Didecyl Dimethyl Ammonium Carbonate and Didecyl Dimethyl

Ammonium Bicarbonate
NYS DEC Letter - Pesticide Registration 3/04
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/pesticid/pesticid.htm
E-Mail: ppr@gw.dec.state.ny.us

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Robert J. Sloan

Sr. Regulatory Services Associate
Lonza, Inc.
17-17 Route 208
Fair Lawn, New Jersey 07410

Dear Mr. Sloan:

Re: Registration of the New Active Ingredients Didecyl Dimethyl Ammonium Carbonate and
Didecyl Dimethyl Ammonium Bicarbonate, Contained in the Pesticide Product Carboquat 150 T
(EPA Reg. No. 6836-236)

The New York State Department of Environmental Conservation (Department) has reviewed the
application, received July 2, 2003 from Lonza, Inc., to register the above-mentioned product in New
York State. The product contains the new active ingredients didecyl dimethyl ammonium carbonate
and didecyl dimethyl ammonium bicarbonate. The application was deemed complete for purposes of
review on October 29, 2003 and a registration decision is due by March 26, 2004.

The Department has reviewed the information submitted to date in support of the application for
registration of Carboquat 150 T (EPA Reg. No. 6836-236).

Carboquat 150 T contains the new active ingredients didecyl dimethyl ammonium carbonate and
didecyl dimethyl ammonium bicarbonate and is labeled for the formulation or repackaging of wood
preservatives. Carboquat 150 T itself is not labeled as an end product for use as a wood preservative.

According to the review, on an acute basis, the Carboquat 150 T product was moderately toxic by
the oral route of exposure. It also was a severe skin irritant, but did not cause skin sensitization. Due to
the severe skin reactions caused by Carboquat 150 T in the primary skin irritation test, the United
States Environmental Protection Agency (USEPA) waived the requirements for acute dermal and
inhalation toxicity studies as well as a primary eye irritation study on this product.
 The USEPA permitted the registrant to use the toxicity data base for the active ingredient didecyl
dimethyl ammonium chloride (DDAC) to support the registration of the active ingredients in Carboquat
150 T, given their chemical similarity. The only diffe rence between these active ingredients is that the
anion attached to the quaternary ammonium cation is carbonate/bicarbonate in the case of Carboquat
150 T, whereas chloride is the anion in DDAC.

As previously reviewed, it was indicated that DDAC produced some toxicity in chronic animal
studies, but did not cause reproductive, oncogenic or genotoxic effects, and produced developmental
effects only at doses that also caused maternal effects. DDAC, however, is moderately toxic by the
acute oral and inhalation routes of exposure. It also is a severe skin and eye irritant and caused dermal
irritation in subchronic laboratory animal studies. The registrant submitted several studies relevant to
the end use of products formulated with Carboquat 150 T, including an occupational risk assessment
for dermal and inhalation exposures and data on the leachability of the active ingredients from treated
lumber. These data, however, are not directly relevant to the Carboquat product given that it is for
manufacturing use only.

There are no chemical specific federal or State drinking water/groundwater standards for didecyl
dimethyl ammonium carbonate and didecyl dimethyl ammonium bicarbonate. Based on their chemical
structures, these compounds fall under the 50 microgram per liter (_g/L) general New York State
drinking water standard for "unspecified organic contaminants" (10 NYCRR Part 5, Public Water
Systems). The New York State drinking water standard for the sum of "unspecified organic
contaminants" and "principal organic contaminants" is 100 _g/L.

The available information indicates that the formulated product, Carboquat 150 T, is moderately
acutely toxic by the oral route of exposure and is also a severe skin irritant. Based on the toxicological
properties of the very chemically similar compound DDAC, the two active ingredients in Carboquat
150 T, didecyl dimethyl ammonium carbonate and didecyl dimethyl ammonium bicarbonate, would be
expected to have moderate toxicity via oral and inhalation exposures and to cause severe skin and eye
irritation. They also would be expected to have limited chronic and developmental toxicity, and not
cause reproductive, oncogenic or genotoxic effects. To minimize inhalation exposure to these
chemicals from Carboquat 150 T use, the product's label requires workers to wear a respirator with an
organic vapor-removing cartridge with a prefilter approved for pesticides, or a NIOSH-approved
respirator with an organic vapor cartridge or canister with any R, P or HE prefilter. While the label also
warns that the product is corrosive and causes irreversible eye damage and skin burns, no personal
protective equipment (PPE) for eyes and skin (such as goggles or a face shield, chemical-resistant
gloves and long-sleeved shirt and pants) is required. Given the severe eye and skin damaging potential
of this product, these basic PPE requirements seem warranted. Consequently, this additional PPE
should be made a label requirement for this product before Carboquat 150 T is granted registration in
New York State. Subsequent to that, if any end-use products formulated with Carboquat 150 T and
labeled for wood preservation are submitted for registration in the State, that such products should be
considered to represent a major change in labeled use. At that time, the Department would evaluate the
information on occupational risks and leachability submitted by the registrant in the Carboquat 150 T
package.

The Department submitted a request for label clarification to the State Label Issue Tracking System
(SLITS) at the USEPA. A response was received from Dennis Edwards, who stated that eye and skin
PPE are required for this product and apparently were left off the label. He also stated that, since the
PPE language is on the May 14, 2003 USEPA Stamped "Accepted" label, he would inform Lonza, Inc.,
that the company could add the PPE by notification.
 Since Carboquat 150 T is labeled as a manufacturing use product intended for repackaging or
formulation of wood preservative products only, no uses that result in environmental exposures other
than manufacturing discharges have been defined. Numerous toxicity and environmental fate studies
are required as conditions of federal registration including a special study "Water 22C50" (Carboquat
150T). A full data package including reviewed, validated results, such as USEPA DERs, from treated
wood leach rate studies, the above dock monitoring study, and the other outstanding work listed in the
USEPA Notice of (conditional) Registration will be required when end-use products containing
Carboquat 150 T is submitted for New York registration.

The analytical methods were reviewed and found to be acceptable as they had adequate sensitivity
and specificity to allow determination of the Carboquat/Barquat actives in the environment.

Our environmental fate review staff stated that, since this product does not have outdoor uses, there
is no impact to groundwater to assess. Therefore, staff has no objection from a groundwater perspective
to the registration of this product as labeled.

Carboquat 150 T should not have an adverse effect on the health of workers or the general public,
the fish and wildlife resources, or the ground and surface water of New York State when used as
labeled.

If any end-use products formulated with Carboquat 150 T and labeled for wood preservation are
submitted for registration in the State, these products will be considered to represent a major change in
labeled use and additional information will need to be submitted.

Therefore, the Department hereby accepts for formulation or repackaging use only, the registration,
in New York State, of Carboquat 150 T (EPA Reg. No. 6836-236) which contains the new active
ingredient didecyl dimethyl ammonium carbonate and didecyl dimethyl ammonium bicarbonate.

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

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

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 University, PMEP