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chlorhexidine diacetate NYS DEC Letter - Major Change in Labeling 10/02

New York State Department of Environmental Conservation
Division of Solid and Hazardous Materials
Bureau of Pesticides Management, 9th Floor
625 Broadway, Albany, New York 12233-7254
Phone: (518) 402-8788     FAX: (518) 402-9024
Website: www.dec.state.ny.us

October 23, 2002

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Ms. Janice L. Dhonau
Regulatory Affairs
The Procter & Gamble Company
11530 Reed Hartman Highway
Cincinnati, Ohio 45241

Dear Ms. Dhonau:

Re: Registration of the Pesticide Product SwifferWetJet Antibacterial Cleaner (EPA Reg. No. 3573-74), Which Represents a Major Change in Labeling for the Active Ingredient Chlorhexidine Diacetate

    The New York State Department of Environmental Conservation (Department) has reviewed the application, received December 28, 2001, to register the above-referenced product in New York State. The application was submitted by The Procter & Gamble Company. The Swiffer WetJet Antibacterial Cleaner product represents a major change in labeling for the active ingredient Chlorhexidine Diacetate (chemical code 045502). This product also contains 0.03% didecyl dimethyl ammonium chloride.

    Chlorhexidine diacetate is currently registered for use in New York State to disinfect hard, inanimate non-porous surfaces in animal premises.

    Swiffer WetJet Antibacterial Cleaner (EPA Reg. No. 3573-74) is a liquid that is applied to the floor by using the WetJet appliance, which resembles a sponge mop. This process involves the insertion of the unopened Swiffer bottle into a receptacle in the handle of the appliance. A portion of the bottle's contents then travels to head of the appliance, and a button on the handle can be pressed to release a coarse, low-pressure spray of the Swiffer product directly to the floor. The sprayed material is then wiped on the floor with the appliance head and allowed to remain wet for five minutes before mopping.

    The United States Environmental Protection Agency (USEPA) stamped "ACCEPTED" label for this product dated November 21, 2001 contains directions for indoor residential uses on hard, non-porous floors.

    The Department has reviewed the information supplied to date in support of Swiffer WetJet Antibacterial Cleaner (EPA Reg. No. 3573-74), which represents a major change in labeling for the active ingredient chlorhexidine diacetate.

HEALTH EFFECTS:
    The New York State Department of Health stated that the Swiffer product was not very acutely toxic to laboratory animals by the oral, dermal or inhalation routes of exposure. In addition, it was neither irritating to the skin (tested on rabbits) nor was it a skin sensitizer (tested on guinea pigs). The Swiffer product, however, was moderately irritating to the eyes (tested on rabbits). Similarly, the active ingredient chlorhexidine diacetate was not very acutely toxic by the oral or dermal routes of exposure and it was neither a skin irritant nor sensitizer. The active ingredient, however, was moderately toxic via acute inhalation exposure and it was a severe eye irritant.

    Limited data were required for the federal registration of chlorhexidine diacetate. In a subchronic (13-week) dermal toxicity study conducted on rabbits, chlorhexidine diacetate caused decreased liver enzyme activity with microscopic degenerative changes in the livers of females at a dose of 500 milligrams per kilogram body weight per day (mg/kg/day); the no-observed-effect level (NOEL) was 250 mg/kg/day. In a rat developmental toxicity study, no developmental effects were noted at doses up to 63 mg/kg/day. Maternal effects (reduced body weight gain, rales and increased salivation) were reported at doses of 31 mg/kg/day; the NOEL was 16 mg/kg/day. The USEPA did not require any chronic toxicity/oncogenicity or reproductive toxicity studies on this chemical. The battery of genotoxicity studies that were required gave negative results.

    There are no chemical-specific federal or State drinking water/groundwater standards for chlorhexidine diacetate. Based on its chemical structure, chlorhexidine diacetate falls under the 50 microgram per liter general New York State drinking water standard for an "unspecified organic contaminant" (10 NYCRR Part 5, Public Water Systems).

    The Swiffer WetJet Antibacterial Cleaner product is not very toxic following acute or repeat dosing in laboratory animals. Swiffer is also not very irritating to skin nor a sensitizer. The product is moderately irritating to eyes, but the use pattern should minimize the potential for eye contact, as well as other means of significant contact.

    The Department concludes that Swiffer WetJet Antibacterial Cleaner should not have an adverse effect on the health of workers or the general public when used as labeled.

    Therefore, the Department hereby accepts for general use registration in New York State Swiffer WetJet Antibacterial Cleaner (EPA Reg. No. 3573-74) which represents a major change in labeling for the active ingredient Chlorhexidine Diacetate.

    Enclosed is your Certificate of Registration and New York State stamped "ACCEPTED" label.

    If you have any questions, please contact Mr. Samuel Jackling, Chief of our Pesticide Product Registration Section, at (518) 402-8768.

Sincerely,

Maureen P. Serafini
Director, Bureau of Pesticides Management
Division of Solid & Hazardous Materials

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