### Page 2 of 48 1,3,5-Triazine-2,4-Diamine, N-Cyclopropyl- N'-(1,1-Dimethyleth yl)-6-(Methylthio)-

REGISTRATION REVIEW DECISION

PRODUCT CHEMISTRY, ENVIRONMENTAL FATE AND

ECOLOGICAL EFFECTS SUMMARY

PC Code: 128996 ; Case No. 5031

Introduction:

1,3,5-Triazine-2,4-diamine, N-cyclopropyl-N' -(1,1-dimethylethyl)-6-(methylthio)- better known under the trade names Irgarol® 1051 and Cybutryn is a chemical compound with a 1,3,5- triazine ring as the basic structure. Irgarol 1051 is an odorless, low volatile, yellowish to white solid granule (powder) which has a low vapor pressure of 6.6 x 10 -7 

### mmHg at 25°C, very low water solubility of 7 mg/L (7 ppm) and a log P

ow 

### of 3.95 at 25°C (moderately lipophilic).

Fouling can significantly increase water resistance to boats which can result in up to 40% higher fuel consumption. Fouling can also decreas e maneuverability (a safety hazard) and it can damage the ship’s body. In the process of fou ling, algae form a substrate for macro-fouling. Irgarol 1051 is an algicide speci fically designed for use in marine antifouling coatings. It is a highly specific and effective i nhibitor of photosynthesis which can control fouling of marine surfaces caused by algae. Its very low water solubili ty contributes to very slow leaching rates and therefore extended antifouling action.

In antifouling paints Irgarol 1051 is often co mbined with copper, or copper compounds such as cuprous oxide or copper thiocyanate. While Irgarol 1051 effectively controls algae, copper is effective at control ling animals. Irgarol 1051 is a s- triazine herbicide used in combination with copper in antifoulant paint as a “booster” biocide, intended to diminish algae growth on ship hulls.

Products containing Irgarol 1051 as an active in gredient were first registered with the EPA for use in boat antifouling paints on January 1 st 

### 1960. Currently, there are 41 active products under a single PC Code 128996 which ar e listed in Table 1. Registered products contain between 0.49 and 98.1% Irgarol 1051. The registered formulations are technical chemical, formulation intermediate, emulsifiab le concentrate, liquid soluble concentrate, pressurized liquid, and ready-to -use solutions. Irgarol 1051 products are registered in combination with cuprous oxide (PC Code: 25601; CAS# 1317-39-1 ), copper thiocyanate (PC Code: 025602; CAS# 1111-67-7), carbe ndazim (PC Code: 128872; CAS# 10605-21-7), chlorothalonil (tetrach loroisophthalonitrile) (P C Code: 81901; CAS# 18 97-45-6), octhilinone (OIT; PC Code: 099901; CAS# 26530-20-1), 3( 2H)-Isothiazolone, 4,5-dichloro-2-octyl- (DCOIT; PC Code: 128101; CAS# 64359-81-5), a nd carbamic acid, butyl, -3-iodo-2-propynyl ester (IPBC; PC Code: 107801; CAS# 55406-53-6).

Irgarol 1051 is a triazine he rbicide possessing biocidal activ ity against algal and diatom fouling species and is used as a 'booster bioc ide' in approved antifouling products for use on

### Page 3 of 48 vessels of any size and on structures below the waterline. The major use sites for these products include antifouling coatings for boats and material s preservatives for exterior paints, coatings, building materials, vinyl roofi ng, stucco, grouting, spackling and joint cement. (E xterior Paints, Coatings, Stains, Building Materi als, Latex and Solvent Based Paints, Semi Transparent Stains, Solid Stains, Vinyl Roofing, Elastomeric Roof, Wa ll Coatings, Mastics, Ca ulks, Sealants, Joint Cements, Spackling, Stucco, Grouting, Applied Film of Paint, Masonry Coatings, Wood Protective Stains, Adhesives, Caulks and Sealants , Roof Coatings, Plasters, Sealants and Fillers used for Architectural Products, Finishes and Sp ecial Purpose Coatings, Hulls on Ships, Boats, Barges, Yachts and Running Gear). For use as a biocide in manufacturing caulking compounds, sealants, joint compounds, stucco, coatings, paints, dry film paint, stains, grouts, adhesives, and wood preservatives. An algicide and slimicide to be formulated into marine and/or freshwater antifoulant paints for boats and/or vessels only.

Table 1. Registered Active Products of Irgarol

Registration # Registration Name Company Name Formulation Type % of

Active Ingredient

707-304 Rocima 65 Industrial Microbicide Rohm & Haas Co. Emulsifiable

Concentrate 3.5

707-312 Rocima 80 Rohm & Haas Co. Soluble

Concentrate 32.5

1258-1270 Densil CA Arch Chemicals, Inc. Soluble

Concentrate 6.0

1529-38 Fungitrol 1075 International Specialty

Products Formulation

Intermediate 15.0

1529-48 Fungitrol 2002 International Specialty

Products Formulation

Intermediate 5.89

2693-170 Fiberglass Bottomkote With

Biolux II - Black International Paint LLC Ready-to-Use

Solution 0.49

2693-181 Tri-Lux III With Bio-Lux 5490

Blue International Paint LLC Ready-to-Use

Solution 2.23

2693-183 Micron CSC Plus With Biolux

Shark White International Paint LLC Ready-to-Use

Solution 1.9

2693-189 Tri-Lux Blue International Paint LLC Ready-to-Use

Solution 2.23

2693-190 Micron CSC Super With Bio-Lux

Blue International Paint LLC Ready-to-Use

Solution 2.0

2693-192 Ultra With Bio-Lux Blue International Paint LLC Ready-to-Use

Solution 1.59

2693-197 VC 17M With Biolux Original International Paint LLC Ready-to-Use 2.38

### Page 4 of 48 Registration # Registration Name Company Name Formulation Type % of

Active Ingredient

Solution

2693-198 VC 17M With Biolux Red International Paint LLC Ready-to-Use

Solution 2.38

2693-199 Trilux With Biolux Black International Paint LLC Pressurized Liquid 0.86

2693-201 Ultra Plus - Blue International Paint LLC Ready-to-Use

Solution 1.6

2693-202 CSC Plus - Blue International Paint LLC Ready-to-Use

Solution 2.0

2693-204 CSC Plus - Blue International Paint LLC Ready-to-Use

Solution 2.0

2693-205 Ultra Plus Blue International Paint LLC Ready-to-Use

Solution 1.59

2693-208 Fiberglass Bottomkote With

Biolux-Blue International Paint LLC Ready-to-Use

Solution 0.98

2693-209 Fiberglass Bottomkote Act With

Biolux-Blue International Paint LLC Ready-to-Use

Solution 0.98

2693-212 Super Epoxycop With Irgarol -

Blue International Paint LLC Ready-to-Use

Solution 0.98

2693-213 Super KL Plus With Irgarol - Blue International Paint LLC Ready-to-Use

Solution 0.98

2693-216 Prop & Drive Clear Aerosol International Paint LLC Pressurized Liquid 1.6

2693-218 Fiberglass Bottomkote Act With

Biolux II - Black International Paint LLC Ready-to-Use

Solution 0.49

2693-219 Super KL Plus With Irgarol II -

Black International Paint LLC Ready-to-Use

Solution 0.49

2693-224 Micron Extra Blue International Paint LLC Ready-to-Use

Solution 1.96

5383-88 Troysan Polyphase 588 Troy Chemical Corp Emulsifiable

Concentrate 10.0

5383-102 Mergal S 90 Troy Chemical Corp Ready-to-Use

Solution 4.9

5383-105 Troysan ALF4 Troy Chemical Corp Emulsifiable

Concentrate 10.0

### Page 5 of 48 Registration # Registration Name Company Name Formulation Type % of

Active Ingredient

5383-108 Polyphase 662 Troy Chemical Corp Soluble

Concentrate 4.0

9339-31 Aquagard II Antifouling Spray

Paint For Outdrive & Outboards Flexabar Corp Ready-to-Use

Solution 0.8

40810-11 Irgarol 1051 Ciba Corporation Technical

Chemical 98.1

40810-15 Irgarol 1071 Ciba Corporation Ready-to-Use

Solution 98.1

44891-13 Sea Hawk Premium Quality Tropikote Biocide Plus Slime Resistant Antifouling Coating New Nautical Coatings

Inc. Ready-to-Use

Solution 2.02

44891-14 Sea Hawk Premium Quality

Cukote Biocide + Slime Resis.

Antifoul. Coat. New Nautical Coatings

Inc. Ready-to-Use

Solution 2.0

60061-94 Pettit Marine Paint Ultima SR Biocide Antifouling Kop-Coat, Inc. Ready-to-Use

Solution 2.0

60061-95 Petit Marine Paint Trinidad SR Antifouling Kop-Coat, Inc. Ready-to-Use

Solution 2.0

60061-110 Petit Marine Paint SR-21 Fresh Water Antifouling Kop-Coat, Inc. Ready-to-Use

Solution 2.0

60061-117 Pettit Marine Paint Ultima SR Antifouling Paint Kop-Coat, Inc. Ready-to-Use

Solution 2.0

74681-4 Copper Pro SCX 67 Bluewater Marine Paint Ready-to-Use

Solution 1.96

74681-6 Copper Shield SCX 45 Bluewater Marine Paint Ready-to-Use

Solution 1.96



### Use Patterns:

707-304:

Industrial Microbicide for Use in Exterior Paints, Coatings, and Building Materials. Coatings: for use as a microbiocide to control bacteria, algae and fungi in exterior paints, coatings, and stains. Building Materials: For use as a microbiocide to control bacteria, algae and fungi in exterior building materials, stucco, caulks, and sealants. May not be used for food grade coatings or a dhesives that may come in contact with food.

### Page 6 of 48 707-312: Algicide for Use in Coati ngs and Building Materials. Coatings: For use as an algicide to control al gae in non-food use/non-food contact coatings such as latex, and solvent-based paints, semi-transparent stains and solid stains. Building Materials: For use as an algicide to c ontrol algae in building materials such as vinyl roofing, elastomeric roof and wall coatings and mastics, cau lks, sealants, joint cements, spackling, stucco, and grouting. The manufactured products are for outdoor use only, are not to be used in products that my come in contact with water, and are not to be used on wood or any other treated ma terial which is to be used for food, feed, potable water, live stock, dairy animals or living plants.

1258-1270: For the Control of Fungal and Algal Growth on Exterior Paints, Caulks , Stucco and Stains.

It is an aqueous dispersion of a broad spectrum fungicide in combination with a broad spectrum algaecide, for control of fungal a nd algal growth on exterior paints , caulks, stucco, and stains. It provides excellent characteristics when used as a fungicide/algaecide in aqueous systems only, such as latex emulsion paints, stains , and coatings, stucco, and caulks.

Like natural substrates, coatings (if unprotected) can be susceptible to the growth of a wide range of fungi and algae. The uncontrolled growth of these organisms can lead to failure of coatings for their intended purpose of protecting expensive subs trates. It is an effective fungicide/algaecide which provides long term protection from funga l and algal defacement of the paint film.

Some critical advantages of it ar e: synergistic biocidal action of the active agents, hydrolytic stability, extremely low water solubility, low vapo r pressure, fine partic le size, excellent pH stability, and endurance to UV radiation.

Mode of Action:

2,4,5,6-Tetrachloroisophthalonitrile is a multisite pr otective fungicide. The mode of action is the binding of the active molecule to the glutathion moiety, thus prev enting completion of the energy cycle of the fungal species, and ultimately controlling fungal growth. Unlike many other systemic fungicides, this is not a site specific activity. Hence th ere is no known re sistance to the fungal control.

N-Cyclopropyl-N'-(1,1-dimethylethyl)-6-(methylthio)-1,3,5-triaz ine-2,4-diamine is a broad spectrum algaecide, it has activity against both fr esh water and sea water algae. The mode of action of this active agent is that of an inhibitor of photosynthesis.

An effective fungicide/algaecide in most aqueous products.

It is the responsibility of the manufacturer to te st DENSIL CA for optimum dosage levels and to determine compatibility and suitability for intended use.

### Page 7 of 48 It is recommended that DENSIL CA be added duri ng or after letdown stag e. If desired DENSIL CA can be added as a post-add to the finished paint. This is especially useful for base paints. It is important to ensure thorough mixing of DE NSIL CA into the formulated paint.

When an in-can preservative is used in .combi nation with DENSIL CA, it should be tested first for compatibility. DENSIL CA is compatible w ith latex paints containing zinc oxide. Further

information is available from our Technical Service personnel.

1529-38:

FOR INDUSTRIAL USE ONLY

FUNGITROL 1075 is intended only for protecting th e applied film of paint, coating, stucco, stain and caulk itself from algal growth. It is not intended to pr otect the substrate to which the preserved material is applied. Products th at incorporate FUNGITROL® 1075 in their manufacture, may not make claims on their labe ls regarding protection of the substrate from algal growth.

An algicide for use in the manufacture of the following aqueous and solvent compositions only: paints, coatings, stucco, stains a nd caulks to protect the applied paint film, coating, stucco, stain and caulk itself from algal growth. The manufact ured products are for outdoors uses only, are not to be used in products that may come in contact with water, and are not to be used on wood or any other treated material which is to be used for food, feed, potable water, livestock, dairy animals or living plants.

1529-48:

FOR INDUSTRIAL USE ONLY

For use as a biocide in manufacturing caulki ng compounds, sealants, jo int compounds, stucco, coatings, paints, dry film paint, stains, grouts, adhesives, and wood preservatives.

2693-170: Irgarol Improves Antifouling Performance by Reducing Slime. Proven All Purpose Antifouling Protection.

It is a hard modified-epoxy an tifouling paint that provides excel lent season long protection. It contains cuprous oxide and Irgarol . The Irgarol works to contro l weed, slime and algae fouling while cuprous oxide works to control shell foulin g such as barnacles and Zebra mussels. This keeps the bottom of boat cleaner longer.

2693-181: Formulated for Use on Aluminum, Fiberglass or Wood

Slime Resistance

Contains Petroleum Distillates Antifoulant paint for use on aluminum boats, outdrives and outboards.

### Page 8 of 48 Cuprous thiocyanate works against shell fouli ng such as barnacles and zebra mussels while Irgarol prevents slime and algae growth. Do Not Apply Above True Waterline.

2693-183: Irgarol Controls Slime Use on fiberglass, wood and steel hulls. Irgarol Improves Antifouling Performance by Reducing Slime. Contains cuprous oxide Cuprous oxide works against shel l fouling and Irgarol protect ag ainst weed, slime, and algae growth. For use below waterline on fiberglass, wood and pr operly primed metal, boat hulls and parts, in fresh, salt and brackish waters.

Do not use on aluminum. This product contains cuprous oxi de and Irgarol. The Irgarol work s to control weed, slime and algae fouling while the cuprous oxi de works to control shell fouli ng such as barnacles and zebra mussels. This keeps the bottom of your boat clea ner longer. It provides excellent protection against all forms of marine fouling in waters with moderate to heavy fouling and can be used in fresh, salt and brackish waters.

2693-189: Biolux Blocks Slime. Biolux boosts performance by controlling slime. It is a hard antifouling paint specifically developed for use on aluminum boa ts, outdrives and outboards. It uses a resin system containing two biocides - Cuprous Thiocy anate and an organic bà oster called Biolux. The Cuprous Thiocyanate works best against shell fou ling such as barnacles and zebra mussels while the Biolux booster helps prevent slime and algae growth. This blend of resins and biocides offer, when properly applied over primer, excellent anti fouling protection. It has been specifically developed for use on primed aluminum, but it can al so be applied to fibe rglass, wood and other

underwater metals on boats. It is for use below the waterline in fresh, salt a nd brackish water. It can be applied by brush, roller or spray. V.O.C.: Less than 400 grams /liter (3.34 lbs/gallon).

2693-190: Biolux Blocks Slime. Biolux boosts performa nce by controlling slime. Biolux® is a multiseason, controlled solubility copolym er antifouling paint that is specially formulated with two biocides - cuprous oxide and a booster called Bi olux®. The cuprous oxide works best against shell fouling, while the Biolux® booster helps protect against weed, s lime and algae growth.

2693-192: Contains Biolux to resist slime. High copper an tifouling for ultimate protection. Teflon® added for durability and easy cleaning. Biolux boosts antifouling performance by controlling slime. Biolux resists slime. Contains petroleum distillates, xylene or xylene range aromatic solutions. Provides excellent long-term protection from shell and weed fouling. Ultra with Blolux® contains a very high loading of Cuprous Oxide and uses Biolux® technology to control slime.

### Page 9 of 48 2693-197:

Biolux Blocks Slime. Biolux Boosts Performanc e by Controlling Slime. Complete protection against zebra mussels, teredo worms, weed, algae a nd slime fouling. This is especially helpful in freshwater or low fouling saltwater.

2693-198:

Biolux Blocks Slime. Biolux Boosts Performanc e by Controlling Slime. Complete protection against zebra mussels, teredo worms, weed, algae a nd slime fouling. This is especially helpful in freshwater or low fouling saltwater.

2693-199: Control slime growth. For use in fresh, salt and brackish water.

2693-201: Resist slime. Control Slime. Long term protection from shell and weed fouling. Best against shell fouling such as barnacles a nd zebra mussels and works to control slime and algae fouling. Can be used in fresh, salt and br ackish water on fiberglass, wood and properly primed metal boat hulls and parts. Do not use on aluminum.

2693-202:

Blocks Slime. Control slime. Works against shell f ouling, protect against weed, slime and algae growth.

2693-204:

Blocks Slime. Control slime. Works against shell f ouling, protect against weed, slime and algae growth.

2693-205: Resist Slime. Control slime. Best against shel l fouling such as barnacles and zebra mussels and works to control slime and algae fouling. Can be used in fresh, salt and brackish water on fiberglass, wood and properly primed metal boa t hulls and parts. Do not use on aluminum.

2693-208:

Control slime. Works to control weed, slime and algae fouling and control shell fouling such as

barnacles and zebra mussels.

2693-209: Fight slime. Works to control shel l fouling such as barnacles and zebra mussels. Can be used in fresh, salt and brakish waters.

2693-212:

Blocks Slime. Control slime. Anti slime add itive. Antifouling protection against barnacles, zebra mussels, hydroids, algae and slime for boats in salt or fresh water on boat bottoms.

### Page 10 of 48 2693-213: Use in high fouling salt or fres h water areas. Algaecide. Provides resistance to barnacles, slime, algae and hydroids.

2693-216: Prop & Drive Clear Aerosol antif ouling paint is formulated specifically for aluminum outboards,

outdrives and aluminum hulls in underwater ar eas. Prop & Drive Clear Aerosol dries quickly so that it can be painted and launched the same day. Prop & Drive Clear Aerosol uses Biolux® Technology to control slime growth. Prop & Drive Clear Aerosol is for use in fresh, salt and brackish water. Prop & Drive Clea r Aerosol also contains Teflon® for added durability and easy cleaning.

FOR ALUMINUM OUTBOARDS, OUTDRIVES AND HULLS

Do not apply primer or Prop & Drive Cl ear Aerosol above th e true waterline.

Do not apply to tin-based paint such as Mi cron®33, Micron 33 Aerosol, Micron 44 or Tri-Lux

lIT. Do not use above the true waterline.

2693-218:

Reduces slime Fights slime The lrgarol works to control weed, slime and al gae fouling while the cuprous oxide works to control shell fouling such as barnacles and zebra mussels.

It provides excellent protection against all forms of marine fouling in waters with moderate to heavy fouling and can be used in fresh, salt and brackish waters.

A multi-season, antifouling paint that is formulated with two biocides that provides effective protection against barnacles, slime, algae and hydr oids. It is recommended for boats that are used in high fouling salt or fresh water areas, or which remain in the water for prolonged periods

between haul outs.

It is for use below the waterline on fiberglass , wood and properly primed metal boat hulls and parts, in fresh, salt and brackish waters.

2693-219: Contain Organic Boosting Bi ocide to Combat Slime. Contain a Specially Formulated Boosting Algaecide to Combat Slime. Use on wood, fiberglass and steel hulls. Provides effective protection for boats that are us ed in high fouling salt or fresh water areas, or which remain in the water for prolonged periods between haul outs. The high load of cuprous oxide and a specially formulated boosting algaecide provides excelle nt resistance to barnacles, slime, algae and hydroids. Resistant to algae, barnacle s and other marine fouling.

### Page 11 of 48 Blocks slime growth.

2693-224:

Blocks slime.

Boosts Performance by Controlling Slime.

Antifouling Protection for All Conditions.

Contains Petroleum Distillates

5383-88: A Fungicide/Algicide For Exte rior Paints, Masonry Coati ngs, Wood Protective Stains, Adhesives, Caulks and Sealants.

Sold for industrial use only in the final use products: Exterior pain t, wood protective stain, adhesives, caulks & sealants, Joint cements, roof coatings, and stucco.

5383-102: Industrial Biocide for Use in Paints, Coatings, Pl asters, Stuccos, Sealants, Caulks and Fillers.

An antimicrobial preservative for control of fungi and algae growi ng on paints, coatings, plasters, sealants, and fillers used for archit ectural products, finishes and special purpose coatings.

5383-105: A Preservative for Exterior Paints and Coatings , Wood Protective Stains, Adhesives, Caulks and Sealants and Exterior Plaster Coatings. Applications: Paints and stains, wood protective stain, adhesives, caulks, grouts and sealants,

stucco.

5383-108: A Broad Spectrum Biocide for use in Exterior Pa int and Stains, Masonry Coatings, Adhesives, Caulks and Sealants, Roof Coati ngs, Stucco and Joint Cements.

It is a water dispersion of biocid es effective against a wide variety of fungal and algal organisms. Its primary application is in water-based products where VOC is a major concern.

It is not to be used in formulations intende d for food contact paper co atings or food contact

adhesive uses.

It should be added to paints and coatings, ex terior paints, wood protective stains, masonry coatings, and roof coatings at the end of the ma nufacturing cycle, after the final pH adjustment

has been made.

### Page 12 of 48 It may be added to exterior caulks and sealan ts at the end of the production cycle with good agitation.

It may be added to stucco and to joint cements.

9339-31: Contains cuprous thiocyanate.

Outboard & lower unit anti-fouling paint.

Controls slime & other fouling organisms.

For use on aluminum & other non-ferrous materials.

Ideal for use on stern drives and other lower units.

40810-11 An Algicide/Slimicide for Use In Formulating Antifouling Paints.

For Industrial Use Only.

An algicide and slimicide to be formulated into marine and/or freshwater antifoulant paints for boats and/or vessels only.

40810-15

An Algicide for Use in the Manufacturing of the Following Aqueous and Solvent Compositions Only: paints, coatings, stucco, stains and caulks to inhibit or control the growth of algae on

the treated surfaces.

An algicide for use in the manufacture of the following aqueous and solvent compositions only: pants, coatings, stucco, stains and caulks to inhi bit or control the growth of algae on the treated surfaces. The manufactured products are for outdoor use only, are not to be used in products that may come in contact with water, and are not to be used on wood or any other treated material which is to be used for food, feed, potable wa ter, livestock, dairy animals or living plants.

44891-13: Biocide Plus Slime Resistant Antifouling Coating.

Hard epoxy-based antifoulant with over 73% copper in every color. This product is designed to control barnacles, algae and other ma rine foulings in salt or fresh water. This product is designed for use on the surfaces of hulls on ships, boats, barges, yachts, or running gear.

44891-14: Biocide Plus Slime Resistant Antifouling Coating.

### Page 13 of 48 Ablative, self-polishing antifoulant. This produc t is designed to contro l barnacles, algae and other marine foulings in salt or fresh water. This product is designed for use on the surfaces of hulls on ships, boats, barges , yachts, or running gear.

60061-94:

Marine Paint Oblative Dual Biocide Antifouling Bottom Paint • High copper content. • Multi-season technology. • Self-polishing. • Reduces paint build-up th rough controlled erosion. • Excellent for fiberglass, wood & steel boats.

• Slime resistant.

Commercial and N on-Commercial Use Do No Apply this Product on Aluminum Hulls or Outdrives.

Marine Paint

60061-95: Antifouling Bottom Paint

• Slime resistant. • Very high copper content. • Long-term protection. • Effective In worst tropical conditions. Hard finish, easily burnished. • Excellent for fiberglass, wood and steel boats.

COMMERCIAL AND PRIVATE CONSUMER USE

60061-110:

Marine Paint Fresh water antifouling Paint • Super Slick Finish • Dual- Biocide Controls Hard and Soft Fouling • Ultra-Thin Film Thickness Prevents Paint Build-Up • Contains Moly-Disulfide & PTFE for Reducing Friction • No Sanding Required • Excellent for Fiberglass, Wood and Steel Boats

THIS PRODUCT IS A TWO-COMPONENT PRODUCT.

TO ONLY BE MIXED WITH POWDER PORTION

LOCATED UNDER THE LID OF THIS CONTAINER

BEFORE USING.

60061-117:

Marine Paint

Slime resistant. Multi-season technology

### Page 14 of 48 Self-polishing. Reduces paint build-up through controlled erosion Excellent for fiberglass, wood & steel boats.

COMMERCIAL AND NON-COMMERCIAL USE

DO NOT USE THIS PRODUCT ON ALUMINUM HULLS OR OUTDRIVES

74681-4: Contains cuprous oxide

Marine Paint

Slime control

Tremendous Protection for Extreme Fouling Conditions.

It provides extended antifouling protection against barnacles, alg ae and hydroids in salt and fresh water on boat bottoms only. It acts like a sunscreen to prevent slime and algae. Its ablative copolymer base renders a smooth- finish with du rability and abrasion resistance. It releases biocide by the constant exposure of new paint film to the water. It has universal application over all types of properly prepared bottom paints (ex cept aluminum). For use on fast fiberglass boats, as well as wood and steel hulls, extended protecti on is possible, since performance is directly proportional to the amount of paint applied.

Do not use on aluminum.

For use on boats below the true waterline.

74681-6: Contains cuprous oxide

Marine Paint

Slime control

It provides extended antifouling protection against barnacles, alg ae and hydroids in salt and fresh water on boat bottoms only. It acts like a sunscreen to prevent slime and algae. Its ablative copolymer base renders a smooth- finish with du rability and abrasion resistance. It releases biocide by the constant exposure of new paint film to the water. It has universal application over all types of properly prepared bottom paints (ex cept aluminum). For use on fast fiberglass boats, as well as wood and steel hulls, extended protecti on is possible, since performance is directly proportional to the amount of paint applied.

Do not use on aluminum.

### Page 15 of 48 Science Findings

The Agency has conducted a review of the available product chemistry, environmental fate, and ecotoxicity data for Irgarol 1051. The findings are summarized below.

Product Chemistry Summary

The data submitted pertaining to the physical and chemical characteristics of the active ingredient Irgarol 1051 are ade quate. All product chemistry da ta requirements have been fulfilled for the active ingredient Irgarol 1051. Therefore, the Agency does not anticipate needing additional product chemistry data for Irgar ol 1051 at this time. Tables 2 and 3 contain the complete product chemistry information for the active ingredient Irgarol 1051.

Table 2. Chemical Identity of Irgarol 1051

Chemical Name 1,3,5-Triazine-2,4-diamine, N-cyclopropyl-N'-(1,1- dimethylethyl)-6-(methylthio)-

Common Names N-Cyclopropyl-N'-( 1,1-dimethylethyl)-6-(methylthio)- 1,3,5-triazine-2,4-diamine Synonyms 2-(tert-Butylamino)-4-(cyclopropylamino)-6- (methylthio)-1,3,5-triazine

s-Triazine, 2-(tert-butylam ino)-4-(cyclopropylamino)-6- (methylthio)- 2-(tert-Butylamino)-4-(cyclopropylamino)-6- (methylthio)-s-triazine

Cybutryne Irgarol

Trade Name Irgarol 1051 Irgarol 1071

IUPAC Name 2-methylthio-4-ter t-butylamino-6-cyclopropylamino-striazine N'-tert-butyl-N-cyclopro pyl-6-(methylthio)-1,3,5- triazine-2,4-diamine Molecular Weight 253.37 g/mole

PC Code 128996 CAS Registry Number 28159-98-0

Molecular Formula C 11 

### H 19 

### N 5 

### S
Registration Review Case No. Registration Review Case Name 5031 1,3,5-Triazine-2,4-diamine, N-cyclopropyl-N'-(1,1- dimethylethyl)-6-(methylthio)-

### Table 2. Chemical Identity of Irgarol 1051

Chemical Family Thio

Triazine

Amine Cyclo

Molecular Structure:

Table 3. Product Chemistry Data Summary of 

### Irgarol 1051 (TGAI 

### 98.1% )



### Page 16 of 48 Guideline No. Physical and Chemical Properties Value

830.1550 Product identity and composition Refer to Table 2.

830.1600 Description of materials used to produce the product CBI

830.1620 Description of production

process CBI

830.1650 Description of formulation

process CBI

830.1670 Discussion of formation of impurities CBI

830.1700 Preliminary analysis CBI

830.1750 Certified limits CBI

830.1800 Enforcement analytical

method HPLC and Gas Chromatography

830.1900 Submittal of samples NA

830.6302 Color Yellowish to white granules

830.6303 Physical St ate Solid granules

830.6304 Odor No odor. No distinguishable odor.

830.6313 Stability to sunlight, normal and elevated temperature,

metals/metal ions Stable under normal and elevated temperatures. Not sensitive to metal. Does not degrade. No decomposition expected under normal storage conditions. Stability: Stable.

### Page 17 of 48 Guideline No. Physical and Chemical Properties Value

The product is not sensitive to metal ions and metal.

830.6314 Oxidation/Reduction: Chemical Incompatibility No oxidizing or reducing agents in product. Based upon chemistry of this product, it is neither an oxidizing nor reducing agent. Incompatibility: Strong oxidizing agents, strong acids, strong

bases.

830.6315 Flammability Data not required; product is not a combustible liquid. Flash point: > 200°C (392°F)

830.6316 Explodability Data not required; product contains no explosive ingredient

830.6317 Storage Stability Unchanged

830.6319 Miscibility Data not required; product is not an emulsifiable liquid.

830.6320 Corrosion Characteristics During storage, no change in packaging material was observed.

During storage of this product in various types of material, including PVC, plastic, cardboard, aluminum, and tinplates, no change in the packaging material was observed.

830.6321 Dielectric breakdown voltage Data not required.

830.7000 pH Data not required; product not dispersible with water

830.7050 UV/visible light absorption

830.7100 Viscosity Data not required; product is not a liquid.

830.7200 Melting point 127-130°C Decomposition Temperature: > 200°C (392°F)

830.7220 Boiling point Data not required.

N.A.

830.7300 Density Sp Gr 1.10 (H20 =1)

830.7370 Dissociation Constant Data not relevant. 5.16 Mean value @pH 4-6

830.7550 Partition coefficient ( n

octanol/water) log Pow 3.95 at 25°C

830.7840 Solubility in water 7 ppm @ 20-25oC

830.xxxx Solubility in organic

solvents Organic solvent, g/100 ml Xylene, 5.0 Shell—sol A, 8.0 Solvent naphtha, 5.0 Butyl acetate, 15.0 Methyl isobutyl ketone, 12.0 Butylene glycol, 15.0 Propylene glycol, 1.0 Octanol, 5.0 Methyl cellosolve, 10.0

830.7950 Vapor pressure 6.6 x 10 -7 torr at 25°C (77oF)

Nitrosamines Less than 0.12 ppm
N/A = Not applicable; TGAI=Technical Grade Active I ngredient; CBI= Confidential Business Information

### Page 18 of 48 Environmental Fate Summary

The Agency has reviewed eleven environmental fate studies for Irgarol 1051. The submitted environmental fate studies were all found to be acceptable. The environmental fate guideline studies and the result s are summarized in Table 6. The chemical structures and identities of degradates are listed in Table 7. The Agency's conclusions for the degradation, metabolism, mobility, bioaccumulation, and sp ecial leaching studies are as follows.

a. Degradation Studies (Abiotic)

Hydrolysis: Irgarol 1051 not hydrolyze in either ster ile aqueous buffered solutions at pH 5, 7, and 9 or in sterile synthetic seawater at pH 8. Irgarol 1051 was hydrolytically stable.

Photodegradation in Water: Irgarol 1051 is stable to photode gradation in sterile, buffered pH 7 water and in sterile synthe tic seawater at pH 8. At pH 7 sterile buffered solution it has a photolytic half-life of 148 days when calculated through least square regression and 723 days if calculated by conventional method; at pH 8 steril e buffered seawater solu tion its half life is 273 days through least square regression and b ecomes 281 days when calculated by conventional methods. It is a persistent and st able molecule in aqueous medium.

b. Metabolism Studies (Biotic)

Aerobic Soil Metabolism: The aerobic soil metabolism ha1f-1ife was 101 days in sandy 1oam soi1. Three metabolism degradates were id entified in the aerobic soil metabolism study; GS 26575 (half life: 273 days), GS 28620 (half li fe: 273 days), and CA 30-0155 (half life: 122 days). The parent (Irgarol 1051) and its degradates are essen tially stable and resistant to

microbes.

Aerobic Aquatic Metabolism: Under aerobic aquatic conditions, Irgarol 1051 degraded with half-lives of >800 days in the marine loamy sand sedimen t:seawater slurry system and 192 days in the loamy sand sediment:lake water (freshwater) slurry system. These data indicate that Irgarol 1051 is stable and not readily metabolized in sedimen t/water systems incubated under aerobic conditions. Three metabolism degradates were identified in the aerobic aquatic metabolism study; GS 26575, CGA 234576, and CA 30-0156.

Anaerobic Aquatic Metabolism: Under anaero bic aquatic conditions, half-1ives were 2050 and 8503 days for flooded 1oamy sand sedime nt: freshwater and loamy sand sediment: seawater systems, respectively. These data indicate that Irgarol 1051 may be extremely persistent in marine/estuarine sediments. Irgar ol 1051 is stable and not readily metabolized in sediment/water systems incubated under anaerobi c conditions. No degradates were found in the anaerobic aquatic metabolism study.

In summary, Irgarol 1051 does not readily me tabolize in soi1:water systems. Irgarol 1051 was stable towards aerobic soil, anaerobic aquatic (freshwater and seawater), and aerobic aquatic

### (freshwater and seawater) metabolism. The result s of these studies do clearly demonstrate that Irgarol 1051 is persistent in the environment.

c. Mobility Studies

Adsorption/Desorption: Unaged lrgarol modera tely adsorbs to soil/sediment particles. The mobility of lrgarol was studied using four soils, a freshwater sediment, and a saltwater

sediment. Freundlich K ads 

### values ranged from 2.59 in a sand to 7.12 in a clay loam which indicate moderate mobility in soil systems while K des 

### ranged between 2.34 to 7.65 which shows that Irgarol gets desorbed from soil systems quite easily (Table 4). The percent lrgarol adsorbed to the test soils ranged from 21.2% for the sand to 43.3% for the clay loam. Both adsorption and desorption K values strongly point to ward the possibility that the molecule is moderately mobile in the soil system and has a potential of leach ing to ground water and runoff to surface water. Moreover, equilibrium batch studies of the Irgarol degradates, namely CA-30-0228, CA-30- 0232, and CA-30-0155 have been conducted for various soil types. These studies indicate that

K ads 

### for CA-30-0228 ranges from 1.10 to 3.38 while K des 

### varies from 1.83 to 5.32; and for the degradate CA-30-0232, K ads 

### varies from 0.716 to 3.38 while K des 

### ranges from 0.296 to 0.962.

All these values indicate that th e two degradates are highly mobile in the soil systems and may pose a problem of ground water contamination a nd surface water run off. For degradate CA-30-

0155 K ads 

### is between 1.52 to 6.17 while K des 

### are between 15.6 to 17.3, a strong indication that it is not released from the soil system easily.

Table 4. Adsorption/Desorptio n of Irgarol 1051 in Soil

d. Bioconcentration Study:

Bioaccumulation in Fish: Fish accumulation data dem onstrated that Irgarol 1051 accumulated in blue gill sunfish with maximum mean bioconcentration factors o f 62x, 290x, and 160x for edible, nonedible, and whole fish tissues , respectively. In the edible tissues, Irgarol 1051 was the major residue identified. In the viscera, the degradate CGA 234576 predominated. Depuration was rapid, with 62, 92, and 85% of the accumulated [ 14 

### C] residues eliminated from the edible, nonedible, and whole fish tissues, respectivel y, by day 14 of the depuration period (Table 5). Strong indication that most of the pesticide does not stay in the tissues.

Page 19 of 48

### Table 5. Bioconcentration and Elimination by Bluegill Sunfish ( Lepomis macrochirus )

e. Antifoulant Special Leaching Studies:

Leach rate test of 16 end-use products (boat bottom antifoulant paints ) established release rates ranging from 0.24 to 16.6 ug Irgarol 1051/cm 2 

### /day.

Table 6. Environmental Fate Data Summary for Irgarol 1051

OPP

Guideline Fate Studies Half-Life Degradates Study

Status

161-1 Hydrolysis (Buffer) pH 5 pH 7 pH 9 Stable None. Acceptable

161-1 Hydrolysis (Seawater) pH 8 Stable None. Acceptable

161-2 Photolysis (Buffer) pH 7 Stable
148 days (by least squares regression) or 723 days (by conventional methods) 

### None. Acceptable

161-2 Photolysis (Seawater) pH 8 Stable
273 days (by least sq. regression)

or 281 days (by conventional method) 

### None. Acceptable

162-1

Aerobic Soil

Metabolism Stable/Persistent Not Readily Metabolized 

### 101 days in sandy loam soil (calculated)

Half-life of Degradates: GS 26575: 273 days GS 28620: 273 days CA 30-0155:122day 

### GS 26575

GS 28620

CA 30-0155 Acceptable

Page 20 of 48

### Page 21 of 48 OPP

Guideline Fate Studies Half-Life Degradates Study

Status

162-3 Anaerobic Aquatic

Metabolism (sediment:freshwater

and sediment:seawater) Stable/Persistent Not Readily Metabolized 

### 2050 days (freshwater)

8503 days (Seawater) None Acceptable

162-4 Aerobic Aquatic

Metabolism (sediment:freshwater

and sediment:seawater) Stable/Persistent Not Readily Metabolized



### 192 days (freshwater)

>800 days (Seawater) GS 26575

CGA 234576

CA 30-0156 Acceptable

163-1

Leaching and Adsorption/Desorption Irgarol 1051 does not readily adsorb to soil particles and has moderate mobility in soils

Soil Type Kads Kdes %ads

sand 2.59 2.34 21.2

loamy

sand (freshwater sediment) 3.12 4.22 24.6

silt loam 6.29 7.95 40.5

loamy

sand (marine sediment) 6.93 7.08 42.5

sandy

loam 6.56 7.65 41.1

clay loam 7.12 6.53 43.3 

### Acceptable

163-1

Equilibrium batch studies (degradates) Degradates Kads Kdes

CA 30-0228 1.10-

3.38 1.83-

5.32

CA 30-0232 0.716-

3.38 0.296-

0.962

CA 30-0155 1.52-

6.17 15.6-

17.3 

### Acceptable

### Page 22 of 48 OPP

Guideline Fate Studies Half-Life Study Degradates Status

165-4

Bioaccumulation in Bluegill sunfish Fish

Tissues Mean

BCF Depuration (14 days)

Edible 62x 62%

Non

edible 290x 82%

Whole body

fish

tissue 160x 85%



### Irgarol 1051 does not stay

in the tissues. No

Bioaccumulation

No

bioconcentration Acceptable

ASTM

D5108–

90 Antifoulant Leach

Rate Test Release rates ranging from 0.24 to 16.6 ug Irgarol

1051/cm 2 

### /day Acceptable

Table 7. Degradates of Irgarol 1051

N'-(1,1-dimethylethyl)-6-(methylthi o)-1,3,5-triazine-2,4-diamine (M1) (parent minus cyclopropyl group) N'-(1,1-dimethylethyl)-1,3,5-triazine-2,4-diamine (parent minus methylthio and cyclopropyl groups)

N-Cyclopropyl-N'-(1,1-dimethylethyl)-1,3,5-triazine-2,4-diamine (parent minus thiomethyl group) 4-[(1,1-dimethylethyl)amino-6-(cyclopropylamino)-1,3,5- triazine-2-(1H)-one (parent minus thiomethyl group replaced with hydroxyl group)

### Table 7. Degradates of Irgarol 1051

(parent minus cyclopropyl and methylthio groups with substituted hydroxyl in place of methylthio) (parent minus cyclopropyl, dimethylethyl, and thiomethyl groups with hydroxyl group in place of methylthio)

(parent minus dimethylethyl group with oxygenated methylthio group) CA 30-0228 2-amino-4-methylthio-6-t-butylamino-s-triazine (parent minus cyclopropyl group)



### The Agency did not conduct an environmental fate assessment for Irgarol 1051. However, the Agency needs to conduct an environmental fate assessment for material preservatives used in exterior paints, coatings, and building materials that potentially pass through waste water treatment plants (WWTPs) and may be discharged into terrestrial and aquatic environments. Also, the Agency anticipates conducting an environmental fate assess ment for Irgarol 1051 used in wood preservatives (outdoor)) and antifouling coatings. For this assessment the Agency anticipates needing those data outlined on page 30 of this document.

Water Quality

Irgarol 1051 is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_na tion_cy.cause_detail_303d ?p_cause_group_id=885

. In addition, no Total Maximum Daily Loads (TMDL) have been developed for Irgarol 1051, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885 &p_pollutant_group_name=PESTICIDES . More information on impaired water bodies and TMDLs

can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and

Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process (see: http://www.epa.gov/oppfead1/cb/ppdc/2006/november06/session1-sop.pdf ), in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.



### Page 23 of 48

### Page 24 of 48 Ecological Effects Summary

The Agency has reviewed 43 ecotoxicology studies for Irgarol 1051. The 43 studies submitted on the 88.54 - 100% Irgarol 1051 and its degradates were all found to be acceptable for use in a hazard assessment. Ecotoxicity gui deline studies and the results are summarized in Table 6. The Agency's conclusions for the avia n and aquatic effects st udies are as follows.

• Irgarol 1051 is practically non-toxic to avian species in the diet and by single oral dose ingestion.

• Irgarol 1051 is highly toxic to moderately t oxic to freshwater fish on an acute basis.

• Irgarol 1051 causes chronic toxic effects on freshwater fish at low levels (9 ppb).

• Irgarol 1051 is moderately to slightly toxi c to freshwater aquatic invertebrates on an

acute basis.

• Irgarol 1051 causes chronic toxic effects on fres hwater invertebrates at levels as low as 560 ppb.

• Irgarol 1051 is moderately toxic to es tuarine/marine fish on an acute basis.

• Freshwater fish early life-stage testing show that Irgarol 1051 cause s chronic toxic effects

on marine/estuarine fish at levels as low as 330 ppb.

• Irgarol 1051 is highly to modera tely toxic to estuarine/mari ne invertebrates on an acute basis. The degradates are moderately toxic.

• Marine/estuarine invertebrate life-cycle testing results s how that Irgarol 1051 causes

chronic toxic effects on marine /estuarine invertebrates at levels as low as 250 ppb.

• Irgarol 1051 is very highly toxic to algae and aquatic plants. The major degradates are less toxic, but are still predominantly in the highly toxic range.

Whole Sediment Acute Invertebrate, Fres hwater and Marine/Estuarine (OPPTS 850.1735)

The data generated during this study estab lished that freshwater amphipod survival was not affected by exposure to lrgarol 1051 at a nom inal concentration of 120 mg a.i./kg sediment.

The Lowest-Observed-Effect Concentration (LOEC) for Irgarol 1051 was > 120 mg a.i./kg

sediment. The No-Observed-Effect Concentration (NOEC) establis hed for this study was 120mg a.i./kg sediment.

Whole Sediment Acute Invertebrate, Fres hwater and Marine/Estuarine (OPPTS 850.1740)

### Page 25 of 48 The data generated during this study estab lished that marine/estuarine amphipod survival was not affected by exposure to Irgarol 1051 at a nominal concentration of 240 mg a.i./kg

sediment. The Lowest-Observed-Effect Con centration (LOEC) for Irgarol 1051 was 240mg a.i./kg sediment. The No-Observed-Effect Concen tration (NOEC) established for this study was 120 mg a.i./kg sediment.

Bioavailability/Bioaccumulation (OPPTS 850.1730)

Bioavailability/bioaccumulation testing was required for Irgarol due to its persistence in water and sediments and potential for cumulative effects (Kow of 2399). A fish bioconcentration factor study on Irgarol was submitted; resu lts of this test are provided below:

Maximum BCF of 62X, 290X and 160X fo r edible, non-edible and whole fish tissues, respectively. Depuration for 14 days resulted in elimin ation of 62%, 92% and 85% for these same tissues, respectively.

The results show that Irgarol does not signifi cantly bioconcentrate in fish tissues. The

Guideline for fish bioaccumulation (850.1730/old 72-6/165-4) is fulfilled.

Estuarine and Marine Field Studies (OPPTS 850.1950)

A marine microcosm was submitted to the Agen cy to address the rate of degradation of Irgarol 1051 from seawater under quasi-natural conditions (light, temperature, evaporation, precipitation, measure the part itioning of Irgarol 1051 betwee n seawater and sediment and measure the change in toxicity to algae as Irgarol 1051 degrades from seawater. Irgarol 1051 dissipated from the microcosm wate r with an approximate 23-day half-life. The metabolite GC 26575 accumulated for the first 30 days of the study, and then declined at the same rate of Irgarol 1051, a 23-day half-life. Neither the parent compound nor the metabolite accumulated in the sediment. Irgarol 1051 was toxic to the marine diatom (71% growth inhibition after 21 days),

Skeletonema costatum , at the high concentrations found in the beginning of the study (nominal concentration of 560 ng a.i./L). However, as the Irgarol 1051 concentration declined over the first 57 days of the study (measured concentratio ns of 31 and 44 ng a.i./L), so did the growth inhibition of the test diatom (9.0 and 10% gr owth inhibition at 57 da ys, declining to 0% inhibition at 77 days) . The study was classifi ed as acceptable, fulfilling Guideline 850.1950/old

72-7.

Table 8. Ecotoxicity Data Summary for Irgarol 1051 (TGAI) and Irgarol 1051 Degradates

CHEMICAL GUIDE

LINE COMMON

NAME TAXONOMIC

NAME TEST

TYPE %

AI STUDY

TIME DOSE

TYPE TOXICITY TOX

LEVEL NOEL TOX

CATEGORY Avian Acute Oral Toxicity

Irgarol

1051 850.2100

71-1 Bobwhite quail Colinus virginianus O 98 14 D LD50 >2250 MGK 810 Core Practically

non-toxic

Avian Subacute Dietary Toxicity

Irgarol 580.2200 Bobwhite Colinus D 98 8 D LC50 >5620 PPM 1780 Core

### Page 26 of 48 CHEMICAL GUIDE

LINE COMMON

NAME TAXONOMIC

NAME TEST

TYPE %

AI STUDY

TIME DOSE

TYPE TOXICITY TOX

LEVEL NOEL TOX

CATEGORY

1051 71-2a quail virginianus Practically

non-toxic

Irgarol

1051 580.2200

71-2b Mallard

duck Anas platyrhynchos D 98 8 D LC50 >5620 PPM 1000 Core Practically

non-toxic

Freshwater Fish Acute Toxicity

Irgarol

1051 850.1075

72-1a Bluegill

sunfish Lepomis

macrochirus S 98.6 96 hr LC50 2.6 PPM <1.0 Core Moderately

toxic

Irgarol

1051 850.1075

72-1c Rainbow

trout Oncorhynchus mykiss S 98.6 96 hr LC50 0.84 PPM <0.26 Core Highly toxic

Irgarol

1051 850.1075

72-1c Rainbow

trout Oncorhynchus mykiss F 98.6 96 hr LC50 0.75 PPM <0.15 Core Highly toxic

Freshwater Fish Early Life-Stage (Chronic)Toxicity

Irgarol

1051 850.1400

72-4a Rainbow

trout Oncorhynchus mykiss F 98 95 D LOEC 0.009 PPM 0.004 Core

Chronic toxic

effects

Freshwater Invertebrate Acute Toxicity

Irgarol

1051 850.1010

72-2 Water flea Daphnia

magna S 98.6 24 hr EC50 66 PPM 7.8 Supplemental Moderately

toxic

Irgarol

1051 850.1010

72-2 Water flea Daphnia

magna S 98 48 hr EC50 5.3 PPM 0.3 Core Slightly toxic

Freshwater Invertebrate Life -Cycle (Chronic) Toxicity

Irgarol

1051 850.1300

72-4b Water flea Daphnia

magna F 99 21 D LOEC <0.56 PPM <0.56 Supplemental

Chronic toxic

effects

Estuarine/Marine Fish Acute Toxicity

Irgarol

1051 850.1075

72-3 Sheepshead

minnow Cyprinodon variegatus F 98 96 hr LC50 3.5 PPM 0.82 Core Moderately

toxic

Irgarol

1051 850.1075

72-3 Inland

silverside Menidia beryllina S 98 96 hr LC50 1.58 PPM 0.6 Core Moderately

toxic

Irgarol

1051
(GS26575 degradate) 850.1075

72-3 Sheepshead

minnow Cyprinodon variegatus S 100 96 hr LC50 11.0 PPM 5.2 Core Moderately

toxic

Irgarol

1051
(GS28620 degradate) 850.1075

72-3 Sheepshead

minnow Cyprinodon variegatus S 88.54 96 hr LC50 >13 PPM 13 Core Moderately

toxic

Irgarol

1051

CA30-0155 degradate) 850.1075

72-3a Sheepshead

minnow Cyprinodon variegatus S 93.4 96 hr LC50 >4.6 PPM >4.6 Core Moderately

toxic

Estuarine/Marine Fish Early Life-Stage Toxicity

### Page 27 of 48 CHEMICAL GUIDE

LINE COMMON

NAME TAXONOMIC

NAME TEST

TYPE %

AI STUDY

TIME DOSE

TYPE TOXICITY TOX

LEVEL NOEL TOX

CATEGORY Irgarol

1051 850.1400

72-4a Sheepshead

minnow Cyprinodon variegatus F 99 33 D LOEC 0.33 PPM 0.17 Supplemental

Chronic toxic

effects

Estuarine/Marine Bivalve (Oyster) Acute Toxicity (embryo larval) - Invertebrates

Irgarol

1051 850.1055

72-3b Eastern
oyster
EmbLrv Crassostrea virginica S 98.6 48 hr EC50 3.2 PPM 0.76 Core Moderately

toxic

Estuarine/Marine Mysid Acute Toxicity - Invertebrates

Irgarol

1051 850.1035

72-3 Mysid Americamysis

bahia S 98.6 96 hr LC50 0.40 PPM <0.13 Core Highly toxic

Irgarol

1051
(GS26575 degradate) 850.1035

72-3 Mysid Americamysis

bahia S 100 96 hr LC50 1.5 PPM 0.88 Core Moderately

toxic

Irgarol

1051
(GS28620 degradate) 850.1035

72-3 Mysid Americamysis

bahia S 88.54 96 hr LC50 >13 PPM 13 Core Slightly toxic

Irgarol

1051
(CA300155 degradate) 850.1035

72-3 Mysid Americamysis

bahia S 93.4 96 hr LC50 >6.0 PPM 3.9 Core Moderately

toxic

Estuarine/Marine Mysid Life-Cycle (Chronic) Toxicity - Invertebrates

Irgarol

1051 850.1350

72-4b Mysid Americamysis

bahia F 98 28 D LOEC 0.26 PPM 0.11 Core

Chronic toxic

effects

Freshwater/Marine Invertebrate Irga rol-Treated Sediment Acute Toxicity

Irgarol

1051 850.1735

73-1 Freshwater Amphipod Hyalella

azteca SR 99 10 D LOEC

LC50 >120

sedimt MGK 120 Core

Survival was

not affected

Irgarol

1051 850.1740

73-2 Marine Amphipod Ampelisca

abdita SR 99 10 D LOEC

LC50 >240

sedimt MGK 120 Core

Survival was

not affected

Aquatic Vascular Plant Toxicity

Irgarol

1051 850.4400

123-2 Duckweed Lemna gibba S 98.2 14 D EC50 1.6 PPB 0.67 Core

Algal toxicity

Irgarol

1051 850.5400

123-2 Freshwater Bluegreen algae Anabaena f

los-aquae S 98.2 5 D EC50 1.9 PPB 0.5 Core

Detrimental

effects

Irgarol

1051 850.5400

123-2 Freshwater

Green algae Selenastrum capricornutum S 98.2 5 D EC50 1.3 PPB <0.65 Core

Detrimental

effects

Irgarol

1051 850.5400

123-2 Marine

diatom Skeletonema

costatum S 98.2 5 D EC50 0.45 PPB 0.14 Core

Detrimental

effects

Irgarol 850.5400 Freshwater Scenedesmus S N.R. 72 hr EC50 2.4 PPB 0.74 Suppl

### Page 28 of 48 CHEMICAL GUIDE

LINE COMMON

NAME TAXONOMIC

NAME TEST

TYPE %

AI STUDY

TIME DOSE

TYPE TOXICITY TOX

LEVEL NOEL TOX

CATEGORY

1051 123-2 Green algae subspicatus Detrimental

effects

Irgarol

1051 850.5400

123-2 Freshwater

Green algae Selenastrum capricornutum S N.R. 72 hr EC50 1.47 PPB <1.0 Suppl

Detrimental

effects

Irgarol

1051 850.5400

123-2 Freshwater

diatom Navicula pelliculosa S 98.2 5 D EC50 0.1 PPB <0.05 Core

Detrimental

effects

Irgarol

1051 850.5400

123-2 Green algae Chlorococcum

sp. S 99.6 5 D EC50 0.42 PPB 0.10 Supplemental

Detrimental

effects

Irgarol

1051 850.5400

123-2 Goldenbrown alga Isochrysis galbana S 99.6 5 D EC 50 0.44 PPB 0.11 Supplemental

Detrimental

effects

Irgarol

1051 850.5400

123-2 Green algae Dunaliella

tertiolecta S 99.6 5 day EC50 0.56 PPB 0.13 Supplemental

Detrimental

effects

Irgarol

1051
(GS26575 degradate) 850.5400

123-2 Freshwater

diatom Navicula pelliculosa S 100 5 D EC50 0.19 PPM <0.077 Core

Detrimental

effects

Irgarol

1051 (GS28620 degradate) 850.5400

123-2 Freshwater

diatom Navicula pelliculosa S 88.54 5 D EC50 14 PPM 1.3 Core

Irgarol

1051
(CA30-

0155 degradate) 850.5400

123-2 Freshwater

diatom Navicula pelliculosa S 93.41 5 D EC50 100 PPB 10 Core

Detrimental

effects

Irgarol

1051
(GS26575 degradate) 850.5400

123-2 Marine

diatom Skeletonema

costatum S 99.94 5 D EC50 0.016 PPM 0.00018 Core

Detrimental

effects

Irgarol

1051

( GS28620 degradate) 850.5400

123-2 Marine

diatom Skeletonema

costatum S 88.54 5 D EC50 >21 PPM 1.2 Core

Irgarol

1051
(CA30-

0155 degradate) 850.5400

123-2 Marine

diatom Skeletonema

costatum S 93.41 5 D EC50 81 PPB 13 Supplemental

Detrimental

effects



### Ecotoxicity data are adequate to provide the Agency with sufficient information to determine appropriate label precautions.

### Page 29 of 48 Ecological Effects Risk Assessment

An ecological risk assessment was not conducted on the Irgarol 1051 use patterns described in this document. Irgarol 1051 uses that have potential for e nvironmental exposure are

exterior or outdoor uses of ma terial preservatives (in exterior paints, coatings, and building materials). The Agency needs to conduct environmental fate and ecological risk assessments for

exterior or outdoor uses of material preservatives that po tentially pass through waste water treatment plants (WWTPs) and ma y be discharged into terrestr ial and aquatic environments. Also, the Agency needs to conduct an ecological risk assessment for Irgarol 1051 used in wood preservatives and antifouling coatings. For th is ecological risk assessment, including an endangered species assessment for all uses, the Ag ency anticipates needing the ecotoxicity data outlined on page 30 of this document.

The Agency has not conducted a risk asse ssment that supports a complete endangered species determination. The ecological risk as sessment planned during registration review will allow the Agency to determine whether Irgarol 1051’s use has “no effect or “may affect” federally listed threatened or endangered spec ies (listed species) or their designed critical habitats. When an assessment concludes that a pe sticide’s use “may affect” a listed species or its designated critical habitat, the Agency will c onsult with the U.S. Fish and Wildlife Service

and/or National Marine Fi sheries Services (the Se rvices), as appropriate.

### Page 30 of 48 Environmental Fate and Ecotoxicity Data Gaps and Anticipated Work

Environmental fate and ecologi cal risk assessments have no t been conducted for Irgarol 1051. Irgarol 1051 is intended for use in formul ating non-aquatic, non-crop use aqueous and solvent coating systems including paints, coatings , stucco, stains, and caulks for outdoor uses to inhibit or control the growth of algae on the coating surfaces. The Agency needs to conduct environmental fate and ecological risk assessments for outdoor uses of material preservatives [(to inhibit or control the growth of algae on the coating surfaces (such as exterior paints, coatings, stains, building materials such as viny l roofing, elastomeric roof and wall coatings and mastics, caulks, sealants, joint cements, spackling, stucco, and grouting)] that potentially pass through waste water treatment plants (WWTPs) a nd may be discharged into terrestrial and aquatic environments. Therefore, the Agency anticipates needing the proposed environmental fate and ecotoxicity data for Irgarol 1051 and/or any of its major degradat ion products that are of potential concern for registered outdoor material preservative uses of Irgarol 1051. Also, the Agency needs to conduct an ecological risk assessment for Irgarol 1051 used in wood preservatives and antifouling coatings. The foll owing environmental fate and ecotoxicity data

are needed to conduct an environmenta l fate and ecological risk assessment:

• The Agency anticipates needing the followi ng data in order to conduct a complete environmental fate and ecological risk a ssessment, including an endangered species

assessment for antifoulant coatings use pattern of Irgarol 1051:

Anticipated Ecological Effects Data Needs : (GLN 850.1045) Acute Penaeid; (GLN 850.4225) Seedling emergence - dose response using rice ( Oryza sativa ); (GLN 850.4250) Vegetative vigor - dose response using rice ( Oryza sativa ); (GLN 850.1500) Fish (freshwater and/or estuarine/marine species) life cycle study; 

### (GLN 850.1710) Oyster BCF; (GLN 850.1850) Aquatic organism bioavailability/biomagnifications, toxicity tests; (GLN 850.2300) Avian reproductive studies with bobwhite quail and/or mallard duck 

### (GLN 850.4300) Terrestrial Plants Field Study; (GLN 850.4450) Aquatic Plants Field Study; and (GLN None) (Special study) Whole sedime nt - chronic invertebrates (freshwater and/or estuarine/marine)

Anticipated Environmental Fate Data Needs : (GLN 850.6800) modified activated sludge respiration inhibition; (GLN 835.1110) activated sl udge sorption isotherm; (GLN 835.3110) ready biodegradability; (GLN 835.6200) Aquatic (sedim ent) Field Dissipation; (GLN None) (Special study) Leachability of Irgarol 1051 used in coating systems for outdoor materials such as vinyl roofing, elastomeric roof and wall coatings; and mastics, caulks, sealants, joint cements, spackling, stucco, and grouting. A special leac hing study is anticipated as being

### Page 31 of 48 needed which would be conducted with various typical end-use products that have been treated with Irgarol 1051. (GLN None) (Special study) M onitoring of representative U. S. waters (residue of concern).

Anticipated Ecological Effects and Environm ental Fate Data Requirements for Outdoor Wood Preservative Uses of Irgarol 1051

Irgarol 1051 is listed as a biocide for us e in manufacturing wood preservatives. For Igrarol 1051 registered for treatment of wood pr oducts used in outdoor scenarios (e.g., decks, decking materials, aquatic uses), the Agency anti cipates requiring the following data in order to conduct the environmental fate and ecological risk assessments, including an endangered species assessment. However, note that expected da ta needs may depend on factors such as the quantities of Irgarol 1051 (and/or major degrad ates or metabolites) leaching from wood (e.g., parent compound, major degradates or metabolites) ; the outdoor use scenarios in which Irgarol 1051 treated wood may be used; and the Agency's ev aluation of the leaching data along with the available use, effects, and expos ure information for Irgarol 1051:

Ecological Effects and Environmental Fate Studies : 1



### For use in this registration review, the following ecological effects and environmental fate data are anticipated as being needed:

Anticipated Ecological Effects Data Needs : (GLN 850.4225) Seedling emergence - dose response using rice ( Oryza sativa ); (GLN 850.4250) Vegetative vigor - dose response using rice ( Oryza sativa ); (GLN 850.1045) Acute Penaeid; (GLN 850.1500) Fish (freshwate r and/or estuarin e/marine species) life cycle study; (GLN 850.1710) Oyster BCF; (GLN 850.1850) Aquatic organism bioavailabil ity/biomagnifications , toxicity tests; (GLN 850.2300) Avian reproductive studies with bobwhite qu ail and/or mallard duck; (GLN 850.3020) Honeybee acute contact LD 50 

### ; (GLN 850.3030) Toxicity of residues to hone ybees, “Honey Bee Toxicity of Residues on Foliage”; (GLN 850.4300) Terrestrial Plants Field Study; (GLN 850.4450) Aquatic Plants Field Study; and (GLN None) (Special study) Whole sediment - chronic invertebrate s (freshwater and/or estuarine/marine)

Anticipated Environmental Fate Data Needs : (GLN 835.2410) Photodegradation in soil; (GLN 835.4200) Anaerobic soil metabolism;

1 Test material for anticipated studies would depend in part on what chemicals are leaching from Irgarol 1051-

treated wood.

### Page 32 of 48 (GLN 835.6200) Aquatic (sedim ent) Field Dissipation; (GLN None) (Special study) Leachability of Wood Preservatives (AWPA E11-06); (GLN None) (Special study) Soil leac hing from wood study (AWPA E20-04); and (GLN None) (Special study) Mon itoring of representative U. S. waters (residue of concern).Page 33 of 48APPENDICESPage 34 of 48Appendix A. Environmental FateGuideline Study JustificationsGuidelineStudy TitlePractical Utility of the Data850.6800ModifiedActivated Sludge,RespirationInhibition1) What is the value of the study?The modified activated sludge, respiration inhibition test would allow EPA to identify antimicrobial pesticideswhich could harm microorganisms found in biologicalwastewater treatment systems and would also helpestablish correct concentrations for use in the ready biodegradability test.2) How would the data be used?The data would be used to determine the potential ofIrgarol 1051 to directly harm the nontarget organismsand/or to microbial treatment processes present in a WWTP and to determine suitable noninhibitoryconcentrations of Irgarol 1051 to be used in biodegradability tests.3) How could the data affect the risk assessment?If the data shows that Irgarol 1051 is toxic to nontarget organisms and/or to microbial process found in WWTPsthen, the Agency may need Tier II environmental fatedata to evaluate potential adverse effects on WWTPs.4) What is triggering the need for this data?Studies are needed to conduct environmental fate assessment and to determine thepotential exposure of Irgarol1051 to waste water treatment plants (WWTPs) (via effects on WWTP microbes).835.1110Activated SludgeSorptionIsotherm1) What is the value of the study?The results from activated sludge sorption study would allow EPA to assess the distribution of the antimicrobialamong the solid, aqueous, and vapor phases of WWTPs. Specifically, this study identifies those chemicalswhich sorb to sludge biomass.2) How would the data be used?The data would be used to determine the sorption potential of Irgarol 1051 to activated sludge biomass and inbiological wastewater treatment systems.3) How could the data affect the risk assessment?If Irgarol 1051 is not sorbed or biodegraded then, it would pass through a biological treatment systemunaffected and it may contaminate surface and drinking waters and also may have potential adverse effects toPage 35 of 48Appendix A. Environmental FateGuideline Study JustificationsGuidelineStudy TitlePractical Utility of the Datanontarget organisms.4) What is triggering the need for this data?Studies are needed to conduct environmental fate assessment and to determine the sorption potential ofactivated sludge for the removal of specific chemicalcompounds in biological wastewater treatment systems.835.3110ReadyBiodegradability1) What is the value of the study?The ready biodegradability study wouldenable the Agency to determine the likelihood that the antimicrobialpesticide of biodegrading in aquaticenvironments under aerobic conditions.2) How would the data be used?The results from the data would be used to determine the rate and extent of aerobic biodegradation of Irgarol1051 when it is released into aquatic environments and would help establish if Irgarol 1051 is stable or notstable under real environmental conditions.3) How could the data affect the risk assessment?If the result shows low biodegradability then, Irgarol1051 would occur in significant quantities in WWTPeffluents (water and biosolids) and in environmentalcompartments (e.g., surface waters) such that potentialadverse effects to nontarget organisms, found in such environmental compartments, may occur.4) What is triggering the need for this data?Data are needed to conduct environmental fate assessment and to determine the ready biodegradability ofIrgarol 1051.835.2410Photodegradationin soil1) What is the value of the study?Pesticides are applied to the surface of soil and/or onthe exposed surfaces of plants, are then subject tophotodegradation. This study will provide data on photolytic pesticide dissipation and on the nature andpersistence of photoproducts formedby soil surface catalyzed photolysis.Biocides introduced into the surfaceof soil in the environment can undergo photolytic transformation bysunlight. Results from the soil photolysis study will indicate the stability and persistence of Irgarol 1051 andpotential degradates in the soil environment when exposed to sunlight. For outdoor wood preservative uses,Irgarol 1051 can reach surface soil through direct contact or discharge to WWTPs. Irgarol 1051 may also reachPage 36 of 48Appendix A. Environmental FateGuideline Study JustificationsGuidelineStudy TitlePractical Utility of the Datasurface soil or groundwater through run-off or leachingprocesses. The Agency will evaluate the potential risksof concern.2) How would the data be used?The data would establish the significance of chemicalphotolysis as a route for degradation and identify, ifpossible, the photolytic degradation products formed that may adversely affect non-target organisms and maycontaminate water and food source ofaquatic organisms. The data would also help establish the photolytichalf-life of Irgarol 1051 and possibly degradates,and assist in developinga degradation pathway.3) How could the data affect the risk assessment?The results of photolysis data would indicate if Irgarol 1051 is persistent or if it degrades into degradationproducts that may adversely affect nontarget organismsand may contaminate their food. The Agency requiresthe photodegradation in soil study for wood preservatives.Leaching of wood preservatives (both the parent ortransformation products) from preservative-treated wood could contaminate the surrounding soils. This wouldprovide data on the dissipation, nature and persistence of wood preservative degradation products formed bysoil surface catalyzed photolysis. Using these data the Agency can assess the extent and duration of human(e.g., children playing below decks) and/or nontargetorganism exposures to soils adjacent to preservativetreated wood structures. Such soils may contain theparent compound and/or transformation products, whichcould include those formed via photodegradation processes.4) What is triggering the need for this data?Soil photodegradation data is needed to conduct the fate assessment to support indoor and outdoor woodpreservative uses for Irgarol 1051.835.4200Anaerobic soilmetabolism1) What is the value of the study?The purpose of an anaerobic soil metabolism study is todetermine the nature and extent of microbialdegradation under anaerobic conditions in soil, and characterize the formation and decline of degradates. Thisinformation is used to ascertain effects of flooding orwater logging on a well-aerated soil, a condition that canhave an effect on many oxidation-reduction systems and, in turn, may indirectly affect biocide metabolism andfate. This information will determine the persistence and concentrations of Irgarol 1051 and potentialdegradates over time in representative soils. The Agency will evaluate the potential risks of concern.Page 37 of 48Appendix A. Environmental FateGuideline Study JustificationsGuidelineStudy TitlePractical Utility of the Data2) How would the data be used?The data would establish the significance of anaerobic microbial degradation of Irgarol 1051 as a route fordegradation and identify, if possible, the degradationproducts formed that may adversely affect non-targetorganisms and may contaminate waterand food sources of aquatic organisms. The data would also helpestablish the anaerobic microbial half-life of Irgarol 1051 in soil, and possibly it’s degradates, and assist indeveloping a degradation pathway.3) How could the data affect the risk assessment?The results would indicate the nature and extent of formation and decline under anaerobic conditions of Irgarol1051 and its degradates to which rotational crops and nontarget organismswill be exposed, and to facilitateassessment of potential disposal problems. The study helps to determine the degradation rate (half-life) ofIrgarol 1051 in the presence of microorganisms in different natural soils and determines what metabolites areformed under anaerobic (oxygen-poor) conditions in the laboratory.4) What is triggering the need for this data?Anaerobic soil metabolism data is needed to conduct the fate assessment to support indoor and outdoor woodpreservative uses for Irgarol 1051.835.6200Aquatic fielddissipation study1) What is the value of the study?The purpose of an aquatic field dissipation study for biocides for aquatic uses is to determine the nature andextent of dissipation and mobility of the biocide andits residues under actual use conditions. These dissipationstudies will generate on-site data for evaluating potential hazards of a biocide under actual use conditions (e.g.,mobility, formation of metabolites, and disappearanceof parent compound) and provide information withrespect to mechanisms of dissipation in various aquatic environments. An aquatic field dissipation study is alsorequired because biocide dissipation may proceed at a different rate in the aquatic environment than inlaboratory aquatic studies. The results will indicate thepotential for Irgarol 1051 to contaminate the aquaticenvironment that may come in contact with the effluent discharge since biocide residues may be taken up byirrigated crops and passed on to other parts of the aquatic food web.The Agency will evaluate the potentialrisks of concern.2) How would the data be used?The data would establish the significance of aquatic microbial degradation along with mobility of Irgarol 1051Page 38 of 48Appendix A. Environmental FateGuideline Study JustificationsGuidelineStudy TitlePractical Utility of the Dataas a route for dissipation under actual use conditions and identify, if possible, the degradation products formedthat may adversely affect non-target organisms andmay contaminate water and food sources of aquaticorganisms. The data would also help establish the aerobic aquatic microbial half-life of Irgarol 1051 in aquaticfield systems, and possibly it’s degradates, and assist in developing a degradation pathway.3) How could the data affect the risk assessment?The results would indicate the nature and extent of leaching and persistence of Irgarol 1051 and its degradatesin an aquatic field system under actual use conditions.The results would also facilitate assessment of potentialdisposal problems. The study helps to determine the degradation rate (half-life) of Irgarol 1051 in an aquaticfield system under actual use conditions.4) What is triggering the need for this data?Aquatic field study data is needed to conduct thefate assessment to support slimicide uses in once-throughindustrial cooling towerwater systems for Irgarol 1051. Also data are needed in order to conduct an ecologicalrisk assessment for antifoulant coatings, outdoor woodpreservative, and aquatic areas use pattern of Irgarol1051.AWPAE11-06Leachability ofWoodPreservatives1) What is the value of the study?The results from the wood preservative leaching study wouldallow measurement of the leaching rate of Irgarol1051 from treated wood windows, doors, and engineeredcomponents used in construction application wheredecay resistance is necessary. The purpose is to provide information on relative permanency of woodpreservatives. The method is designed for waterborne preservatives and may not be applicable to other types ofpreservatives. For outdoor wood preservative uses, Irgarol1051 can reach surface water through direct contactor discharge to WWTPs. Irgarol 1051 can also reach surface water or groundwater through run-off or leachingprocesses. The Agency will evaluatethe potential risks of concern.2) How would the data be used?The data would be used to determine the leachability of wood preservatives expressed as a percentage of theoriginal preservative retention. The amount of preservative leached is expressed as the ratio of the preservativecontained in the leachate to the total preservative present.3) How could the data affect the risk assessment?Page 39 of 48Appendix A. Environmental FateGuideline Study JustificationsGuidelineStudy TitlePractical Utility of the DataIf Irgarol 1051 is leached from the wood in large percentage, then it may contaminate surface and drinkingwaters and also have potential adverse effects tonontarget organisms and the aquatic environment.4) What is triggering the need for this data?For wood preservatives, an aquatic leaching study is required. This study is alsoneeded to conduct theecological effects assessment, to determine the leachability of wood preservatives expressed as a percentage ofthe original preservative retention and to confirm that ion levels in the leachate would be of no toxicologicalconcern.AWPAE20-06Leachability ofWoodPreservatives inSoil Contact1) What is the value of the study?The results from the wood preservative leaching study wouldallow measurement of the leaching rate of Irgarol1051 from treated wood resulting from physical/chemical reactions during exposure to wet soil. The purpose isto provide information on the relative permanency ofwood preservatives designed for treating wood that willbe exposed to soil contact. The results are based on the moisture content of the treated wood after removalfrom the soil and the amount of biocide(s) loss fromthe treated wood for each specimen. For some outdoornon-aquatic wood preservative uses (i.e., decks and decking material), the wood will be in direct contact withthe soil. Irgarol 1051 can reach surface water through direct contact or discharge to WWTPs. Irgarol 1051 canalso reach surface water or groundwaterthrough run-off or leaching processes. The Agency will evaluate thepotential risks of concern.2) How would the data be used?The data would be used to determine the leachability of wood preservatives expressed as a percentage of theoriginal preservative retention. The amount of preservative leached is expressed as the ratio of the preservativecontained in the leachate to the total preservative present.3) How could the data affect the risk assessment?If Irgarol 1051 is leached from the wood in large percentage then, it may contaminate surface and drinkingwaters and also may have potential adverse effectsto nontarget organisms and the aquatic environment.4) What is triggering the need for this data?For wood preservatives, a soil leaching study is requiredif human or environmental exposures are likely tooccur from leachates that contain the active ingredient or principal transformation products from wood treatedPage 40 of 48Appendix A. Environmental FateGuideline Study JustificationsGuidelineStudy TitlePractical Utility of the Datawith a preservative product. Leachability of wood preservatives in soil contact data is needed to conduct thefate assessment to support indoor and outdoor wood preservative uses for Irgarol 1051. This study is alsoneeded to conduct the ecological effects assessment, to determine the leachability of wood preservativesexpressed as a percentage of the original preservative retention and to confirm that ion levels in the leachatewould be of no toxicological concern.(GLN None)Monitoring ofrepresentative U.S. waters (residueof concern)Monitoring of representative U. S. waters is requiredbecause environmental fate study results listed in Table 6indicate that the active ingredient and principal transformation products are likely to occur in nontargetfreshwater, estuarine, or marine waters such thathuman or environmental exposures are likely to occur.Page 41 of 48Appendix B: Ecological Guideline Study JustificationsGuidelineStudy TitlePractical Utility of the Data:Aquatic Organism Testing850.1035or850.1045Acute LC50with anestuarine/marineshrimp species1) What is the value of the study?Shrimp are important economic species to the United States as are lobsters, crabs, and other crustaceans.Shrimp are used as surrogate for all other crustaceans. These acute toxicity tests measure mortality ofestuarine/marine shrimp species, including mysids (OPPTS 850-1035) and penaeids (OPPTS 850-1045)across a range of concentrations to determine if survival is inhibited by short-term (96-h) exposure toIrgarol 1051 in estuarine/marine waters.2) How would the data be used?Data would be used to describe the concentration-response curves and determine 48- and 96-h LC50’s(concentrations calculated to kill 50% of the population) along with 95%confidence intervals.3) How could the data affect the risk assessment?Mysidopsis bahiais considered as a surrogate species to represent all estuarine/marine invertebrates in therisk assessment process. As part of the acute risk assessment for aquatic animals, the lowest EC50or LC50for estuarine/marine invertebrates is used in the RQmethod for expressing risk. An acute RQ > 0.5 wouldindicate an acute LOC, defined as the potential for acuterisk to non-target aquatic organisms which maywarrant regulatory action in addition to restricted useclassification. An acute RQ > 0.1 would result in anacute restricted use LOC, defined as the potential foracute risk to non-target organisms, which may bemitigated through restricted use classification. An acute RQ > 0.05 would fall under the LOC for acuteendangered species.4) What is triggering the need for this data?Data are needed in order to conduct an ecologicalrisk assessment for the use of Irgarol 1051 as anantifoulant coating, and outdoor wood preservative anddetermine the acute toxicity of Irgarol 1051 toestuarine/marine shrimp.850.1500Fish (freshwaterand/or estuarine/marine species) life1) What is the value of the study?This study allows the Agency to determine if a pesticide is toxic to fish offspring, reproductive functionsand ultimate survival. The fish life cycle toxicitystudy is required: if the estimated environmentalPage 42 of 48Appendix B: Ecological Guideline Study JustificationsGuidelineStudy TitlePractical Utility of the Data:cycle studyconcentration is equal to or greater than one-tenth of the NOAEC in the fish early life-stage or invertebratelife-cycle tests; or if studies of other organisms indicate that the reproductive physiology of fish may beaffected. Fish are exposed to the pesticide from one stage of the life cycleto at least the same stage in thenext generation (e.g., egg to egg),This duration allows examination not only of effects on survival, butalso on reproduction (spawning, egg numbers, fertility, and fecundity), locomotion, behavior, physiology,and pathology.2) How would the data be used?Data would be used to establish an LC50for mortality and EC50s for selected sublethal (e.g. reproductive)parameters, in addition to NOAECs. Sublethal parameters include embryo hatch rate, time to hatch,growth (length), exposed adult egg production,second generation hatch rate, and second generationgrowth.3) How could the data affect the risk assessment?As part of the chronic risk assessment for aquatic animals, the lowest NOAEC for estuarine/marine fish isused as inputs to the RQ equation. A chronic LOC is defined by an RQ > 1, and would indicate that thereis the potential for chronic risk that may warrantregulatory action and thatendangered species maypotentially be affected through chronic exposure.4) What is triggering the need for this data?Data are needed in order to conduct an ecologicalrisk assessment for the use of Irgarol 1051 as anantifoulant coating, and outdoor wood preservative and determine the chronic toxicity of Irgarol 1051 tofreshwater and marine fish using life-cycle studies.850.1710850.1730850.1850Aquatic organismbioconcentration/biomagnification/toxicity tests1) What is the value of the study?The value of these studies is that freshwater and/or marine aquatic species of invertebrates and vertebratescan be examined to determine if a pesticide has the potential to accumulate in body tissues directly throughbioconcentration from the water and/or indirectly through biomagnification via food transfer up the foodchain.2) How would the data be used?In the oyster (850.1710) and fish (850.1730) BCFtests, parameters include mortality, abnormalities,Page 43 of 48Appendix B: Ecological Guideline Study JustificationsGuidelineStudy TitlePractical Utility of the Data:steady-state or maximum bioconcentration factors (BCF) and uptake and depuration rate constants.Additionally, the major degradates can be identified and quantified at steady state. In the aquatic foodchain transfer study (850.1850), a hierarchy of organisms at different trophic levels is included to assessbiomagnification. Typically, the categories include insect nymphs, crustaceans, mollusks, and fish(bottom-feeding, cold-water, and warm-water or marine).3) How could the data affect the risk assessment?In the risk assessment process, direct effects LOCsfor each taxonomic group are used to make inferencesconcerning the potential for indirect effects upon listed species that rely upon non-endangered organisms.Information on the bioconcentration from water and biomagnification via the food chain would assist riskassessors in making the inferences about indirect effects.4) What is triggering the need for this data?Data are needed in order to conduct an ecologicalrisk assessment for the use of Irgarol 1051 as anantifoulant coating, and outdoor wood preservative anddetermine any potential bioconcentration from thewater or biomagnification via food transfer.Sediment TestingNoneWhole sediment -chronic invertebrates(freshwater and/orestuarine/marine)1) What is the value of the study?Some pesticides tend to build up in sediments over time. Some pesticides are released from sediments intowater and some are bound to sediments. The valuein these non-guideline chronic studies is that theyprovide longer-term toxicity data than the acutewhole sediment freshwater and estuarine/marineinvertebrate studies. These studies use natural sediment spiked with different concentrations of testchemical to determine the toxicity and bioaccumulation potential of chemicals in sediments and freshwaterand estuarine/marine invertebrates. Whole sediment toxicity tests may include the freshwater amphipod,Hyalella azteca, and the midge,Chironomus tentans, for freshwater tests and the estuarine/marineamphipods,Ampelisca abdita, Eohaustorius estuarius, Rhepoxynius abronius, and Leptocheirusplumulosusfor salt water tests.2) How would the data be used?Reported endpoints from whole sediment chronic toxicity tests may include the LC50, EC50, NOAEC, orthe LOAEC. Results from the sediment toxicity tests can be used to determine causal relationshipsPage 44 of 48Appendix B: Ecological Guideline Study JustificationsGuidelineStudy TitlePractical Utility of the Data:between the chemical and biological responses within the sediment and the organisms.3) How could the data affect the risk assessment?While other studies address the aquatic toxicity and/orbioconcentration of invertebrates in the watercolumn, this whole sediment acute toxicity test can provide valuable information on the toxicity of Irgarol1051 to freshwater invertebrates in and/or on the sediment. In addition to the interface with the overlyingwater, these invertebrates are exposed via the sedimentpore water, for which the water chemistry is oftensignificantly different. Furthermore, freshwater amphipods and midges and estuarine/marine amphipodsserve important ecological roles as food sources for vertebrates and larger invertebrates.4) What is triggering the need for this data?Sediment testing with estuarine/marine test species isrequired because the log Kow is greater than 3 andthe Koc is equal to or greater than 1,000.These values indicate thatthere is a high potential forIrgarol 1051 to preferentially partition to aquatic sediment.Data are needed in order to conduct anecological risk assessment for the use of Irgarol1051 as an antifoulant coating and outdoor woodpreservative and determine chronic toxicity and bioaccumulation potential of chemicals in sediments andfreshwater and estuarine/marine invertebrates.Avian Testing850.2300Avian reproductivestudies with bobwhitequail and/or mallardduck1) What is the value of the study?Birds eat certain insects and plants, wade in contaminated water, and ingest residue by preening. Overtime, the residues build up to toxic levels. The value of this study is that it provides data on thereproductive effects of Irgarol 1051 via dietary exposure on the bobwhite and mallard. The test consists ofthree phases. In the initial phase, hens are fed the testdiets for 6 to 8 weeks. During the second phase, thephotoperiod is manipulated to bring the hens into laying condition, and this phaseends with the onset ofegg-laying. The final phase comprises 8-10 weeks of egg-laying.2) How would the data be used?Results of this study will be used to measure anypossible reproductive risks to birds from exposure toIrgarol 1051 by examining the numbers of eggs laid, eggs cracked, viable embryos (fertility), embryosalive at 18 days, and chicks surviving to 14 days.Additionally, hatchability and eggshell thickness arereported.Page 45 of 48Appendix B: Ecological Guideline Study JustificationsGuidelineStudy TitlePractical Utility of the Data:3) How could the data affect the risk assessment?These bird species act as surrogate species for reptiles and terrestrial-phase amphibians, in addition to allother birds in the risk assessment process. There aremany avian, reptile, and amphibian species that arelisted as threatened and endangered in the United States.Amphibian declines, in particular, are a recentconcern. As part of the chronic risk assessment for terrestrial animals, the lowest NOAEC for aviantoxicity is used in the RQ equation. A chronic LOC isdefined by an RQ > 1, and would indicate that thereis the potential for chronic risk that may warrantregulatory action and thatendangered species maypotentially be affected through chronic exposure.4) What is triggering the need for this data?Data are needed in order to conduct an ecologicalrisk assessment for the use of Irgarol 1051 as anantifoulant coating and outdoor wood preservative anddetermine the effects of Irgarol 1051 on avianreproduction.Insect Pollinator Testing850.3020850.3030Honeybee acutecontact LD50Honey BeeToxicity ofResidues onFoliage (Toxicity ofresidues tohoneybees)1) What is the value of the study?Pesticide treated wood is sometimes used to makebee hives resulting in bee exposure to pesticideresidues. The honey bee acute contact toxicity test provides data on the acute toxicity (following a singleexposure via microapplicator or dusting)followed by a 48-h observation period.2) How would the data be used?Results of this study will be used to assess risks tohoneybees (nontarget insects) from exposure to Irgarol1051. Mortality, signs of intoxication, and other abnormal behavior (e.g., ataxia, lethargy,hypersensitivity) are reported. The LD50with 95% confidence interval is calculated from the doseresponse curve data.3) How could the data affect the risk assessment?Data are needed for future regulatory decisions andfor an endangered species assessment in particular.There are many terrestrial invertebrates that are listed as threatened and endangered. The data would allowthe Agency better characterize the potential risk to insects (including beneficial pollinators) from the useof Irgarol 1051.Page 46 of 48Appendix B: Ecological Guideline Study JustificationsGuidelineStudy TitlePractical Utility of the Data:4) What is triggering the need for this data?This study has been added to the battery of studies that EPA requires to support outdoor uses whenhoneybees are likely to be exposed to pesticides. Theproposed use of Irgarol 1051 for potential outdooruse as a wood preservative would likely allow bees to be exposed to the pesticide.Plant Testing850.4225Seedling emergence,Tier II - doseresponse using rice(Oryza sativa)1) What is the value of the study?Plants prevent erosion and provide animals with food andshelter. The rooted aquatic plant, rice is used torepresent exposure to all vascular rooted plants. Tier II (Definitive Studies) tests are initiated following adetermination that a greater than 25% adverse effect occurred in the Tier I (Initial Screening Study)seedling emergence study for one or more plant species. These Tier II terrestrial nontarget plantphytotoxicity tests evaluate the acute toxicity ofpesticides to 10 crop plant species, including six Dicotsand four Monocots. Although rice (Oryza sativa) is not one of the surrogate terrestrial crop plantstypically tested, its semiaquatic environment is applicable to run-off scenarios. If conducting tests underTSCA, the test material is applied daily with each watering for the duration of the study. Observations arecarried out for at least 14 days after seedling emergence.2) How would the data be used?Along with vegetative vigor studies, results of these studies will be used to assess risks to of Irgarol 1051exposure to terrestrial, semiaquatic, and aquatic nontarget plants. Parameters of plant growth includepercent emergence, number of emerged plants, seedling height, seedling dry weight,root length, root dryweight, and signs of phytotoxicity. Results are reported as EC05(NOAEC), EC25, and EC50.3) How could the data affect the risk assessment?Because Irgarol 1051 would not be directly applied tothe field, information on environmental fate andtransport would affect the risk identification and characterization to non-target plants.Nontarget plants include plants outside the area ofintended application (which would typically includefood and cover vegetation for animals, food, fiber, fuel, and ornamental plants for humans, andendangered and threatened plants). Terrestrial plantsserve as food and shelter for fish and wildlife, helpcontrol erosion, and serve as air pollution filters. Shoreline vegetation buffers reduce siltation and providean environment in which aquatic invertebrates can contribute to the food supply of fish, reptiles, andamphibians. Vegetation adjacent to streams servesto regulate water temperature, which in turnPage 47 of 48Appendix B: Ecological Guideline Study JustificationsGuidelineStudy TitlePractical Utility of the Data:contributes to improved aquatic life. Decaying vegetation provides nutrients essential for the aquatic foodchain. Hedgerows, woodlots, and other similar nontarget areas provide food and cover to mammalian andavian species.There are many terrestrial plants that may be affected where Irgarol 1051 is used as an antifoulant coatingand outdoor wood preservative. If EPA is unable to evaluate the potential risks to terrestrial plantsassociated with the new use of Irgarol 1051, these risksmust be presumed. As part of the risk assessmentfor terrestrial plants (non-endangered and endangered), the lowest EC25for monocots and dicots is used inthe RQ equation. The LOC for endangered and non-endangered plants is defined as a RQ > 1.4) What is triggering the need for this data?Data are needed in order to conduct an ecologicalrisk assessment for the use of Irgarol 1051 as anantifoulant coating and outdoor wood preservative anddetermine the effects of Irgarol 1051 on seedlingemergence.850.4250Vegetative vigor,Tier II - doseresponse using rice(Oryza sativa)1) What is the value of the study?Plants prevent erosion and provide animals with food andshelter. The rooted aquatic plant, rice is used torepresent exposure to all vascular rooted plants. TierII (Definitive Studies) tests are initiated following adetermination that a greater than 25% adverse effect occurred in the Tier I (Initial Screening Study)vegetative vigor study for one or more plant species.These Tier II terrestrial nontarget plant phytotoxicitytests evaluate the acute toxicity of pesticides to10 crop plant species, including six Dicots and fourMonocots. Although rice (Oryza sativa) is not one of the surrogate terrestrial crop plants typically tested,its semiaquatic environment is applicable to both leaching and run-offscenarios. The test material isapplied 2 to 4 weeks after the plants have emergedfrom the soil, and observations are carried out for atleast 14 days.2) How would the data be used?Along with the seedling emergence studies, results of these studies will be used to assess risks to terrestrialand aquatic plants from exposure to Irgarol 1051. Parameters of plant growth include plant height, plantdry weight, root length, root dry weight, and signs of phytotoxicity. Results are reported as EC05(NOAEC), EC25, and EC50.Page 48 of 48Appendix B: Ecological Guideline Study JustificationsGuidelineStudy TitlePractical Utility of the Data:3) How could the data affect the risk assessment?Because Irgarol 1051 would not be directly applied tothe field, information on environmental fate andtransport would affect the risk identification and characterization to non-target plants. There are manyterrestrial plants that are listed as threatened andendangered in the United States where Irgarol 1051 isused as an antifoulant coating and outdoor wood preservative. If EPA is unable to evaluate the potentialrisks associated with the antifoulant coating and outdoor wood preservative uses of Irgarol 1051, theserisks must be presumed. As part of the risk assessment for terrestrial plants (non-endangered andendangered), the lowest EC25for monocots and dicots is used in the RQ equation. The LOC forendangered and non-endangered plants is defined as a RQ > 1.4) What is triggering the need for this data?Data are needed in order to conduct an ecologicalrisk assessment for the use of Irgarol 1051 as anantifoulant coating and outdoor wood preservative and determine the effects of Irgarol 1051 on vegetativevigor.