United States Prevention, Pesticides EPA 739-R-08-010 

Environmental Protection and Toxic Substances March 2009 

Agency (7510P) 

Reregistration Eligibility Decision 

for Phenol & Salts 
 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

PREVENTION, PESTICIDES 

AND TOXIC SUBSTANCES 

CERTIFIED MAIL 

Dear Registrant: 

This is to inform you that the Environmental Protection Agency (hereafter 

referred to as EPA or the Agency) has completed its review of the available data and 

public comments received related to the preliminary risk assessments for the 

antimicrobial phenol and salts. The Reregistration Eligibility Decision (RED) was 

approved in the form of a decision memorandum which summarized the regulatory 

decision for phenol and salts on September 30, 2004. Public comments and additional 

data received were considered in this decision. 

Based on its review, EPA is now publishing its Reregistration Eligibility Decision 

(RED) and risk management decision for phenol and salts and its associated human 

health and environmental risks. A Notice of Availability will be published in the Federal 

Register announcing the publication of the RED. 

The RED and supporting risk assessments for the phenol and salts are available to 

the public in EPA’s Pesticide Docket EPA-HQ-OPP-2004-0301 at: 

http://www.regulations.gov. 

The phenol and salts RED was developed through EPA’s public participation 

process, published in the Federal Register on September 17, 2004, which provides 

opportunities for public involvement in the Agency’s pesticide tolerance reassessment 

and reregistration programs. Developed in partnership with USDA and with input from 

EPA’s advisory committees and others, the public participation process encourages 

robust public involvement starting early and continuing throughout the pesticide risk 

assessment and risk mitigation decision making process. The public participation process 

encompasses full, modified, and streamlined versions that enable the Agency to tailor the 

level of review to the level of refinement of the risk assessments, as well as to the amount 

of use, risk, public concern, and complexity associated with each pesticide. Using the 

public participation process, EPA is attaining its strong commitment to both involve the 

public and meet statutory deadlines. 

Please note that the phenol and salts risk assessment and the attached RED 

document concern only this particular pesticide. This RED presents the Agency’s 

conclusions on the dietary, drinking water, occupational and ecological risks posed by 

exposure to phenol and salts alone. This document also contains both generic and 

product-specific data that the Agency intends to require in Data Call-Ins (DCIs). Note 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ABSTRACT....................................................................................... i 

I. INTRODUCTIONS................................................................. -1-

II. CHEMICAL OVERVIEW........................................................ -3-

A. Regulatory History............................................................... -3- 

B. Chemical Identification......................................................... -3- 

C. Use Profile........................................................................ -5- 

III. SUMMARY OF RISK ASSESSMENTS....................................... -7-

A. Human Health Risk Assessments.............................................. -7- 

1. Toxicity of Phenol & Salts................................................ -7-

a. Acute Toxicity...................................................... -7- 

b. Carcinogenicity.................................................... -9-

c. Toxicological Endpoints......................................... -9-

2. Endocrine Disrupter Potential.......................................... -11-

3. FQPA Safety Factor...................................................... -11-

4. Dietary Exposure & Risk................................................ -11-

a. Dietary Exposure Assumptions................................ -12- 

5. Dietary Risk Assessment................................................ -12- 

a. Acute PAD........................................................ -12-

b. Chronic PAD...................................................... -13-

c. Dietary Risk from Drinking Water............................ -13- 

6. Residential Exposure and Risk.......................................... -13-

a. Residential Handler Exposure and Risk...................... -13-

b. Post-application Residential Exposure and Risk............ -15- 

7. Aggregate Risk Assessment............................................. -17- 

8. Occupational Handler Exposure and Risk............................ -18-

9. Post-application Occupational Exposure and Risk.................. -20- 

10. Phenol and Salts Human Incident Data............................... -20- 

B. Environmental Risk Assessment............................................. -21- 

1. Environmental Fate and Transport........................................ -22-

2. Risks to Listed Species...................................................... -22- 

IV.	 REREGISTRATION ELIGIBILITY & RISK MANAGEMENT 

DECISION.......................................................................... -24-

A. Determination of Reregistration Eligibility Decision..................... -24- 

1. Public Comments and Response....................................... -24- 

2. Regulatory Rationale..................................................... -24-

3. Other Labeling Requirements.......................................... -27- 

V. WHAT REGISTRANTS NEED TO DO...................................... -28-

A. Manufacturing Use Products.................................................. -28- 

1. Generic Data Requirements............................................. -28- 

B. End-Use Products............................................................... -31- 

1. Product Specific Data Requirements................................... -31- 

2. Labeling For End-Use Products........................................ -32-
Phenol and salts Reregistration Team 

Health Effects Risk Assessment 

Jonathan Chen 

Timothy McMahon 

Timothy Leighton 

Timothy Dole 

Najm Shamim 

Ecological Risk Assessment 

Kathryn Montague 

Environmental Fate Risk Assessment 

Najm Shamim 

Risk Management 

K. Avivah Jakob 

Diane Isbell 

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GLOSSARY OF TERMS AND ABBREVIATIONS 

a.i. Active Ingredient 

aPAD Acute Population Adjusted Dose 

APHIS Animal and Plant Health Inspection Service 

ARTF Agricultural Re-entry Task Force 

BCF Bioconcentration Factor 

CDC Centers for Disease Control 

CDPR California Department of Pesticide Regulation 

CFR Code of Federal Regulations 

ChEI Cholinesterase Inhibition 

CMBS Carbamate Market Basket Survey 

cPAD Chronic Population Adjusted Dose 

CSFII USDA Continuing Surveys for Food Intake by Individuals 

CWS Community Water System 

DCI Data Call-In 

DEEM Dietary Exposure Evaluation Model 

DL Double layer clothing {i.e., coveralls over SL} 

DWLOC Drinking Water Level of Comparison 

EC Emulsifiable Concentrate Formulation 

EDSP Endocrine Disruptor Screening Program 

EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee 

EEC Estimated Environmental Concentration. The estimated pesticide concentration in an 

environment, such as a terrestrial ecosystem. 

EP End-Use Product 

EPA U.S. Environmental Protection Agency 

EXAMS Tier II Surface Water Computer Model 

FDA	 Food and Drug Administration 

FFDCA	 Federal Food, Drug, and Cosmetic Act 

FIFRA	 Federal Insecticide, Fungicide, and Rodenticide Act 

FOB Functional Observation Battery 

FQPA Food Quality Protection Act 

FR Federal Register 

GL	 With gloves 

GPS Global Positioning System 

HIARC Hazard Identification Assessment Review Committee 

IDFS	 Incident Data System 

IGR	 Insect Growth Regulator 

IPM	 Integrated Pest Management 

RED Reregistration Eligibility Decision 

LADD	 Lifetime Average Daily Dose 

LC50	 Median Lethal Concentration. Statistically derived concentration of a substance expected 

to cause death in 50% of test animals, usually expressed as the weight of substance per 

weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm. 

LCO Lawn Care Operator 

LD50	 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test 

animals when administered by the route indicated (oral, dermal, inhalation), expressed as 

a weight of substance per unit weight of animal, e.g., mg/kg. 

LOAEC	 Lowest Observed Adverse Effect Concentration 

LOAEL	 Lowest Observed Adverse Effect Level 

LOC	 Level of Concern 

LOEC	 Lowest Observed Effect Concentration 

mg/kg/day Milligram Per Kilogram Per Day 

MOE Margin of Exposure 

MP Manufacturing-Use Product 

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

submitted. 

MRL Maximum Residue Level 

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N/A Not Applicable 

NASS National Agricultural Statistical Service 

NAWQA USGS National Water Quality Assessment 

NG No Gloves 

NMFS National Marine Fisheries Service 

NOAEC No Observed Adverse Effect Concentration 

NOAEL No Observed Adverse Effect Level 

NPIC National Pesticide Information Center 

NR No respirator 

OP Organophosphorus 

OPP EPA Office of Pesticide Programs 

ORETF Outdoor Residential Exposure Task Force 

PAD Population Adjusted Dose 

PCA Percent Crop Area 

PDCI Product Specific Data Call-In 

PDP USDA Pesticide Data Program 

PF10 Protection factor 10 respirator 

PF5 Protection factor 5 respirator 

PHED Pesticide Handler’s Exposure Data 

PHI Pre-harvest Interval 

ppb Parts Per Billion 

PPE Personal Protective Equipment 

PRZM Pesticide Root Zone Model 

RBC Red Blood Cell 

RED Reregistration Eligibility Decision 

REI Restricted Entry Interval 

RfD Reference Dose 

RPA Reasonable and Prudent Alternatives 

RPM Reasonable and Prudent Measures 

RQ Risk Quotient 

RTU (Ready-to-use) 

RUP Restricted Use Pesticide 

SCI-GROW Tier I Ground Water Computer Model 

SF Safety Factor 

SL Single layer clothing 

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

STORET Storage and Retrieval 

TEP Typical End-Use Product 

TGAI Technical Grade Active Ingredient 

TRAC Tolerance Reassessment Advisory Committee 

TTRS Transferable Turf Residues 

UF Uncertainty Factor 

USDA United States Department of Agriculture 

USFWS United States Fish and Wildlife Service 

USGS United States Geological Survey 

WPS Worker Protection Standard 

iii 
ABSTRACT 

The Environmental Protection Agency (EPA or the Agency) has completed the 

human health and environmental risk assessments for phenol and salts and is issuing its 

risk management decision. The risk assessments, which are summarized below, are 

based on the review of the required target database supporting the use patterns of 

currently registered products and additional information received through the public 

docket. After considering the risks identified in the revised risk assessments, comments 

received, and mitigation suggestions from interested parties, the Agency developed its 

risk management decision for uses of phenol and salts that pose risks of concern. As a 

result of this review, EPA has determined that products containing phenol and salts are 

eligible for reregistration, provided that risk mitigation measures are adopted and labels 

are amended accordingly. That decision is discussed fully in this document. 

i 
I. INTRODUCTION 

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended 

in 1988 to accelerate the reregistration of products with active ingredients registered prior 

to November 1, 1984 and amended again by the Pesticide Registration Improvement Act 

of 2003 to set time frames for the issuance of Reregistration Eligibility Decisions. The 

amended Act calls for the development and submission of data to support the 

reregistration of an active ingredient, as well as a review of all submitted data by the U.S. 

Environmental Protection Agency (EPA or the Agency). Reregistration involves a 

thorough review of the scientific database underlying a pesticide’s registration. The 

purpose of the Agency’s review is to reassess the potential hazards arising from the 

currently registered uses of the pesticide; to determine the need for additional data on 

health and environmental effects; and to determine whether or not the pesticide meets the 

“no unreasonable adverse effects” criteria of FIFRA. 

The Agency made its reregistration eligibility determination for phenol and salts based on 

the required data, the current guidelines for conducting acceptable studies to generate such data, 

and published scientific literature. The Agency has found that currently registered phenol and 

salts products are eligible for reregistration provided that the risk mitigation and label 

amendments identified in this reregistration eligibility decision (RED) document are 

implemented. 

In 2004, the EPA issued the “Phenol/Sodium Phenate Reregistration Decision” memo, 

dated September 30, 2004. The decision memo addresses the risks of concern identified in the 

phenol and salts risk assessment (“Phenols RED Document,” July 7, 2004) and the Agency’s risk 

management decisions to address these risks of concern. However, the use of fogging clean 

rooms use and the use of phenol and salts to treat HVAC ductwork were, inadvertently, not 

addressed in either of these documents. The purpose of this reregistration eligibility decision 

document is to not only summarize the findings and mitigation decisions outlined in the “Phenols 

RED Document” and the “Phenol/Sodium Phenate Reregistration Decision” memorandum but to 

present the findings of the Occupational and Residential Exposure (ORE) assessments that have 

been recently conducted for the fogging clean room and HVAC ductwork treatment uses. In 

addition, the Agency’s risk management decisions to support the continuation of these uses are 

also provided in this document. For further information refer to the “Phenols RED Document,” 

dated July 7, 2004, the “Occupational and Residential Exposure and Risk Assessment for the 

Existing Fogging Clean-room Use of Phenol (Sporicidin),” dated December 18, 2008 and the 

“Occupational and Residential Exposure and Risk Assessment for the Duct Cleaning Use of 

Phenol (Sporicidin),” dated December 18, 2008. These documents are located in the Public 

Docket at http://www.regulations.gov in docket number EPA-HQ-OPP-2004-0301. 

This document consists of six sections: Section I contains the regulatory framework for 

reregistration reassessment; Section II provides an overview of the chemical, including a profile 

of its use and usage; Section III gives an overview of the human health and ecological risk 

assessments; Section IV presents the Agency’s reregistration eligibility and risk management 

decisions; Section V summarizes label changes necessary to implement the risk mitigation 

measures outlined in Section IV; and Section VI includes the appendices, related supporting 

documents, and Data Call-In (DCI) information. The final risk assessment documents, related 

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addenda, and public comments are not included in this document and are available in the Public 

Docket at http://www.regulations.gov in docket number EPA-HQ-OPP-2004-0301. 

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II. Chemical Overview 

A. Regulatory History 

Phenol and salts is regulated by both the U.S. EPA and the U.S. Food and Drug 

Administration (FDA). The EPA regulates the antimicrobial uses of phenol and salts when used 

as a materials preservative, disinfectant and deodorizer. Phenol and salts (PC Codes 064001 & 

064002) were first registered as active ingredients by the United Sates Department of Agriculture 

(USDA) on June 11, 1969. In 1970, the Environmental Protection Agency (EPA) was 

established and was charged with protecting human health and the environment, and assumed all 

pesticide registration from USDA. Currently there are six products that contain phenol and salts 

as active ingredients. Phenol and salts are active ingredients in disinfectant, deodorizer and 

cleaning formulations. Phenol and salts are also used as materials preservatives for polishes and 

cleansers, and protectants. These formulations have bactericidal, virucidal, fungicidal and 

tuberculocidal properties, kill mold and mildew, and eliminate odor. Prior to April 12, 2005 

phenol and salts were used as a materials preservative in paints. However, this use was 

voluntarily cancelled as a result of the risks identified in the “Phenol/Sodium Phenate 

Reregistration Decision” memorandum, dated September 30, 2004. 

Use site categories for these formulations include material preservatives, commercial, 

institutional and industrial premises and equipment, medical premises and equipment, food 

handling establishments and residential and public access premises. A review of product labels 

indicate that most of these formulations are intended for use in hospitals, clinics, medical and 

veterinary offices, nursing homes, laboratories, industrial clean rooms, ambulances, hotels, 

restaurants, schools, transportation facilities, health spas and toilets. The FDA-regulated uses of 

phenol and salts can be found in over-the-counter drugs, which are used for the treatment of 

various conditions including insect bites, poison ivy, diaper rash, antiseptics and acne (21 CFR § 

310.531 and §310.545). 

B. Chemical Identification 

Technical Phenol 

Figure #1. Molecular Structure of Phenol 

Common name: Phenol 

Chemical name: Phenol 

Chemical family: Phenols 

Empirical formula: C6H 6O 

- 3 -
 

 

 

 

CAS Registry No.: 108-95-2 

Case number: 4074 

OPP Chemical Code: 064001 

Molecular weight: 94.11 g/mol 

Other names: Carbolic acid; Hyroxybenzene 

Registrants: Contec, Inc. and World Pharmaceuticals Corporation 

Chemical properties: Phenol is colorless to light pink. Its physical state is crystalline 

solid and it is mildly acidic. Phenol is stable at normal conditions 

 and its melting point is at 43.0°C and 40.9°C (ultra pure 

 material). Its boiling point is 181.8°C at 760 mm Hg and its water 

solubility is 67 g/L in water at 16°C. Phenols Log 

KOW is 1.46 at 25o C. Its vapor pressure is 0.341 mm Hg at 25oC, 

2.48 mm Hg at 50o

C and 41.3 mm Hg at 100oC. Phenol’s relative 

 vapor density is 3.24 and its saturation concentration in air is 0.77 

g/m3 at 20oC. 

Technical Phenol Salts 

O-Na 

Sodium Phenoate 

Figure #2. Molecular Structure of Phenol Salts 

Common name: Phenol salts (salts) 

Chemical name: Sodium phenate 

Chemical family: Phenoxy 

Empirical formula: C6H 6ONa 

CAS Registry No.: 139-02-6 

Case number: 4074 

OPP Chemical Code: 064002 

Molecular weight: 116.10 g/mol 

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Other names: Sodium phenolate; Phenol, sodium salt; Salts 

Basic manufacturer: Contec, Inc. 

Chemical properties: The color of phenol salts is white to reddish in color and its 

physical state is crystalline needles or rods. Its pH is alkaline in 

aqueous solutions, and it is stable at normal conditions and is 

highly soluble in water. 

C. Use Profile 

The following information is a description of the currently registered uses of phenol and 

salts products and an overview of use sites and application methods. A detailed table of the uses 

of phenol and salts eligible for reregistration is contained in Appendix A. 

Type of Pesticide: Sanitizer, Bacteriostat, Fungicide/Fungistat, Tuberculocide, Disinfectant, 

Virucide 

Summary of Use:	 Agricultural Premises & Equipment 

Phenol and salts are used as disinfectants, deodorizers and cleaners for the 

following hard, non-porous surfaces: farm equipment, animal and poultry 

housing, barns, kennels, breeding pens, hatcheries, trucks and other 

vehicles. 

Commercial, Institutional and Industrial Premises & Equipment 

Phenol and salts are used as disinfectants, deodorizers and cleaners for the 

following hard, non-porous surfaces: telephones, keyboards, furniture, 

wheelchairs, walkers, sinks, floors, walls, light switches, linen hampers, 

bathrooms, kennels and animal areas, schools, restaurants, hotels, boats, 

planes, buses, industrial clean rooms (fogging), and air ducts (HVAC). 

Phenol and salts are also used to clean, deodorize and remove debris from 

carpets and fabrics. 

Food Handling/Storage Establishments Premises & Equipment 

Phenol and salts are used as disinfectants, deodorizers and cleaners for the 

following hard, non-porous surfaces: food processing plants, food 

handling areas, poultry and meat packaging facilities and slaughter houses, 

sinks, drain boards, cabinets, garbage cans, under sinks, faucets. 

Medical Premises and Equipment 

Phenol and salts are used as disinfectants, deodorizers and cleaners for the 

following hard, non-porous surfaces: health/hospital treatment and patient 

rooms, operating rooms, ambulances, medical and dental equipment, beds, 

surgical carts, countertops, mannequins, hemodialysis and dialysis 

machines, bathrooms, wheelchairs, walkers, animal areas, trash containers, 

medical devises. 

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Residential and Public Premises 

Phenol and salts are used as disinfectants, deodorizers and cleaners for the 

following hard, non-porous surfaces: telephones, keyboards, furniture, 

wheelchairs, walkers, sinks, floors, walls, light switches, linen hampers, 

bathrooms, kennels and animal areas, schools, restaurants, hotels, boats, 

planes, trains, buses, health spas, nursing homes, walls, countertops, 

floors, and air ducts (HVAC). Phenol and salts are also used to clean, 

deodorize and remove debris from carpets and fabrics. 

Materials Preservative 

Phenol and salts are used as an industrial additive for polishes, cleansers 

and protectants. Prior to April 12, 2005 phenol and salts were used as a 

materials preservative in paints. This use was voluntarily cancelled as a 

result of the risks identified in the “Phenol/Sodium Phenate Reregistration 

Decision” memorandum, dated September 30, 2004. However, the 

findings of the risk assessment conducted for the paint use are outlined in 

this document. 

Target Pests:	 Animal Pathogenic Bacteria (G- and G+ Vegetative); Animal Pathogenic 

Fungi; Aspergillus Niger; Avian Influenza Virus A; Canine Parvovirus; 

Coronavirus; Cytomegalovirus; Herpes Simplex Virus I; Herpes Simplex 

Virus II; HIV-I (Human Immunodeficiency Virus); Hydrophilic Virus; 

Influenza A2 (Hong Kong); Influenza Virus A2 (Japan 305/57 Asian 

Strain); Lipophilic Viruses; Mold/Mildew; Mycrobacterium SPP 

(Tubercle Bacilli); Parvovirus; Poliovirus Type 1; Pseudomonas SPP; 

Streptococcus Pyogenes; Vaccinia Virus 

Formulation Types: Ready-to-Use, Pressurized Liquid, Impregnated Materials 

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III. Summary of Risk Assessments 

The purpose of this summary is to assist the reader by identifying the key features and 

findings of these risk assessments and to help the reader better understand the conclusions 

reached in the assessments. The human health and ecological risk assessment documents and 

supporting information listed in Appendix C were used to formulate the safety finding and 

regulatory decision for phenol and salts. While the risk assessments and related addenda are not 

included in this document, they are available from the OPP Public Docket EPA-HQ-OPP-2004-

0301, and may also be accessed from www.regulations.gov. Hard copies of these documents 

may be found in the OPP public docket. The OPP public docket is located in Room S-4900, One 

Potomac Yard, 2777 South Crystal Drive, Arlington, VA 22202, and is open Monday through 

Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m. 

The Agency’s use of human studies in the phenol and salts risk assessment is in 

accordance with the Agency's Final Rule promulgated on January 26, 2006, related to 

Protections for Subjects in Human Research, which is codified in 40 CFR Part 26. 

A. Human Health Risk Assessment 

1. Toxicity of Phenol and Salts 

A brief overview of the toxicity studies used for determining endpoints in the risk 

assessment is outlined below in Table 1. Further details on the toxicity of phenol and salts can 

be found in the “Phenol/Sodium Phenate: Toxicology Chapter for the AD Preliminary Risk 

Assessment Document. PC Code: 064001, 064002,” dated July 6, 2004 and the “Phenol-Report 

of the Antimicrobials Division Toxicology Endpoint Selection Committee,” dated July 7, 2004. 

These documents are available on the Agency’s website in the EPA Docket at: 

http://www.regulations.gov (Docket ID EPA-HQ-OPP-2004-0301). 

The Agency has reviewed all toxicity studies submitted for phenol and salts and has 

determined that the toxicological database is sufficient for reregistration. The studies have been 

submitted to support guideline requirements. Major features of the toxicology profile are 

presented below. Table 1 is a summary of the acute toxicity data and Table 2 summarizes the 

toxicological endpoints selected for the exposure scenarios. 

a. Acute Toxicity 

The acute toxicity database for phenol and salts is considered complete. For oral and 

dermal routes of exposure the acute toxicity of phenol and salts is moderate (Toxicity Category 

II or III) and produces severe and marked irritation to the eyes and skin (Toxicity Category I or 

II). Phenol concentration used in acute inhalation studies failed to induce mortality in the study 

animals and, therefore, toxicity endpoints and a toxicity category could not be established. 

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The following table summarizes the acute toxicity of phenol and salts. 

Table 1. Summary of Acute Toxicity Data for Phenol and Salts 

Guideline 

No. 

Study Type/ Test 

Substance (% AI) 

MRID #(s)/ 

Citation 

Results Toxicity 

Category 

Acute Toxicity 

870.1100 

(§81-1) 

Acute Oral- Rat 

Phenol purity > 99% Berman, et al., 

1994 

LD50 = 400 (297-539) mg/kg/day II 

870.1100 

(§81-1) 

Acute Oral- Rat 

Phenol purity 100% 

OTS# 0515567 

86-870001405 

LD50 = 1,030 (940-1120) mg/kg/day III 

870.1100 

(§81-1) 

Acute Oral- Rat 

Phenol purity not reported 

Flickinger, 1976 LD50 = 650 (490-860) mg/kg/day III 

870.1200 

(§81-2) 

Acute Dermal ToxicityRat 

Phenol Purity not reported 

Brown, et al., 

1975 

LD50 (non-occluded) = 0.68 (0.57-0.78) 

mL/kg 

LD50 (occluded) = 0.50 mL/kg 

II 

870.1200 

(§81-2) 

Acute Dermal- Rabbit 

Sodium Phenate purity 

57% 

OTS # 0515564 

86-870001402 LD50 = 2,350 (1,880-2,940) mg/kg/day III 

870.1200 

(§81-2) 

Acute Dermal- Rabbit 

Phenol purity 100% 

OTS # 0515567 

86-870001405 LD50 = 0.63 (0.56-0.70) mL/kg II 

870.1200 

(§81-2) 

Acute Dermal- Rat 

Phenol purity laboratory 

reagent grade 

Conning et al., 

1970 LD50 = 669.4 mg/kg/day II 

870.1200 

(§81-2) 

Acute Dermal- Rabbit 

Phenol purity not reported Flickinger, 1976 LD50 = 850 (600-1,200) mg/kg/day II 

870.1300 

(§81-3) 

Acute Inhalation- Rat 

Phenol purity 100% 

OTS # 0515567 

86-870001405 

No deaths occurred at 2.5 L/min for 8 

hours 

Not 

established 

870.1300 

(§81-3) 

Acute Inhalation- Rat 

Phenol purity not reported Flickinger, 1976 

No deaths occurred at 900 mg/m3

 for 8 

hours 

Irritation and time-related CNS effects 

Not 

established 

870.2400 

(§81-4) 

Acute Eye IrritationRabbit 

Sodium Phenate purity 

57% 

OTS #0515564 

86-870001402 

15% solution caused corneal necrosis 

and conjunctiva lesions II 

870.2400 

(§81-4) 

Acute Eye IrritationRabbit 

Phenol purity 100% 

OTS # 0515567 

86-870001405 

Severe damage to the cornea at 15% and 

lesser damage in 5% 

Not 

established 

870.2400 

(§81-4) 

Acute Eye IrritationRabbit 

Phenol purity not reported Flickinger, 1976 

Dose not provided. Severe conjunctiva, 

iritis, corneal opacities and ulcerations 

with no improvement after 14 day 

observation period. I 

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Guideline 

No. 

Study Type/ Test 

Substance (% AI) 

MRID #(s)/ 

Citation 

Results Toxicity 

Category 

870.2500 

(§81-5) 

Acute Dermal IrritationRabbit 

Sodium Phenate purity 

57% 

OTS # 0515564 

86-870001402 

Mild to marked erythema and marked 

capillary injection were observed in 

50% of animals tested II 

870.2500 

(§81-5) 

Acute Dermal IrritationRabbit 

Phenol purity 100% 

OTS # 0515567 

86-870001405 

10% solution caused moderate to 

marked erythema 

Not 

established 

870.2500 

(§81-5) 

Acute Dermal IrritationRabbit 

Phenol purity not reported Flickinger, 1976 Corrosive I 

b. Carcinogenicity 

The two carcinogenicity studies preformed by the National Cancer Institute produced no 

incidences of neoplasms in male and female mice or rats following administration of phenol, 

with the exception of a statistically significant increase in the occurrence of leukemia, 

lymphoma, or interstitial-cell tumors in low-dose male rats. Due to the lack of significant tumors 

in high-dose males, females and mice, phenol was found to be non-carcinogenic in the 2-year 

drinking water studies. Although phenol-treated rats and mice experienced a decrease in mean 

body weight and body weight gain, reduction was not significantly different from the respective 

controls and there was no chronic toxicity at concentration up to 5,000 ppm. A 20-week dermal 

toxicity study exhibited effects of chronic irritation and hair growth inhibition with 

administration of 3 mg phenol (in 200 uL acetone). A single papilloma was found 7 weeks into 

the study but there was no evidence that it was significantly increased or treatment-related. In a 

special mechanistic study there was no evidence of tumor initiation or hepatocyte GSH depletion 

following administration of 100 mg/kg/day phenol. 

c. Toxicological Endpoints 

The phenol and salts toxicity endpoints used in the current risk assessment are 

summarized below in Table 2. 

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Table 2. Toxicological Endpoints for Phenol and salts 

Exposure 

Scenario 

Dose Used in Risk 

Assessment, UF 

Target MOE, 

Uncertainty 

Factory (UF) for 

Risk Assessment 

Study and Toxicological Effects 

Dietary Risk Assessments 

Acute Dietary 

(gen population) 

This risk assessment is not needed because there are no use patterns that result in 

acute dietary exposure. 

Acute Dietary 

(females 13-49) 

This risk assessment is not not needed because there are no use patterns that result 

in acute dietary exposure. 

Chronic Dietary 

(all populations) 

NOAEL= 60 

mg/kg/day 

UF = 100 

Chronic RfD = 

0.6 mg/kg/day 

Chronic PAD = 

0.6 mg/kg/day 

FQPA SF = 1x Developmental toxicity study in rats (Argus, 

1997) 

NOAEL based on decreases in maternal 

body weight gain at 120 mg/kg/day 

(LOAEL). 

Non-Dietary Risk Assessments 

Incidental Oral 

(short-term) 

Residential Only 

NOAEL= 60 

mg/kg/day 

MOE = 100 Developmental toxicity study in rats 

(Argus, 1997) 

NOAEL based on decreases in maternal 

body weight gain at 120 mg/kg/day 

(LOAEL). 

Incidental Oral 

(intermediateterm) 

Residential Only 

NOAEL= 60 

mg/kg/day 

MOE = 100 Developmental toxicity study in rats 

(Argus, 1997) 

NOAEL based on decreases in maternal 

body weight gain at 120 mg/kg/day 

(LOAEL). 

Dermal1 

(short- and 

intermediate-term 

NOAEL = 60 

mg/kg/day

 MOE = 100 Developmental toxicity study in rats 

(Argus, 1997) 

NOAEL based on decreases in maternal 

body weight gain at 120 mg/kg/day 

(LOAEL). 

Inhalation 

(All durations) 

LOAEL = 0.1 mg/L 

(26 mg/kg/day) 

MOE = 300 

(ST, IT) 

MOE = 1,000 (LT) 

Dalin and Kristofferson: Physiological 

Effects of a Sub-lethal Concentration of 

Inhaled Phenol on the Rat. Ann. Zool. 

Fennici 11: 193-199, 1974 

LOAEL of 0.1 mg/L, based on alterations in 

sliding angle from tilting plane test, and 

significant increases in liver enzymes. 

Cancer Data inadequate for assessment of human carcinogenic potential (USEPA, 2002a) 

1

A dermal absorption factor of 50% is used since an oral endpoint was selected. Dermal absorption data were available from the 

IRIS Toxicological profile for phenol. From the available data, dermal absorption percentages of 20-50% have been observed 

from in-vivo and in-vitro studies. The Agency selected the 50% dermal absorption value for phenol for use in risk assessments as 

a conservative value. This value also takes into account the irritant properties of phenol which may increase its dermal 

absorption. 

- 10 -
2. Endocrine Disruptor Potential 

The EPA is required under the FFDCA, as amended by the Food Quality Protection Act 

(FQPA), to develop a screening program to determine whether certain substances (including all 

pesticide active and other ingredients) “may have an effect in humans that is similar to an effect 

produced by a naturally occurring estrogen, or other endocrine effects as the Administrator may 

designate.” Following recommendations of its Endocrine Disruptor Screening and Testing 

Advisory Committee (EDSTAC), EPA determined that there was a scientific basis for including, 

as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen 

hormone system. EPA also adopted EDSTAC's recommendation that EPA include evaluations 

of potential effects in wildlife. For pesticides, EPA will use its authorities under FIFRA and/or 

the FFDCA to require any necessary data on endocrine-related effects. As the science develops 

and resources allow, screening for additional hormone systems may be added to the Endocrine 

Disruptor Screening Program (EDSP). 

3. FQPA Safety Factor 

The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is 

intended to provide an additional 10-fold safety factor (10X), to protect for special sensitivity in 

infants and children to specific pesticide residues in food, drinking water, or residential 

exposures, or to compensate for an incomplete database. The Agency has concluded that the 

FQPA Safety Factor should be removed (i.e., reduced to 1X) for phenol and salts based on: (1) a 

complete toxicology data base with respect to assessing the increased susceptibility to infants 

and children as required by FQPA; (2) a lack of evidence that phenol and salts will induce 

neurotoxic effects; (3) no evidence of increased susceptibility to the fetus following in utero 

exposure in the prenatal developmental toxicity studies; (4) no evidence of increased 

susceptibility to the offspring when adults are exposed in the two-generation reproductive study; 

and (5) the risk assessment does not underestimate the potential exposure for infants and 

children. Based on the analysis of submitted developmental toxicity studies, the Agency 

determined that no special FQPA Safety Factor was needed since there were no residual 

uncertainties for pre- and/or post-natal toxicity. 

4. Dietary Exposure and Risk 

Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which 

reflects the reference dose (RfD), either acute or chronic, that has been adjusted to account for 

the FQPA Safety Factor (SF). This calculation is performed for each population subgroup. A 

risk estimate that is less than 100% of the acute or chronic PAD is not of concern. The Agency 

has conducted a dietary exposure and risk assessment for the use of phenol and salts as a hadsurface disinfectant for counter tops (e.g., kitchen countertops). Currently, phenol and salts 

products are registered to disinfect countertops in kitchens, among other areas. A dietary risk 

assessment was conducted to address the possibility of indirect food contact resulting from the 

use of phenol and salts as a disinfectant on countertops, which may come in to contact with food 

after treatment. For further information on the dietary exposure assessment for phenol and salts, 

please refer to the “Phenol Dietary Exposure Assessment for the Reregistration Eligibility 

Decision,” document, dated May 18, 2004. 

- 11 -
 

a. Dietary Exposure Assumptions 

There are two exemptions from the requirement of a tolerance for phenol as an inert 

ingredient under 40 CFR 180.920 and 180.930; however, there are no active registrations for 

these uses. Therefore, as outlined in the “Phenol/Sodium Phenate Reregistration Decision” 

document memo, the Agency recommends that these exemptions from the requirement of a 

tolerance be revoked. The revocation of these exemptions from tolerances will be revoked in the 

future. 

The dietary risk assessment considered potential food exposures from the use of phenol 

and salts as a disinfectant for hard surface, non-porous countertops (e.g., kitchen countertops). 

There are two phenol and salts products, which are currently registered to disinfect countertops 

in kitchens, among other areas. One product is a ready-to-use solution, while the other is a 

wettable disposable cloth that is impregnated with phenol and salts. A countertop that has been 

treated with either of these products may come into contact with food prepared on the treated 

countertop, which in turn may be ingested. Although neither product label states that it should 

be used on food preparation equipment, it is possible that food could be prepared or placed on 

treated kitchen countertops before being eaten and, therefore, a dietary exposure assessment was 

needed. 

In the absence of residue data, the Agency estimated residue levels that may occur in 

food that contacts countertop surfaces treated with disinfectants from the maximum application 

rates on phenol and salts product labels. When assessing the dietary risks, the Agency used the 

Food and Drug Administration’s (FDA) Center for Food Safety & Applied Nutrition’s (CFSAN) 

screening-level approach as presented in the “Preparation of Food Contact Notifications and 

Food Additive Petitions for Food Contact Substances: Chemistry Recommendations,” dated 

April 2002. Using the maximum application rates and U.S. FDA’s default assumptions, “worstcase” dietary concentration values were calculated by the Agency. This model was used to 

determine the estimated daily intake (EDI). The Agency also used this methodology to assess 

possible indirect food contact exposure and risk from disinfectants. Additional information 

regarding the dietary exposure assessment can be found in the “Phenol Dietary Exposure 

Assessments for the Reregistration Eligibility Decision,” dated May 18, 2004, the “Phenol RED 

Document,” dated July 7, 2004 and the “Phenol/Sodium Phenate Reregistration Decision” 

document memo, dated September 30, 2004. 

5. Dietary Risk Assessment 

a. Acute PAD 

Acute dietary risk is assessed by comparing acute dietary exposure estimates (in 

mg/kg/day) to the acute Population Adjusted Dose (aPAD). Acute dietary risk is expressed as a 

percent of the aPAD. The aPAD is the acute reference dose modified by the FQPA Safety Factor. 

An acute dietary assessment was not conducted for phenol and salts because no endpoints 

appropriate for a dietary risk assessment were identified in the toxicity database, which is largely 

complete. This conclusion was based on examination of the available toxicity hazard data. Also, 

the body weight effects observed in the available data were not felt to be the result of a single 

exposure and there were no other adverse effects from the data that were considered reflective of 

- 12 -
 

 

 

a single exposure. Therefore, an acute RfD/PAD value was not selected. Phenol and salts do not 

pose as an acute dietary risk and an acute dietary risk assessment was not conducted. 

b. Chronic PAD 

Chronic dietary risk for phenol and salts is assessed by comparing chronic dietary 

exposure estimates (in mg/kg/day) to the chronic Population Adjusted Dose (cPAD). Chronic 

dietary risk is expressed as a percent of the cPAD. The cPAD is the chronic reference dose (0.6 

mg/kg/day) modified by the FQPA Safety Factor (1x). The cPAD was derived from a 

developmental toxicity study in rats in which the NOAEL (60 mg/kg/day) was determined. For 

the disinfectant solutions use, the cPAD is 7.5% for adult males, 9.0% for adult females and 36% 

for children. Because the risk estimate is less than 100% of the chronic PAD, there are no 

chronic dietary risks of concern from the use of phenol and salts as a disinfectant. The 

disinfectant solutions use was assessed for indirect food contact and 10% transfer efficiency was 

assumed. The Agency determined that there are no chronic dietary concerns as a result of this 

use. 

Table #3. Disinfectant Solutions Indirect Dietary Exposure and Risk 

Population Subgroup EDI 

(mg/person/day) Dietary Exposure 

(mg/kg/day) a % cPAD b 

Chronic Dietary 

Disinfectant Solutions 

Adult male 3.2400 4.50e-02 7.50 

Adult female 3.2400 5.40e-02 9.0 

Child 3.2400 2.16e-01 36.0 

a- For adult males, chronic exposure analysis is based on a body weight of 70 kg. For adult females, chronic exposure analysis is based on a body
 

weight of 60 kg. For children, exposure is based on a body weight of 15 kg.
 

b- %cPAD = dietary exposure (mg/kg/day) * 100 / cPAD, where cPAD for adults and children = 0.6 mg/kg/day.
 

c. Dietary Risk from Drinking Water 

Phenol and salts are not used for water treatment and the active ingredients are not 

expected to contact fresh water environments. Despite phenol’s high water solubility and poor 

sorption to soil, biodegradation of phenol is sufficiently rapid. Therefore, the probability of 

groundwater contamination is low. Because phenol absorbs lightly (in the region of 290-330 

nm) it might photodegrade directly in surface water and it is not expected to absorb to sediment 

in the water column. Also, based on its use patterns, the potential for phenol and salts to impact 

drinking water sources is negligible. Therefore, a drinking water assessment was not conducted. 

6. Residential Exposure and Risk Assessments 

a. Residential Handler Exposure and Risk 

The residential exposure scenarios assessed for phenol and salts represent worst case 

exposure scenarios. The EPA selected high-end representative use scenarios based on maximum 

- 13 -
 

 

application rates as stated on the product labels. The Agency considered the following use 

scenarios for residential handlers of phenol and salts: 

Residential Handler Use Scenarios 

• Application of treated paint- brush/roller 

• Application of treated paint- airless sprayer 

• Hard surface disinfection- aerosol spray 

• Hard surface disinfection- towelettes 

• Painting- vapor exposure 

• General purpose cleaning solution- vapor exposure 

Dermal and inhalation exposures were assessed for these scenarios using the Pesticide 

Handler Exposure Database (PHED, Version 1.1) and values were found in the EPA’s Standard 

Operating Procedures (SOP) for Residential Exposure Assessments (U.S. EPA, 1997a, 2001). 

The dermal and inhalation exposures from these techniques have been normalized by the amount 

of active ingredient handled and are reported as unit exposures (UE), which are expressed as 

mg/lb of active ingredient handled. Dermal and inhalation exposures were also assessed by 

using surrogate data from the Chemical Manufacturers Association (CMA, 1992), the Exposure 

and Fate Assessment Screening Tool Model (EFAST, v1.0), Wall Paint Exposure Assessment 

Model (WPEM) and several studies that relate to the use patterns of phenol and salts. 

Based on toxicological criteria and potential for exposure, the Agency has conducted 

dermal and inhalation risk assessments for residential handler exposure. An MOE greater than 

or equal to 100 is considered adequately protective for the dermal route of exposure. Also, a 

dermal absorption factor of 50% is used since an oral endpoint was selected. For inhalation 

exposure the target MOE for identifying risks of concern for short- and intermediate-term 

exposure durations is 300 (10x inter-species extrapolation, 10x intra-species variation, 3x for 

use of a LOAEL). For long-term inhalation exposures the target MOE is 1,000 (10x interspecies extrapolation, 10x intra-species variation, 3x for use of a LOAEL and 3x for lack of a 

long-term study). However, no long-term uses for phenol and salts have been identified. For the 

residential handler risk assessment the following use scenarios indicate risks of concern: 

Residential Handler Risks of Concern 

(Target Inhalation MOE = 300/ Target Dermal MOE = 100) 

•	 Painting: Airless Sprayer1

 (ST Dermal MOE = 12) 

(ST/IT Inhalation MOE = 290) 

•	 Painting: Paintbrush/Roller1

 (ST Dermal MOE = 12) 

•	 Painting: Vapor Exposure1

 (ST Inhalation MOE = 27) 

However, it should be noted that all phenol and salts paint uses were voluntarily 

cancelled on April 12, 2005 to mitigate the residential and occupational risks of concern that 

- 14 -
 

were identified within the “Phenol/Sodium Phenate Reregistration Decision” memorandum, 

dated September 30, 2004. Therefore, there are no longer any residential or occupational 

applicator risks of concern associated with the use of phenol and salts as a paint preservative 

because this use has been cancelled. 

For further information regarding the residential handler exposure and risk estimates refer 

to the “Phenols Occupation & Residential Exposure Assessment,” dated September 9, 2004, the 

“Phenol RED Document,” dated July 7, 2004 and the “Phenol/Sodium Phenate Reregistration 

Decision” memo, dated September 30, 2004. 

b. Post-Application Residential Exposure and Risk 

Residential post-application exposures result when adults and children come in contact 

with phenol and salts in areas where pesticide end-use products have recently been applied (e.g., 

treated carpets, HVAC ductwork), or when children incidentally ingest the pesticide residues 

through mouthing the treated end-products/treated articles (i.e., hand-to-mouth or object-tomouth contact). The residential post-application exposure scenarios assessed for phenol and 

salts represent worst case exposure scenarios. The EPA selected high-end representative use 

scenarios based on maximum application rates as stated on the product labels. The Agency 

considered the following use scenarios for post-application residential exposure to phenol and 

salts: 

Post-Application Residential Exposure Scenarios 

•	 Treated Carpets (machine cleaned/shampooed) 

(ST Dermal & Oral- children) 

 (ST Inhalation exposure from vapors- adults & children) 

•	 Paint Vapors (resulting from painting indoors) 

(ST Inhalation) 

•	 Re-entering residential and/or occupational sites with treated HVAC Ductwork 

(ST/IT Inhalation- occurs as the phenol evaporates from the duct surface and mixes 

with air flowing through the duct) 

At this time, the Agency does not have residue dissipation data or reliable use pattern 

data, including the frequency and duration of use of antimicrobial products in the residential 

setting. Therefore, to assess residential handler and post-application risks, the Agency used 

surrogate unit exposure data from the following proprietary resources: Chemical Manufacturers 

Association (CMA) antimicrobial exposure study; the Pesticide Handlers Exposure Database 

(PHED); Exposure and Fate Assessment Screening Tool Model (EFAST, v1.0), and the Wall 

Paint Exposure Assessment Model (WPEM). Additionally, the EPA’s Health Effects Division’s 

(HED) Standard Operating Procedures (SOPs) for Residential Exposure Assessments, was used 

when estimating post-application/ bystander exposures. 

The Agency assessed potential post-application inhalation exposure to residents resulting 

from re-entry into residential and occupational buildings, which previously had HVAC ductwork treatment. Post-application inhalation exposures resulting from re-entry into buildings with 

treated HVAC duct-work were assessed using the Indoor Air Quality and Inhalation Exposure 

- 15 -
 

 

 

(IAQX Model 21, Version 1.0), a chamber emissions study and the Antimicrobial Version of the 

EPA Risk Model (Antimicrobial Screening Model Version 1.9, Les Sparks, US EPA ORD, 

10/1/2004). Given that there are many uncertainties with the HVAC assessment, the Agency 

used several models to assess possible exposure resulting from the phenol and salts HVAC use. 

Uncertainties with this risk assessment include extremely limited label instructions (e.g., no 

application rates on registered label), lack of model validation for this specific use pattern, and 

limitations regarding the submitted chamber emission study. When estimating possible postapplication residential risks of concern resulting from the HVAC use, the Agency used the model 

that yielded the most conservative risk estimates to account for these uncertainties. 

 Based on the registered phenol and salts HVAC use label there are no risks of concern, if 

re-entry is delayed for 24 hours after application to residential buildings (e.g., homes) and 3 

hours after application to occupational/commercial buildings (e.g., offices/commercial sites). 

However, if there is no re-entry delay after application to residential buildings, post-application 

inhalation risks of concern were identified (MOE = 47 w/ no waiting time before re-entry into a 

residential building, using IAQX Model). Post-application inhalation risks of concern were also 

identified if there is no re-entry delay after application to an occupational building (MOE = 26 w/ 

no waiting time before re-entry into occupational building, using Anti-Microbial Risk Model). 

The registrant has voluntarily requested to lower the application rate for the HVAC use to 

4 ounces per 2,000 square feet (sf) of building area to reduce the REI at which exposures do not 

result in risks of concern, from 24 hours to 3 hours (for residential sites) and from 3 hours to 

none (for occupational sites). Using the lower application rate, the estimated MOEs (for 

residential treated sites) are greater than the target MOE of 300 if re-entry into treated residential 

buildings is delayed by 3 hours after application (using the AntiMicrobial Risk Model). For the 

occupational/commercial treated sites the MOEs are at or above 300 immediately after 

application and no re-entry delay is needed for the commercial building scenarios using the 

lower application rate of 4 ounces per 2,000 square ft. 

Also, confirmatory data are needed to support the Agency’s post-application HVAC 

exposure assessment due to uncertainties with this assessment. Uncertainties with this risk 

assessment include extremely limited label instructions (e.g., no application rates on registered 

label), lack of model validation for this specific use pattern and limitations regarding the 

submitted chamber emission study. Additional data are needed to quantify phenol emissions and 

exposures. This data must include chamber data to determine the emission rate of phenol under 

the conditions of use and whole building data to determine how these conditions affect real 

world phenol exposures. 

The MOEs for all of the other post-application residential exposure scenarios assessed are 

above their respective target MOEs and, therefore, there are no residential post-application 

exposure risks of concern from phenol and salts for these use scenarios. However, as previously 

mentioned, in order to lower the REI at which exposures do not result in risks of concern, from 

24 hours to 3 hours for treated residential sites and to eliminate the need for an REI for treated 

occupational sites, all HVAC use labels must be updated with the new application rate of 4 

ounces per 2,000 square feet. 

- 16 -
 

 

 

 

 

For further information regarding the residential post-application exposures and risk 

estimates please refer to the “Phenols Occupation & Residential Exposure Assessment,” dated 

September 9, 2004, the “Occupational and Residential Exposure and Risk Assessment for the 

Duct Cleaning Use of Phenol (Sporicidin),” dated December 18, 2008 and the “Phenol RED 

Document,” dated, July 7, 2004. 

7. Aggregate Risk Assessment 

The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic 

Act (FFDCA, Section 408(b)(2)(A)(ii)) require “that there is reasonable certainty that no harm 

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

dietary exposures and other exposures for which there are reliable information.” Aggregate 

exposure is the total exposure to a single chemical (or its residues) that may occur from dietary 

(i.e., food and drinking water), residential, and other non-occupational sources, and from all 

known or plausible exposure routes (oral, dermal, and inhalation). 

When selecting the exposure scenarios for the aggregate assessments, the use patterns of 

phenol and salts and the probability of co-occurrence were considered. Dietary and residential 

exposure scenarios for phenol and salts were aggregated for adults and children (dietary & 

residential exposure from cleaning solutions for adults; dietary & dermal and incidental oral 

exposure from treated carpets for children). The aggregate exposure MOEs were all above the 

target MOEs of 100 and, therefore, there are no aggregate risks of concern for phenol and salts. 

Inhalation exposures were not aggregated because the Agency believes that inhalation exposures 

are not likely to co-occur (e.g., the use of phenol and salts as a paint preservative was cancelled 

and the likelihood for inhalation co-exposure resulting from the use of phenol and salts to treat 

HVAC systems and fogging clean rooms is very unlikely). For further information regarding the 

aggregate assessment please refer to the “Phenol RED Document,” dated July 7, 2004. 

Table 4. ST/IT Aggregate Oral/Dermal Exposure and Risk Assessment 

Population

Exposure Scenarios (ST/IT) 

 NOAEL 

mg/kg/day 

Target 

MOE1 

Max 

Exposure2 

mg/kg/day 

Average 

Food Exposure 

mg/kg/day 

Residential 

Exposure3 

mg/kg/day 

Aggregate MOE (food 

and residential)4 

Adult Male 60 100 0.6 0.045 0.46 119 

Adult 

Female 

60 100 0.6 0.054 0.46 117 

Toddlers 60 100 0.6 0.216 0.0035 273 

1

10x intra-species, 10x inter-species uncertainty factors applied. 2

 Maximum Exposure (mg/kg/day) = NOAEL/Target MOE 

3

 Residential Exposure = Dermal exposure from cleaning (adults); dermal + incidental oral exposure from carpets 

(toddlers)

4

 Aggregate MOE = [NOAEL ÷ (Avg. Food Exposure + Residential Exposure)] Target MOE of 100. 

- 17 -
8. Occupational Handler Exposure and Risk 

Workers can be exposed to a pesticide through mixing, loading, applying a pesticide, or 

re-entering treated sites. Phenol and salts are used as disinfectants and as materials 

preservatives. Potential occupational handler exposure can occur in various use sites during the 

application and use of disinfectant solutions, disinfectant/deodorizing sprays, and disinfectant 

towelettes; and the preservation of materials. The “preservation of materials” refers to the 

scenario of a worker adding the preservative to the material being treated (paint, etc.) through 

either liquid pour or liquid pump methods. The representative uses that were assessed are as 

follows: 

Occupational Exposure Scenarios 

• Materials Preservation of Paints- liquid pour 

• Application of Treated Paint- airless sprayer 

• Application of Treated Paint- paintbrush/roller 

• Hemodialysis Machine- liquid pour of disinfectant 

• Hard Surface Disinfection- aerosol spray 

• Hard Surface Disinfection- towelette 

• Loading fogger (for fogging clean rooms)- liquid pour 

• Application of disinfectant to HVAC ductwork- fogging 

• Paint vapor exposure (WEPM) 

• General purpose cleaning solution vapor exposure 

Dermal and inhalation exposures were assessed for these scenarios using application rates 

from currently registered product labels, EPA estimates of daily amount handled, the Pesticide 

Handler Exposure Database (PHED, Version 1.1), surrogate data from the Chemical 

Manufacturers Association (CMA, 1992), the Exposure and Fate Assessment Screening Tool 

Model (EFAST, v1.0), the Wall Paint Exposure Assessment Model (WPEM), and by using the 

Multi-Chamber Concentration and Exposure Model (MCCEM, v1.2). 

An MOE greater than or equal to 100 is considered adequately protective for the dermal 

route of exposure. A dermal absorption factor of 50% was used because an oral endpoint was 

selected. For inhalation exposure the target MOE for identifying risks of concern for short-term 

and intermediate-term exposure durations is 300 (10x inter-species extrapolation, 10x intraspecies variation, 3x for use of a LOAEL). For long-term inhalation exposures the target MOE 

is 1,000 (10x inter-species extrapolation, 10x intra-species variation, 3x for use of a LOAEL 

and 3x for lack of a long-term study). However, no long-term uses for phenol and salts have 

been identified. For the occupational handler risk assessment the following use scenarios 

indicate risks of concern. 

- 18 -
 

 

 

Occupational Handler Risks of Concern 

(Target Inhalation MOE = 300/ Target Dermal MOE = 100) 

•	 Hard Surface Disinfection: Towelette 

 (ST Dermal (with gloves) MOE = 70) 

•	 Painting: Airless Sprayer1

 (ST Dermal MOE = 21) 

(ST/IT Inhalation MOE = 88) 

•	 Painting: Vapor Exposure 1
 

(ST/IT Inhalation MOE = 72) 

It should be noted that all phenol and salts paint uses were voluntarily cancelled on April 

12, 2005 to mitigate the residential and occupational risks of concern that were identified within 

the “Phenol/Sodium Phenate Reregistration Decision” memorandum, dated September 30, 2004. 

Therefore, there are no longer any residential or occupational risks of concern associated with 

the use of phenol and salts as a paint preservative because this use has been cancelled. 

Short-term dermal risks of concern were identified for occupational handlers who use 

impregnated towelettes to disinfect hard surfaces (MOE = 70 with gloves). Although the MOE 

is below the target of 100, the Agency does not believe that there is a real risk issue of concern 

resulting from this use. Therefore, the Agency is requiring indoor dermal exposure data (OPPTS 

GL 875.1200) to confirm this assumption. The Agency used conservative methods in the 

absence of chemical specific data to assess this use. For example, the Agency used surrogate 

data from the Chemical Manufacturers Association (CMA, 1992) and the Pesticide Handlers 

Exposure Database; and in the absence of more specific use information, it was assumed that 1 

liter (equivalent to two 16oz cans) of the solution (used to wet the towelette) is used by the 

exposed individual per day. Therefore, confirmatory indoor dermal exposure data are required 

because the Agency believes that this data will confirm that these risk estimates are conservative 

and that there are in fact no dermal risks of concern resulting from the treated towelette use. 

Also, all phenol and salts product labels must be amended to require the use of gloves (PPE) by 

occupational handlers for all uses. 

For the application of phenol and salts to ductwork via fogging, there are no risks of 

concern if Personal Protective Equipment (PPE) is used during application. Product labels must 

be amended to include appropriate PPE as identified in Section IV of this document. If 

applications are made using probes inserted into the ductwork, such as might occur during 

residential and smaller scale commercial jobs, exposures will be limited to dermal contact with 

the probe and can be mitigated with the use of protective gloves. If the applications are made by 

an operator in the duct or plenum, such as might occur during large scale commercial jobs, both 

significant dermal and inhalation exposures could occur. 

1

 The use of phenol and salts as a materials preservative in paints was voluntarily cancelled on April 12, 2005 to 

mitigate the residential and occupational risks of concern identified in the memo “Phenol/Sodium Phenate 

Reregistration Decision,” dated September 30, 2004. Therefore, there are no longer any risks of concern associated 

with the use of phenol and salts as a paint preservative because this use has been cancelled. 

- 19 -
For further information regarding the occupational handler exposure and risk estimates 

refer to the “Phenols Occupation & Residential Exposure Assessment,” dated February 14, 2005, 

the “Phenol RED Document,” dated July 7, 2004, the “Phenol/Sodium Phenate Reregistration 

Decision” memorandum, dated September 30, 2004, the “Occupational and Residential Exposure 

and Risk Assessment for the Duct Cleaning Use of Phenol (Sporicidin),” dated December 18, 

2008 and the “Occupational and Residential Exposure and Risk Assessment for the Existing 

Fogging Cleanroom Use of Phenol (Sporicidin),” dated December 18, 2008. 

9. Post-Application Occupational Exposure and Risk 

Occupational handlers may have post-application inhalation exposure to phenol and salts 

by remaining in areas of treatment (e.g., medical personnel, janitors, etc.) and by re-entering 

treated sites (e.g., fogging clean rooms). The representative post-application occupational uses 

that were assessed are as follows: 

Post-Application Occupational Exposure Scenarios 

•	 General solution cleaning vapor exposure (medical personnel, janitors, etc.)

 (ST/IT Inhalation) 

•	 Re-entering a treated fogging clean room site 

(ST/IT Inhalation) 

Inhalation exposures for these post-application occupational scenarios were assessed 

using application rates from labels, EPA estimates of daily amount handled, the Exposure and 

Fate Assessment Screening Tool Model (EFAST, v1.0) and the Multi-Chamber Concentration 

and Exposure Model (MCCEM, v1.2). 

The MOEs for all of the post-application occupational exposure scenarios assessed are 

above their respective target MOEs and, therefore, there are no occupational post-application 

exposure risks of concern from phenol and salts for these use scenarios. 

For further information regarding the post-application occupational handler exposure and 

risk estimates refer to the “Phenols Occupation & Residential Exposure Assessment,” dated 

February 14, 2005, the “Phenol RED Document,” dated July 7, 2004, the “Occupational and 

Residential Exposure and Risk Assessment for the Duct Cleaning Use of Phenol (Sporicidin),” 

dated December 18, 2008 and the “Occupational and Residential Exposure and Risk Assessment 

for the Existing Fogging Cleanroom Use of Phenol (Sporicidin),” dated December 18, 2008. 

10. Phenol and salts Human Incident Data 

The Agency reviewed the following information for human poisoning incidents related to 

phenol and salts use and discovered that a large number of incidences associated with the 

exposure to phenol and salts end-use products have been reported: (1) OPP Incident Data System 

(IDS)- The Office of Pesticides Programs (OPP) Incident Data System contains reports of 

incidents from various sources, including registrants, other federal and state health and 

environmental agencies and individual consumers, submitted to OPP since 1992; (2) California 

Department of Pesticide Regulation (1982-2004)- The California Department of Pesticide 

Regulation pesticide poisoning surveillance program consists of reports from physicians of 

- 20 -
illness suspected of being related to pesticide exposure since 1982; (3) National Pesticide 

Telecommunications Network (NPTN)- NPTN is a toll-free information service supported by 

OPP that provides a ranking of the top 200 active ingredients for which telephone calls were 

received during calendar years 1984-1991; and (4) National Poison Control Centers (PCC) 

(1993-2002)- The Agency has received PCC data covering the years 1993-2002 for all 

pesticides. Most of the national PCCs participate in a national data collection system, the Toxic 

Exposure Surveillance System, which obtains data from about 65-70 centers at hospitals and 

universities. PCCs provide telephone consultation for individuals and health care providers on 

suspected poisonings involving drugs, household products, pesticides, etc. 

After review of the available incidence data it was determined that the primary routes of 

exposure are dermal, ocular and inhalation pathways. For dermal exposure, most of the incidents 

are related to irritation and/or allergic type reaction. The most common symptoms reported for 

cases of dermal exposure were skin irritation/burning, rash, itching, skin discoloration/redness 

and blistering. Also, allergic type reactions have been reported. For ocular exposure incidents 

eye pain, burning of eyes, conjunctivitis, blurring vision and acute inflammation have been 

reported. The most common symptoms reported for cases of inhalation exposure were 

respiratory irritation/burning, irritation to mouth/throat/nose, coughing/choking, shortness of 

breath, dizziness, flu-like symptoms and headache. Other systemic effects associated with 

phenol exposure can also occur through oral, dermal and inhalation routes of exposure. 

Neurologic effects, cardiac effects, nephrology and death have also been reported. 

For additional information refer to the “Incident Reports Associated with Phenol,” dated 

July 27, 2004 and the “Phenols RED Document,” dated July 24, 2004. 

B. Environmental Risk Assessment 

Phenol and salts are registered for indoor use only (e.g., disinfectants and sanitizers for 

non-porous hard-surfaces, materials preservatives). These indoor uses are considered to have 

minimal to no environmental exposure potential following use. It is unlikely that any 

appreciable exposure to terrestrial or aquatic organisms will occur when phenol and salts are 

used according to labeled directions. Also, the rapid degradation through multiple pathways in 

environmental media, as well as low toxicity to fish, invertebrates and aquatic plants indicate a 

low potential for risk in the unlikely event of environmental exposure from the registered uses. 

The toxicity of phenol and salts to birds could not be assessed due to a lack of available data; 

however, the low exposure potential makes risk to birds unlikely from the registered indoor uses 

of phenol and salts. Therefore, as a result of the extremely low probability for environmental 

exposure, an environmental exposure risk assessment was not needed or conducted for phenol 

and salts. 

For a detailed discussion of all aspects of the environmental hazard assessment refer to 

the “Ecological Hazard and Environmental Risk Assessment: Phenol and Salts,” July 28, 2004, 

the “Science Chapter on Environmental Fate Studies and Environmental Fate Assessment of 

Phenol,” dated January 29, 2003 and the “Phenols RED Document,” July 7, 2004. 

- 21 -
1. Environmental Fate and Transport 

Phenol degrades rapidly in soil, air and water and has a half life of less than one to five 

days. Its low Kow indicates little potential for bioaccumulation in fish and although it is readily 

taken up by plants, the high respiratory decomposition rate of phenol to CO2 indicates little 

potential for bioaccumulation in plant tissues. It is not expected to sorb to sediment. Due to 

multi-media degradation pathways, phenol and salts are not expected to be of environmental 

concern. 

2. Risks to Listed Species 

Section 7 of the Endangered Species Act (ESA), 16 U.S.C. Section 1536(a)(2), requires 

that federal agencies consult with the National Marine Fisheries Service (NMFS) for marine and 

andronomus listed species, or with the United States Fish and Wildlife Services (FWS) for listed 

wildlife and freshwater organisms, if proposing an "action" that may affect listed species or their 

designated habitat. Each federal agency is required under the Act to insure that any action they 

authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species 

or result in the destruction or adverse modification of designated critical habitat. To jeopardize 

the continued existence of a listed species is to "to engage in an action that reasonably would be 

expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and 

recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of 

the species." 50 CFR §402.02. 

To comply with subsection (a)(2) of the ESA, EPA’s Office of Pesticide Programs has 

established procedures to evaluate whether a proposed registration action may directly or 

indirectly appreciably reduce the likelihood of both the survival and recovery of a listed species 

in the wild by reducing the reproduction, numbers, or distribution of any listed species (U.S. 

EPA 2004). If any of the Listed Species LOC Criteria are exceeded for either direct or indirect 

effects in the Agency’s screening-level risk assessment, the Agency identifies any listed or 

candidate species that may occur spatially and temporally in the footprint of the proposed use. 

Further biological assessment is undertaken to refine the risk. The extent to which any species 

may be at risk determines the need to develop a more comprehensive consultation package as 

required by the ESA. 

For certain use categories, the Agency assumes there will be minimal environmental 

exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk 

Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency - 

Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB, 

pg.81). Chemicals in these categories therefore do not undergo a full screening-level risk 

assessment. Phenol and salts are registered for indoor use only (e.g., disinfectants and sanitizers 

for non-porous hard-surfaces, materials preservatives) and these uses typically fall into this 

category. This preliminary analysis does not indicate whether there is a potential for such phenol 

and salts uses to overlap with listed species and whether a more refined assessment is warranted, 

to include direct, indirect and habitat effects. The more refined assessment should involve clear 

delineation of the action area associated with proposed use of phenol and salts and the best 

available information on the temporal and spatial co-location of listed species with respect to the 

- 22 -
action area. This analysis has not been conducted for this assessment. Therefore, an endangered 

species effect determination will not be made at this time. 

- 23 -
IV. Reregistration Eligibility and Risk Management Decisions 

A. Determination of Reregistration Eligibility Decision 

Section 4(g)(2)(A) of FIFRA calls for EPA to determine, after submission of relevant 

data concerning an active ingredient, whether or not products containing the active ingredient are 

eligible for reregistration. EPA has previously identified and required the submission of the 

generic (i.e., active ingredient-specific) data required to support reregistration of products 

containing phenol and salts as an active ingredients. The Agency has completed its review of 

these generic data and has determined that the data are sufficient to support reregistration of all 

supported products containing phenol and salts (see Appendix B). 

The Agency has completed its assessment of the residential, occupational and ecological 

risks associated with the use of pesticide products containing the active ingredients phenol and 

salts. The Agency has determined that all uses of phenol and salts presented in Appendix A will 

not pose unreasonable risks to humans or the environment provided that: 1) all risk mitigation 

measures are implemented; 2) current data gaps and confirmatory data needs are addressed; and 

3) label amendments are made as described in Section V. Appendix A summarizes the uses of 

phenol and salts that are eligible for reregistration. Appendix B identifies the generic data 

requirements that the Agency reviewed as part of its determination for reregistration eligibility of 

phenol and salts and lists the submitted studies that the Agency found acceptable. Data gaps are 

identified as generic data requirements that have not been satisfied with acceptable data. 

The Agency has concluded that continued use of phenol and salts products would not 

meet the “no unreasonable adverse effects” criteria of FIFRA unless the mitigation measures and 

associated label changes presented in this document are implemented and confirmatory data are 

submitted. Accordingly, should a registrant fail to implement the risk mitigation measures, 

submit confirmatory data and make the label changes identified in this document, the Agency 

may take regulatory action to address the risk concerns from the use of phenol and salts. If all 

changes outlined in this document are fully complied with, then no risks of concern exist for the 

registered uses of phenol and salts for the purpose of this determination. 

1. Public Comments and Response 

Through EPA’s public participation process, EPA worked with stakeholders and the 

public to reach the regulatory decisions for phenol and salts. During the public comment period 

ending on September 29, 2004, the Agency received comments on the risk assessments from 

several respondents: California Regional Water Quality Control Board San Francisco Bay 

Region, Sanitation Districts of LA County, and the Natural Resource Defense Council (NRDC). 

All comments are available at http://www.regulations.gov in docket number EPA-HQ-OPP2004-0301. 

2. Regulatory Rationale 

The Agency has determined that phenol and salts are eligible for reregistration provided 

that the registrants implement the conditions, requirements and risk mitigation measures outlined 

within this RED including amended labeling and submission of additional data. The Agency 

24
 
believes that the uses presented in Appendix A will not present risks inconsistent with FIFRA as 

long as the required label amendments and risk mitigation measures, which are described in 

detail below, are implemented. A summary of the EPA’s rationale for reregistering and 

managing risks associated with continued use of phenol and salts products is presented below. 

In 2004, the EPA issued the “Phenol/Sodium Phenate Reregistration Decision” 

memorandum, dated September 30, 2004. The decision memorandum addresses the risks of 

concern identified in the 2004 phenol and salts risk assessment (“Phenols RED Document,” 

dated July 7, 2004) and the Agency’s risk management decisions to address these risks of 

concern. However, the fogging clean rooms use and the use of phenol and salts to treat HVAC 

ductwork were, inadvertently, not addressed in either of these documents. The purpose of this 

reregistration eligibility decision document is to not only summarize the findings and mitigation 

decisions outlined in the “Phenols RED Document” and the “Phenol/Sodium Phenate 

Reregistration Decision” memorandum but to present the findings of the Occupational and 

Residential Exposure (ORE) assessments that have been recently conducted for the fogging clean 

room and HVAC ductwork treatment uses. In addition, this document presents the Agency’s risk 

management decisions to support the continuation of these uses. For further information 

regarding these two assessments please refer to the “Occupational and Residential Exposure and 

Risk Assessment for the Existing Fogging Clean-room Use of Phenol (Sporicidin),” dated 

December 18, 2008 and the “Occupational and Residential Exposure and Risk Assessment for 

the Duct Cleaning Use of Phenol (Sporicidin),” dated December 18, 2008. Also, for further 

information regarding the risk management decisions discussed below please refer to the 

“Phenol/Sodium Phenate Reregistration Decision” memorandum, dated September 30, 2004. 

This document is located at http://www.regulations.gov in docket number EPA-HQ-OPP-2004-

0301. 

a. Risk Management 

The following is a summary of the Agency’s risk management measures developed to 

mitigate identified risks of concern associated with the use of phenol and salts products. 

Residential Handler Exposure Risk Mitigation 

Short-term dermal risks of concern were identified for residential paint application via 

airless sprayer and via paintbrush/roller. Risks of concern were also identified for short-

/intermediate-term inhalation exposure resulting from painting via airless sprayer. The use of 

phenol and salts as a paint preservative was voluntarily cancelled on April 12, 2005 to mitigate 

residential and occupational handler exposure risks of concern. Therefore, there are no longer 

any residential handler risks of concern associated with the use of phenol and salts as a paint 

preservative, because this use has been cancelled. All phenol and salts labels have been 

amended to delete the paint preservative use in April of 2005. 

Residential Post-Application Exposure Risks 

Residential post-application inhalation exposures are anticipated following the 

application of phenol and salts to HVAC ductwork, as phenol evaporates from the duct surface 

25
 
and mixes with air flowing through the duct. For residential buildings (e.g., houses) with treated 

HVAC systems there are no post-application risks of concern if re-entry into the residential 

building is delayed for 24 hours after application. However, if there is no waiting time before 

re-entry into a residential treated site, post-application inhalation risks of concern are identified 

(MOE = 47 if no time before re-entry; MOE = 300 if re-entry delayed by 24 hrs). For 

occupational buildings (e.g., offices/commercial settings) with treated HVAC systems there are 

no post-application risks of concern if re-entry into the occupational building is delayed for 3 

hours after application. However, if there is no waiting time before re-entry into an occupational 

treated site, post-application inhalation risks of concern are identified (MOE = 26 if no time 

before re-entry; MOE = 500 if re-entry delayed by 3 hrs). Therefore, to mitigate possible postapplication inhalation risks of concern all product labels with the HVAC use must be amended to 

indicate a 24 hour Restricted Entry Interval (REI) for re-entry into a residential treated site and a 

3 hour REI for re-entry into an occupational treated site. 

In order to reduce the REI from 24 hours to 3 hours (for residential sites) and from 3 

hours to none (for occupational sites), the registrant has voluntarily requested to lower the 

application rate for the HVAC use to 4 ounces per 2,000 square feet (sf) of building area. Using 

the lower application rate, the estimated MOEs (for residential treated sites) are greater than the 

target MOE of 300 if re-entry into treated residential buildings is delayed by 3 hours after 

application. For the occupational/commercial treated sites the MOE is above 300 immediately 

after application and no re-entry delay is needed for the commercial building scenarios using the 

lower application rate of 4 ounces per 2,000 square ft. Therefore, to reduce the REI from 24 

hours to 3 hours for re-entry into treated residential sites and to eliminate the need for an REI for 

treated occupational sites all labels with the HVAC duct-work treatment use must be amended to 

indicate the new application rate of 4 ounces per 2,000 sf. Also, to mitigate possible postapplication inhalation risks of concern resulting from re-entry into residential sites (MOE = 145 

with no waiting time before re-entry into residential settings with the lower application rate of 4 

ounces per 2,000 sf), all HVAC duct-work treatment use labels must be amended to include an 

REI of 3 hours for re-entry into treated residential sites. However, if the HVAC use labels are 

not amended to include the new application rate of 4 ounces per 2,000 square feet, an REI of 24 

hours for re-entry into treated residential sites and an REI of 3 hours for re-entry into treated 

occupational sites will be required on all HVAC labels to mitigate potential post-application 

inhalation risks of concern. 

Also, confirmatory data are needed to support the Agency’s current HVAC use 

assessment due to many uncertainties with this assessment. Uncertainties with this risk 

assessment include extremely limited label instructions (e.g., no application rates on registered 

label), lack of model validation for this specific use pattern and limitations regarding the 

submitted chamber emission study. The current chamber study that was used for the risk 

assessment has serious limitations, which include the fact that the chamber was maintained at an 

elevated temperature of 38o

 C (i.e. 100 F) and the first samples were not collected until four 

hours after application. Given these conditions, it is likely that a substantial amount of phenol 

was emitted before the first sample was collected. Therefore, new data (OPPTS GL 875.1200) 

are needed to determine the emission rate of phenol under the conditions of use. Also, whole 

building data (OPPTS GL 875.1200) are needed to determine how these conditions affect real 

26
 
 

 

work phenol exposures. The current label must also be amended to specify the application rate 

(4 ounces per 2,000 square feet) and methods of duct treatment. 

Occupational Handler Exposure Risks 

Short-term dermal and short-/intermediate-term inhalation risks of concern were 

identified for occupational paint application via an airless sprayer. The use of phenol and salts as 

a paint preservative was voluntarily cancelled on April 12, 2005 to mitigate residential and 

occupational handler exposure risks of concern. Therefore, there are no longer any occupational 

handler risks of concern associated with the use of phenol and salts as a paint preservative, 

because this use has been cancelled. All phenol and salts labels were amended to delete the paint 

preservative use in April of 2005. 

There are no occupational handler risks of concern resulting from the application of 

phenol and salts to HVAC ductwork if appropriate personal protective equipment (PPE) are used 

during application. Applicators treating the inside of an air duct system must wear chemical 

resistant coveralls, chemical resistant gloves and chemical resistant goggles. If the level of 

contamination cannot be determined in the space being treated, a maximum respiratory 

protection (SCBA or airline with an escape bottle) must be used. If needed, the full face 

respirator should also be equipped with a spray mist pre-filter in addition to the charcoal filters. 

All HVAC use labels must be amended to require the use of appropriate PPE. Also, all HVAC 

labels must be amended to include an application rate of 4 ounces per 2,000 sf. For a detailed 

explanation of the required PPE and application rate label language, please refer to Table 6 in 

this document. 

Short-term dermal risks of concern were identified for occupational handlers who use 

impregnated towelettes to disinfect hard surfaces (MOE = 70 with gloves). Although the MOE 

is below the target of 100, the Agency does not believe that there is a real risk issue of concern 

resulting from this use. Therefore, the Agency is requiring indoor dermal exposure data (OPPTS 

GL 875.1200) to confirm this assumption. The Agency used conservative methods in the 

absence of chemical specific data to assess this use. For example, the Agency used surrogate 

data from the Chemical Manufacturers Association (CMA, 1992) and the Pesticide Handlers 

Exposure Database; and in the absence of more specific use information, it was assumed that 1 

liter (equivalent to two 16oz cans) of the solution (used to wet the towelette) is used by the 

exposed individual per day. Therefore, confirmatory indoor dermal exposure data are required 

because the Agency believes that this data will confirm that these risk estimates are conservative 

and that there are in fact no dermal risks of concern resulting from the treated towelette use. 

Also, all phenol and salts product labels must be amended to require the use of gloves (PPE) by 

occupational handlers for all uses. 

3. Other Labeling Requirements 

In order to be eligible for reregistration, various use and safety information will be 

included in the labeling of all end-use products containing phenol and salts. For the specific 

labeling statements and a list of outstanding data, refer to Section V of this RED document 

27
 
 

V. What Registrants Need to Do 

The Agency has determined that products containing phenol and salts are eligible for 

reregistration provided that the conditions and requirements for reregistration identified in this 

RED are implemented (see Section IV). The registrants will also need to amend product 

labeling. 

The database supporting the reregistration of phenol and salts has been reviewed and 

determined to be adequate to support a reregistration eligibility decision. However, additional 

confirmatory data are required to support continued registration. 

A. Manufacturing Use Products 

1. Generic Data Requirements 

The generic databases supporting the reregistration of phenol and salts for currently 

registered products has been reviewed and determined to be adequate to support a reregistration 

eligibility decision. However, the following additional data requirements have been identified by 

the Agency as confirmatory data requirements and are included in the generic data-call-in (DCI) 

for this RED. The confirmatory data presented in Table 5 are required. 

Occupational Hander Confirmatory Data Needs 

Dermal risks of concern were identified for occupational handlers using impregnated 

towelettes to disinfect hard surfaces (MOE = 70 with gloves). Although the MOE is below the 

target of 100, the Agency does not believe that there is a real risk issue of concern resulting from 

this use. Therefore, the Agency is requiring indoor dermal exposure data (OPPTS GL 875.1200) 

to confirm this assumption. The Agency used conservative methods in the absence of chemical 

specific data to assess this use. For example, the Agency used surrogate data from the Chemical 

Manufacturers Association (CMA, 1992) and the Pesticide Handlers Exposure Database; and in 

the absence of more specific use information it was assumed that 1 liter (equivalent to two 16oz 

cans) of the solution used to wet the towelette, is used by the exposed individual per day. 

Therefore, the Agency believes the required dermal exposure data will confirm that these risk 

estimates are conservative and that there are in fact no dermal risks of concern resulting from this 

use. 

Residential & Occupational Post-Application Confirmatory Date Needs 

Due to uncertainties with the HVAC ductwork treatment assessment a chamber study and 

whole building study are needed to support the Agency’s current assessment. Uncertainties with 

this risk assessment include extremely limited label instructions (e.g., no application rates on 

label), lack of model validation and limitations regarding the submitted chamber emission study. 

These data are needed to quantify phenol emissions and exposures. 

The chamber study must be based on OPPTS Guideline 875.1200- Indoor Inhalation 

Exposure and ASTM D5116-06-Standard Guide for Small-Scale Environmental Chamber 

Determinations of Organic Emissions from Indoor Materials/Products. The specific conditions 

of the chamber study such as ventilation rate, air temperature, application method and 

28
 
 

application rate must match the conditions of the labeled use. It is recommended that a study 

protocol be submitted for review by the Agency prior to the initiation of the actual study. 

The whole building study must be based on OPPTS Guideline 875.1200- Indoor 

Inhalation Exposure. This study must be conducted at a representative application site during an 

actual application or at a simulated application site that is configured to match the characteristics 

of a representative application. The specific conditions such as ventilation rate, air temperature, 

application method and application rate must match the conditions of the labeled use. It is 

recommended that a study protocol be submitted for review by the Agency prior to the initiation 

of the actual study. 

Ecological Data Requirements 

As previously noted, an environmental exposure risk assessment was not conducted 

because the indoor uses of phenol and salts are considered to have minimal to no environmental 

exposure potential following use. However, in the event of accidental environmental exposure to 

phenol and salts (e.g., a spill resulting from a transportation accident), data are needed to 

determine the toxicity effects to non-target organisms. 

The following ecological studies are needed so that the Agency can determine whether a 

precautionary label statement concerning toxicity or potential adverse effects to non-target 

organisms is necessary: OPPTS GL 850.2100- avian acute oral; OPPTS GL 850.1075- acute 

freshwater fish; and OPPTS GL 850.1010- acute freshwater invertebrates. These acute studies 

measure toxicity in representative species of the non-target species most likely to be adversely 

affected and allow the EPA to develop precautionary labeling. Such labeling includes statements 

such as, “This product is extremely toxic to birds,” or “This product is toxic to fish.” These 

statements provide needed information in case of unintended or coincident exposure to phenol 

and salts, such as a transportation accident. 

Generally, registrants will have 90 days from receipt of a generic data call-in (GDCI) to 

complete and submit response forms or request time extensions and/or waivers with a full written 

justification. Timeframes for submitting generic data will be presented in the GDCI. 

29
 
 

 

 

 

 

 

 

 

Table 5. Generic Data Required to Support Phenol and Salts Registrations 

EPA Guideline Number Requirement Name 

875.1200 Dermal Indoor Exposure 

875.1200 Dermal Indoor Exposure1 

875.1200 Dermal Indoor Exposure2 

850.2100 Avian Acute Oral Toxicity 

850.1075 Fish Acute Toxicity- freshwater & marine 

850.1010 Aquatic Invertebrate Acute Toxicity- freshwater daphnids 

1- A chamber study is needed as confirmatory data for the HVAC ductwork treatment use. This chamber study must be based on 

OPPTS Guideline 875.1200 Indoor Inhalation Exposure and ASTM D5116-06 Standard Guide for Small-Scale Environmental 

Chamber Determinations of Organic Emissions from Indoor Materials/Products. The specific conditions of the chamber study 

such as ventilation rate, air temperature, application method and application rate must match the conditions of the labeled use. It 

is recommended that a study protocol be submitted for review by the Agency prior to the initiation of the actual study. 

2- A whole building study is needed as confirmatory data for the HVAC ductwork treatment use. The whole building study must 

be based on OPPTS Guideline 875.1200 Indoor Inhalation Exposure. This study must be conducted at a representative 

application site during an actual application or at a simulated application site that is configured to match the characteristics of a 

representative application. The specific conditions such as ventilation rate, air temperature, application method and application 

rate must match the conditions of the labeled use. It is recommended that a study protocol be submitted for review by the 

Agency prior to the initiation of the actual study. 

For phenol and salts technical grade active ingredient products, the registrant needs to 

submit the following items: 

Within 90 days from receipt of the generic data call-in (DCI): 

1. Completed response forms to the generic DCI (i.e., DCI response form and 

requirements status and registrant’s response form); and 

2. Submit any time extension and/or waiver requests with a full written justification. 

Within the time limit specified in the generic DCI: 

1. Cite any existing generic data which address data requirements or submit new generic 

data responding to the DCI. 

Please contact K. Avivah Jakob at (703) 305-1328 with questions regarding generic 

reregistration. 

By US mail: By express or courier service: 

Document Processing Desk Document Processing Desk 

K. Avivah Jakob K. Avivah Jakob 

Office of Pesticide Programs (7510P) Office of Pesticide Programs (7510P)
 

U.S. Environmental Protection Agency U.S. Environmental Protection Agency 

1200 Pennsylvania Ave., NW One Potomac Yard, Room S-4900 

Washington, DC 20460-0001 2777 South Crystal Drive 

 Arlington, VA 22202 

30
 
B. End-Use Products 

1. Product Specific Data Requirements 

Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific 

data regarding the pesticide after a determination of eligibility has been made. The registrant 

must review previous data submissions to ensure that they meet current EPA acceptance criteria 

and if not, commit to conduct new studies. If a registrant believes that previously submitted data 

meet current testing standards, then the study MRID numbers should be cited according to the 

instructions in the Requirement Status and Registrants Response Form provided for each 

product. The Agency intends to issue a separate product-specific data call-in (PDCI) outlining 

specific data requirements. 

Generally, registrants will have 90 days from receipt of a PDCI to complete and submit 

response forms or request time extensions and/or waivers with a full written justification. 

Registrants will have eight months to submit product-specific data. 

For end-use products containing the active ingredients phenol and salts, the registrants need to 

submit the following items for each product. 

Within 90 days from the receipt of the product-specific data call-in (PDCI): 

1. Completed response forms to the PDCI (i.e., PDCI response form and requirements 

status and registrant’s response form); and 

2. Submit any time extension or waiver requests with a full written justification. 

Within eight months from the receipt of the PDCI: 

1. Two copies of the confidential statement of formula (EPA Form 8570-4); 

2. A completed original application for reregistration (EPA Form 8570-1). Indicate on 

the form that it is an “application for reregistration”; 

3. Five copies of the draft label incorporating all label amendments outlined in Table 10 

of this document; 

4. A completed form certifying compliance with data compensation requirements (EPA 

Form 8570-34); 

5. If applicable, a completed form certifying compliance with cost share offer 

requirements (EPA Form 8570-32); and 

6. The product-specific data responding to the PDCI. 

31
 
 

 

 

 

 

Please contact K. Avivah Jakob at (703) 305-1328 with questions regarding product 

reregistration and/or the PDCI. All materials submitted in response to the PDCI should be 

addressed as follows: 

By US mail: By express or courier service: 

Document Processing Desk Document Processing Desk 

K. Avivah Jakob K. Avivah Jakob 

Office of Pesticide Programs (7510P) Office of Pesticide Programs (7510P) 

U.S. Environmental Protection Agency U.S. Environmental Protection Agency 

1200 Pennsylvania Ave., NW Room S-4900, One Potomac Yard 

Washington, DC 20460-0001 2777 South Crystal Drive 

 Arlington, VA 22202 

2. Labeling for End-Use Products 

To be eligible for reregistration, labeling changes are necessary to implement measures 

outlined in Section IV. Specific language to incorporate these changes is presented in Table 10. 

Generally, conditions for the distribution and sale of products bearing old labels/labeling will be 

established when the label changes are approved. However, specific existing stocks time frames 

will be established case-by-case, depending on the number of products involved, the number of 

label changes, and other factors. 

Registrants may generally distribute and sell products bearing old labels/labeling for 26 

months from the date of the issuance of this Reregistration Eligibility Decision document. 

Persons other than the registrant may generally distribute or sell such products for 52 months 

from the approval of labels reflecting the mitigation described in this RED. However, existing 

stocks time frames will be established case-by-case, depending on the number of products 

involved, the number of label changes, and other factors. Refer to “Existing Stocks of Pesticide 

Products; Statement of Policy,” Federal Register, Volume 56, No. 123, June 26, 1991. 

32
 
Table 6. Required Label Changes for Manufacturing and End-Use Products Containing Phenol and Salts 

Description Amended Labeling Language 

Manufacturing Use Products 

Environmental "This product is toxic to birds, fish and aquatic invertebrates. Do not discharge effluent containing this P

Hazards Statements product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the 

Required by the requirements of a National Pollution Discharge Elimination System (NPDES) permit and the permitting 

RED and Agency authority has been notified in writing prior to discharge. Do not discharge effluent containing this product 

Label Policies to sewer systems without previously notifying the local sewage treatment plant authority. For guidance 

contact your State Water Board or Regional Office of the EPA." 

End-Use Products 

Fogging CleanRoom End-Use Products 

Sporicidin product label 8383-3 and Bulletin 301 must be amended to include an application rate of “1 gallon per 30,000 sq/ft” for the fogging clean-room use. D

PPE Requirements- “All handlers must wear chemical resistant gloves.” ImMust be on all end- fuse product labels Pwith occupational Huses DPPE RequirementsMust be on all HVAC end-use product labels 

“Special Instructions For Applicators: Applicators treating the inside of an air duct system with this product must wear chemical resistant coveralls, chemical resistant gloves and chemical resistant goggles. 

In addition, the ductwork must be ventilated with an airflow of approximately 50 CFM per sq. foot of duct cross sections. If this is not possible, Occupational Safety and Health Administration (OSHA) confined space regulations must be followed and the requirements for a permit required space apply. These requirements include testing the atmosphere and use of adequate respirator protection. If the level of contamination cannot be determined, then maximum respiratory protection (SCBA or airline with an escape bottle) must be used. If needed, the full face respirator should also be equipped with a spray mist pre-filter in addition to the charcoal filters.” “Engineering Controls: During ULV application the duct interior must be maintained under slight 

negative pressure (0.015 to 0.025 In WG) with an outdoor exhaust. Avoid higher pressure differentials that would be likely to disrupt the coverage pattern.” 

ImfPHD

33
Directions for Use- Air Duct Treatment End-Use Products 

HVAC Use “Apply up to 4 fluid ounces of product per 2,000 square feet of building space by ULV application only.” D

Application RateMust be on all HVAC/Air Duct end-use labels Restricted Entry Interval (REI)- Must be on all HVAC/Air Duct end-use labels 

“Affected areas of the building are not to be occupied during treatment. Do not enter treated residence until 3 hours after treatment.” D

HVAC/Air Duct Use PERSONAL PROTECTIVE EQUIPMENT REQUIRMENTS FOR HANDLERS: All handlers must DDirections- Must be wear protective eyewear, long pants, long sleeved shirts and chemical resistant gloves. on all HVAC/Air Duct end-use labels SPECIAL INSTURCTIONS FOR APPLICTORS: Applicators treating an air duct system with this 

product must wear chemical resistant coveralls, chemical resistant gloves, and chemical resistant goggles. 

In addition, the ductwork must be ventilated with an airflow of approximately 50 CFM per square foot of duct cross section. If this is not possible, OSHA confined space regulations must be followed and the requirements for a permit-required space apply. These requirements include testing the atmosphere and use of adequate respirator protection. If the level of contamination cannot be determined, then maximum respiratory protection (SCBA or airline with an escape bottle) must be used. If needed, the full face respirator should also be equipped with a spray mist pre-filter in addition to the charcoal filters. ENGINERRING CONTROLS: During ULV application, the duct system interior must be maintained under slight negative pressure (0.015 to 0.025 in WG) with an outdoor exhaust or using a negative air machine equipped with HEPA filter. Avoid higher pressure differentials that would be likely to disrupt the overage pattern. FOR USE ONLY BY HVAC INSTALLERS AND REPARIERS When using this product for HVAC (fungistatic) (bacteriostatic), all Personal Protective Equipments (PPE) must be used. Please read all instructions before using this product. All applicable use directions must be followed precisely. If you do not understand the use of this product for HVAC (fungistatic) (bacteriostatic), please contact (company name) for more information at (company number). HVAC DIRECTIONS FOR USE For use on hard non-porous air duct surfaces only. ULV application only. It is a violation of Federal law to use this product in a manner inconsistent with its labeling. 

34
THE PERSON APPLYING THIS PRODUCT IS RESPONSIBLE FOR FOLLOWING THESE 

DIRECTIONS UNDER BOTH STATE AND FEDERAL LAWS. For use on Unlined Ductwork only. 1.0 General This product is designed to be used as one component of a comprehensive HVAC and duct maintenance program. The purpose of such a program is to assure that the HVAC system and ducts function in the manner they were designed to, remain free from mold and other microbial growth and other contamination, and continue in that condition. This product should only be used in only those cases where visible microbial growth has been detected in the system and then only after removing that growth and identifying and correcting the conditions that led to that growth. If you need help in understanding any part of these instructions or have additional questions after reading these instructions, DO NOT APPLY THIS PRODUCT until you have received the answers for all of your questions. 2.0 Inspection Prior to inspecting, cleaning, treating, repairing or otherwise working on the HVAC or duct section, the HVAC system should be turned off or the section under repair physically isolated from sections in active use. Prior to any application of this product the system must be inspected for cleanliness and mechanical condition. When initiating any measures to repair, clean or treat HVAC system components or air ducts, industry standards from the American Society of Heating and Refrigeration Engineers (ASHRAE), 

National Air Duct Cleaners Association (NADCA), Indoor Air Quality Association (IAQA) and other organizations must be followed. HVAC systems should be routinely inspected for cleanliness by visual means. The NADCA Standard, Assessment, Cleaning and Restoration of HVAC Systems (ACR 2002or the latest revision), provides minimum recommended inspection frequency schedules for ducts and other system components. More information on NADCA standards can be obtained from the NADCA web site at www.nadca.com. 

2.1 Cleanliness Inspection According to NADCA Standards, HVAC system cleaning must be performed when any of the following conditions are found in the cleanliness inspection. If any of these deficiencies are found during inspection, cleaning in accordance with industry standards must be performed prior to the application of this product. 2.1.1 Contamination 

• HVAC systems should be operated in a clean condition. If significant accumulations of 

35
contaminants or debris are visually observed within the HVAC system, then cleaning is necessary. 

Likewise, if evidence of microbial growth is visually observed or confirmed by analytical methods, then cleaning is required. 

• If the HVAC system discharges visible particulate into the occupied space, or a significant 

contribution of airborne particles from the HVAC system into the indoor ambient air is confirmed, then cleaning is necessary. 

• Heat exchange coils, cooling coils, air flow control devices, filtration devices, and air-handling 

equipment determined to have restrictions, blockages, or contamination deposits that may cause system performance inefficiencies, air flow degradation, or that may significantly affect the design intent of the HVAC system, require cleaning. 

• Drain pans must be free from slime and sludge or other contamination. Badly rusted or corroded 

drain pans must either be repaired or replaced. 

• Fans and fan housings must be free from accumulations of microbial growth and particulate matter. 

If you need help in understanding existing industry standards, consult a professional or consult the information at www.epa.gov (search on “HVAC Systems” or “air ducts”). In addition, the following 

association and society internet sites should be consulted for information on standards and guidelines they have developed: ACCA - www.acca.org 

ASHRAE - www.ashrae.org 

NADCA - www.nadca.com 

NAIMA - www.naima.org 

SMACNA - www.smacna.org 

2.2 Mechanical Inspection This product must be used only on HVAC air ducts in sound mechanical condition as defined in 2.2.1 and 2.2.2 (below). The HVAC system components must be designed and installed in conformance with industry standards and guidelines. Prior to using the product, inspect the HVAC system and ducts and assure that they are in sound mechanical condition. The following general guidelines, supplemented by industry standards from SMACNA, NAIMA, ASHRAE, ACCA and other organizations, must be followed: 2.2.1 Air Leaks and Mechanical Defects The ducts must be free from air leaks and other mechanical defects. Air leaks will promote condensation of water that causes microbial growth and will lead to failure of this product to protect the system adequately. 

36
2.2.2 Design and Installation 

ASHRAE, SMACNA, NAIMA and other industry organizations have established guidelines and standards for the design and installation of HVAC and duct systems. You should determine that the duct system you wish to treat conform to industry practice. If you are not knowledgeable of industry guidelines and standards, consult a qualified professional for assistance. In some situations, the inspection may reveal that a component of the HVAC or duct system is badly damaged or in such poor operating condition that it cannot be corrected through cleaning and/or minor repair. In these situations, the system should be replaced or rebuilt in conformity to the applicable industry standards prior to using this product. Some (but not all) of the conditions that would indicate the need for major repairs or replacement of the system include: 

• Improper size of ducts- The ducts must be sized to achieve correct airflow. When air-handling 

equipment is changed or new inlets or outlets added, the size of all components in the system should be recalculated and replacements made as needed. 

• Physical damage - Crushed or physically damaged equipment may leak or fail to perform as 

designed. Deformed air ducts will restrict airflow and may leak (especially at joint areas). Damaged equipment must be repaired or replaced or if there is extensive damage, the entire system should be replaced. 

• Badly corroded metal components including duct sections, housings and cabinets, coil assemblies, 

drain pans, fans and their housings and heat exchange surfaces. 

• Loose, damaged, friable or missing insulation - Insulation is important in preventing moisture 

condensation and subsequent growth of mold and other organisms. If insulation (either interior or exterior) is damaged, missing or not properly fastened it must be repaired or replaced or the associated duct sections replaced. Air handler, mixing, and VAV box housings are also normally insulated and this insulation should be checked for damage in a like manner. 

Removed components that are contaminated with mold and other microbial growth may spread contamination while being removed from the building. To prevent this, smaller items should be placed in plastic bags that should then be sealed before being removed. Larger items that cannot be safely packaged should be treated before being moved through occupied spaces. An appropriately labeled disinfectant can 

be used during treatment. Care must be used during treatment to assure that fumes from the agent being used are not released into occupied spaces. Products used should be used according to their label directions. AIR DUCTS For use on hard non-porous air duct surfaces only. ULV application only. Affected areas of the building are not to be occupied during treatment. Do not enter treated residence until 3 hours after treatment. 

37
3.0 General Directions for (This Product) Usage 

This product effectively controls by inhibiting growth of odor causing bacteria, fungi, and other odor, stain or damage causing organisms in air ducts in residential, commercial, institutional, and industrial buildings. This product also eliminates odors associated with bacteria, mold, mildew, animals, cooking, spoilage, musty and other odors and removes odor-causing organisms when used as part of such a comprehensive preventative maintenance program in air ducts. This product is a bacteriostat, fungistat (mold and mildew), mildewstat and deodorizer for use in 

residential, commercial and industrial settings. Apply up to 4 fluid ounces of product per 2,000 square feet of building space by ULV application only. Follow the directions below for the specific type of duct being treated. It is vital that the following directions be carefully read and understood prior to using the product. 3.1 Application Instructions For use on hard non-porous air duct surfaces only. Apply up to 4 fluid ounces of product per 2,000 square feet of building space by ULV application only. 3.2 Application Equipment and Devices ULV application only. Refer to the precautionary statements for the Personal Protective Clothing and other special instructions that must be followed. 3.2.1 ULV ULV application only. Equipment capable of generating particles in the 15 to 60 micron range is most satisfactory. Avoid use of thermal type fog generators. Generally a fog will carry and provide adequate coverage up to 8 feet from the point of application so adequate penetrations must be cut in the ducts to assure complete coverage without wetting. SMACNA, NADCA and NAIMA have established standards and guidelines for making and sealing openings in ducts. Operators should be trained on proper application techniques as well as correct duct penetration and sealing procedures using these standards and guidelines. Operators should also carefully read and follow directions for the brand of equipment used. Duct penetrations should be properly closed following application, in accordance with industry standards. 3.3 Application Techniques This product must be applied evenly throughout the duct system and over other surfaces that are being treated. Even and uniform application is essential for satisfactory results. The procedures, equipment and techniques described below have been tested and provide the desired results. Other procedures, equipment and techniques may also achieve satisfactory results but should not be used without discussing the specific situation and equipment with a qualified professional for assistance. 

38
3.3.1 Application from the Exterior of the HVAC System 

This product may be sprayed into openings at intervals throughout the duct system or on components that are accessible through removable panels or access doors. Spray into openings every 8 feet at a minimum. 

Existing supply openings can be used where they will provide a clear view of the surfaces being sprayed 

so that uniform application can be achieved. However, additional penetrations will have to be made as needed so that enough openings will be available to achieve total and uniform coverage. Spray application is not an acceptable technique where openings are greater than 8 feet apart, additional openings cannot be made and properly sealed and/or the duct geometry does not allow for uniform coverage. In such cases, application from within the HVAC system is necessary (see 3.3.2 below). 3.3.2 Application from Within the HVAC System When this product cannot be sprayed into openings at intervals throughout the ducts system, you must gain entry into the system and spray the product onto interior duct and other surfaces until they are thoroughly and uniformly covered using hand or power spray equipment. This is the most frequently used technique and is the technique of choice for air-handlers, other components with access panels or doors and large diameter (generally 20” X 20” minimum) ducts where direct access can be gained to surfaces being treated. 3.4 Rate of Application Users of this product must carefully follow the rate of application instructions provided below. Apply up to 4 fluid ounces of product per 2,000 square feet of building space by ULV application only. 

3.4.1 Bare Metal and Flexible Ducts Apply until surface is evenly wet. Apply up to 4 fluid ounces of product per 2,000 square feet of building space by ULV only. If the above application rate results in surface runoff or liquid pooling on the bottom 

of the duct, lower the application rate until the surface is thoroughly and evenly wet without runoff or 

pooling. AIR DUCTS This product is formulated for use on hard non-porous air duct surfaces only. ULV application only. 

Affected areas of the building are not to be occupied during treatment. Do not enter treated residence until 3 hours after treatment. It is vital that the directions for use are carefully read and understood prior to using this product. 3.5 Frequency of Application Normally, infrequent application (registrant must provide a time frame) will provide effective control. (The registrant must provide product specific details on the frequency of application of this product here.) Prior to reapplication, the interior of the ducts and other surfaces must be inspected and found to be free of 

39
accumulated soil. If soil or growth is found, the cause should be determined and corrected and then the 

ducts cleaned in accordance with accepted industry practice. If microbial growth persists following application re-inspect for duct leaks carryover of water from cooling coils or humidifiers and other sources of moisture promoting growth. Eliminate such sources of moisture before re-treating. 3.6 Returning the System to Operation Following Application Fans and blowers in the section of duct being treated must be turned off during application of this product. If the system cannot be shut down, the section of duct being treated must be isolated until treatment is complete. This will prevent the spray of fog from being blown away from the surface that is being treated. Do not attempt to use the system fan or blower to carry this product to the surfaces in the air duct system. Such a practice will not result in uniform application of the product to the surfaces being treated and will 

lead to ineffective control. This should never be attempted. The system can be returned to full operation as soon as treatment is complete anytime following completion of treatment. This product will dry on surfaces within (provide time frame) following 

application. Extended drying time does not have an impact on effectiveness of treatment. Affected areas of the building are not to be occupied during treatment. Do not enter treated residence until 3 hours after treatment. 

Use Cancellation 

All product labels The use of phenol and salts as a paint preservative must be deleted from all product labels. This use was voluntarily cancelled by the registrant on April 12, 2005. 

40
Appendix A: Table of Use Patterns for Phenol & Salts 

Use Site Formulation Method of 

Application 

Application Rate/ No. of 

applications 

Use 

Agricultural Premises and Equipment Hard Non-Porous Surfaces: 

Farm Equipment, Animal and Poultry Housing, Barns, Kennels, Breeding Pens, Hatcheries, Trucks and Other Vehicles 

Ready to Use 8383-3 

Spray, Immerse or Soak 

Remove poultry, animal feed, water, trucks, coops, and crates from the premises. Remove liter droppings from floors, walls, and surfaces of facilities occupied or transversed by animals. Empty all troughs, racks and other feeding and watering appliances. Thoroughly clean all surfaces with soap or detergent and rinse with water. Apply product and allow it to remain wet for 10 minutes. Allow to air dry. 

Ventilate buildings, coonot house animals or emabsorbed, set dried. For Avian Influenza A- which are conducive to excess liquid. Do not dichemicals. 

Commercial, Institutional and Industrial Premises and Equipment Carpets and Fabrics Hard Non-Porous Surfaces: 

Telephones, Keyboards, Furniture, Wheelchairs, Walkers, Sinks, Floors, Walls, Light Switches, Linen Hampers, Bathrooms, Kennels and Animal Areas, Schools, Restaurants, Hotels, Boats, Planes, Buses, Air Ducts (HVAC) 

Ready to Use 8383-3 

Spray, Immerse or Soak 

Pre-clean: Clean surfaces using product to remove soil or filth. Wipe dry with a paper towel, cloth or sponge. Disinfect and Deodorize: Thoroughly wet pre-cleaned surface with product and allow to remain wet for 10 minutes at room temperature to kill listed organisms. Use spray for surfaces that cannot be immersed or soaked. 

All surfaces and materiafood must be washed wwith potable water prior with other chemicals. 

41
Use Site Formulation Method of 

Application 

Application Rate/ No. of 

applications 

Use 

Carpets and Fabrics Hard Non-Porous Surfaces: 

Telephones, Keyboards, Furniture, Wheelchairs, Walkers, Sinks, Floors, Walls, Light Switches, Linen Hampers, Bathrooms, Kennels and Animal Areas, Schools, Restaurants, Hotels, Boats, Planes, Buses. 

Impregnated Materials 8383-7 

Wipe Pre-clean: Clean surfaces with 

product’s solution to remove soil and filth. Wipe dry with a paper towel, cloth or sponge. To Disinfect and Deodorize: Items which cannot be immersed such as electrical panels: Thoroughly wet pre-cleaned surface with disinfectant towelettes and allow surface to remain wet for 10 minutes. Use as many towelettes as necessary for the treated area to remain wet for 10 minutes at room temperature 28 Degrees Celsius/68 Degrees Fahrenheit to kill listed organisms. To Spot Clean, Deodorize and remove Debris from Carpets and Fabrics: Blot or scrub area to be treated with disinfectant towelette to remove soiling. Wipe dry with a clean cloth or towel. 

Do not dilute or mix wi

Hard Non-Porous Surfaces: Pressurized Spray Pre-clean: Clean surfaces using Do not use near fire, sp

Industrial Clean Rooms Liquid 

8383-4 

product to remove soil or filth. Wipe dry with a paper towel, cloth or sponge. Disinfect and Deodorize: Thoroughly wet pre-cleaned surface with product and allow to remain wet for 10 minutes at room temperature to kill listed organisms. Use spray for surfaces that cannot be immersed of soaked. 

or incinerate container. 130 degrees may cause 

42
Use Site Formulation Method of 

Application 

Application Rate/ No. of 

applications 

Use 

Fogging Clean-Rooms Ready To Use 

8383-3, Sporicidin Bulletin No. 301 

Fogging 1 gallon per 30,000 sq/ft 

For fogging articles and surfaces in sealed rooms and cubicles as an adjunct to manual cleaning and disinfecting procedures. Unscrew pump bottle and change the fogging device with the required volume of solution. Seal all windows and doors. Set time for treatment cycle as recommended by device manufacturer. Turn on device, leave room and reseal door. Do not allow anyone to re-enter room or cubicle for at least 2 hours after fogging cycle has been completed. Upon reentering room or cubicle, following regular cleaning and disinfecting procedures. 

Avoid eye contact. Do not allow anyone to least 2 hours after foggi

Food Handling /Storage Establishments Premises and Equipment Hard Non-Porous Surfaces: 

Food Processing Plants, Food Handling Areas, Poultry and Meat Packaging Facilities, and Slaughter Houses 

Ready to Use 8383-3 

Spray, Immerse or Soak 

Pre-clean: Clean surfaces using product to remove soil or filth. Wipe dry with a paper towel, cloth or sponge. Disinfect and Deodorize: Thoroughly wet pre-cleaned surface with product and allow to remain wet for 10 minutes at room temperature to kill listed organisms. Use spray for surfaces that cannot be immersed of soaked. 

All surfaces and materiafood must be washed wwith potable water prior with other chemicals 

43
Use Site Formulation Method of 

Application 

Application Rate/ No. of 

applications 

Use 

Hard Non-Porous Surfaces: 

Food Processing Plants, Food Handling Areas, Poultry and Meat Packaging Facilities, and Slaughter Houses 

Ready to Use 8383-7 Impregnated Materials 

Wipe Pre-clean: Clean surfaces with 

product’s solution to remove soil and filth, wipe dry with a paper towel, cloth or sponge. To Disinfect and Deodorize: Items which cannot be immersed such as electrical panels: Thoroughly wet pre-cleaned surface with disinfectant towelettes and allow surface to remain wet for 10 minutes. Use as many towelettes as necessary for the treated area to remain wet for 10 minutes at room temperature 28 Degrees Celsius/68 Degrees Fahrenheit to kill listed organisms. 

 Do not dilute or mix w

Hard Non-Porous Surfaces: 

Sinks, Drain Boards, Cabinets, Garbage Cans, Under Sinks, Faucets 

Ready to Use 69658-3 

Spray Use as a start day/end day 

antimicrobial treatment on precleaned surfaces. Allow product to fully dry. To Sanitize Non-Food Contact Surfaces: Before treatment clean surface of loose dirt. Hold spray bottle upright 4-6 inches from surfaces. Spray surfaces 2-4 seconds until covered with mist. Allow to air dry and remain undisturbed for 15 minutes. 

This product must not rcontamination of food p

44
Use Site Formulation Method of 

Application 

Application Rate/ No. of 

applications 

Use 

Medical Premises and Equipment Hard Non-Porous Surfaces: 

Health/Hospital Treatment and Patient Rooms, Operating Rooms, Ambulances, Medical and Dental Equipment, Beds, Surgical Carts, Countertops, Mannequins, Hemodyalysis and Dialysis Machines, Bathrooms, Wheelchairs, Walkers, Animal Areas, Trash Containers, Air Ducts (air duct use is only on 8383-3 and 8383-4 only) 

Ready to Use 8383-3 8383-6 Pressurized Liquid 8383-4 

Spray, Immerse, or Soak 

Pre-clean: Clean surfaces using product to remove soil or filth. Wipe dry with a paper towel, cloth or sponge. Disinfect and Deodorize: Thoroughly wet pre-cleaned surface with product and allow to remain wet for 10 minutes at room temperature to kill listed organisms. Use spray for surfaces that cannot be immersed or soaked Dialysis Machine: Place 150cc into the hemodialysate system. Allow machine to run until all of the product is down into the concentrate line. This will allow for automatic proportioning of solution with water. Multipatient Delivery System: Place 1.0 liter into the hemodialysate system. Allow machine to run until all of the product is down into the concentrate line. This will allow for automatic proportioning of solution with water. Fill machine for a minimum of 10 minutes. Drain product from system and thoroughly rinse with water. Test final rinse water for residual using product’s residual test kit to assure complete rinsing. 

Dialysis Machine: It is procedures be accompahemodialysate system. Pressurized Liquid: Dflame. Do not puncture Exposure to temperaturbursting. This product is not to be high level disinfectant ointroduced directly into in contact with the blooareas of the body, or (2) membranes but which dblood barrier or otherwiof the body. Do not dilute or mix wi

45
Use Site Formulation Method of 

Application 

Application Rate/ No. of 

applications 

Use 

Hard Non Porous Surfaces: Impregnated Wipe Pre-clean: Clean surfaces with This product is not to be Health/Hospital Treatment and Materials product’s solution to remove soil sterilant/high level disinPatient Rooms, Operating 8383-7 and filth, wipe dry with a paper (1) is introduced directlRooms, Ambulances, Medical towel, cloth or sponge. into or in contact with tand Dental Equipment, Beds, sterile areas of the bodySurgical Carts, Countertops, To Disinfect and Deodorize: membranes but which d

Mannequins, Hemodyalysis and Items which cannot be immersed blood barrier or otherwi

Dialysis Machines, Bathrooms, such as electrical panels: of the body. Wheelchairs, Walkers, Animal Thoroughly wet pre-cleaned Areas, and Trash Containers surface with disinfectant 

towelettes and allow surface to remain wet for 10 minutes. Use as many towelettes as necessary for the treated area to remain wet for 10 minutes at room temperature 28 Degrees Celsius/68 Degrees Fahrenheit to kill listed organisms. To Spot Clean, Deordorize Carpets and Fabric: Blot or scrub area to be treated with disinfectant towelette to remove soiling. Wipe dry with a clean cloth or towel. Dialysis Machine: Place 150cc into the hemodialysate system. Allow machine to run until all of the product is down into the concentrate line. This will allow for automatic proportioning of solution with water. 

Do not dilute or mix wi

46
Use Site Formulation Method of 

Application 

Application Rate/ No. of 

applications 

Use 

Medical Devices Ready to Use 

69658-3 

Spray This product may be used to preclean or decontaminate critical 

or semi critical medical devices prior to sterilization or high level disinfection. To Sanitize Non-Food Contact Surfaces: Before treatment clean surface of loose dirt. Hold spray bottle upright 4-6 inches from surfaces. Spray surfaces 2-4 seconds until covered with mist. Allow to air dry and remain undisturbed for 15 minutes. 

This product must not rcontamination of food p

Residential and Public Premises Carpets and Fabrics Hard Non-Porous Surfaces: 

Telephones, Keyboards, Furniture, Wheelchairs, Walkers, Sinks, Floors, Walls, Light Switches, Linen Hampers, Bathrooms, Kennels and Animal Areas, Schools, Restaurants, Hotels, Boats, Planes, Trains, Buses, Health Spas, Nursing Homes, and Air Ducts. 

Ready to Use 8383-3 Pressurized Liquid 8383-4 

Spray, Immerse or Soak 

Pre-clean: Clean surfaces using product to remove soil or filth. Wipe dry with a paper towel, cloth or sponge. Disinfect and Deodorize: Thoroughly wet pre-cleaned surface with product and allow to remain wet for 10 minutes at room temperature to kill listed organisms. Use spray for surfaces that cannot be immersed of soaked. Carpets and Fabrics: For manual cleaning spray product onto carpet and wipe clean with a cloth or sponge. Allow to air dry. For machine cleaning apply product in accordance with machine manufacturer’s guidelines. 

Do not dilute or mix wiPressurized Liquid: Dflame. Do not puncture Exposure to temperaturbursting. 

47
Use Site Formulation Method of 

Application 

Application Rate/ No. of 

applications 

Use 

Carpets and Fabrics Hard Non-Porous Surfaces: 

Telephones, Keyboards, Furniture, Wheelchairs, Walkers, Sinks, Floors, Walls, Light Switches, Linen Hampers, Bathrooms, Kennels and Animal Areas, Schools, Restaurants, Hotels, Boats, Planes, and Buses. 

Impregnated Materials  8383-7 

Wipe Preclean: Clean surfaces with 

product’s solution to remove soil and filth, wipe dry with a paper towel, cloth or sponge. To Disinfect and Deodorize: Items which cannot be immersed such as electrical panels: Thoroughly wet pre-cleaned surface with disinfectant towelettes and allow surface to remain wet for 10 minutes. Use as many towelettes as necessary for the treated area to remain wet for 10 minutes at room temperature 28 Degrees Celsius/68 Degrees Fahrenheit to kill listed organisms. Carpets and Fabrics: To Spot Clean, Deodorize and remove Debris from Carpets and Fabrics. Blot or scrub area to be treated with disinfectant towelette to remove soiling. Wipe dry with a clean cloth or towel. (Continued) 

This product is not to be sterilant/high level disinintroduced directly into introduced in contact wsterile areas of the bodyother chemicals 

Hard Non-Porous Surfaces: Ready to Use Spray To Sanitize Non-Food Contact This product must not r

Walls, Counter Tops, Floors 69658-3 Surfaces: Before treatment 

clean surface of loose dirt. Hold spray bottle upright 4-6 inches from surfaces. Spray surfaces 2-4 seconds until covered with mist. Allow to air dry and remain undisturbed for 15 minutes. 

contamination of food p

48
Use Site Formulation Method of 

Application 

Application Rate/ No. of 

applications 

Use 

Materials Preservatives Industrial Additive for Polishes, Cleansers and Protectants 

Ready to Use 8383-1 

Add Add 2.5% weight of active 

ingredient according to directions of the manufacturer. 

Rinse empty container tdiscard it. 

49
APPENDIX B: Phenols and Salts (Case 4074) 

Guide to Appendix B Appendix B lists the generic (not product specific) data requirements which support the reregistration of phenol and salts. 

apply to phenol and salts in all products, including data requirements for which a technical grade active ingredient is the tes

table is organized in the following formats: 1. Data Requirement (Columns 1 and 2). The data requirements are listed by Guideline Number. The first column 

Guideline numbers, and the second column lists the old Part 158 Guideline numbers. Each Guideline Number has a

protocol set forth in the Pesticide Assessment Guidance, which are available on the EPA website. 

2. Guideline Description (Column 3). Identifies the guideline type. 3. Use Pattern (Column 4). This column indicates the standard Antimicrobial Division use patterns categories for w

product specific) data requirements apply. The number designations are used in Appendix B. 

(1) Agricultural premises and equipment (2) Food handling/ storage establishment premises and equipment (3) Commercial, institutional and industrial premises and equipment 

(4) Residential and public access premises (5) Medical premises and equipment (6) Human water systems 

(7) 

Materials preservatives 

(8) Industrial processes and water systems (9) Antifouling coatings (10) Wood preservatives (11) Swimming pools 

(12) 

Aquatic areas 

3. Bibliographic Citation (Column 5). If the Agency has data in its files to support a specific generic Guideline requ

will identity each study by a “Master Record Identification (MRID) number. The listed studies are considered “val

satisfying the Guideline requirement. Refer to the Bibliography appendix for a complete citation of each study. 

50
DATA REQUIREMENT C

New Guideline 

Number 

Old Guideline 

Number Study Title Use Pattern M

PRODUCT CHEMISTRY 

830.1550 61-1 Product Identity and Composition 41605001, 42

830.1600 830.1620 830.1650 

61-2a 

Starting Materials and Manufacturing Process 

41605001, 4141609502, 420

830.1670 61-3 Formation of Impurities 41605001, 416830.1700 62-1 Preliminary Analysis 41605001, 41830.1750 62-2 Certification of Limits 41605001, 41830.1800 62-3 Analytical Method 41609501, 41

63-0 Reports of Multiple phys/chem Characteristics 42381901, 10

830.7200 63-5 Melting Point 41609504 

830.7840 830.7860 

63-8 

Solubility 42441701, 425

830.7950 63-9 Vapor Pressure 42441702, 41

830.7370 63-10 Dissociation Constant 42441703, 425830.7550 830.7560 830.7570 63-11 Partition Coefficient (Octanol/Water) 42441704 830.7000 63-12 pH 41914901 

830.6313 63-13 Stability 42457001 

830.6317 63-17 Storage Stability 41605001 

ECOLOGICAL EFFECTS 

850.1010 72-2 Aquatic Invertebrate Acute Toxcitiy- freshwater daphnids DATA GAP 

850.1025 72-3 Acute Toxicity to Estuarine/Marine Organisms 46751203 

51
DATA REQUIREMENT C

New Guideline 

Number 

Old Guideline 

Number Study Title Use Pattern M

850.1075 72-1 and 72-3 Fish acute toxicity test, freshwater and marine DATA GAP 

850.1025 72-3 Oyster acute toxicity test (shell deposition) 46751202 

850.1035 72-3 Mysid acute toxicity test 46751203 

850.2100 71-1 Avian Acute Oral Toxicity Test (Quail/Duck) DATA GAP 

850.2200 71-2 Avian Dietary Toxicity 42500205, 425850.4100 122-1 Terrestrial plant toxicity, Tier 1 (seeding emergence) 46751207 

850.4150 122-1 Terrestrial plant toxicity, Tier 1 (vegetative vigor) 46751204 

840.5400 123-2 Aquatic plant growth 45688201 

850.4225 123-1 Seedling emergence dose-response in rice 46751207 

850.4250 123-1 Vegetative vigor dose-response in rice 46751204 

850.5400 123-2 Acute algal dose-response toxicity - 4 species 46751205, 467

TOXICOLOGY 

870.1100 81-1 Acute Oral - Rat 43334201, 43

870.1200 81-2 Acute Dermal - Rabbit 00078779 

870.1200 81-2 Acute Dermal - Rat 00078779 

870.2500 81-5 Primary Dermal Irritation - Rabbit 43334202 

870.2600 81-6 Dermal Sensitization – Guinea pigs 43334203, 43

870.3100 82-1 Subchronic Oral Toxicity: 90-Day Study 40760206, 145870.3200 82-2 21/28-Day Dermal Toxicity - Rat 42881901 

870.4100 83-1 Chronic Toxicity 

43954301, 4443545501, 41161577 

870.4200 83-2 Oncogenicity 

43954301, 4443545501 

52
DATA REQUIREMENT C

New Guideline 

Number 

Old Guideline 

Number Study Title Use Pattern M

870.3700 83-3 Teratogenicity -- 2 Species 

00067616, 9241925001, 41943735402, 437

870.3700a 83-3a Teratogenicity - rat 43735402 870.3800 83-4 2-generation repro.-rat 43928801 870.3800 83-4 Reproduction - Rat 

Ryan et al., 2020) 

870.4200a 83-2 Carcinogenicity - rat 

NIH PB# 80-1Non-guideline 

870.4200b 83-2 Carcinogenicity - mouse 

NIH PB# 80-1Non-guideline 

870.5100 84-2 Bacterial reverse mutation test 

Florin, et al. 1Non-guidelineHaworth et al.(Env. MutagenNon-guidelinePool and Lin, Vol. 20) Non-guidelineGocke et al., 190) Non-guideline 

Non-Guideline Non-Guideline Excretory System Effects 44197601, 44Non-Guideline Non-Guideline Sub-acute Oral Toxicity 44197601, 44870.5275 82-4 Sex-linked recessive lethal test in Drosophila melanogaster 

Gocke et al., 190) Non-guidelineWoodruff et aMutagenesis VNon-guideline 

84-2 Intreraction with Gonadal DNA 92154039, 92

53
DATA REQUIREMENT C

New Guideline 

Number 

Old Guideline 

Number Study Title Use Pattern M

84-2 

Intreraction with Gonadal DNA: Structural Chromosome Aberration/ Mammalian Cells/ Tissues in Culture 145962 

84-2 

Intreraction with Gonadal DNA: Structural Chromosome Aberration/ Laboratory Mammals (Rat) 145962 

870.5300 84-2 In Vitro mammalian call gene mutation test 

Pashin and BaRes. Vol. 104) Non-guideline 

870.5375 84-2 In Vitro mammalian chromosome aberration test 

Kolachana et Vol. 53) Non-guideline 

870.5380 84-2 Mammalian spermatogonial chromosomal aberration test - Rat 

Bulsiewicz, 19Vol. 36) Non-

870.5385 84-2 Mammalian bone marrow chromosome aberration test - Mouse 

Kolachana et Vol. 53) Non-guideline 

870.5395 84-2 Mammalian erythrocyte - Mouse 

Barale et al., 1Acceptable - NEastmond, 199(CarcinogenesAcceptable - NGocke et al., 1 (Mutation Re

870.7485 85-1 Metabolism and pharmacokinetics - Rat 

Capel et al., 1Non-guidelineHughes and HNon-guideline 

870.7485 85-1 Metabolism and pharmacokinetics - Mouse 

Capel et al., 1Non-guideline 

870.7485 85-1 General metabolism/Biotransformation 71253 

870.7485 85-1 General metabolism/ Excretion & Secretion 71253 

870.7485 85-1 

General metabolism: Pesticide Fate in Animals/ Laboratory 

Mammals (Rat) 145962 

54
DATA REQUIREMENT C

New Guideline 

Number 

Old Guideline 

Number Study Title Use Pattern M

870.7600 85-3 Dermal Penetration 

Behl and Linn(J Pharm. Sci. Non-guideline 

875.1200 233 Dermal Indoor Exposure DATA GAP 

875.2400 875.2900 133-3 Dermal passive dosimetry expo 

43432901, 45543432901 

875.2500 875.2900 133-4 Inhalation passive dosimetry expo 

43432901, 45543432901 

None-Guideline None-Guideline Excretory System Effects 127249 

Non-Guideline Non-Guideline Kidney 127249 

Non-Guideline Non-Guideline Bladder/Duct 12749 

Non-Guideline Non-Guideline Exposure of Humans -- General Population 41742601 

Environmental Fate 

835.2120 161-1 Hydrolysis of Parent and Degradates 43994201, 439

870.7600 85-3 Dermal Penetration/Absorption 46882301 

Non-Guideline Non-Guideline Physiological/Anatomical Effects of Pesticides 46882301 

835-6200 164-2 Dissipation in Water (Field Studies) 46601401 

860.1300 835.2120 171-4A2 Nature of the Residue in Plants 43298301, 435860.1300 171-4A3 Nature of the Residue in Livestock 44349301 

860.1340 171-4B Residue Analytical Methods 

43384101, 43743996401 

860.1400 171-4C Magnitude of the Residue [by commodity]: Orange 43992401, 44

860.1400 171-4C Magnitude of the Residue [by commodity]: Grapefruit 43992401, 44860.1400 171-4C Magnitude of the Residue [by commodity]: Lemon 43992401, 44

55
DATA REQUIREMENT C

New Guideline 

Number 

Old Guideline 

Number Study Title Use Pattern M

860.1520 171-4C 

Magnitude of the Residue [by commodity]: PROCESSED FOOD 43992401, 44

56
Appendix C. Technical Support Documents 

Additional documentation in support of this RED are maintained in the OPP docket, 

located in Room S-4400, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA, and is 

open Monday through Friday, excluding legal holidays, from 8:30 am to 4 pm. 

All documents, in hard copy form, may be viewed in the OPP docket room or 

downloaded or viewed via the Internet at the following site: 

http://www.regulations.gov 

These documents include: 

Reregistration Eligibility Decision (RED) Document: 

•	 Reregistration Eligibility Decision for Phenol and Salts, March 30 2009. Antimicrobials 

Division 

•	 Phenol/Sodium Phenate Reregistration Eligibility Decision, September 30, 2009. 

Antimicrobials Division 

Risk Assessment and Supporting Science Documents: 

•	 Occupational and Residential Exposure and Risk Assessment for the Existing Fogging 

Cleanroom Use of Phenol (Sporicidin), December 18, 2008. Antimicrobials Division. 

Dole, Timothy. 

•	 Occupational and Residential Exposure and Risk Assessment for the Duct Cleaning Use 

of Phenol (Sporicidin), December 18, 2008. Antimicrobials Division. Dole, Timothy. 

•	 Phenol/Sodium Phenate Summary, September 15, 2004. Antimicrobials Division. 

•	 Overview of the Phenol/Sodium Phenate Preliminary Risk Assessment, September 13, 

2004. Antimicrobials Division. 

•	 Phenol RED Document, September 10, 2004. Antimicrobials Division. 

•	 Phenols Occupational/Residential Exposure Assessment, September 9, 2004. 

Antimicrobials Division. 

•	 Product Chemistry Chapter, August 10, 2004. Antimicrobials Division. 

•	 Incident Reports Associated with Phenol, July 27, 2004. Antimicrobials Division. 

•	 Phenol/Sodium Phenate: Toxicology Chapter for the AD Preliminary Risk Assessment 

Document, July 6, 2004. Antimicrobials Division. Centra, Michelle 

•	 Phenol Dietary Exposure Assessments for the Reregistration Eligibility Decision, May 

18, 2004. Antimicrobials Division. Shamim, Najm 

•	 Ecological Hazard and Environmental Risk Assessment: Phenol and Salts, April 29, 

2004. Antimicrobials Division. 

•	 Science Chapter on: Environmental Fate Studies and Environmental Fate Assessment of 

Phenol, January 29, 2004. Antimicrobials Division. Shamim, Najm. 

•	 Phenol-Report of the Antimicrobials Division Toxicity Endpoint Selection Committee, 

July 7, 2004. McMahon, Timothy. 

57
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Appendix D. Citations Considered to be Part of the Data Base Supporting the 

Reregistration Decision (Bibliography) 

1. MRID Studies 

MRID #	 Citation 

34735401 Jones-Price, C and T.A. Ledoux. (1983). Teratologic Evaluation of 

Phenol (CAS No. 108-95-2) in CD1 Mice. RTI 

43735402 Jones-Price, C and TA Ledoux. (1983). Teratologic Evaluation of Phenol 

(CAS No. 108-95-2) in CD Rats. RTI 

41609501 Deford, C. (1990) Product Chemistry Data for Dowcide 1 Anti- 

 micro- bial. Unpublished study prepared by Dow Chemicals 

U.S.A. 74 p. 

41609502 Deford, C. (1990) Product Chemistry Data for Dowcide A 

 Antimicro- bial. Unpublished study prepared by Dow Chemical 

U.S.A. 64 p. 

42381901 Cocciardo, C.; Stroech, K. (1992) Product Chemistry Data 

Upgrades as Requested in Phase IV Data-Call-In for 2-

 Phenylphenol (49-155 ortho-Phenylphenol): Lab Project Number: 

39967-3. Unpublished study prepared by Bayer Ag. 60 p. 

42097001 Lickly, L. (1991) O-Phenylphenol: Description of Beginning 

 Materi- als and Manufacturing Process (...): Lab Project Number: 

 Unpub- lished study prepared by The Dow Chemical Co. 6 p. 

42528701 Lickly, L. (1991) Sodium O-Phenylphenate--Description of 

 Beginning Materials and Manufacturing Process: An amendment.

 Unpublished study prepared by The Dow Chemical Co. 6 p. 

101697 Dow Chemical Co. (1969) Dowicide 1 Antimicrobial. Midland, 

 MI: Dow. (Antimicrobial agents, section I-1; also In unpublished 

 submission received Jun 20, 1969 under 464-70; CDL:003397-A) 

41609503 Deford, C. (1990) Physical and Chemical Characteristics of 

 Dowcide A Antimicrobial. Unpublished study prepared by Dow 

 Chemical U.S.A.. 5 p. 

41609504 Black, C.; Frurip, D. (1990) Melting Point of Sodium o-Phenyl 

 Phenate (Dehydrated): Lab Project Number: ML-AL 90-020344. 

 Unped study prepared by Dow Chemical U.S.A.. 10 p. 

58
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 42441701 Heimerl, J.; Engel, J. (1992) Solubility of Dowicide 1 Antimicrobial 

 for Registration: Lab Project Number: ML-AL 92-080421. 

 Unpublished study prepared by Dow Chemical USA, Analytical 

Sciences. 52 p. 

42500201 Heimeri, J.; Engel, J. (1992) Solubility of Dowicide A Antimicrobial 

 for Registration: Lab Project Number: ML-AL 92-080543. 

 Unpublished study prepared by Dow Chemical, USA, Analytical 

Sciences. 45 p. 

42441702 Srivastava, R.; Chakrabarti, A.; Griffin, K. (1992) Vapor Pressure of 

 Ortho-Phenylphenol Measured by the Knudsen-Effusion/Weight 

 Loss Method: Lab Project Number: ML-AL 91-020408. 

 Unpublished study prepared by Dow Chemical USA. 15 p. 

41609505 Chakrabarti, A. (1990) Vapor Pressure of the Sodium Orthophenyl- phenate Measured by the Knudsen-Effusion/Weight Loss 

 Method: Lab Project Number: ML-AL 90-020313. Unpublished 

 study prepared by Dow Chemical U.S.A.. 10 p. 

42441703 Reim, R. (1992) Dissociation of Dowicide 1 Antimicrobial: Lab 

 Project Number: ML-AL 92-080459. Unpublished study prepared by 

 The Dow Chemical Co. 15 p. 

42500202 Reim, R. (1992) Dissociation of Dowicide A Antimicrobial: Lab 

 Project Number: ML-AL 92-041093. Unpublished study prepared by 

 Dow Chemical, USA, Analytical Sciences. 15 p. 

42441704 Heimerl, J. (1992) Octanol/Water Partition Coefficient 

 Determination of Dowicide 1 Antimicrobial for Registration: Lab 

 Project Number: ML-AL 92-080459. Unpublished study prepared by 

 The Dow Chemical Co. 43 p. 

42457001 Engel, J.; Heimerl, J. (1992) Stability of Dowicide 1 Antimicrobial 

 for Registration: Lab Project Number: ML-AL 92-080398. 

 Unpublished study prepared by Dow Chemical USA. 45 p. 

42500204 Campbell, S.M. and M. Jaber. 1992. Sodium o-phenylphenalte 

(DOWICIDE A): An Acute Oral Toxicity Study with the Northern 

Bobwhite Unpublished data. Conducted by Wildlife International 

 for the Dow Chemical Co. 

42500205 Campbell, S.M., and S.P. Lynn. 1992. Sodium o-phenylphenate 

 (DOWICIDE A): A Dietary LC50 Study with the Northern 

Bobwhite. Unpublished data. Conducted by Wildlife International 

 for the Dow Chemical Co. 

59
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

42500206 Campbell, S.M., and M Jaber. 1992. Sodium o-phenylphenate 

 (DOWICIDE A): A Dietary LC50 Study with the Mallard. 

Unpublished data. Conducted by Wildlife International for the 

 Dow Chemical Co. 

45688201 Hicks, S. 2002. Ortho-phenyl Phenol: Growth Inhibition Test 

with Green Alga, Selenastrum capricornutum. Unpublished data. 

 Conducted by ABC Laboratories for The Dow Chemical Co. 

160150 Grimes, J. (1986) Ortho-phenylphenol Technical: An Acute Oral 

Toxi- city Study with the Mallard: Final Report: Project No. 103- 

248. Unpublished study prepared by Wildlife International Ltd. 

18 p. 

160149 Grimes, J. (1986) Ortho-phenylphenol Technical: A Dietary LC50 

 Study with the Bobwhite: Final Report: Project No. 103-246. Un- 

 published study prepared by Wildlife International Ltd. 17 p. 

160151 Grimes, J. (1986) Ortho-phenylphenol Technical: A Dietary LC50 

 Study with the Mallard: Final Report: Project No. 103-247. Un- 

 published study prepared by Wildlife International Ltd. 18 p. 

156044 Dill, D.; Milazzo, D.; Bartlett, E.; et al. (1985) Evaluation of the 

 Toxicity of Dowicide 1 Antimicrobial, Technical O-Phenyl- 

 phenol, to Representative Aquatic Organisms: ES-811. Unpub- 

 lished study prepared by Dow Chemical U S A. 17 p. 

110232 Bentley, R. (1975) Acute Toxicity of Dowicide CO to Bluegill ... 

 and Rainbow Trout ...: GH-RC 62. (Unpublished study re- ceived 

 Aug 25, 1976 under 464-126; prepared by Bionomics, EG & G 

 Environmental Consultants, submitted by Dow Chemical U.S.A., 

Midland, MI; CDL:233706-A) 

110222 Batchelder, T.; McCarty, W. (1977) Toxicity of Dowicide A to 

 Daph- nids: ES-154. (Unpublished study received Oct 28, 1977 

 under 464-78; submitted by Dow Chemical U.S.A., Midland, MI; 

CDL: 232113-A) 

46751202 Cafarella, M. (2006) OPP/SOPP - Acute Toxicity to Eastern Oyster 

 (Crassostrea virginica) Under Flow-Through Conditions. Project 

 Number: 12550/6382, 050368. Unpublished study prepared by 

 Springborn Bionomics. 60 p. 

60
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

46751203 Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to Mysids 

 (Americamysis bahia) Under Flow - Through Conditions. Project 

Number: 12550/6383, 050369. Unpublished study prepared by 

 Springborn Bionomics. 61 p. 

46751207 Teixeira, D. (2006) OPP/SOPP - Determination of Effects on 

 Seedling Emergence of Rice (Oryza sativa). Project Number: 

12550/6384, 050370. Unpublished study prepared by Springborn 

 Smithers Laboratories. 60 p. 

46751204 Teixeira, D. (2006) OPP/SOPP - Determination of Effects on 

Vegetative Vigor of Rice (Oryza sativa). Project Number: 

12550/6385, 050371. Unpublished study prepared by Springborn 

 Bionomics. 61 p. 

46751205 Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to the Freshwater 

 Diatom (Navicula pelliculosa). Project Number: 12550/6388, 

 050374. Unpublished study prepared by Springborn Bionomics. 

63 p. 

46751201 Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to the Marine 

Diatom, Skeletonema costatum, Under Static Conditions. Project 

 Number: 12550/6389, 050375. Unpublished study prepared by 

 Springborn Bionomics. 68 p. 

46823801 Hoberg, J. (2006) OPP/SOPP - Growth Inhibition Test with 

Freshwater Blue-Green Alga (Anabaena flos-aquae). Project 

 Number: 12550/6387, 050373. Unpublished study prepared by 

 Springborn Smithers Laboratories. 66 p. 

43994201 The Hydrolysis of o-Phenylphenol in Buffered Solution: SJ Gonsior, 

 1996, Study ID#: ES 3034, Performing Lab: The Environmental 

 Chemistry Research Laboratory, The Dow Chemical company, 

Midland, Michigan 48674 

43973501 Dullau (1990) Preventol O Extra Hydrolysis Study: (Ortho- 

 phenylphenol): Lab Project Number: G 89/0056/02 LEV: ZF- 

 DZA/OAL: K2011-0058701-95E. Unpublished study prepared by 

Bayer AG. 162 p. 

46601401 Davis, J.; Gonsior, S. (2005) Ortho-Phenylphenol, Sodium Salt: 

 Determination of the Leaching Rate from Wood Following a 

 Simulated Sapstain Treatment. Project Number: 051089. Unpublished 

 study prepared by The Dow Chemical Co. 31 p. 

61
 
 

 

 

 

 

 

 

 

 

 

 

 43334201 Gilbert, K.; Crissman, J. (1994): Dowicide 1 Antimicrobial: Acute 

 Oral Toxicity study in Fischer 344 Rats: Lab Project Number: 

K/001024/057A: K/001024/057A2: K/001024/057A3. Unpublished 

 study prepared by Dow Chemical Co. 53 p. 

43334202 Gilbert, K. (1994): Dowicide 1 Antimicrobial: Primary Dermal 

 Irritation study in New Zealand White Rabbits: Lab Project Number: 

 K/001024/057B. Unpublished study prepared by Dow Chemical Co. 

18 p. 

43334203 Gilbert, K. (1994): Dowicide 1 Antimicrobial: Dermal Sensitization 

 Potential in the Hartley Albino Guinea Pig: Lab Project Number: 

 K/001024/057E. Unpublished study prepared by Dow Chemical Co. 

16 p. 

43334204 Gilbert, K.; Stebbins, K. (1994): Dowicide A Antimicrobial: Acute Oral 

 Toxicity study in Fischer 344 Rats: Lab Project Number: 

K/001024/014A: K/001024/014A2. Unpublished study prepared by Dow 

 Chemical Co. 78 p. 

43334205 Gilbert, K. (1994): Dowicide A Antimicrobial: Dermal Sensitization 

 Potential in the Hartley Albino Guinea Pig: Lab Project Number: 

 K/001025/014E. Unpublished study prepared by Dow Chemical Co. 

16 p. 

40760206 Iguchi, S.; Takahashi, H.; Fujii, T.; et al. (1984): Subchronic Toxicity of 

 o-Phenolphenol (OPP) by Food Administration to Rats. Unpublished 

translation of Ann. Rept. Tokyo Res. Lab. 35: 407- 415. 29 p. 

41925001 Zablotny, C.L., et al. (1991): Ortho-phenylphenol (OPP): 13-Day 

 Range Finding Oral Gavage Study in New Zealand White Rabbits. 

 The Toxicology Research Laboratory, Midland, MI. Study ID K-001-

24-043. 

41925002 Zablotny, C.L., et al. (1991): Ortho-phenylphenol (OPP): Gavage 

Teratology Probe Study in New Zealand White Rabbits. The 

 Toxicology Research Laboratory, Midland, MI. Study ID K-001-24-

044. 

41925003 Zablotny, C.L., et al. (1991): Ortho-phenylphenol (OPP): Gavage 

 Teratology Study in New Zealand White Rabbits. The Toxicology 

 Research Laboratory, Midland, MI. Study ID K-001-24-045. 

62
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

43928801 Eigenberg, D.; Lake, S. (1995): A Two-Generation Dietary 

 Reproduction Study in Sprague-Dawley Rats Using Technical Grade 

ortho-Phenylphenol: Lab Project Number: 93-672-VX: 7788. 

Unpublished study prepared by Bayer Corp. 1213 p. 

42881901 Zempel, J.A. and J.R. Szabo (1993): Ortho-Phenylphenol: 21-

 Day Repeated Dermal Dose Study of Systemic Toxicity in 

 Fischer 344 Rats. Health and Environmental Sciences- Texas, 

Freeport, Texas. Study ID K-001024-056. 

43954301 Wahle, B.S. and W.R. Christenson (1996): Technical Grade ortho- 

 PHENYLPHENOL: A Combined Chronic Toxicity/ Oncogenicity 

 Study in the Rat. Bayer Corporation, Stillwell, KS. Study ID 92-

272-SC. 

44832201 Wahle, B.S. and W.R. Christenson (1996): Supplemental 

Submission to Bayer Toxicology Report No. 7908 (EPA MRID 

43954301). Bayer Corporation, Stillwell, KS. Study ID 92-272-

SC. 

44852701 Wahle, B.S. and W.R. Christenson (1996): Supplemental 

Submission to Bayer Toxicology Report No. 7908 (EPA MRID 

43954301). Bayer Corporation, Stillwell, KS. Study ID 92-272-

SC. 

43545501 Quast, J.F. and McGuirk, R.J. (1995): Ortho-phenylphenol: Two 

 Year Dietary Chronic Toxicity/Carcinogenicity Study in B6C3F1 

 mice. Study conducted by Dow Chemical Company, Midland, 

 Michigan and Freeport Texas for Dow Chemical Company, 

 Midland, Michigan and Miles Inc., Stillwell, KS. 

46882301 Timchalk, C. (1996) 14C-Orthophenylphenol: Pharmacokinetics 

 following dermal application in male human volunteers. 

 Unpublished report No. HET-K-001024-064 from Dow Chemical 

 Co., Midland, Michigan, USA. Submitted to WHO by Leng 

Associates, Midland, Michigan, USA. 

92154037 John, J.S. et al. (1978, reformatted 1990): Phase 3 Reformat of 

MRID 00067616/ 164362: The Effect(s) of Orally Administered 

 Orthophenylphenol on Rat Embryonal and Fetal Development. 

 Toxicology Research Laboratory, Midland, MI. Study ID HET K0001024-33 (R). 

63
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

78779 Carreon, R.E.; New, M.A. (1981) Dowicide(TM) 1: Acute 

 Percutaneous Absorption Potential: HET K-1024-(37). (Unpublished 

 study received Jun 18, 1981 under 464-70; submitted by Dow 

 Chemical U.S.A., Midland, Mich.; CDL:245514-A) 

41656401 Cosse, P.; Stebbins, K.; Stott, W.; et al. (1990) Ortho-phenylphen- 

 ol: Palatability/Probe, Four-week and One-year Oral Toxicity 

 Studies in Beagle Dogs: Lab Project Number: K-001024-038: K- 

 001024-038A: K-001024-039. Unpublished study prepared by Dow 

 Chemical Co., Health and Environmental Sciences. 321 p. 

92154039 Brusick, D. (1990) Dow Chemical U S A Phase 3 Reformat of 

MRID 00073282 and Related MRIDs 00079551. Mutagenicity of

 Ortho-Phenylphenol: LBI Project No. 2547. Prepared by Litton 

Bionetics, Inc. 11 p. 

161577 US Public Health Service, National Institutes of Health (1986) NTP 

Technical Report on the Toxicology and Carcinogenesis Studies of 

 Ortho-phenylphenol (CAS No. 90-43-7) Alone and with 7,12-Dimethylbenz(a)anthracene (CAS No. 57-97-6) in Swiss CD-1 Mice: 

 (Dermal Studies). NIH Publication No. 86-2557. 144 p. 

127249 Reitz, R.; Fox, T.; Quast, J.; et al. (1983) Follow-up Studies of the 

 Effects of Orthophenylphenol ... and Sodium Orthophenyl- phenol 

on the Urinary Tract of F344 Rats: HET K-1025-(11). 

(Unpublished study received Mar 28, 1983 under 464-70; sub-

 mitted by Dow Chemical U.S.A., Midland, MI; CDL:249835-A) 

92154038 Deford, C. (1990) Dow Chemical U S A Phase 3 Summary of 

 MRID 00127249. Biochemical Factors Involved in the Effects of 

 Orthophenylphenol (OPP) and Sodium Orthophenylphenol (SOPP) 

on the Urinary Tract of Male F344 Rats. Prepared by Dow Chemical 

Company. 6 p. 

145962 Reitz, R.; Fox, T.; Quast, J.; et al. (1983) Molecular mechanisms 

involved in the toxicity of orthophenylphenol and its sodium salt. 

 Chem.-Biol. Interactions 43:99-119. 

71253 Savides, M.C.; Oehme, F.W. (1980) Urinary metabolism of orally 

 administered~ortho~-phenyl phenol in dogs and cats. Toxicology 

 17:355-363. (Also~In~unpublished submission received Feb 12, 

 1981 under 464-70; submitted by Dow Chemical U.S.A., Midland, 

Mich.; CDL:244358-A) 

64
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 44197601 Christenson, W.; Wahle, B.; Cohen, S. (1996) Technical Grade 

 ortho-Phenylphenol: A Special Subchronic Dietary Study to 

 Examine the Mechanism of Urinary Bladder Carcinogenesis in the 

 Male Rat: Lab Project Number: 92-972-MS: 8042. Unpublished 

study prepared by Bayer Corp. and University of Nebraska Medical 

Center. 47 p. 

44197602 Christenson, W.; Wahle, B.; Cohen, S. (1996) Technical Grade 

 ortho-Phenylphenol: A Special Subchronic Dietary Study to 

 Examine the Mechanism of Urinary Bladder Carcinogenesis in the 

 Male Rat: Supplement: Lab Project Number: 92-972-MS: 8042-1. 

Unpublished study prepared by Bayer Corp. and University of 

Nebraska Medical Center. 11 p. 

41609502 Deford, C. (1990) Product Chemistry Data for Dowcide A 

 Antimicro- bial. Unpublished study prepared by Dow Chemical 

U.S.A. 64 p. 

43298301 Wu, D. (1994) Metabolism of (carbon 14) Sodium Ortho- 

 Phenylphenate (SOPP) in Stored Oranges: Nature of the Residue in 

 Plants: Lab Project Number: XBL/93011: RPT00165. Unpublished 

 study prepared by XenoBiotic Lab., Inc. 150 p. 

43537101 Wu, D. (1995) Metabolism of (carbon 14)Sodium Ortho- 

 Phenylphenate (SOPP) in Stored Pears: Nature of the Residue in 

 Plants: Lab Project Number: 93013: RPT00211. Unpublished study 

prepared by XenoBiotic Labs., Inc. 209 p. 

44349301 Thalacker, F. (1997) Nature of the Residue of (carbon-14)- 

Orthophenylphenol in Lactating Goats: Final Report: Lab Project 

 Number: CHW 6578-105: AM-066: MILKG2S2.XLS. Unpublished 

 study prepared by Corning Hazleton Inc. 160 p. 

43384101 Harsy, S. (1994) Validation of Method for Determination of o- 

 Phenylphenol Residues in Pears: Lab Project Number: HWI 6524- 

106. Unpublished study prepared by Hazleton Wisconsin, Inc. 36 p. 

43742101 Harsy, S. (1995) Validation of Method for Determination of o- 

 Phenylphenol Residues in Pears: Addendum No. 1 to the Final 

 Report: Lab Project Number: HWI 6524-106. Unpublished study 

 prepared by Hazleton Wisconsin, Inc. 13 p. 

65
 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

44038501 Harsy, S. (1996) Validation of Methods for Determination of o- 

 Phenylphenol Residues and Phenylhydroquinone Residues in Citrus: 

 Addendum No.1 to the Final Report: Lab Project Number: HWI 

 6524-107. Unpublished study prepared by Hazleton Wisconsin, Inc. 

14 p. 

43996401 Harsy, S. (1996) Validation of Methods for Determination of oPhenylphenol Residues and Phenylhydroquinone Residues in Citrus: 

 Final Report: Lab Project Number: HWI 6524-107. Unpublished 

 study prepared by Hazleton Wisconsin, Inc. 89 p. 

43992401 Johnson, G.; Strickland, M. (1996) Storage Stability of 

 Orthophenylphenol and Phenylhydroquinone Residues in/on Raw 

Orange, Grapefruit, Lemon Fruit and Processed Orange Products: 

 Final Report: Lab Project Number: CCQC 94-06: 101-009: HWI 

 6578-104. Unpublished study prepared by Western EcoSystems

 Technology (WEST, Inc.); Research for Hire; and Wm. J. Englar & 

Associates, Inc. 178 p. 

44112001 Johnson, G.; Strickland, M. (1996) Storage Stability of 

 Orthophenylphenol and Phenylhydroquinone Residues in/on Raw 

Orange, Grapefruit, Lemon Fruit, and Processed Orange Products: 

 Addendum 1 to the Final Report: Lab Project Number: 101-009: 

 R289505: CCQC 94-06. Unpublished study prepared by Western 

 EcoSystems Technology (WEST, Inc.); Research for Hire; and 

Corning Hazleton. 42 p. 

44182601 Johnson, G.; Strickland, M. (1996) Storage Stability of 

 Orthophenylphenol and Phenylhydroquinone Residues in/on Raw 

 Orange, Grapefruit, Lemon Fruit and Processed Orange Products 

 Addendum 2 to the Final Report (MRID 43992401): Lab Project 

 Number: 101-009: R289505: CCQC 94-06. Unpublished study 

 prepared by Western EcoSystems Technology. 33 p. 

45524304 Bestari et al., 1999 Measurement and Assessment of Dermal and 

 Inhalation Exposures to Didecyl Dimethyl Ammonium Chloride 

 (DDAC) Used in the Protection of Cut Lumber (Phase III). (Task 

force #73154). 

41412201 Popendorf, W.; Selim, M.; Kross, B. (1990) Chemical Manufacturers 

Association Antimicrobial Exposure Assessment Study: Lab Project 

ID: Q626. Unpublished study prepared by Univ. of Iowa, Insti- tute 

of Agricultural Medicine and Occupational Health. 209 p. Has 

different statistics when compared to 41742601 and 41761201. 

66
 
 

 

 

41742601 Popendorf, W.; Selim, M.; Kross, B. (1990) Chemical Manufacturers 

 Association Antimicrobial Exposure Assessment: Lab Project 

 Number: Q626. Unpublished study prepared by The Univ. of Iowa. 

209 p. 

43432901 Maxey, S.; Murphy, P. (1994) Evaluation of Post-Application 

 Exposures to Sodium o-Phenylphenate Tetrahydrate/ o-Phenylphenol 

 to Workers During Post-Harvest Activities at Pear and Citrus Fruit 

 Packaging Facilities: Lab Project Number: HEH2.1-1-174(39). 

 Unpublished study prepared by Dow Chemical Co. 180 p. 

2. Open Literature 

Citation 

Arambasic, M.B., Bjelic, S., and G. Subakov. 1995. Acute Toxicity of Heavy Metals (Copper, 

Lead, Zinc), Phenol and Sodium on Allium cepa L., Lepidium sativum L. and Daphnia 

magna Strauss. Water Res. 29(2): 497-503. 

Argus Research Laboratories, Inc. (1997). Oral (gavage) developmental toxicity study of phenol 

in rats. Horsham, Pennsylvania. Protocol number: 916-011. 

Barale, Marrazzini, Betti, Vangelisti, Loprieno, and Barrai. (1990). Genotoxicity of Two 

Metabolites of benzene: Phenol and Hydroquinone Show Strong Synergistic Effects In 

Vivo. Mutation Research 244:15-20. 

Bartels, M.J., McNett, D.A., Timchalk, C., Mendrala, A.L., Christenson, W.R., Sangha, G.K., 

Brzak, K.A., Shabrang, S.N. (1998): Comparative metabolism of ortho-phenylphenol in 

mouse, rat, and man. Xenobiotica 28(6): 579-594. 

Behl, Linn, et al. (1983). Permeation of Skin and Eschar by Antiseptics I: Baseline Studies 

With Phenol. J Pharm Sci 72.4:391-396. 

Bentley, R.E. 1975. Acute Toxicity of Dowicide Co to the Bluegill and Rainbow Trout. 

Unpublished data. Conducted by Bionomics EG&G Environmental Consultants for The 

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Fischer 344 rats after gavage, drinking water, and inhalation exposure, with cover letter 

dated 07/13/1994. U.S. EPA/OPTS Public Files Fiche # OTS0557473; Doc#: 

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 TOXNET System. 

Hodson, P.V., Dixon D.G., and K.L. Kaiser. 1984. Measurement of Median Lethal Dose 

 as a Rapid Indication of Contaminant Toxicity to Fish. Environ. Toxicol. 

Chem. 3(2):243-254. 

Hu, J., and T. Aizawa. 2003. Quantitative Structure-Activity Relationships for Estrogen 

 Receptor Binding Affinitiy of Phenolic Chemicals. Water Res 37: 1213-22. 

Hughes and Hall.. 1995 "Disposition of Phenol in Rat after Oral, Dermal, Intravenous, and 

Intratracheal Administration." 

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Kolachana P, Subrahmanyam V, Meyer K, Zhang L, Smith M. "Benzene and its 

 phenolic metabolites produces oxidative DNA damage in HL60 cells in vitro and 

 in the bone marrow in vivo." 1993 Cancer Research 53:1023-1026. 

Kolachana, P. et al. (1991): Metabolism of phenylhydroquinone by prostaglandin (H) 

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12(1): 145-149. 

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 John Wiley, NY, Volume 13, pp 1004. 

Kuhn, R., M. Pattard, K. Pernak, and A. Winter. 1989. Results of the Harmful Effects of 

 Selected Water Pollutants (Anilines, Phenols, Aliphatic Compounds) to Daphnia 

magna. Water Res 23(4): 495-499. 

McCann, J. 1973. Fish Toxicity Laboratory Report on Dowicide A, Test No. 640. Unpublished 

data. Conducted by the Animal Biology Laboratory, EPA-PR, ARC, Beltsville, MD. 

Meylan W.M., and Howard P.H., 1993; Chemosphere, Volume 26, pp 2293 

Miller, D., B. B. Wheals, N. Beresford, and J. P. Sumpter. 2001. Estrogenic Activity of 

Phenolic Additives Determined by an In Vitro Yeast Bioassay. Environ Health Perspec 

109(2); 133-38. 

Moser, V.C., B.M. Cheek and R.C. MacPhail. 1995. A multidisciplinary approach to 

toxicological screening: III. Neurobehavioral toxicity. J Toxicol Environ Health. 45(2): 

173-210. 

Nagel et al. "Induction of filamentation by mutagens and carcinogens in a ion mutant of 

Esherichia coli." 1982 Mutation Research 105(5): 309-312. 

Narotsky M, Kavlock R. "A multidisciplinary approach to toxicological screening: II. 

Developmental Toxicity." 1995. J Toxicol Env Health 45: 145-171. 

National Institute for Occupational Safety and Health (NIOSH): Criteria for a 

 Recommended Standard-Occupational Exposure to Metalworking Fluids. 

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(1998). 

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Vienna, VA. NIH, 1980. 

Niho, N et al. (2002): Dose- and time-response studies of sodium o-phenylphenate urinary 

bladder carcinogenicity in rats. Food and Chemical Toxicology 40: 715-722. 

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NTP (National Toxicology Program). 1986. Toxicology and carcinogenesis studies of benzene 

(CAS No. 71-43-2) in F344/N rats and B6C3F1 mice (gavage studies). NTIS 

PB86-216967/AS. 

OTS # - 0515564/ 86-870001402: Carpenter, C.P. "Skin Absorption and Irritation of

 Sodium Phenate." Mellon Institute of Industrial Research, University of

 Pittsburgh. May 5, 1948 (unpublished). 

OTS # - 0515567/ 86-870001405: Carpenter, C.P. " The Acute Toxicity of Phenol." Mellon 

Institute of Industrial Research, University of Pittsburgh. May 6, 1949 (Unpublished). 

Ozawa, S. et al. (2000): Metabolic activation of o-phenylphenol to a major cytotoxic metabolite, 

phenylhydroquinone: role of human CYP1A2 and rat CYP2C11/CYP2E1. Xenobiotica 

30(10): 1005-1017. 

Paschin and Bahitova. "Mutagenicity of benzo[a]pyrene and the antioxidant phenol at 

 the GHPRT locus of V79 Chinese hamster cells." 1982 Mutation Research 104: 

389-393. 

Pool and Lin. "Mutagenicity testing in the Salmonella typhimurium assay of phenolic 

compounds and phenolic fractions obtained from smokehouse smoke condensates." 1982 

Food and Chem Tox 20(4): 383-391. 

Reitz, R.H. et al. (1983): Molecular mechanisms involved in the Toxicity of Orthophenylphenol 

and its Sodium salt. Chem.-Biol. Interactions 43: 99-119. 

Ryan et al. 2001. "Two-generation reproduction study and immunotoxicity screen in rats dosed 

with phenol via the drinking water." International Journal of Toxicology 20: 121-142. 

Routledge, E. J., and J. P. Sumpter. 1997. Structural Features of Alkylphenolic Chemicals 

Associated with Estrogenic Activity. J Biol Chem 272(6): 3280-88. 

Sarakha et al.; Chemophere, 1989, volume 18, pp 1391). 

Salaman, M.H. and O.M. Glendenning. 1957. Tumor promotion in mouse skin by sclerosing 

agents. Br. J. Cancer. 11: 434-444. 

Schmeider, P.K., M.A. Tapper, J.S. Denny, R.C. Kolanzyk, B.R. Sheedy, T.R. Henry, and G. D. 

Veith. 2004. Use of Trout Liver Slices to Enhance Mechanistic Interpretation of 

Estrogen Receptor Binding for Cost-Effective Prioritization of Chemicals within Large 

Inventories. Environ. Sci. Technol. 38: 6333-6342. 

Schmeider, P., M. Tapper, A. Linnum, J. Denny, R. Kolanzyk, and R. Johnson. 2000. 

Optimization of a Precision-Cut Trout Liver Tissue Slice Assay as a Screen for 

Vitellogenin Induction: Comparison of Slice Incubation Techniques. Aquat. Toxicol. 

49: 251-268. 

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Stenius U, Warholm M, Rannug A et al. 1989. "The role of GSH depletion and toxicity in 

hydroquinone-induced development of enzyme-altered foci." Carcinogenesis. 

10:593-599. 

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Tallin, T.R. 1975; Polytech. Inst., Volume 390, pp 107 

Tisler, T. and J. Zagorc-Koncan. 1995. Relative Sensitivity of some Selected Aquatic 

Organisms to Phenol. Bulletin of Environmental Contamination and Toxicology, 54: 

717-723. 

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Edition, Van Nostrand, NY, pp 536. 

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in Drosophilae. V. Results of 53 Coded Compounds Tested for the National Toxicology 

Program." Environmental Mutagenesis 7: 677-702. 

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acidic fractions as promoters. Cancer. 14(6): 1306-1315. 

3. Website References 

Citation 

Addinsoft, 2004. XLSTAT v7.5. http://www.xlstat.com. 

FDA, 2003a. “Guidance For Industry: Preparation of Food Contact Notifications and 

 Food Additive Petitions for Food Contact Substances: Chemistry 

 Recommendations. Final Guidance.” April, 2003. 

http://www.cfsan.fda.gov/~dms/opa2pmnc.html. Last accessed June 9, 2003. 

FDA, 2003b. “Sanitizing Solutions: Chemistry Guidelines for Food Additive Petitions.” 

January, 1993. http://www.cfsan.fda.gov/~dms/opa-cg3a.html. Last accessed 

June 9, 2003. 

IPCS, 1999: Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food 

 and the Environment: 2-phenylphenol and its sodium salt. Available at: 

www.inchem.org/documents/jmpr/jmpmono/v99pr08.htm 

SIMetric, 2005. Mass, Weight, Density, or Specific Gravity of Bulk Materials. 

http://www.simetric.co.uk/si_materials.htm , last accessed June 2005 

72
 
 

 

 

 

United States Environmental Protection Agency (USEPA). 2002b. ECOTOX User 

 Guide: ECOTOXicology Database System. Version 3.0. Available: 

http://www.epa.gov/ecotox/ 

Whatman, 2005. Whatman Absorbent Sinks. 

http://www.whatman.com/products/?pageID=7.32.42 , Accessed March 2005 

4. Other Supporting Documents 

Citation 

United States Environmental Protection Agency (USEPA). 1980. Ambient Water 

 Quality Criteria for Phenol. U.S. EPA 440/5-80-066. October, 1980. 

United States Environmental Protection Agency (USEPA). 2000. Residential SOPs. EPA 

Office of Pesticide Programs–Human Health Division. Dated April 5, 2000. 

United States Environmental Protection Agency (USEPA). 2002a. Toxicological Review of 

Phenol. Integrated Risk Information System (IRIS). September 2002. EPA/635/R02/006. 

United States Environmental Protection Agency (USEPA). 2004. Phenol - Report of the 

Antimicrobials Division Toxicology Endpoint Selection Committee. Dated May 20, 

2004. Memorandum from Timothy F. McMahon, Chair, ADTC, Antimicrobials Division. 

United States Environmental Protection Agency (USEPA). 1997. “Exposure Factors 

 Handbook, Volume III: Activity Factors.” EPA/600/P-95/002Fc August 1997. 

United States Environmental Protection Agency (USEPA). 1999. “Available Information 

 on Assessing Exposure from Pesticides, A User’s Guide.” 

http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf. Last 

accessed June 9, 2003. 

United States Environmental Protection Agency (USEPA).1997. Standard Operating 

 Procedures (SOPs) for Residential Exposure Assessments. EPA Office of 

 Pesticide ProgramsBHuman Health Effects Division (HED). Dated December 

18, 1997. 

United States Environmental Protection Agency (USEPA). 1997a. Exposure Factors 

 Handbook. Volume I-II. Office of Research and Development. Washington, 

D.C. EPA/600/P-95/002Fa. 

73
 
 

United States Environmental Protection Agency (USEPA). 1997b. Risk Analysis for 

Microban Additive AB@ (Triclosan or Irgason DP300). Treated Toys for Infants. 

 Memorandum from Winston Dang, USEPA to Frank Sanders and William

 Jordan, USEPA. Dated February 27, 1997. 

United States Environmental Protection Agency (USEPA). 1998. PHED Surrogate 

 Exposure Guide. Estimates of Worker Exposure from the Pesticide Handler 

 Exposure Database Version 1.1. Washington, DC: U.S. Environmental 

Protection Agency. 

United States Environmental Protection Agency (USEPA). 1999. Evaluation of 

 Chemical Manufacturers Association Antimicrobial Exposure Assessment Study. 

 Memorandum from Siroos Mostaghimi, Ph.D., USEPA, to Julie Fairfax. 

United States Environmental Protection Agency (USEPA). November 4, 1999. 

DP Barcode D247642. (HED=s Science Advisory council for Exposure Policy 

#009. Agricultural Default Daily Acres Treated. April 1, 1999). 

United States Environmental Protection Agency (USEPA) 2000. Residential SOPs. 

 EPA Office of Pesticide ProgramsBHuman Health Effects Division. Dated April 

5, 2000. 

United States Environmental Protection Agency (USEPA). 2001. HED Science Advisory 

 Council for Exposure. Policy Update, November 12. Recommended Revisions to 

 the Standard Operating Procedures (SOPs) for Residential Exposure Assessment, 

February 22, 2001. 

United States Environmental Protection Agency (USEPA).2005. A. Najm Shamim, and 

 Kathryn Montague, (memorandum); Review on the Determination of the Leaching 

 Rate of NA-OPP From Wood Following A Simulated Sapstain Treatment (DP Bar 

Code: 319656). 

74
 
Appendix E. Generic Data Call-In 

The Agency intends to issue a Generic Data Call-In at a later date. See Chapter V of the Phenol 

and Salts RED for a list of studies that the Agency plans to require. 

75
 
Appendix F. Product Specific Data Call-In 

The Agency intends to issue a Product Specific Data Call-In for Phenol and Salts at a later date. 

76
 
Appendix G. Batching of Phenol and Salts Products for Meeting Acute Toxicity Data 

Requirements for Reregistration 

The Agency will complete the batching for phenol and salts at a later date. 

77
 
Appendix H. List of All Registrants Sent the Data Call-In 

A list of registrants sent the data call-in (DCI) will be posted at a later date. 

78
 
 

 

Appendix I. List of Available Related Documents and Electronically Available Forms 

Pesticide Registration Forms are available at the following EPA internet site: 

http://www.epa.gov/opprd001/forms/. 

Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader) 

Instructions 

1. Print out and complete the forms. (Note: Form numbers that are bolded can be 

filled out on your computer then printed.) 

2. The completed form(s) should be submitted in hardcopy in accord with the 

existing policy. 

3. Mail the forms, along with any additional documents necessary to comply with 

EPA regulations covering your request, to the address below for the Document 

Processing Desk. 

DO NOT fax or e-mail any form containing ‘Confidential Business Information’ or ‘Sensitive 

Information.’ 

If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-

5551 or by e-mail at williams.nicole@epamail.epa.gov. 

The following Agency Pesticide Registration Forms are currently available via the 

internet at the following locations: 

8570-1 Application for Pesticide Registration/Amendment http://www.epa.gov/opprd001/forms/8570-1.pdf 

8570-4 Confidential Statement of Formula http://www.epa.gov/opprd001/forms/8570-4.pdf 

8570-5 Notice of Supplemental Registration of Distribution of

a Registered Pesticide Product 

http://www.epa.gov/opprd001/forms/8570-5.pdf 

8570-17 Application for an Experimental Use Permit http://www.epa.gov/opprd001/forms/8570-17.pdf 

8570-25 Application for/Notification of State Registration of a 

Pesticide To Meet a Special Local Need 

http://www.epa.gov/opprd001/forms/8570-25.pdf 

8570-27 Formulator’s Exemption Statement http://www.epa.gov/opprd001/forms/8570-27.pdf 

8570-28 Certification of Compliance with Data Gap Procedures http://www.epa.gov/opprd001/forms/8570-28.pdf 

8570-30 Pesticide Registration Maintenance Fee Filing http://www.epa.gov/opprd001/forms/8570-30.pdf 

8570-32 Certification of Attempt to Enter into an Agreement 

with other Registrants for Development of Data 

http://www.epa.gov/opprd001/forms/8570-32.pdf 

8570-34 Certification with Respect to Citations of Data (in PR 

Notice 98-5) 

http://www.epa.gov/opppmsd1/PR_Notices/pr98-

5.pdf 

8570-35 Data Matrix (in PR Notice 98-5) http://www.epa.gov/opppmsd1/PR_Notices/pr98-

5.pdf 

8570-36 Summary of the Physical/Chemical Properties (in PR 

Notice 98-1) 

http://www.epa.gov/opppmsd1/PR_Notices/pr98-

1.pdf 

8570-37 Self-Certification Statement for the Physical/Chemical 

Properties (in PR Notice 98-1) 

http://www.epa.gov/opppmsd1/PR_Notices/pr98-

1.pdf 

79
 
 

 

 

 

 

 

 

 

 

 

 

 

Pesticide Registration Kit

www.epa.gov/pesticides/registrationkit/. 

Dear Registrant: 

For your convenience, we have assembled an online registration kit that contains the 

following pertinent forms and information needed to register a pesticide product with the U.S. 

Environmental Protection Agency’s Office of Pesticide Programs (OPP): 

1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal 

Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality 

Protection Act (FQPA) of 1996. 

2. Pesticide Registration (PR) Notices 

a. 83-3 Label Improvement Program—Storage and Disposal Statements 

b. 84-1 Clarification of Label Improvement Program 

c. 86-5 Standard Format for Data Submitted under FIFRA 

d. 87-1 Label Improvement Program for Pesticides Applied through 

Irrigation Systems (Chemigation) 

e. 87-6 Inert Ingredients in Pesticide Products Policy Statement 

f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement 

g. 95-2 Notifications, Non-notifications, and Minor Formulation 

Amendments 

h. 98-1 Self Certification of Product Chemistry Data with Attachments (This

document is in PDF format and requires the Acrobat reader.) 

Other PR Notices can be found at http://www.epa.gov/opppmsd1/PR_Notices. 

3. Pesticide Product Registration Application Forms (These forms are in PDF format 

and will require the Acrobat reader.) 

a. EPA Form No. 8570-1, Application for Pesticide 

Registration/Amendment 

b. EPA Form No. 8570-4, Confidential Statement of Formula 

c. EPA Form No. 8570-27, Formulator’s Exemption Statement 

d. EPA Form No. 8570-34, Certification with Respect to Citations of Data 

e. EPA Form No. 8570-35, Data Matrix 

80
 
 

 

4. General Pesticide Information (Some of these forms are in PDF format and will 

require the Acrobat reader.) 

a. Registration Division Personnel Contact List 

b. Biopesticides and Pollution Prevention Division (BPPD) Contacts 

c. Antimicrobials Division Organizational Structure/Contact List 

d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data 

Requirements (PDF format) 

e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF

format) 

f. 40 CFR Part 158, Data Requirements for Registration (PDF format) 

g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 

1985) 

Before submitting your application for registration, you may wish to consult some

additional sources of information. These include: 

1. The Office of Pesticide Programs’ Web Site 

2. The booklet “General Information on Applying for Registration of Pesticides in 

the United States”, PB92-221811, available through the National Technical 

Information Service (NTIS) at the following address: 

National Technical Information Service (NTIS) 

 5285 Port Royal Road 

 Springfield, VA 22161 

The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in

the process of updating this booklet to reflect the changes in the registration program resulting 

from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We 

anticipate that this publication will become available during the Fall of 1998. 

3. The National Pesticide Information Retrieval System (NPIRS) of Purdue 

University’s Center for Environmental and Regulatory Information Systems. This 

service does charge a fee for subscriptions and custom searches. You can contact 

NPIRS by telephone at (765) 494-6614 or through their Web site. 

4. The National Pesticide Telecommunications Network (NPTN) can provide 

information on active ingredients, uses, toxicology, and chemistry of pesticides. 

You can contact NPTN by telephone at (800) 858-7378 or through their Web site: 

ace.orst.edu/info/nptn. 

The Agency will return a notice of receipt of an application for registration or amended 

registration, experimental use permit, or amendment to a petition if the applicant or petitioner 

encloses with his submission a stamped, self-addressed postcard. The postcard must contain the 

following entries to be completed by OPP: 

81
 
 

 

 Date of receipt 

 EPA identifying number 

 Product Manager assignment 

Other identifying information may be included by the applicant to link the 

acknowledgment of receipt to the specific application submitted. EPA will stamp the date of 

receipt and provide the EPA identifying File Symbol or petition number for the new submission. 

The identifying number should be used whenever you contact the Agency concerning an 

application for registration, experimental use permit, or tolerance petition. 

To assist us in ensuring that all data you have submitted for the chemical are properly 

coded and assigned to your company, please include a list of all synonyms, common and trade 

names, company experimental codes, and other names which identify the chemical (including 

“blind” codes used when a sample was submitted for testing by commercial or academic 

facilities). Please provide a CAS number if one has been assigned. 

82