UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

June 7. 2011 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

MEMORANDUM 

SUBJECT: 

FROM: 

TO: 

THRU: 

Introduction: 

Summary of Product Chemistry, Environmental Fate, and 

Ecotoxicity Data for the Glycolic Acid Registration Review 

Decision Document. 

PC Code: 000101 DP Barcode: 383020 

Decision No.: 44082 1 Registration Nos.: See Table I 

Petition No(s).: NA Regulatory Action: Ecological Environmental 

Scapin.!!; Document for Registration Review 

Risk Assessment Type: Case No.: 4045 

Single chemical 

TXRNo.:NA CAS No.: 79-14-1 

MRJD Nos.: See Table 2 40 CFR: None 

Risk 

Srinivas 

Assessment 

Gowda, Microbiologist/Chemist 

and Science Support Branch 

S 

(RASSB) 

~ I. ~ V 0..9.. ~ 

Antimicrobials Division (75 lOP) 

Seiichi Murasaki, Chemical Review Manager 

Regulatory Management Branch I I 

Antimicrobials Division (751 OP) 4 ~ ,4 if 

Siroos 

Nader Elkassabany, 

Mostaghimi, Peer 

Branch 

Reviewer 

Chief 

~ ~~ - fltff6--v J L ___ _ 

Risk Assessment and Science Support Branch (RASSB) 

Antimicrobials Division (751 OP) 

Glycolic acid, also known as hydroxy acetic acid is a constituent of sugar cane 

JUIce. It is a member of the group of compounds classified as alpha hydroxy acids 

(AHAs). Pure (100%) glycolic acid is a colorless, odorless, crystalline solid with high 

water solubility. However, technical grade glycolic acid is usually sold as a 68% solution 

which is a clear to light amber-colored liquid with a mild burnt sugar odor. 

The first product containing glycolic acid as an active ingredient was registered 

with the Agency on May 31, 200 I. Currently, there are seven end-use products and one 

Page I of9 
Page 2 of 9

manufacturing use product registered for use as a disinfectant/sanitizer for hard nonporous surfaces in residential and public access premises listed in Table 1.

The manufacturing use product (68% a.i.) is registered for use in the formulation 

of liquid cleaning products or in the formulation of the following types of liquid 

antimicrobial cleaning products: household disinfecting cleaners for use in cleaning 

toilet bowls, bathrooms, floors, and other hard non-porous surfaces. Industrial 

disinfecting cleaners for use in cleaning toilet bowls, urinals, bathrooms, floors, walls, 

ceilings, equipment, piping, and other hard non-porous surfaces. Institutional and 

commercial premises disinfecting cleaners for use in cleaning toilet bowls, urinals, 

bathrooms, floors, walls, ceilings, and other hard non-porous surfaces. Disinfecting 

cleaners for use in agricultural premises and food processing facilities and on food 

processing equipment.

End-use products are registered for use in residential and public access premises

as a disinfectant/sanitizer for hard non-porous household and domestics surfaces such as:

baby furniture (cribs, changing tables), stove tops, bathroom -or- restroom 

surfaces, bathtubs, tables, cabinets, highchairs (non-food contact areas), 

telephones, chairs, kitchen appliance[s] exteriors, light fixtures, toilet[s] exteriors, 

metal blinds, tubs, countertops -or- counters, microwave oven[s] exteriors, urinal 

exteriors, diaper pails, mirrors, washable kitchen surfaces, doorknobs, oven 

doors, [washable] walls, plastic laundry hampers -or- baskets, window(s) [sills], 

fiberglass bathtubs, range hoods, fiberglass shower and tub enclosures, 

refrigerator (exteriors), glass, sealed fiberglass surfaces, (glass) [showers] [doors] 

[walls], sinks [and fixtures], glazed [bathroom -or- restroom] tiles, stainless steel 

or metal surfaces, glazed ceramic [tile(s)] bathrooms -or- restrooms and kitchens.

There are two active ingredients in the glycolic acid and salts case 4045; however, 

one of these active ingredients, sodium glycolate (PC Code 000103), does not have 

registered products. This chemical is not being supported and is not addressed in this 

registration review. Glycolic acid is the only active ingredients in the case with active 

products. A Reregistration Eligibility Decision (RED) has not been issued by EPA for 

glycolic acid, and salts because of the initial registration date (i.e., post November 1984 

mandated cutoff) they were not subject to the conduct of a RED action.

Table 1. Registered Products of Glycolic Acid

Registration # Registration 

Name Company Name Formulation Type

% of Active 

Ingredient

5813-80 Clorox Patch The Clorox Company Soluble 

Concentrate 1.5

5813-86 CBW The Clorox Company Impregnated 

Materials 11.185

5813-87 X-Men The Clorox Company Ready-to-Use 

Solution 3.07
Page 3 of 9

Registration # Registration 

Name Company Name Formulation Type

% of Active 

Ingredient

5813-93 Show The Clorox Company Impregnated 

Materials 11.185

5813-101 Tuck 3 The Clorox Company Ready-to-Use 

Solution 1.75

71654-1

DuPontTM 

Glyclean® AM

E.I. du Pont de Nemours 

and Company

Formulation 

Intermediate 68

71654-2

DuPontTM Bowl 

Cleaner

E.I. du Pont de Nemours 

and Company

Ready-to-Use 

Solution 9.5

71654-5 DuPontTM KleanIt

E.I. du Pont de Nemours 

and Company

Ready-to-Use 

Solution 5.0

Science Findings

The Agency has conducted a review of the available product chemistry, 

environmental fate, and ecotoxicity data for glycolic acid. The findings are summarized 

below.

Product Chemistry Summary

Common Name: Glycolic acid

Chemical Name: Hydroxyacetic acid; 2-Hydroxyethanoic acid; HAA

CAS Registry Number: 79-14-1

OPP Chemical Code: 000101

Case: 4045

Molecular Formula: C2H4O3

Trade and Other Name: Glycolic acid

Molecular weight: 76.05 g/mol

Molecular Structure: HO-CH2-COOH

Color: Colorless crystalline solid. White, powdery solid (100%)

Clear, light amber-colored liquid (68% Technical solution)

Physical State: Solid (100%).

68% Technical solution is a liquid.

Odor: Odorless (100%).

68% Technical solution has a mild burnt sugar odor.
Page 4 of 9

Stability: Stable under ordinary conditions of use and storage. Stable 

to normal and elevated temperature. Incompatible with 

bases, oxidizing agents and reducing agents.

Reactivity: Stable, will not decompose, polymerize, or burn.

Solid form may be combustible at high temperature.

Oxidation/Reduction: Not applicable - product does not contain any oxidizing or 

reducing agents. May react with oxidizers. Like most acids, 

it will react with active metals, such as sodium or 

potassium, to release hydrogen gas.

Flammability: Not applicable - product is not a liquid (100%).

As a 68% solution, is non-flammable.

Flash Point: 112 oC

Explodability: Product does not contain any explodable components.

Storage Stability: Glycolic acid 68% solution is chemically stable in storage 

indefinitely. DuPont guarantees chemical stability for 2 

years. If the material is cooled below 50oF, crystals of 

glycolic acid will begin to form. These can be resolubilized by warming with agitation with no effect on 

chemical composition.

Miscibility: Not applicable - product is not an emulsifiable liquid 

intended to be mixed with petroleum solvents.

Corrosion Characteristics: Low corrosivity to common materials of construction under 

normal use conditions.

Dielectric breakdown voltage: Not Applicable - product not intended for use around 

electrical equipment.

pH: 68% Technical solution has a pH of 0.1 to 0.5

UV/Visible absorption: Absorbs UV radiation up to approximately 310 nm, with a 

maximum at 252 nm. Glycolic acid is not susceptible to 

photochemical degradation.

Viscosity: Not applicable product is not a liquid (100%).

Technical 68% solution: 11.28 mPa/s at 15.6 °C (60°F).

Melting point: 75-80°C (176°F) (100%)

10°C (50°F) (68% solution)
Page 5 of 9

Boiling Point: Decomposes at >100 °C (212°F) (100%)

112°C (234°F) (68% solution)

Density: 1.25 g/ml at 25 °C; 1.27 g/cm3(68% solution)

10.6 lb/gal (68% solution)

Specific Gravity: 1.49 at 25°C (100%)

Technical 68% solution has a specific gravity of 1.265 at 

20°C

Dissociation Constant: Acidity (pKa) (pH of 50% dissociation) = 3.83 at 25°C

Ka = 1.48 x 10-4at 25°C

Technical 68% solution at 25°C: 1.5 x 10-4

log Kow: -1.11at 19°C

Technical 68% Solution – not applicable 

Glycolic acid is polar.

Solubilities: Solubility in water

0.1 g/ml, clear

Highly soluble in water

Glycolic Acid is completely soluble in water (68% 

Solution).

Solubility in organic solvents

Alcohols

Chloroform

Acetone

Acetic acid

Ethyl acetate

Methanol

Ether

Sensitive: Hygroscopic; Deliquescent (100%)

Vapor Pressure: 2.0 x10-2 mm Hg at 25°C (extrapolated) (100%)

0.017 mm Hg at 25°C (Source: EPI Suite)

The vapor pressure of 68% Technical solution is 11.2 mm 

Hg at 25°C.

Henry's Law Constant: 8.5x10-8atm-cu m/mole at 25°C (estimated)

Enforcement

Analytical Methods: Spectrophotometric method

Thin layer chromatography
Page 6 of 9

All product chemistry data requirements have been satisfied for the active 

ingredient glycolic acid. (Source: MRID 44556001)

Environmental Fate and Ecological Effects Summary

The Agency has not received any guideline environmental fate studies on glycolic 

acid, and no studies are required at this time. Unless a toxicological concern is identified, 

the Agency believes that, based on the currently registered use pattern of glycolic acid for 

household use as a disinfectant/sanitizer for hard non-porous surfaces in homes, guideline 

environmental fate or ecological effects studies are inappropriate and unnecessary based 

on the following grounds.

Glycolic acid occurs widely in nature. Based on the available data and literature 

information on glycolic acid, its natural presence in human body, sugar cane, sugar beets,

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

beans), as well as in a wide variety of common foods including coffee, expected use 

patterns, safe history of use as indirect food additive, extensive use in cosmetics and skin 

care products, and because glycolic acid is practically nontoxic to nontarget organisms, 

the Agency has determined that environmental fate and ecological effects risk 

assessments are not needed for the current use of glycolic acid. Glycolic acid is approved 

by the Food and Drug Administrations (FDA) as an indirect food additive for use in food 

packaging adhesives. Also, the amount of glycolic acid disinfecting cleaners used in 

cleaning toilet bowls, bathrooms, floors, and other hard non-porous surfaces would not 

result in environmental concentrations that would reduce the environmental margin of 

safety.

The available environmental fate and ecotoxicity data for glycolic acid from 

literature indicate that this compound is expected to be readily biodegradable in the 

environment and is of low toxicity to fish and other aquatic organisms, mammals and 

birds. Therefore, EPA believes that the currently registered use pattern of glycolic acid 

as a household disinfectant/sanitizer for hard non-porous surfaces will not cause 

unreasonable adverse effects on the environment, and is not anticipated to cause adverse 

effects on fish, invertebrates, plants or wildlife.

Glycolic acid is a well-known chemical that is not subject to hydrolysis based on 

its chemical structure (lack of hydrolysable functional groups) and does not contain 

chromophores that absorb at wavelengths >290 nm and therefore is not expected to be 

susceptible to direct photolysis by sunlight. Because it has a pKa of 3.83, it is expected to 

exist as negatively-charged chemical species (anion) in the environmentally relevant pH 

range and will be highly mobile in soil based on the estimated Koc of 6. However, it will 

have a limited tendency to volatilize from soil or water based on the estimated Henry’s 

Law constant of 8.5x10-8atm-m

3

/mole. The biodegradability of glycolic acid has been 

extensively studied and it is expected to be readily biodegradable (>90% mineralization

in less than 2 weeks) in the environment. From the experimental data on 

bioconcentration (est. BCF of 3.2), and rate of biodegradation, a low potential for 

bioaccumulation is to be expected.
Page 7 of 9

Water Quality

Glycolic acid is not identified as a cause of impairment for any water bodies listed 

as impaired under section 303(d) of the Clean Water Act, based on information provided 

at the Agency’s National Pesticides Cause of Impairment of Waters website (searched 

April 7, 2011)1. In addition, no Total Maximum Daily Loads (TMDL) have been 

developed for glycolic acid, based on information provided at the Agency’s National 

Pesticide TMDL web site (searched April 7, 2011)2. 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/oppfead1/cb/ppdc/2006/november06/session1-sop.pdf ), in order to 

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

Ecological Effects Data Summary

The Agency has reviewed six ecotoxicity studies for glycolic acid. These data are 

adequate to provide the Agency with sufficient information to determine approximate

label precautions, and may be seen in Table 2.

Toxicity to Birds

Available data indicate that glycolic acid is practically non-toxic to birds on a 

sub-acute dietary basis.

Toxicity to Mammals

Glycolic acid is slightly toxic to mammals on an acute oral basis.

Glycolic acid has no effect on reproductive performance in one-generation 

reproduction study in rats.

Toxicity to Aquatic Animals

On an acute basis, glycolic acid is practically non-toxic to freshwater fish and

invertebrates.

Toxicity to Aquatic Plants

Algal toxicity data indicate that glycolic acid is not detrimental below 20,000 ppb 

(20 ppm).

 

1 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

2

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_p

ollutant_group_name=PESTICIDES
Page 8 of 9

Table 2. Ecotoxicity Data Summary for Glycolic Acid

GuideLineCommon

Name

Taxonomic

Name

Test

Type

%

ai

Study

Time

Dose

Type

Toxicity

Tox

Level NOEL Study

Status

Toxicity

Category

MRID

No.

Avian Subacute Dietary Toxicity

850.2200

(71-2)

Bobwhite 

quail

Colinus 

virginianus

D 8 day LC50 >5000 ppm Supplemental Practically 

non-toxic

110131

850.2200

(71-2)

Mallard 

duck

Anas 

platyrhynchos

D 8 day LC50 >5000 ppm Supplemental Practically 

non-toxic

110129

Freshwater Fish Acute Toxicity

850.1075

(72-1)

Bluegill 

sunfish

Lepomis 

macrochirus

S 70-

90

48 hr EC50 93 ppm Supplemental Slightly 

toxic

Lit.

850.1075

(72-1)

Fathead 

minnow

Pimephales 

promelas

S 70-

90

96 hr LC50 164 ppm Supplemental Practically 

nontoxic

Lit.

Freshwater Invertebrate Acute Toxicity

850.1010

(72-2)

Daphnia Daphnia 

magna

S 98 48 hr EC50 141 ppm Supplemental Practically 

nontoxic

Lit.

Toxicity to Aquatic Plants

850.5400

(OECD 

201)

Green 

Algae

Selenastrum 

capricornutum

S 98 72 hr EC50

(growth)

EC50

(biomass)

44

21.6

ppm 20 Supplemental Algistatic Lit.

Mammalian Acute Oral Toxicity

870.1100

(81-1)

SpragueDawley Rat70 LD50 1938 mg/kgbw

Acceptable Slighty 

toxic (III)

44975301

Mammalian Subchronic Oral Toxicity

870.3100

(82-1)

Albino rat 70 90 day LOAEL 300 mg/kgbw/day 150 for 

systemic 

toxicity

Acceptable Decreased 

food 

consumption, 

body weight 

& body 

weight gain; 

and renal 

insufficiency

44975304

One-Generation Reproduction in Rats

870.3550

NGLN

Albino Rat 70 Following a 

90-day 

feeding 

study

LOAEL Not 

attained

mg/kgbw/day≥600 for 

reproductive 

toxicity

Acceptable No effect on 

Reproductive 

performance

44975304

Oral Developmental Toxicity

83-3 Crl:CD®BR 

Rats

99.6 21 day LOEL

Maternal

Developmental

300

300

mg/kgbw/day

150

150

Acceptable Not 

considered

developmental

hazard to the 

conceptus

44589501

Test Type—D: dietary; S: static

Tox Level—ppm: parts per million (equivalent to milligrams per kilogram-diet (mg/kg-diet) for dietary exposure and milligrams per liter (mg/L) for aquatic 

exposures)

Categories of acute toxicity for aquatic organisms (U.S. EPA, 2004) based on EC50/LC50(mg/L): < 0. 1 very highly toxic; 0.1-1 highly toxic; >1-10 moderately 

toxic; >10-100 slightly toxic; >100 practically nontoxic. Toxicity categories for terrestrial plants have not been defined.

Categories of acute toxicity to terrestrial animals, avian and mammalian (U.S. EPA, 2004). LC50 (ppm): < 50 very highly toxic; 50 - 500 highly toxic; 501 – 1000 

moderately toxic; 1001-5000 slightly toxic; >5000 practically non-toxic. LD50

(mg/kg bw): < 10 very highly toxic; 10 - 50 highly toxic; 51 - 500 moderately toxic; 501-2000 slightly toxic; >2000 practically non-toxic.

Lit—Robust Summary for Glycolic Acid dated April 2, 2002

NGLN—Non-guideline study
Page 9 of 9

Ecotoxicity data are adequate to provide the Agency with sufficient information 

to determine appropriate label precautions.

Ecological Effects Risk Assessment

Based on the environmental fate profile of glycolic acid, exposures from labeled 

uses in household premises as a disinfectant/sanitizer for hard non-porous surfaces are 

unlikely to reach concentrations necessary to create adverse effects in aquatic organisms. 

Glycolic acid does not appear to be toxic to nontarget organisms (see Table 2) and 

adverse effects from labeled uses is not expected. Taking into account the rapid 

biodegradability, low bioaccumulation potential, low-toxicity to non-toxicity to most 

aquatic species, and the rapid metabolism of this substance, glycolic acid will pose no 

adverse risk to aquatic organisms. Therefore, the Agency does not anticipate the need to 

conduct environmental fate and ecological risk assessments for glycolic acid use patterns 

listed in this document.

Threatened and Endangered Species Effects Determination

A quantitative ecological risk assessment was not conducted on the glycolic acid 

use patterns described in this document. The Agency has made a ―no effect‖ finding for 

the use pattern of glycolic acid based on favorable environmental fate and ecotoxicology 

data.

Adverse Ecological Incidents

There are no reported incidents in the Agency's Ecological Incident Information 

System (EIIS) regarding glycolic acid. The absence of documented incidents does not 

necessarily mean that such incidents did not occur.

Environmental Fate and Ecotoxicity Data Gaps and Anticipated Work

None.