PMEP Home Page --> Pesticide Active Ingredient Information --> Insecticides and Miticides --> mevinphos (Phosdrin) to propargite (Omite) --> p-menthane-3,8-diol (Off) --> p-menthane-3,8-diol (Off) NYS DEC Letter - New Active Ingredient Registration 09/01

p-menthane-3,8-diol (Off)
NYS DEC Letter - New Active Ingredient Registration 09/01

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
Bureau of Pesticides Management
Pesticide Product Registration Section
625 Broadway, Albany, New York 12233-7257
Phone 518-402-8768     FAX 518-402-9024
Website: http://www.dec.state.ny.us/website/dshm
E-Mail: ppr@gw.dec.state.ny.us

September 14, 2001

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. E. David Lewis
Agent for S. C. Johnson & Son, Inc.
c/o Lewis & Harrison, L.L.C.
122 C Street, N.W., Suite 740
Washington, DC 20001

Dear Mr. Lewis:

Re: Registration of Off! Botanicals Insect Repellent (EPA Reg. No. 4822-515) Containing the New Active Ingredient p-menthane-3,8-diol

    The New York State Department of Environmental Conservation (the Department) has completed review of the application (received 06/07/00) and supplemental information supplied to date regarding registration of the referenced pesticide product in New York State. Off! Botanicals Insect Repellent (EPA Reg. No. 4822-515) contains the new active ingredient p-menthane-3,8-diol.

    Off! Botanicals Insect Repellent (10.0% p-menthane-3,8-diol) is an end-use insect repellent product labeled for application to exposed skin to repel mosquitoes, black flies, gnats and no-see-ums. This product is an alternate brand name (same formulation) for the basic federal registration, Off! Botanicals 2.

    The subject application and data package were deemed complete for purposes of technical review on October 19, 2000 following one determination of incompleteness (07/25/00). Pursuant to the review time frame specified in ECL 33-0704.2, a registration decision date of February 25, 2001 was established. By mutual agreement, the registration decision date was subsequently waived to allow S. C. Johnson & Son, Inc. to respond to issues raised by the New York State Department of Health (NYSDOH). A meeting between the registrant and State registration officials was held on May 3, 2001 to discuss these issues.

    The registration package for the active ingredient p-menthane-3,8-diol and the Off! Botanicals formulated product was reviewed by this Department and the NYSDOH.

    Since the United States Environmental Protection Agency (USEPA) classified p-menthane-3,8-diol as a biochemical pesticide, only limited toxicity testing was required for federal registration. Neither the active ingredient nor the formulated product was very toxic from a lethality standpoint in acute oral or dermal exposure studies in laboratory animals. However, the active ingredient caused numerous skin reactions and the formulated product caused dermal irritation in rabbits during the acute dermal studies. In primary dermal irritation studies, the active ingredient caused some erythema and the formulated product caused erythema and desquamation in rabbit skin. The active ingredient did not cause skin sensitization in guinea pigs. While the active ingredient was corrosive, the Off! Botanicals product was a mild to moderate irritant to rabbit eyes. The above studies (with the exception of the sensitization study) involve single applications. Given the label directions and the general use pattern of insect repellents, repeat applications to skin are likely and could result in more skin reactions than were identified in the acute exposure studies.

    The USEPA also required a 90-day dermal toxicity study, a dermal immunotoxicity study, a dermal developmental toxicity study, and a battery of genotoxicity studies. The genotoxicity studies with the active ingredient p-menthane-3,8-diol gave negative results and the compound was not immunotoxic in the limited study. Also, the dermal developmental toxicity study in rats showed no treatment-related effects at doses up to 3,000 milligrams per kilogram body weight per day (mg/kg/day) for gestational days 6 through 19, which was the highest dose tested. On the other hand, the active ingredient caused erythema, edema, scarring and inflammation of the skin, organ weight changes and kidney effects in a 90-day dermal toxicity study in rats at a dose of 3,000 mg/kg/day. The no-observed-effect level (NOEL) for these effects was 1,000 mg/kg/day. The USEPA apparently has not developed a reference dose (RfD) for p-menthane-3,8-diol. No toxicokinetic, reproductive, subchronic feeding or chronic feeding/oncogenicity studies were required. Also, only the one developmental toxicity study in rats was conducted.

    Given the limited database for the active ingredient and the use pattern of the formulated product, i.e., direct application to human skin, there were several issues that needed to be addressed. The primary concerns were possible skin irritation following repeated use and the potential effects from exposure in very young children.

    In recognition of the data gap for studies that address the potential for risks to very young children from exposure to p-menthane-3,8-diol, S. C. Johnson & Son, Inc. proposed to mitigate potential concerns by changes/additions to the label text. The proposal included addition of the statement "Do not use on children under the age of three" under the Precautionary Statements section of the labeling and removing from the label the statement "With this plant-based repellent, you can feel good about putting it on the whole family." An application for amendment to revise the Off! Botanicals 2 federal label was filed on July 11, 2001. The USEPA approved the label amendment on August 7, 2001.

    The Department hereby accepts Off! Botanicals Insect Repellent (EPA Reg. No. 4822-515) for registration in New York State. Enclosed for your files are the Certificate of Pesticide Registration and New York State stamped "ACCEPTED" labeling.

    Lewis & Harrison, L.L.C./S. C. Johnson & Son, Inc. have expressed an interest in working with the Department and the NYSDOH regarding this registration action and future registration issues. To that end, we welcome any new information that becomes available on the subject product and p-menthane-3,8-diol (e.g., results of the proposed dermal absorption study using p-menthane-3,8-diol). In addition, S. C. Johnson & Son, Inc. indicated that similar products are used in other countries. We request any information on their use history and adverse reactions in these countries as well as the United States following its distribution and use.

    Please note that a proposal by S. C. Johnson & Son, Inc. or any other registrant to register a product containing p-menthane-3,8-diol, whose labeled uses are likely to increase the potential for significant exposure to humans or impact to the environment (e.g., a product with a greater active ingredient concentration or a product formulated for spray application), would constitute a major change in labeled (MCL) use pattern. Such a proposal must be accompanied by a new application fee and meet the requirements listed in Appendix 1.B. of "New York State Pesticide Product Registration Procedures" (August 1996).

    Please contact me at (518) 402-8788, if you have any questions.

Sincerely,

Maureen P. Serafini
Director
Bureau of Pesticides Management

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 PMEP