# EPA Registration Jacket 73304

‐ 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*

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# , S (DaR, BRAD) ourca c.& 

### Oral Toxicity/ Pathogenicity 

## vlJ2I1V 

# tli' Cirolc¥ 

## 2.4fUD

# I~~VI'I EP (TGAIJAI 

## Iqq5

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

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## h.**~** Ttl1\1 " '-'



### Comments:



# , . . 

# . . .


### Today's Date: 

## 5 

# Dec- 05"

. Last Name, First Initial: 

# DUjtJ?!:Y?'i J . 

## .M..
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## ..) 

## ; 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)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

### 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

# .~/**I~j~ ~/0·** **'~-444fl"e'** Co.**~--t~-'** _5//3. 

### '11 EEB/EFED/OPP CM-2, RM 815-J, 557-7358



## IIIIW

## ~!I~ 11M 1I1I1 111m III

.... "

................**~**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.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.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.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.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

### 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)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.,

# ~M'''' N. N. N. 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 , ,

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

# 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.

, "
, "

,

### 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.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.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.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.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:•



# 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

..

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

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# .. • ••••• • • •• ••

### 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

### )



## ) 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 Syntex r S.A. De C.V. Division Quimica, company number 42473, to Reactimex r 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

### )



### ) 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.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

# )



# 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.

# , 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

### 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)

# 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 HallidavOPTIONAL 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:

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

### 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 '"
,

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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 .. & Fe",

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# ." )



# \ 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,

# ~:::~e~~ector**~~~esticides** and Pollution

Prevention Division (7501W)

### ) 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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### )**~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

### 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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### 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)

# ~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

### )

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)

### ) 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)

### 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

### , ) 

### F/vt

.. 

## z. 'l### C'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· e1}la •

# .v.\'~\)J I, 

## "I"'" Precautionary Review section**CY~U ~** **~** 

### 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

### 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.

### 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-

### 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.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 aroundACUTE 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 Research16-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(

# 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 sn3king C 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

### 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



### / /

### 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

### 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.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

. 

## •

### 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. >"),,

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,. >"-DATAREOUIREMENTLISTINGFORTHESELECTIVEMETHODOFSUPPORTPRODUCTNAME,Indole-3-ButyricAcid*2"EPAREG.NO./FILESYMBOL,42473-13.FORMUL]:I"TOR,'SEXEMPTION"SELECTt:o,':, , :APPLICANT'S(COMPANY)lDRESS,NAMEANDYES: :NO'X""-'--'-',"SyntexCorporationP.O.Box517Cuernavaca,Mor.Mexico102293Indol.e-3-:BtrGyri:CAcid:MONTHDAYYEAR40CFRPart158-IDATAREOUIREM=__"____i9.SOURCEOFDATASATUlfYINGREOUIREMENT.,8b.9a.9b.9c.9d.NameofTestSubmittedDateSubmittedcertificateinebySubmittedbyanotherofperrnisefer-Applicantperson/firms'lon(P)ornee(givename)OffertoumberPay(OTP)enclosed:indi.catege.PublicLiterature__L_________________L_______ection58.190PRODUCTCHEMISTRY5/11/89&9f.N.A.orWaiverorother(explain)410.MRIDNumber,EPAAccessiorNumber,orotheridentifyingnwnber61-1IdentityofIYes7/20/9041584401inqredientst_StatementofYes7/20/90"41584401composition51-2.,-.DiscussionofofYes7/20/90II41584401lnaredlents5.-362-1lPreliminary[4/11/e9&IanalYsis_______1Yes7/20/9041584402CertificationOf7/20/"""41584402limitsL-______V__"-____________JL______________i-________JL__________"-______________52-2-----------I--AnalyticalmethodIYes7/20/90II41584402forenforcementI52-3limits:IIiI!4158440353-2ColorI_1.__53-3PhysicalStateYes"415844..0.3.53-4OdorYes,(/20790If41584403-X"Registrationforuseinformulationofagriculturalrootingcompoundonly.SyntexCorporationP.O.Box517Cuernavaca,Mer.Mexico1CFRPart158-IDATAREQUIREMENTLISTINGFORTHESELECTIVEOFSUPPORTIndole-3-ButyricAcid'vATARJ';Q]HRENENTSi9"SQURCEOFDATASATISFYINGREQUIRE11EN'I'LIISb.Ilga.11gb.IlgC.19d.[ge.19f.110.lide-INameofTestISubmittedlDateISubmitted[CertificateIPublicIN.A.orIMRIDNumber,Lne\IbyISubmittedlbyanotherofPermis-ILitera-\Waiveror\EPAAccessionApplicant:Iperson/firmsian(P)orlturelotherINurnber,or1ceI:(givename)Offerto:(explain)lotherlIflber:IPay(OTP)::identifying58.190PRODUCTCHEMISTRY(continued)I :enclosed::Inumber::indicate::__L____iLIIPIIorJlOTplJi____________Yes4/11/89&7/20/9053-5point415844032-."'6\BoilingpointYes-1.,-----------------41584403)''.:r-IiDensity,bulkI2.1-"3-,3-11densityIorYesI41584403specificqravi.t'liISQ1ubilitYYesII,IVaporYes7720/90II4 I 5 844",0,;!3__41584403:Octano1/waterIpartitionYes7/20/90"41584403Icoefficient:;12IHYesII415!44Q3.13Yes7720790415[;4403)J14:Oxidizing/reducing:::'"","onIIIN.A.LfL,·.I___L__I,OAT!\.REOUIREHENTLISTINGFORTHESELECTIVEMETHODOfSUPPORT1.PRODUCTNAME':2.REG.NO./fILESYMBOL,Indole-3-Butyr1cAcid\3.FORNULATOR'SSELECTED,YES":EXEMPTIOiN14.PAGE:__3__OF45.APPLICANT'S(COMPANY)NAMEAND]42473-1WDRESS;]NO"X-"!--7.NANEOF)\1::TIVESyntexCorporationiREGISTRATIONDATED:P.O.Box517\Cuernavaca,Mor.Mexico1102293Indol.e-3-BUty::-le-hb:;;l1iMONTHDAYYEAR->..-3.40eFRPart15S-fDATAREQUIREMENTSSQURCEOFDATASATISFYINGREOUIREMENT3a.ISb.19a.19b.9c.9d,1,ge.\9f.\10.;uide-:NameofTestISubmitted:DateSubmittedCertificateIPublicIN.A.or/MRIDNumber,l::byISubmittedbyanotherofPermis-\Litera-:Waiveror:EPAAccessio::App1icant:person/firmsion(P)orIture:other:Number,or:l:(givename)Offerto::(explain)lother\\:Pay(OTP)\:\identifying,"1ed'IIIwnbIIIencos.IIInerIII.d·t',,IIIIInlcae III'---___IL__:P_"_Qr__l : I. . IIIIII)ectlonIIIIII.5S .190IIPRODUCTCHENISTRY:IIII:, ( .IIIIIIcontInued)IIIIIIIIIIIIIIIIN A 'I. .IIII'·I-L_f1ammab1IItv___1-.._I63-16iExplodabilit··63-17(StoraGestabilityYes7/20/g063-1Slviscositv-----N.A.1j---.-----.--.--.---.----..-,-"NA '63-9,MISClbllltv,_____,__-'--••L€20lCorrosionN.A._"----ICharacteristics63-21\DielectricbreakN.A.Idownvol.t..a...qeSAMPLEHATRIXFORMAT-DATALISTINGFORTtl.,,>ELF;CTIVI!HmIOOOFSUPPORTPRODUCTNAME:2.EPAREG.NO./FILESYMBOL:3.FORMULATOR'SEXEMPTION4.PAGEHndole3-ButyricAcidSELECTED:OF_4_APPLICANT'S(COMPANY)NAMEAND42473-1YESNOXADDRESS:c;.:-'.:..,..,.;.''=:-_____SyntexCorporation6.APPLICATIONFOR7.NAMEACTl'VEINJiiRi:UJ:llNcr:(S):P.O.Box517REGISTRATIONDATED:,,'''-:,.<,<Cuernavaca,Mor.Mexico-__2293Indole-3-ButyricAcid-=-;;;==-,.-:c=-=-____r-__0111:::<:':<'4 0CFRPart158_!.!!llLL. : " ..:DATAEOUTI'EMENTS19.SOURCEOFDATASATISFYINGREOUJRRHENT.,,<•8b.9a.9b..9c.9d.ge.9f.10•.ide-NameofTestSubmittedDatesubmittedCertificatePublicN.A.or.MRIDNumber,.1,bySubmittedbyanotherofPerolis-Litera-WaiverorEPAAccession,f'er-Applicantperson/firmsian(P)ortureotherNumber,orIce(givename)Offerto(eXplain)other,mberPay(OTP)identifyinqenclosed:numberindioateor"OTPIM;8.340TOXICOLOGY(continued)81-1AcuteOral,toxitWaived___-I-;,-::rat:.81-2AcutedermalW'd_to_xil:'ity_,rabbital.ve81_3Waived81-4:priI!lary.eye..418630-01___-II_'=.rr1t-at10nIt_1-____-11-____+_______81-51?riIpar:y.dermal418630-021rr1ta"t-i.on81-6sensiti-Waivedzat10n6-32

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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

# , 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 mw2

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 registrant3

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: 6-2-804



### 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-toe ll 

### 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.)"

## 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.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 icitycategory


### 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. )



# -

### 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 

### / /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

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.........

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### e:J,'1**C{J&?r'i."1<;;1\Cf;~ ~10t·.**  ?"tt)(.1,:.::;



### :·11(0

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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.

### )

) 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

# )

) - 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- 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

### ) - 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.

### 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

### - 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

### 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

)

### ATTACHMENT II SUSPENSION REPORT

- REQUIREMENT LIST
SYNTEX, S.A. DE C.V. DIVISON QUIMICA PAGE: 1

Guideline Requirement Name 

### original Due Date 

### Reference No.



##  
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

### 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.)

) 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 Paperl 

# 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**~-ri** Thomas**Ellwan~er,** 

### Jr..

.**~** 

### / , 

# C. 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 justified l 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

# 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 toxic

### ology 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."

# (!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 chem

### icals), 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) 

# {!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:) 

### 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.

### · 

## -.

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.

## , ! )

# 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



### , " ,



### " ,

# 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

### 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:

Acute Oral Toxicity Previously waived. Please see attachment #1 152B-1O 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,



# · " 

# · .

,., ;,,-.._,'-_/_.F.ac;e·:1of2'unitedStatesEnvironmentalProtectionAgency'.FormApflrOVctl•Washington,D.C.20460OMBNO.2070-0107REQUIREMENTSSTATUSANDREGISTRANT'SRESPONSEl.!ppriSValExpires12-31-92INSTRUCTIONS:Pleaset)lpeorprinTinink.Pleasereadcarefullytheattachedinstructionsandsupply!Ill"informationrequestedo't!)l)"sIjlrm.UseaddiTionalsheet(s)ifnecessary.1_CompanynameandAddressD.HALLIDAY&COAGENTFOR:SYNTEXtS.A.DEC.V.DIVI3803LUNETALANEFALLBROOKCA920284.Guideline15.StudyTitleRequirement,...,"ProdCh.....-Bioch_ieal151B-10ProductidentityIS1B-11ManufacturingprocesS(1)IS1B-12Oiscussionofformationof(2)ununtentionalingrdientslS1B-13Analysisofsflnllles,/(3)lS1B-1SCertificationoflimitslSlB-16Analyticalmethods111)151B-17(a)Color(12)151B-17(b)Physicalstate151B-17(C)<>Jo,(12)151B-17(f)Oensity",/151B-17(i)pH'(6)151B-17(k)flalmlilbility'"151B-17(1)Storagestability(13)lSlB-17(m)Viscosity[8)10.Certification2.CaseIIandName2330Indole-3-butyricacidEPAReg.No.42473-1g6.Use7.testSubstance6Pattern!ABCDEFGHIJKLMNOMP/EPABCDEFGHIJKLMNOMP/EPABCDEFGHIJKLMNOMP/EPABCDEFGHIJKLMNOMP/EPABCDEFGHIJKLMNOMPjEPABCDEFGHIJKLMNOMP/EPABCDEFGHIJKLMNOMP/EPABCDEFGHIJKLMNOMP/EPABCDEFGHIJKLMNOMP/EPABCDEFGHIJKLMNOMPjEPABCDEFGHIJKLMNOMP/EPABCDEFGHIJKLMNOMP/EPABCDEFGHIJKLMNOMP/EPABCDEFGHIJKLMNOMP/EP3.DateundTypeofOCIPRODUCTSPECIFICID#42473-RD-189011.Oalc8.timeframe8mos.8mos.8mos.8mos.8mos.8mos.8mos.8mos.8mos.8mos.8mos.8mos.8mos.8mos.9.RegistrantResponsek,bk>e,e,e"e;,(,b(,e,AlA0AlAIcertifythatthestatementsmadeonthisformandattachmentsare1acknowledgethatanyknowinglyfalseormisleadingstatememaybe)orb9thunderapplicablelaw./....2/9;;;z.SignatureandTitleofCompany'sAuthorizedRepresentative;12.NameofCOOfJallyContact-----13.P)loneNUTberDebD""-I--I",!LJ"'-jCI'l/7;7f-.28"7'3: 2ofUnitedStatesEnvironmentalProtectionAgency,lj.Jpro:tJWashington,D.C.204602REQUIREMENTSSTATUSANDREGIS'I'RANT'SRESPbNSEOMSNo.2070'0107ExpiresINSTII:UCTIONS:Pleasetypeorprintinink.Plellsereadcarefullytheattllchedinstructionsandsupplytheinformationrequested011this.form.Useadditionalsheet(s)ifnecessary.1.COIIpanynameandAddressD'HALLIDAY&COAGENTFOR:SYNTEX,S.A.DEC.V.DIVI3803LUNETALANEFALLBROOKCA920284.GuidelinelI:equirement"""",5.StudyTitle2.Case#andName2330Indole-3-butyricacidEPAReg.No.42473-1Progress6Reports6.UsePattern7.TestSubstllnce3.OateandTypeofOCIPRODUCTSPECIFIC10#42473-RD-18908.Timeframe9.RegistrantResponse11 2 31151B-17(n)Miscibility/_(9)ABCDEFGHIJKLMNOMPjEP8mos.N-4151B-17(0)CorrosionchllrllcteristicsABCDEFGHIJKLMNOMPjEP8mos.A152B-10152B-11152B-12152B-13152B-14152B-15152B-16AeuteToxic-BiochemicalAcuteoraltoxicityAcutedermaltoxicityAcuteinhallltionPrimaryeyeirritationPrimarydermalirritationOermalsensitizlItionHypersensitivityincidents(1)0,2)(3)m(1,2)(4)(5)ABCOEFGHIJKLMNOABCDEFGHIJKLMNOABCDEFGHIJKLMNOABCDEFGHIJKLMNOABCDEFGHIJKLMNOABCDEFGHIJKLMNOABCDEFGHIJKLMNOMPjEP8mos.7MPjEP8mos.7MPjEP8mos.7MPjEP8mos.&MP/EP8mos.e.MPjEP8mos.78mos.7[---_.,__L_L_i_Oille(fulltextofce,tification15onpageone)./;;.?7":2--__"..-------"----"Page-1of1UnitedEnvironmental""-,--"-,--statesProtectionAgency-,-,---Washington,D.C.20460- -,,--,--'.'".CflilNo.;:01&.(11)1DATACALL-INRESPONSEApproval12-31-92INSTRUCTIONS:PleasetypeorprintinPleasereadcarefullytheattachedinstructions1II'1dsupplytheinformationrequestedonUseadditionalsheet(s)ifnecessary.,-"-<-----___.o1.COI!'iPilInynfl!lleandAddress2.Case11andNiIIOO3.DateandTypeofDCID.HALLIDAY&CO2330Indole-3-butyricacidPRODUCTSPECIFICAGENTFOR:SYNTEX,S.A.DEC.V.DIVI3803LUNETALANEFALLBROOKCA920284.EPAproduct5.Iwishto6.G.mericData7.ProductSpecificDataRegistrationcancelthis60.Iamclaimimg8GeneriC6b.IagreetosatisfyGenericla.MyproductisaMUPand7b.MyproductisanEUPandproductregis-DatabecouseIDatorequin!lllentsosindicatedIagreetosatisfytheHUPIagreetosatisfytheEUPtrationvolun-obtaintheaetiveingredientontheattachedformentitledrequirementsontheattachedontheattochedtarity.fromthesourceEPAregis-"RequirementsStatusandformentitled"Requirementsformentitled"Requirementstrationnumberlistedbelow.Registrant'sResponse."StatusandRegistrant'sStatusandRegistrant'sResponse."Response."42473-1N.A.N.A.71-.s8.Certification9.ODteIo.,tlfyth'ttho,t.t.,.,t,....'"thl'f".,nd,II,tt,oh"'.t,•.I,",00","".thot,.y,."I.,ly"',,"m;,'"d;"""",m1'''by'-.'d,_.torbothunderapplicablelaw.(rAPSi<;:lnatureandTitleofCoopany'sRepresentutiveVIl--,-kCJ11.PhoneNumberGI'l/J;2./?-;:;"i?93

# \ 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:

Acute Oral Toxicity Previously waived. Please see attachment #1 152B-IO 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) 

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# .}1-"'''-'. -2of2UnitedstatesEnvironmentalI?rotectionAgencyWashington,D.C.20460REQUIREMENTSSTATUSANDSRESPONSE1OMD110.2070-0107; • ; --App,-ova\Expires12-31-92fNSTRUCTlOIIS:Plcasetypeorprintinink.P\casereadcarefullytheattachedinstructionsandsupplytheinFor"mtionrequcsted0,1thisforlll.UselIdditiDnll1sheet(s)itnecessllry_. 'I.nllmelindAddress2.CaseIIandName3.Datc;mdTypeofDCID'HALLIDAY&CO2330d 1 b ""dAGENTFOR:SYNTEX,S.A.DEC.V.DIVlInae-3-utyr2caC2PRODUCTSPECIFIC3803LUNETALANE10#42473-RD-1890FALLBROOKCA92028_EPAReg.No.42473-1I..Guideline5.StudyTitlegProgress6.Use7.TestB.Timc9.RegistrantRequirementlReportsPattcrnSubstanceFrameRcsponselIurberCoI 2 3,151B-17(n)HiscibiHty,(9)ABCDEFGHIJKLMNOMPjEP8mos.N4151B-17(0)CorrosionchoracteristicsABCDEFGHIJKLMNOM¥'jEP8mos.Jl}AAcuteToxic-Biochemical152B-10Acuteorllltoxicity(1)ABCOEFGHIJKU1NOMPjEP8mos.7152B-11AcuTedermaltoxicity(1,2)ABCDEFGHIJKLMNOMPjEP8mos.71528-12Acuteinhllllltion(3)ABCDEFGHIJKLMNOMPjEP8mos.7152B-13Primaryeyeirritation(2)ABCDEFGHIJKLMNOMPjEP8mos.fa152B-14Primaryderma\irritation(1,2):/ABCDEFGIUJKLMNOMPjEP8mos.Go152B-15Oermalsensitizlltion(I.)ABCDEFGHIJKLMNOMPjEP8mos.7152B-16Hypersensitivityincidents(5)ABCDEFGHIJKLMNO8mos.7'<":::-____=:10""/__-_=:=='-------: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..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 

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# 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 , 

# ... , , , 

## ., ,

### 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 ,

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NAME i\ND ADDRESS OF AF'PLI CliNT.

PRODUCT NUMBER.

PRODUCT NAME:

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[ndole-3-Butyric Acid 

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DATA SUPPORTING GUIDELINE Hio(1UIREMENTS FOr, THE REREGISTRATION OF INlJDLE-:'(--BlJTYf'<lC ACID

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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



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. DATA SUPPORTING GUIDELINE REGIUIREI1ENTS FOr, THE

. REREGISTRATION OF INDDLE-·3-

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> , > • > ,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

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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 , , "
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# 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

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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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### Page 

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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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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 o , )

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NAME AND ADDRESS OF APPLI CANT.



### PRODUCT NUMBER,

PRODUCT NAME,**Syntfi.~,>:** GOy"pr.wi,ttion P"O. Ben: !'H7**Cuernacac8~** 

### Mer. Mexico

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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

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.151-10 PI'"oduct lcJeni:i. ty C.ll< [) 41.:5EI4401

1.51-11 Manufacturi.ng**PI··{JC,8S~::,** [;11<n 41 :'iE"JII40l

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### Analyt.ical Methocl CII«() 415fJ4402
.l.51-17(a) Color- 

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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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Octan'olJWatel'" pc.'tl'""i:i.ti(m CITATIDN

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OATE UNJTED STATES ENVJRONMENT

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### 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 

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,.,., OPFICIAL FILE COPY

### 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.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.

### ) 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 , > , J

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### Application for Pesticide:

May 6", "1993



### D. Halliday &.,Cg. ,3803.**_LuI'!~ta** 

### ,Lan,e,,)_ Fallbrook, CA 9202;8
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### RE-REGISTRATION

lithograph 

# 145733

GilesSyP:teJ;C Corporation P.O'. Box 517 cuernavaca',"Mor. Mexico

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### Deborah Halliday

Vice President

Deborah Hallida

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### 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

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Vice President

May 6, 1993 

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# Paperwork Reduction Act Notice and Instructions



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### 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 rcgis**tration~** 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,, 

### ,

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 

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# ::::A"'**fit~f;~;;** 

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................................. .

EPA F 0'"' 132Of-l (12-70) OFFICIAL FILE COpySYNTEX 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.

### 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.

### '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.**--~" ;.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:\ 

# 17 CP
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.**

### 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 burdenMs. 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)

### 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.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.

# - 

# ..

SYMBOL

SURNAME

DATI!: UNITED STArES ENV1RONloIENTA!. PROTECTION AGENCY



# - ,41> • 'F 

# -

Deborah Halliday D. Halliday 

### & Co, 3803 Luneta Lane Fallbrook, California 92028

Dear Ms.**Halliday~** 

### "'N 3 ,)\J. 

## 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

# /

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 Claims l shown in are

### 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.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.

# ECT

ST D'EThis 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.** !.nSYNTEX 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

### 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.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

, , "
, 

# ,

# 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. MEXICOUN !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

# .• 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)

### 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.

### 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

### '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. , "

, " 

### "


### , ,

, 

### "

, "

>

, " , "

> " "

### 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 

### / 

### /

### 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** 

### 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.

### 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 , 

### --- 

# ---

### 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.ToxChernNo.______________FileLastUpdated________CurrentDate10/29/91Study/Anirnal/Lab/DatePrimaryeyeirritationIRS11608-XX-00-01rabbit1SyntexResearchDepartmentofToxicologyandPathologyl5-30-80Primaryskinirrit./RS11608-XX-00-01rabbit1SyntexResearchDepartmentToxicologyandPathologyl6-2-80ofIMaterialIndole-3-butyricaCidl.....100%EPAAccessionNumber418630-01418630-02Results:LD50,LC50,etc.Cornealopacification,iritis,rednessandchemosis.Clearbyday14.Nodermalirritationwasobserved.Tax.Cat.II IIVCOREGradeGuidelin!IGuidelin.

# 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

## )

)

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

### 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**

### '~ 

# (

) " , , 

### .TO '1703312)87026 P.01 

# : ,. " 'I**~** 

# ... ..".

# (~ UNITED STATES**ENVIRONM~NTAt.** 

### PROTECTION AGENOY

WASHINGTON. tJC ao4S0 

# /J. f/ f\ 

# cR;**~** k IA 

### r11cJv 

# r

- 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. . ':'

., 

# ....

### . 

## -. • I • :; 

### "I' r ,'1

_ '" • _"T 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 ll 

### p l an t-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

# 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

### ) " EPA REGISTRATION NO. r

## DOCTOF2s~t~90 US ENVIRONMENTAL PROTECTION AGENCY 42473-1 OFFICE OF pESTICIDES PROGRAMS

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 " c -11 data requ**ir~(;** for registration/ Cl_2 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.** , arEUNITED 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 "" \ 1 \ 

# I l 

## J ;**S,ln~~11ly** I

# \'L~\LvJ\.A 

# C**~V\.·VIW**

.. Robert J. 

### Taylor Product Manager (25) Fungicide-Herbicide Branch Registration Division (H7505C)

CONCURRI!NCES 

### .

### 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. MEXICOUNITED 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

### 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 

### / /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: \**~** 

# 1 0 

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### -

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~ch** 

### nology 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.DATAREQUIREMENTLISTINGFORTHESELECTIVEMETHODOFSUPPORT1.PRODUCTNAME:: 2 .Indole-3-ButyricAcid* :EPAREG.NO./FILESYMBOL,5.APPLICANT'S(COMPANYINAMEAND:U;!If'73-f(3.FORMUi:ATOR!S2XEMPTrONSELECrEu:YESNOX:4.PAGEOFADDRESS::6.APPLICATIONFOR7.NAMEOFACTIVEINGREDIENT(SIS.SyntexCorporationP.O.Box517Cuernavaca)Mor.Mexico40CFRPart158-,,,,REGISTRATIONDATED:July241990Indole-3-ButyricAcidMONTHDAY._YEARD8TAREOUIREMENTSi9.SOURCE_OFDATAS_ATISFYINGREQUIREMENTj8b.:9a.19b.19C.:9d.ige.:9f.:10._5_Sa.Guide-jNameofTestjsubmittedDateSubmittedjCertificate:Public:N.A.or:MRIDNumberlineReferenceNwnbersection15S.190IIIIbySubmittedbyanotherofPermis-IILitera-:WaiverorjEPAACCessi{::Applicantperson/firmsion(P)or:ture:other:Number,or:(givename)Offerto::(explain):other1Pay(OTP):::identifyingjenclosed::::numberIIindicate::"P"_or"OTP"::,I:PRODUCTCHEMISTRY5/11/89:&:,,61-1IdentityofYes7/20/90':41193801_____..L-.liI!;nqredient_s_L_,,61-2StatementofYes7/20/90" ::41193801_____Lo.n....L___61-3DiscussionofformationofYes7/20/90"41193801inqredients. . .4/11/8,)&'"4119370162-1Prel1m1naryYes7/20/90__1...___,S____,62-2ofYes7/20/90":41193701Ilm1ts....L_62-3AnalyticalmethodiYes7/20/90",41193701forenforcement.J41193702limitsYes'"411o'n0263-2ColorIi63-3PhysicalStateYes63-4OdO_L_______:Yes'(/20/90"41193702-X-Registrationforuscin:COl:1tionofagricu1tU1'a1rootingpoundonly.DATAREQUIREMENTLISTINGFORTHESELECTIVEMETHODOFSUPPORT1.PRODUCTNAME:---rZ.EPAREG.NO./FILESYMBOL:13.FORMULATOR'SEXEMPTION:4.PAGEIndo1e-3-ButyricAcid::SELECTED::_2_Of55.APPLICANT'S(COMPANY)NAMEANDIIIIYESNOXIIADDRESS:):______:6.APPLICATIONFOR:7.NAMEOFACTIVEINGREDIENTIS),SyntexCorporationP.O.Box517:REGISTRATIONDATED::,,,,Cuernavaca,Mar.Mexico1July241990:___________________MONTHDAYYEAR:8.40CFRPart158-:DATAREOUIREI'-rENTS__i'3.SOURCEOFDATASATISFYINGREOUIREMENTIndole-3-ButyricAcid8a.:8b.:9a.:9b.9c.9d.:ge,)9f,:10,Guide-:NameofTest1Submitted:DateSubmittedcertificateIPublicIN.A.or!MRIDNumber,lineRefer-):by:submittedbyanotherofPermis-:Litera-:Waiveror:EPAAccession)IIApplicant)person/firmsion(P)or)IturelotherI)Nwnber,orenceNumberI(givename)OffertoI!(explain):other:Pay(OTP)I:)identifyingienclosed:::)nwnberSection158.190)1indicateIII)I)__________"pI!or__!loTP"-l...L___:PRODUCTCHEMISTRY(continued)Yes4/11/89&7/20/9063-5iMeltinqpoint636.--llill_il.i11QPOiL__YesJI_____63-7:Density,bulkIdensity,or7/20/90,'f""Ispec1 1CgravllL----t---c;::---i--,,---;---------i'---'---------i-------i--------+QJ._-8iSOlubilitvYes"63-9)Vaporpress-lireYes7720/90")41193702411937024119370241193702,1l93702I'")63-10:Dlssoclatlon:7/20/90"41193702!CQnstant_____,,63-11I:-Yes7/20/90II:partltlonI:coefficienti"41193702bJ-12pHxes),ll9'170263-1}---.LStabili_tvYes63-14:Oxidizing/reducing:",______'__r eact1.,0n----------',•___----'------__,_________1...-'"_.___••__•______1,,_."________________rL___'_l:_/\._______"_________DATAREOUIREMENTLISTINGfORTHESELECTIVENETHODOFSUPPORT1.PRODUCTNAME:/FIiE S---;--3-.-roRNuLATOREXEr-lPTION·!4.PAGEIndole-3-ButyricAcidSELECTED::_3_Of_5_NOX,,NAMEAND,5.APPLICANT'S(COMPANY)ADDRESS:6.APPLICATIONFORREGISTRATIONDATED:SyntexCorporationP.O.Box517Cuernavaca,Mor.MexicoJuly241990MONTH_____YEAR.__Indole-3-ButyricAcidS.40CFRPart158-:DATAREOUIREMEN'l'_S._-----.l.3.SOURCEOFDATASATISFYINGREOUIRENENTSa.:Sb.9a.9b.9c.9d.Guide-:NameofTestSubmittedDatesubmittedCertificatelineJbySubmittedbyanotherofPermisRefer-:Applicantperson/firmsion(P)orence:(givename)OffertoNumber:Pay(OTP)enclosed:indicatege.:9f.pub1ic:N.A.orLitera-:Waiverorlotherture:(explain),,,,,,L..L_,"P"or:section158.190,IPRODUCTCHEMISTRY(continued),15:flanuna_bilitv__N.A.:____...l63-1663-163-1863-1963-2063-21IExplodabiIstoraqestabi1itvyes7/20/90I"I,VISCOSItyIN.A.::Miscibility_1_N.A·l:Corrosion::characteristics___1._____N.A.:DielectricbreaX-N.A.:downvoltage10.MRIDNwnber,EPAAccessionNwnber,orotheridentifyingnumberll93702DATAHEDIJIRENENTLISTINe;U)F-i.THESELECTIVEMETHODOFSUPPOR'r1.PRODUCTNAl"1E..-....-..------.----.--:2.[Pi\REG.N6':"7r':-ILE'J .Indo1e-3-ButyricAcid:5.APPLICANT'S(COMPANY')NAMEAND:,,,,,.__.fORNULATOR'SSELECTED:YES___EXEr-!PTIONNOX:4-PACE4OfADDRESS:II'--cc=APPLICATIONFOR------.--:"7-.R"E"D=r"'ENT ( S )syntexCorporationP.O.Box517Cuernavaca,Mer.Mexico8.40CFRPart158-r:REGISTRATIONDATED:,,:July2412901.MONTHDAYIndole-3-ButyricAcidDATARJ;::OUIREMENTS._:9.SQURCE.OFDATASATISFYING......RCOUIRI:M.ENT:8b.19a.19b.:9C.19d.:9f.:10._5_Sa.GuidelineReferenceNumber:NameofTest,,ISubmittedlDate:submitted:Certificate\byISubmittedlbyanother:otPermis1ge.:Public:LiteraitureiN.A.or:MRIDNumberIWaiveror:EPAAccessi,,,,,,,,,,SectionWILDLIFEANDAQUATIC158.145ORGANISl1l-lt.o71-5AvianandMammalianTestingto72-7AquaticOrganismTestingSection15.8.135TOXICOLOGY_-1to81-3AcuteTestingto82-3SubcbronicTesting83-3Chronic'?esting--2toel(-4MutagenicityTestingIIApplicant::person/firm:sion(P)orII:(oivename)IOfferto: I:r:pay(OTP):I::enclosed:I:::indicate,,,,,,,,,, ,I"p"or"OTp!!IIIl,IIIIII,i,,,i!II,iIiI,:other:Number,or:(explain);other::ident.lfying:;number, ,,,HaivedSeeAttachment#1WaivedSeeA.ttacbment-#:HaivedSeeIIrlaivedSee'IIHaivedSeeAttachmcootIfIIDATAREQUIRE.:M£NTLISTINGfORTHESELECTIVEMETHQDOFSUPPORT1.PRODUCTNAME::2:4.PAGE-'-----Indo1e-3-ButyricAcidII:SELECTED::_5_OF55.APPLICANT1S(COMPANY)NAMEAND]:YESNOX1--ADDRESS:1i_____16.APPLICATIONFOR]7.NAMEOFACTIVEINGREDIENT{Sl:SyntexCorporation1REGISTRATIONDATED:I,,,,P.O.Box517Cuernavaca)Mor.Mexico1July241990I:___MONTHDA'L----.Y..E:AR)Indo1e-3-ButyricAcid8.40CFRPart158-rDATAREDJJIREMENTL____SOURCE_OFDATASATIS_E'YING_BEQUIREMENT8a.GuidelineReferenceNumberSection158.13585-1Section158.150122-1/122-Section158.140132-1to133-4Section158.130161-1to164-1:8b.!9a.9b.:9c.9d.INameofTeStSubmittedDateISubmittedCertificate1bySubmittedlbyanotherofPermis-:Applicantlpersonjfirmsion(Plor:(givename)Offerto:Pay(OTP)::enclosed:I:indicate--t'..U,1t'"TOXICOLOGY(continued)SpecialTestingPLAN'rPROTECTIONNONTARGETAREA,iI,FEOTECTION,.ENVrHOJofE:N'l'ALFATE,.V-.T____1ge.lpubliciLitera-:ture,,,,,,,,I9f.110.iN.A.orIMRIDNumber,:WaiverorlEPAAccessiolotherINumber,or:(explain)lother::identifying:1number, ,, ,HaivedSeeAttachmen-#nWaivedSeeAttachment#1Haived·xWaivedSee1:]Waived Testing per the Enviromental Protection Agency

Attachment I and Attachment II

### 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 

### vaituzis t 

### Microbiologist 

# J /

1 1

# ~~ Ecological Effects Branch (H7507-C) 

## 1 

# --?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.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:'ISU -> LUncl;;L i1!t'f?'**>~,<~ab;oQk,** /\ 92G2f:;



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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 

### / /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

### -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



# I 'c::

# ~ 

# Crj (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.

### -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/mLProperty

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

### 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.



# ..

### · 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.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 '"''

',.' 

### ,.

""'" , ,,,

# 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 regislra**tio!~** 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. ) ), 

# . 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/dwUnited 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'"-: 'j 0 ,J ) , J" ;)'

!;



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### imtrati'(},n ox not he met,

# ] 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 similar l 

### 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.",----"-.-,'DATAREQUIREMENTLISTINGFORTHESELECTIVEMETHODOFSUPPORT-----i2.:3.:4.1.PRODUCTNAME,EPAREG.NO./FILESYMBOL:FORMUL.-iVrOR'.8.SXEMP'I'IONPAGE*Indole-3-ButyricAcid,,.,-...L-OF_5_,,,. :I5.APPLICANT'S(COMPANY)NAMEAND:,YEStJO'l::2.Y?3-fZ.,,ADDRESS:,,,,,,116.APPLICATIONFOR17·NAMEOFACTIVEINGREDIENT(S),SyntexCorporation,REGISTRATIONDATED:,,,P.O.Box517,,,,Cuernavaca,Mar.Mexico,July241990,,,,MONTHDAYYEAR___i,S.40CFRPart158-:_-"D"ATA.....RE_illLLREl'1E...rITS____----.l9_.SOURCEREOUIREMENT8a.ISb.!9a.!9b.i9c.]9d.1ge.Guide-jNameofTestISubmittediDateIsubmittedICertificate:publiclineI1byISubmitted'byanotherlofPermis-ILiteraRefer-]!Applicantlperson/firm]sion(P)ortureenceII:(givename):OffertoNumber:I::Pay(OTP)I::lenclosed::IIIindicatei_____J__1___10);__"OTp"section:i,158.190lPRODUCTCHEMISTRXll5/11/89II 1&II:9f.:10.IN.A.orIMRIDNumber,WaiverorlEPAAccessiOIother[Number,or(explain)lotheridentifyingnumberIIIIIIdentityofIYesI7/20/90II:41193801,., ,-,IInqredlents_____.I.--------'---_I..._61-161-2IIIII:StatementofIYesI7/20/90II::II. .II-----1_L___compos1tIon__1.__-------L_____-------L-_______.61-3DiscussionofformationofYes7/20/90"41193801inarenients.. .'·"711/89&4112370162-1prelImInaryYesI7/20/90_.....,_____analYsis------1._____----III62-2Of!Yes:7/20/90":\__l41193701llmIts___.I--------L-___1__.____.__62-3AnalyticalmethodiYes7/20/90 "41193701forenforcementl41193702limits:Yes"4119370263-2ColorYesII41193702633PhysicalStateYes'(/20/90"634Qdor-X"Registrationforuseinformulationofagriculturalrootingcompoundonly.DATAREQUIREMENTLISTINGFORTHESELECTIVEMETHODOFSUPPORT1.PRODUCTNAME:2.EPAREG.NO./FILESYMBOL::3.FORMuLATOR'SEXEMPTION:4.PAGEIndole-3-ButyricAcid:SELECTED::_2_OF55.APPLICANT'S(COMPANY)NAMEANDL/,;l,1"3_b:YESNOX:-_.ADDRESS:/"I:6.APPLICATIONFOR:7.NAMEOFACTIVESyntexCorporationP.O.Box517Cuernavaca,Mor.Mexico8.40eFRPart158-REGISTRATIONDATED::,,July241990IIndole-3-ButyricACid__-'.__MONTH_DAY___iDATfIL_HEOUIRENENTS!9,-__SOURCEOFDATASAT!SFYINGREQUIREMENTSa.lab.:9a.9b.9c.:9d.ige.9f.:10.GuidelineReferNameofTest:SubmittedDateSubmitted:CertificatebySubmittedbyanotherIIofPermis-iPublicILitera-ItureN.A.oriMRIDNumber,WaiverorjEPAAccessionApplicantperson/firmlsion(P)orotherjNumber,orenceNumberI(givename)IOfferto,,(explain)lotherIIIIPay(OTP):ienclosed::JIindicateII__1____.._..___n_--.L__section:158.190IPRODUCTCHEMISTRYYes4/ll/89I(continued)/&/II72090identifyingnumber63-5!Melt_inapoint4119370263-6___iBoilinqpointYesw-n--J_-----....--:--..------:---4ll93702,,',63-7:Density,•',•••:Yes7/20/90!41193702Idenslty,"!specificqrc-:vi::t\;'ft63-8ISOlubilityYes"if1l9370263-9I,VaporPreSsureYes1/2,0/90"I4119370263-10:ies7/20/90"!41193702--:c:c-:c:---t::6311:Yes7/20/90":lpartltlonII,..t',coefflClen,It3-12:pH!Yes63-13I,StabilityYesI,]/206J-14:Oxic1izing/reducing:::,.II,,:'411937024ll9,70241191702____----'-.__,_______...__l__..__._______i'L1\.:_.__-_1.---."_,,_.,0DAT.i\REOliIRENENTLISTINGfORTHESELECTIVEf'olETHODOfSUPPORT1.PRODUCTNAME:·"-------IT.-EP:l\SYMBOL::J.:4.PAGEIndo1e-3-ButyricAcid.___:ISELECTED::_3_OFNAMEANDI:'-I;2y,/3_fJ.:YESNOX!_5_5.APPLICANT'S(COMPANY)ADDRESS:,,16.APPLICATIONFORi7.NANEOFACTIVEINGREDIENT(S):SyntexCorporationP.O.Box517Cuernavaca,Mor.Mexico8.40CFRPart158-f1REGISTRATIONDATED:,,:July241990:MONTHDAYYE:.ARDATAREQUIREMENTS19.SOURCE_OFSATISFYINGREQUIREMENTIndole-3-ButyricAcidSa.GuideIIBb.:9a.9b.19C.:9d.ge.19f.110.!NameofTest:SubmittedDate:Submitted:CertificatepublicIN.A.orIt'1RIDNumber,lineRefer-:!bySubmitted:byanother:ofPermis-Litera-WaiveroriEPAAccession::Applicantiperson/firm!sion(P)ortureother!Number,orence:I:(givename):Offerto(explain)IIotherNumber!I::Pay(OTP)\identifying:II::enclosed::numberIIII'.IIItIIIndlcateI:__.__1__.L------L_:section::158.190!PRODUCTCHEMISTRY::(continued):IIIIIIIIII N AI . .IIII••------LflruN!labILItv--------'____.__......63-16_LE:xpLQdabilit"l\T"63-17:Storaqes_t.abilityYes7/20/9063-1B__:Viscosi.ty_..____.6..1.-::::19_..j--.l..---.1._IN.A.63-20ICorrosionI!!.Lc.bara_Gter_i.s.tics-----.l..N.A.0,63-21:Dielectric:N.A.:downvo11193T02"''',---"-DATAREQUIREMENTLISTINGfUR.THESELECTIVEMETHODOfSLJepORT1.PRODUCTNAME:-.------._-------;:2-..EP.A.J.: 4 ."_-.-.-PACEIndo1e-3-ButyricAcid:SELECTED:5.APPLICANT'S(COMPANY)NAMEAND:L/.YES____ADDRESS,:I.zY-?3 -R4Of,_5_NOX:6.APPLICATIONfOR-----.----SyntexCorporationP.O.Box517CuernavacaJMor.Mexico8.40CFRPart158-:-IREGISTRATIONDATED:,,1July241990L__MDNTHDAY.YEAR7.NAMEOFACTIVEINGREDIENT(S);Indole-3-ButyricAcidDATAREQUIREMENTS:9.SOURCEOFDATASATISFYINGREQUIREMENT8a.:8b.19a.i9b.:9c.i9d.ge.i9f.10.GuidelineReferenceNumberSection158.145'1-1to-(1-5'2-1to72-7Section15,8.1351-1to81-32-1to82-383-31+-2toI:)L;4INameofTest!Submitted!Date:SubmittediCertificatePublicN.A.orMRIDNumberbyIsubmitted:byanother:ofPermis-Litera-WaiverorEPAAccessiApplicant::person/firmision(P)ortureotherNumber,or:(givename):Offerto(explain)otherPay(OTP)identifyingenclosed:numberindicate,I"P""OTP"I,or,wILDLIFEANDAQUATICWaivedSeeAvianandMammalianAttachmentTestingi#1AquaticOrganismiWaivedTestingISee,ttachment#JII,"-"·IWaived".·,---·ISee. ..--IAcuteTestihz--__=._·IIISubchronicTestingIaivedSee,"'...-IAttj/cl"i'ent. ...-,-Chrort;:i.c:te$t1n,g"'...,..·l,Attl):Chmcnt.,.......II,MutagenicityTest-,iIiWaivedingI,See,iAttachuicnt,!lIIIIDATAREOUIREMENTLISTINGfORTHESELECTIVEMETHODOrSUPPORT1.PRODUCTNN1E::i-.---E"-PA---REG:-NO./FILE-SYMBOL":--·":J.:4.PAGE------Indole-3-ButyricAcid!:SELECTED::_5_OF55.APPLICANT!S(COMPANY)NAMEAND:zJ.,//?3 _M:YESNOx:--ADDRESS::""/""'"-,I...::16.APPLICATIONFOR:7.NAMEOFACTIVESyntexCorporation:REGISTRATIONDATED:,,P.O.Box517Cuernavaca,Mar.MexicoIJuly,241990iMONTHDAY1Indole-3-ButyricAcid8.40CFRPart158-rDATAREQUIREMENTSi___.sOURCE_OFD'ATA---.SATISFY_ING_HEOULREMENT8a.:Bb.J9a.:9b.!9c.:9d.:ge.Guide-:NameofTestSubmittediDateSubmitted:certificate:Publicline1bysubmittedbyanotherjotPermis-jLiteraRefer-IApplicantperson/firmsion(P)orItureence(givename)OffertoNumberPay(OTP)enclosed:indicateSection158.13585-1Section158.150Section158.140132-1to133-4Section158.130161-1to164-1TOXICOLOGY(continued)SpecialTestingPROTECTIONNONTARGErAREAENVTIlOl;ff;N'l'ALFATE"P"or"OTP"1--:9f.IN.A.orIWaiverorother(explain)HaivedSeeJ\ttac!1men"ill"J10.MRIDNumber,EPAAccessioNumber,orotheridentifyingInumber,,,Waived Testing per the Enviromental Protection Agency

Attachment I and Attachment II

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### 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 Vaituzis, Microbiologiet 

# J/11**~~** Ecological Effects Branch (H7507-C)**~** 

# ····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.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 ll 

### p l 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

, 

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# .. ..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 sold l 

### 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\...;'