United States Chemical Safety June 2012

Environmental Protection and Pollution Prevention

Agency (7510P)

Aliphatic Alcohols, C1-C5

Ethanol and Isopropyl Alcohol

Summary Document

Registration Review: Initial Docket

June 2012

Docket Number: EPA-HQ-OPP-2012-0340

www.regulations.gov

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TABLE OF CONTENTS

Aliphatic Alcohols, C1-C5 (Ethanol and Isopropyl Alchol) Registration Review Team....4

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

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

III. Summary of Anticipated Data Requirements..............................................................21

IV. Appendix A..................................................................................................................22

________________________________________

Please Note

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

current position based on the following documents: 

1. Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in 

Support of Registration Review of Aliphatic Alcohols, C1-C5 (Ethanol and Isopropyl 

Alcohol). May 31, 2012

2. Aliphatic Alcohols, C1-C5: Human Health Effects Scoping Document for the 

Registration Review Decision. April 16, 2012

Additional supporting documents for the Aliphatic Alcohols, C1-C5 (Ethanol and Isopropyl 

Alcohol) Case may be found in the registration review docket EPA-HQ-OPP-2012-0340 located 

on the internet at www.regulations.gov.
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Aliphatic Alcohols, C1-C5 (Ethanol and Isopropyl Alcohol) Registration Review Team

Human Health & Environmental Effects

Talia Lindheimer

Jonathan Chen

Steven Malish

Srinivas Gowda

James Breithaupt

David Bays

Risk Management

Wanda Henson

Lance Wormell

Office of General Counsel

Philip Ross
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I. Preliminary Work Plan -- Aliphatic Alcohols, C1-C5 (Ethanol and Isopropyl Alcohol)

Introduction: 

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

pesticides distributed or sold in the United States generally must be registered by the U.S. 

Environmental Protection Agency (USEPA, EPA, or the Agency) based on scientific data 

showing that they will not cause unreasonable risks to human health or the environment when 

used as directed on product labeling. The registration review program is intended to make sure 

that, as the ability to assess risk evolves and as policies and practices change, all registered 

pesticides continue to meet the statutory standard of no unreasonable adverse effects to human 

health or the environment. Changes in science, public policy, and pesticide use practices will 

occur over time. Through the registration review program, the Agency periodically reevaluates 

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

Information on this program is provided at http: //www.epa.gov/oppsrrd1/registration_review/.

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

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

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

registration. The Agency will consider benefits information and data as required by FIFRA. The 

public phase of registration review begins when the initial docket is opened for each case. The 

docket is the Agency’s opportunity to state what it knows about the pesticide and what additional 

risk analyses and data or information it believes are needed to make a registration review 

decision. After reviewing and responding to comments and data received in the docket during 

this initial comment period, the Agency will develop and commit to a final work plan and 

schedule for the Aliphatic Alcohols, C1-C5 (Ethanol and Isopropyl Alcohol) Case.

The Aliphatic Alcohol Case (Case 4003) contains two active ingredients: ethanol (PC Code 

001501) and isopropyl alcohol (PC Code 047501)

The first product containing ethanol was registered in the United States on April 21, 1948, and is 

registered for use as a glassware sanitizer in eating establishments and hard non-porous surface 

disinfectant and bacteriocide in eating establishments and institutional premises. There are 

currently 50 registered active products containing the active ingredient ethanol. End use products 

containing the chemical ethanol are registered for use as surface disinfectants in use sites such as 

agricultural premises and equipment, medical premises and equipment, industrial areas and 

residential and public access areas. Ethanol is also registered for use in antifouling paints for use 

on boats bottoms and boat running gear below the water line. End use products are also 

registered for use in aquatic industrial processes and water systems such as cooling towers as 

well as pulp and paper mill process water systems. In addition to being registered for use in 

human drinking water systems, ethanol is also registered for use as an ingredient in products 

used in pools, hot tubs and spas. In addition, ethanol containing products are also used in aquatic 

areas such as commercial fishery water systems and fish containing lakes, ponds and reservoirs. 

There are two registered food contact uses for this chemical. One is for the sanitization of food 

eggs and the other is as a post harvest treatment for specific fruits and vegetables. 
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Ethanol also is registered for use as a plant growth regulator (a ripener). There is also a registered 

use of ethanol with ARCO Ethylene Generators (catalytic generation of ethylene gas) involving

EPA Reg. No.# 58502-1, a product that is registered for use as a ripening agent for citrus fruits, 

pear, avocado, banana, papaya, melons, tomato, flue-cured tobacco/cigar/cigar wrapping. The 

receptors in fruits and vegetables absorb free atmospheric ethylene molecules, and this in turn 

accelerates the ripening process. Due to the product based conversion of ethanol to ethylene gas, 

there are no expected exposures to ethanol on the raw agricultural commodity, (RAC) and 

residual ethylene gas is not expected. Fruits and vegetables produce ethylene gas naturally, and 

reabsorb the gas to stimulate the production of more; as this is the process by which ripening 

occurs. Ethanol is converted to ethylene gas, and the gas is pumped into ripening rooms.

The first product containing isopropyl alcohol was registered on March 5, 1948 and is registered

for use as a glassware sanitizer in eating establishments and hard non-porous surface disinfectant 

and bacteriocide in household, commercial and institutional premises. There are currently 31 

registered products containing the active ingredient isopropyl alcohol. Products containing 

isopropyl alcohol are also registered for use in spray, ready to use solution and impregnated wipe 

forms. End use products containing the chemical isopropyl alcohol are registered for use as 

porous (fabrics, mattresses, etc.) and non-porous surface disinfectant in use sites such as 

agricultural premises and equipment, industrial areas and residential and public access areas. 

Products containing isopropyl alcohol are also registered for use in/on medical premises and 

equipment and veterinary premises as well as in/on salon and barber shop areas and utensils as 

well as ultra sonic cleaners and for precleaning of medical instruments prior to disinfection. In 

addition, isopropyl alcohol containing products are also used in non-pesticidal products as a 

deodorizer in air fresheners. It is also registered for use in retail and institutional food 

establishments, food processing plants and other health department regulated food facilities. 

There are no EPA established tolerances or exemptions from tolerances identified for 

isopropanol; however, there are several FDA established tolerances for isopropanol in modified 

hop extract (21 CFR 172.560) and in foods for human consumption (21 CFR 173.240). Ethanol 

has three inert exemptions from the requirement of a tolerance in 40 CFR 180.910, -.930, and -

.940. Both ethanol and isopropanol also have a wide range of non-pesticidal uses. For example, 

ethanol is contained in some beverages, and isopropanol is the major ingredient in rubbing 

alcohol. 

The Agency completed a Reregistration Eligibility Decision (RED) for Aliphatic Alcohols, C1-

C5 (Ethanol and Isopropyl Alcohol) in 1995. When the aliphatic alcohols, C1-C5 (ethanol and 

isopropyl alcohol) registration review case was established, it was considered that C1-5 alcohols 

are all very water-soluble and are expected to be similar. The remaining alcohol groups, C6-16, 

which were in reregistration case 4004 for which a RED was completed in 2007, will be 

addressed under a separate registration review case.

Documents associated with the registration review of Aliphatic Alcohols, C1-C5 can be viewed 

at www.regulations.gov in docket EPA-HQ-OPP-2012-0340. Below is a summary of the issues 

relevant to this registration review case.
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Anticipated Risk Assessment and Data Needs: 

The Agency does not anticipate the need to conduct an ecological risk assessment. The Agency 

does not anticipate the need to conduct a human health risk assessment. The Agency does not 

anticipate needing additional data for use in conducting the registration review for aliphatic 

alcohols, C1-C5 (ethanol and isopropyl alcohol). 

Ecological Risk: 

The most recent qualitative ecological risk assessment was performed for aliphatic 

alcohols, C1-C5 (ethanol and isopropyl alcohol) in support of the 1995 RED. 

Based on ethanol and isopropyl alcohol’s use patterns, volatility, ready biodegradability, 

and low toxicity, and the use of these compounds as a nutrient source by microbes, the 

Agency intends to conclude that the registered uses of ethanol and isopropyl alcohol will 

have 'no effect' (NE) on endangered or threatened terrestrial or aquatic species, or their 

designated critical habitats, as listed by the U.S. Fish and Wildlife Service (USFWS) and 

the National Oceanic and Atmospheric Administration's (NOAA) National Marine 

Fisheries Service (NMFS). EPA anticipates conducting no further analysis of potential 

risks to endangered or threatened species unless public comment or other submissions 

provide data or information that would otherwise inform the Agency's determination. 

The Agency does not anticipate the need to require additional ecological data for use in

registration review for Aliphatic Alcohols, C1-C5 (ethanol and isopropyl alcohol) Case at 

this time. The use pattern is restricted to indoor uses (listed above), and its use will lead 

to little, if any, exposure to non-target organisms. 

The Agency does not anticipate the need to require additional environmental fate data for 

use in the aliphatic alcohols, C1-C5 (ethanol and isopropyl alcohol) registration review

case at this time. There is sufficient information in the public literature on the fate of 

aliphatic alcohols in the environment. Aliphatic alcohols chemistry is well known and 

well documented in the open literature. Although the aliphatic alcohols are expected to 

be stable in water under typical use conditions, the compounds are not hazardous to the 

environment because they are readily biodegradable, a nutrient for microbes, and a 

metabolite of microbes. 

For more information, please refer to Product Chemistry, Environmental Fate, and 

Ecological Effects Scoping Document in Support of Registration Review of Aliphatic 

Alcohols, C1-C5 (Ethanol and Isopropyl Alcohol)., located in the docket.

Human Health Risk: 

No human health risk assessment has been performed for aliphatic alcohols, C1-C5

(ethanol and isopropyl alcohol). Human health risk assessments were not needed at the 

time of the RED, because the Agency determined that toxicological criteria were not 

triggered and that the exposure and risk from the active ingredients were not significant
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when compared to the frequent intentional human exposures resulting from nonpesticidal uses. 

The Agency does not anticipate the need to require additional human health data for use 

in this registration review for aliphatic alcohols, C1-C5 (ethanol and isopropyl alcohol) at 

this time.

For more information, please refer to Aliphatic Alcohols, C1-C5: Human Health Effects 

Scoping Document for the Registration Review Decision, located in the docket.

Product Chemistry: 

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

use in this registration review for ethanol and isopropyl alcohol at this time.

For more information, please refer to Product Chemistry, Environmental Fate, and 

Ecological Effects Scoping Document in Support of Registration Review of Aliphatic 

Alcohols, C1-C5 (Ethanol and Isopropyl Alcohol), located in the docket.

Endocrine Disruptor Screening Program

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

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

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

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

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

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

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

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

taxonomic groups. A human health risk assessment identifying the most sensitive endpoints has 

not been conducted for the Aliphatic Alcohols, C1-C5 (ethanol and isopropyl alcohol) 

registration review case. However, as required by FFDCA section 408(p), ethanol and isopropyl 

alcohol are subject to the endocrine screening part of the Endocrine Disruptor Screening 

Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

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

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

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

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect.
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Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Ethanol and 

isopropyl alcohol are not among the group of 58 pesticide active ingredients on the initial list to 

be screened under the EDSP. Accordingly, as part of registration review, EPA will issue future 

EDSP orders/data call-ins, requiring the submission of EDSP screening assays for ethanol and 

isopropyl alcohol. For further information on the status of the EDSP, the policies and 

procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening 

battery, please visit our website: http://www.epa.gov/endo/.

Timeline

EPA has created the following estimated timeline for the completion of the Aliphatic alcohols, 

C1-C5 registration review: 

Anticipated Schedule1

Activities Estimated Month/Year

Phase 1: Opening the docket

Open Public Comment Period for Docket June 2012

Close Public Comment Period for Docket August 2012

Phase 2: Case Development

Develop Final Work Plan (FWP) December 2012

Issue DCI N/A

Data Submission N/A

Open Public Comment Period for Preliminary Risk Assessments N/A

Close Public Comment Period for Preliminary Risk Assessments N/A

Phase 3: Registration Review Decision

Open Public Comment Period for Proposed Reg. Review Decision December 2012

Close Public Comment Period for Proposed Reg. Review Decision February 2013

Final Decision and Begin Post-Decision Follow-up 2013

Total (years) 1

Guidance for Commenters: 

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

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

timely manner prior to issuing a final work plan for the aliphatic alcohols, C1-C5 (ethanol and 

isopropyl alcohol) registration review case.

 

1

The schedule will be updated as appropriate based on the need to issue test orders under the 

Endocrine Disruptor Screening Program.
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Trade Irritants: 

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

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

other stakeholders are asked to comment on any trade irritant issues resulting from lack of 

Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key 

export markets, providing as much specificity as possible regarding the nature of the concern. 

Water Quality: 

Aliphatic Alcohols, C1-C5 (Ethanol and Isopropyl Acohol) are not identified as a cause of 

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

based on information provided at 

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

5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for Aliphatic 

Alcohols, C1-C5 (Ethanol and Isopopyl Alcohol), based on information provided at 

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

=885&p_pollutant_group_name=PESTICIDES.

More information on impaired water bodies and TMDLs can be found at http: 

//www.epa.gov/owow/tmdl/. The Agency invites submission of water quality data for this 

pesticide. To the extent possible, data should conform to the quality standards in Appendix A of 

the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water 

Quality Data in OPP’s Registration Review Risk Assessment and Management Process (see: 

http: //www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm), in order to ensure the 

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

Environmental Justice: 

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to aliphatic alcohols, C1-C5 (ethanol and isopropyl alcohol) 

compared to the general population. Please comment if you are aware of any sub-populations 

that may have atypical, unusually high exposure compared to the general population.

Structure Activity Relationships: 

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

the Agency. In the Office of Pesticide Programs (OPP), the evaluation process for a pesticide 

chemical traditionally begins with the applicant’s submission of a set of studies conducted with 

the specific pesticide chemical of interest. The use of the results of such testing (measured data) 

is a logical, scientifically rigorous process that identifies the physical, chemical, and 

environmental fate properties of the pesticide, as well as the dose and endpoints at which an 

adverse effect can occur in various animal species. 
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Today, there is significant interest in alternative techniques, i.e., techniques other than data 

generation that could significantly inform the Agency’s decision-making process. Recently, OPP 

has made increasing use of structure activity relationship (SAR) as part of its regulatory 

decision-making process. In the SAR process, a chemical's molecular structure is compared to 

that of other chemicals for which data are available. These structural similarities are then used to 

make predictive judgments about a chemical’s physical, chemical, and biological properties.

Thus, the chemical’s physical, chemical, and biological properties are a function of (or directly 

related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To 

develop a QSAR, a selected set of measured data on a single physical, chemical, or biological 

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

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

scientists, OPP has begun a process shift that envisions shifting from the current study-by-study 

approach to an approach in which the use of predicted data, generated using validated models, is 

considered along with information from open literature and studies specifically generated under 

Part 161 requirements. All relevant information would be considered as part of a weight-of-theevidence evaluation.

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

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

for many antimicrobial pesticide chemicals. When considering biological properties, at this time, 

EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of 

chemicals that exhibit lower toxicity for human health and/or ecotoxicity parameters. This is 

appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a 

screening-level assessment procedure rather than multiple tiers of assessments with progressively 

more data requirements.

If stakeholders believe that submission of predicted data can fulfill one of the data needs for the 

Aliphatic Alcohols, C1-C5 (Ethanol and Isopropyl alcohol) case, then the Agency invites 

submission of this information. The submitter would be expected to supply a rationale describing 

the utility of the information and provide documentation on the scientific validity of the 

information. The determination that the predicted data fulfills the data requirement would be at 

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

Additional Information: 

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

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

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

1. Confirmation on the following label information: 

a. Sites of application

b. Formulations

c. Application methods and equipment

d. Maximum application rates

e. Frequency of application, application intervals and maximum number of 

applications
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f. Geographic limitations on use

2. Use or potential use distribution

3. Use history

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

5. Typical application interval

6. State or local use restrictions

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

and mammalian mortalities) not already reported to the Agency

8. Monitoring data

Next Steps: 

After the 60-day comment period, the Agency will review and respond to any comments 

received in a timely manner, and then issue a Final Work Plan for the Aliphatic Alcohols, C1-C5

(ethanol and isopropyl alcohol) case.
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II. Fact Sheet

Background Information: 

Active Ingredient: Isopropyl alcohol

Case number: 4003

PC Code: 047501

CAS number: 67-63-0

Technical registrants: There are no technical registrants for isopropyl alcohol

First approved for use in a registered product: 1948

There are no EPA established tolerances or exemptions from tolerances for isopropanol; 

however, there are several FDA established tolerances for isopropanol in modified hop 

extract (21 CFR 172.560) and in foods for human consumption (21 CFR 173.240).

Isopropanol is currently not used as an inert, and does not have any inert based exemptions 

from the requirement of a tolerance.

Antimicrobials Division Chemical Review Manager (CRM): Wanda Henson, 

Henson.Wanda@epa.gov

Antimicrobials Division Product Manager (PM): Marshall Swindell, 

Swindell.Marshall@epa.gov

Chemical Structure: 

Active Ingredient: Ethanol

Case number: 4003

PC Code: 001501

CAS number: 64-17-5

Technical registrants: H & S Chemicals Division

First approved for use in a registered product: 1948

There are EPA established tolerances for ethanol. Ethanol has three inert exemptions from 

the requirement of a tolerance in 40 CFR 180.910, -.930, and -.940, (USEPA, 2006). 

Ethanol is listed in 21 CFR 184.1293 as generally recognized as safe (GRAS). 

Additionally, as defined in 21 CFR 170.3(o)(2), it may be used as an antimicrobial agent on 

pizza crusts prior to final baking at levels not to exceed 2.0% active by product.

Antimicrobials Division Chemical Review Manager (CRM): Wanda Henson, 

Henson.Wanda@epa.gov

Antimicrobials Division Product Managers (PM’s): Jacqueline Campbell-Mcfarlane, 

Campbell-McFarlane.Jacqueline@epa.gov and Velman Noble, Noble.Velma@epa.gov

Chemical Structure
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Use & Usage Information: 

Products containing ethanol are registered for use as a glassware sanitizer in eating 

establishments and hard non-porous surface disinfectant and bacteriocide in eating 

establishments and institutional premises. There are currently 50 registered products 

containing the active ingredient ethanol. End use products containing the chemical 

ethanol are registered for use as surface disinfectant in use sites such as agricultural 

premises and equipment, medical premises and equipment, industrial areas and 

residential and public access areas. Ethanol is also registered for use in antifouling paints 

for use on boats bottoms and boat running gear below the water line. End use products 

are registered for use in aquatic industrial processes and water systems such as cooling 

towers as well as pulp and paper mill process water systems. In addition to being 

registered for use in human drinking water systems, ethanol is also registered for use as 

an ingredient in products used in pools, hot tubs and spas. In addition, ethanol containing 

products are also registered for use in aquatic areas such as commercial fishery water 

systems and fish containing lakes, ponds and reservoirs. There are two registered food 

contact uses for this chemical. One is for the sanitization of food eggs and the other is as 

a post harvest treatment for specific fruits and vegetables. 

Ethanol also is registered for use as a plant growth regulator (a ripener). There is also a 

registered use of ethanol with ARCO Ethylene Generators (catalytic generation of 

ethylene gas) involving, EPA Reg. No.# 58502-1, a product that is registered for use as a 

ripening agent for citrus fruits, pear, avocado, banana, papaya, melons, tomato, flue-cured

tobacco/cigar/cigar wrapping. The receptors in fruits and vegetables absorb free 

atmospheric ethylene molecules, and this in turn accelerates the ripening process. Due to 

the product based conversion of ethanol to ethylene gas, there are no expected exposures 

to ethanol on the raw agricultural commodity, RAC. It is also conclusive that there will 

not be any residual ethylene gas. Fruits and vegetables produce ethylene gas naturally, 

and reabsorb the gas to stimulate the production of more; as this is the process by which 

ripening occurs. Ethanol is converted to ethylene gas, and the gas is pumped into ripening 

rooms.

Products containing isopropyl alcohol are registered for use as a glassware sanitizer in 

eating establishments and hard non-porous surface disinfectant and bacteriocide in 

household, commercial and institutional premises. There are currently 31 registered for 

use active products containing the active ingredient isopropyl alcohol. It is registered for 

use in spray, ready to use solution and impregnated wipe forms. End use products 

containing the chemical isopropyl alcohol are registered for use as porous (fabrics, 

mattresses, etc.) and non-porous surface disinfectant in use sites such as agricultural 

premises and equipment, industrial areas and residential and public access areas. It is 

registered for use in/on medical premises and equipment and veterinary premises as well 

as in/on salon and barber shop areas and utensils. It is registered for use in ultra sonic 

cleaners and for precleaning of medical instruments prior to disinfection. In addition, 

isopropyl alcohol containing products are also as a deodorizer in air fresheners. It is also 

registered for use in retail and institutional food establishments, food processing plants 

and other health department regulated food facilities. 
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Recent/Pending Regulatory Actions:

There are currently no pending regulatory actions for isopropyl alcohol.

There are currently 3 new product registration applications pending for ethanol.

Ecological Risk Assessment Status: 

Please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping 

Document in Support of Registration Review of Aliphatic Alcohols, C1-C5 (Ethanol and 

Isopropyl Alcohol)., located in the docket, for a detailed discussion of the ecological risk 

assessments.

The Aliphatic Alcohols RED and the public literature found in the High Production 

Volume (HPV) Screening Information Data Set (SIDS) database, state that ethanol and 

isopropanol are practically non-toxic to mammals, fish, and aquatic invertebrates. No 

additional ecological effects studies are anticipated to be needed for these chemicals. The 

use pattern is restricted to indoor uses, and its use will lead to little, if any, exposure to 

nontarget organisms. In addition, both alcohols are highly volatile, which supports the 

conclusion that exposure to terrestrial and aquatic nontarget organisms would be 

extremely minimal. 

Human Health Risk Assessment Status: 

The following are key findings of the recent human health risk assessments for Aliphatic 

alcohols, C1-C5. Please refer to Aliphatic Alcohols, C1-C5: Human Health Effects Scoping 

Document for the Registration Review Decision, located in the docket, for a detailed discussion 

of the human health risk assessment.

Hazard Characterization: 

Ethanol and isopropanol have low acute toxicity (Toxicity Category III or IV).

Human health risk assessments were not needed at the time of the RED because the 

Agency determined that the toxicological criteria were not triggered and that the exposure 

and risk from the active ingredients were not significant when compared to the frequent 

intentional human exposures resulting from non-pesticidal uses.

Dietary (Food and Water): 

The registered uses of the aliphatic alcohols are not expected to result in contamination of 

surface water or ground water based on the antimicrobial use patterns as well as the rapid 

volatilization from the treated surface. Residues of ethanol and isopropyl alcohol, along 

with byproducts resulting from degradation, are not expected to migrate through 

wastewater treatment facilities into drinking water or migrate into residential 

groundwater wells. In the event that the treated surface is rinsed after pesticidal 

application and subsequently, the rapid volatilization supports that ethanol and isopropyl 

alcohol are not expected to be present in the drinking water.
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Residential: 

Based on frequent intentional human exposures to ethanol and isopropyl alcohol along 

with the rapid volatilization of the active ingredients from the treated surfaces, it is not 

expected that there will be measurable residues available to trigger the need for a 

residential exposure assessment.

Aggregate: 

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

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

well as non-occupational pesticide exposures. A human health risk assessment is not 

expected to be necessary for ethanol and isopropyl alcohol registration review; therefore 

an aggregate assessment would not be appropriate.

Occupational: 

Based on frequent intentional human exposures to ethanol and isopropyl alcohol along 

with the rapid volatilization of the active ingredient from the treated surfaces, it is not 

expected that there will be measurable residues available to trigger the need for a 

residential exposure assessment.

Cumulative: 

EPA does not have, at this time, available data to determine whether ethanol and 

isopropyl alcohol have a common mechanism of toxicity with other substances or how to 

include this pesticide in a cumulative risk assessment. For the purposes of this 

Registration Review, EPA has assumed that ethanol and isopropyl alcohol does not have 

a common mechanism of toxicity with other substances when used as an antimicrobial as 

registered.

Human Studies:

There has not been any historical reliance on human studies when assessing exposure and 

risk to the aliphatic alcohols. In the course of registration review, EPA is considering a 

21-day dermal study, Phillips et al., 1972, in which human volunteers were involved, and 

results concluded no dermal irritation. EPA will also consider any other research 

involving intentional exposure of human subjects brought to its attention. If EPA 

determines that the above intentional exposure human study (or any additional intentional 

exposure human studies brought to EPA’s attention) are sufficiently sound from a 

scientific perspective to warrant inclusion in future risk management decisions, EPA will 

consider the ethical acceptability of the study. Before reaching a final decision to rely on 

this study, EPA will ensure that all applicable regulatory requirements are met, including 

but not limited to the requirements for EPA ethics review and Human Studies Review 

Board review of certain research involving intentional exposure of human subjects.
Docket Number: EPA-HQ-OPP-2012-0340

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Incidents: 

Ecological: 

No ethanol ecological incidents have been reported in the Agency’s Ecological Incident 

Information System (EIIS).

No isopropyl alcohol ecological incidents have been reported in the Agency’s Ecological 

Incident Information System (EIIS).

Human Health: 

No ethanol alcohol human poisoning incidents have been reported in the OPP Incident Data 

System (IDS).

No isopropyl alcohol human poisoning incidents have been reported in the OPP Incident 

Data System (IDS).

Tolerances and International Harmonization: 

There are no EPA established tolerances or exemptions from tolerances for isopropanol; 

however, there are several FDA established tolerances for isopropanol in modified hop 

extract (21 CFR 172.560) and in foods for human consumption (21 CFR 173.240).

There are EPA established tolerances for ethanol. Ethanol has three inert exemptions from 

the requirement of a tolerance in 40 CFR 180.910, -.930, and -.940, (USEPA, 2006). 

Isopropanol is currently not used as an inert, and does not have any inert based exemptions 

from the requirement of a tolerance. 

Ethanol is listed in 21 CFR 184.1293 as generally recognized as safe (GRAS). 

Additionally, as defined in 21 CFR 170.3(o)(2), it may be used as an antimicrobial agent on 

pizza crusts prior to final baking at levels not to exceed 2.0% active by product 

Data Call-In Status: 

There are currently no Data Call-Ins for either ethanol or isopropyl alcohol.

Labels: 

Registered products, including EPA registration numbers are provided in Table 1 below. For 

future reference, during registration review a list of product registration numbers will be included 

in the docket. Product registration labels may be obtained from the Pesticide Product Label 

System (PPLS) website at: http: //oaspub.epa.gov/pestlabl/ppls.home.
Docket Number: EPA-HQ-OPP-2012-0340

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Table 1. Registered Products – Ethanol

Registration 

#

Registration Name Company Name % of Active 

Ingredient

211-32 PHENO-CEN SPRAY 

DISINFECTANT/DEODORANT

CENTRAL SOLUTIONS, 

INC. 69.623

498-134 SPRAYPAK SPRAY 

DISINFECTANT FORMULA 2 CHASE PRODUCTS CO 63.2

498-179 CHAMPION SPRAYON SPRAY 

DISINFECTANT FORMULA 3 CHASE PRODUCTS CO 30.8

498-194 SPRAYPAK SPRAY 

DISINFECTANT/LUBRICANT CHASE PRODUCTS CO 63.2

498-197 SPRAY DISINFECTANT CHASE PRODUCTS CO 63.2

706-69 CLAIRE DISINFECTANT 

SPRAY

CLAIRE 

MANUFACTURING 

COMPANY

49.95

777-99 BRACE RECKITT BENCKISER 

LLC. 58

777-105 LYSOL BRAND IV I.C. 

DISINFECTANT

RECKITT BENCKISER 

LLC. 60.825

1043-19 STAPHENE DISINFECTANT 

SPRAY AND DEODORIZER STERIS CORPORATION 53.096

1270-237 ZEP REFRESH II ZEP INC. 66.825

4313-93 OCIDE PLUS CARROLL COMPANY 37

5741-22 STERIPHENE II BRAND 

DISINFECTANT DEODORANT

SPARTAN CHEMICAL 

COMPANY, INC. 64

5813-59 CLOROX DISINFECTING 

SPRAY III CLOROX CO., THE 53.088

5813-67 CLOROX 409-R CLOROX CO., THE 65

5813-97 BRAC CLOROX CO., THE 58.06

7405-51

CHEMI-CAP HOSP-I-SEPTIC G 

SURFACE DISINFECTANT 

DEODORANT

CPC AEROSCIENCE, 

INC. 53.72
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8284-6

BISSELL DISINFECTANT 

SPRAY PENN CHAMP 68.5

10088-104

MIS-TERY HOUSEHOLD 

DISINFECTANT AND 

DEODORIZER SPRAY

ATHEA 

LABORATORIES INC 53.46

10088-105 C-SPRAY DISINFECTANT 

DEODORANT

ATHEA 

LABORATORIES INC 66

10807-177 MISTY II DISINFECTANT & 

DEODORANT AMREP, INC 61.348

11525-30 DISINFECTANT SPRAY "G" KIK CUSTOM 

PRODUCTS, INC. 53.088

11694-98 MEDAPHENE PLUS 

DISINFECTANT DEODORANT

ILLINOIS TOOL 

WORKS, INC. 68

11694-99 MEDAPHENE PLUS 

DISINFECTANT SPRAY

ILLINOIS TOOL 

WORKS, INC. 68

15136-9 WAVICIDE-06 PLUS MEDICAL CHEMICAL 

CORP. 50

33176-5

AIRYSOL BRAND SURFACE 

DISINFECTANT AMREP, INC. 44.25

33176-24 AIRYSOL BRAND SURFACE 

DISINFECTANT SPRAY AMREP, INC. 53

37433-1

ETHY-GEN(R) II 

CONCENTRATE

CATALYTIC 

GENERATORS, LLC 90

42964-17 ASEPTICARE

AIRKEM 

PROFESSIONAL 

PRODUCTS

62.74

44446-67 CONCEPT HOSPITAL 

DISINFECTANT DEODORANT

QUESTVAPCO 

CORPORATION 53

46781-12 CAVICIDE 1 METREX RESEARCH 7.5

46781-13 CAVIWIPES 1 METREX RESEARCH 7.5

47371-13

FMB 6075-8 QUAT 

CONCENTRATED 

GERMICIDE

H & S CHEMICALS 

DIVISION 12.5

47371-16 FMB 4500-5 QUAT 

CONCENTRATED 

H & S CHEMICALS 

DIVISION 10
Docket Number: EPA-HQ-OPP-2012-0340

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GERMICIDE

47371-22 FMB 4500-28 QUAT H & S CHEMICALS 

DIVISION 20

56392-2

CITRACE HOSPITAL 

GERMICIDAL DEODORIZER

CLOROX 

PROFESSIONAL 

PRODUCTS COMPANY

66.34

56392-4

CITREX HOSPITAL SPRAY 

DISINFECTANT

CLOROX 

PROFESSIONAL 

PRODUCTS COMPANY

69.1

58502-1 RIPENER 1 CONCENTRATE AMERICAN RIPENER, 

LLC 90

67346-1 ETHYLENE FLUID PRECISION 

GENERATORS, LLC 90

67603-4 SPRAY DISINFECTANT SHERWIN-WILLIAMS 

DIVERSIFIED BRANDS 37

67619-3 CPPC SPRAY 1

CLOROX 

PROFESSIONAL 

PRODUCTS CO

65

67619-21 CARB

CLOROX 

PROFESSIONAL 

PRODUCTS CO

58.06

68959-1 STER-AHOL VELTEK ASSOCIATES 

INC. 70

68959-3 STER-AHOL AEROSOL VELTEK ASSOCIATES 

INC. 70

69658-3 NOVIGARD (QUICK DRY)

WORLD 

PHARMACETICALS 

CORPORATION

98

70467-3 BioSURF MICRYLIUM 

LABORATORIES 70.5

70627-1 SPRAY DISINFECTANT HG DIVERSEY, INC. 53.088

70627-12

JOHNSON END BAC 

PRESSURIZED 

DISINFECTANT SPRAY

DIVERSEY, INC. 62.56

83831-1

SURFACE DISINFECTANT 

PLUS GERM PRO PRODUCTS 60
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84368-1 URTH PRO URTHTECH, LLC 29.4

87819-1

ABLUERE DISINFECTANT 

SPRAY JDBJ ASSOCIATES 60

Table 2. Registered Products – Isopropyl Alcohol

Registration # Registration Name Company Name % of Active 

Ingredient

397-13 STERI-FAB NOBLE PINE 

PRODUCTS CO 60.39

498-97 SPATPAK SPRAY 

DISINFECTANT FORMULA 1 CHASE PRODUCTS CO 30.8

498-180 CHAMPION SPRAYON 

DISINFECTANT FORMULA 4 CHASE PRODUCTS CO 55

833-3 WYANDOTTE SANIFECT D2 ALEX C. FERGUSSON, 

INC

50

954-10 CLIPPERCIDE SPRAY KING RESEARCH, INC. 45.6

1130-15 WEIMAN GERMICIDAL 

SOLUTION

WEIMAN PRODUCTS, 

LLC. 21

1130-19 WEIMAN DISINFECTING 

WIPES

WEIMAN PRODUCTS, 

LLC. 21

1677-208 SPIRICLENS SPRAY ECOLAB INC. 70

1677-224 PREMIER 70/30 STERILE IPA 

SPRAY ECOLAB INC. 70

1839-85 AEROSOL SURFACE 

DISINFECTANT STEPAN COMPANY 53

1839-188 AEROSOL SDAS STEPAN COMPANY 53

5813-81 CGW CLOROX CO., THE 1

9480-7 SANI-WIPE

PROFESSIONAL 

DISPOSABLES 

INTERNATIONAL, 

INC.

5.48

9688-135 CHEMSICO SURFACE 

DISINFECTANT CHEMSICO 53

10492-4 DISCIDE ULTRA PALMERO HEALTH 63.25
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DISINFECTING 

TOWELETTES

CARE

10492-5

DISCIDE ULTRA 

DISINFECTING SPRAY

PALMERO HEALTH 

CARE 63.25

11623-24 ENVICIDE II APOLLO INDUSTRIES 

INCORPORATED 53

46781-6 CAVICIDE METREX RESEARCH 17.2

46781-8 CAVIWIPES METREX RESEARCH 17.2

46781-12 CAVICIDE 1 METREX RESEARCH 15

46781-13 CAVIWIPES 1 METREX RESEARCH 15

59894-9

KWIKKILL 

DISINFECTING/DEODORIZIN

G SPRAY/SOLUTION

M & S RESEARCH, 

INC. 41.58

59894-10

KWIKKILL DISINFECTANT 

DEODORIZING CLEANING 

WIPES

M & S RESEARCH, 

INC. 41.58

60142-1 VIRAHOL VERIDIEN 

CORPORATION 70

60142-3

VIRAHOL HOSPITAL 

SURFACE DISINFECTANT 

TOWELETTE

VERIDIEN 

CORPORATION 70

68959-2 DECON-AHOL VELTEK ASSOCIATES 

INC. 70

68959-4 DECON-AHOL AEROSOL VELTEK ASSOCIATES 

INC. 70

70144-1 OPTI-CIDE 3 MICRO-SCIENTIFIC 

INDUSTRIES, INC. 21

73232-1 ALPET D2 BEST SANITIZERS, 

INC. 58.6

73232-2

ALPET D2 SURFACE 

SANITIZING WIPES

BEST SANITIZERS, 

INC. 58.6

73232-3 SMART-SAN D2 BEST SANITIZERS, 

INC. 58.6
Docket Number: EPA-HQ-OPP-2012-0340

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III. Summary of Anticipated Data Requirements – Aliphatic Alcohols, C1-C5

The Agency does not anticipate needing additional data for use in conducting the registration 

review for Aliphatic Alcohols, C1-C5 (ethanol and isopropyl alcohol).