UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

November 3, 2010

MEMORANDUM

SUBJECT: Summary of Product Chemistry. Envirorunental Fate, and

Ecotoxicity Data for the Benzoic acid Registration Review

Decision Document.

PC Code: 009101

CAS No.: 65-85-0

Case No.: 5107

DP Barcode: 382193

FROM:

TO:

THRU:

Introduction:

Srinivas Gowda, Microbiologist g"";~1/ a..9, e.

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (75 lOP)

Seiichi Murasaki. Chemical Review Manager

Regulatory Management Branch 11

Antimicrobials Division (751 OP) 'aJ.<A

Nader Elkassabany, Branch Chief 11 r / fL._-

Siroas Mostaghimi, Peer Reviewer - ;II(.?- 7

Risk Assessment and Science Support Branch CRASSB)

Antimicrobials Division (75 loP)

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

with the Agency on July I, 1987. Currently, there is only one active product registered

for use as an antimicrobial preservative for industrial use in food grade lubricating oils

which is listed in Table 1. MICROL Preservative solution is added to the mineral oil

component oflubricants at a maximum level of 1.0% to prevent decomposition and odors

caused by microorganisms. A Reregistration Eligibility Decision (RED) has not been

issued by EPA for Benzoic acid. However, when RED was issued for Benzyl Benzoate

(Benzoic Acid case 4013) by EPA in June 2007, it was stated that no products containing

benzoic acid were being supported under reregistration. Benzoic acid was again

registered as an active ingredient in 2005; as a result, it was assigned a new case number,

case 5107.
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Table 1. Registered Active Product of Benzoic Acid

Registration

#

Registration 

Name Company Name Formulation Type

% of Active 

Ingredient

82076-1

MICROL 

Preservative

Petro-Canada 

Lubricants Division End-use product 99.98

Science Findings

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

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

below.

Product Chemistry Summary

Common Name: Benzoic acid

Chemical Name: Benzenecarboxylic acid

CAS Registry Number: 65-85-0

OPP Chemical Code: 009101

Case: 5107

Molecular Formula: C7H6O2

Trade and Other Name: Benzoic acid

Molecular weight: 122.12 g/mol

Molecular Structure:

Color: White, colorless crystalline solid.

Physical State: Solid.

Odor: Odorless-to-slight benzaldehyde-like odor.

Stability: Stable.

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

reducing agents. May react with oxidizers.

Flammability: Not applicable - product is not a liquid.

Flash Point: 250 oF (121°C) by closed cup.

Explodability: Product does not contain any explodable components.
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Storage Stability: Stable.

Miscibility: Not applicable - product is not an emulsifiable liquid 

intended to be mixed with petroleum solvents.

Corrosion Characteristics: Product does not react with packaging. Non-corrosive to 

polyethylene bags inside fiberboard drum.

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

electrical equipment.

pH: 2.8 (saturated solution at 25°C)

3.1 (concentration of 0.1%)

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

maximum at 252 nm.

Viscosity: Not applicable product is not a liquid.

Melting point: 252°F (122.4°C)

Boiling Point: 480°F (249.2°C)

Density: 1.2659 g/cm3 @ 15 °C

Specific Gravity: 1.2659

Dissociation Constant: 6.335 × 10-5(25°C)

Acidity (pKa) = 4.19

Benzoic acid dissociates in water:

C6H5COOH + H2O = C6H5COO-+ H3O

+

log Kow: 1.87

Solubility: Solubility in water

3.4 g/litre (25 °C) (3.4 x 103 mg/L at 25°C)

2.91 g/litre (20 °C)

Soluble in hot water.

Solubility in organic solvents in g/100 g at 25°C

Benzene: 12.17 g/100

Chloroform: 15.02

Acetone: 55.6

Hexane: 0.94

Methanol: 71.5

Toluene: 10.6

Ethanol: 58.4

Ethyl ether 40.8
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Vapor Pressure: 7 x 10-4 mm Hg at 25°C (0.0007 mm Hg)

Henry's Law Constant: 3.81E-08 atm-m3/mole

Enf. Analytical Methods: Gas Chromatography (GC) Method

Infrared (IR)

Ultraviolet absorption (UV)

Nuclear Magnetic Resonance (NMR)

High-Performance Liquid Chromatography (HPLC)

All product chemistry data requirements have been satisfied for the active 

ingredient benzoic acid.

Environmental Fate and Ecological Effects Summary

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

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

the Agency believes that, based on the nature and occurrence of benzoic acid and 

currently registered use pattern of benzoic acid as a material preservative in the mineral 

oil component of lubricants, guideline environmental fate studies are inappropriate and 

unnecessary based on the following grounds.

Based on the available data and literature information on benzoic acid, its natural 

occurrence in berries, expected use patterns, safe history of use as food additives, 

extensive use in cosmetics and bath products, and because benzoic 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 benzoic acid. 

Benzoic acid is classified by the U.S. Food and Drug Administration as a Generally 

Recognized As Safe (GRAS) substance as a direct food additive at 0.1% or less. Also, the 

amount of benzoic acid used in food grade lubricating oil formulations is expected to be 

minuscule in comparison to the amount naturally present in the environment.

The available environmental fate and ecotoxicity data for benzoic acid 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 benzoic acid as a material preservative 

in the mineral oil component of lubricants will not cause unreasonable adverse effects on 

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

plants or wildlife.

Benzoic 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 light from 290-800 nm. Because it has a pKa of 4.19, it is 

expected to exist as negatively-charged chemical species (anion) and will be highly 

mobile in soil. However, it will have limited tendency to volatilize from soil or water. 

The biodegradability of benzoic acid has been extensively studied and it is expected to be 
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readily biodegradable in the environment. From the experimental data on 

bioconcentration, a low potential for bioaccumulation is to be expected.

Water Quality

Benzoic 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 

http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_grou

p_id=885 . In addition, no Total Maximum Daily Loads (TMDL) have been developed 

for benzoic acid, based on information provided at 

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

oup_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/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 four ecotoxicity studies for benzoic acid. The available

ecotoxicology studies submitted in support of the 95.9% active ingredient are acceptable 

only for currently registered use pattern as a material preservative in the mineral oil 

component of lubricants and for use in a hazard assessment (Table 2). Expanded uses 

may require additional studies. The Agency's conclusions for the avian and aquatic 

effects studies are as follows.

a. Terrestrial Studies

Avian Acute Oral and Subacute Dietary Toxicity 

Benzoic acid is considered to be practically non-toxic to birds, with an acute oral 

LD50 value of >2510 mg/kg for the mallard (Anas platyrhynchos) and subacute 

dietary LC50s >5620 ppm for the northern bobwhite (Colinus virginianus) and 

mallard. The studies fulfill guidelines requirements (OPPTS 850.2100 and 

850.2200) for avian testing using the technical grade active ingredient.

b. Aquatic Studies

Freshwater Fish Acute Toxicity – Published Literature

The following data from literature reviews (WHO 2000) show that benzoic acid is 

not toxic to freshwater fish. Two different tests with the freshwater fathead 

minnow (Pimephales promelas) resulted in 96-hour LC50 values of 484 mg/L and 
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>100 mg/L which indicate that benzoic acid is practically non-toxic to freshwater 

fish. For the freshwater fish golden ide (Leuciscus idus), a 48-h LC50 of 460 

mg/L has been determined. Fish data from literature reviews were not formally 

reviewed or accepted by the agency.

Invertebrate Acute Toxicity

Daphnia (Daphnia magna) testing indicate that benzoic acid is practically nontoxic to freshwater invertebrates with an LC50 >100 ppm.

Table 2. Ecotoxicity Data Summary for Benzoic acid

GUIDE

LINE

COMMON

NAME

TAXONOMIC

NAME TYPE %AI

STUDY

TIME

DOSE

TYPE

TOXI

CITY

TOX

LEVEL NOEL

Study 

Status

TOX

CATEGORY

MRID

Avian Acute Oral Toxicity

850.2100 Mallard 

Duck

Anas 

platyrhynchos

O 95.9 14 D LD50 >2510 MGK 2510 Acceptable Practically 

non-toxic

148303

Avian Subacute Dietary Toxicity

850.2200 Bobwhite 

quail

Colinus 

virginianus

D 95.9 8 D LC50 >5620 PPM 5620 Acceptable Practically 

non-toxic

148304

850.2200 Mallard 

duck

Anas 

platyrhynchos

D 95.9 8 D LC50 >5620 PPM 5620 Acceptable Practically 

non-toxic

148304

Freshwater Invertebrate Acute Toxicity

850.1010 Water 

flea

Daphnia 

magna

S 95.9 48 hr EC50 >100 PPM 100 Acceptable Practically 

non-toxic

147398

Ecotoxicity data are adequate to provide the Agency with sufficient information 

to determine appropriate label precautions.

Based on the environmental fate profile of benzoic acid, exposures from label 

uses as a material preservative in the mineral oil component of lubricants are unlikely to 

reach concentrations necessary to elicit effects in aquatic organisms. Benzoic acid does

not appear to be toxic to nontarget organisms and adverse effects from labeled uses as a 

material preservative in the mineral oil component of lubricants is not expected. Taking 

into account the rapid biodegradability, the low bioaccumulation potential, the low to 

non-toxicity to most aquatic species, and the rapid metabolism of this substance, benzoic 

acid will pose only a minimal to no risk to aquatic organisms.

Ecological Effects Risk Assessment and Risk to Threatened and Endangered Species

An ecological risk assessment was not conducted on the benzoic acid use patterns 

described in this document. The Agency has made a “no effect” finding for the use 

pattern of benzoic acid.

Environmental Fate and Ecotoxicity Data Gaps and Anticipated Work

None.
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Sign-off Date : 11/03/10

DP Barcode No. : D382193