UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

Date: February 23, 20 l~ 

SUBJECT: Benzyl Benzoate: Tier I (Scoping) Review of Human incidents and Epidemiology 

PCCode:00910 1,009 103. 00950 1 

Decision No.: 514096 

Petition No.: NA 

Risk Assessment Type: A 

TXR No.: NA 

MRID No.: 1 A 

DP Barcode: 43180 I 

Registration No.: NA 

Regulatory Action: A 

Case No.: 4013 

CAS No.: 120-51-4 

40 CFR: NA 

Ver.Apr.OS 

FROM: 

Tox

Elizabe

icol

th 

ogy 

Evans

and 

, 

Epidemio

Environm

logy 

enta

Br

l Protect

anch 

ion Specialist 

C; f ~ 

~ ,,, M/A~ ~ 

Health Effects Division (7509P) V --...,0 - · · 

and 

Shanna Recore, Industrial Hygienist O. _ /""'\ . /1 Toxicology 

Health Effect 

and 

Division 

Epidemiolo

(7509P) 

gy Branch 

~v--v----

A f'i. A ", IA 11 ..-~ 

THROUGH: David Miller, Acting Branch Chie[ /7,; J;!/t. :tJ/.b.tC/b 

Toxicology and Epidemiology Bran~ Health Effects Division (7509P) 

TO: Wade Britton, Risk Assessor 

Risk Assessment Branch IV 

Health Effects Division (7509P) 

and 

Mmma Appleyard, Chemical Review Manager 

Risk Management & Implementation Branch 5 

Pesticide Re-evaluation Division (7508P) 

Summarv and Conclusions 

Based on the low frequency and severity of incident cases reported for benzyl benzoate in both 

IDS and SENSOR-Pesticides there does not appear to be a concern at this time that would 

warrant further investigation. The Agency will continue to monitor the incident information and 

if a concern is triggered, additional analysis will be included in the risk assessment. 

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Detailed Review 

I. ACTION REQUESTED 

This review is intended to fulfill our requirement to docket summaries of incident data that were 

reported to the Agency, as well as to ensure human incident data and the Agricultural. Health 

Study (AHS) are part of the problem formulation phase of registration review. Reports of 

adverse health effects allegedly due to a specific pesticide exposure (i.e., an " incident") are 

largely self-reported and therefore, generally speaking, neither exposure to a pesticide or 

reported symptom (or the connection between the two) is validated or otherwise confinned. 

Typically, causation cannot be determined based on incident data. However, incident 

information can be an important source of feedback to the Agency: incidents of severe outcome, 

or a suggested pattern or trend among less severe incidents, can signal the Agency to further 

investigate a particular chemical or product. Observational epidemiology studies relate the risk 

of disease, e.g. , cancer, and exposure to an agent such as a pesticide product in the general 

population or specific sub-groups like pesticide applicators. 

II. BACKGROUND 

Benzyl benzoate (PC Code 009501) is 1 of3 active ingredients which compose registration review 

Case #4013 whjch also includes benzoic acid (PC Code 009101) and sodium benzoate (PC Code 

009103). Of the 3 active ingredients, benzyl benzoate is the only with registered products and 

subject to registration review. 1 

Benzyl Benzoate is an insecticide/miticide used for control of dust mites in carpets, mattresses, 

upholstery, and on furniture, and for control of mites on dogs. Benzyl benzoate is a member of 

the benzyl derivatives family, which is used in food flavors and fragrances, and occurs naturally 

in many foods. Based on product labels, benzyl benzoate is formulated as a liquid spray 

(Aerosol) and as powder formulation; all are " ready-to-use" (RTU) products. Application rates 

vary depending upon the application method and use-site. There are no agricultural (food) uses 

for benzyl benzoate. The residential uses are limited to indoor treatments.2 

For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease Control 

and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel 

Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted 

for pesticide incident data on the active ingredient benzyl benzoate (pc code: 00910 l ). The 

purpose of the database search is to identify potential patterns in the frequency and severity of the 

health effects attributed to benzyl benzoate exposure. Benzyl benzoate is not included in the AHS, 

and therefore this study does not provide information for this report. 

1 2016 Benzy l Benzoate draft scoping (W. Britton) 2 Benzyl Benzoate: Risk assessment - Preliminary (Phase I) 1 IED Chapter of the Re-registration Eligibility Decision Document 

(RED). PC Code: 009501. Reregistration Case No. 401 3. DP 13arcodc D327107 

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Ill. RESULTS/DISCUSSION 

a. IDS (Incident Data System) 

OPP's IDS includes reports of alleged human health incidents from various sources, including 

mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports 

from registrants, other federal and state health and environmental agencies, and individual 

consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from 

across the U.S. and most incidents have all relevant product information recorded. Reports 

submitted to the IDS represent anecdotal reports or all egations only, w1 less otherwise stated in 

the report. 

IDS records incidents in one of two modules: Main IDS and Aggregate IDS: 

o Main IDS contains incidents resulting in higher severity outcomes and provides 

more detail with regard to case specifics. This system stores incident data for 

death, major and moderate incidents, and it includes information about the 

location, date and nature of the incident. Main IDS incidents involving only one 

active ingredient (as opposed to pesticide products with multiple active 

ingredients) are considered to provide more certain information about the 

potential effects of exposure from the pesticide. 

o Aggregate IDS contains incidents resulting in less severe human incidents (minor, 

unknown, or no effects outcomes). These are reported by registrants only as 

counts in what are aggregate summaries. 

For the Main IDS, from January 1, 2010 to September 25, 2015, there were two incidents 

reported for the single chemical benzyl benzoate onl y in the database. Both incidents were 

moderate in severity. 

Aggregate IDS, from January l, 20 I 0 to September 25, 2015, there were 16 incidents reported 

involving benzyl benzoate. These incidents were classified as minor severity. Overall, there are 

few incidents reported to IDS involving benzyl benzoate. 

Note that all of the above incident repo11s involved EPA Registration No 4822-433 (AllerCare) 

which was cancelled in February 2008. 

b. SENSOR-Pesticides 

The SENSOR-Pesticides database covers 12 states from 1998-2011 , although reporting varies 

from state to state. Cases of pesticide-related illnesses are ascertained from a variety of sources, 

including: reports from local Poison Control Centers, state Department of Labor workers' 

compensation claims when reported by physicians, reports from State Departments of 

Agriculture, and physician reports to state Departments of Health. Although both occupational 

and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on 

occupational pesticide incidents, and is of particular value in providing that information. The 

state coordinator at each of the 12 respective state Departments of Health conducts case followPage 3of5 
up activities such as obtaining medical records to verify symptoms and severity. Using 

standardized protocol and case definitions derived from poison center reporting, the state 

SENSOR-Pesticide coordinator enters the incident information into the state-based system which 

is sent to NIOSH annually to be aggregated. 

A query of SENSOR-Pesticides 1998-2011 identifies a total of 11 cases involving benzyl 

benzoate. Ten cases involve a single ai and these are summarized. One case is high in severity, 

two cases are moderate in severity, and seven cases are low in severity. All but one of the I 0 

single ai cases occurred in 1999 or 2000 (one low severity case occurred in 2005). 

The high severity case involved a woman who was hospitalized twice for asthma and the patient 

believes it is related to the product. The case's daughter applied AllerCare, a pesticide product 

marketed to kill dust mites that lead to allergies and asthma, around the home. This product has 

been taken off the market: http://www.cbsnews.com/news/allercare-warning/ 

In fact, four of the case reports involve All erCare. An additional four cases involved unspecified 

dust mite carpet powder which may have been AllerCare. The 2005 case involved an 

unspecified product that was "taken off the market years earlier". 

Symptoms were generally allergic reactions following exposure. Nine cases experienced 

respiratory symptoms including upper respiratory pain (n=6) and wheeze (n=4). 

Table 1. SENSOR-Pesticides 1998-2011 

Symptoms reported for benzyl benzoate 

cases (n=lO) 

Dermal 6 

Ocular 2 

Resoiratorv 9 

Gastrointestinal 4 

Nervous system s 

Renal I 

*Cases may report mulllplc symptoms 

c. Agricultural Health Study (AHS) 

The AHS is a high quality, prospecti ve epidemiology study evaluating the link between pesticide 

use and various health outcomes including cancer. The AHS includes private and commercial 

pesticide applicators and their spouses. If there are AHS findings relevant to a particular 

pesticide going through registration review, the Agency will ensure they are considered in the 

problem formulation/scoping phase of the process and, if appropriate, fully reviewed in the risk 

assessment phase of the process. The Al-IS includes information on use of 80 different pesticide 

active ingredi ents commonly used in agriculture. Benzyl benzoate is not included in the AHS, 

and therefore this study does not provide information for this report. 

IV. CONCLUSION 

Based on the low frequency and severi ty of incident cases reported for benzyl benzoate in both 

IDS and SENSOR-Pesticides there does not appear to be a concern at this time that would 

Page 4 of 5 
warrant further investigation. The Agency will continue to monitor the incident infonnation and 

if a concern is triggered, additional analysis will be included in the risk assessment. 

Page 5 of 5