UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

May 31, 2011 

OFFICE OF CHEMICAL SAfETY 

AND POLLUTION PREVENTION 

MEMORANDUM 

SUBJECT: 

PC Code s : 000101 

Decision No.: 440822 

Petition No s .: NA 

Summary of Human Health Effects Data for the Glycolic Acid 

Registration Review Decision Document. 

OP Barcode s lNo s: 0383022 

Registration No(s).: 5813·80, 5813·86, 5813-87, 5813·93, 5813-101 

71654-1,71654-2, and 71654·5 

Re ulato Action: Human Health Re istration Review 

Risk Assess Type: Single Chemical Case No(s .: 4045 

TXRNo.:NA 

MRIO No s.: NA 

FROM: 

TO: 

THRU: 

CASN s: 79-14-1 

40 CFR: None 

Nathan Mottl, Biologist I./~ ~ s-/3/ /11 

Risk Assessment and Science Support Branch (RASSB) 

Antimicrobials Division (751 OP) 

Seiichi Murasaki, Chemical Review Manager 

Regulatory Management Branch II 

Antimicrobials Division (75 1 OP) 

Lance Wonnell, Team Leader 

Regulatory Management Branch II 

Antimicrobials Division (751 OP) 

Nader Elkassabany, Branch Chief 

Risk Assessment and Science Support Branch (RASSB) 

Antimicrobials Division (751 OP) 

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EXECUTIVE SUMMARY

The Antimicrobials Division (AD) Registration Review Team has evaluated the status 

of the human health assessments for glycolic acid (P.C. Code 000101, Registration 

Review case 4045). Glycolic acid is an antimicrobial pesticide used as an end-use 

disinfectant and cleaner primarily used for toilet bowls, showers, baths, and sinks in 

household bathrooms and restrooms. Additionally, end-use products are also used in

kitchens as a disinfectant and cleaner on countertops, floors, and to launder clothes, 

fabrics and upholstery. AD looked at the hazard and exposure databases for glycolic acid

to determine whether changes in science policy or deficiencies in the databases materially 

affected the overall risk picture. Glycolic acid was first registered as a pesticide in 2001

and a Registration Eligibility Decision (RED) document has not yet been initiated. A RED 

is not required for chemicals registered after November 1, 1984. 

According to Agency data in OPPIN, there are currently 8 registered glycolic acid 

products. The concentration can range from 1.5 to 68% active ingredient. However, the 

68% a.i. product is a Manufacturing Use Product (MUP) used to formulate other 

antimicrobial products. Typically end use product concentrations are less than 10% ai.

Many of the applications for glycolic acid typically involve the use of a child proof 

squeeze bottle to disinfect and deodorize toilet bowls and urinals. These squeeze bottles 

minimize aerosol generation and typically last for only 12 seconds. However, there are 

also some registered disinfectant products which are used for spray, mop and wipe

applications of countertops and floors in bathrooms and kitchens. In addition, a registered 

disinfectant product is also used for laundry. The Agency typically assumes that a trigger 

pump sprayer or aerosolized can is used for the spray and wipe applications. The Agency 

will need product use information to understand whether this product is likely to have the 

potential to aerosolize.

There are no existing tolerances, exemptions from the requirement of tolerances, or 

tolerance petitions for this antimicrobial pesticide. Glycolic acid is commonly used as a 

cosmetic; is ubiquitous in nature and is present in the human body, sugar cane, sugar 

beets, and several fruits. Glycolic acid is also approved by FDA as an indirect food 

additive for use in food packaging adhesives (175.105). In addition, there are some public 

health claims for this pesticide when used as a disinfectant. The label states it is effective 

against disease causing organisms such as Staphylococcus aureus, Salmonella 

cholerasesuis, and Pseudomonas aeruginosa. 

Although the product is designed primarily as a disinfectant for bathroom and 

restroom premises, this disinfectant has some claims that it can be used on hard, nonporous, non-food contact surfaces in kitchens such as countertops, sinks and stovetops, for 

a contact time of 30 seconds at full strength. If used on a food preparation surface, the 

label maintains that all food must be removed prior to application and after application 

surfaces must be rinsed with potable water. Although dietary exposure from indirect food 

contact surfaces are expected to be minimized based on the application and label 

statements, EPA will still need to perform dietary and aggregate risk assessments to 

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

existing registered uses.
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No new sub-chronic toxicity data for glycolic acid have been submitted to the Agency 

since registration. The purpose of this screen is to determine whether sufficient data are 

available to support registration review, whether new human health assessments are 

needed to support registration review, and to report why the Agency feels it may be

appropriate to conduct new risk assessments under the registration review process.

Based on this review of the data, occupational and residential risk assessments would 

be needed to examine potential exposure scenarios including:

Dermal and inhalation application exposure to trigger pump spray and wipe,

Dermal and inhalation application exposure to aerosol spray can and wipe,

Dermal and inhalation application exposure by mopping, and

Dermal and inhalation application exposure by open pour.

EPA also expects that dermal and incidental oral postapplication exposures may occur. 

The potential scenarios include children crawling on previously mopped floors, wearing 

laundered clothes, mouthing treated fabrics or hand-to-mouth exposure from counter tops

wiped with disinfectant.

EPA expects that some of the exposures will also likely be minimized based upon

specific label use directions, personal protective equipment (PPE) and specific application 

equipment which are designed to minimize aerosols. Therefore, product use data will be 

essential to further characterize the need for these risk assessments. In addition, the 

Agency will also require additional the following exposure data: 

Inhalation Exposure Indoor (GLN 875.1400); 

Dermal Exposure Indoor (GLN 875.1200); 

Application Exposure Monitoring Data Reporting (GLN 875.1600);

Product Use Data (GLN 875.1700 and 875.2800);

Indoor Surface Residue Dissipation (GLN 875.2300)

Non-dietary Ingestion (875.3000)

As a result of the inhalation concerns, the Agency anticipates that a 90-day inhalation 

study will be needed to identify an inhalation toxicity endpoint for risk assessment. 

Typically the Agency also requires a 90-day dermal study GLN (870.3250). However, 

during registration, the EPA waived this requirement and granted a data waiver for a 

dermal sub-chronic toxicity study based upon the pH of the test material and possible 

precautions based on the corrosivity of glycolic acid to animal skin. In lieu of a 90-day 

dermal toxicity study, the Agency accepted an oral toxicity study (GLN 870.3150; 

D239541).

Section 1. Chemical Identity

Glycolic acid is an alpha-hydroxyl acid in which there is a hydroxyl (-OH) group 

attached at the two alpha positions of the carbon chain. Glycolic acid is a light amber 

liquid, which is highly miscible in water. It has a boiling point of 112oC and a vapor 

pressure similar to water. At a 30% concentration in water, it has a pH ≥ 3.5. It has a 

density of 10.6 lb/gal and dissociation constant of 1.5E-4. Glycolic acid is registered as an 
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active ingredient in six end-use products for residential and public access premises to 

clean toilet bowls. The registered products contain 1.5-9.5% active ingredient (ai.). Table 

1 presents the chemical identity of glycolic acid.

Table 1. Chemical Identity

Common 

Name

Glycolic acid

Synonyms Hydroxy Acetic Acid, Hydroacetic Acid, 

and Hydroxy Ethanoic Acid

PC Code 000101

CAS registry 

number

79-14-1

Registration 

Review Case 

No.

4045

Empirical 

Formula

Vapor 

Pressure

11.2 mm Hg for 70% technical at 100C.

Section 2. Toxicology

The Agency has reviewed all toxicity studies submitted for glycolic acid and the 

existing toxicity database and has determined that an additional 90-day inhalation toxicity 

study may be needed. The toxicological database for glycolic acid is currently comprised 

of published and unpublished studies either submitted to the Agency or obtained directly 

from published literature during the registration process. 

Several studies for the acute toxicity 6-pack were waived due to the low pH of glycolic 

acid (0.5). The acute dermal, dermal irritation, and eye toxicity studies were all waived

during registration based on a low pH (<2) and the expected corrosivity of the product. 

The toxicity categories would default to toxicity category I based on the waiver.

For the other submitted tests, an acute oral toxicity of glycolic acid ranged from LD50

of 1938 mg/kg in the MUP to 2968 mg/kg for the cosmetic formulation. In mice, the LD50

was 2000 mg/kg, using a 70% concentration of glycolic acid. An oral toxicity category of 

III was assigned to the product. The acute inhalation toxicity study reported an LC50 of 

3.6 to > 5.2 mg/L. The LC50 would be expected to result in a toxicity category IV rating. A 

modified draize test was conducted with glycolic acid. Following dermal application

glycolic acid was determined not to be a dermal sensitizer.

Based on the registered uses, only one sub-chronic study, one developmental study 

and a battery of mutagenicity tests were determined to be needed for glycolic acid 

registration. The registrant submitted a 90-day sub-chronic oral toxicity test (MRID 

449753-04) in lieu of a 90-day dermal toxicity study. The rationale for not conducting a 

dermal test was based on the pH of the test material and possible precautions based on the 
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corrosivity of glycolic acid to animal skin. The Agency accepted this rationale and the

oral study was considered the only study needed to satisfy the sub-chronic data 

requirement (GDLN 870.3100) during registration. MRID 449753-04 was considered to 

be an acceptable guideline study.

In the 90-day sub-chronic oral toxicity study, rats were administered oral doses by 

gavage at 0, 150, 300 and 600 mg/kg/day for 90 days. The systemic toxicity of glycolic 

acid was evident at 300 mg/kg/day. At these dose levels decreases in body weight, body 

weight gain, food consumption, and food intake was reported. Male rats had kidney 

pathology which consisted of hyperplasia of renal pelvis dilation, unilateral 

hydronephrosis, and oxalate crystal formation. These results were not reported in the 

female. The systemic LOAEL of 300 mg/kg/day is based upon decreased body weight 

and body weight gain as a result of decreased food consumption and food efficiency in 

both males and females. The NOAEL for systemic toxicity is 150 mg/kg/day in male and 

female rats. For other parameters measured, a LOAEL was not established for 

immunotoxicity, neurotoxicity or reproductive toxicity effects. 

In an acceptable guideline (GDLN 870.3700) developmental toxicity study (MRID 

44589501) glycolic acid was administered to at 0, 75, 150, 300 and 600 mg/kg/day on 

gestation days (GD) 7 through 21. The maternal toxicity LOAEL of 300 mg/kg/day was

based on the effect of lung noise with a NOAEL of 150 mg/kg/day. The developmental 

toxicity LOAEL of 300 mg/kg/day was based upon fused ribs and vertebrae and a 

developmental NOAEL was established at 150 mg/kg/day.

Three mutagenicity studies were submitted to EPA. The studies include a reverse gene 

mutation study on Salmonella typhenium and Escherichia coli (MRID 449753-05), an in 

vitro forward gene mutation assay in mice lymphoma cells (MRID 449753-06), and a 

mouse erythrocyte micronucleus assay in mice (MRID 449753-07). The three 

mutagenicity studies submitted were reviewed in 2001 by EPA (D264011, D264012, and 

D264014). MRID 449753-05 did not induce gene mutations with or without activation in 

bacteria and was classified guideline acceptable as per GDLN 870.5100. MRID 449753-

06 also did not induce gene mutations in mice lymphoma cells and was found guideline 

acceptable as per GDLN 870.5300. MRID 449753-07 did not induce chromosome

aberrations of erythrocytes and was found guideline acceptable as per GDLN 870.5395. 

Since inhalation exposure is considered as a primary route of exposure, the Agency 

anticipates that a 90-day inhalation study will be needed to identify an inhalation 

toxicological endpoint for risk assessment. No sub-chronic inhalation toxicity studies for 

glycolic acid were identified in the existing literature.

Section 3. Dietary Assessment

Glycolic acid is ubiquitous in nature and is present in the human body, sugar cane, 

sugar beets, several fruits (pineapple, cantaloupe, unripe grapes) and vegetables (parsley, 

celery, and beans), as well as in a wide variety of common foods including coffee 

(D383020). However, there could be indirect food contact from countertops in residential 

homes. Formulations on countertops are typically diluted and the label recommends that 

food found on countertops must be removed prior to application, and countertop surfaces 
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must be rinsed with potable water. Although, residues of glycolic acid on countertops 

after potable water rinses are not expected to concentrate on food products and exposure 

will be minimal, EPA will still need to conduct a dietary (food) assessment for this use.

According to the environmental fate and ecotoxicity registration review document 

(D383020), glycolic is expected to be readily biodegradable in the environment. Glycolic 

acid is also expected to be diluted when it is flushed down the drain. Resulting 

concentrations drinking water are not expected to be above background levels found in the 

environment and a drinking water assessment is not necessary.

Section 4. Occupational/Residential Exposure

There is potential short- term application exposure to occupational workers and 

homeowners while spraying disinfectants to indoor surfaces. The scenarios which the 

Agency will consider for assessment would include application of aerosol spray, trigger 

pump spray, and wiping. The Agency will need to conduct screening level risk

assessments for the hard surface disinfection use; therefore, the Agency will anticipate 

needing exposure studies in the Anticipated Data Needs (Section 7). The potential 

exposure scenarios would include occupational and residential exposure assessments 

which would include:

Dermal and inhalation application exposure to trigger pump spray and wipe,

Dermal and inhalation application exposure to aerosol spray can and wipe,

Dermal and inhalation application exposure to open pouring, and

Dermal and inhalation application exposure to mopping.

EPA expects that some of the exposures will also likely be minimized based upon

specific label use directions, and specific application equipment which are designed to 

minimize aerosols. In addition, product use data will be essential to further characterize 

exposures to glycolic acid and whether a risk assessment will be needed on certain 

application equipment. For example, glycolic acid can be used to disinfect, sanitize, and 

deodorize toilet bowls and urinals and the products are applied in a child proof squeeze 

bottle. The inhalation concern for the squeeze bottle is expected to be minimized by the 

design of the bottle which minimizes any inhalation aerosols upon application. 

In addition, EPA expects that dermal and incidental oral postapplication exposures 

may occur from children crawling on treated floors, wearing treated clothes, mouthing of 

treated fabrics or hand-to-mouth exposure from counter tops and floors.

There are acute toxicity concerns for dermal and eye irritation for the technical active 

ingredient for occupational exposure. However, the acute toxicity concerns for the diluted 

end use products are considerably less when considering labeling precautions that 

typically include eye protection and rubber or chemical resistant gloves.

Section 5. Aggregate and Cumulative Exposure
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In examining aggregate exposure, EPA takes into account the available and reliable 

information concerning exposures to glycolic acid residues in food and drinking water, 

and non-occupational pesticide exposures. Residential application risks such as spraying, 

mopping, wiping exposures are expected to be aggregated as well as post-application 

hand-to-mouth exposure from treated counter tops and mouthing treated fabrics. The 

Agency will also need to conduct a dietary risk assessment for glycolic acid based on 

indirect food contact exposure on countertops.

Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, 

or revoke a tolerance, the Agency consider "available information” concerning the 

cumulative effects of a particular pesticide's residues and "other substances that have a 

common mechanism of toxicity.” EPA does not have, at this time, available data to 

determine whether glycolic acid has a common mechanism of toxicity with other 

substances or how to include this pesticide chemical in a cumulative risk assessment.

Section 6. Incidents

No human incidents have been reported specifically for glycolic acid in the OPP 

Incident Database.

Section 7. Anticipated Data Needs

The Antimicrobial Division (AD) anticipates requiring further exposure studies for 

glycolic acid for registration review.

Toxicity Studies

90-day inhalation toxicity study (GLN 870.3465).

Exposure Studies

Table 2 –Exposure Studies Needed for Glycolic Acid Registration Review

Study Needed Guideline Rationale 

Indoor Exposure 

(Trigger Spray)

875.1200 (Dermal)

875.1400 (Inhalation)

875.1600 (Data Reporting)

Exposure may occur while spraying with a trigger pump 

cleaning spray in a bathroom, kitchen or other areas of the 

home or office.

Indoor Exposure

(Aerosol Spray)

875.1200 (Dermal)

875.1400 (Inhalation)

875.1600 (Data Reporting)

Exposure may occur while spraying with a aerosol can in a 

bathroom, kitchen or other areas of the home or office.

Indoor Exposure 

(Sponge and Wipes)

875.1200 (Dermal)

875.1400 (Inhalation)

875.1600 (Data Reporting)

Exposure may occur while sponging or wiping disinfectant 

on a hard surface area.

Product Use 875.1700 (Handler)

875.2800 (Postapplication)

Product use data will be needed to characterize any 

uncertainties with regard to the application equipment.

Indoor Surface Residue 

Dissipation Data

875.2300 Residue data for countertops, floors, and clothing would be 

needed to assess dermal and incidental oral exposure.

Nondietary Ingestion 875.3000 The design of the non dietary ingestion exposure study can 

be combined with the Indoor Surface Residue Dissipation 

study (875.2300) to determine the available residue 

leaching from hand-to-mouth behavior on countertops, 
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floors and mouthing treated fabric.

Section 8. Tolerances

There are no tolerances or exemptions from tolerances for glycolic acid and no 

registered food uses. As mentioned, glycolic acid is used as a sanitizer on countertops and 

is also used by the FDA as an indirect food additive in food packaging adhesives.

Therefore, EPA will be reassessing the need for a tolerance or exemption from tolerance.

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

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

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

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

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

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

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

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

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

result, EPA will be performing risk assessments to determine if tolerances or exemptions

from tolerances will be needed to support the existing registered uses of glycolic acid.

Section 9. Endocrine Disruption

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

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

subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, 

developmental, reproductive, and general or systemic toxicity. These studies include 

endpoints which may be susceptible to endocrine influence, including effects on endocrine 

target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, 

pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard 

assessments, EPA evaluates acute tests and chronic studies that assess growth, 

developmental and reproductive effects in different taxonomic groups. As part of its

registration decision, EPA reviewed these data and selected the most sensitive endpoints 

for relevant risk assessment scenarios from the existing hazard database. However, as 

required by FFDCA section 408(p), glycolic acid is 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 
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endocrine-related effects caused by the substance, and establish a dose-response 

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

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. 

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

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

ingredients. Glycolic acid is 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 glycolic acid. 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/.

Section 10. References

D239543. DuPont’s Specialty Chemical Plan to Register Glycolic Acid for Certain 

Antimicrobial Uses. Memorandum from Norm Cook, Branch Chief, AD/RASSB, U.S. 

EPA to Robert Brennis, Product Manager PM 32, U.S. EPA. June 29, 1998.

Memorandum: Glycolic Acid, New Chemical. Memorandum from Frank Sanders, 

Division Director, AD, U.S. EPA to Marcia Mulkey, Director, Office of Pesticide 

Programs, U.S. EPA. March 31, 2001. 
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APPENDIX A: TOXICITY

Guideline Numbers: 870.3465

Study Titles: 90-day Inhalation Toxicity Study

Rationale for Requiring the Data

The Agency does not have a full picture of the potential effects which glycolic acid could 

occur as a result of exposure via the inhalation route. The needed study would provide 

insight into concerns regarding toxicity via the inhalation route. It may also provide a 

toxicity endpoint applicable to risk assessment. It is possible that an inhalation toxicological 

endpoint may be established and the Agency may determine a level of safety based on the 

results of this study, which has not been determined. The study could also eliminate any 

potential inhalation exposure concerns the Agency has if it is determined the dose response 

does not trigger the need to establish an inhalation toxicological endpoint. 

Practical Utility of the Data

1. How will the data be used?

The inhalation toxicity data will be used to assess toxicity via the inhalation route. The needed 

study would provide insight into concerns regarding toxicity via the inhalation route. It may 

also provide a toxicity endpoint applicable to risk assessment.

2. How could the data impact the Agency’s future decision-making?

The study may result in a change in how risks are quantified. It is possible that an inhalation 

toxicological endpoint may be established and the Agency may determine a level of safety 

based on the results of this study, which has not been determined. The study could also 

eliminate any potential inhalation exposure concerns the Agency has if it is determined the 

dose response does not trigger the need to establish an inhalation toxicological endpoint. 

The difficulty of predicting real world human inhalation exposure with limited data and no 

inhalation data or other alternative information, such as SAR (structure-activityrelationship), surrogate data, and/or weight-of-evidence to the Agency triggered the need 

for a 90-day (guideline) Inhalation toxicity study, in order to adequately evaluate real world 

human exposure to glycolic acid particles based on how it is used (The OPPTS Guidelines 

require an MMAD of 1-3 m in inhalation toxicity studies of aerosols so that a portion of 

the test article will reach the lungs). The potential inhalation exposure concerns from 

application equipment from aerosols from trigger pump sprayers are triggering this

inhalation toxicity endpoint. The Agency believes there exists the potential for lung

irritation effects based on the corrosivity of this chemical.
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APPENDIX B: HUMAN EXPOSURE

Guideline Numbers: 875.1200 

Study Titles: Dermal Exposure (Indoor)

Rationale for Requiring the Data

Note: Dermal exposure data are needed for both residential and occupational uses. The selection 

of an outdoor versus an indoor site is based on the high end exposure scenario. In almost all 

cases, repeating an exposure study for the same scenario outdoors and indoors is not necessary.

The potential for dermal exposure is very likely for exposure scenarios involving wiping and 

spraying hard surface disinfectants. The existing CMA data base and PHED for these scenarios are 

limited in scope for QA/QC and number of monitoring units. EPA presented the need for 

additional handler exposure data to the January 2007 Science Advisory Panel (SAP) as well as to 

the April 2007 Human Studies Review Board (HSRB) and both groups agreed that additional data 

are warranted. 

The criteria for the dermal exposure data are based on the potential for dermal exposure from the 

labeled uses (e.g., occupational and residential exposures from spraying and wiping) and evidence 

of toxicity. If the toxicological endpoints from glycolic acid are used to assess the risks, there is an 

endpoint selected for the dermal route.

Practical Utility of the Data

1. How will the data be used?

The dermal exposure data will be used to assess dermal exposures from wiping and spraying 

disinfectants. For occupational uses, the dermal exposure data will be used to assess the short-, and 

intermediate- term exposures. The dermal exposure data will be used to determine the accuracy of 

the dermal risks to both residence and occupational workers.

2. How could the data impact the Agency’s future decision-making?

If risks warrant mitigation, the dermal exposure data will provide the types of mitigation necessary 

such as chemical resistant gloves or closed systems for commercial uses, or potential removal of 

uses from the label.

Guideline Numbers: 875.1400 

Study Titles: Inhalation Exposure (Indoor)

Rationale for Requiring the Data

Note: Inhalation exposure data are needed for both residential and occupational uses. The 

selection of an outdoor versus an indoor site is based on the high end exposure scenario (for 

inhalation the selection is typically indoors). In almost all cases, repeating an exposure study for 

the same scenario outdoors and indoors is not necessary.

The inhalation exposure route is very important for exposure scenarios such application of paints or 

metalworking fluids where aerosols would be generated. In addition, inhalation exposures from 

application are evident in exposure studies in the Pesticide Handlers Exposure Database (PHED). 

The significance of these exposures is directly affected by the severity of the inhalation 

toxicological endpoint of concern. At this point in time, no toxicological data are available to 

assess the inhalation risk. The existing Chemical Manufacturer Association (CMA) data base and 

PHED for these scenarios are limited in scope for QA/QC and number of monitoring units. EPA 

presented the need for additional handler exposure data to the January 2007 Science Advisory 

Panel (SAP) as well as to the April 2007 Human Studies Review Board (HSRB) and both groups 
Page 12 of 14

agreed that additional data are warranted. 

The criteria for the inhalation exposure data are based on the potential for respiratory exposure 

from the labeled uses (e.g., exposure to disinfectants) and evidence of toxicity. If no toxicological 

endpoints of concern were identified, then the inhalation exposure data would not be needed.

Practical Utility of the Data

1. How will the data be used?

The inhalation exposure data would be used to assess the residential and occupational short-term 

duration of spraying disinfectants. 

2. How could the data impact the Agency’s future decision-making?

If risks warrant mitigation, the inhalation exposure data will provide the types of mitigation 

necessary such as dust mist respirators, full face respirators or closed systems for commercial uses, 

or potential removal of uses from the label.

Guideline Numbers: 875.1600

Study Title: Data Reporting and Calculations 

Rationale for Requiring the Data

For all exposure studies this data need is needed to facilitate the review of the data.

The study report and all raw data/calculations would be reviewed for the adequacy of the 

data.

Practical Utility of the Data

1. How will the data be used?

The data are needed to interpret the dermal and inhalation exposure data collected.

2. How could the data impact the Agency’s future decision-making?

This data need is triggered if an exposure study is conducted. It would aid the Agency to 

make accurate interpretations of the studies to develop an accurate and refined risk 

assessment and refined mitigation.

Guideline Numbers: 875.1700 and 875.2800

Study Title: Product Use Information

Rationale for Requiring the Data

Product use information is a description of how the product is actually applied; it is not a 

field study. A description of how this product is used would provide for a comprehensive 

realistic assessment of its potential applications. The description of the application 

techniques would be used to define the exposure scenarios to be assessed in the risk 

assessment. Product use will be required for handler as well as postappliction exposures

Practical Utility of the Data
Page 13 of 14

1. How will the data be used?

A complete description of product use would ensure that the risk assessment is inclusive of 

the types of exposures occurring during residential and occupational use.

2. How could the data impact the Agency’s future decision-making?

The need for a risk assessment as needed under Registration Review would require that the 

risk assessor understands how the product is applied.

Guideline Numbers: 875.2300

Study Title: Indoor Surface Residue Dissipation

Rationale for Requiring the Data

Based on the use of glycolic acid as a hard surface disinfectant for countertops, human contact to 

treated countertops may occur. There are no data available to estimate exposure to adults and 

children from exposure to treated countertops, floors, carpets and clothing with glycolic acid

Practical Utility of the Data

1. How will the data be used?

Without data, the Agency will conduct a screening level assessment using a conservative surface 

residue value of 1 mg/cm2. Currently, there are no data that can be used to estimate exposure to 

adults or to children exposed to treated wood. These data will be used to refine the Agency’s risk 

assessment and to confirm or refute the Agency’s screening level assessment.

2. How could the data impact the Agency’s future decision-making?

Depending on the results of the dislodgeable residue study, the Agency may pursue risk mitigation 

measures regarding the use of formulated products containing glycolic acid as the active ingredient 

in occupational and residential scenarios.

Guideline Number: 875.3000 

Data Requirement: Non-Dietary Ingestion

Rationale for Requiring the Data

The design of the non dietary ingestion exposure study can be combined with the Indoor 

Surface Residue Dissipation study (875.2300) to determine the available residue leaching 

from hand-to-mouth behavior on counter tops treated with glycolic acid disinfectant.

Practical Utility of the Data

1. How will the data be used? 

This product is used as a disinfectant on counter tops. The available residues from hard 

surfaces will be used to determine the magnitude of children’s incidental exposure from 

these uses.

2. How could the data impact the Agency’s future decision-making?

The data are needed to refine the risk estimates if risks of concern are identified assuming 
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100% residue transfer from contact from hard surfaces (e.g., counter tops). 

If risks of concern are not identified when 100% residue transfer is assumed, the data are 

not needed.