United States Chemical Safety March 2011 

Environmental Protection and Pollution Prevention 

Agency (7510P) 

 

p-chloro-m-cresol & 

sodium p-chloro-m-cresolate 

Summary Document 

Registration Review: Initial Docket 

March 2011 

 
Docket Numbers: EPA-HQ-OPP-2011-0071, EPA-HQ-OPP-2011-0073

www.regulations.gov

p-chloro-m-cresol &

sodium p-chloro-m-cresolate

Summary Document

Registration Review: Initial Docket

March 2011

Case # 3046 & 5011

Approved By:

oan Harrigan- relly

Director, Antimicrobials Division

Date:

rl

20f22
Docket Numbers: EPA-HQ-OPP-2011-0071, EPA-HQ-OPP-2011-0073 

www.regulations.gov

TABLE OF CONTENTS 

p-chloro-m-cresol and sodium p-chloro-m-cresolate Registration Review Team ...............4 

I. Preliminary Work Plan .....................................................................................................5

II. Fact Sheet ......................................................................................................................12 

III. Summary of Anticipated Data Requirements ..............................................................16 

IV. Use Pattern Appendices ...............................................................................................17 

________________________________________ 

Please Note 

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's 

current position based on the following documents: 

1. Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the pchloro-m-Cresol and Sodium p-chloro-m-Cresolate Registration Review Decision 

Document. March 11, 2011 

2. Summary of Human Health Effects Data for the p-chloro-m-cresol and Sodium p-chlorom-cresolate Registration Review Decision Document. February 18, 2011 

Additional supporting documents may be found in the registration review docket EPA-HQ-OPP2011-0071 for the p-chloro-m-cresol Case and in the registration review docket EPA-HQ-OPP2011-0073 for the sodium p-chloro-m-cresolate Case, both located on the internet at

www.regulations.gov. 

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p-chloro-m-cresol and sodium p-chloro-m-cresolate Registration Review Team

Human Health & Environmental Effects

Nathan Mottl 

Srinivas Gowda 

Risk Management

Seiichi Murasaki 

Lance Wormell 

Office of General Counsel

Philip Ross 

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I. Preliminary Work Plan -- p-chloro-m-cresol and sodium p-chloro-m-cresolate 

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 p-chloro-m-cresol and sodium p-chloro-m-cresolate cases. 

The current registration review cases include two chemicals: p-chloro-m-cresol (case 3046, PC 

Code 064206) and its salt, sodium p-chloro-m-cresolate (case 5011, PC Code 064205). Because 

sodium p-chloro-m-cresolate rapidly protonates in water to form p-chloro-m-cresol, data will be 

bridged between sodium p-chloro-m-cresolate products and the technical product for p-chloro-mcresol. 

The first product containing 4-chloro-3-cresol (p-chloro-m-cresol or PCMC) (PC Code 064206) 

as an active ingredient was registered in the United States in 1968. Currently, there are three 

active products registered with EPA. PCMC is registered for use to control slime-forming 

bacteria, yeasts, and fungi in industrial preservatives including oil recovery drilling muds/packer 

fluids, adhesives, coatings, emulsions, leather processing liquors and leather products, metal 

working fluids, and paints. PCMC has a use classification as a material preservative and 

currently does not have a pesticide tolerance or exemptions from the requirement of a tolerance. 

PCMC is cleared by the Food and Drug Administration (FDA) as an indirect food additive and 

formulated into adhesives (21 CFR 175.105), and paper and paperboard components (176.180, 

176.200, 176.210). The Agency completed a Reregistration Eligibility Decision (RED) for pchloro-m-cresol in 1996. Since the completion of the risk assessments for the RED, PCMC has 

been registered for disinfectant uses for industrial, hospital, household, institutional, and hard 

surface disinfection. During registration review, the Agency will determine if any tolerances or 

exemptions from the requirement of a tolerance are needed for the registered uses. 

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The first product containing sodium p-chloro-m-cresolate (Na PCMC) (PC Code 064205) as an 

active ingredient was registered in the United States in 2000. Currently, there are six active 

products registered with EPA. Registered uses for Na PCMC are the same as uses of PCMC 

(i.e., Na PCMC is registered for use as a disinfectant for industrial, hospital, household, 

institutional, and hard surface disinfection and as a material preservative to control slimeforming bacteria, yeasts, and fungi in oil recovery drilling muds/packer fluids, adhesives, 

coatings, emulsions, leather processing liquors and leather products, metal working fluids, and 

paints). Na PCMC currently does not have a pesticide tolerance or exemptions from the 

requirement of a tolerance. The Agency will determine if any tolerances or exemptions from the 

requirement of a tolerance are needed for registered uses of Na PCMC during registration 

review. The Agency did not identify any FDA clearances for Na PCMC. A RED was not 

completed for sodium p-chloro-m-cresolate because it was registered after November 1, 1984. 

Documents associated with the registration review of p-chloro-m-cresol can be viewed at 

www.regulations.gov in docket EPA-HQ-OPP-2011-0071. Documents associated with the 

registration review of sodium p-chloro-m-cresolate can be viewed at www.regulations.gov in 

docket EPA-HQ-OPP-2011-0073. Below is a summary of the issues relevant to the registration 

review cases. 

Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, 

including an endangered species risk assessment, for all uses of p-chloro-m-cresol and sodium pchloro-m-cresolate. The Agency anticipates the need to conduct a human health risk assessment. 

The Agency anticipates needing additional data to conduct the registration review for p-chlorom-cresol and sodium p-chloro-m-cresolate. 

Ecological Risk: 

• No ecological risk assessments were performed for p-chloro-m-cresol or sodium pchloro-m-cresolate due to limited indoor use patterns and low likelihood of 

environmental exposure. Because of the potential for environmental exposure if material 

preservatives pass through waste water treatment plants (WWTPs) and are discharged 

into terrestrial and aquatic environments, the Agency will conduct ecological and 

environmental fate risk assessments for material preservative uses. 

• The Agency has not conducted risk assessments that support a complete endangered 

species determination for p-chloro-m-cresol or sodium p-chloro-m-cresolate. The 

ecological risk assessments planned during registration review will allow the Agency to 

determine whether the use of p-chloro-m-cresol or sodium p-chloro-m-cresolate 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 Services (the 

Services), as appropriate. 

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• The Agency anticipates the need to require the following additional ecological data to 

conduct the registration review of p-chloro-m-cresol and sodium p-chloro-m-cresolate. 

850.5400 -- Algal Toxicity Tier II using freshwater green alga, Selenastrum 

capricornutum

• The Agency anticipates the need to require the following additional environmental fate 

data to conduct the registration review of p-chloro-m-cresol and sodium p-chloro-mcresolate. 

835.2120 -- Hydrolysis 

835.2240 -- Photodegradation in water 

850.6800 -- Modified activated sludge, respiration inhibition test 

835.1110 -- Activated Sludge Sorption Isotherm 

835.3110 -- Ready Biodegradability 

• For more information, please refer to Summary of Product Chemistry, Environmental 

Fate, and Ecotoxicity Data for the p-chloro-m-Cresol and Sodium p-chloro-m-Cresolate 

Registration Review Decision Document, located in the docket. 

Human Health Risk: 

• Assessments to support sodium p-chloro-m-cresolate’s initial registration in 2000 utilized 

the same toxicity, chemistry, and exposure data used in support of the p-chloro-m-cresol 

RED in 1996. Because the PCMC RED was pre-FQPA, the Agency expects new risk 

assessments will be necessary. Furthermore, risk assessments must be performed for the 

disinfectant and leather product uses for both p-chloro-m-cresol and sodium p-chloro-mcresolate. 

• The Agency anticipates the need to require the following additional human health data to 

conduct the registration review of p-chloro-m-cresol and sodium p-chloro-m-cresolate. 

870.3465 -- 90-day inhalation toxicity (rat) 

870.3700 -- Developmental toxicity study (rabbit) 

870.3800 -- Reproduction and fertility effects 

875.1100 -- Dermal outdoor exposure 

875.1200 -- Dermal indoor exposure 

875.1300 -- Inhalation outdoor exposure 

875.1400 -- Inhalation indoor exposure 

875.1600 -- Application exposure data reporting and calculations 

875.1700 -- Product use information 

875.2300 -- Indoor surface residue dissipation 

875.2500 -- Inhalation exposure 

875.2700 -- Product use information 

875.2900 -- Data reporting and calculations 

875.3000 -- Nondietary ingestion exposure 

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• For more information, please refer to Summary of Human Health Effects Data for the pchloro-m-cresol and Sodium p-chloro-m-cresolate Registration Review Decision 

Document, located in the docket. 

Product Chemistry: 

• The Agency does not anticipate the need to require additional product chemistry data for 

the registration review at this time. 

• For more information, please refer to Summary of Product Chemistry, Environmental 

Fate, and Ecotoxicity Data for the p-chloro-m-Cresol and Sodium p-chloro-m-Cresolate 

Registration Review Decision Document, located in the docket. 

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its most recent registration decision, EPA reviewed these data and 

selected the most sensitive endpoints for relevant risk assessment scenarios from the existing 

hazard database. However, as required by FFDCA section 408(p), p-chloro-m-cresol and 

sodium p-chloro-m-cresolate are subject to the endocrine screening part of the Endocrine 

Disruptor Screening Program (EDSP). 

EPA has developed the 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 dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. 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. P-chloro-mcresol and sodium p-chloro-m-cresolate are not among the group of 58 pesticide active 

ingredients on the initial list to be screened under the EDSP. Accordingly, as part of registration 

review, EPA will issue future EDSP orders/data call-ins, requiring the submission of EDSP 

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screening assays for p-chloro-m-cresol and sodium p-chloro-m-cresolate. For further 

information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, 

future lists, the test guidelines and the Tier 1 screening battery, please visit our website: 

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

Timeline

EPA has created the following estimated timeline for the completion of the p-chloro-m-cresol 

and sodium p-chloro-m-cresolate registration review: 

Anticipated Schedule

Activities Estimated Month/Year

Phase 1: Opening the docket 

Open Public Comment Period for Docket March 2011

Close Public Comment Period for Docket May 2011 

Phase 2: Case Development 

Develop Final Work Plan (FWP) September 2011 

Issue DCI September 2012 

Data Submission September 2016 

Open Public Comment Period for Preliminary Risk Assessments March 2017 

Close Public Comment Period for Preliminary Risk Assessments June 2017 

Phase 3: Registration Review Decision 

Open Public Comment Period for Proposed Reg. Review Decision September 2018 

Close Public Comment Period for Proposed Reg. Review Decision December 2018 

Final Decision and Begin Post-Decision Follow-up 2019 

Total (years) 8 

Guidance for Commenters:

The public is invited to comment on EPA’s Preliminary Work Plan and rationale. The Agency 

will carefully consider all comments as well as any additional information or data provided in a 

timely manner prior to issuing a final work plan for the p-chloro-m-cresol and sodium p-chlorom-cresolate registration review cases. 

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. 

Water Quality:

P-chloro-m-cresol and sodium p-chloro-m-cresolate are not identified as causes of impairment 

for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on 

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information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=88

5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for p-chloro-mcresol or sodium p-chloro-m-cresolate, based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_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 the 

data can be used quantitatively or qualitatively in pesticide risk assessments. 

Environmental Justice:

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 p-chloro-m-cresol or sodium p-chloro-m-cresolate 

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 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 

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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-theevidence 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 predicted data can fulfill one of the data needs for the 

p-chloro-m-cresol or sodium p-chloro-m-cresolate cases, 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 the data requirement would be at the sole discretion 

of the Agency. Pre-submission consultation with the Agency is encouraged. 

Additional Information:

Stakeholders are also specifically asked to provide available information and data that will assist 

the Agency in refining its risk assessments, including any species-specific ecological effects 

determinations. The Agency is interested in receiving the following information: 

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 

Next Steps:

After the 60-day comment period closes in May 2011, the Agency will review and respond to 

any comments received in a timely manner, and then issue a Final Work Plan for the p-chloro-mcresol and sodium p-chloro-m-cresolate cases. 

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II. Fact Sheet 

Background Information - p-chloro-m-cresol:

• Active Ingredient: 4-chloro-3-cresol (p-chloro-m-cresol) 

• Case number: 3046 

• PC Code: 064206 

• CAS number: 59-50-7 

• Technical registrants: LANXESS Corporation 

• First approved for use in a registered product: 1968 

• PCMC has a use classification as a material preservative and currently does not have a 

pesticide tolerance or exemptions from the requirement of a tolerance. PCMC is cleared 

by the Food and Drug Administration (FDA) as an indirect food additive and formulated 

into adhesives (21 CFR 175.105), and paper and paperboard components (176.180, 

176.200, 176.210). During registration review, the Agency will determine if any 

tolerances or exemptions from the requirement of a tolerance are needed for the 

registered uses. 

• Antimicrobials Division Chemical Review Manager (CRM): Seiichi Murasaki, 

murasaki.seiichi@epa.gov

• Antimicrobials Division Product Manager (PM): Jacqueline Campbell-McFarlane, 

campbell-mcfarlane.jacqueline@epa.gov

• Chemical Structure: 

Background Information - sodium p-chloro-m-cresolate:

• Active Ingredient: sodium p-chloro-m-cresolate 

• Case number: 5011 

• PC Code: 064205 

• CAS number: 15733-22-9 

• Technical registrants: LANXESS Corporation 

• First approved for use in a registered product: 2000 

• Na PCMC currently does not have a pesticide tolerance or exemptions from the 

requirement of a tolerance. The Agency did not identify any FDA clearances for Na 

PCMC. The Agency will determine if any tolerances or exemptions from the 

requirement of a tolerance are needed for registered uses of Na PCMC during registration 

review. 

• Antimicrobials Division Chemical Review Manager (CRM): Seiichi Murasaki, 

murasaki.seiichi@epa.gov

• Antimicrobials Division Product Manager (PM): Wanda Henson, 

henson.wanda@epa.gov

• Chemical Structure: 

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Use & Usage Information:

• PCMC and Na PCMC are registered for use as disinfectants for industrial, hospital, 

household, institutional, and hard surface disinfection and as material preservatives to 

control slime-forming bacteria, yeasts, and fungi in oil recovery drilling muds/packer 

fluids, adhesives, coatings, emulsions, leather processing liquors and leather products, 

metal working fluids, and paints. 

Ecological Risk Assessment Status:

Please refer to Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for 

the p-chloro-m-Cresol and Sodium p-chloro-m-Cresolate Registration Review Decision 

Document, located in the docket, for a detailed discussion of the ecological risk assessments. 

• Toxicity studies indicate PCMC is slightly toxic to birds, highly toxic to freshwater fish, 

and moderately toxic to aquatic invertebrates. 

• Ecological and environmental fate risk assessments were not conducted on the currently 

registered use patterns. Material preservatives may potentially pass through waste water 

treatment plants (WWTPs) and be discharged into terrestrial and aquatic environments. 

The Agency will conduct ecological and environmental fate risk assessments for material 

preservative uses because of the potential for environmental exposure. To support the 

planned risk assessments during registration review, the Agency anticipates requiring 

additional environmental fate and toxicity data. 

Human Health Risk Assessment Status:

The following are key findings of the recent human health risk assessments for p-chloro-mcresol and sodium p-chloro-m-cresolate. Please refer to Summary of Human Health Effects Data 

for the p-chloro-m-cresol and Sodium p-chloro-m-cresolate Registration Review Decision 

Document, located in the docket, for a detailed discussion of the human health risk assessment. 

Hazard Characterization: 

• Since Na PCMC rapidly protonates in water to form PCMC, data, including toxicity 

studies, are bridged between Na PCMC products and the technical product for PCMC. 

• PCMC exhibits low to moderate acute oral toxicity (toxicity category III and IV) based 

on acute oral and dermal studies in animals. PCMC was identified as corrosive to the eye 

and skin (Category I). Because PCMC is corrosive on skin and will, therefore, damage 

the sensitive respiratory mucosa if inhaled, the rat inhalation study was waived. 

• The carcinogenic potential of PCMC has been classified as Group D, not classifiable as 

to human carcinogenicity. 

• Possible reproductive and developmental effects resulting from chronic exposure to 

certain uses (e.g., metalworking fluids) will be examined in the planned risk assessments 

during registration review. 

Dietary (Food and Water): 

• Although categorized for non-food use, the Agency anticipates the need to conduct 

dietary exposure and risk assessments because of possible indirect dietary exposure 

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resulting from migration of residues from pesticidal sources (e.g., adhesives, cements, 

coatings, food contact paper, and lubricant oils) into food. 

• The Agency will also assess potential acute and chronic indirect ingestion exposure 

estimates resulting from kitchen surface disinfectant and detergent uses. 

• The Agency will determine the need for a dietary drinking water risk assessment 

following the submission and review of required environmental fate data. 

Residential: 

• Assessments of residential risk are planned for registration review because potential 

exposure is expected through dermal, inhalation, and incidental ingestion routes resulting 

from the use of treated paints, leather, and household disinfectants. 

Aggregate: 

• An aggregate risk assessment for PCMC/Na PCMC is needed to assess aggregate 

exposures from dietary sources (food and water), residential handler, and post-application 

exposures for paint. 

Occupational: 

• Assessments of occupational risk are planned for registration review because potential 

exposure is expected through dermal and inhalation routes during open-pour and mixing 

for materials preservation, oil recovery, leather production, and textile production. 

Dermal and inhalation exposure are also expected to result from the use of treated paints, 

disinfectants, and metal-working fluids. 

Cumulative: 

• EPA does not have, at this time, available data to determine whether PCMC/Na PCMC 

have common mechanisms of toxicity with other substances or how to include these 

pesticides in a cumulative risk assessment. 

• For the purposes of this Registration Review, EPA has assumed that PCMC/Na PCMC 

do not have a common mechanism of toxicity with other substances when used as an 

antimicrobial as registered. 

Incidents:

Ecological: 

• No p-chloro-m-cresol or sodium p-chloro-m-cresolate ecological incidents have been 

reported in the Ecological Incident Information System (EIIS), maintained by the 

Environmental Fate and Effects Division (EFED) of the Agency. 

Human Health: 

• No p-chloro-m-cresol or sodium p-chloro-m-cresolate human poisoning incidents have 

been reported in the OPP Incident Data System (IDS). 

Tolerances and International Harmonization: 

• PCMC has a use classification as a material preservative and currently does not have a 

pesticide tolerance or exemptions from the requirement of a tolerance. PCMC is cleared 

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by the Food and Drug Administration (FDA) as an indirect food additive and formulated 

into adhesives (21 CFR 175.105), and paper and paperboard components (176.180, 

176.200, 176.210). 

• Na PCMC currently does not have a pesticide tolerance or exemptions from the 

requirement of a tolerance. The Agency did not identify any FDA clearances for Na 

PCMC. 

• During registration review, the Agency will determine if any tolerances or exemptions 

from the requirement of a tolerance are needed for the registered uses of PCMC/Na 

PCMC. 

Data Call-In Status:

• GDCI-064206-16860 was issued on October 31, 1991 and GDCI-064206-17313 was 

issued on September 18, 1993 for PCMC. Requirements for these DCIs have been 

fulfilled. 

• There are no outstanding data call-in (DCI) requirements for Na PCMC. 

• The studies identified in the data needs section of the current document are anticipated to 

be required to support the registration review of PCMC and Na PCMC. 

Labels: 

Registered active products, including EPA registration numbers are provided in Tables 1 and 2 

below. For future reference, during registration review a list of product registration numbers will 

be included in the docket. 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 – p-chloro-m-cresol 

Registration # Registration Name Company Name Formulation Type % A.I. 

39967-8 

Preventol® CMK 

Parachlorometacresol 

(PCMC) 

LANXESS Corporation Technical Chemical Solid 99.9 

39967-9 Preventol® WB LANXESS Corporation Soluble Concentrate 29.6 

39967-12 Preventol® CMK Preservative LANXESS Corporation End Use Product Pellets 99.9 

Table 2. Registered Active Products – sodium p-chloro-m-cresolate 

Registration # Registration Name Company Name Formulation Type % A.I. 

39967-21 Preventol CMK-NA LANXESS Corporation Intermediate Solid MUP 71 

39967-22 Preventol CMK-NA 

Preservative LANXESS Corporation Ready-to-Use Solid MUP 71 

39967-25 Preventol CMK 40 LANXESS Corporation Soluble Concentrate MUP 46.13 

39967-26 Preventol WB Plus LANXESS Corporation Soluble Concentrate 31.9 

39967-27 Preventol CMK-NA 

Preservative Solution LANXESS Corporation Soluble Concentrate MUP 34.5 

39967-46 Preventol CT-L LANXESS Corporation Soluble Concentrate 37.3 

 

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III. Summary of Anticipated Data Requirements – p-chloro-m-cresol 

The table below summarizes anticipated data needs for the p-chloro-m-cresol and sodium pchloro-m-cresolate cases in Section I of this document (Preliminary Work Plan), Summary of 

Product Chemistry, Environmental Fate, and Ecotoxicity Data for the p-chloro-m-Cresol and 

Sodium p-chloro-m-Cresolate Registration Review Decision Document, and Summary of Human 

Health Effects Data for the p-chloro-m-cresol and Sodium p-chloro-m-cresolate Registration 

Review Decision Document. 

Table 3. Summary of Anticipated Data Requirements 

Guideline 

Number Anticipated Data Requirement Test Material 

Est. Timeframe 

(from DCI 

Receipt in 

months) 

835.2120 Hydrolysis TGAI 12 

835.2240 Photodegradation in water TGAI 12 

850.6800 Modified activated sludge, respiration 

inhibition test TGAI 12 

835.1110 Activated Sludge Sorption Isotherm TGAI 12 

835.3110 Ready Biodegradability TGAI 12 

850.5400 Algal Toxicity Tier II using freshwater 

green alga, Selenastrum capricornutum TGAI 12 

870.3465 90-day inhalation toxicity (rat) TGAI 24 

870.3700 Developmental toxicity study (rabbit) TGAI 24 

870.3800 Reproduction and fertility effects TGAI 48 

875.1100 Dermal outdoor exposure TGAI 24 

875.1200 Dermal indoor exposure TGAI 24 

875.1300 Inhalation outdoor exposure TGAI 24 

875.1400 Inhalation indoor exposure TGAI 24 

875.1600 Application exposure data reporting and 

calculations TGAI 12 

875.1700 Product use information TGAI 12 

875.2300 Indoor surface residue dissipation TGAI 24 

875.2500 Inhalation exposure TGAI 24 

875.2700 Product use information TGAI 12 

875.2800 Description of human activity TGAI 24 

875.2900 Data reporting and calculations TGAI 12 

875.3000 Nondietary ingestion exposure TGAI 24 

16 of 22 
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IV. Use Pattern Appendices 

Appendix A: Use Patterns – p-chloro-m-cresol 

Reg. # Treatment Site / Surface App 

Method 

Max Application / Use Rate Use 

Limitations 

39967-8 Industrial adhesives -- -- 

39967-8 Leather -- -- 

39967-8 Paper products -- -- Not for use 

in CA 

39967-8 Textiles, fibers and cordage -- -- Not for use 

in CA 

39967-8 Metalworking (cutting) fluids -- -- 

39967-8 Industrial coatings -- -- Not for use 

in CA 

39967-8 Resin, latex or polymer emulsions -- -- Not for use 

in CA 

39967-8 General hard non-porous surfaces -- -- 

39967-8 General hard non-porous surfaces -- -- 

39967-9 Leather Pour 

SALTED HIDES: Dilute 1:3 with water 

and pour onto the salt using a watering 

can and mix thoroughly; may also be 

sprayed onto the salt when using a mixer. 

At least 250-Kg raw hide can be 

satisfactorily preserved with 100 Kg of 

salt containing product. 

RAW HIDES: Add 300 - 500 g per m3 to 

the water to be used for soaking. 

PICKLED PELTS: Add 0.2 - 0.5% 

product, calculated on the weight of the 

pelts, to the salt solution. Running time 

approximately 10 minutes. Dilute with 2 - 

5 parts water before use. 

WET BLUES: 0.2 - 0.3% product, based 

on pelt weight. 

VEGETABLE TANNAGE: Pit Tannage 

– Add 50- 100 g product per m3 to 

vegetable tan float Additions should be 

diluted 1:2 - 1:3 and should be added 

gradually while stirring or circulating the 

float. Drum Tannage - Add 0.3 - 0.5% 

product (diluted 1:2 - 1:5 and calculated 

on pelt weight) to vegetable tanning 

substance. 

39967-9 Adhesives and glues -- Effective concentrations .15 - .55% 

39967-9 

Pigment slurries; materials in the 

building industry: joint cements, 

concrete, other materials & 

auxiliaries 

-- Effective concentrations .02 - .70% 

39967-9 Metalworking (cutting) fluids -- Effective concentrations .1 - 4.0% 

39967-9 Materials in the textile industries -- Effective concentrations .15 - .4% 

39967-9 

Materials in the paper industry: 

filler, rosin paper, starch slurries, 

other materials and auxiliaries 

-- Effective concentrations .15 - .4% 

39967-9 

Polishing and wax material; 

Protein solutions; Ceramic glazes; 

Fire extinguishing materials; 

-- Effective concentrations .15 - .5% 

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Reg. # Treatment Site / Surface App 

Method 

Max Application / Use Rate Use 

Limitations 

Cleaning solutions, detergents 

39967-12 Adhesives and glues -- Effective concentrations .05 - 1.0%. 

39967-12 

Joint cements; Polymer 

dispersions: 

emulsions 

-- Effective concentrations .05 - .2%. 

39967-12 Leather -- Effective concentrations .1 - .4%. 

39967-12 Lubricoolants and mineral oil 

based products -- Effective concentrations .05 - 6.0%. 

39967-12 

Materials in the printing industry: 

inks; fount solutions; printing 

pastes; other printing materials 

and auxiliaries 

-- Effective concentrations .05 - 0.3%. 

39967-12 

Materials in the building industry: 

bitumen emulsions; concrete 

additives; other building materials 

and auxiliaries 

-- Effective concentrations .15 - 0.4%. 

39967-12 

Materials in the coatings industry: 

dyestuff paste; knifing fillers and 

plastic putty; casein based 

coatings; paints; other auxiliaries 

and coating materials; synthetic 

resin dispersions 

-- Effective concentrations .05 - 0.4%. 

39967-12 

Materials in the paper industry: 

rosin paper sizes; filler 

suspensions and coating 

compounds; starch slurries; 

pigment slurries; other materials 

and auxiliaries 

-- Effective concentrations .05 - 0.3%. 

39967-12 

Materials in textile industry: 

spinning preparations; sizes and 

finishing agents; yarn humidifiers; 

printing thickeners (solid); 

printing thickeners (liquid); other 

materials and auxiliaries 

-- Effective concentrations .05 - 2.0%. 

39967-12 

Materials in the photo industry: 

gelatin; other materials and 

auxiliaries 

-- Effective concentrations .05 - 0.2%. 

39967-12 

Materials in the oil industry: 

biopolymers, solid (xanthan, 

starch, galactomannan, etc.); 

Biopolymers, liquid (drilling 

muds); other materials and 

auxiliaries 

-- Effective concentrations .05 - 2.0%. 

39967-12 Materials and auxiliaries in the 

leather industry -- Effective concentrations 0.1 - 0.3%. 

39967-12 

Polishing and wax material; 

protein solutions; cleaning 

solutions, detergents; ceramic 

glazes; fire extinguishing 

materials; cosmetic and toiletry 

raw materials; industrial 

lubricants 

-- Effective concentrations .05 - 1.0%. 

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Appendix B: Use Patterns – sodium p-chloro-m-cresolate 

Reg. # Treatment Site / Surface App 

Method 

Max Application / Use Rate Use 

Limitations 

39967-21 

Industrial, Hospital, Household, 

Institutional, and Hard Surface 

Disinfectants. Industrial, 

Hospital, Household, 

Institutional, and Hard Surface 

Disinfection. 

Industrial, Hospital, Household, 

Institutional, and Hard Surface 

Disinfection. 

Industrial Preservatives for 

Leather/Leather Products, 

Polymer/Resin/Latex 

Emulsions, Coatings, Paints, 

Specialty Industrial Products, 

Materials in the Building Industry

(concrete additives/masonry and 

joint cements), Adhesives, Glues, 

Metalworking/Cutting Fluids, 

Materials in the Paper Industry 

(wet end additives, industrial 

processing chemicals), Textiles, 

Materials in the Photographic 

Industry, Thickeners (starch, 

cellulose, guar, etc.), Air Filter 

Oils, 

Starches, Clay Slurries, Slurries, 

Printing Inks, Graphite, and Hard 

Surface Treatment Products 

(polishes, waxes, ceramic glazes). 

 

39967-22 

Animal and synthetic adhesives 

and glues 

Metered 0.15-2.00% by weight during 

manufacture 

 

39967-22 

Acrylic, Polyvinylacetate (PVA), 

Vinyl/Acrylic, Styrene Butadiene 

(SBR Latex) dispersons and 

emulsions 

Metered 0.15-0.40% by weight during 

manufacture 

 

39967-22 

Pickle solutions and pickled 

hides, Chrome leather (calculated 

on pelt weight), Leather pasting 

adhesives, Leather pigment 

finishes 

Metered 0.10-0.65% by weight during 

manufacture 

 

39967-22 

Straight oils (Mineral-oil based), 

Soluble oils (oil emulsions, 

aqueous), Semi-synthetic 

(emulsions, aqueous), Synthetic 

(solutions) 

Metered 0.08-0.50% by weight during 

manufacture 

 

39967-22 

Straight oils (Mineral-oil based), 

Soluble oils (oil emulsions, 

aqueous), Semi-synthetic 

(emulsions, aqueous), Synthetic 

(solutions) 

Metered 1.6-5.00% by weight during 

manufacture 

 

39967-22 

Inks, fount solutions, printing 

pastes, other related printing 

Metered 0.10-0.50% by weight during 

manufacture 

 

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Reg. # Treatment Site / Surface App 

Method 

Max Application / Use Rate Use 

Limitations 

materials 

39967-22 

Joint cements, Concrete 

additives, other related materials 

Metered 0.15-0.65% by weight during 

manufacture 

 

39967-22 

Dyestuff paste, knifing fillers and 

plastic putty, casein based 

coatings, paints, other auxiliaries 

and coating materials, synthetic 

resin dispersions. 

Metered 0.15-0.65% by weight during 

manufacture 

 

39967-22 

Rosin paper sizes, filler 

suspensions and coating 

compounds, starch slurries, 

pigment slurries, other related 

materials and auxiliaries. 

Metered 0.10-0.50% by weight during 

manufacture 

 

39967-22 

Printing thickeners, yarn 

humidifiers, finishing agents and 

other related materials 

Metered 0.15-4.00% by weight during 

manufacture 

 

39967-22 

Solid Biopolymers (xanthan, 

starch, galactomannan, etc.), 

Liquid Biopolymers (drilling 

muds) 

Metered 0.15-4.00% by weight during 

manufacture 

 

39967-22 

Polishing and wax material 

Protein solutions 

Ceramic glazes 

Fire extinguishing materials 

Cleaning solutions, detergents 

Metered 0.15-0.50% by weight during 

manufacture 

 

39967-22 

(Kaolin-, Calcium carbonateTalcum-,lron oxide etc.), Kaolin 

slurries, Calcium carbonate 

slurries, Talcum slurries, Iron 

oxide slurries 

Metered 0.02-0.125% by weight during 

manufacture 

 

39967-25 

Animal and synthetic adhesives 

and glues 

Metered 0.25-0.90 % by weight during 

manufacture 

 

39967-25 

Acrylic, Polyvinylacetate (PVA), 

Vinyl/Acrylic, Styrene Butadiene 

(SBR Latex) dispersons and 

emulsions 

Metered 0.25-0.60% by weight during 

manufacture 

 

39967-25 

Pickle solutions and pickled 

hides, Chrome leather (calculated 

on pelt weight), Leather pasting 

adhesives, Leather pigment 

finishes 

Metered 0.25-1.00% by weight during 

manufacture 

 

39967-25 

Straight oils (Mineral-oil based), 

Soluble oils (oil emulsions, 

aqueous), Semi-synthetic 

(emulsions, aqueous), Synthetic 

(solutions) 

Metered 0.125-0.75% by weight during 

manufacture 

 

39967-25 

Straight oils (Mineral-oil based), 

Soluble oils (oil emulsions, 

aqueous), Semi-synthetic 

(emulsions, aqueous), Synthetic 

(solutions) 

Metered 2.5-15.0% by weight during 

manufacture 

 

39967-25 

Inks, fount solutions, printing 

pastes, other related printing 

Metered 0.25-0.75% by weight during 

manufacture 

 

20 of 22 
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Reg. # Treatment Site / Surface App 

Method 

Max Application / Use Rate Use 

Limitations 

materials 

39967-25 

Joint cements, Concrete 

additives, other related materials 

Metered 0.25-1.00% by weight during 

manufacture 

 

39967-25 

Dyestuff paste, knifing fillers and 

plastic putty, casein based 

coatings, paints, other auxiliaries 

and coating materials, synthetic 

resin dispersions. 

Metered 0.25-1.00% by weight during 

manufacture 

 

39967-25 

Rosin paper sizes, filler 

suspensions and coating 

compounds, starch slurries, 

pigment slurries, other related 

materials and auxiliaries. 

Metered 0.25-0.75% by weight during 

manufacture 

 

39967-25 

Printing thickeners, yarn 

humidifiers, finishing agents and 

other related materials 

Metered 0.25-0.60% by weight during 

manufacture 

 

39967-25 

Solid Biopolymers (xanthan, 

starch, galactomannan, etc.), 

Liquid Biopolymers (drilling 

muds) 

Metered 0.30-0.75% by weight during 

manufacture 

 

39967-25 

Polishing and wax material 

Protein solutions 

Ceramic glazes 

Fire extinguishing materials 

Cleaning solutions, detergents 

Metered 0.25-2.50% by weight during 

manufacture 

 

39967-25 

(Kaolin-, Calcium carbonateTalcum-,lron oxide etc.), Kaolin 

slurries, Calcium carbonate 

slurries, Talcum slurries, Iron 

oxide slurries 

Metered 0.03-0.20% by weight during 

manufacture 

 

39967-26 

Joint cements, Concrete 

additives, other related materials 

Metered 0.20-0.70% by weight during 

manufacture 

 

39967-26 

Pickle solutions and pickled 

hides, Chrome leather (calculated 

on pelt weight), Leather pasting 

adhesives, Leather pigment 

finishes 

Metered 0.2-1.00% by weight during 

manufacture 

product 

should be 

diluted 1:3 

with water 

before 

incorporation. 

39967-26 

Soaking raw hides, Vegetable 

tannage 

Metered 50-500g per cubic meter product 

should be 

diluted 1:3 

with water 

before 

incorporation. 

39967-27 

Animal and synthetic adhesives 

and glues 

Metered 0.35-1.20% by weight during 

manufacture 

 

39967-27 

Acrylic, Polyvinylacetate (PVA), 

Vinyl/Acrylic, Styrene Butadiene 

(SBR Latex) dispersons and 

emulsions 

Metered 0.35-0.80% by weight during 

manufacture 

 

39967-27 

Pickle solutions and pickled 

hides, Chrome leather (calculated 

on pelt weight), Leather pasting 

Metered 0.35-1.40% by weight during 

manufacture 

 

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22 of 22 

Reg. # Treatment Site / Surface App 

Method 

Max Application / Use Rate Use 

Limitations 

adhesives, Leather pigment 

finishes 

39967-27 

Straight oils (Mineral-oil based), 

Soluble oils (oil emulsions, 

aqueous), Semi-synthetic 

(emulsions, aqueous), Synthetic 

(solutions) 

Metered 0.25-1.5% by weight during 

manufacture 

 

39967-27 

Straight oils (Mineral-oil based), 

Soluble oils (oil emulsions, 

aqueous), Semi-synthetic 

(emulsions, aqueous), Synthetic 

(solutions) 

Metered 4.00-15.0% by weight during 

manufacture 

 

39967-27 

Inks, fount solutions, printing 

pastes, other related printing 

materials 

Metered 0.35-1.00% by weight during 

manufacture 

 

39967-27 

Joint cements, Concrete 

additives, other related materials 

Metered 0.35-1.40% by weight during 

manufacture 

 

39967-27 

Dyestuff paste, knifing fillers and 

plastic putty, casein based 

coatings, paints, other auxiliaries 

and coating materials, synthetic 

resin dispersions. 

Metered 0.35-1.30% by weight during 

manufacture 

 

39967-27 

Rosin paper sizes, filler 

suspensions and coating 

compounds, starch slurries, 

pigment slurries, other related 

materials and auxiliaries. 

Metered 0.35-1.00% by weight during 

manufacture 

 

39967-27 

Printing thickeners, yarn 

humidifiers, finishing agents and 

other related materials 

Metered 0.35-0.80% by weight during 

manufacture 

 

39967-27 

Solid Biopolymers (xanthan, 

starch, galactomannan, etc.), 

Liquid Biopolymers (drilling 

muds) 

Metered 0.40-1.00% by weight during 

manufacture 

 

39967-27 

Polishing and wax material 

Protein solutions 

Ceramic glazes 

Fire extinguishing materials 

Cleaning solutions, detergents 

Metered 0.35-1.20% by weight during 

manufacture 

 

39967-27 

(Kaolin-, Calcium carbonateTalcum-,lron oxide etc.), Kaolin 

slurries, Calcium carbonate 

slurries, Talcum slurries, Iron 

oxide slurries 

Metered 0.05-0.30% by weight during 

manufacture 

 

39967-46 

Pickle solutions and pickled 

hides, Chrome leather (calculated 

on pelt weight), Leather pasting 

adhesives, Leather pigment 

finishes 

Metered 0.2-0.5% by weight during manufacture product 

should be 

diluted with 2 

to 5 parts 

water before 

incorporation.