!~~,.g.~<Ji.":"" 

,vi /I M-'-...s:d2"-d",,,<_f-<Ld ""fNL ~';d--~"""---9=<;--"9"-<l...~":-­

lI.&J.'~dad_~4"'""_b_XLCJ...i¥.c¥1v....dj&£-~----------------
168

· -

UNiTED STATES ENViRONMENTAL PROTECTiON AGENCY 

WASHINGTON. DC 20460 

l1EMORANDUM 

SUBJECTs Classification of Indole-3-Butyric Acid as a Bio~lemical 

Pesticide (Caswell #499) 

TO, 

FROM, 

Robert Taylor/Angela Bar.nes (PM-25) 

Registration Division (H750SC) 

J. Thomas McClintocK, ph.D" MicrObiologist\\<\<>';-:j,'~' Science Analysis and Coordination \' s! ," 

Health Effects Division (H7509C) \ 

THROUGH: Reta Engler, Ph.D., Chief 

Science Analysis and Coordination 

Health Effects Division (H7509C) 

ACTION REQUESTED, S~CB and the opp Biotechnology Workgro~p were 

asked to classify indole-3-butyrtc acid (IBA) as a conventional 

chemical or biochemical pesticide. In a l-ecent corres1?ondence (see 

attached memorandum from J. '1'. NcClintock to R. Taylor) the registrant 

was asked to submit information verifying the natural occurrence of 

the subject compound in plants. Prior to a response from the 

registrant, SACS and the opP Biotechnology Workgroup recommends that 

this memorandum supercedes our review of 2/23/90, J. T. McClintock. 

DISCUSSION CONCLUSION: The cu,!"rent definition of a biochemical 

pest c e sates t at "In order for synthesized pesticides to be 

considered as biochemical pesticides, they must be structurally 

similar, and funct ionally ident i c·al, to a na t ura lly occurr i ng bi 0-

chemical pesticide." No evidence was presented by the registrant 

on the natural occurrence of IBA in plants. 

Following extensive review and diSCUssion, SACS and th'e opp Biot~chnology Workgroup haY'e considered an alternative approac:h tor :'hc 

claSSification of lEA as a biochemical pesU.cide. Sevei;~l na~l.:t:ally 

occur;;ing plant growth compounds have been identified ... ·ldc:h displ'ay 

activity resembling auxin (indoleacetic acid - lAA), a pl~nt grdwth 

r.egulator. Such plant compounds, which are intermedl.ate metabcli:;es 

produced dur.ing the synthesis of IAA from tryptophan, are indole 

acetamide, indoleacetaldehyde, and j.ndolepyr.uvic acid. When Q.?f'.1.led 

to auxin-deficient plant tissue these compounds are thought to be 

converted to !AA before they are effective. rBA is a synthetic auxin 

that structurally resembles not only IAA but all of the intermediate 

metabolites. ConsequentlYt since lBA is ~ufficiently similar to the 

chemical str.ucture; and fUhctionally equivalent to natur.ally occurring 

auxins we believe that lBA ehould be classified as a biochemical 

pesticide. 
169

DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT 

: 2 . 

 * : EPA REG.NO./FILE SYMBOL, 

ANY I NAME AND: U;! If '73-f( 

3. FORMUi:ATOR! S 2XEMPTrON 

SELECrEu: 

YES NO X 

:4. PAGE 

OF 

:6. APPLICATION FOR 7. NAME OF ACTIVEINGREDIENT(SI 

xico 

, 

, , 

, 

REGISTRATION DATED: 

July 24 1990 Indole-3-Butyric Acid 

MONTH DAY ._ YEAR 

i 9. SOURCE _OF DATA S_ATISFYING REQUIREMENT 

:9a. 19b. 19C. :9d. ige. :9f. :10. 

_5_ 

t jsubmitted Date Submitted jCertificate :Public :N.A. or :MRID Number 

II by Submitted by another of Permis- IILitera- :Waiver orjEPA ACCessi{ 

:Applicant person/firm sion (P) or :ture :other : Number , or 

(give name) Offer to: : (explain) :other 

Pay (OTP): : : identifying 

enclosed:: : : number 

indicate: : "P"_ or "OTP": : 

MISTRY 5/11/89 : 

& : 

, , 

f Yes 7/20/90' : 41193801 

s _L_ 

, , 

of Yes 7/20/90 " : : 41193801 

n ....L __ _ 

 of 

of Yes 7/20/90 " 41193801 

s 

y 

Yes 7/20/90 4/11/8,) & '" 41193701 _ _1... ___ , 

___ _ 

, 

of Yes 7/20/90 " : 41193701 

....L_ 

 method i Yes 7/20/90 ", 41193701 

ement .J 41193702 

Yes'" Ii 411o'n02 

tate Yes 

_ _____ : Yes '(/20/90 " 41193702 

ation for usc in :COl :1tion of agricu1tU1'a1 rooting pound only. 
170

DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SU

1. PRODUCT NAME: ---rZ. EPA REG. NO. /FILE SYMBOL: 13. FORMULATOR'S EXEM

Indo1e-3-Butyric Acid: : SELECTED: 

5. APPLI CANT'S (COMPANY) NAME AND II II YES NO X 

ADDRESS: ) : 

:6. APPLICATION FOR :7. NAME OF ACTIVE IN

Syntex Corporation 

P.O. Box 517 

: REGISTRATION DATED: : 

, , 

, , 

Cuernavaca, Mar. Mexico 1 July 24 1990 : 

___________________ MONTH DAY YEAR : 

8. 40 CFR Part 158 - : 

DATA REOUIREI'-rENTS __ i '3. SOURCE OF DATA SATISFYING REOUIREMENT 

Indole-3-Butyric A

8a. :8b. :9a. :9b. 9c. 9d. :ge, )9

Guide- :Name of Test 1 Submitted: Date Submitted certificate IPublic IN

line 

Refer-

) : by : submitted by another of Permis- :Litera- :W) IIApplicant) person/firm sion (P) or )Iture lo

ence 

Number 

I (give name) Offer to I ! (

: Pay (OTP) I : 

i enclosed:: : 

Section 

158.190 

)1 indicate II I) 

_ _________ "pI! or __ !loTP"-l ...L___ 

PRODUCT CHEMISTRY 

(continued) 

Yes 4/11/89 

& 

7/20/90 

63-5 iMeltinq point 

63 6 .--llill_i l.i11Q PO i L __ Yes JI __ __ _ 

63-7 :Density, bulkI density, or 7/20/90 

, 'f" " 

I spec 1 1 C gr a v llL----t---c;::---i--,,---;---------i'---'---------i-------i--

QJ._-8 iSOlubilitv Yes " 

63-9 ) Vapor press-lire Yes 7720/90 ") 

I' " ) 

63-10 : Dlssoclatlon : 7/20/90 " 

! CQnstant _____ 

, , 

63-11 I :- Yes 7/

20/90 II :partltlon I 

:coefficient i " 

bJ-12 pH xes 

63-1} ---.LStabili_tv Yes 

63-14 :Oxidizing/reducing: 

______ 

' " 

__ r e act 1.,0 n ----------' , , • ___ ----'------ __ , _________ 1...- '"_. ___ •• __ • ______ 1 ,,_." ______ __________ rL _
171

DATA REOUIREMENT LISTING fOR THE SELECTIVE NETHOD OF SU

1. PRODUCT NAME: / F Ii E S ---;--3-.-roRNuLATO R EXEr-l

Indole-3-Butyric Acid SELECTED: 

NO 

NAME AND 

5. APPLICANT'S (COMPANY) 

ADDRESS: 

6. APPLICATION FOR 

Syntex Corporation REGISTRATION DATED: 

P.O. Box 517 

Cuernavaca, Mor. Mexico July 24 1990 

MONTH ___ __ YEAR. __ Indole-3-Butyric A

S. 40 CFR Part 158 - : 

DATA REOUIREMEN'l'_S._ -----.l.3. SOURCE OF DATA SATISFYING REOUIRENENT 

Sa. :Sb. 9a. 9b. 9c. 9d. 

Guide- :Name of Test Submitted Date submitted Certificate 

line J by Submitted by another of PermisRefer- : Applicant person/firm sion (P) or 

ence : (give name) Offer to 

Number : Pay (OTP) 

enclosed: 

indicate 

ge. : 9

pub 1 ic :N

Litera- :W

ture lo

: (

, 

, , 

, 

, , 

L.. L_ ,"P" or : 

section 

158 . 190 ,I PRODUCT CHEMI STR Y 

(continued) 

15 :flanuna_bilitv__ 

63-16 

63-1 

63-18 63-19 63-20 

63-21 

I Explodabi I storaqe stabi 1 itv yes 7/20/90 

I" I ,VISCOSIty I 

:Miscibility _1_ 

:Corrosion : 

: characteristics ___ 1._ ____ 

:Dielectric breaX- 

:down voltage 
172

DATA HEDIJI RENENT LI STINe; U)F-i. THE SELECTIVE METHOD OF S

1. PRODUCT NAl"1E .. -.... -.. -- - ---.----.-- : 2. [Pi\ REG. N6':"7r':-ILE' J . 

Indo1e-3-Butyric Acid : 

5. APPLICANT'S (COMPANY') NAME AND: 

, 

, 

, 

, 

, 

. 

__ 

. 

fORNULATOR'S 

SELECTED: 

YES __ _ 

EXE

NO 

ADDRESS: II '--cc= 

APPLICATION FOR ------.-- : "7 -. 

syntex Corporation 

P.O. Box 517 

Cuernavaca, Mer. Mexico 

8. 40 CFR Part 158 - r 

: REGI STRATI ON DATED: 

, 

, 

: July 24 1290 1. MONTH DAY Indole-3-Butyric 

DATA RJ;::OUIREMENTS ._: 9. SQURCE.OF DATA SATISFYING......RCOUIRI:M.ENT 

:8b. 19a. 19b. :9C. 19d. 

Sa. 

Guideline 

Reference 

Number 

:Name of Test 

, 

, 

ISubmittedl Date :submitted :Certificate 

\ by ISubmittedlby another :ot Permis1ge. :Public :Literaiture 

, , 

, , , , 

, 

, , 

, 

Section WILDLIFE AND AQUATIC 

158.145 ORGANISl1 

l-l t.o 71-5 Avian and Mammalian 

Testing 

to 72-7 Aquatic Organism 

Testing 

Section 

15.8.135 TOXICOLOGY 

_-1 to 81-3 Acute Testing 

to 82-3 Subcbronic Testing 

83-3 Chronic '?esting 

--2 to el(- 4 Mutagenicity Testing 

I 

IApplicant: :person/firm:sion (P) or 

I I : (oive name) IOffer to : I : r :pay (OTP) 

: I : : enclosed: 

I : : : indicate 

, , 

, 

, 

, 

, 

, 

, 

, , , I"p" or "OTp!! I 

I I 

l 

, 

I 

I 

I I 

I 

I , i , , 

, i ! I 

I , i 

I i I , 
173

DATA REQUIRE.:M£NT LISTING fOR THE SELECTIVE METHQD OF S

1. PRODUCT NAME: : 2 

Indo1e-3-Butyric Acid II : SELECTED: 

5. APPLICANT 1 S (COMPANY) NAME AND] : YES NO 

ADDRESS: 1 i 

16. APPLICATION FOR ]7. NAME OF ACTIVE IN

Syntex Corporation 1 REGI STRATION DATED: I 

, , P.O. Box 517 , , 

Cuernavaca) Mor. Mexico 1 July 24 1990 I 

: ___ MONTH DA'L ----.Y..E:AR ) Indo1e-3-Butyric A

8. 40 CFR Part 158 - r 

DATA REDJJIREMENTL_ ___ SOURCE_ OF DATA SATIS_E'YING _BEQUIREMENT 

8a. 

Guideline 

Reference 

Number 

Section 

158.135 

85-1 

Section 

158.150 122-1/122-

Section 

158.140 

132-1 to 

133-4 

Section 

158.130 161-1 to 164-1 

: 8b. ! 9a. 9b. : 9c. 9d. 

IName of TeSt Submitted Date I Submitted Certificate 

1 by Submittedlby another of Permis-

: Applicant lpersonjfirm sion (Pl or : (give name) Offer to : Pay (OTP) 

: :enclosed: 

I : indicate 

--t' .. U, 1 t'" 

TOXICOLOGY 

( continued) 

Special Testing 

PLAN'r PROTECTION 

NONTARGET AREA 

, 

i I , 

FEOTECTION 

, . 

ENVrHOJofE:N'l'AL FATE 

, 

.V-. T ____ 

1ge. 

lpublic iLitera-

:ture 

, 

, 

, , 

, , 

, 

, 

I 

i

:

l

: : : 

, , 
174

Waived Testing per the Enviromental Protection Agency 

Attachment I and Attachment II 
175

MEMORANDUM 

SUBJECT, 

FROM, 

THRU, 

ATfAGllMENT I 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, DC 20460 

MAY 2 1 1990 

Request for Nontarget Data Waivers for 

Currently Registered Indole-3-butyric Acid Uses 

OF'loeOF 

>'E~TlCIO~S AND 

TOXIC ~V6l>TANCi<~ 

Zig 

Ecological 

vaituzis

Effects 

t Microbiologist Branch (H7507-C) 

J1 /11 ~~ --?Iv 

Environmental Fate and Effects Divis' 

Raymond w. Matheny, Head Section 1 i\ " I 

Ecological Effects Branch 7507-C) ,,~~~' 

Environmental Fate and Ef Divisi'90v~ 

James W. Akerman, Chief 

Ecological Effect. Branch ( 

Environmental Fate and Eff 

j(,~.W 

507-C) 

ts Division 

TO: Ruby Whiter. (PM-50) 

Generic Chemical Support 

Reregistration Division (H750BC) 

BACKGl\OUND: 

Indol~-3-butyric acid (IBA), a synthetic auxin structurally 

resembling the naturally occurring auxin indole acetic acid, 

haa been registered as a chemical with low vOlume/minor use 

data waivers. Following extensive review the opp has 

classified (lBA) as a biochemical. 

As a result of FIFRA 188 data call-in, the companic~ mKrke~in1 

lBA have requested th~rt- the aliia-n, freshwater fish an-:. 

invertebrate testing requirements be waived for th£ 

reregistration of lBA as a biochemical. 

DISCUSSION 

IBA is a plant growth hormone used to stimulate plant cuttings 

to produce healthy roots in container grown ornamental plant 

crops. It is applied to plants .in a very dilute form (0.1% to 

0.6%) in a powder or liquid form by dipping of cuttings 

prior to planting in pots or flats. Most growers can treat 

between one and two million cuttings with one kilogram of 

technical grade lEA. 
176

Page 2 

ATTACHMENT I 

-2-

Plant propagation takes place in enclosed, controlled areas. 

After rooting the cuttings are transplanted and placed in 

pots either in greenhouses or outdoors. Since IBA is absorbed 

by the plant cutting within 24 hours the amount of residue 

corning in contact with the environment is negligible. Technical 

grade tBA is shipped in sealed 1 kg plastic containers and 

the potential of environmental contamination through an 

accidental spill is very low. 

CONC"US!ONI 

BEB concludes that the environmental exposure to the plant 

root growth hormone IBA from the treatment of plant cuttings 

is negligible. This essentially amounts to a greenhouse use 

pattern. As a result no ecological effects data are required 

for the reregistration of IBA for plant root treatments in 

the nursery industry. 

In order to make a risk assessment for use patterns other than 

nursery "plant-cutting~-dip-methodrr (e. g. lawn spray) EEB needs 

the following data: 

Guidelines 

Reference 

Numberl 

154-6 

154-7 

154-8 

154-9 

154-10 

Kind of Data Requ...i,red: 

Avian Acute Oral (bobl."hite quail Or mallard} 

Avian Dietary (bobwhite quail or mallard) 

Freshwater Fish LeSO (rainbow trout} 

Freshwater Invertebrate LeSO (Daphnia magna) 

Nontarget Plant studies 
177
178

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179

a@SPQn~& ~$ Phamw 2 &ubmi®w1on ~H:1iTx1m'""'t~ ____ "",";gPif*tlo/",~,ppn'ffi'MM";"1''.'mr;;j,~,.,;;;,;':;'::'.,._;;';~_,'::'~';:'.;,!,!~_;;';;, .,~_;",';;'~';';'~';' .. ;;m~_;';;';;';;~';;~~~~==~"'._=~~="""W"~='~'",< , ':",'-'0'!~"f1 ,,~,.0,,~~ i e~fty !n.j\bt~ .: ii!lmt 

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, 

DP BARCODE: 0155508 

CASE: 041238 DATA PACKAGE RECORD DATE: 09/10/90 

SUBMISSION: 8381728 BEAN SHEET Page 1 of 1 

* * * CASE/SUBMISSION INFORMATION * * * 

CASE TYPE: REGISTRATION ACTION: NEW PRODUCT - OLD CHEMICAL MINOR CHANGE 

CHEMICAL: 046701 Indole-3-butyric acid 

ID#: 042473-R INDOLE-3-BUTYRIC ACID 

COMPANY: 042473 CHEM.DIV.KM4 CARR FED.CUERNVACA CUATLA 

PRODUCT MANAGER: 25 ROBERT TAYLOR 703-557-1800 ROOM: CM-2 245 

PM TEAM REVIEWER: CYNTHIA GILES- PARKER 703-557-0705 ROOM: CM-2 251 

RECEIVED DATE: 07/27/90 DUE OUT DATE: 02/02/91 

* * * DATA PACKAGE INFORMATION * * * 

DP BARCODE: 155508 EXPEDITE: 

DP TYPE: 001 Submission Related 

ADMIN DUE DATE: 02/07/91 

: ASSIGNED TO DATE IN 

\IV:RD / / 

"RAN: RSB / / 

SECT: PCRS / / 

Y DATE SENT: 09/10/90 

Data Package 

CSF: Y 

ASSIGNED TO 

REVR : 

CoNTR: 

DATE RET.: 

LABEL: Y 

DATE IN 

/ / 

/ / 

* * * DATA PACKAGE REVIEW INSTRUCTIONS * * * 

Please review application to register technical IRA. 

Product chemistry data is attached MRID Nos. 411938-01C, 

411938-01, 411937-01). 

If this product is registered, this will be the only 

technical IBA registered in the USA. 

FHB is requesting an expedited review of this product to 

allow the registrant to make the growing season if this 

product is approved for registration. 

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

DP BC 

155510 

BRANCH 

RSB 

DATE OUT 

09/10/90 

DUE BACK 

02/07/91 

INS 

Y 

CSF 

Y 

LABEL 

Y 

/ / 
185

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

SUBJECT: 

FROM: 

TO: 

THRU: 

OCT I 6 !9~O 

Product Chemistry Review of Indole-3-Butyric 

(EPA File Symbo 4 473 ~ 

Alfred Smith, Ch ist 

Product Chemistry Review Section 

Registration Support Branch 

Registration Division (H7505C) 

Cynthia Giles-Parker, PM Team 25 

Fungicide-Herbicide Branch 

Registration Division (H7505C) 

Don R. stubbs, Acting Section Chie 

Product Chemistry Review Section 

Registration Support Branch 

Registration Division (H7505C) 

Registrant: Syntex Corporation 

EPA ID No.: 42473-R 

MRID Nos.: 411937-01, 411938-01, 411938-01C 

Pesticide Chemical Code: 046701 

CAS No.: 133-32-4 

Chemical Name: Indole-3-butyric acid 

Use: Plant Growth Regulator 

OFFICE OF 

PESTICIDES AND TOXIC 

SUBSTANCES 

Acid 

Printed on Recyd9d Paper 
186

-2-

Introduction 

The Syntex Corporation has submitted product chemistry 

data in support of the requested registration of the plant 

growth regulator Indole-3-butyric acid for formulation use 

only. Product chemistry requirements relative to the technical grade of the active ingredient (TGAI)/manufacturinguse product (MP) as described in 40 CFR 158.150 must be met 

to achieve registration. 

Product Identity and Composition 

61-1 - Product Identity and Disclosure of Ingredients 

Indole-3-butyric acid is the active ingredient (ai) in 

the TGAI/MP produced by Syntex. 

Chemical Structure 

Crj I 'c:: ~ 

(CH2)3COOH 

~ H 

Molecular Formula: C12H13N02 

Molecular Weight: 203.23 

A Confidential Statement of Formula (CSF~ EPA Form 

8570-4) is discussed in Confidential Appendix B. 

61-2 - Beginning Materials and Hanufacturing Process 

See Confidential Appendix A for a discussion of the 

beginning materials and the manufacturing process. 

The data submitted in support of 40 CFR 158.160 to 162 

[Guidelines Reference No. (GRN) 61-2] are adequate. No 

additional data are needed. 

61-3 - Discussion of Formation of Impurities 

See Confidential Appendix A for a discussion of the 

formation of impurities. 

The data submitted are sufficient to satisfy the 

requirements of 40 CFR 158.167 concerning discussion of 

impurities. No additional data are needed. 
187

-3-

Analysis and Certification of Product Ingredients 

62-1 - Preliminary Analysis (MRID No. 411937-01) 

Product samples are analyzed for indole-3-butyric acid 

by sodium hydroxide titration of an isopropyl alcohol/water 

solution. The percent indole-3-butyric acid is determined 

from the sample weight and the volume of standard sodium 

hydroxide used in the assay. A thin-layer chromatography 

procedure is used to qualitatively identify the indole-3-

butyric acid. 

The assay results range from 99.7 to 100.2 percent with 

an average of 99.96 percent and a standard deviation of 0.17. 

The data are sufficient to satisfy the requirements of 

40 CFR 158.170 concerning preliminary analysis. No 

additional data are needed. 

62-2 - Certified Limits 

A CSF (EPA Form 8570-4) contains the certified limits 

and is discussed in Confidential Appendix B. 

The data satisfy the requirements of 40 CFR 158.175 

(Certified Limits), and no additional data are needed. 

62-3 - Enforcement Analytical Methods 

See the discussion in Section 62-1 (Preliminary 

Analysis) above for discussions on enforcement methods. 

The methods are adequate for enforcement and satisfy the 

requirements of 40 CFR 158.180 concerning the ai indole-3-

butyric acid. No additional data are needed. 

Physical and Chemical Characteristics 

The physical and chemical characteristics of the TGAI 

are summarized below (MRID No. 411937-02): 

GRN Property Description 

63-2 - Color Creamy white to tan 

63-3 - Physical State Powder 

63-4 - Odor Not given 

63-5 - Melting Point 119.0 °c minimum 

63-7 - Bulk Density 0.25 g/mL 
188

Property 

63-8 - Solubility 

63-9 - Vapor Pressure 

63-12 - pH 

63-13 - Stability 

-4-

Description 

Insoluble in water, chloroform; 

soluble in acetone, ethyl alcohol, 

and tetrahydrofuran 

None 

Insoluble in water 

Not given 

The submitted data do not satisfy the requirements of 40 

CFR 158.190, GRN 63-13, regarding stability of the TGAI. The 

information on stability should include a discussion of the 

sensitivity of the ai to metal ions and metal, stability at 

normal and elevated temperatures, and sensitivity to 

sunlight. 

Summary of Deficiencies 

Section 63 - Physical and Chemical Properties 

Information on stability (63-l3) should include a 

discussion of the sensitivity of the ai to metal ions and 

metal, stability at normal and elevated temperatures, and 

sensitivity to sunlight. 

Attachments: Confidential Appendices A and B 
Pages 189-193-*Manufacturing process information may be entitled to confidential treatment*
194

AUG 1 5 1990 

U.S. ENVIRONMENTAL PROTECTION AGENCY 

Office of Pesticide Programs 

SYNTEX CORPORATION 

C/O D. HALLIDAY & CO. 

3803 LUNETA LANE 

FALLBROOK, CA 92028 

Report of Analysis for Compliance with PR Notice 86-5 

Thank you for your transmittal of 07/25/90. Our staff 

has completed a preliminary analysis of the material. The results are 

provided as follows: 

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. 

.. 
195

· HALLIDAY & CO. 

415844- tp@ 

Ms. Ruby Whiters \ 

3803 Luncta Lane Fallbrook, CA 92028 

619/728·2893 FAX 619/723·8590 

Telex 181734 

Environmental Protection Agency 

Generic Chenicals Support Branch (H750BC) 

Office of Pesticide Program 

401 Elm Street South West 

Washington~ D.C. 20460 

July 17, 1990 

Reference: EPA letter of January 29. 1990 concerning product 

chemistry information for Indole-3-butyric Acid 

Dear Ms. Whiters: 

In response to the above referenced letter, we are ~ending 

yOll the following data to complete our submission of product A J AAtJl)) 

chemistry for Indole-3-butyric Acid. /veW I~~ ----I 

Volume 1 

MRID-41193801 

Volume 2 

HRID-41193701 

Volume 3 

HRID-41193702 

61-1 Product Identity and 

Disclosure of Ingredients 

61-2 Manufacturing Flo'R' Chart & 

Quality Control Procedure 

" 61-3 Discussion of Formation of 

Impurities 

62-1. Preliminary Analysis 

62-2 Certification of Limi,;ts 

62-3 Analyt ical Methods t'o 

63-1-

63-13 

Verify Certified Limits 

Physical and Chemical 

Characteristics 

" " " 

" , " " 

, ,., 

As you requested, here is a list of the EPA registrants' who 

have pernission to cite this data in support of their ;?rodt,~~:t' 

registrations for formulations containing Indole Butyric Acid. 
196

No, 

&EPA Application for Pesticide: 145690 

AGe,q,. lIa~liday & co 

3803 Luneta Lane 

Fallbrook, CA 92028 

"-

Acid 

FOR Syntex Corporation 

P.O. Box 517 

Cuernavaca, Mor. 

Mexico 

~~~~~~~~~"~'~~~~~;';~~~======~~~~;;'~~~~~~~========~~~ ~ Mot., 

i;,\~~"--'---'=------tAc".L""~=.J.!"'------+."'-j Plastic 

Glass 

No.1er container No. per container Paper 

~[Oiatk,",;n;iWCOi""",,,",;;m,",;;;f.rii.'~iFiOtim:oniiii""---L _____ -'-------1_.:.J Other (Specify) 

" 

None 

Uthograph 

Paper glued 

Stenciled 

o Other (Specify) 

'U,,"', " , 

t. Contact Point (Complete items directly be/ow for identification of individual to be '" 

Deborah Halliday D, 

Vice President 

Deborah Halliday 

,,,. 

, -. ,,~., 

& co 

all attachments thereto are true, accurate, and 

or misleading statement may be punishable by fine or 

Vice President 

July 24, 1990 

'"'' 

',.' ,. 

""'" 

, ,,, 
197

Paperwork Reduction Act Notice and Instructions 

Papcrw'ork Reduction Act Notice 

Public: reporting burden for litis collection ofinform31ion L'icSlimalcd 

\0 average of 0.85 hours per respol)se, Including time for reviewing 

instructions, searc]ling existing dala sources, gathering and maintaining lile data nceded, and completing and reviewing the cnUcet'!on of 

Information. Send conUl1cnts regarding the burdell estimate or any 

olher aspect of this collection of informalion, including suggcstions' 

(or reducing this burden, 10 Chief, Information Pulicy Brauch, PM223, U,S. Environmental Prolection Agency, 401 M Slrccl,SW, Washington, DC 20460; and 10 the Oflice of informatiun and Regulatory 

Affairs, Office of Management and Budgel, Washington, DC 20503. 

Instructions 

General 

This f(lnn is to be used for all npplieations for new and amended registrations for pestieide prodnets. 

In order to process an application for n~ registration ~ubmillcd on 

this furm. the fonowing material must aceompany the application: 

1. Offer 10 Pay Statement (EPA Form 8570-27, -28, -29), (If 

not exempted by 40 CFR 1629-1(b),} 

2 Confidential Statement of Fonnula (EPA Form 8570-4). 

3. Five copies of draft labeling. 

4. 111rce copies of any data submitted 

Submissioo of Lubeling " Laheling should first be submillcd In the 

form of draft labels with all applications for new registralion. Such 

draft labels may be in the fonn of typed label text on 8 1/2 x 11 inch 

paper or as a mockull of the proposed label If prepared as a mockup 

it sho\lld be constructed in such a wa!] as to facilitate sloragc in an 8 

1/2 x II inell file. Mockup labeis significantly smaller tllan 8 1/2 x II 

inches should be muUnted on 8 l/2x 11 inch Ilaper for submission. 

SubmiJ;sion of Datil _ Data submitted in support of this application 

must be submiued in accordance with pn Notice 86-5. 

Specific 

Please read the instructions li.~ted below before completing this application. First determine the type of registration aelioll, listed in Block 

A , for whiell you are submitting this application. For applications 

submitted in connection with New Registration actions, Section I, Ill, 

and IV must be completed by the applieanL For applications submitted in connection with amended registratioo actions, Section I, II, and 

IV must be completed by the applicant 

Block A " Cheek dIe appropriate action for whieh you are submitting 

this form. 

Seetion I -111is Section must be completed for bOlh Registration and 

Amended iieGiStra"t'ton aetlons. , ." ,'. , 1. Comp~ny/Produ~N}~'u~ - Insert yourrompany number, if 

one has b<1en assi~ed. 'llns number may have been assigned 

to ,6u ",5'", basic reais,h':lnt, a distributor, or as an establishmem. 'If applieati91l is/pr an amendment, insert tlte regislratio!~ nf;tillber of the ,,'Itt>duct. 

2. Daf~' -,Fill in the ap,ilt~;1~te date. 

3. Produ~1 M~nager -.. 1'\!i6Wn, fin in the name and number of 

the-~'~'~ Manager. 

4. ProJlil5~Classifieatioo _ Speeify the proposed classifieation 

for l:h~~,prJ'dueL 

• 

5. Name Ilnd Add(l!5s of Applieant _ TIle name of tile firm or 

person and address shown inyour appliealion Is the person or 

finn to whom registration will be fssued. If you are aeting in 

beilalf of another party, you must 5Ubmit authOrization from 

that patty to act for tilem in regisl(atlon matters. 

EPA Form 8570-1 (Rev. 9-88) 

An applicant not residing in tile United States must have an 

authorized agent residing in the Ullited States to act for them 

in nil registration mailers. TIle nama and complete mailing 

address of such an agellt must accompany this application. 

6. Product Name· Enter the cumlllete product name of tills pesticide as it will appear on the label. 'Ille nail Ie l11USt be sl)Ceilie 

to this productunly. Duplieation of names is not permitted 

among produets of the same company, Do not Include any 

brand name or company line designations. 

Anlendm~ntlnfonnlltioo 

Sedion n ·111ls Section must be completo:d for aU applications submitled in connectioo with Amended Registration. 

1. Subjed of Amendment - Check tile appropriate block, and 

provide a brief expiallation of tile purpose(s) for the amend· 

ment, such as: "the addition of a site, peSt, or crop"; "to 

change Inert ingredient"; "general label revisions of precautionary statements," cte. 

Paekagillg and Container Infonnation 

S«tion m -111is Section mUSt be completed for all applications submhted in connection whh New Registratloo. 

1. Type of I'adwging - aleck tile appropriate block if your product will be packaged in tile indicaled packaging types. Indicate tile size of the individn;ll packet .. and number per ret an 

container. 

2 ~ of Rdail Container _ Indicate type of container in which 

product will be marketed 

3. Loenlillu of Net Contents _ SpeciJYthe ne! contents of all retail 

cOnlainers for your produet 

4. Siu{s) of Retail Container _ Specify tile nct coments of all 

retail container.; for your producL 

5. IAoltion of Use Dlnctions • Indicate the lucmion of the usc 

directions for your product. 

6. Manner in whleh label is afrutd to prtl(luct - Indicate the 

metllOO productlabcling is allaeilcd 10 retail container. 

<Antact Pomt 

Senion IV _ 111is Seetion musr be completed for all Registration and 

Amended Registration applications.. 

1-5. Self-explanatory. 

6. EPA Use Only. 

) 

) 
198

, . D. HALLIDAY & CO. 

Robert Taylor 

Environmental Protection Agency 

Fungicide-Herbicide Branch 

Product Management Team 25 

1921 Jefferson Davis Highway 

Arlington, VA 22202 

July 24, 1990 

D~ar Bob: 

3803 LunCla Lane Fallbrook, CA 92028 

619m8·2893 FAX 619n2J.8590 

Telex 181734 

We are enclosing our application for registration of 

fndole-3-butyric Acid as a technical use biochemical 

agent. As we discussed. all product chemistry data has 

already been submitted through the data call-in program 

and all other testing reqUirements have been waived. We 

have attached the relevant memoranda from the EPA to our 

data rnatri x. 

The current status of the enforcement action against lEA 

is as follows. We have permission to sell and distribute 

only product which was imported prior to June 1. Any 

future shipments will be denied entry until we have a 

registration number. We estimate our present stocks may 

last as much as 4 weeks with careful rationing. Any help 

you can give us in expediting the registration will be 

much appreCiated. We are quite concerned about about the 

problems it will cause in the nursery industry if we run 

out of product. 

Your continuing advice and assistance has been very 

helpful. It is certainly gratifying to deal with someone 

who is trying to make the system work for everyone. 

Please call us right away if you see any deficiencie~"~n; 

our submission. We wi II do Whatever is neces;sar':>; to " , ., 

remedy the situation immediately. -,) , 

Cordial I y, 

(2)LL1DY~~ 

lliday ~ 

DH/dw 
199

United States Environmental Protection Agency 

Washington, DC 20460 Fornt Approved 

&EPA Certification with Respect to 

Citation of Data 

OMB No. 2070·0060 

Approval expires 9-30-90 

Applicant's Name and Address EPA File Symbol/Registration Number 

". 

Syntex Corporation 

P.O. Box 517 

Cuernavaca, Mar. 

Mexico 

Product Name 

Indole-3-Butyric Acid 

Date 01 Application 

July 24, 1990 

1. This application is supported by all data submitted or cited in the application. 

In addition, if cite-all options are indicated, this application is supported by all 

data in the Agency's files that concern the properties or effects of this product or 

of any other product that is identical or substantially similar, and that is one of 

the types of data that would be required to be submitted if this application 

sought the initial registration of a product of identical or similar composition 

and intended uses under the data requirements in effect on the date of approval 

of this application. 

2. 1 certify that, for each study cited in support of this application for registration that is an exclusive use study, 1 am the original data submitter, or have 

obtained the written permission ofthe original data submitter to cite that study. 

3. I certify that, for each study cited in su pport of th is application for registration that is not an exclusive use study: 

I am the original data submitter; or 1 have obtained the written permission 

of the original data submitter to cite that study; or 

I have notified in writing the companies who have submitted data 1 have 

cited to support this application and have offered to: (a) Pay compensation 

for those data in accordance with section 3( c)(l )(D) and 3( c)(2)(D) of the 

Federal Insecticide, Fungicide and Rodenticide Act; and (b) Commence 

negotiations to determine which data are subject to the compensation 

requirement of FIFRA and the amount and terms of compensation due, 

if any. The companies 1 have notified are: (Check one) 

o All companies listed on the Pesticide Data Submitters !...j~tf9r all 

active ingredients contained in my product (cite-all metho~ or~cite-all 

option under Selective Method). (Also sign the General Offer}'Q Pay~" , 

Statement below.) -' ' 

5a Those companies who have submittted the studies which I bav~ cited 

(Selective method)...· ..• 

Name and Dtle Date 

Deborah Halliday/Vice Pres. Jul 24 l 

General Offer to! a hereby offer and agree to pay compensation to other 

persons, with re d to the approval of this application, to the extent required 

by FIFRA sec. 3(c)(l)(D) and 3(c)(2)(D). 

Name and ritle Date 

Deborah Halliday/Vice Pres. Jul 24 l 
200

'"-: 'j 0 ,J ) , 

J" 

;)' 

!; 

Ie ,'-,-,--~~---->'~,' 

,'f;,I;ln: ,),,;, In';!?,';, 

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201

appliciltl0fl 

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ff<JSB~ 

ts' ,qCCfl5pt-a 

i ):;,:;:1' @£,' 

atiHJ'flOft)<J ,m!:1110ate 

imtrati'(},n ox 

not he met, 
202

] 

MEMORANDUM 

UNITeD STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON. DC 20460 

SUBJECT: Classification of Indo!e-3-Butyric Acid as a Biocilemical 

Pesticiae (Caswell #499) 

FROM: 

THROUGH, 

Robert Taylor/Angela Barnes (Pl'1-25) 

Regietration Division (H7505C) 

J. Thomas McClintock/ Ph.D. t MicrObiolo9ist\\<JJ~ .,~ \~,.,. Science Analysis and Coordination \' 's! i·' 

Health Effects Division (H7509C) \ 

Reto Engler l ph.D., Chief 

Science Analysis and Coordination 

Health Effects Division (H7509C) 

\ 

I~NL .-~ 

ACTION REQUESTED, S~CB and the OPP Biotechnology Workgro£p were 

asked to classify indole-3-buty:d.c acid (lBA) as a conventional 

chemical or biochemical pesticide. In a recent correspondence (see 

attached memorandum from .J. T. NcClintocK to R. Taylor) the regist!"ant 

Was asked to submit information verifying the natur&l occurrence of 

the sUbject compound ~n plants. Prior to a response from the 

registrant l SACB and the oPP Biotechnology Workgroup recommends that 

this memorandUm supercedes our review of 2/23/90 1 J. T. MCClintock. 

DISCUSSION CONCLUSION. The current definition of a biochemical 

pest c e sates t at uIn order for synthesized pesticides to be 

considered as biochem~cal pe6tic~des, they must be structurally 

similarl and functionally identic'al l to a naturally occurring biochemical pesticide. U No evidence was presented by the registrant 

on the natural occurrence of rBA in plants. ". , , , , " 

Following extensive review and discussion, SACB and tl}~' ;app Biot.echnology Workgroup have considered an alternative app;:oa'ch tor ,tthe. 

classification of rBA as a biochemical pestlcide. Seve~"ai natul:"Blly 

occurring plant growth compounds have been identified wh'i,bh d'i'!:§pJ!ay 

activity resembling auxin (indoleacetic acid - IRA), ~"p7?nt groVth 

r.-egulator. Such plant compounds I which B:t:e intermedia,tk»metabolites , " produced during the synthesis or IAA from tryptophan, are indo,~~. 

acetamide, indoleacetaldehyde, and tndolepyr.uvic acid. When aB:9,lied 

to auxin-deficient plant tissue these compounds are thought to"D£,' 

converted to IAA before they are effective. rBA is a synthetic auxin 

that structurally r.esembles not only IAA but all of the intermediate 

metabolites. Consequently, since rBA is sufficiently similar to the 

chemical structure: and functionally equivalent to naturally occurri~g 

auxins we believe that IBA should be classified as a biochemical 

pesticide. 
203

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

DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SU

-----

1. PRODUCT NAME, i 2. EPA REG.NO./FILE SYMBOL: : 3. FORMUL.-iVrOR '.8 .SXEM

* Indole-3-Butyric Acid , , . 

, , 

5. APPLICANT'S (COMPANY) NAME AND: 

, YES tJO 'l::2. Y? 3-fZ., , ADDRESS: , , 

, , 

11 6 . APPLICATION FOR 17· NAME OF ACTIVE IN

Syntex Corporation , REGISTRATION DATED: , , , 

P.O. Box 517 , , , , 

Cuernavaca, Mar. Mexico , July 24 1990 , , , 

, 

, MONTH DAY YEAR ___ i 

S. 40 CFR Part 158 - : 

_-"D"ATA.....RE_illLLREl'1E...rITS ____ ----.l9_. SOURCE REOUIREMENT 

8a. ISb. !9a. !9b. i9c. ]9d. 1ge. 

Guide- jName of Test ISubmittedi Date I submitted ICertificate :public 

line I 1 by ISubmitted'byanother lof Permis- ILiteraRefer- ] !Applicantl person/firm]sion (P) or ture 

ence I I: (give name):Offer to 

Number : I: : Pay (OTP) I :: lenclosed: 

: I I I indicate 

i 

_____ J __ 1 ___ 1 0); __ "OTp" 

section : i, 

158.190 lPRODUCT CHEMISTRX l l 5/11/89 

I I 1 & I I 

:9

IN

W

o

(

I I I I 

,. 

I Identity of I Yes I 7/20/90 I I 

I Inqredl ents_ _ ___ .I. , , --------'--- _I... _ 

61-1 

61-2 I I I I I 

Statement of I Yes I 7/20/90 II : : I 

compos 1 . . I I -----1 

t Ion_ _1.__ -------L__ ___ -------L- ___ ____ . 

61-3 Discussion of 

formation of Yes 7/20/90 " 

inarenients 

. . . '·"711/89 & 

62-1 prelImInary Yes I 7/20/90_.....,____ 

analYsis ------1. ____ _ 

---- I I 

62-2 Of! Yes : 7/20/90 " : \ 

llmI ts ___ .I --------L-___ 1 __ . ____ ._ _ 

62-3 Analytical method i Yes 7/20/90 " 

for enforcement l 

limits : Yes " 

63-2 Color Yes II 

63 3 Physical State Yes '(/20/90 " 63 4 Qdor 

-X"Registration for use in formulation of agricultural rooting compound only. 
204

DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUP

1. PRODUCT NAME: 2. EPA REG.NO./FILE SYMBOL: :3. FORMuLATOR'S EXEMP

Indole- 3-Butyric Acid : SELECTED: 

5. APPLICANT'S (COMPANY) NAME AND L/,;l ,1"3_b : YES NO X

ADDRESS: /" I 

6. APPLICATION FOR :7. NAME OF ACTIVE 

Syntex Corporation 

P.O. Box 517 

Cuernavaca, Mor. Mexico 

8. 40 eFR Part 158 -

REGISTRATION DATED: : 

, 

, 

July 24 1990 I Indole- 3-Butyric AC

__ 

-' . 

__ MONTH _DAY ___ i 

DATfIL_HEOUIRENENTS ! 9,-__ SOURCE OF DATA SAT! SFYING REQUIREMENT 

Sa. lab. :9a. 9b. 9c. :9d. ige. 9f

Guideline 

ReferName of Test : Submitted Date Submitted :Certificate by Submi tted by another II of Permis- i Public ILitera- Iture N.

W

Applicant person/firmlsion (P) or ot

ence 

Number 

I (give name) IOffer to , , (eII IIPay (OTP) 

: ienclosed: 

: J I indicate I I 

__ 

1 

____ .. _ .. ___ n_ --.L __ 

section : 

158.190 I PRODUCT CHEMISTRY Yes 4/ll/89 

I (continued) /& / II 72090 

63-5 ! Mel t_ina point 63-6 ___ iBoilinq point Yes w-n--J_ -----.... --:--.. -- ----:-- 

' 

63-7 : Densi ty, • ', ••• : Yes 7/20/90 

Idenslty, " ! specific qrc-:vi::t\;'f t 

63-8 I SOlubility Yes " 

63-9 I, Vapor PreSsure Yes 1/2,0/90 "I 

63-10 : ies 7/20/90 " 

--:c:c-:c:---t: 

63 11 :Yes 7/20/90" 

lpartltlon I 

, .. t ' ,coefflClen, It 

3-12 :pH ! Yes 

63-13 I,Stability Yes I, ]/20 

6J-14 

,. 

:Oxic1izing/reducing:: : I I , , : 

____ 

----'-

. __ , _______ ... __ l __ .. __ . __ _____ 

_._
205

"_,,_.,0 

DAT.i\ REOliIRENENT LISTING fOR THE SELECTIVE f'olETHOD Of SUP

1. PRODUCT NAME: ·"-------IT.-EP:l\ SYMBOL: : J. 

Indo1e-3-Butyric Acid . ___ : I SELECTED: 

NAME AND I: '-I ;2 y,/ 3 _ fJ. : YES NO X 

5. APPLICANT'S (COMPANY) 

ADDRESS: 

, , 16. APPLICATION FOR i 7. NANE OF ACTIVE ING

Syntex Corporation 

P.O. Box 517 

Cuernavaca, Mor. Mexico 

8. 40 CFR Part 158 - f 

1 REGISTRATION DATED: 

, , 

: July 24 1990 : MONTH DAY YE:.AR 

DATA REQUIREMENTS 19. SOURCE_OF SATISFYING REQUIREMENT 

Indole-3-Butyric A

Sa. 

GuideIIBb. :9a. 9b. 19C. :9d. ge. 19

!Name of Test : Submitted Date : Submitted :Certificate public IN

line 

Refer-

: ! by Submitted:byanother :of Permis- Litera- W

: :Applicant iperson/firm!sion (P) or ture ot

ence : I : (give name) :Offer to (e

Number ! I : :Pay (OTP) 

: II :: enclosed: 

I I I I' . 

I I t I IIndlcate 

: __ . __ 1 __ .L ------L_ 

section : : 

158.190 !PRODUCT CHEMISTRY : 

: (continued) : I I I I I 

I I I I I 

I . . I I I I 

------LflruN!lab I LIt v --------'___ _. __ .. .

63-16 _LE:xpLQdabilit" 63-17 : Storaqe s_t.ability Yes 7/20/90 

63-1B __ :Viscosi.ty_.. ____ 

.6..1.-::::19 _ .. j --.l.. ---.1. _I 

63-20 ICorrosion I! ! 

.Lc.bara_Gter_i.s.tics -----.l.. 

0, 

63-21 : Dielectric : 

: down vo 1 
206

"''', ---"-

DATA REQUIREMENT LISTING fUR. THE SELECTIVE METHOD Of S

1. PRODUCT NAME :-.----- - ._-------;:2-.. EP.A. J. 

Indo1e-3-Butyric Acid: SELECTED: 

5. APPLICANT'S (COMPANY) NAME AND: L/ . YES ___ _ 

ADDRESS, : I .z Y-? 3 -R

NO 

:6. APPLICATION fOR 

Syntex Corporation 

P.O. Box 517 

CuernavacaJ Mor. Mexico 

8. 40 CFR Part 158 - :-

I REGISTRATION DATED: 

, 

, 

1 July 24 1990 

L__ MDNTH DA Y. YEAR 

7. NAME OF ACTIVE I

Indole-3-Butyric 

DATA REQUIREMENTS :9. SOURCE OF DATA SATISFYING REQUIREMENT 

8a. :8b. 19a. i9b. :9c. i9d. ge. i

Guideline 

Reference 

Number 

Section 

158.145 

'1-1 to -(1-5 

'2-1 to 72-7 

Section 

15,8.135 

1-1 to 81-3 

2-1 to 82-3 

83-3 

1+-2 to I:)L; 4 

I 

Name of Test !Submitted! Date :Submitted iCertificate Public 

by Isubmitted:by another :of Permis- Litera- 

Applicant: :person/firmision (P) or ture 

: (give name) :Offer to 

Pay (OTP) 

enclosed: 

indicate 

, I "P" "OTP"I 

or 

wILDLIFE AND AQUATIC Avian and Mammalian 

Testing i 

Aquatic Organism i 

Testing I , 

I I 

, 

" -" · I 

" . · , -- - · I 

. . . - - I Acute Testihz- - __ = ._ · I 

Subchronic Testing I 

, " ' ... - . . . . I

- , 

Chrort;:i.c: 

-

te$t1n,g"' . . . , . . · l , 

. , ... . ... , 

Mutagenicity Test- , i I i 

ing I , , 

i 

, 

I I 
207

DATA REOUIREMENT LISTING fOR THE SELECTIVE METHOD Or SU

1. PRODUCT NN1E: :i-.---E"-PA---REG:-NO./FILE-SYMBOL":--·":J. 

Indole-3-Butyric Acid! : SELECTED: 

5. APPLICANT! S (COMPANY) NAME AND: zJ ., / /? 3 _ M : YES NO 

ADDRESS: :""/ ""'" -, I...: 

16. APPLICATION FOR :7. NAME OF ACTIVE 

Syntex Corporation : REGISTRATION DATED: 

, P.O. Box 517 , 

Cuernavaca, Mar. Mexico I July , 24 1990 

i MONTH DA Y 1 Indole-3-Butyric A

8. 40 CFR Part 158 - r 

DATA REQUIREMENTS i ___ .sOURCE_ OF D'ATA---.SATISFY_ING _HEOULREMENT 

8a. : Bb. J 9a. : 9b. ! 9c. : 9d. : ge. 

Guide- :Name of Test Submitted i Date Submitted :certificate :Public 

line 1 by submitted by another jot Permis- jLiteraRefer- I Applicant person/firm sion (P) or Iture 

ence (give name) Offer to 

Number Pay (OTP) 

enclosed: 

indicate 

Section 

158.135 

85-1 

Section 

158.150 

Section 

158.140 

132-1 to 

133-4 

Section 

158.130 

161-1 to 

164-1 

TOXICOLOGY 

( continued) 

Special Testing 

PROTECTION 

NONTARGEr AREA 

ENVTIlOl;ff;N'l'AL FATE 

"P" or "OTP" 

1- -

: 9

IN

IW

o
208

Waived Testing per the Enviromental Protection Agency 

Attachment I and Attachment II 

) ) ) , > ) 

j > > ) , ) , 

, , , i) 

, " 

. , , , , ) 

) , > 
209

) 

t - ,', ., - . - . •• ' • '0 

ATrACHMENT I 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASH!NGTON, DC 20460 

MAY 2 1 1990 

0I'1'101! OF 

~snc:o~~ "NO 

TOXIC SVSoSr"'NCia 

MEMORANDUM 

SUBJECT: Request for Nontarget Data Waivers for 

Currently Registered Indole-3-butyric Acid Uses 

FROM, zig 

Ecological 

Vaituzis, 

Effects Microbiologiet Branch (H7507-C) 

J/11 ~ ~~ ····ti v 

Environmental Fate and Effects Divis' 

Raymond W. Matheny, Head section I (I ()JI~ Ecological Effects Branch 7507-C) V"""",,"'!!. 5!2./1Cj(f 

THRU: 

Environmental Fate and Ef DiVisi90'J~ (' 

James W. Akerman, Chief 

Ecological Effects Branch ( 

Environmental Fate and Eff 

/f.,i«.w ~~( 507-C) ~JS("" ts Division 

TO, Ruby Whiter. (PM-50) 

Generic Chemical Support 

Reregistration Division (H750SC) 

BACKGROUND: . .. 

Indol~-3-butyric acid (lBA), a synthetic auxin structurally 

resembling the naturally occurring auxin indole acetic acid, 

has been regietered as a chemical with low volume/minor uee 

data waivers. Following extensive review the opp hee ;" , 

, claeeified (lBA) as a biochemical. ,no» , , " , , 

As a result of FIFRA '88 data call-inr the companies markebin~ 

lBA have requested that the avian, freshwater fish 'and; ',. 

invertebrate testing requirements be waived for the ',,' '''',; 

reregistration of lEA as a biochemical. n:~~ .. , " , » 

DISCUSSION , 

, , ) , , , , > 

rnA ie a plant growth hormone used to etimulate plant cuttings' 

to produce healthy roots in container grown ornamental plant 

crops. It is applied to plante if, a very dilute ~orrn (0.1% to 

0.6%) in a powder or liquid form by dipping of cuttinge 

prior to planting in pots or flats. Most grower6 can treat 

between one and two million cuttings with one kilogram of 

technical grade lBA. 
210

Page 2 

ATTACIIMilNT I 

Plant propagation takes place in enclosed, controlled areas. 

After rooting the cuttings are transplanted and placed in 

pots aither in greenhouses or outdoors. Since lBA is absorbed 

by the plant cutting within 24 hours the amount of residue 

coming in contact with the environment ie negligible. Technical 

grade rBA is shipped in sealed 1 kg plastic containers and 

the potential of environmental contamination through an 

accidental spill is very low. 

£2.NCLUSION I 

EEB conCludes that the environmental exposure to the plant 

root growth hormone IBA from the treatment of plant cuttings 

is negligible. This essentially amounts to a greenhouse use 

pattern. As a result no ecological effects data are reguired 

for the reregistration of lBA for plant root treatments in 

the nursery industry. 

In order to make a risk assessment for use patterns other than 

nursery llpl an t-cuttingf.i-dip-method" (e.g. lawn spray) EEE needs 

the following data: 

Guidelines 

Reference 

Fumber J 

154-6 

154-7 

154-8 

154-9 

154-10 

Kind of D~a Required: 

Avian Acute Oral (bobwhite quail or mallard) 

Avian Dietary (bobwhite quail or mallard) 

Freshwater Fish Leso (rainbow trout) 

Freshwater Invertebrate LeSO (Daphnia magna) 

Nontarget Plant Studies 

, .. , 

• , , , , , , " • • , , , , " • " " . , , , " • " " . , • , 

" • , " " , .. ... .. ", • , 

" .. .. .. 
211

ATTACHMENT II 

UNITf:D STATES f:NVIRONMf:NTAL PROTf:CTION AGENCY 

WASHINGTON, D,C, 20460 

007637 

I'il I 0 :9:<, " . 

OI'I"I~1I: 01' 

I't:QTIClcr' ANO TOXIC IUfl5TANCltJ 

StJaJECrl Indole-3--blltyric Acidl IJ::M Voll..'l!re/Minor Use Rsqceet fur Cata Waiver 

TO. yay Ellenbergerr, FM Team 50 

Sepecial ReVi..,; and Reregi8tra~~n ~v~ (H7S09C) 

Robert P. Zendzian Ph.D., .~.y:?:~-- l\Ct.ing He";, Rev Sec I .:JIfY .__---_ 

'lbxicc1ogy Branch I 

Health ~fects Division (H7509C) 

Edwin B\XJ.d 

l\Ct.ing Chief 

'!'e.xioo1ogy Branch I 

Willi "" Bur"",,, 

DePJty Director 

Health Effects Division 

CCOloound, Indole-3-butyric Acid 

Registrant; N/A 

Action ~e8ted. 

'!'ex Chen #499 

MRID #N/A 

Re9istration 11802-549 

'!'ex Project #9-1S09A 

In response to a data. call in notice on Indole-3-butryic Acid (I.BA) I oov~r~ 

l"93'istrant6 have requeste:l data waivers based in low volume/minor 'U3~1 ~ ToxicolQ:Jy 

data requirerrents fur the technical rraterial as stated in the .ccI, ian!! ; I ~ ~} 

81-1 Acute oral - Ret 

81-2 Acute dermal - Rabbit 

81-3 Acute inhalation - Rat 

Recomoendation 

~ > , > > , 

82-3 90-daydennal - RaBbii 

" > ~ , ~ ~ 

83-3 Teratolcgy - One Sned;es 

, J ) , ~ 

84-2 Mutagenicity Battery 

, , > > :, 

I 1 , , , , 

" 

, 

"') 

'}' ) 

>, >} 

~C01~ r~ri!.s that the data waiver be grantoo.. lEA i.5 used s:pecifically 

as a r ~ngaertt fOr \'may C!U'tt:ings. Ose concem:tat16l'r1n the end use product 

i6 0.004%. The h:me a.omer prcxfuct is ibl:Jnulated as a ,PO"Ajer and sold in foil 

packages of 0.4 to 2 ounces. The green hoosQ product:. is formulatoo as a liquid in 

water an::l soldl only to CQnITercial usel;'S I in containers up 1:0 one gallon in size. 

Exposure to the user I even the cc:rran=.rcial user I is eXfEcted to be minute. 

one kilogram of the ftlnnu1ated product contains only 4 miligrams of 1131\. 
212
..;

'

Pages 213-220-*Confidential Statement of Formula may be entitled to con