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

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Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (75 lOP)

Seiichi Murasaki. Chemical Review Manager Regulatory Management Branch 11

Antimicrobials Division (751 OP) 

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Nader Elkassabany, Branch Chief 

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Siroas Mostaghimi, Peer Reviewer

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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.Page 2 of 7

Table 1. Registered Active Product of Benzoic Acid

Registration

# Registration

Name Company Name Formulation Type % of Active

Ingredient

82076

- 1 MIC ROL

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.

P roduct Chemistry Summary

Common Name: Benzoic acid

Chemical Name: Benzenecarboxylic acid CAS Registry Number: 65

- 85

- 0

OPP Chemical Code: 009101

Case: 5107

Molecular Formula: C 7 H 6 O 2 Trade and Other Name: Benzoic acid Molecular weight: 122.12 g/m ol

Molecular Structure:

Color: W hite , 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 P oint: 250 oF (121°C) by closed cup

.

Explodability: Product does not co ntain any explodable components

.Page 3 of 7

Storage Stability: Stable

.

Miscibility: Not applicable

- product is not an emulsifiable liquid intended to be mixed with p e troleum solvents

.

Corr osion 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 soluti on 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/cm 3 @ 15 °C Specific Gravity : 1.2659

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

a ) = 4. 19

Benzoic acid dissociates in water : C 6 H 5 COOH + H 2 O = C 6 H 5 COO - + H 3 O +

log Kow : 1.87

Solubility: Solubility in water 3.4 g/l itre (25 ° C) (3.4 x 10 3 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

C hloroform: 15.02

Acetone: 55.6

Hexane: 0.94

Methanol: 71.5

Toluene: 10.6

E thanol: 58 .4

E thyl ether 40

. 8Page 4 of 7

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 Method s : Gas C hromatography (GC) Met hod Infrared (IR) Ultraviolet absorption (UV) Nuclear Magnetic R esonance (NMR)

H igh

- Performance L iquid C hromatography (HPLC)

All product chemistry data requirements have been satisfied for the active ingredient benzoic acid

.

Environmental Fate and Ecologi cal 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 n ontarget 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 availab le 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, invertebrate s, 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 specie s (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 stud ied and it is expected to bePage 5 of 7

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

at http://iaspub.epa.gov/tmdl_waters10/att ains_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 th e 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 ecotoxic ity studies for benzoic acid . The available ecotoxicology studies submitted in support of the 95.9 % active ingredient are acceptable only for c urrently registered use pattern as a material preservative in the mineral oil component of lubricants and for use in a hazar d 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

LD 50 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 s tudies fulfill guidelines requireme nts (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 test s with the freshwater fathead

minnow ( Pimephales promelas) resulted in 96

- hour LC 50 value s of 484 mg/L andPage 6 of 7 >100 mg/ L which indicate that benzoic acid is practically non

- toxic to freshwater

fish. For the freshw ater fish golden ide (Leuciscus idus), a 48

- h LC 50 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 non

toxic to freshwater invertebrates with an LC 50 >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 M RID

Avian Acute Oral Toxicity

850.2100 Mallard

Duck Anas

platyrhynchos O 95.9 14 D LD 50 >2 51 0 MGK 2510 Acceptable Practically

non

- toxic 148303

Avian Subacute Dietary Toxicity

8 5 0.2200 Bobwhite quail Colinus

virginianus D 95.9 8 D LC 50 >5620 PPM 5 620 Acceptable Practically

non

- toxic 148304

8 5 0.2200 Mallard

d uck Anas

platyrhynchos D 95.9 8 D LC 50 >5620 PPM 5620 Acceptable Practically

non

- toxic 14 8304

Freshwater Invertebrate Acute Toxicity

850.1010 Water

flea Daphnia

magna S 95.9 48 hr EC 50 >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 la bel

uses as a material preservative in the mineral oil component of lubricants are unlikely to reach concentrations necessary to elicit effects in aquatic organisms. B enzoic acid do es 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 th is 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
d escribed 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.Page 7 of 7 Sign

- off Date : 11/ 0 3 /10

DP Barcode No. : D 382193