Docket Number: EPA–HQ–OPP–2010–0004 

www.regulations.gov 

 

 

United States Prevention, Pesticides March 2010 

Environmental Protection and Toxic Substances 

Agency (7510P)

1-(3-chloroally)-3,5,7-triaza-1-azoniaadamantane (CTAC) 

Summary Document: Registration Review 

Docket Number: EPA–HQ–OPP–2010–0004 

www.regulations.gov 

TABLE OF CONTENTS

CTAC Registration Review Team Members.............................................. 1 

I. Preliminary Work Plan..................................................................... 2 

II. Fact Sheet.................................................................................... 13 

III. Glossary of Terms and Abbreviations................................................ 17 

IV. Appendix A................................................................................. 19 
Docket Number: EPA–HQ–OPP–2010–0004 

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1-(3-chloroally)-3,5,7-triaza-1-azoniaadamantane (CTAC) Registration Review 

Team

Human Health & Environmental Effects 

Timothy Dole 

Srinivas Gowda 

Risk Management

K. Avivah Jakob 

Lance Wormell 

Office of General Counsel

Philip Ross 

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I. PRELIMINARY WORK PLAN - 1-(3-chloroally)-3,5,7-triaza-1-

azoniaadamantane 

Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review 

program. All pesticides distributed or sold in the United States generally must be 

registered by the U.S. Environmental Protection Agency (USEPA, EPA, or the Agency), 

based on scientific data showing that they will not cause unreasonable risks to human 

health or the environment when used as directed on product labeling. The registration 

review program is intended to make sure that, as the ability to assess risk evolves and as 

policies and practices change, all registered pesticides continue to meet the statutory 

standard of no unreasonable adverse effects to human health or the environment. 

Changes in science, public policy, and pesticide use practices will occur over time. 

Through the registration review program, the Agency periodically reevaluates pesticides 

to make sure that as change occurs, products in the marketplace can be used safely. 

Information on this program is provided at 

http://www.epa.gov/oppsrrd1/registration_review/. 

The Agency is implementing the registration review program pursuant to Section 3(g) 

of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each 

registered pesticide every 15 years to determine whether it continues to meet the FIFRA 

standard for registration. The Agency will consider benefits information and data as 

required by FIFRA. The public phase of registration review begins when the initial 

docket is opened for each case. The docket is the Agency’s opportunity to state what it 

knows about the pesticide and what additional risk analyses and data or information it 

believes are needed to make a registration review decision. After reviewing and 

responding to comments and data received in the docket during this initial comment 

period, the Agency will develop and commit to a final work plan and schedule for the 

registration review of 1-(3-chloroally)-3,5,7-triaza-1-azoniaadamantane (CTAC). 

The chemical name for this registration review case is 1-(3-chloroally)-3,5,7-triaza-1-

azoniaadamantane chloride (CTAC). CTAC can be in the form of a cis or trans isomer. 

The CTAC registration review case consists of two active ingredients: PC Code 017901, 

Trade Name DowicilTM 75, which contains a mixture of the cis and trans isomers and PC 

Code 017902, Trade Name DowicilTM 150, which contains primarily the cis isomer of 

CTAC. Because both active ingredients contain the cis isomer of CTAC and one also 

contains the trans isomer of CTAC, the Agency will use the name CTAC when referring 

to both of these active ingredients. 

CTAC is registered as a microbiocide/microbiostat for use as a materials preservative 

in pesticide formulations, adhesives, construction materials, latex emulsions, metal 

working fluids, paints, coatings and inks. It is also registered for use in household, 

institutional and industrial cleaning and laundry products. Additional use sites include oil 

production (packer fluids, re-circulated muds and underground strata), pulp and paper 

(coatings, finishes and printing colors) and textiles (finishing and spinning fluids). 

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CTAC is also used as a preservative in cosmetics and personal care products and is 

known by the name DowicilR

 200 when used in these items (examples of personal care 

products include but are not limited to moisturizers, lotions, shampoos, conditioners, 

soaps, body washes, etc.). These cosmetic and personal care product uses are regulated 

by the Food and Drug Administration (FDA). 

CTAC was first registered in the United States in 1964. A Reregistration Eligibility 

Decision (RED) for CTAC was issued in 1995. The RED can be located at: 

http://www.epa.gov/pesticides/reregistration/status.htm. 

Formaldehyde

CTAC is a formaldehyde (HCHO) releasing biocide. Therefore, this registration 

review case also addresses potential exposure to HCHO resulting from the use of CTAC. 

However, this registration review case does not address possible aggregate risks from 

HCHO. When the HCHO registration review case is at the stage in which a risk 

assessment is conducted, aggregate risks from HCHO derived from the use of CTAC will 

be considered at that time. The Agency issued a Reregistration Eligibility Decision 

(RED) document for formaldehyde in 2008 to address potential risks associated with 

formaldehyde. The formaldehyde RED did not include potential exposure to HCHO 

resulting from the use of products containing CTAC as an active ingredient. . 

The Office of Pesticide Programs (OPP) developed the formaldehyde inhalation noncancer toxicological endpoint used in the 2008 formaldehyde RED through the 

established reregistration process, which includes stakeholder consultation and public 

comment. However, the result has not been subjected to an inter-agency review or 

external peer review. Because of time constraints imposed by statutory deadline, OPP 

could not consider all available peer reviewed science (for example, the intentional 

human dosing toxicity studies). Thus, this value (10 ppb residential and 100ppb 

occupational) should be considered an interim value, developed solely for the purposes of 

the RED and subject to future revision and subsequent peer review and should not be 

used in other contexts as EPA's opinion of the best available science on the non-cancer 

effects of formaldehyde. 

The Agency has formed a work group that is charged with developing a harmonized 

non-cancer hazard characterization document for formaldehyde. The Agency intends to 

use this non-cancer information when assessing the risks associated with the 

antimicrobial uses of CTAC and other formaldehyde releasers. In the near term, the 

antimicrobial uses will also be assessed for cancer risks in the same manner as presented 

in the formaldehyde RED (i.e., a range of cancer risks using the Chemical Industry 

Institute of Toxicology [CIIT] model and the existing Integrated Risk Information 

System [IRIS] unit risk). Once the IRIS update of the formaldehyde cancer unit risk is 

available, the Agency will adopt that value in our risk assessments. The formaldehyde 

risk assessments are available on EPA’s Pesticide Docket at: www.regulations.gov. The 

docket number is EPA-HQ-OPP-2008-0121. 

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Risk Assessment Status & Anticipated Risk Assessment and Data Needs

Human Health Risk Assessment Status 

 The Agency has reviewed the hazard and exposure databases for the CTAC registration 

review case. As a result of this review, EPA believes risk assessments are needed to 

ensure that the CTAC registration review case meets the FIFRA and FFDCA standards. 

Because CTAC releases formaldehyde it will also be necessary to assess formaldehyde 

exposures. The Agency will complete the human health risk assessments presented 

below. 

• Dietary (Food) Risk Assessment - Indirect dietary (food) exposure resulting 

from the use of CTAC in food packaging materials. 

• Residential Handler Risk Assessment - Dermal and inhalation exposure to 

CTAC and inhalation exposure to formaldehyde during the use of treated 

paints and general purpose cleaners. Residential inhalation exposure to 

formaldehyde during the use of CTAC treated laundry detergents. 

• Residential Post-Application Risk Assessment - Incidental oral and incidental 

dermal exposure from wearing clothing made from textiles treated with 

finishing fluids preserved with CTAC. 

• Occupational Handler Risk Assessment - Occupational dermal and inhalation 

exposure to CTAC and inhalation exposure to formaldehyde during the open 

pour addition of CTAC powder for materials preservation, oil products, pulp 

and paper production and textile production. Occupational dermal and 

inhalation exposure to CTAC and inhalation exposure to formaldehyde during 

the use of CTAC treated metal working fluids and preserved paints. 

Dietary and Drinking Water Exposure and Risk

Dietary Food Exposure 

CTAC is FDA-approved for use as an indirect food additive in adhesives and 

components of coatings (21 CFR 175.015); paper and paperboard board components (21 

CFR 176.170 & 21 CFR 176.180); and polyurethane resins in contact with bulk 

quantities of dry foods (21 CFR 177.1680). These uses may result in indirect dietary 

food exposure. However, they were not assessed in the 1995 CTAC RED. Therefore, an 

indirect dietary (food) exposure risk assessment is needed in support of this registration 

review. 

Dietary Drinking Water Exposure 

The registered uses of CTAC are not likely to result in contamination of surface water 

and ground water and as a result drinking water exposure is not expected. However, the 

need for a dietary drinking water exposure assessment for CTAC will be determined 

upon review of environmental fate data, which the Agency anticipates requiring. The 

Agency anticipates that environmental fate data will be useful to determine if CTAC can 

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pass through waste-water treatment facilities into drinking water or migrate into 

residential groundwater wells as a result of its current use patterns. Therefore, the need 

for a dietary drinking water assessment will be revisited upon submission and review of 

the environmental fate data that are anticipated as being needed. 

Tolerances

CTAC is permitted for use as an inert ingredient in non-food use pesticide products 

(40CFR Part 180). CTAC is also exempt from the requirement of a tolerance when used 

as an inert ingredient as a preservative at 0.14% by weight (wt) or less of pesticide 

formulations (40 CFR 180.920). 

There are no tolerances or exemptions from tolerances for the use of CTAC as an 

active ingredient and no registered food uses. As previously mentioned, CTAC is FDAapproved for use as an indirect food additive in adhesives and components of coatings, 

paper and paperboard components and polyurethane resins in contact with bulk quantities 

of dry foods. 

It is noted that exemptions and regulations for food additives under Section 409 of the 

Federal Food, Drug, and Cosmetic Act (FFDCA) do not relieve the registrant of meeting 

the standard under Section 408 as amended by the Food Quality Protection Act (FQPA), 

when the active ingredient is subject to regulation as a food-use pesticide under the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Under Section 408, a 

determination of safety for residues of a pesticide that may be in food is required, and as 

defined in Section 408(b)(2)(A)(ii), “that there is a reasonable certainty that no harm will 

result from aggregate exposure to the pesticide chemical residue, including all anticipated 

dietary exposures and all other exposures for which there is reliable information.” EPA 

will be performing risk assessments to determine if tolerances or exemptions from 

tolerances will be needed to support the existing registered uses of CTAC. 

Aggregate and Cumulative Exposure and Risk

 In examining aggregate exposure, EPA takes into account the available and reliable 

information concerning exposures to pesticide residues in food and drinking water, as 

well as non-occupational pesticide exposures. An aggregate risk assessment may be 

needed for CTAC if it is determined that drinking water exposure could occur based on 

the environmental fate data. This assessment would consist of the aggregation of the 

indirect dietary food exposure from CTAC residues in treated food packaging and the 

exposure that would occur from CTAC residues in drinking water. If it is determined that 

an aggregate assessment is needed, the need for including residential incidental oral, 

dermal and inhalation exposures in the aggregate assessment will be determined when the 

toxicity data that are anticipated as being required are completed and added to the 

database for use in endpoint selection. Therefore, the need for an aggregate assessment 

will be revisited upon submission and review of the environmental fate data and human 

toxicology data that are anticipated as being required. 

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 Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to 

establish, modify, or revoke a tolerance, the Agency consider “available information” 

concerning the cumulative effects of a particular pesticide's residues and “other 

substances that have a common mechanism of toxicity.” EPA has not yet determined 

whether CTAC has a common mechanism with other compounds; consequently, a 

cumulative assessment will not be performed at this time. 

 It should be noted that this registration review case does not address aggregate 

exposure from HCHO. When the HCHO registration review case is at the point at which 

a risk assessment is to be conducted, aggregate exposure from HCHO will be assessed 

and the need for a cumulative HCHO assessment also will be addressed at that time. 

Occupational and Residential Exposure and Risk

 The Agency reviewed all available data associated with CTAC and has determined 

that the currently registered uses of CTAC may result in residential and occupational 

exposure. Therefore, the Agency will conduct residential (handler and post-application) 

and occupational (handler) risk assessments to assess possible dermal, inhalation, 

incidental oral and incidental dermal exposure to CTAC and possible inhalation exposure 

to HCHO. 

Dermal exposure may possibly lead to dermal sensitization. During its review the 

Agency has identified dermal sensitization in open literature studies. This literature may 

be reviewed during the registration review process. If the Agency decides to rely on this 

open literature study, the Agency will make sure it meets all applicable standards that 

apply to human study ethics. Formaldehyde has been identified as one of the major 

allergens in the cosmetic related allergic contact dermatitis (Groot,et al, 1988 and Storrs, 

et al. 1989). Although the individuals involved in these incidents may have been exposed 

to different types of allergens, the Agency cannot rule out the possibility that CTAC may 

be related to the cosmetic related allergic contact dermatitis. It is also not known if the 

contact dermatitis is due to exposure to the CTAC parent or if it is due to exposure to the 

formaldehyde released by the parent. In a patch test study (Zug et. al., 2009) of 4,454 

patients who had suspected contact dermatitis, 10.3% had positive reactions to 

Quaternium 15 and 9% had positive reactions to formaldehyde. Quaternium 15 was 

among the 4 most positive allergens with the top three being nickel sulfate (19.0%), 

balsam of Peru (11.9%) and fragrance mix (11.5%). 

Anticipated Human Health Data Needs 

The Agency anticipates that the following toxicity and exposure data will be needed 

to conduct residential (handler and post-application) and occupational (handler) exposure 

risk assessments for the registered uses of CTAC. 

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Anticipated Toxicity Data Needs

• (GLN 870.3250) 90-Day Oral Toxicity- rodent and non-rodent 

• (GLN 870.3700) Developmental Toxicity- non-rodent 

• (GLN 870.3465) 90-Day Inhalation- rat 

• (GLN 870.3800) Reproductive Study- oral 

• (GLN 870.4100) Chronic Oral- rodent*

• (GLN 870.4200) Carcinogenicity*

* A combined chronic toxicity/carcinogenicity study (OPPT 870.4300) can fulfill both the 

chronic oral and carcinogenicity data requirements.

Anticipated Residential and Occupational Handler Exposure Data Needs

• (GLN 875.1200) Dermal Exposure 

• (GLN 875.1400) Inhalation Exposure 

• (GLN 875.1600) Data Reporting/Calculations 

• (GLN 875.1700) Product Use Information 

• (Non-Guideline Study) Textile Leaching Study 

Anticipated Physical/Chemical Property Data Needs 

All product chemistry data requirements have been fulfilled for CTAC. Therefore, it 

is anticipated that additional product chemistry data will not be needed for CTAC. 

Environmental Fate and Ecological Risk Assessment Status 

The Agency reviewed the environmental fate and ecological hazard databases for 

CTAC. Based on its review, EPA believes risk assessments are needed to ensure that the 

CTAC registration review case meets the FIFRA standards. The Agency will complete 

the environmental fate and ecological hazard risk assessments presented below. Further 

information and detailed justifications for the studies that are expected to be required are 

available in the document titled “Summary of Product Chemistry, Environmental Fate, 

and Ecotoxicity Data for the CTAC Registration Review Decision Document,” dated 

March 23, 2010. 

• Environmental fate 

• Ecological hazard 

• Endangered species assessment 

Environmental fate and ecological risk assessments have not been conducted for 

CTAC. The use of CTAC as a materials preservative could potentially result in 

environmental exposure. These uses may result in waste water treatment plant (WWTP) 

discharges into terrestrial and aquatic environments. Therefore, the Agency will conduct 

environmental fate and ecological risk assessments to assess environmental exposure 

resulting from possible discharges into terrestrial and aquatic environments. The Agency 

also anticipates that environmental fate and ecological data will be needed to conduct 

these assessments. 

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Anticipated Environmental Fate and Ecological Data Needs 

The Agency anticipates conducting environmental fate and ecological risk 

assessments for CTAC based on its use as a materials preservative. The use of CTAC as 

a materials preservative could potentially result in CTAC passing through waste water 

treatment plants (WWTPs), which may then be discharged into terrestrial and/or aquatic 

environments. Therefore, the Agency anticipates needing environmental fate and 

ecological toxicity data for CTAC and/or any of its major degradation products that are of 

potential concern. The environmental fate and ecological toxicity data listed below are 

anticipated as being needed to conduct environmental fate and ecological risk 

assessments. 

Anticipated Environmental Fate Data Needs

• (GLN 835.1110) Activated Sludge Sorption Isotherm 

• (GLN 835.2240) Photodegradation in Water 

• (GLN 835.3110) Ready Biodegradability 

Anticipated Ecological Data Needs

• (GLN 850.4225) Seedling Emergence, Tier II dose response study on rice 

 (Oryza sativa) 

• (GLN 850.4250) Vegetative Vigor, Tier II dose response study on rice (Oryza 

 sativa) 

• (GLN 850.4400) Aquatic Plant Growth (aquatic vascular plant toxicity), Tier 

 II dose response study on floating macrophyte (Lemna gibba) 

• (GLN 850.5400) Aquatic Plant Growth (algal toxicity), Tier II dose response 

 studies on Anabaena flos-aquae (blue-green cyanobacteria), Navicula 

 pelliculosa (freshwater diatom), and Skeletonema costatum (marine diatom) 

Endangered Species 

The Agency has not conducted a risk assessment that supports a complete endangered 

species determination. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether use of CTAC has “no effect” or “may affect” 

federally listed threatened or endangered species (listed species) or their designated 

critical habitats. When an assessment concludes that a pesticide’s use “may affect” a 

listed species or its designated critical habitat, the Agency will consult with the U.S. Fish 

and Wildlife Service and/or National Marine Fisheries Service (the Services), as 

appropriate. 

Incidents

No CTAC specific incidents have been reported in the OPP Incident Data System 

(IDS). CTAC (as Quaternium-15) has been used as a preservative in cosmetics and it has 

been reported as one of the potential causes of allergic contact dermatitis in consumers of 

cosmetics (Groot,et al, 1988; Storrs, et al. 1989; and O'Reilly and Murphy, 1996). 

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Timeline

The EPA has created the following estimated timeline for the completion of the 

CTAC registration review case. The Agency anticipates requiring additional data and 

conducting residential, occupational and ecological exposure assessments for this 

registration review case. 

Anticipated Schedule

Registration Review for CTAC 

Projected Registration Review Timeline 

Activities 

Time 

Opening Docket 

Open Public Comment Period for CTAC Docket March 2010 

Close Public Comment Period May 2010 

Case Development 

Develop Final Work Plan (FWP) September 2010 

Issue Final DCI September 2011 

Data Submission September 2015 

Open Public Comment Period for Preliminary Risk Assessments March 2016 

Close Public Comment Period June 2016 

Registration Review Decision 

Open Public Comment Period for Proposed RR Decision September 2016 

Close Public Comment Period December 2016 

Final Decision 2017 

Total (years) 7 years 

Guidance for Commenters

The public is invited to comment on the Agency’s preliminary registration review 

work plan and rationale. The Agency will consider all comments as well as any 

additional information or data provided in a timely manner prior to issuing a final work 

plan (FWP) for the CTAC case. 

Trade Irritants 

Through the registration review process, the Agency intends to solicit information on 

trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. 

Growers and other stakeholders are asked to comment on any trade irritant issues 

resulting from lack of Maximum Residue Limits (MRLs) or disparities between U.S. 

tolerances and MRLs in key export markets, providing as much specificity as possible 

regarding the nature of the concern. 

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Water Quality 

CTAC 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_nation_cy.cause_detail_303d?p_cause_grou

p_id=885. In addition, no Total Maximum Daily Loads (TMDL) have been developed 

for CTAC, based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_gr

oup_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/oppsrrd1/registration_review/water_quality_sop.htm) in order to 

ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice 

The EPA seeks to achieve environmental justice, the fair treatment and meaningful 

involvement of all people, regardless of race, color, national origin, or income, in the 

development, implementation, and enforcement of environmental laws, regulations, and 

policies. To help address potential environmental justice issues, the Agency seeks 

information on any groups or segments of the population who, as a result of their 

location, cultural practices, or other factors, may have atypical, unusually high exposure 

to CTAC, compared to the general population. Please comment if you are aware of any 

sub-populations that may have atypical, unusually high exposure compared to the general 

population. 

Structure Activity Relationships 

EPA must rely upon information of appropriate quality and reliability for each 

decision made by the Agency. In the Office of Pesticide Programs (OPP), the evaluation 

process for a pesticide chemical traditionally begins with the applicant’s submission of a 

set of studies conducted with the specific pesticide chemical of interest. The use of the 

results of such testing (measured data) is a logical, scientifically rigorous process that 

identifies the physical, chemical, and environmental fate properties of the pesticide, as 

well as the dose and endpoints at which an adverse effect can occur in various animal 

species. 

Today, there is significant interest in alternative techniques, i.e., techniques other than 

data generation that could significantly inform the Agency’s decision-making process. 

Recently, OPP has made increasing use of structure activity relationship (SAR) as part of 

its regulatory decision-making process. In the SAR process, a chemical's molecular 

structure is compared to that of other chemicals for which data are available. These 

structural similarities are then used to make predictive judgments about a chemical’s 

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physical, chemical, and biological properties. Thus, the chemical’s physical, chemical, 

and biological properties are a function of (or directly related to) the chemical’s 

molecular structure. Quantitative SAR is referred to as QSAR. To develop a QSAR, a 

selected set of measured data on a single physical, chemical, or biological property is 

used to derive a model (an equation) to predict the value of that property. 

 Since SAR assessments and QSAR modeling are another set of tools that are 

available to Agency scientists, OPP has begun a process shift that envisions shifting from 

the current study-by-study approach to an approach in which the use of predicted data, 

generated using validated models, is considered along with information from open 

literature and studies specifically generated under Part 161 requirements. All relevant 

information would be considered as part of a weight-of-the-evidence evaluation. 

 At this time, EPA believes that for certain endpoints, especially physical/chemical 

and fate properties, that SAR and QSAR might be effectively utilized to fulfill these data 

requirements for many antimicrobial pesticide chemicals. When considering biological 

properties, at this time, EPA believes that SAR and QSAR can be most effectively 

utilized in the evaluation of chemicals that exhibit lower toxicity for human health and/or 

ecotoxicity parameters. This is appropriate because the risk assessment for lower toxicity 

chemicals can be stream-lined, i.e., a screening-level assessment procedure rather than 

multiple tiers of assessments with progressively more data requirements. 

 If stakeholders believe that submission of data may affect this registration review case 

for CTAC, then the Agency invites submission of this information. The submitter would 

be expected to supply a rationale describing the utility of the information and provide 

documentation on the scientific validity of the information. The determination that the 

predicted data fulfills a data requirement would be at the sole discretion of the Agency. 

Pre-submission consultation with the Agency is encouraged. 

Endocrine Disruptor Screening Program 

As required under FFDCA section 408(p), EPA has developed the Endocrine 

Disruptor Screening Program (EDSP) to determine whether certain substances (including 

pesticide active and other ingredients) may have an effect in humans or wildlife similar to 

an effect produced by a “naturally occurring estrogen, or other such endocrine effects as 

the Administrator may designate.” The EDSP employs a two-tiered approach to making 

the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays 

to identify the potential of a chemical substance to interact with the estrogen, androgen, 

or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening 

and are found to have the potential to interact with E, A, or T hormonal systems will 

proceed to the next stage of the EDSP where EPA will determine which, if any, of the 

Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to 

identify any adverse endocrine related effects caused by the substance, and establish a 

quantitative relationship between the dose and the E, A, or T effect. 

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Between October 2009 and February 2010, EPA issued test orders/data call-ins for 

the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert 

ingredients. This list of chemicals was selected based on the potential for human 

exposure through pathways such as food and water, residential activity, and certain postapplication agricultural scenarios. This list should not be construed as a list of known or 

likely endocrine disruptors. 

CTAC is not among the group of 58 pesticide active ingredients on the initial list to 

be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all 

pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP orders/data callins for all Registration Review cases, including those for which EPA has already opened 

a Registration Review docket for a pesticide active ingredient. 

For further information on the status of the EDSP, the policies and procedures, the list 

of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our 

website: http://www.epa.gov/endo/. 

Additional Information 

Stakeholders are also specifically asked to provide available information and data in 

the following areas: 

1. Confirmation on the following label information: 

a. Sites of application 

b. Formulations 

c. Application methods and equipment 

d. Maximum application rates 

e. Frequency of application, application intervals and maximum 

number of applications 

f. Geographic limitations on use 

2. Use or potential use distribution 

3. Use history 

4. Usage/use information for non-agricultural uses (e.g., materials 

preservation) 

5. Typical application interval 

6. State or local use restrictions 

7. Ecological incidents (non-target plant damage and avian, fish, 

reptilian, amphibian and mammalian mortalities) not already reported 

to the Agency 

8. Monitoring data 

9. Structure Activity Relationships 

Next Steps

After the 60-day comment period closes in May 2010, the Agency will review and 

respond to any comments received in a timely manner and then issue a Final Work Plan 

(FWP) for CTAC. 

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 II. FACT SHEET 

 

Background Information

• Active Ingredient: 1-(3-chloroally)-3,5,7-triaza-1-azoniaadamantane (CTAC) 

• Case Number: 3069 

• PC Codes: 017901 (Cis/Trans CTAC, DowicilTM 75); 017902 (Cis CTAC, 

Dowicil 150TM) 

• CAS Registry Numbers: 4080-31-3 (Dowicil 75TM); 51229-78-8 (Dowicil 150TM) 

• Technical Registrant: The Dow Chemical Company 

• First approved for use in a registered product: 1964 

• Antimicrobials Division Chemical Review Manager (CRM): K. Avivah Jakob, 

jakob.kathryn@epa.gov 

• Antimicrobials Division Acting Product Manager (PM): Jacqueline CampbellMcFarlane,Campbell-Mcfarlane.Jacqueline@epa.gov

Chemical Identity/Structure

• Empirical Formula: C9H16N4Cl2

 Trans-Form Cis-Form

Use & Usage Information

For additional usage information and use details please refer to “Appendix A: Use and 

Usage Information for 1-(3-chloroally)-3,5,7-triaza-1-azoniaadamantane (PC Codes 

017901, 017902),” in this document. 

• There are two end-use products (EP). 

• CTAC is registered for use as a microbiocide/microbiostat. 

• Antimicrobial Use Sites: Materials preservative in pesticide formulations, 

adhesives, construction materials, latex emulsions, metal working fluids, paints, 

coatings and inks, oil production (packer fluids, re-circulated muds and 

underground strata), pulp and paper (coatings, finishes and printing colors) and 

textiles (finishing and spinning fluids); use in household, institutional and 

industrial cleaning and laundry products. 

• CTAC is a formaldehyde (HCHO) releasing biocide. 

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• There are no tolerances or exemptions from tolerances for the use of CTAC as an 

active ingredient and no registered food uses. 

• CTAC is FDA-approved for use as an indirect food additive in adhesives and 

components of coatings, paper and paperboard components and polyurethane 

resins in contact with bulk quantities of dry foods. 

Earlier Regulatory Actions

• Dowicil CTACR

 Reregistration Eligibility Decision (RED) Document, 1995 

http://www.epa.gov/pesticides/reregistration/status.htm

Human Health Risk Assessment Status

 The Agency will conduct residential and occupational exposure risk assessments as 

well as an indirect dietary (food) exposure risk assessment for CTAC. The Agency will 

also conduct residential and occupational exposure risk assessments to assess exposure to 

formaldehyde during the use of CTAC. The need for an aggregate exposure assessment 

will be revisited upon submission and review of the environmental fate data and human 

toxicology data that are anticipated as being required. Prior to conducting the risk 

assessments, the Agency anticipates requiring additional data. Further information and 

detailed justifications for the studies that are expected to be required are available in the 

document titled “Summary of Human Health Effects Data for the CTAC Registration 

Review,” dated March 23, 2010. 

Product Chemistry Database Status

The Agency has reviewed the product chemistry database for the CTAC 

registration review case and anticipates that no additional product chemistry data will be 

needed for registration review. Further information is available in the “Summary of 

Product Chemistry, Environmental Fate, and Ecotoxicity Data for the CTAC Registration 

Review Decision Document,” dated March 23, 2010. 

Ecological Risk Assessment Status

 The Agency will conduct environmental fate and ecological risk assessments for 

CTAC. Prior to conducting the risk assessments, the Agency anticipates requiring 

additional data. Further information and detailed justifications for the studies that are 

expected to be required are available in the document titled, “Summary of Product 

Chemistry, Environmental Fate, and Ecotoxicity Data for the CTAC Registration Review 

Decision Document,” dated March 23, 2010. 

The Agency has not conducted a risk assessment that supports a complete endangered 

species determination. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether use of CTAC has “no effect” or “may affect” 

federally listed threatened or endangered species (listed species) or their designated 

critical habitats. When an assessment concludes that a pesticide’s use “may affect” a 

listed species or its designated critical habitat, the Agency will consult with the U.S. Fish 

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and Wildlife Service and/or National Marine Fisheries Service (the Services), as 

appropriate. 

Tolerances

 There are no tolerances or exemptions from tolerances for CTAC as an active 

ingredient and no registered food uses. EPA will be performing risk assessments to 

determine if tolerances or exemptions from tolerances will be needed to support the 

existing registered uses of CTAC. As previously mentioned, CTAC is FDA-approved for 

use as an indirect food additive in adhesives and components of coatings, paper and 

paperboard components and polyurethane resins in contact with bulk quantities of dry 

foods. 

CTAC is permitted for use as an inert ingredient in non-food use pesticide products 

(40CFR Part 180). Also, as an inert ingredient CTAC is exempt from the requirement of 

a tolerance when used as a preservative at 0.14% by weight (wt) or less of pesticide 

formulations (40 CFR 180.920). 

Data Call-In Status

• In March of 1992, EPA issued a GDCI (generic data call-in) for cis/trans-CTAC 

(DowicilTM 75) for product chemistry data, ecological effects and environmental 

fate data. The data requirments for this GDCI have been satisfied. 

• In September of 1993, EPA issued a GDCI for cis/trans-CTAC (DowicilTM 75) 

for human toxicity data, human exposure data, product chemistry data, ecological 

effects data and environmental fate data. The data requirments for this DCI have 

been satisfied. 

• In July of 1995, EPA issued a PDCI (product data all-in) for cis/trans-CTAC 

(DowicilTM 75) for human toxicity and exposure data, and product chemistry data. 

The data requirements for this PDCI have been satisfied. 

• In March of 2002, EPA issued a GDCI for cis-CTAC (Dowicil 150TM) for product 

use information. The data requirements for this GDCI have been satisfied. 

• In July of 1995, EPA issued a PDCI for cis-CTAC (Dowicil 150TM) for product 

use data and human toxicity data. The data requirements for this PDCI have been 

satisfied. 

• The Agency anticipates issuing a data call-in (DCI) for CTAC to support the 

registration review risk assessment processes. 

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Labels 

There are two registered products that are a part of the CTAC registration review 

case. A list of product registration numbers is below. Product registration labels may be 

obtained from the Pesticide Product Label System (PPLS) website at: 

http://oaspub.epa.gov/pestlabl/ppls.home. 

Table #1. Registered Active Products of CTAC 

Registration Number Product Name Company Name 

464-327 DowicilTM 150 The Dow Chemical Company 

464-403 DowicilTM 75 The Dow Chemical company 

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III. GLOSSARY of TERMS & ABBREVIATIONS

AI Active Ingredient 

AR Anticipated Residue 

ASTM American Society for Testing and Materials 

AWPA American Wood Preserver’s Association 

CBI Confidential Business Information 

CFR Code of Federal Regulations 

cPAD Chronic Population Adjusted Dose 

CSF Confidential Statement of Formula 

CSFII USDA Continuing Surveys for Food Intake by Individuals 

DCI Data Call-In 

DEEM Dietary Exposure Evaluation Model 

DFR Dislodgeable Foliar Residue 

DNT Developmental Neurotoxicity 

DWLOC Drinking Water Level of Comparison 

EC Emulsifiable Concentrate Formulation 

EDWC Estimated Drinking Water Concentration 

EEC Estimated Environmental Concentration 

EP End use Product 

EPA Environmental Protection Agency 

EUP End-Use Product 

FDA Food and Drug Administration 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FFDCA Federal Food, Drug, and Cosmetic Act 

FQPA Food Quality Protection Act 

FOB Functional Observation Battery 

GENEEC Tier I Surface Water Computer Model 

IR Index Reservoir 

LC50 Median Lethal Concentration. A statistically derived concentration of a 

substance that can be expected to cause death in 50% of test animals. It is 

usually expressed as the weight of substance per weight or volume of water, air 

or feed, e.g., mg/l, mg/kg or ppm. 

LD50 Median Lethal Dose. A statistically derived single dose that can be expected to 

cause death in 50% of the test animals when administered by the route indicated 

(oral, dermal, inhalation). It is expressed as a weight of substance per unit 

weight of animal, e.g., mg/kg. 

LOC Level of Concern 

LOAEL Lowest Observed Adverse Effect Level 

μg/g Micrograms Per Gram 

μg/L Micrograms Per Liter 

mg/kg/day Milligram Per Kilogram Per Day 

mg/L Milligrams Per Liter 

MOE Margin of Exposure 

MRID Master Record Identification (number). EPA's system of recording and tracking 

submitted studies. 

MUP Manufacturing-Use Product 

NA Not Applicable 

NAWQA USGS National Ambient Water Quality Assessment 

NPDES National Pollutant Discharge Elimination System 

NR Not Required 

NOAEL No Observed Adverse Effect Level 

OPP EPA Office of Pesticide Programs 

OPPTS EPA Office of Prevention, Pesticides and Toxic Substances 

PAD Population Adjusted Dose 

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PAIRA Pure Active Ingredient Radiolabelled 

PCA Percent Crop Area 

PDP USDA Pesticide Data Program 

PHED Pesticide Handler's Exposure Data 

PHI Preharvest Interval 

phr Pounds Per Hundred 

ppb Parts Per Billion 

PPE Personal Protective Equipment 

ppm Parts Per Million 

PRZM/EXAMS Tier II Surface Water Computer Model 

Q1* The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer 

Risk Model 

RAC Raw Agriculture Commodity 

RED Reregistration Eligibility Decision 

REI Restricted Entry Interval 

RfD Reference Dose 

RQ Risk Quotient 

RTU Ready to Use 

SCI-GROW Tier I Ground Water Computer Model 

SAP Science Advisory Panel 

SF Safety Factor 

SLN Special Local Need (Registrations Under Section 24©) of FIFRA) 

TGAI Technical Grade Active Ingredient 

TEP Typical End-Use Product 

USDA United States Department of Agriculture 

UF Uncertainty Factor 

WPS Worker Protection Standard
Docket Number: EPA–HQ–OPP–2010–0004 

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Appendix A: Use and Usage Information for1-(3-chloroally)-3,5,7-triaza-1-azoniaadamantane 

(PC Codes 017901, 017902) 

Use Site Formulation Method of 

Application 

Application Rate/ No. of 

applications 

Use 

Cis/Trans-CTAC (PC Code 017901) 

Materials Preservatives Indoor Non-food

Adhesives, Industrial (non-food contact) 

Formulation Intermediate 464-403 

Pour Add 0.07 - 0.66% product 

preservative by wt of the formulation. Add at a suitable point in the mfg. process. For use in the following types of adhesives: Starch Based (corn, tapioca, sago, potato): Add 0.13% - 0.27%. Protein-Derived (animal glues such as hide, bone, fish, blood and gelatin): Add 0.13 - 0.66%. Natural Gums (Arabic, guar and tragacanth): Add 0.07 - 0.27%. Natural Rubber Latex: Add 0.07 - 0.2%. Polyvinyl Acetate Emulsions: Add 0.07 - 0.2%. Synthetic Gums (e.g. METHOCEL* methylcellulose gums) and Other SyntheticBased Adhesives: Add 0.07 - 0.2% 

Highly concentrated gubacterial or fungi growtconcentrations product concentrated gum solutiSynthetic adhesives formincorporate natural subsproteinaceous materialsformulations, use the lerecommended for the adnatural material. 

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Use Site Formulation Method of 

Application 

Application Rate/ No. of Use 

applications 

Indoor Non-food

Caulks 

caulking, grouting, spackling compounds, joint cements, construction adhesives, tape joint compounds, concrete admixes and sealing coatings 

Metalworking cutting fluids Specialty products  Latex emulsions  Paint, coatings & inks Papermaking (Non-food contact) 

 Pulp and paper 

Textiles 

Textile finishing and spinning fluids 

Janitorial products (in container) 

Household, institutional and industrial cleaning & laundry products 

Add 0.015 - 0.3% product by wt of the formulation. 

Product is incompatible dry systems and with soclays. 

Indoor/Outdoor Non-food

Dispersions/Emulsions/ Solutions/Suspensions 

Packer fluids, recirculating muds and underground strata 

For use with closed delivery systems only. Add 0.03 - 0.05% product by wt of mud or packer fluid. Add .0025 - .005 % by wt underground water flooding. Add at a suitable point in the closed delivery system. 

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Use Site Formulation Method of 

Application 

Application Rate/ No. of 

applications 

Use 

Indoor/Outdoor Non-food

Coatings: Industrial, 

Household institutional & industrial polishes and waxes 

Add 0.07 - 0.2% product by wt of the formulation. Add at a suitable point during the mfg. process. 

Indoor Food

Papermaking (Food contact) 

Add 0.13 – 0.27% product by wt of the formulation. Add as an aqueous solution. 

Cis-CTAC (PC CODE 017902) 

Materials Preservatives Indoor non-food

Janitorial products 

Detergents Floor wax emulsions and floor polishes 

Specialty products 

Laundry Starch Inks Latex emulsions 

Caulks 

Construction materials (caulking. grouting, and spackling compounds) 

Metalworking Cutting Fluids Paints 

Pulp & paper 

Textiles 

Add 0.03 - 0.2% product wt of the formulation. 

Indoor Food

Papermaking (Food contact) 

Soluble Concentrate Pour 464-327 

Add 0.1 - 0.2% product wt of the formulation. Add as an aqueous solution. 

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Use Site Formulation Method of 

Application 

Application Rate/ No. of 

applications 

Use 

Indoor non-food

Adhesives, Industrial (non-food contact) 

Add 0.06 - 0.5% product by wt to the formulation. For use in the following types of adhesives: Starch Based (corn, tapioca, sago. potato): Add 0.1 - 02% product by wt. Protein-derived (animal glues such as hide, bone, fish, blood, and gelatin): Add 0.1 - 0.5% product by wt. Natural gums (Arabic, guar, and tragacanth): Add 0.05 - 02% product by wt. Natural Rubber Latex: Add 0.05 - .2% product by wt. Polyvinyl Acetate Emulsions: Add 0.05 - 0.15 product by wt. Synthetic gums and Other Synthetic-based Adhesives: Add 0.05 - 0.15% product by wt. 

Synthetic adhesive formnatural substances such materials. To preserve tof antimicrobial recommcontaining only the natu

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