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irgarol (Irgarol) NYSDEC Registration of Marine Use 7/00

New York State Department of Environmental Conservation
Division of Solid and Hazardous Materials
Bureau of Pesticides Management, Room 498
Pesticide Product Registration Section
50 Wolf Road, Albany, New York 12233-7257
Phone: (518) 457-7446     FAX: (518) 485-8990
Website: www.dec.state.ny.us/website/dshm/pesticid/pesticid.htm


June 8, 2000

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Ms. Cheryl Romanik
Product Registration Specialist
Kop-Coat, Inc.
1850 Koppers Building
Philadelphia, PA 15219-1818

Dear Ms. Romanik:

Re: Registration of Marine Use for Irgarol Contained in the Pesticide Product - Pettit Marine Paint Trinidad SR Antifouling Bottom Paint, 1277 Blue, 1677 Red & 1877 Black (EPA Reg. No. 60061-95)

    The New York State Department of Environmental Conservation (NYSDEC) has completed its review of your application (received March 11, 1999) for the registration of the above referenced pesticide product. Pettit Marine Trinidad SR Antifouling Bottom Paint contains 70% cuprous oxide and 2% irgarol [N-cyclopropyl-N'-(1,1-dimethyl)-6-(methylthio)-1,3,5-triazine-2,4-diamine] and is labeled for use in marine paints. The active ingredient cuprous oxide is currently registered for marine use in New York State. The active ingredient irgarol is currently registered for use in the manufacture of aqueous and solvent coating compositions for paints, coatings, stucco, stains, and caulks for outdoor uses to inhibit or control the growth of algae on coating surfaces. Irgarol is also registered for use only in formulating antifouling paints for boats and vessels. However, as a condition of federal registration, end-use product formulators are required to generate additional product specific ecological effects and environmental fate data to support registration of products containing irgarol. Therefore, this first marine use was considered a major change in label for irgarol requiring additional review.

    On April 16, 1999, the Pesticide Product Registration Section requested that Kop-Coat, Inc. submit the necessary documentation to support their application for registration of this product in New York State. On May 28, 1999, supporting documentation was received from Kop-Coat, Inc. However, on July 16, 1999 the application was determined incomplete. Kop-Coat, Inc. submitted additional data on August 30, 1999 but the application remained incomplete. On October 12, 1999, Kop-Coat requested a 60-day extension until, December 11, 1999, to allow the company time to obtain the U.S. Environmental Protection Agency (USEPA) Data Evaluation Record (DER) reports regarding irgarol from the federal agency. On November 5, 1999 additional data was received from Kop-Coat, Inc., however, the application remained incomplete until January 6, 2000 when the final four required studies were provided to the Department. The application was determined complete on January 11, 2000, with the registration decision date set at June 9, 2000.

    Irgarol was originally registered for use in New York State in 1996 as an algicide for use only in formulating antifouling paints for boats and vessels. Due to its intended use limited toxicity testing was required for the initial registration. In our previous review for irgarol, the Department found that on an acute basis, irgarol is not very toxic to laboratory animals by the oral, dermal, or inhalation routes of exposure, is mildly irritating to rabbit eyes and is a moderate dermal sensitizer in guinea pigs. Irgarol was not very toxic in a 90-day rat feeding study, did not cause teratogenic effects in a rat developmental toxicity study nor caused local or systemic effects in a 21-day rat dermal study. It was negative in a battery of genotoxicity tests.

    For the formulated Pettit product, Kop-Coat, Inc. submitted data on acute toxicity studies that were conducted on a similar product, Hempel's Antifouling Combic Tin-free 7190 Paint, which the USEPA accepted as a surrogate for fulfillment of federal registration requirements. On an acute basis the Hempel's product was not very toxic to laboratory animals by the oral, dermal and inhalation exposure routes. This product was moderately irritating to rabbit eyes, but was not irritating to rabbit skin and did not cause dermal sensitization to guinea pig skin.

    There are no chemical specific federal or State drinking water/groundwater standards for irgarol and cuprous oxide. Based on its chemical structure, irgarol falls under the 50 micrograms per liter New York State drinking water standard for "unspecified organic contaminants" (10 NYCRR Part 5 - Public Water Systems). Because cuprous oxide is not an organic compound, the general New York State drinking water standards for principal and unspecified organic compounds do not apply to this chemical. The federal and State action level for inorganic copper in first-draw tap water is 1.3 milligrams per liter.

    The available toxicity data for irgarol indicate that it is not very toxic following acute or subchronic exposures. Nevertheless, to limit worker exposure, the Pettit product's label requires users to "wear protective coating [sic] such as gloves, long-sleeved cotton shirt, long pants and hat" when handling this product. [The term "protective coating" is a typographical error and should read "clothing."] The label also warns against breathing vapors from the use of the Pettit product, which contains volatile petroleum distillates. The label further states that "when this product is used in confined areas or while spraying paint or sanding or sandblasting boat surfaces, wear a mask or respirator jointly approved by the Mining Safety Health Administration and the National Institute for Occupational Safety and Health." Given the above, the Pettit product does not pose an undue risk to human health. However, to avoid misunderstanding by the user, the labeling term "protective coating" which describes clothing that workers are required to wear when handling the Pettit product, should be replaced with the term "protective clothing."

    Irgarol has a water solubility of 7 mg/l. Because it has a low vapor pressure (6.6 x 10-7 mm Hg at 25%C) volatilization will not contribute significantly to its dissipation. As irgarol has a octanol/water partitioning coefficient (Kow) of 8912, bio-accumulation may occur. A whole-body bio-accumulation factor (BCF) of 160x was determined for irgarol using bluegill sunfish, however, depuration was rapid following exposure cessation.

    The parent irgarol is practically non-toxic to birds or mammals. On an acute basis it is moderately to highly toxic to freshwater fish, and moderately toxic to freshwater invertebrates. It is moderately toxic to marine fish and is moderately to highly toxic to marine invertebrates.

    Irgarol water concentrations resulting from varying levels of use were calculated for a typical recreational marina and compared to toxicity thresholds. Roughly 125 boats can be moored per acre. An average length of 20 feet, and a painted surface area of 136 square feet was assumed. The average release rate for the three paints is 4.04 &g per square centimeter per day. Assuming an average water depth of ten feet, using the 23-day half-life from the microcosm study, and assuming half of the boats in the water were painted with the irgarol product, the irgarol water concentration would be approximately 4.9 &g per liter. While this concentration exceeds algal toxicity thresholds, the fifty percent use rate is not likely to occur. No other organism toxicity thresholds are exceeded.

    Irgarol is stable. There was no hydrolysis in either fresh or salt water. There were no degradates in the hydrolysis studies while there were three degradates in the aqueous study. Only one degradate (GS 26575 at 16.8%) was greater than ten percent of the parent compound and this compound further degraded to less than ten percent.

    While the potential does exist for algal toxicity to occur within marinas through use of this product, given its potential market share and use rate this is unlikely.

    Therefore the Department accepts for registration Pettit Marine Paint Trinidad SR Antifouling Bottom Paint (EPA Reg. No. 60061-95) for use as labeled in New York State. However, as a condition of this registration Kop-Coat, Inc. must correct "protective coating" to read "protective clothing" at the next printing or prior to reregistration, whichever occurs first.

    Enclosed for your records are the Certificate of Registration and a stamped accepted label for the above pesticide product.

    If you have any questions on this matter, please contact Francis Hegener, Acting Chief of our Pesticide Product Registration Section, at (518) 457-7446.

Sincerely,

Maureen P. Serafini
Director
Bureau of Pesticides Management

Enclosures

cc: w/enc. - G. Good/W. Smith, Cornell University
R./ Zimmerman/R. Mungari, NYS Dept. of Ag. & Mkts.
N. Kim/D. Luttinger, NYS Dept. of Health

BS:scy
(betty\kopcoatreg.ms)