United States Prevention, Pesticides EPA738-R-07-010
Environmental Protection and Toxic Substances September 12,2008
Agency (7508P)
&EPA
Reregistration
Eligibility Decision
for
Naphthalene
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Reregistration Eligibility Decision (RED) for
Naphthalene
ListC
Case No. 3058
Approved by: ^
Steven Bradbury, Ph.D., Director
Special Review and Reregistration Division
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TABLE OF CONTENTS
I. Introduction 8
II. Chemical Overview 8
A. Regulatory History 8
B. Chemical Identification 9
C. Use Profile 9
D. Estimated Usage of Pesticide 10
HI. Summary of Naphthalene Risk Assessments 10
A. Human Health Risk Assessment 10
1. Toxicity of Naphthalene 11
2. Carcinogenicity of Naphthalene 16
3. Metabolites and Degradates 17
4. Endocrine Disruption 17
5. Dietary Risk (Water Only) 17
6. Residential (Non-Occupational) Exposure Risk 20
7. Aggregate Risk 24
8. Occupational Risk 24
9. Human Incident Data 24
B. Environmental Risk Assessment 25
1. Environmental Fate and Transport 26
2. Terrestrial Organisms 27
3. Aquatic Organisms 31
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 34
A. Determination of Reregistration Eligibility 34
B. Public Comment Period 35
C. Regulatory Position 36
1. Regulatory Rationale 36
2. Endocrine Disrupter Effects 39
3. Endangered Species 40
D. Labeling Requirements 40
V. What Registrants Need to Do 40
A. Manufacturing Use Products 40
1. Additional Generic Data Requirements 40
2. Labeling for Manufacturing-Use Products 41
B. End-Use Products 41
1. Additional Product-Specific Data Requirements 41
2. Labeling for End-Use Products 41
C. Labeling Changes Summary Table 42
Appendix A. Use Patterns Eligible for Reregistration for Naphthalene 46
Appendix B Data Supporting Guideline Requirements for the Reregistration of
Naphthalene 47
Appendix C. Technical Support Documents 49
Appendix D. Citations Considered to be Part of the Database Supporting the
Reregistration Decision (Bibliography) 49
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Glossary of Terms and Abbreviations
ai Active Ingredient
CFR Code of Federal Regulations
DCI Data Call-In
EC Emulsifiable Concentrate Formulation
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration
EPA Environmental Protection Agency
EUP End-Use Product
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FIRST FQPA Index Reservoir Screening Tool
FFDCA Federal Food, Drug, and Cosmetic Act
GLN Guideline Number
HED Health Effects Division
HOT Highest Dose Tested
IRIS Integrated Risk Information System
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected
to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or
volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of
the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as
a weight of substance per unit weight of animal, e.g., mg/kg.
LOG Level of Concern
LOAEL Lowest Observed Adverse Effect Level
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
umol Millimoles Per Liter
MOA Mode of Action
MOE Margin of Exposure
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
MUP Manufacturing-Use Product
N/A Not Applicable
NAWQA National Water-Quality Assessment Program
NCEA National Center for Environmental Assessment
NDETF Non-Dietary Exposure Task Force
NLAA Not Likely to Adversely Affect
NR Not Required
NOAEL No Observed Adverse Effect Level
NTP National Toxicology Program
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
PCC Poison Control Center
PII Primary Irritation Index
PK Pharmacokinetic
ppb Parts Per Billion
POD Point of Departure
ppm Parts per Million
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfC Reference Concentration
RfD Reference Dose
SCI-GROW Screening Concentration In Ground Water
SF Safety Factor
IV
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TREX Terrestrial Residue Exposure (T-REX)
USDA United States Department of Agriculture
USGA US Geological Survey
UF Uncertainty Factor
UFdb Database Uncertainty Factor
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NAPHTHALENE TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Wade Britton
Danette Drew
John Liccione, Ph.D.
Ecological Fate and Effects Risk Assessment
Stephen Carey
Mark Corbin
Biological and Economics Analysis Assessment
Rafael Prieto
Steve Jarboe
LaVerne Dobbins
Registration Division
Dan Peacock
John Hebert
Risk Management
Molly Clayton
Kevin Costello
VI
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Abstract
The Environmental Protection Agency (EPA or the Agency) has completed the human
health and ecological risk assessments for naphthalene and is issuing its risk management
decision. The human health and ecological risk assessments, which are summarized below, are
based on the review of the required target database supporting the use patterns of currently
registered products. As a result of this review, EPA has determined that naphthalene-containing
products are eligible for reregi strati on, provided that risk mitigation measures described in this
document are adopted and labels are amended accordingly. That decision is discussed fully in
this document.
Naphthalene is an insecticide; the majority of its pesticidal use is as a moth repellant to
protect garments from insect damage (indoor) and as an animal repellant against nuisance
vertebrate pests (indoor and outdoor). There are no food uses, and all registered products of
naphthalene are intended for residential uses only. The indoor products are formulated as
mothballs or flakes, while outdoor products are formulated as flakes or granules. Of the risk
scenarios assessed, only the risk from episodic ingestion of mothballs by toddlers was of
concern. Mitigation measures, including special packaging and precautionary label language,
will be required to address this potential risk of concern.
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act calls for the development and submission of data to support the
reregistration of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency (referred to as EPA or "the Agency"). Reregistration involves
a thorough review of the scientific database underlying a pesticide's registration. The purpose of
the Agency's review is to reassess the potential risks arising from the currently registered uses of
the pesticide, to determine the need for additional data on health and environmental effects, and
to determine whether or not the pesticide meets the "no unreasonable adverse effects" criterion
of FIFRA.
This document summarizes EPA's human health and ecological risk assessments and
reregistration eligibility decision (RED) for naphthalene. The document consists of six sections.
Section I contains the regulatory framework for reregistration; Section II provides an overview
of the chemical and a profile of its use and usage; Section III gives an overview of the human
health and ecological risk assessments; Section IV presents the Agency's decision on
reregistration eligibility and risk management; and Section V summarizes the label changes
necessary to implement the risk mitigation measures outlined in Section IV. Finally, the
Appendices list related information, supporting documents, and studies evaluated for the
reregistration decision. The risk assessments for naphthalene and all other supporting documents
are available in the Office of Pesticide Programs (OPP) public docket
(http://www.regulations.gov) under docket number EPA-HQ-OPP-2008-0343.
II. Chemical Overview
A. Regulatory History
The Agency's predecessor for pesticide registrations, the U.S. Department of Agriculture
(USDA), first registered a product containing naphthalene in 1948. The Agency issued a
Registration Standard for this active ingredient in 1981 and required submission or citation of the
following data: chemistry; environmental fate and effects; acute, subchronic, chronic human
health effects; and efficacy data. In the latter half of the 1990s, the Agency initiated a Label
Improvement Program (LIP) to update the precautionary text, use directions, storage, and
disposal instructions to reduce exposure to naphthalene, especially when used in homes.
Currently, there are 9 registered naphthalene products. One is a manufacturing-use
product and 8 are end-use products. All are registered under Section 3 of FIFRA. There are no
Special Local Need (SLN) registrations under Section 24(c) of FIFRA. The Agency has
registered products for domestic, indoor use to kill moths inside of airtight spaces (closets,
chests, and garment bags) and to repel bats, tree squirrels, and birds from attics and wall voids.
There are naphthalene products for domestic, outdoor use to repel rabbits, snakes, Norway rats,
roof rats, and house mice.
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B. Chemical Identification
NAPHTHALENE:
Naphthalene is a white, crystalline solid with a characteristic odor.
Common Name: Naphthalene
Chemical Class: Insecticide
PC Code: 055801
Case Number: 0022
CAS Registry Number: 91-20-3
Molecular Weight: 128.18 g/mole
Empirical Formula: CioH8
Technical Registrants: Reochem, Inc.
C. Use Profile
The following information on the currently registered uses includes an overview of use
sites and application methods. A detailed table of the uses of naphthalene eligible for
reregi strati on is contained in Appendix A.
Type of Pesticide: Insecticide and repellant.
Target Organism: The primary target pests are moths and nuisance vertebrate pests (squirrels,
rats, rabbits, bats, etc).
Use Sites: Naphthalene is registered for use on indoor and outdoor residential use sites. It is
used indoors as a moth repellant, and placed in closed drawers, closets, and other storage areas.
It is also used in attics as a squirrel and bat repellant. Outdoors, it is used around garden and
building peripheries to repel animals such as snakes and rabbits.
Use Classification: Naphthalene products are designated as general use.
Formulation Types: Balls, granules, and flakes.
Application Methods: By hand.
Application Rates: Actual application rates for naphthalene products are imprecise, based on
formulation type and application method. It is registered for use on indoor sites as a moth
repellant in mothballs and flakes at rates ranging from 0.25 pounds of active ingredient per 12
cubic feet (0.25 Ib ai/12 ft3) to 0.37 Ib ai/12 ft3. When used indoors as an animal repellant, it is
formulated as a flake and applied at a rate of 1 Ib ai/400 ft3 (or 1 oz/3 ft3 for smaller spaces).
When used outdoors and formulated as granules or flakes, it is applied at rates ranging from 0.56
Ib ai/treated area to 10.8 Ib ai/treated area.
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Application Timing: Registered labels for indoor moth treatment use recommend keeping the
product in an airtight space for a minimum of seven days. Re-treatment is recommended when
the mothballs have dissipated. Since moths are active all year, there is the potential for continual
treatment indoors. One moth control label recommends re-treatment twice per year. Re-
treatment for indoor/outdoor repellant uses is recommended as needed to maintain odor intensity.
Hot weather, wind, and rain may diminish the effectiveness of the product and necessitate re-
treatment.
D. Estimated Usage of Pesticide
Approximately 7.5 million Ibs of naphthalene are marketed on average per year as a
pesticide. The vast majority of the usage is in indoor moth repellant products.
Pesticide usage accounts for a small portion of total US naphthalene exposure. More
than 90% of total naphthalene usage comes from other sources. Naphthalene is produced as a
naturally occurring constituent of fossil fuels (i.e., petroleum and coal) as well as a byproduct of
combustion of organic matter (e.g., it is generated by burning wood). Approximately 369
million Ibs. of naphthalene is consumed by the Department of Defense annually, and 1.84 billion
Ibs. of naphthalene is consumed in the US jet fuel market.
HI. Summary of Naphthalene Risk Assessments
The following is a summary of EPA's revised human health and ecological risk
assessments for naphthalene, as presented fully in the documents, Phase 4 Amendment:
Response to Comments in Reference to "Naphthalene: HED Chapter for the Reregistration
Eligibility Decision Document (RED)'" dated August 22, 2008 and Revised Ecological Risk
Assessment for Reregistration Eligibility Decision (RED) for Naphthalene, dated April 21, 2008.
These documents are available in the OPP Public Docket, docket number EPA-HQ-OPP-2008-
0343, and may also be accessed through the Agency's website at https://www.regulations.gov.
The purpose of the following summary is to assist the reader by identifying the key features and
findings of the naphthalene human health and ecological risk assessments, and to help the reader
better understand the conclusions reached in the assessments.
EPA's use of human studies in the naphthalene risk assessment is in accordance with the
Agency's Final Rule promulgated on January 26, 2006, related to Protections for Subjects in
Human Research, which is codified in 40 CFR Part 26.
A. Human Health Risk Assessment
The human health risk assessment incorporates potential exposure, hazard, and risks from
all sources, which for naphthalene are indoor and outdoor residential use. Naphthalene has no
registered food or occupational uses. The Agency's human health assessment considers all U.S.
populations, including infants and young children. For more information on the naphthalene
human health risk assessments, see Phase 4 Amendment: Response to Comments in Reference to
"Naphthalene: HED Chapter for the Reregistration Eligibility Decision Document (RED)" dated
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August 22, 2008, and Naphthalene: Phase 4 Amendment: Response to Comments In Reference
to "Naphthalene: Occupational and Residential Exposure Assessment and Recommendations for
the Reregistration Eligibility Decision Document", dated August 8, 2008.
1. Toxicity of Naphthalene
Toxicity assessments are designed to predict whether a pesticide could cause adverse health
effects in humans (including short-term or acute effects, such as skin or eye damage, and lifetime or
chronic effects, such as cancer, developmental effects, or reproductive effects), and the level or dose at
which such effects might occur. The Agency has reviewed all toxicity studies submitted for
naphthalene.
a. Acute Toxicity Profile
Naphthalene is considered slightly toxic on an acute basis by the oral and dermal routes
(Toxicity Category III). It is considered to be moderately toxic by the inhalation route (Toxicity
Category II). It is categorized also as slightly toxic for primary eye and skin irritation (Toxicity
Category III). Naphthalene did not induce delayed contact sensitivity (dermal sensitization)
when tested in guinea pigs. The acute toxicity profile for naphthalene is summarized in Table 1
below.
Table 1. Acute Toxicity Profile for Naphthalene
Guideline
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute Oral - rat
Acute Dermal
Acute Inhalation
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
Master
Record
Identification
(MRID)
257224
257229
257902
257228
257227
00148173
Results
LD50: 2649 mg/kg (#+$)
LD50>2000 mg/kg ((?+?)
LC50 > 0.4 mg/L (77.7 ppm)
((?+?)
Slight-moderate irritation
Moderate irritation
Nonsensitizer - guinea pig
Toxicity
Category"
III
III
II
III
III
N/A
a. These technical acute toxicity values included in this document are for informational purposes only. The data
supporting these values may or may not meet the current acceptance criteria.
b. Toxicological Endpoints
Based on the use pattern, the standard toxicology database for naphthalene is complete
for assessing dermal and oral exposure risks to humans. There is no reproductive study on
naphthalene, nor is one required since this is a nonfood use pesticide.
Naphthalene inhalation studies include nose-only, i.e. compound introduced directly to
the nose (4-week, 13-week, and subchronic 90-day neurotoxicity) and chamber studies (2 year)
in rodents, which involves whole body exposures. These studies indicate that naphthalene is a
nasal toxicant in rodents at low experimental concentrations. Although standard inhalation
rodent toxicity studies are available, some mechanism studies have raised the issue of notable
species differences (in regard to respiratory toxicity and metabolism) and the applicability of the
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rodent model as a default approach to estimate human risk following inhalation exposures.
There is support from published studies and ongoing research on naphthalene that indicate that
risk estimates would be considerably less than those using default procedures when known
species differences between rodents and primates (including humans) in metabolism and
respiratory toxicity are factored into the estimates. The mechanism data are not yet complete and
ongoing research, when completed, is expected to significantly refine the potential toxicity
hazard associated with human exposure to naphthalene via inhalation. At this time, dose range
and endpoints have been qualitatively characterized for the purposes of estimating human
inhalation (cancer and non-cancer) risk. See Phase 4 Amendment: Response to Comments in
Reference to "Naphthalene: HED Chapter for the Reregistration Eligibility Decision Document
(RED)" dated August 22, 2008 for additional information.
Subchronic oral toxicity of naphthalene is manifested by body weight changes, organ
weight changes and/or clinical signs of toxicity following gavage treatment to rats. In a 90-day
dermal toxicity study in the rat, effects were noted only at the high dose of 1000 mg/kg/day.
Because effects were seen only at the limit dose, dermal toxicity is not likely a concern. There
was no evidence of developmental toxicity in the rat or rabbit. The toxicological endpoints used in
the human health risk assessment for naphthalene are listed in Table 2 below.
To estimate residential (dermal and incidental oral) risk, the Agency calculates a margin
of exposure (MOE), which is the ratio of the point of departure (POD) selected for risk
assessment to the exposure. The POD is typically a No Observed Adverse Effects Level
(NOAEL) or a Lowest Observed Adverse Effects Level (LOAEL). This MOE is compared to a
level of concern (LOG), which is the same value as the uncertainty factor (UF) applied to a
particular toxicity study. In the case of the naphthalene risk assessment for acute dietary
exposure, the endpoint selected occurred following a single exposure and is relevant for all
populations, including infants and children. A UF of 1000 was applied to account for the use of
a LOAEL because there is no NOAEL (10X), in addition to the standard uncertainty factors (UF)
of 10X for intraspecies extrapolation and 10X for interspecies variation.
For chronic oral exposure, an UF of 10X has been applied to the chronic RfD to account
for extrapolation from subchronic to chronic oral exposure, in addition to the 100-fold
uncertainty factor applied to account for inter and intraspecies differences. The composite
uncertainty factor of 1000-fold would address the lack of reproductive toxicity data. The target
MOE (i.e., level of concern) for incidental oral and dermal exposures is 100 (10X for
intraspecies extrapolation and 10X for interspecies variation).
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Table 2. Toxicological Doses and Endpoints for Naphthalene for Use in Human Health Risk
Assessments
Exposure/
Scenario
Acute Dietary
All populations
including
infants and
children
Chronic Dietary
All populations
including
infants and
children
Episodic
Ingestion
(Short-term; 1-
30 days)
Point of
Departure
(POD)
LOAEL= 400
mg/kg/day
NOAEL= 100
mg/kg/day
NOAEL= 50
mg/kg/day
Uncertainty
Factors (UF)
UFA= 10X
UFH= 10X
UFL= 10X
UFA= 10X
UFH= 10X
UFS=10X
UFA= 10X
UFH= 10X
Level of
Concern for
Risk
Assessment
(LOG)
aRfD=0.4
mg/kg/day
cRfD = 0.1
mg/kg/day
MOE= 100
(residential)
Study, MRID, and
Toxicological Effects
Acute Oral Neurotoxicity Study -
Rat (44282801)
NOAEL = not identified.
LOAEL = 400 mg/kg/day based on
hunched posture in females, head
shaking in males and females, and
reduced motor activity in males and
females.
National Toxicology Program
(NTP) Subchronic Rat Study
(NTP 1980a)
NOAEL = 100 mg/kg/day
LOAEL = 200 mg/kg/day based on
significant decreases in body
weights/body weight gains.
NTP Developmental Rat Study
(NTP 1991)
NOAEL = 50 mg/kg/day
LOAEL= 150 mg/kg/day based on
maternal effects -transient clinical
signs of lethargy and slow
breathing, and significant decreases
in body weights/body weight gains
and decreased food and water
consumption.
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Table 2. Toxicological Doses and Endpoints for Naphthalene for Use in Human Health Risk
Assessments
Exposure/
Scenario
Dermal (Short-
Term; 1-30
days)
Inhalation
(Short-term; 1-
30 days)
Point of
Departure
(POD)
Dermal
NOAEL= 300
mg/kg/day
Inhalation
LOAEL
= 10 ppm or
52 mg/m3
NOAEL
= 3 ppm or
16 mg/m3
Uncertainty
Factors (UF)
UFA= 10X
UFH= 10X
N/A
Level of
Concern for
Risk
Assessment
(LOG)
MOE= 100
(residential)
N/A
Study, MRID, and
Toxicological Effects
90-Day Dermal Toxicity Study -
Rat (40021801)
NOAEL = 300 mg/kg/day
LOAEL = 1000 mg/kg/day based on
atrophy of seminiferous tubules in
males, and nonneoplastic lesions in
the cervical lymph node
(hyperplasia), liver (hemosiderosis),
thyroid thyroglossal duct cysts,
kidneys (pyelonephritis), urinary
bladder (hyperplasia) and skin
(acanthosis, hyperkeratosis) in
females.
4-Week (Nose-Only) Inhalation -
Rat (42934901)
NOAEL = 3 ppm
LOAEL = 10 ppm based increased
incidence and severity of nasal
lesions (slight disorganization,
rosette formation, basal cell
hyperplasia, erosion, atrophy, and
degenerate cells in the olfactory
epithelium; loss of bowman's
glands; respiratory epithelium
hypertrophy; rosette formation in
the septal organ of Masera and
fusion of the turbinates).
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Table 2. Toxicological Doses and Endpoints for Naphthalene for Use in Human Health Risk
Assessments
Exposure/
Scenario
Inhalation
(Intermediate-
term; 1-6
months)
Point of
Departure
(POD)
Inhalation
LOAEL
= 2 ppm or
10 mg/m3
NOAEL
= 1 ppm or
5.2 mg/m3
Uncertainty
Factors (UF)
N/A
Level of
Concern for
Risk
Assessment
(LOG)
N/A
Study, MRID, and
Toxicological Effects
13-Week (nose-only) Inhalation
Rat Study (44956401);
Subchronic (nose-only)
Neurotoxicity Rat Study
(44856401)
NOAEL = 1 ppm (Subchronic
neurotoxicity study)
NOAEL (13 week inhalation study)
- not identified.
LOAEL = 2 ppm (13 week
inhalation study) based on increased
incidence and severity of nasal
lesions (degeneration, atrophy and
hyperplasia of basal cells of the
olfactory epithelium; rosette
formation of olfactory epithelium;
loss of Bowman's glands;
hypertrophy of respiratory
epithelium).
LOAEL =10 ppm (subchronic
neurotoxicity study) based on
atrophy /disorganization of the
olfactory epithelium and hyperplasia
of the respiratory and transitional
epithelium.
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Table 2. Toxicological Doses and Endpoints for Naphthalene for Use in Human Health Risk
Assessments
Exposure/
Scenario
Inhalation
(Long-term; > 6
months)
Point of
Departure
(POD)
Inhalation
LOAEL
= 10 ppm or
52 mg/m3
Uncertainty
Factors (UF)
N/A
Level of
Concern for
Risk
Assessment
(LOG)
N/A
Study, MRID, and
Toxicological Effects
NTP ChronicToxicity and
Carcinogenicity Studies in the Rat
and Mouse (NTP 1992)
NOAEL = not identified
LOAEL (rat study) = 10 ppm based
on increased incidence and severity
of atypical (basal cell) hyperplasia,
atrophy, chronic inflammation, and
hyaline degeneration of the
olfactory epithelium; hyperplasia,
squamous metaplasia, hyaline
degeneration, and goblet cell
hyperplasia of the respiratory
epithelium; and glandular
hyperplasia and squamous
metaplasia.
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and
used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human
exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF =
uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a
NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of key
date (i.e., lack of a critical study). RfD = reference dose. MOE = margin of exposure. LOG = level of concern.
N/A = not applicable.
2. Carcinogenicity of Naphthalene
In the National Toxicology Program (NTP) chronic studies, carcinogenic effects have
been observed in both rats and mice following inhalation exposure to naphthalene. In the rat,
nasal tumors included neuroblastomas of the olfactory epithelium and adenomas of the
respiratory epithelium. There was also an increase in the incidences of adenoma of the
respiratory epithelium. The NTP concluded that "under the conditions of this 2-year inhalation
study, there was clear evidence of carcinogenic activity of naphthalene in male and female
F344/N rats based on increased incidences of respiratory epithelial adenoma and olfactory
epithelial neuroblastoma of the nose."
In the mouse study, male mice had statistically significant increased incidences of liver
adenomas, and adenomas and carcinomas combined. Female mice exhibited increased
incidences of alveolar/bronchiolar adenomas, and adenomas and carcinomas combined. The
NTP concluded that "under the conditions of this 2-year inhalation study, there was no evidence
of carcinogenic activity' of naphthalene in male B6C3F1 mice exposed to 10 or 30 ppm. There
was "some evidence of carcinogenic activity" of naphthalene in female B6C3F1 mice, based on
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increased incidences of pulmonary alveolar/bronchiolar adenomas.
The carcinogenic and noncarcinogenic potential of naphthalene is currently undergoing
review by the EPA Integrated Risk Information System (IRIS). The EPA process of regulating
pesticides allows for re-evaluation at any time if relevant new information becomes available.
Thus, when the IRIS assessment is finalized, OPP would determine whether the human health
hazard potential of naphthalene warrants revisiting.
3. Metabolites and Degradates
A number of degradates were identified in the open literature. A degradation pathway for
naphthalene was proposed, which ultimately resulted in catechol. Transitional degradates
included cis-l,2-dihydroxy-l,2-dihydronaphthalene, 1,2-dihydroxy-naphthalene, 2-
hydroxchromene-2-carboxylate (HCCA), trans-o-hydroxy-benzylidenpyruvate (tHBPA),
salicyladehyde, and salicylate. However, there are no environmental fate data for these
degradates, and therefore, exposure estimates are for parent only. For additional details, refer to
the Revised Ecological Risk Assessment for Reregistration Eligibility Decision (RED) for
Naphthalene, dated April 21, 2008.
4. Endocrine Disruption
EPA is required under the Federal Food, Drug, and Cosmetic Act (FFDCA), to develop a
screening program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other such endocrine effects as the Administrator may designate." Following
recommendations of its Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC),
EPA determined that there was a scientific basis for including, as part of the program, the androgen
and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted
EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For
pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine
whether a substance may have an effect in humans, FFDCA authority to require the wildlife
evaluations. As the science develops and resources allow, screening of additional hormone systems
may be added to the Endocrine Disrupter Screening Program (EDSP).
When additional appropriate screening and/or testing protocols being considered under the
Agency's EDSP have been developed, naphthalene may be subjected to further screening and/or
testing to better characterize effects related to endocrine disruption.
5. Dietary Risk (Water Only)
There are no agricultural or food-related pesticide uses of naphthalene; therefore, no
dietary exposure from food is expected. There is potential for drinking water exposure, since
naphthalene is registered for residential outdoor use an animal repellant.
a. Estimated Drinking Water Exposure
A Tier I aquatic exposure assessment was conducted using FIRST (FQPA Index
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Reservoir Screening Tool), which is a program that calculates acute, as well as longer-term,
estimated environmental concentration (EEC) values in surface water. FIRST considers
reduction in dissolved pesticide concentration due to adsorption of a pesticide to soil or
sediment, incorporation, degradation in soil before washoff to a water body, direct deposition of
spray drift into the water body, and degradation of the pesticide within the water body.
Given the limited use of this compound in an outdoor setting and the fact that it is applied
in a band around ornamentals, planting beds, and building perimeters as a repellent, an
adjustment to the modeled EEC was made assuming 4.1% of a typical residential lot would be
treated. The resultant FIRST EEC has been adjusted by this factor.
Two scenarios were modeled to represent both high and low use scenarios. The high use
scenario was modeled at 10.8 Ibs active ingredient/acre (ai/A) with six applications per year,
while the low use scenario was modeled at 0.56 Ibs ai/A with six applications per year. The
modeling results are summarized in Table 3.
Table 3. Results of FIRST Modeling for Naphthalene
Use Site
Ornamentals for rabbit
& dog repellent
Ornamentals for snake
repellent
Application Rate
(Ibs/acre)
10.8
0.56
Number of
Applications
(interval)
6
(2 months)
6
(2 months)
Peak
EEC
(ppb)
43.4
2.2
Annual
Average
EEC
(ppb)
6.5
0.3
Unaccounted for in this exposure assessment is the fact that naphthalene is volatile.
Given the potential volatility of this compound and the fact that the Tier I model used to estimate
exposure does not account for volatility as a route of dissipation, it is likely that the exposure
estimates derived above are over-predictions of potential exposure to naphthalene in drinking
water derived from surface water sources.
The Tier I Screening Concentration in Ground Water (SCI-GROW) model was used to
estimate naphthalene residues in groundwater. Because the EECs for groundwater residues
(ranging from 4.5 to 0.2 ppb) are lower than those for surface water, the FIRST surface water
exposure estimates are used for the drinking water risk assessment and are considered to be
protective.
b. Reference Dose
Dietary risk assessment incorporates both exposure to and toxicity of a given pesticide.
For chemicals with no food uses, such as naphthalene, acute and chronic dietary risk is expressed
as a percentage of the acute or chronic Reference Dose (RfD). The RfD is the POD (NOAEL or
LOAEL) divided by uncertainty factors (UFs). A total UF of 1000 was applied to both the acute
and chronic LOAELs to calculate the acute and chronic RfDs, respectively. To estimate risks
18
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from potential dietary exposure to naphthalene, exposure estimates are compared to the acute or
chronic RfDs. An acute or chronic exposure that is less than 100% of the acute or chronic RfD is
not of concern.
c. Dietary (Drinking Water Only) Risk Estimates
The dietary exposure and risk estimates resulting from intake of water with residues of
naphthalene were determined for the general U.S. population and all population sub-groups using
the Dietary Exposure Evaluation Model (DEEM-FCID), which uses food consumption data from
the U.S. Department of Agriculture's Continuing Surveys of Food Intakes by Individuals (CSFII)
from 1994-1996 and 1998. The screening-level acute drinking water assessment using the
DEEM-FCID Model was reported at the 95th percentile of exposure for the general U.S.
population and all of its sub-groups. It is based exclusively on the peak EEC of 43.4 ppb for all
direct and indirect drinking water sources. Risk estimates were all found to be well below the
100% acute Reference Dose (aRfD) threshold level of concern. The acute drinking water
exposure for naphthalene was estimated to be 0.0023 mg/kg/day at 0.6% of the aRfD for the
general U.S. population. The acute drinking water exposure for the most highly exposed
population subgroup, all infants, was estimated to be 0.0085 mg/kg/day at 2.1% of the aRfD.
The chronic screening-level drinking water assessment is another conservative evaluation
based exclusively on the annual average EEC of 6.5 ppb for all direct and indirect drinking water
sources. Risk estimates were all found to be well below the 100% chronic Reference Dose
(cRfD) threshold level of concern. The chronic drinking water exposure for naphthalene was
estimated to be 0.0001 mg/kg/day at 0.1% of the cRfD for the general U.S. population. The
chronic drinking water risk for the most highly exposed population sub-group, all infants, was
estimated to be 0.0004 mg/kg/day at 0.4% of the cRfD.
As previously noted, a drinking water assessment for naphthalene was carried out by the
Agency for its use as a pest repellant outdoors around the home. This screening-level assessment
relied on modeling analyses to calculate EECs for drinking water. Given the potential volatility
of this compound and the fact that the Tier I model used to estimate exposure does not account
for volatility as a route of dissipation it is likely that the EECs are overestimated. Additionally,
the dietary (drinking water only) assessment used only the high end EECs from a maximum use
rate and the resulting risk estimates, while not of concern, can be considered upper bound.
Although a number of potential water degradates have been identified, the drinking water
assessment is only for the parent compound naphthalene. There were no data on the
environmental fate of the degradates, or on the toxicity of the degradates in relation to the parent.
However, given the overall conservative nature of the water assessment it is unlikely that risks
from exposure to naphthalene in drinking water were underestimated.
Available water monitoring data, while non-targeted, indicate that naphthalene was
infrequently detected in water supplies, and those detects were usually well below the Health
Reference Level (HRL) of 140 ppb. EPA's Office of Water has concluded that the regulation of
naphthalene in drinking water is unlikely to represent a meaningful opportunity for health risk
reduction. While it is not known if detects in ambient water are from pesticide or industrial uses,
it should be noted that about 190,000 Ibs of naphthalene a year is used for outdoor pest control
19
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compared to the approximately 1.8 billion Ibs of naphthalene used for the US jet fuel market.
6. Residential (Non-Occupational) Exposure Risk
The Agency has determined that there is a potential for exposure (dermal and inhalation)
in residential settings during the application process for homeowners who purchase and use
pesticide products containing naphthalene. There is also a potential for postapplication
inhalation exposure from inhabiting indoor areas previously treated with naphthalene, as well as
potential (postapplication) episodic ingestion exposure to toddlers.
To quantitatively estimate residential risks, the Agency calculates a margin of exposure
(MOE), which is the ratio of the endpoint derived from a toxicity study (NOAEL) to the
exposure. This MOE is compared to a level of concern (LOG), which is the same value as the
uncertainty factor (UF) applied to the endpoint. For naphthalene, the uncertainty factors are 100
for both dermal and episodic ingestion exposures. A summary of naphthalene residential risk
follows. For further information on residential risk, refer to the Naphthalene: Phase 4
Amendment: Response to Comments In Reference to "Naphthalene: Occupational and
Residential Exposure Assessment and Recommendations for the Reregistration Eligibility
Decision Document,'" dated September 10, 2008.
A quantitative exposure assessment was performed for homeowners applying
naphthalene in the residential environment (dermal) and for toddler episodic (oral) ingestion of
naphthalene used for indoor/outdoor treatments. Human health risk estimates were not
calculated for postapplication inhalation scenarios because of the uncertainties associated with
extrapolating animal (rodent) data to humans as discussed previously in this document. Rather
than quantifying inhalation (cancer and noncancer) risks to humans, the levels of ambient
naphthalene measured in the human exposure study were compared directly to the levels
resulting in 1) no adverse effects in the rodent studies (NOAELs) and 2) a toxic effect in rodents
(LOAELs). This comparison provides a sense of the difference between actual naphthalene
concentrations that a human may encounter and the doses which elicit either no adverse response
or a toxic response in rodents.
a. Residential Handler Risk
The Agency determined that there is potential for exposure in residential settings during
the application process for homeowners who purchase and use naphthalene-containing products.
According to label instructions, homeowners must physically place naphthalene formulations
into indoor storage areas and around the perimeter of outdoor areas to be protected. The Agency
anticipates handler dermal and inhalation exposure during the application process. However, as
previously described, the Agency did not select an inhalation endpoint, nor is there inhalation
exposure data available to assess this handler scenario. Furthermore, data for acute (15 minute)
inhalation exposure were used in conjunction with animal studies to derive a direct comparison
for postapplication inhalation exposure to areas treated with naphthalene. The Agency assumes
that the acute postapplication inhalation assessment is protective for handler inhalation exposure.
Measured concentrations of naphthalene would likely be greater in the acute post-application
exposure scenario due to the time allotted in the exposure study (4-6 days) for the vapors of the
20
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product to accumulate in the enclosed areas that would be accessed than a handler would
experience during an application event. Therefore, only dermal handler exposure was
quantitatively assessed.
Applications of naphthalene are expected to be short-term in nature because the products
are typically applied only intermittently and usually on a seasonal basis, i.e. when storing winter
clothes or when outdoor pests are active. As a result, no intermediate-term or long-term
exposure scenarios were assessed for handlers.
Exposure data for the residential handler dermal assessment were taken from the
exposure study, "Estimation of Homeowner Exposure to LX1298-01 (Naphthalene) Resulting
from Simulated Residential Use as an Insect Repellent" (MRID 43716501). EPA determined
that this study utilized adult human subjects that were intentionally exposed, and therefore,
required review of its ethical conduct; the study has received that review, and it was concluded
that there are no regulatory barriers to EPA's reliance on this study in its actions under FIFRA.
In the study, dermal handler exposure data was derived from the result of monitoring a person
weighing out and placing mothballs in a closet and dresser at three different locations. In
addition, standard assumptions for residential applicators were used.
The residential handler dermal MOEs for both scenarios assessed (applying mothballs
and animal repellant treatments) were greater than 100 (MOE = 28,000 and 17,000, respectively)
and, therefore, are below the Agency's LOG.
b. Residential Postapplication Risk
i. Episodic Ingestion Risk
Naphthalene applications are made indoors for moth treatments and indoors/outdoors for
animal repellency. The Agency anticipates that toddlers could come in contact with naphthalene
formulations inside a treated home or in treated outdoor areas. While labels specify that indoor
moth treatments be made in airtight containers, it is assumed that a toddler could potentially
access these areas and ingest naphthalene products. Outdoor applications of naphthalene are
labeled for use around the perimeter of areas to be protected. While a toddler could potentially
access outdoor treated areas, naphthalene incident reports indicate that a large majority of
incidents for children under six years old are from ingestion of indoor products.
Inhalation and episodic ingestion routes of exposure were not combined for toddlers in
order to differentiate the occurrence of a discrete accidental event (assessed to give a worst-case
estimate of risk) from the expected daily exposure via the inhalation route. It would not be
appropriate to combine episodic exposure for comparison to a short-(or longer) term endpoint.
The Agency's standard assumptions and risk assessment procedures were used to derive
the potential dose rate of a toddler ingesting one mothball, which was then compared to the
incidental oral endpoint to calculate an MOE. In addition, the Agency estimated the amount of a
single mothball that a toddler could ingest to result in an MOE of 100.
21
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Toddler episodic ingestion of one naphthalene mothball results in an MOE < 1 and,
therefore, is of concern (LOG = 100). An oral dose of 0.5 mg/kg/day would be required to result
in an MOE of 100. This dose is equivalent to a toddler ingesting less than 1% of one mothball.
It is important to note that the episodic ingestion MOE is calculated from an endpoint
derived from a developmental oral rat study in which dams were repeatedly treated with a high
oral bolus dose and the resulting clinical signs (lethargy and slow breathing) and body weight
decrement were transient. The effects were attributed to the administration of a high bolus and
were not permanent; the animals displayed quick recovery. There were no persistent effects or
treatment-related deaths. While the episodic ingestion of naphthalene by a toddler results in an
MOE below the LOG, and does represent an exposure concern, the effects of this type of
exposure, if any, are not expected to be severe. The study results are consistent with what might
be inferred from the incident reports, which are described in more detail below.
ii. Inhalation (Cancer and Noncancer) Risk
The Agency has determined that there is potential for inhalation exposure to adults and
children from naphthalene applications made indoors for moth treatments and animal repellency,
and to a lesser extent, outdoors for animal repellency. While labels specify that treated indoor
areas should be airtight to be effective, the Agency anticipates that naphthalene will volatilize
and be inhaled by adults accessing treated areas (i.e., containers, dresser drawers, closets, etc.)
and by adults and children that inhabit treated areas exposed to ambient concentrations of
naphthalene. Exposures from accessing treated areas are expected to be acute (approximately 15
minutes) in duration, and exposures from inhabiting treated areas are short-(6 months) in duration.
As previously described, there is support from published studies and ongoing research on
naphthalene that indicate that risk estimates, factoring in known species differences between
rodents and primates (including humans) in metabolism and respiratory toxicity, would be
considerably less than those using default procedures. Therefore, rather than quantifying
inhalation risks to humans, the levels of ambient naphthalene measured in the human exposure
study were compared directly to the levels resulting in a 1) no adverse effects in the rodent
studies (NOAELs) and 2) a toxic effect in rodents (LOAELs). This comparison provides a sense
of the difference between actual naphthalene concentrations that a human may encounter and the
doses which elicit either no adverse response or a toxic response in rodents.
Anticipated acute and short-term exposures were calculated using standard assumptions
and the results of the aforementioned naphthalene exposure study (MRTD 43716501). The 15
minute (acute) and 24 hour (short-term) samples resulted in average concentrations of 0.85 and
0.66 mg/m3 of naphthalene, respectively. These values were compared directly to the animal
LOAEL (10 ppm or 52 mg/m3) and NOAEL (3 ppm or 16 mg/m3) selected for acute and short-
term exposure durations.
Estimated acute and short-term exposures to naphthalene in residences are 20X and 3OX,
respectively, below the rodent dose resulting in no adverse effects (NOAEL). Anticipated acute
and short-term exposures to naphthalene in residences are 60X and SOX, respectively, below the
rodent dose resulting in respiratory toxicity, specifically olfactory epithelium lesions (LOAEL).
22
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Anticipated intermediate- and long-term exposures were also calculated using standard
assumptions; however, because of the lack of a naphthalene-specific study of an appropriate
duration, a different exposure study was used to assess these durations of exposure ("Polycyclic
Aromatic Hydrocarbon Exposure of Children in Low-Income Families, Chuang et al., 1999").
This study was reviewed for its ethical conduct, and it was concluded that it does not meet the
regulatory definition of research involving intentional human exposure. Therefore, it is not
required to undergo ethical review and that there are no regulatory, ethical, or policy barriers to
using this study for risk assessment. The study was conducted to observe exposures to
poly cyclic aromatic hydrocarbons (PAHs), including naphthalene, inside of 24 homes from air,
dust, soil, and food. This study is not specific to intermediate- or long-term exposure durations,
nor does naphthalene necessarily originate from a mothball source; however, it has been
identified as the best available data source to account for naphthalene volatilization and
dissipation over time. Due to the uncertainty associated with the use of an exposure study which
is not specific to the duration assessed, the Agency selected the most conservative exposure
value (i.e., maximum concentration observed) to represent intermediate- and long- term exposure
levels. During reregi strati on for naphthalene, a Data Call-In will be issued requiring a
confirmatory chamber study to determine levels of naphthalene in the air resulting from use of
mothballs at the maximum label rate.
The indoor ambient samples which pertain to the air concentrations of naphthalene
resulted in a maximum level of 0.0097 mg/m3. This exposure value was directly compared to the
animal LOAEL for olfactory epithelium lesions selected for intermediate- (2 ppm or 10 mg/m3
identified in a nose-only study) and long-term (10 ppm or 52 mg/m3 identified in an exposure
chamber study) durations, as well as to the NOAEL selected for the intermediate-term duration
(1 ppm or 5.2 mg/m3). A NOAEL was not identified for long-term inhalation exposure.
Intermediate- and long-term exposures to naphthalene in residences are 1000X and
5400X, respectively, below the animal dose (LOAEL) resulting in respiratory toxicity (olfactory
epithelium lesions) and intermediate-term exposure is 540X below the animal dose NOAEL.
The long-term duration was not assessed since a NOAEL was not identified.
Generally, in the absence of information on kinetics/dynamics, it is assumed that humans
may be 10 times more sensitive than animals (10X interspecies factor). The current research
indicates that primates, thus humans, are less sensitive than rodents because of differences in the
rate of bioactivation of naphthalene as well as anatomical and physiological differences in the
nose and respiratory tract. These critical differences between primates and rodents have not been
accounted for in this assessment. Thus, with consideration of differences in dosimetry and
species metabolism of naphthalene, the margins of exposure for human inhalation risk
assessment are likely larger than the differences calculated here between the rodent NOAELs
and LOAELs and the measured ambient naphthalene levels from the best available exposure
study.
Studies determining the differences in nasal metabolism of naphthalene between rodents
and primates are part of ongoing research. There are no data to indicate that humans have a
slower rate of clearance, but if they did, then there would be a longer time for humans to produce
23
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the active metabolite. These issues are being addressed in current pharmacokinetic research.
7. Aggregate Risk
An aggregate risk assessment for all expected routes of exposure was not performed as
there is no common toxicity among all the routes of exposure. A short-term aggregate risk
assessment could be performed by combining short-term incidental oral exposure and
average/background dietary (in this case drinking water) exposures. However, a short-term
aggregate risk assessment was not performed for naphthalene since the short-term incidental oral
exposure risk estimate alone exceeds the LOG, and combining with other routes of exposure
would only further exceed the LOG.
8. Occupational Risk
Naphthalene pesticide products are not registered for occupational use and, therefore
occupational exposure to the pesticidal uses of naphthalene is not anticipated and has not been
assessed
9. Human Incident Data
Four databases were consulted for poisoning incident data on naphthalene for the period
of 1993 to 2005. These include: OPP Incident Data System (IDS), Poison Control Centers
(PCC), California Department of Pesticide Regulation, and National Institute of Occupational
Safety and Health's Sentinel Event Notification System for Occupational Risks (NIOSH
SENSOR). A summary of the findings from the "Review of Naphthalene Incident Reports, "
dated June 25, 2007 is as follows:
• Naphthalene produces a disproportionately high number of exposure incidents when
compared to the composite average of exposure incidents reported for all other pesticides.
This pattern observed in the combined population (occupational, non-occupational,
children) is largely due to the frequency of reported incidents among children less than 6
years;
• Exposure to children is much higher than a typical pesticide;
• Naphthalene PCC data show average results of about 1647 exposures/year, 133
symptomatic cases/year, and 310 cases/year seen in a heath care facility;
• No apparent annual trend is evident in the 13 year-span of data collected, as the number
of reported incidents/year has remained relatively stable;
• NIOSH/SENSOR data indicate that indoor uses of naphthalene are responsible for a large
number of cases; and
• The large majority of incidents for children under 6 years of age were from ingestion of
mothball products used indoors.
Reported incidents of naphthalene ingestion among children account for the majority of
reported exposures, and occur with much greater frequency than for most other pesticides. This
may be attributed to the widespread use of naphthalene products in homes and the ease of
accessing the product as it is applied as loose mothballs. The severity of the reported incidents
24
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are much lower than for other pesticides as a whole. From a 13-year period of PCC data,
approximately 7% of naphthalene incidents in children resulted in any symptoms at all, and less
than 1% had moderate or major symptoms. Symptoms that did occur (both adults and children;
all routes of exposure) were not life-threatening and include nausea, vomiting, headache,
dizziness, drowsiness/lethargy, eye irritation, respiratory irritation, and dermal edema and
erythema.
B. Environmental Risk Assessment
Indoors, naphthalene is used principally as mothballs, and this use is not considered likely
to result in exposure to non-target organisms (other than humans), and therefore, is not
considered in the ecological risk assessment. It is also used indoors in attics as an animal
repellant (e.g., Chaperone Squirrel and Bat Repellent), and while there is potential for exposure
to animals from this use, it only affects pest species trying to enter homes. Currently, four
registered naphthalene products include outdoor uses. These products are formulated as flakes or
granules, and are applied in a band around ornamentals, planting beds and gardens as an animal
repellent. The following is a summary of EPA's revised ecological risk assessment for
naphthalene, as presented fully in the Revised Ecological Risk Assessment for Reregistmtion
Eligibility Decision (RED) for Naphthalene, dated April 21, 2008. This document is available in
the OPP Public Docket, docket number EPA-HQ-OPP-2008-0343, and may also be accessed
through the Agency's website at https://www.regulations.gov.
For naphthalene, ecological risk was assessed to determine the potential for acute effects
(i.e., lethality) to mammals, birds, fish and invertebrates using screening-level risk assessment
models. Risk was assessed for the treated site for birds and mammals, and in an adjacent pond
for freshwater fish and invertebrates. Ecotoxicity data on sublethal (e.g., reproductive, growth)
effects were not available, so chronic risk was not addressed.
To estimate potential ecological risk, EPA integrates the results of exposure and ecotoxicity
studies using the risk quotient method. A risk index (RQ or LDso/ft2) is calculated by dividing
acute estimated environmental concentrations (EECs) by ecotoxicity values for various wildlife
species. The LD50/ft2 (for terrestrial animals) or RQ (for aquatic animals) is then compared to
the Agency's Levels of Concern (LOCs), which serve as criteria for categorizing potential risk to
non-target species. At the screening level, the Agency presumes that there is not an
unreasonable risk for a particular category if the risk quotient is below the LOG. If calculated
RQs exceed the LOG, the Agency presumes that there is a potential for risk in that category. See
Table 4 below for the Agency's ecological LOCs. Risk characterization provides further
information on potential adverse effects and the possible impact of those effects by considering
the fate of the chemical and its degradates in the environment, organisms potentially at risk, and
the nature of the effects observed.
25
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Table 4. EPA's Ecological Levels of Concern (LOCs) and Risk Presumptions
If a calculated RQ is greater than the LOG presented, then the Agency presumes
that...
Acute Risk . . .there is potential for acute risk; regulatory action may be warranted in
addition to restricted use classification
Acute Endangered Species ...endangered species may be adversely affected
Chronic Risk . . .there is potential for chronic risk
LOC
terrestrial
animals
0.5
0.1
1
LOC
aquatic
animals
0.5
0.05
1
LOC
plants
1.0
1.0
NA
1. Environmental Fate and Transport
There are no acceptable fate studies for naphthalene. A single supplemental study has
been provided which summarizes open literature data on adsorption/desorption and aerobic soil
metabolism data (MRID 45346801). Other fate parameters needed to conduct the ecological
assessment have either been extrapolated from the open literature data (e.g., aerobic aquatic
metabolism half life) or conservatively assumed to be stable (photolysis and hydrolysis). The
lack of these data provides uncertainty to this assessment. Elimination of this uncertainty would
require submission of additional data for these fate processes. However, the data used in the
assessment are sufficient to allow evaluation of potential risk, and no additional environmental
fate data are needed for current outdoor uses of naphthalene.
Open literature data indicated that the solubility of naphthalene ranged from 30 to 31.7
mg/L and that the Koc ranged from 200 to 1470 for a variety of soils from North America,
Europe and China. The study citation concluded that naphthalene was bound relatively rapidly
to soils with a sustained desorption over days to weeks. For biodegradation, naphthalene
degraded with aerobic soil metabolism half-lives between 3.5 and 40 days with no appreciable
degradation under anaerobic conditions. Possible dissipation processes affecting naphthalene
include volatilization, bioaccumulation, adsorption, and leaching. Volatilization is the method
by which naphthalene is effective as an animal repellant. Data suggest that once in air,
naphthalene should degrade or dissipate rapidly. Naphthalene principally dissipates via direct
sublimation from granules, but data suggests that if naphthalene does enter soil, up to 30% of
loss from soil can occur due to volatilization.
Additional open literature data describe both aerobic soil degradation and adsorption
values that are consistent with values described above, although under certain conditions
degradation from soil may be somewhat longer. In addition, these data suggest that naphthalene
degrades rapidly by aqueous photolysis. The data also suggest that under certain conditions
naphthalene dissipates rapidly from open water systems, although it is unclear whether the
dissipation observed was due to degradation or lumped dissipation processes including transport
out of the systems by flowing water. Finally, these data confirm that naphthalene is relatively
stable under anaerobic conditions.
A number of transformation products were identified in the various open literature
studies. The study author proposed a degradation pathway for naphthalene, which ultimately
resulted in catechol. Transitional transformation products included cis-l,2-dihydroxy-l,2-
dihydronapthalene, 1,2-dihydroxy-napthalene, 2-hydroxchromene-2-carboxylate (HCCA), trans-
26
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o-hydroxy-benzylidenpyruvate (tHBPA), salicyladehyde, and salicylate. There are no registrant
submitted environmental fate data on these degradation products that would allow for an
approximation of environmental fate inputs, the available open literature data are sparse, and
there are no available toxicity data for these compounds. Therefore, these degradates were not
quantitatively assessed in the exposure assessment, and risk estimates are based on the parent
only.
2. Terrestrial Organisms
a. Exposure
Naphthalene's outdoor products are formulated as flakes or granules, and are applied in
bands 1 to 12 inches wide around ornamental plants, gardens, or building perimeters (snake
products only). For birds and rabbits, naphthalene products are formulated with 100%
naphthalene ai. This is roughly equivalent to an application rate of 10.8 Ibs ai/A. Snake
repellant products consist of 7% naphthalene (i.e. 0.56 Ibs ai/A). For modeling purposes,
granules are used as a surrogate for flakes. The Tier-1 model, T-REX (Terrestrial Residue
Exposure), was used to estimate terrestrial exposure and risk values for naphthalene. Input
values on avian and mammalian toxicity, as well as chemical application and foliar dissipation
half-life data, are required to run the model. A default dissipation half-life of 35 days was
assumed. The LD50/ft2 is used to estimate risk for granular formulations through row and banded
applications. The appropriate T-REX input parameters were selected from the product labels.
For the method of application using granules (or flakes), one row length of 209 feet with a 1-foot
bandwidth and 0% incorporation was assumed. These parameters are summarized in Table 5
below. Since naphthalene is used only as a granular or flake application, exposures to animals
foraging on food items with naphthalene residues (short and tall grass, broadleaves, seeds) are
not estimated in this assessment.
Table 5. Input Parameters for T-REX Analysis
Application
Type
Rows/Band
Formulation
Granular
Input
Number of
Row,
Length
Band width
Guidance
Row spacing is the amount
of space (inches) between
crop rows and is obtained
from the product label.
Bandwidth is the width of
the applied pesticide row
(inches) and is obtained
from the product label.
Comments
Only one row was assumed.
A row length of 209 foot
was used assuming
application occurs on one
side of a one-acre field.
A 12 inch bandwidth was
obtained from the Dr. T's
Snake-A-Way label
(registration #58630-1),
which is the greatest labeled
bandwidth.
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Table 5. Input Parameters for T-REX Analysis
Application
Type
Formulation
Input
%
Incorporated
Weight of
granule
Guidance
Value depends on the
method of application:
T-Banded - covered with
specified amount of soil:
99% In-furrow, drill, or
shanked-in: 99%
Side-dress, banded, mix, or
lightly incorporate with soil:
85%
Broadcast, mix, or lightly
incorporated: 85%
Side-dress, banded,
unincorporated: 0%
Broadcast, aerial broadcast,
unincorporated: 0%
Estimated from data
obtained from registrant
Comments
Not incorporated according
to labels.
38 me
JO lllg
b. Toxicity
Effects characterization describes the potential effects a pesticide can produce in an
organism, and is generally based on registrant-submitted studies or studies found in the open
literature which describe acute and chronic toxicity effects for various animals. Table 6
summarizes the toxicity effects and reference values used to assess risks for naphthalene to
terrestrial organisms.
Table 6. Toxicity of Naphthalene to Terrestrial Animals and Plants
Taxon
Bird
Mammal
Beneficial
insects
Soil
Invertebrates
Test Organism
Bobwhite quail
Colinus virginianus
Mallard duck
Anas platyrhynchos
Rat
Rattus norvegicus
Honey bee
Apis mellifera
Folsomia Candida
Enchytaeus crypticus
Test Type
Acute Oral
Subacute Dietary
Subacute Dietary
Acute Oral
Acute Contact
Chronic Effects
on Soil
Invertebrates
(reproduction
and survival)
Endpoint
LD50
LC50
LCso
LD50
LD50
NOAEC
LOAEC
NOAEC
LOAEC
Value
2690 mg/kg bw1
>5620 mg/kg diet
No data
2649 mg/kg bw
No data
88 umol/kg soil
409 umol/kg soil
220 umol/kg soil
2045 nmol/kg soil
Ecotoxicity
Category
Practically nontoxic
Practically nontoxic
Not available
Practically nontoxic
Not available
None
None
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Table 6. Toxicity of Naphthalene to Terrestrial Animals and Plants
Taxon
Terrestrial
plants
Test Organism
Monocots and dicots
Test Type
Seedling
emergence and
Vegetative vigor
Endpoint
EC25
NOAEC
LOAEC
Value
No data
Ecotoxicity
Category
Not available
1. Body weight
c. Risk to Terrestrial Organisms
i. Birds
At a rate of 10.8 Ibs ai/A, risk estimates for birds of all the weight classes, exceed the
Agency's LOG. However, naphthalene is a repellent and it is manufactured to ensure that birds
will avoid the naphthalene products (e.g., Dr.T's Rabbit, Squirrel, Bat, and Bird Repellent, reg. #
58630-2).
Although it may be unlikely that birds will consume naphthalene granules, since it is not
formulated as an attractant but as a repellent to terrestrial animals and is comprised of granules
with a strong odor of coal tar, it is uncertain if the repellent nature of the compound will be
sufficient to keep birds away entirely. Therefore, further steps were taken to characterize the
potential for acute risk to avian species by evaluating how many granules a bird would need to
ingest in order to trigger the Agency's LOG; these estimates are presented in Table 7.
Table 7. Estimate of the number of granules ingested to reach an EEC exceeding the adjusted
LD50 LOC for birds at 10.8 Ibs ai/A
No. of Consumed Granules Required
Adjusted LD50
Acute Risk LOC (0.5)
Endangered Species LOC (0.1)
Bird Size (grams)
20
1
0.51
0.1
100
7
4
0.65
1000
92
46
10
EEC = 1 12.46 mg/square feet (excluding row spacing, bandwidth, and # of rows input parameters).
While the Agency believes it is unlikely that birds will consume naphthalene, it is
possible that a bird might accidentally ingest it, and if that occurs, the screening-level assessment
indicates that a small bird (20 g) will exceed the Agency's LOC at 1 granule if eating
avian/mammalian repellant product. These risk estimates assume that birds eat granules
containing 100% ai immediately following application, before loss of naphthalene to
sublimation. One of the outdoor formulations of naphthalene, "Dr. T's Snake-A-Way", consists
of granules that contain 7% naphthalene ai; therefore, a bird would have to consume over 14
times more of the snake repellant granules to exceed an LOC.
Because no toxicity data are available on avian reproductive risk, the Agency was unable
to assess chronic risk to birds.
29
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ii. Terrestrial-phase Amphibians and Reptiles
The Agency currently uses data on surrogate species, birds, to assess risk to non-target
terrestrial-phase amphibians and reptiles. Based on the evaluation of potential risks to birds,
potential risks to reptiles and terrestrial-phase amphibians are also higher than the Agency's
levels of concern. However, naphthalene is a repellent and it is formulated to repel reptiles (e.g.,
Dr. T's Snake-A-Way).
iii. Mammals
The acute risk estimates (LDso/ft2) to terrestrial mammals, as a result of the assessed uses
of naphthalene at 10.8 and 0.56 Ibs ai/acre exceed the LOCs for acute risk and endangered
species. As for birds, the risk estimates are based on a granular formulation.
Table 8. Mammalian LD50/ft2 (RQs) from Direct Ingestion of Naphthalene Granules
Weight Class
LD50/ft2A
LOCs Exceeded
10.8 Ib ai/A - EEC/Toxicity (adjusted mg/ft2 / adjusted LD50)
15 g
35 g
1000 g
268.18
142.05
11.49
Acute Risk, Endangered Species
Acute Risk, Endangered Species
Acute Risk, Endangered Species
0.56 Ib ai/A - EEC/Toxicity (adjusted mg/ft2 / adjusted LD50)
15 g
35 g
15 g
13.91
7.37
13.91
Acute Risk, Endangered Species
Acute Risk, Endangered Species
Acute Risk, Endangered Species
A Mammal LD50 = 2649 mg/kg
Curently, T-REX does not have the capacity to estimate the minimum foraging area needed
to allow for direct ingestion of sufficient mass of naphthalene to achieve a dose that exceeds the
LOG for mammals. However, naphthalene is a repellent and it is manufactured to ensure that
mammals will avoid the naphthalene flakes (e.g., Chaperone Squirrel and Bat Repellent, reg. #
2724-685).
Because no toxicity data is available on mammalian reproductive risk, the Agency was
unable to assess chronic risk to mammals.
iv. Non-Target Insects
EPA does not estimate RQs for terrestrial non-target insects. Furthermore, the Agency has no
insect toxicity data for naphthalene.
v. Terrestrial Plants
The Agency currently uses terrestrial plant data to estimate potential risks to non-target
terrestrial plants from surface water runoff. Some naphthalene labels state that the products
should not be applied directly to foliage or stems. This statement indicates that there is a
possibility of phytotoxicity. In addition, open literature suggests that naphthalene is selectively
30
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phytotoxic to plants. However, terrestrial plant studies have not been submitted for naphthalene,
nor has data been located in published literature. Therefore, the potential risks to terrestrial
plants are unknown.
3. Aquatic Organisms
a. Exposure
Risk to aquatic animals was assessed using Generic Estimated Environmental
Concentration (GENEEC2), a Tier 1 model that estimates concentrations in a 1-hectare, 2-meter-
deep water body adjacent to a 10-hectare treated site that drains into the water body. Since there
are no liquid outdoor use formulations of naphthalene and granular applications are assumed, this
water body is also assumed to receive no drift from the treated site. The model assumes an area
is 100% treated. Given the limited size of the outdoor area treated (it is applied in a band around
ornamentals, planting beds and gardens) an adjustment of 4.1% to the modeled EEC was made to
account for the use pattern.
Two scenarios were modeled to represent high and low naphthalene use scenarios. The
high use scenario was modeled at 10.8 Ibs ai/A with six applications per year, while the low use
scenario was modeled at 0.56 Ibs ai/A with six applications per year. The EECs are summarized
in Table 9.
Table 9. Results of GENEEC2 Modeling for Naphthalene Use on Ornamentals
Use Site
Ornamentals for
rabbit & dog
repellent
Ornamentals for
snake repellent
Application
Rate
(Ibs/acre)
10.8
0.56
Number of
Applications
(interval)
6
(2 months)
6
(2 months)
Peak
EEC
(ppb)
26.9
1.4
4 day
EEC
(ppb)
26.6
1.4
21 day
EEC
(ppb)
25.2
1.3
60-day
EEC
(ppb)
22.4
1.2
90-day
EEC
(ppb)
20.5
1.1
Unaccounted for in this exposure assessment is the fact that naphthalene is volatile. No
product chemistry data are available, but an estimate of the vapor pressure was made using
EpiSuite (http://www.epa.gov/opptintr/exposure/pubs/episuite.html). EpiSuite reported an
experimentally derived value for vapor pressure of 8.5 xlO"2 mm Hg (which is consistent with
the registrant reported value of 10.5 Pa, or 7.8 x 10"2 mm Hg), suggesting that naphthalene is
volatile. Given the volatility of this compound and the fact that the Tier I model used to estimate
exposure does not account for volatility as a route of dissipation, it is likely that the exposure
estimates derived above are over-predictions of potential exposure. However, it is unknown
from the open literature data used in this assessment whether the systems were closed or flow-
through. If the aerobic metabolism data (and hence the half-life used in this assessment) were
flow-through, then the degradation reported would include volatilization as a process.
It is possible that naphthalene may leach to groundwater. An overview of US Geological
Survey (USGS) National Water-Quality Assessment Program (NAWQA) groundwater data
indicates that of6,977 samples only 37 detections of naphthalene were found. While the
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maximum concentration detected was 70 ppb, there are a number of possible sources of
naphthalene contamination of groundwater, including many with significantly higher usage (e.g.,
petroleum, jet fuel). Thus it appears that leaching is not likely a significant route of exposure for
the pesticidal use of naphthalene. Potential groundwater leaching was assessed using SciGrow,
and a concentration of 16.3 ppb at the highest application rate (10.8 Ibs ai/A x 6 applications)
and 0.84 ppb at the lowest rate (0.56 Ibs ai/A x 6 applications) was estimated. These values are
below the surface water concentrations predicted by GENEEC2, are lower than the NAWQA
values described above, and assume a much broader area of application than anticipated for this
use pattern (bands surrounding gardens and planting beds). Given the lines of evidence
described, it is expected that as an exposure route for ecological risk assessment, naphthalene in
groundwater resulting from pesticidal use is minimal.
Unlike the drinking water assessment described in the human health risk assessment
section of this document, the exposure values used in the ecological risk assessment do not
include the Index Reservoir (IR). These factors represent a drinking water reservoir, not the
variety of aquatic habitats relevant to a risk assessment for aquatic animals, such as ponds
adjacent to treated fields. Therefore, the EEC values used to assess exposure and risk to aquatic
animals are not the same as those used to assess exposure and risk to humans from pesticides in
drinking water.
b. Toxicity
Available freshwater and estuarine/marine fish and invertebrate acute toxicity data
suggest that naphthalene is moderately toxic to most aquatic test species (Table 10). Chronic
freshwater fish reproduction data indicates that survival and growth are affected. Aquatic plant
growth studies with green algae were less sensitive than animals, and naphthalene is categorized
as slightly toxic to green alga. No toxicity study with aquatic vascular plants is available for this
ecological risk assessment.
Table 10. Toxicity of Naphthalene to Aquatic Organisms and Plants
Taxon
Freshwater
Fish
Freshwater
Invertebrate
Test Organism
Rainbow trout
Onchorhynchus mykiss
Bluegill sunfish
Lepomis macrochims
Coho salmon
Oncorhynchus kisutch
Water flea
Daphnia magna
Endpoint
96-hr LC50
NOAEC (mortality)
NOAEC (sublethal)
96-hr LC50
NOAEC (mortality)
NOAEC (sublethal)
40D NOAEC
40D LOAEC
48-hr EC50
NOAEC (mortality)
NOAEC (sublethal)
Value1
(mg a.i./L)
2.0
0.86
0.86
3.2
1.4
1.4
0.37
0.67
1.6
0.48
>8.8
Ecotoxicity
Category
Moderately Toxic
Moderately Toxic
None
Moderately Toxic
32
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Table 10. Toxicity of Naphthalene to Aquatic Organisms and Plants
Taxon
Estuarine/
Marine
Fish
Estuarine /
Marine
Invertebrates
Vascular
Plant
Non-vascular
Plant
Test Organism
Fathead minnow
Pimephales promelas
Pacific oyster
Crassostrea gigas
Grass shrimp
Palaemonetes pugio
Duckweed
Lemna gibba
Green algae
Chlorella vulgaris
Endpoint
96-hr LC50
NOAEC (mortality)
NOAEC (sublethal)
Chronic NOAEC
Chronic LOAEC
96-hr EC50
NOAEC (mortality)
NOAEC (sublethal)
96-hr LC50
NOAEC (mortality)
NOAEC (sublethal)
7-day EC50
NOAEC
48-hr EC50
NOAEC
LOAEC
Value1
(mg a.i./L)
6.6
NR
NR
0.62
NR
199
NR
NR
2.35
NR
NR
No data
33
NR
NR
Ecotoxicity
Category
Moderately Toxic
None
Practically Nontoxic
Moderately Toxic
No Data
Slightly Toxic
folded values indicate toxicity thresholds used to calculate risk quotients.
c. Risk to Aquatic Organisms
RQs for naphthalene do not exceed the acute LOG for aquatic animals and aquatic
nonvascular plants (i.e., fish, aquatic-phase amphibians, invertebrates, and algaes) when used at
six applications, 60 days apart, at the highest application rate (10.8 Ibs ai/A). Therefore, minimal
acute risk is also expected from the lower application rate (0.56 Ibs ai/A). Risks to aquatic
vascular plants are also unknown due to lack of ecotoxicity data. Aquatic organism risk
estimates based on the maximum application rate are presented in Table 11 below.
Table 11. Risks to Aquatic Animals and Plants for Naphthalene Use on Ornamentals
Taxon
Freshwater Fish
Freshwater
Invertebrate
Marine/estuarine
Fish
Species
Rainbow trout
Onchorhynchus
mykiss
Coho salmon
Oncorhynchus
kisutch
Water flea
Daphnia magna
Fathead minnow
Pimephales
promelas
Toxicity Endpoint
96-hrLC50 = 2.0mg/L
(or 2000 ug/L)
40-day NOAEC = 0.37 mg/L
(or 370 ug/L)
48-hr LC50= 1.6 mg/L
(or 1600 ug/L)
LC50 = 6.6 mg/L
(or 6600 ug/L)
NOAEC = 0.62 mg/L
(or 620 ug/L)
EEC
(ug/L)
26.9 (peak)
22.4 (60D)
26.9 (peak)
26.9 (peak)
22.4 (60D)
RQ1
0.013
0.06
0.017
O.01
0.04
LOCs
Exceeded2
None
None
None
None
None
33
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Table 11. Risks to Aquatic Animals and Plants for Naphthalene Use on Ornamentals
Taxon
Marine/estuarine
Invertebrate
Vascular Plant
Freshwater Non-
Vascular Plant
Species
Grass shrimp
Palaemonetes
pugio
Duckweed
Lemna gibba
Green Algae
Chlorella
vulgaris
Toxicity Endpoint
LC50 = 2.35 mg/L
(or 2350 ug/L)
No data
EC50=33mg/L
(or 33000 ug/L)
EEC
(ug/L)
26.9 (peak)
26.9 (peak)
26.9 (peak)
RQ1
0.01
LOCs
Exceeded2
None
Not available
O.01
None
1 Acute risk quotients= EEC/LC50; Chronic Risk Quotients =EEC/NOAEC.
2 Aquatic animal acute LOG: >0.05 for endangered species and >0. 5 for non-listed species; LOG for aquatic
plants: >1; Chronic LOG for aquatic animals: >1.
d. Endangered Species
The acute risk to birds, terrestrial-phase amphibians and reptiles, and mammals exceed
the endangered species LOG, and therefore there is a potential for direct effect to these taxa. In
addition, there is a potential for indirect effects to species that depend on them. The data are
currently insufficient to determine if there is a potential for direct or indirect effect to terrestrial
or aquatic plants. Naphthalene is not likely to affect aquatic animals (fish or invertebrates)
directly; the potential for indirect effects depends on whether naphthalene could affect semi-
aquatic or aquatic plants.
e. Ecological Incidents
A search of the EIIS (Environmental Incident Information System) database for ecological
incidents (run on May 31, 2007) identified one ecological incident involving naphthalene. The
incident reported includes possible impact to fish. See table 12 for further detail.
The number of documented kills in EIIS is believed to be a very small fraction of total
mortality caused by pesticides for a variety of reasons. An absence of reports does not
necessarily equate to an absence of incidents given the nature of incident reporting.
Table 12. Naphthalene Ecological Incident
Formulation
Unknown
Crop
N/A
Date and
Location
May 2003,
Craven Co., NC
Species
Affected
Unknown fish
Number
Found
2,000
Residue
Analysis
No
App. Rate, Method,
etc.
Treated directly
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
34
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ingredient are eligible for reregi strati on. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support reregi strati on
of products containing naphthalene as the active ingredient. The Agency has completed its
review of these generic data, and has determined that the data are sufficient to support
reregi strati on of all products containing naphthalene.
The Agency has completed its assessment of the human health and ecological risks
associated with the use of pesticide products containing naphthalene. The Agency has
determined that naphthalene-containing products are eligible for reregi strati on provided that
label amendments are made as outlined in Chapter V. Appendix A summarizes the uses of
naphthalene that are eligible for reregi strati on. Appendix B identifies the generic data the
Agency reviewed as part of its determination of reregi strati on eligibility of naphthalene, and lists
the submitted studies that the Agency found acceptable.
Based on its evaluation of naphthalene, the Agency has determined that products
containing naphthalene, unless labeled and used as specified in this document, would present
risks inconsistent with FIFRA. Accordingly, should a registrant fail to implement any of the risk
mitigation measures identified in this document, the Agency will take regulatory action to
address the risk concerns from the use of naphthalene. If all changes outlined in this document
are incorporated into the product labels, then all current risks for naphthalene will be adequately
mitigated for the purposes of this determination under FIFRA.
B. Public Comment Period
Through the Agency's public participation process, EPA worked with stakeholders and
the public to reach the regulatory decision for naphthalene. EPA released the naphthalene
preliminary risk assessments for public comment on May 14, 2008, for a 60-day public comment
period (Phase 3 of the public participation process). During the public comment period on the risk
assessments, which closed on July 14, 2008, the Agency received comments from registrants
(technical and end use), Honeywell, and the Naphthalene Council. These comments in their
entirety, responses to the comments, as well as the preliminary and revised risk assessments, are
available in the public docket (EPA-HQ-OPP-2008-0343) at http:www.regulations.gov. In brief,
the comments included the following:
• Landis International, the agent for the technical registrant (Reochem, Inc.), agrees to
conduct the required exposure study (Guideline 875.2500).
• An end use registrant, Willert Home Products, suggested that 1) packaging is not
necessary to reduce potential risk from episodic ingestion of mothballs, since the
symptoms described in incident reports are not severe in nature; and 2) the aquatic
exposure modeling overestimates the amount of naphthalene product typically applied.
• Honeywell International Inc. stated that the carbon adsorption coefficient used in the
ecological risk assessment was unreasonably low and thus led to an unrealistically high
estimate of the risks naphthalene poses to drinking water.
35
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C. Regulatory Position
1. Regulatory Rationale
The Agency has determined that products containing naphthalene are eligible for
reregi strati on provided that specified label amendments are made. The following is a summary
of the rationale for managing risks associated with the use of naphthalene. Where labelling
revisions are warranted, specific language is set forth in the summary table of Section V.
a. Dietary Risk
There are no agricultural or food uses of naphthalene; therefore, no dietary exposure from
food is expected. However, there is potential for drinking water exposure from the outdoor uses
of naphthalene. The acute and chronic risk estimates were found to be well below the 100%
Reference Dose (RfD) level of concern. Overall dietary exposure to naphthalene via drinking
water is expected to be insignificant, and thus, no mitigation measures are required.
b. Residential Risk
Handlers
For residential risk, the MOEs for all handler scenarios assessed were 17,000 or greater,
which is greater than the Agency's MOE of 100, and therefore, no mitigation measures are
required.
Episodic Ingestion
Toddler episodic ingestion of one naphthalene mothball results in an MOE < 1 (LOG =
100). While this represents an exposure concern, the effects of this type of exposure, if any, are
not expected to be severe. The episodic ingestion MOE is calculated from an endpoint derived
from a developmental oral rat study in which dams were repeatedly treated with a high oral bolus
dose, and the resulting clinical signs (lethargy and slow breathing) and body weight decrement
were transient. The effects were attributed to the administration of a high bolus and were not
permanent; the animals displayed quick recovery. There were no persistent effects or treatment-
related deaths.
The study results are consistent with symptoms described in the incident reports.
Reported incidents of naphthalene ingestion among children account for the majority of reported
naphthalene exposures. This may be attributed to the widespread use of naphthalene products in
homes and the ease of accessing the product as it is applied as loose mothballs. The severity of
the reported incidents are much lower than for other pesticides as a whole. From a 13-year
period of PCC data (1993-2005), approximately 7% of naphthalene incidents in children resulted
in any symptoms at all and less than 1% had moderate or major symptoms. Symptoms that did
occur (both adults and children; all routes of exposure) were not life-threatening and included
nausea, vomiting, headache, dizziness, drowsiness/lethargy, eye irritation, and dermal edema and
36
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erythema. Of greater concern than the potential health effects is the accessibility of the indoor
use product to young children, as evidenced by the large number of reported incidents.
Limiting accessibility to naphthalene is expected to significantly reduce the number of
incidents, including those that may result in symptoms. To that end, the Agency has conducted
risk mitigation discussions with the naphthalene end-use registrants. Since the large majority of
naphthalene incidents for children under 6 years of age were from episodic ingestion of indoor
use mothball products, the Agency determined that mothballs can no longer be marketed in such
a way that individual mothballs are applied to areas accessible to children.
The registrants have agreed to take product stewardship steps to ensure that products are
packaged in a way that would discourage children from eating the product. Loose mothballs
will no longer be sold, and there are several formulation and packaging options that registrants
can employ instead. Mothballs can be sold in sachets, for example, if made with a tear- and
moisture-resistant wrapping material. Mothballs can also be packaged in plastic containers that
allow for volatilization, but which would prohibit direct contact with the naphthalene product
enclosed. Alternatively, naphthalene could be formulated into larger sized cake or block
products (minimum of 2.5 inches in diameter), which incident data show are not an exposure
source of concern for episodic ingestion. The registrants further agreed that cake and block
products will also be enclosed in plastic, metal or cardboard packaging while in use. The
implementation of packaging mitigation measures is required within 5 years (September 2013).
See Table 13 for details on packaging requirements.
In addition, the Agency will require prominently displayed precautionary label language
on packaging which warns consumers of a possible episodic ingestion risk to children and to
keep product out of reach of children (see Table 13). These new product labelling requirements
will be implemented within 12 months (September 2009). The Agency is confident that based
on the rigorous nature of the mitigation measures to be implemented, episodic ingestion
exposures will be reduced to such an extent that this scenario no longer poses a risk of concern.
Postapplication Inhalation (Cancer and Noncancer)
A quantification of cancer risk for exposures via inhalation, or derivation of an inhalation
reference concentration (RfC) for the nonfood-pesticidal uses of naphthalene was not performed.
This is because, as described in Section III of this document, there is support from published
studies and ongoing research on naphthalene that indicate that risk estimates, factoring in known
species differences between rodents and humans (including humans) in metabolism and
respiratory toxicity, would be considerably less than those using default procedures.
Pharmacokinetic research may quantify the species difference and is forthcoming (approximately
2-3 years).
Anticipated acute and short-term inhalation exposures to naphthalene in residences are
estimated to be 20X and 3OX below the rodent dose (NOAEL) resulting in no adverse effects,
respectively. Anticipated acute and short-term inhalation exposures to naphthalene in residences
are estimated to be 60X and SOX, respectively, below the rodent dose (LOAEL) resulting in
respiratory toxicity (olfactory epithelium lesions).
37
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Anticipated intermediate-term inhalation exposures to naphthalene in residences are
estimated to be 540X below the rodent dose (NOAEL) resulting in no adverse health effects.
Intermediate- and long-term inhalation exposures to naphthalene in residences are estimated to
be 1000X and 5400X, respectively, below the rodent dose (LOAEL) resulting in respiratory
toxicity (olfactory epithelium lesions).
These inhalation exposure estimates do not represent a risk of concern to the Agency.
The carcinogenic and noncarcinogenic potential of naphthalene is currently undergoing review
by EPA Integrated Risk Information System (IRIS). The EPA process of regulating pesticides
allows for re-evaluation at any time if relevant new information becomes available. Thus, when
the IRIS assessment is finalized OPP would determine whether the human health hazard
potential of naphthalene warrants revisiting. Similarly, when pharmacokinetic research is
complete the Agency will revisit naphthalene inhalation risk.
c. Aggregate Risk
An aggregate risk assessment for all expected routes of exposure was not performed as
there is no common toxicity among all the routes of exposure. A short-term aggregate risk
assessment could be performed by combining short-term incidental oral exposure and
average/background dietary (in this case drinking water) exposures, but this was not done for
naphthalene since the short-term incidental oral exposure risk estimate alone exceeds the LOG,
and combining with other routes of exposure would only further exceed the LOG. As previously
described, while the episodic ingestion of naphthalene by a toddler results in an MOE less then
the target MOE, the effects of this type of exposure, if any, are transient and are not expected to
be severe.
However, the Agency is requiring extensive mitigation measures, including special
packaging of indoor use products and prominent precautionary label language. These mitigation
measures are expected to reduce the potential for episodic ingestion to such an extent that this
scenario no longer represents a risk of concern. Furthermore, naphthalene's highly conservative
dietary risk estimates for potential drinking water exposure are far below the Agency's LOG and
are not of concern.
d. Occupational Risk
Naphthalene pesticide products are not registered for occupational use and, therefore,
occupational exposure to the pesticidal uses of naphthalene is not anticipated and has not been
assessed.
e. Ecological Risk
Birds, Terrestrial-phase amphibians, and Reptiles
Based on a screening-level assessment, naphthalene may pose an acute risk to birds,
terrestrial-phase amphibians and reptiles. The ecological assessment was conducted with
38
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conservative use assumptions: six applications per year were assumed, the highest application
rate was used (10.8 Ibs ai/A, although some products are labeled for use at 0.56 Ibs ai/A), and the
model did not account for volatilization. Furthermore, animal repellant products are formulated
as flakes and granules, but the assessment was conducted for granules only due to modeling
limitations. While there is some potential for a bird to accidentally ingest a granule of
naphthalene during gritting activities, it is unlikely that a bird would consume naphthalene in
flake form. The modeling limitations, the conservative assumptions, and the uncertainty
surrounding volatility may have resulted in an over-estimate of risk. Based on the conservative
nature of the risk assessment and the fact that naphthalene is a bird repellant, the Agency does
not anticipate a risk of concern and is not requiring mitigation measures for the naphthalene
animal repellent products.
Mammals
When marketed as a rabbit repellent, the use directions instruct the user to place the
product in small bands around ornamentals; this use is limited to small areas during the growing
season. While the acute risk estimates to terrestrial mammals exceed the Agency's LOCs, as for
birds, the assessment was highly conservative and may have over-estimated risk. In addition, the
incident data show very little history of pet exposure. The Agency does not anticipate risk of
concern to mammals from the outdoor uses of naphthalene, based on the use pattern (localized
treatments around ornamentals as an animal repellant), and is not requiring mitigation.
Aquatic Organisms
Acute risk is not expected for freshwater animals, aquatic-phase amphibians and aquatic
nonvascular plants, and therefore, no mitigation is required.
Non-Target Insects and Plants
Due to lack of toxicity data, risks to honey bees and to terrestrial and aquatic vascular
plants can not be quantified; however, given its method of application and use as a repellent
around gardens, effect on insects and plants are not anticipated.
2. Endocrine Disrupter Effects
Following recommendations of its Endocrine Disrupter Screening and Testing Advisory
Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of
the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that EPA include evaluations of
potential effects in wildlife. For pesticides, EPA will use FIFRA, and to the extent that effects in
wildlife may help determine whether a substance may have an effect in humans, FFDCA
authority to require the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine Disrupter Screening
Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
39
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EDSP have been developed, individual pesticides may be subject to additional screening and/or
testing to better characterize effects related to possible endocrine disruption.
3. Endangered Species
The Endangered Species Act required federal agencies to ensure that their actions are not
likely to jeopardize listed species or adversely modify designated critical habitat. The Agency
has developed the Endangered Species Protection Program to identify pesticides whose use may
cause adverse impacts on federally listed endangered and threatened species, and to implement
mitigation measures that address these impacts. A determination that there is a likelihood of
potential effects to a listed species may result in limitations on the use of the pesticide, other
measures to mitigate any potential effects, and/or consultations with the Fish and Wildlife
Service or National Marine Fisheries Service, as necessary.
For naphthalene, the acute risk to birds, terrestrial-phase amphibians and reptiles, and
mammals exceed the endangered species LOG, and therefore there is a potential for direct effect
to these taxa. In addition, there is a potential for indirect effects to species that depend on them.
The data are currently insufficient to determine if there is a potential for direct or indirect effect
to terrestrial or aquatic plants. Naphthalene is not likely to affect aquatic animals (fish or
invertebrates) directly; the potential for indirect effects depends on whether naphthalene could
affect semi-aquatic or aquatic plants.
D. Labeling Requirements
In order to be eligible for reregi strati on, various use and safety information will be
needed in the labeling of all end-use products containing naphthalene. For the specific labeling
statements, refer to Section V of this RED document.
V. What Registrants Need to Do
The Agency has determined that products containing naphthalene are eligible for
reregi strati on provided that the required risk mitigation measures, including product packaging,
are adopted and label amendments are made. The Agency intends to issue Data Call-In Notices
(DCIs) requiring generic and product-specific data. Generally, registrants will have 90 days
from receipt of a DCI to complete and submit response forms or request time extension and/or
waiver requests with a full written justification. For product-specific data, the registrant will
have eight months to submit data. Table 13 describes the packaging requirements and label
amendments that the Agency is requiring for naphthalene products to be eligible for
reregi strati on.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of naphthalene for currently registered
uses has been reviewed and determined to be substantially complete. However, the Agency
40
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intends to issue a DCI requiring a confirmatory chamber study (Guideline 875.2500) to
determine levels of naphthalene in the air resulting from use of mothballs at the maximum label
rate. It is recommended that a study protocol be submitted to the Agency for review and
approval prior to the inception of the study. The Agency does not currently anticipate requiring
additional generic data. Other entities are conducting ongoing naphthalene research to address
toxicology issues including:
• More accurate assessment of species differences in metabolism and clearance of
naphthalene.
• Cell proliferation data to provide linkage to cytotoxicity.
• DNA adduct and mutagenicity studies in relevant target tissues in vivo to confirm
lack of direct DNA mutagenicity.
• Physiologically Based Pharmacokinetic (PBPK) model under development (2-3 years
rough estimate) to better support the mode of action, and to characterize species
differences in metabolism, and address involvement of multiples enzymes and
clearance in humans versus rodents. The PBPK model may provide a more accurate
determination of a human equivalent dose to be used in inhalation risk assessment.
These data will be included in future assessments of naphthalene.
2. Labeling for Manufacturing-Use Products
To ensure compliance with FIFRA, manufacturing-use product (MUP) labeling should be
revised to comply with all current EPA regulations, PR Notices, and applicable policies. The
MUP labeling should bear the labeling contained in Table 13.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The Registrant
must review previous data submissions to ensure that they meet current EPA acceptance criteria
and if not, commit to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product. The Agency intends to issue a separate product-specific data call-in (PDCI), outlining
specific data requirements. For any questions regarding the PDCI, please contact Veronica
Dutch at 703-308-8585.
2. Labeling for End-Use Products
To be eligible for reregi strati on, labeling changes are necessary to implement measures
outlined in Section IV above. Specific language to incorporate these changes is specified in
Table 13. Generally, conditions for the distribution and sale of products bearing old
labels/labeling will be established when the label changes are approved. However, specific
41
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existing stocks time frames will be established case-by-case, depending on the number of
products involved, the number of label changes, and other factors.
C. Labeling Changes Summary Table
For naphthalene to be eligible for reregi strati on all naphthalene mothball products must be
packaged, and labels must be amended to incorporate the risk mitigation measures, as outlined in
Section IV. Table 13 describes the packaging requirements and how language on the labels
should be amended.
42
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Table 13. Summary of Labeling Changes for Naphthalene
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
For All Manufacturing Use Products
"Only for formulation into an insecticide/repellent for the following
use(s) [fill blank only with those uses that are being supported by MP
registrant]."
Note to registrant:
Special packaging for moth repellant end use products are required to
reduce the risk that children will ingest the product.
Directions for use
For Manufacturing Use Products
Formulated as Indoor Use Moth
Repellant Products
Note to registrant:
After September 30, 2013 formulation into loose mothball products is not
permitted. See End Use Product requirements for a description of
approved indoor moth repellant formulation types and packaging
specifications.
Directions for use
One of these statements may be added to
a label to allow reformulation of the
product for a specific use or all
additional uses supported by a
formulator or user group
"This product may be used to formulate products for specific use(s) not
listed on the MP label if the formulator, user group, or grower has
complied with U.S. EPA submission requirements regarding support of
such use(s)."
Directions for Use
Environmental Hazards Statements
"ENVIRONMENTAL HAZARDS"
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or other waters unless in accordance with the
requirements of a National Pollutant Discharge Eliminations System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge. Do not discharge effluent containing this product to
sewer systems without previously notifying the local sewage treatment
plant authority. For guidance, contact your State Water Board or
Regional Office of the Environmental Protection Agency."
Precautionary Statements:
Environmental Hazards
43
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Table 13. Summary of Labeling Changes for Naphthalene
Description
Amended Labeling Language
Placement on Label
End-Use Products
Availability Statements
Indoor Moth Repellant Sachet Products
For End Use Products Formulated as
Indoor Use Moth Repellant Products
"IMPORTANT: Keep out of reach of children."
"Do not place in areas accessible to children."
"IMPORTANT: It is illegal to sell the sachets individually."
"Do not open sachets."
Note to registrant:
After September 30, 2013, naphthalene may no longer be formulated into
loose mothball products unless contained in sachets meeting the
following minimum manufacturing specifications:
Physical Property
Tear Initiation
Machine Direction
Tear Initiation
Transverse Direction
Tensile Strength
Machine Direction
Tensile Strength
Transverse Direction
Heat Seal Strength
Minimum Value
2.2 Ibs
2.2 Ibs
16,3000 psi
20,000 psi
500 g/in
Test
ASTMD1004
Standard Test
Method for Tear
Resistance (Graves
Tear) of Plastic Film
and Sheeting
ASTMD1004
ASTM D882A
Standard Test
Method for Tensile
Properties of Thin
Plastic Sheeting
ASTMD882A
285° F, 40 PSI, 1 sec
HS/HS heat seal side
to heat seal side
After September 30, 2013, naphthalene indoor moth repellant products
formulated as cakes or blocks must have a minimum diameter size of 2.5
Directions for Use
Directions for Use
Directions for use
44
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Table 13. Summary of Labeling Changes for Naphthalene
Description
Amended Labeling Language
Placement on Label
inches.
Precautionary Statement for All Indoor
Moth Repellant Products
Note to registrant:
The following statement will be placed within a shaded box within the
Precautionary Statements on the label. The coloring of the box and text
will be such to provide a contrasting color to other label text. The shaded
box must contain the following:
"Keep out of reach of children. Do not place in areas accessible to
children."
Include the following statement prominently on the front panel of
product packaging (in bold), "Keep out of reach of children."
Precautionary Statements
45
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Appendix A. Use Patterns Eligible for Reregistration for Naphthalene
Use Site
Attics, Basements, Etc. (indoor animal
repellant use)
Household/Domestic Dwellings Contents
Garden or House Perimeter
Formulation
Type
Crystalline
Crystalline
Crystalline
Product Type
Flakes
Balls, Flakes,
Sachets
Granules,
Flakes
Maximum
Application
Rate/Application2
1
0.37
0.014
Unit
lb ai/400 ft3
or oz ai/3 ft3
lb ai/12 ft3
gal/ 1000 ft2
Maximum
Retreatment
Interval
7
7
7
46
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Appendix B
Data Supporting Guideline Requirements for the Reregistration of Naphthalene
REQUIREMENT
Use
Pattern
CITATION(S)
PRODUCT CHEMISTRY
New
Guideline
Number
830.1600
830.1620
830.1650
830.1670
830.1700
830.1800
830.7050
830.7550
Old
Guideline
Number
158.160
158.162
158.165
158.167
158.170
158.180
N/A
63-11
Study Description
Description of Materials
Used to Produce the Product
Description of Production
Process
Formulation Process
Formation of Impurities
Preliminary Analysis
Analytical Method
UV/Visible Absorption
Partition Coefficient
All
All
All
All
All
All
All
46862001
43112501
46862001
46862001
43170801
46862001
Data Gap
42335803
ECOLOGICAL EFFECTS
850.2100
850.2200
850.1075
850.1010
850.1400
71-1
71-2
72-1
72-2
72-4a
Avian Acute Oral Toxicity
Avian Dietary Toxicity -
Quail
Freshwater Fish Acute
Toxicity
Invertebrate Toxicity
Freshwater Fish Early Life-
Stage Toxicity
A, B
A, B
A, B
A,B
A,B
148176
00148175
45030801,44302701
44302702
46220970
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Non-
guideline
870.3250
870.3465
Non-
guideline
Non-
guideline
Non-
guideline
870.3700
870.3700
81-1
81-2
81-3
81-4
81-5
81-6
82-3
82-4
83-3
83-3
Acute Oral Toxicity
Acute Dermal Toxicity
Acute Inhalation Toxicity
Primary Eye Irritation
Primary Dermal Irritation
Dermal Sensitization
Acute Neurotoxicity - Rat
90-Day Dermal - Rodent
90-Day Inhalation - Rat
90-Day Neurotoxicity -
Mammal
Oncogenicity - Rat
Oncogenicity - Mouse
Teratogenicity - Rabbit
Prenatal Developmental -
Rat
A, B
A,B
A,B
A, B
A, B
A,B
A,B
A,B
A,B
A, B
A, B
A, B
A,B
A,B
00148174,257224
00148409, 257229
00144557,257902
00148408,257228
00148177,257227
00148173
44282801
40021801
42835901
44856401
45630101
42458301
42195401,00157145
NTP 1991
47
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Appendix B
Data Supporting Guideline Requirements for the Reregistration of Naphthalene
REQUIREMENT
870.3700
870.5100
Non-
guideline
870.5300
870.5550
870.5375
870.5375
870.6200
870.5395
870.5265
870.6200
Non-
guideline
Non-
guideline
Non-
guideline
Non-
guideline
Non-
guideline
Non-
guideline
83-3
84-2
84-2
84-2
84-2
84-2
82-7
84-2
84-2
82-7
Prenatal Developmental -
Rabbit
Gene Mutation - Ames
Genotoxicity
Structural Chromosome
Aberration
UDS Assay
CHO Chromosome
Aberration
CHO Sister Chromatid
Exchange
Acute Neurotoxicity (Oral)
-Rat
In Vivo Mouse Bone
Marrow Micronucleus
Gene Mutation in
S. typhimurium
Subchronic Neurotoxicity
(Inhalation) - Rat
4-Week Inhalation - Rat
90-Day Oral Toxicity - Rat
90-Day Oral Toxicity -
B6C3F1 Mouse
90-Day Oral Toxicity -
DC1 Mouse
Chronic Toxicity/
Carcinogenicity (Chamber)
Inhalation - Rat
Chronic
Toxicity/Carcinogenicity
(Chamber) Inhalation -
Mouse
Use
Pattern
A,B
A,B
A,B
A, B
A,B
A, B
A, B
A,B
A, B
A, B
A,B
A, B
A,B
A, B
A,B
A, B
A,B
CITATION(S)
NTP 1992
42071601
42071604
42071603
42071604
NTP 2000
NTP 2000
44282801
42071603
42071602
44856401
42934901
NTP 1980a
NTP 1980b
Shopp et al. 1984
NTP 2000
NTP 1992
OCCUPATIONAL/RESIDENTIAL EXPOSURE
Non-
guideline
875.2500
133-4
Indoor Air Monitoring
Inhalation Exposure
A, B
A,B
43716501
Data Gap
ENVIRONMENTAL FATE
835.2120
835.1230
161-1
163-1
Hydrolysis
Sediment and Soil
Adsorption/Desorption
A, B
A, B
45346801
45346801
48
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Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket,
located in Room S-4400, One Potomac Yard (South Building), 1777 S. Crystal Drive, Arlington,
VA. It is open Monday through Friday, excluding legal holidays, from 8:30 am to 4 pm.
The risk assessments and other supporting documents for naphthalene are available in the
Public Docket, under docket number EPA-HQ-OPP-2008-0343, and on the Agency's web page,
http://www.regulations.gov. The docket contains risk assessments and related documents as of
November, 2008.
Technical support documents for the Naphthalene RED include the following:
Health Effects Documents
1. Phase 4 Amendment: Response to Comments in Reference to "Naphthalene: HED
Chapter for the Reregistration Eligibility Decision Document (RED)" dated August 22, 2008.
2. Naphthalene: Phase 4 Amendment: Response to Comments In Reference to
"Naphthalene: Occupational and Residential Exposure Assessment and Recommendations for
the Reregistration Eligibility Decision Document,'" dated September 10, 2008.
3. 'Review of Naphthalene Incident Reports, dated June 25, 2007.
Ecological Fate and Effects Documents
1. Revised Drinking Water Exposure Assessment for the Human Health Risk Assessment for
the Reregistration Decision Eligibility (RED) of Naphthalene Incorporating the Registrant's
Error Correction Comments, dated April 9, 2008.
2. Revised Ecological Risk Assessment for Reregistration Eligibility Decision (RED) for
Naphthalene, dated April 21, 2008.
Appendix D. Citations Considered to be Part of the Database Supporting the
Reregistration Decision (Bibliography)
GUIDE TO APPENDIX D
49
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1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in
the Reregi strati on Eligibility Document. Primary sources for studies in this bibliography
have been the body of data submitted to EPA and its predecessor agencies in support of past
regulatory decisions. Selections from other sources including the published literature, in
those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct title (or at least a single subject),
can stand alone for purposes of review and can be described with a conventional
bibliographic citation. The Agency has also attempted to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation, and
should be used whenever a specific reference is required. It is not related to the six-digit
"Accession Number" which has been used to identify volumes of submitted studies (see
paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier.
These entries are listed after all MRID entries. This temporary identifying number is also to
be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists
of a citation containing standard elements followed, in the case of material submitted to EPA,
by a description of the earliest known submission. Bibliographic conventions used reflect the
standard of the American National Standards Institute (ANSI), expanded to provide for
certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to
show a personal author. When no individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When no author or laboratory
could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the
date is followed by a question mark, the bibliographer has deduced the date from the
evidence contained in the document. When the date appears as (1999), the Agency was
unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
50
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d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears immediately
following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
number, or other administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to
the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the original
submission of the study appears. The six-digit accession number follows the symbol
"CDL," which stands for "Company Data Library." This accession number is in turn
followed by an alphabetic suffix which shows the relative position of the study within
the volume.
MRID Citation Reference
4898 Means, R.G. (1973) Preliminary evaluation of the effectiveness of Mosquito
BeaterA(R)I, a granular repellent, against mosquitoes and blackflies. Mosquito News
33(4):542-545. (Also~In~unpub- lished submission received Jul 16, 1975 under 4-123;
submitted by Bonide Chemical Co., Inc., Yorkville, N.Y.; CDL: 126291-A)
4900 Nowak, L.M. (1975) Interim Material Safety Data Sheet for Naphtha- lene.
(Unpublished study received May 6, 1977 under unknown admin, no.; prepared by
Ashland Oil, Inc., submitted by Kenova Chemical Co., St. Louis, Mo.; CDL:229765-A)
4901 Samuel I. Milazzo Manufacturing Company (1967) Ten Day Test for Milazzo
Company Animal Chaser. (Unpublished study received Sep 12, 1967 under 8218-1;
prepared in cooperation with United States Testing Co., Inc. and Hermel Exterminating;
CDL:224446-A)
4902 Hunsberger, J.F. (1969) Testing Program. (Unpublished study re- ceived Oct 28, 1969
under 8218-1; prepared by Allentown Testing Laboratories, Inc., submitted by Samuel
I. Milazzo Co., Pitts- ton, Pa.; CDL:224446-B)
4903 Niper, R. (1963) Milazzo Brand Animal Chaser Test No. 1. (Unpub- lished study
including letter dated Dec 9, 1963 from R. Niper to Samuel I. Milazzo, received Dec
17, 1963 under 8218-1; prepared by Monroe County Society for the Prevention of
Cruelty to Ani- mals, submitted by Samuel I. Milazzo Co., Pittston, Pa.; CDL: 224446-
C)
51
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4904 Uni-Research (1973) Evaluation of Dog Repellent Product: Technical Report.
(Unpublished study received Dec 12, 1973 under 1663-11; submitted by Grant
Laboratories Div., Oakland, Calif.; CDL: 022675-A)
4906 Taylor, R.E. (1974) Acute Oral Toxicity (LDI50A). (Unpublished study received Feb
26, 1974 under 779-29; prepared by Harris Laboratories, Inc., submitted by Faesy &
Besthoff, Inc., Edge- water, N.J.; CDL:050215-A)
4907 Harmad Laboratories (1976) Use of Naphthalene as an Insecticide in Controlling Lice
and Fleas. (Unpublished study received Nov 16, 1976 under 1548-3; submitted by
Vermex Co., Calabasas, Calif; CDL:227450-A)
4908 Harmad Laboratories (1976) Use of Naphthalene as an Insecticide in Controlling Mites.
(Unpublished study received Nov 16, 1976 un- der 1548-3; submitted by Vermex Co.,
Calabasas, Calif; CDL: 227450-B)
4909 Harmad Laboratories (1976) Use of Naphthalene as a General Insect- icide.
(Unpublished study received Nov 16, 1976 under 1548-3; submitted by Vermex Co.,
Calabasas, Calif; CDL:227450-C)
4911 Whitmire, H.E. (1958) Fly Larvicide Test Reports Made on Cubetoid (L.L.) Liquid
Larvicide Concentrate. (Unpublished study re- ceived Jan 16, 1958 under 499-110;
submitted by Whitmire Re- search Laboratories, Inc., St. Louis, Mo.; CDL:228313-A)
4912 Gerade, H.W. (19??) Di- and Tricyclic aromatic hydrocarbons. Pages 216-
232,~In~Toxicology & Biochemistry of Aromatic Hydrocarbons. N.P.
(Also~In~unpublished submission received Jun 22, 1965 under 862-EX-4; submitted by
Sun Oil Co. of Pa., Philadelphia, Pa.; CDL: 123931-A)
4913 Sun Oil Company of Pennsylvania (1959?) Toxicity of Naphthalene. (Unpublished
study received Jun 2, 1965 under 862-EX-3; CDL: 123930-A)
4914 Hamilton, D.W. (1964?) Results of Screening of Naphthalene, ENT No. 278 for
Control of Third-Instar Japanese Beetle Grubs. (Un- published study received Sep 23,
1965 under 862-EX-2; prepared by U.S. Agricultural Research Service, Entomology
Research Div., Japanese Beetle Investigations, submitted by Sun Oil Co. of Pa.,
Philadelphia, Pa.; CDL:123929-B)
5578 Coulter, JB. (1977) Field Trial Efficacy Test Evaluation Using Vermex as a control for
Fleas, Sarcoptic Mange, Ticks. (Un- published study received Jun 2, 1977 under 1548-
3; prepared by Brownsville Animal Research Center for Harmad Laboratories; sub-
mitted by Vermex Co., Calabasas, Calif.; CDL:230521-A)
12997 Innis, Speiden & Company (1941) The Larvacide Log (August). New York: ISCO.
(Also~In~unpublished submission received on unknown date under unknown admin.
no.; submitted by E.J. Scarey, New York, NY.; CDL:222934-A)
19056 Baker, R.S.; Holstun, J.T., Jr. (1965) Weed Control in Cotton on Tunica Clay: Line
Project CR fl-19; Research Report CF-221. (Unpublished study received May 11, 1965
under 100-549; prepared by Mississippi State Univ., Delta Branch Experiment Station
in cooperation with U.S. Dept. of Agriculture, submitted by Ciba- Geigy Corp.,
Greensboro, N.C.; CDL:007072-AM)
19915 Stout, D.M. (1964) (Efficacy of Cat Away as a Repellent). (Unpub- lished study
received May 13, 1964 under 499-136; submitted by Whitmire Research Laboratories,
52
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Inc., St. Louis, Mo.; CDL: 020043-A)
26091 Williamson, H.O.; McDuffie, W.E.; Jasper, R.L. (1972) (Grant's Napthalene: Toxicity
to Rats). (U.S. Pharmacology Laboratory, unpublished report.)
26232 Mississippi State University, Agricultural Experiment Station (1967) 1967 State Weed
Committee Report: Weed Control Recommen- dations for Mississippi. State College,
Miss.: MSU. (pp. 13, 24,48,50,54 only; also~In~unpublished submission received Oct
2, 1967 under 8F0643; submitted by Stauffer Chemical Co., Westport, Conn.;
CDL:091116-S)
26929 Jasper, R.L. (1963) (Farnam Rotenox: Toxicity to Rats). (U.S. Pharmacology
Laboratory, unpublished report.)
32961 Brooks, D.M. (1959) Muskrat Damage: Prevention and Control. Indi- anapolis, Ind.:
Indiana, Dept. of Conservation, Div. of Fish & Game. (Indiana W-2-R;
also~In~unpublished submission received Oct 29, 1971 under 201-118; submitted by
Shell Chemical Co., Washington, D.C.; CDL:000772-I)
33603 Davis, C.S.; Deal, A.S.; Hart, W.H.; et al. (1967) Pest and Disease Control Program For
Olives, 1967. ?: Univ. of California, Agricultural Experiment Station, Extension
Service. (Also~In~ unpublished submission received Jul 28, 1967 under 239-1839;
submitted by Chevron Chemical Co., Richmond, Calif.; CDL: 001386-A)
44481 Ralston Purina Company (1968) Health Product Specification. (Un- published study
received Dec 11, 1970 under 602-193; CDL: 004118-A)
51053 Grant Laboratories (1964) ?Data on Grant's Dog Repellent). (Com- pilation;
unpublished study received Jun 5, 1964 under 1663-11; CDL:220938-A)
51355 Unkel, M.W. (1962) Letter sent to C.C. McDonell dated Jan 26, 1962 ?Lice-kill tests on
birds). (Unpublished study received Jan 30, 1962 under unknown admin, no.; submitted
by Hudson Associates, Inc., Hudson, Ohio; CDL: 108791-A)
53225 Strong Cobb Arner, Incorporated (1962) ?Effect of Pesticide Tablets on Chicken and
Parakeets). (Unpublished study received Jan 30, 1962 under unknown admin, no.;
submitted by Hudson Associates, Inc., Hudson, Ohio; CDL: 108791-B)
57823 Bottimer, L.J. (1929) Notes on Paradichlorobenzene and Naphthalene as repellents
against clothes moth larvae. Journal of Economic Entomology 22(Jun):570-573.
(Also~In~unpublished submission re- ceived May 25, 1977 under 38510-1; submitted
by Specialty Organ- ics, Inc., Irwindale, Calif; CDL:230291-A)
59195 Mallis, A. (1961) Letter sent to Sam C. Billings dated May 10, 1961 ?Results of studies
on effect of PDB and Naphthalene against larvae of fabric insects . (Unpublished study
received May 12, 1961 under unknown admin, no.; submitted by Gulf Re- search
Development Co., Pittsburgh, Pa.; CDL:228336-A)
59196 Feldmesser, J. (1965) Letter sent to K. Deane Groves dated Aug 5, 1965 ?Results with
Naphthalene in laboratory and greenhouse tests . (U.S. Agricultural Research Service,
Crops Research Div.; unpublished study; CDL: 123929-A)
60828 Grant Laboratories (1964) ?Efficacy of Grant's Dog Repellent). (Reports by various
sources; unpublished study received May 21, 1964 under 1663-11; CDL:220937-A)
64153 Grant Laboratories (1964) ?Efficacy Studies on Dog Repellent. (Compilation;
53
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unpublished study received Jun 25, 1964 under 1663-11; CDL:220938-A)
65068 Brookes, P.; Lawley, P.D. (1964) Evidence for the binding of poly- nuclear aromatic
hydrocarbons to the nucleic acids of mouse skin: Relation between carcinogenic power
of hydrocarbons and their binding to deoxyribonucleic acid. Nature ?(May):782-784.
(Published study)
65069 Harvey, R.G.; Halonen, M. (1968) Interaction between carcinogenic hydrocarbons and
nucleosides. Cancer Research 28(Nov):2183- 2186. (Published study)
65070 Peters, A.C.; Thake, D.C. (1980) Subchronic Toxicity Study: Naph- thalene (C52904),
Fischer 344 Rats: Subcontract No. 76-34- 106002. (Battelle; unpublished study)
65071 Peters, A.C.; Thake, D.C. (1980) Subchronic Toxicity Study: Naph- thalene (C52904),
B6C3F1 Mice: Subcontract No. 76-34-106002. (Battelle; unpublished study)
68188 Shell Chemical Company (1966) ?Efficacy of Various Rodenticides for Muskrats|.
(Compilation of published data; unpublished study received Oct 29, 1971 under 201-
118;CDL:227781-C)
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54
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52.
5017184 Traxler, R.W. (1973) Bacterial degradation of petroleum materials in low temperature
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5017304 Slavnina, G.P. (1970) Bakterii, ispol'zuyushchiye aromaticheskiye uglevodorodi_
?Bacteria which utilize aromatic hydrocarbons_ Trudy, Vsesoyuznyi Nauchno-
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5017892 Aly, O.M.; Faust, S.D.; Suffet, I.H. (1971) Ultraviolet spectrophotometry in residue
analysis; spectra-structure correlations. Pages 95-118,~In~Pesticides Identification at
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5019746 D'Asaro Biondo, M. (1933) L'azione dei vapori di naftalina sull'occhio (richerche
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5019904 Hansen, N.; Jensen, V.B.; Appelquist, H.; Morch, E. (1978) The uptake and release of
petroleum hydrocarbons by the marine mussel-Mytilus edulis?-. Progress in Water
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5020080 Chen, K.C.; Dorough, H.W. (1979) Glutathione and mercapturic acid conjugations in
the metabolism of naphthalene and 1-naphtyl N-methylcarbamate (carbaryl). Drug and
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Chemical Toxicology 2(4):331-354.
40021800 Texaco Chemical Co. (1986) Sub-chronic Dermal Toxicity Study of Naphthalene to
Rats. Compilation of 1 study.
40021801 Frantz, S.; Van Miller, J.; Papciak, R. (1986) Ninety-day (Sub- chronic) Dermal
Toxicity Study with Naphthalene in Albino Rats: Final Report: Project No. 49-539
Revised. Unpublished study prepared by Union Carbide Corp., Bushy Run Research
Center. 269 p.
40784100 Dr. T's Original Nature Products (1988) Submission of Product Chemistry in Support of
Dr. T's Original Snake-A-Way Registra- tion. Transmittal of 2 studies.
40784101 Tennyson, D. (1988) Dr. T's Original Snake-A-Way: Product Chemis- try Data.
Unpublished study. 19 p.
40784102 Tennyson, D. (1988) Dr. T's Original Snake-A-Way: Product Specific Data: Efficacy
Data. Unpublished study. 6 p.
41219100 Dow Chemical U.S.A. (1989) Submission of Data To Support Registra- tion of
Triclopyr Acid and Triclopyr butoxyethyl ester. Trans- mittal of 10 studies.
41219102 Nicholson, L. (1989) Determination of the Octanol/Water Partition Coefficient for
Napthalene Using Generator Column Technology: Project ID: AL 88-080546.
Unpublished study prepared by Dow Chemical U.S.A. 30 p.
41272800 Dr. T's Nature Products, Inc. (1989) Submission of Efficacy Data in Support of
Registration of Dr. T's Original Snake-A-Way. Trans- mittal of 1 study.
41272801 Lillywhite, H. (1989) Dr. T's Original Snake-A-Way ...: Product Pe- rformance: Project
ID Cl-1989. Unpublished study. 45 p.
41332006 Nicholson, L. (1989) Determination of the Octanol/Water Partition Coefficient for
Naphthalene Using Generator Column Technology: Lab Project Number:
AL/88/080546. Unpublished study prepared by The Dow Chemical Co. 29 p.
42066100 Texaco Chemical Co. (1991) Submission of Data in Response to Data Call-in for
Naphthalene: Toxicology Summaries. Transmittal of 1 study.
42066101 Adkins, B. (1991) NTP Technical Report on the Toxicology and Carcinogenesis
Studies of Naphthalene (...) in B6C3F Mice (Inhalation Studies): Interim Report.
Unpublished study prepared by Northrop Environmental Services/MAN Tech
Environmental Tech, Inc. 41 p.
42071600 Texaco Chemical Co. (1991) Submission of Data to Support the Data Call-In Response
for Naphthalene: Toxicological Data. Transmittal of 4 Studies.
42071601 Godek, E. (1985) Ames Salmonella/Microsome Plate Test (EPA/OECD). Unpublished
study prepared by Pharmakon Research International, Inc. 26 p.
42071602 Stankowski, L. (1987) Ames Salmonella/Microsome Plate Incorporation Assay.
Unpublished study prepared by Pharmakon Research Intern- ational, Inc. 22 p.
42071603 Sorg, R. (1985) Micronucleus Test (MNT) OECD. Unpublished Study prepared by
Pharmakon Research International, Inc. 41 p.
42071604 Barfknecht, T. (1985) Rat Hepatocyte Primary Culture/DNA Repair Test. Unpublished
63
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study prepared by Pharmakon Research International, Inc. 52 p.
42072300 Texaco Chemical Co. (Landis Intern. Inc.) (1991) Submission of teratology data to
support a data call-in for Naphthalene. Transmittal of 1 study.
420723 01 Margitich, D. (1991) Developmental Toxicity Study in Rabbits-- ?Napthalene |: Lab
Project Number: PH 329-TX-001-85. Unpublished study prepared by Pharmakon
Research International, Inc. 43 p.
42195400 Texaco Chemical Co. (1992) Submission of supplemental toxicity data in support of
registration of Texaco Napthalene Technical. Transmittal of 1 study.
42195401 Margitich, D. (1985) Addendum to Developmental Toxicity Study in Rabbits.
Unpublished study prepared by Pharmakon Research International, Inc. 29 p.
42335800 landis International, Inc. (1992) Submission of Product Chemistry Data in Support of
Registration Standard for Naphthalene. Transmittal of 4 studies.
42335801 Kellenbenz, R. (1992) Naphthalene: Description of Beginning Materials and
Manufacturing Process. Unpublished study prepared by Texaco Chemical Co. 9 p.
42335802 Wells, D. (1992) Naphthalene Technical-Pesticide Assessment Guidelines Subdivision
D: Determination of the Upper and Lower Limits of an Active Ingredient in Five
Batches of a Manufacturing-Use Pesticide Product: Lab Project Number: 10934.
0392.6130.210: 92-4-4213. Unpublished study prepared by Springborn Laboratories,
Inc. 87 p.
42335803 Blaushild, D. (1992) Naphthalene: Octanol/Water Partition Coefficient: Lab Project
Number: 022/013/031/91: 6311-91-058-01-31C-04. Unpublished study prepared by
Center for Hazardous Materials Research. 50 p.
42335804 Blaushild, D. (1992) Naphthalene: Aqueous Photolytic /degradation of ?carbon 14|
Naphthalene: Lab Project Number: 022/013/002/91: 1612-91-058-01-28B-05.
Unpublished study prepared by Center for Hazardous Materials Research. 67 p.
42370300 Texaco Chemical Co. (1992) Submission of Data in Response to Requirements Status
and Registrant's Response and Data Call-in Response for Naphthalene: Toxicology
Study. Transmittal of 1 study.
42370301 Adkins, B. (1992) NTP Technical Report on the Toxicology and Carcinogenesis
Studies of Napthalene (CAS No. 91-20-3) in B6C3F Mice (Inhalation Studies): Interim
Report #2: Lab Project Number: NTP TR410: 92-3141. Unpublished study prepared by
MAN Tech Environmental Tech, Inc. 168 p.
42458300 Texaco Chemical Co. (1992) Submission of toxicity data in support of the data call-in
for Naphthalene. Transmittal of 1 study.
42458301 Adkins, B. (1992) NTP Technical Report on the Toxicology and Carcinogenesis
Studies of Naphthalene in B6C3F1 Mice (Inhalation Studies): Final Report: Lab Project
Number: NTP TR410; Pub. No. 92-3141. Unpublished study prepared by Man Tech
Environmental Tech, Inc. 168 p.
42532000 Faesy & Besthoff, Inc. (1992) Submission of product chemistry, efficacy, and toxicity
data in support of the registration eligibility document for Dried Blood. Transmittal of 4
studies.
64
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42532001 Besthoff, A. (1992) Acute Toxicity Data for Case Number 4030: Dried Blood.
Unpublished study prepared by Harris Laboratories, Inc. 7 p.
42532002 Besthoff, A. (1992) Efficacy-Vertebrate Control Agents: Dried Blood-Case 4030.
Unpublished study prepared by Faesy & Besthoff, Inc. 115 p.
42532003 Besthoff, A. (1992) Product Chemistry for Case 4030: Dried Blood. Unpublished study
prepared by Faesy & Besthoff, Inc. 4 p.
42532004 Besthoff, A. (1992) Product Chemistry-Certification of Limits: Case 4030: Dried
Blood. Unpublished study prepared by Faesy & Besthoff, Inc. 8 p.
42548100 Horizon Micro-Environments (1992) Submission of efficacy data to support registration
of Utility Box Repellent (Naphthalene). Transmittal of 1 study.
42548101 Range, F. (1992) Utility Box Repellent: Efficacy Study: Unpublished study prepared by
Horizon Micro-Environments. 7 p.
42631100 Faesy & Besthoff, Inc. (1993) Submission of toxicity data in support of the registration
of F&B Rabbit & Dog Chaser. Transmittal of 5 studies.
42631101 Kuhn, J. (1992) Acute Dermal Toxicity Study in Rabbits: F&B Rabbit & Dog Chaser:
Lab Project Number: 9643-92. Unpublished study prepared by Stillmeadow, Inc. lip.
42631102 Holbert, M. (1992) Acute Inhalation Toxicity Study in Rats: F&B Rabbit & Dog
Chaser: Lab Project Number: 9644-92. Unpublished study prepared by Stillmeadow,
Inc. 17 p.
42631103 Kuhn, J. (1992) Primary Eye Irritation Study in Rabbits: F&B Rabbit & Dog Chaser:
Lab Project Number: 9645-92. Unpublished study prepared by Stillmeadow, Inc. 17 p.
42631104 Kuhn, J. (1992) Primary Dermal Irritation Study in Rabbits: F&B Rabbit & Dog
Chaser: Lab Project Number: 9646-92. Unpublished study prepared by Stillmeadow,
Inc. 12 p.
42631105 Besthoff, A. (1974) Acute Oral Toxicity (LD50): F&B Rabbit & Dog Chaser.
Unpublished study prepared by Harris Labs, Inc. 8 p.
42640000 Faesy & Besthoff, Inc. (1993) Submission of toxicity data in support of the RED for
Feasy & Besthoff Rabbit & Dog Chaser. Transmittal of 1 study.
42640001 Kuhn, J. (1993) Dermal Sensitization Study in Guinea Pigs: F&B Rabbit & Dog
Chaser: Lab Project Number: 9647-92. Unpublished study prepared by Stillmeadow,
Inc. 17 p.
42835900 Recochem (1993) Submission of toxicity data in support of the registration standard for
naphthalene. Transmittal of 1 study.
42835901 Coombs, D.; Kieran, P.; Hardy, C.; et al. (1993) Naphthalene: 13-Week Inhalation
Study in Rats: Lab Project Number: LDA 2/930704. Unpublished study prepared by
Huntingdon Research Centre Ltd. 218 p.
42894000 Recochem (1993) Submission of product chemistry data in support of registration
standard for naphthalene. Transmittal of 1 study.
42894001 Kellenbenz, R. (1993) Discussion of Formation of Impurities: Naphthalene.
Unpublished study prepared by Texaco Chemical Co. 7 p.
65
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42934900 Recochem (1993) Submission of Toxicology Data in Response to Requirements Status,
Registrant's Response, and Data Call-in for Naphthalene. Transmittal of 1 study.
42934901 Coombs, D. (1993) Naphthalene 4-Week Inhalation Study in Rats: Lab Project
Number: LDA 1/921559. Unpublished study prepared by Huntingdon Research Centre
Ltd. 165 p.
43112500 Recochem Inc. (1994) Submittal of Product Chemistry Data in Support of Data Call-in
for Naphthalene Registration Standard. Transmittal of 1 study.
43112501 Fletcher, C. (1994) Description of Beginning Materials and Manufacturing Process:
Unpublished study prepared by Recochem Inc. 12 p.
43170800 Recochem Inc. (1994) Submission of Product Chemistry Data for Naphthalene (LX
1298-01) in Support of a Data Call-In Reregistration. Transmittal of 1 study.
43170801 Mullee, D.; Bartlett, A. (1994) LX 1298-01 (Naphthalene): Preliminary Analysis: Lab
Project Number: 486/007. Unpublished study prepared by Safepharm Labs. Ltd. 37 p.
43224700 Dr. T's Nature Products Co., Inc. (1994) Submittal of Efficacy Data in Support of
Registration of Dr. T's Rat Scat Rat and Mouse Repellent. Transmittal of 1 study.
43224701 Scheiring, J. (1994) Dr. T's Rat Scat Rat and Mouse Repellent: Efficacy. Unpublished
study prepared by Dept. of Biological Sciences, The University of Alabama. 26 p.
43294600 Dr. T's Nature Products Co., Inc. (1994) Submission of efficacy data in support of the
registration for Dr. T's Rat Scat Rat and Mouse Repellent. Transmittal of 1 study.
43294601 Scheiring, J. (1994) DR. T's Rat Scat Rat and Mouse Repellent: Efficacy: Addendum to
MRID No. 43224701. Unpublished study prepared by The University of Alabama. 38
P-
43375600 Faesy & Besthoff, Inc. (1994) Submittal of Supplemental Toxicity Data in Support of
Registration for F&B Rabbit and Dog Chaser. Transmittal of 1 study.
43375601 Kuhn, J. (1994) Dermal Sensitization study in Guinea Pigs: F&B Rabbit & Dog Chaser:
Amendment: Lab Project Number: 9647-92. Unpublished study prepared by
Stillmeadow, Inc. 10 p.
43523300 Dragon Chemical Corp. (1995) Submission of toxicology data in support of RED for
dried blood. Transmittal of 1 study.
43523301 Kuhn, J. (1994) Acute Oral Toxicity Study in Rats: (F&B Rabbit and Dog Chaser):
Final Report: Lab Project Number: 1607-94. Unpublished study prepared by
Stillmeadow, Inc. lip.
43716500 Recochem, Inc. (1995) Submission of Exposure and Reentry Protection Data in Support
of the Registration Standard for Napthalene. Transmittal of 1 Study.
43716501 Waggoner, T. (1994) Estimation of Homeowner Exposure to LX1298-01 (Napthalene)
Resulting from Simulated Residential Use as an Insect Repellent: Final Report: Lab
Project Number: 93-9083: 92-298-01-21H-02: 92-298-01-21H-03. Unpublished study
prepared by Landis International, Inc. and Pharmaco LSR, Inc. 100 p.
43765100 Dr. T's Nature Products Co., Inc. (1995) Submission of Efficacy Data in Support of the
Registration of Dr. T's Snake-a-Way Snake Repellent. Transmittal of 2 Studies.
66
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43765101 Scheiring, J. (1995) Dr. T's Rat Scat Rat and Mouse Repellent: Efficacy: Edited Final
Report. Unpublished study prepared by University of Alabama. 20 p.
43765102 Scheiring, J. (1995) Dr. T's Rat Scat Rat and Mouse Repellent: Efficacy: Revised Final
Report: (Includes Raw Data). Unpublished study prepared by University of Alabama.
46 p.
43874000 Faesy & Besthoff, Inc. (1995) Submission of Toxicity Data in Support of the RED for
Dried Blood in F & B Rabbit & Dog Chaser. Transmittal of 1 Study.
43874001 Bennick, J. (1995) F & B Rabbit and Dog Chaser: Acute Inhalation Toxicity Study in
Rats: Final Report: Lab Project Number: 2376-95: S9-FF81-3. Unpublished study
prepared by Stillmeadow, Inc. 10 p.
44009800 Faesy & Besthoff, Inc. (1996) Submission of Pesticide Use Data in Support of
Registration of F&B Rabbit and Dog Chaser. Transmittal of 1 Study.
44009801 Fletcher, D. (1996) Captive Study for Efficacy of a Repellent in Outdoor Cats: F&B
Rabbit and Dog Chaser: Lab Project Number: 95 CR-100. Unpublished study prepared
by DWF Research. 198 p.
44282800 Recochem, Inc. (1997) Submission of Toxicity Data in Support of the Naphthalene
Registration Standard. Transmittal of 1 Study.
44282801 Reynolds, S. (1997) Naphthalene: Neurotoxicity Study by a Single Oral Gavage
Administration to CD Rats Followed by a 14-Day Observation Period: Final Report:
Lab Project Number: 96/1140: 96/RCE001/1140: RCE/001. Unpublished study
prepared by Huntingdon Life Sciences Ltd. 383 p.
44302700 Recochem, Inc. (1997) Submission of Hazard to Aquatic Organisms Data in Support
the Naphthalene Registration Standard. Transmittal of 2 Studies.
44302701 Kelly, C.; Thirkettle, K.; Smith, B. (1997) Naphthalene: Acute Toxicity to Bluegill
Sunfish (Lepomis macrochirus): Lab Project Number: RCE 3/971511. Unpublished
study prepared by Huntingdon Life Sciences, Ltd. 47 p.
44302702 Kelly, C.; Thirkettle, K.; Smith, B. (1997) Naphthalene: Acute Toxicity to Daphnia
magna: Lab Project Number: RCE 4/971512. Unpublished study prepared by
Huntingdon Life Sciences, Ltd. 41 p.
44856400 Recochem, Inc. (1999) Submission of Toxicity Data in Support of the Reregistration of
Napthalene. Transmittal of 1 Study.
44856401 Kenny, T. (1999) Naphthalene: Neurotoxicity Study by Inhalation Administration to
CD Rats for 13 Weeks: Lab Project Number: RCE005/984517. Unpublished study
prepared by Huntingdon Life Sciences, Ltd. 218 p.
44898400 Bonide Products, Inc. (1999) Submission of Product Chemistry Data in Support of the
Registration of Mosquito Beater. Transmittal of 1 Study.
44898401 Krenick, F. (1992) Bonide Mosquito Beater, EPA Reg. No. 4-123: The Repellent
Effectiveness of Mosquito Beater Granules Against Adult Mosquitoes in an Urban
Neighborhood. Unpublished study prepared by Bonide Products, Inc. 10 p.
44914700 Laurence Finberg (1999) Submission of Toxicity Data Related to Adverse Effects of
Naphthalene. Transmittal of 1 study.
67
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44914701 Finberg, L. (1999) Undated Letter Sent to D. Peacock: (Toxic and Mutagenic Effects of
Napthalene Including Information of Human Anemia and G-6-PD Deficiency). 27 p.
45030800 Recochem, Inc. (1999) Submission of Toxicity Data in Support of the Registration of
Naphthalene Technical. Transmittal of 1 Study.
45030801 Bell, G. (1999) Naphthalene: Acute Toxicity for Rainbow Trout (Oncorhynchus
mykiss): Amended Final Report: Lab Project Number: LDA 013/994061. Unpublished
study prepared by Huntingdon Life Sciences Ltd. 34 p.
45346800 Recochem, Inc. (2001) Submission of Environmental Fate Data in Support of the
Reregistration of Naphthalene. Transmittal of 1 Study.
45346801 Hummel, R. (2001) Overview of the Environmental Fate of Naphthalene. Unpublished
study prepared by Landis International, Inc. 318 p.
45498500 Bonide Products, Inc. (2001) Submission of Product Chemistry Data in Support of the
Registration of Mosquito Beater. Transmittal of 1 Study.
45498501 Horton, R. (2001) Bonide Mosquito Beater Product Identity and Composition.
Unpublished study prepared by Bonide Products, Inc. 16 p. {OPPTS 830.1550,
830.1600, 830.1670, 830.1700, 830.1750, 830.1800, 830.6303, 830.6315, 830.6317,
830.6320, 830.7000, 830.7300}
45630100 Recochem, Inc. (2002) Submission of Toxicity and Fate Data in Support of the
Reregistration of Naphthalene Technical. Transmittal of 1 Study.
45630101 National Toxicology Program (2000) NTP Technical Report on the Toxicology and
Carcinogenesis Studies of Naphthalene: Lab Project Number:
NAPHTHALENE/NTP/TR/500: NTP TR 500. Unpublished study. 174 p.
46233900 Bonide Products, Inc. (2004) Submission of Efficacy Data in Support of the
Registration of Bonide Mosquito Beater. Transmittal of 1 Study.
46233901 Paulson, S. (2004) Efficacy Testing of a Bonide Mosquito Beater. Unpublished study
prepared by Virginia Polytechnic Inst. and State University. 10 p.
46631200 I-Ching Chemical Co., Ltd. (2005) Submission of Product Chemistry Data in Support
of the Application for Registration of I-Ching Naphthalene Moth Balls. Transmittal of 3
Studies.
46631201 Chang, S. (2005) I-Ching Naphthalene Moth Balls - Product Chemistry. Unpublished
study prepared by I-Ching Chemical Company, Ltd. 15 p.
46631202 Chang, S. (2005) I-Ching Naphthalene Moth Balls - Product Chemistry. Project
Number: 051260/1/5. Unpublished study prepared by I-Ching Chemical Company, Ltd.
and New Jersey Laboratories, Inc. 37 p.
46631203 Chang, S. (2005) Physical/Chemical Properties of I-Ching Naphthalene Moth Balls.
Unpublished study prepared by I-Ching Chemical Co., Ltd. 6 p.
46657700 I-Ching Chemical Company, Ltd. (2005) Submission of Product Chemistry Data in
Support of the Application for Registration of I-Ching Naphthalene Moth Balls.
Transmittal of 1 Study.
46657701 Chang, S. (2005) Storage Stability of I-Ching Naphthalene Moth Balls. Project
Number: NJL/051260/1/5. Unpublished study prepared by I-Ching Chemical Company,
68
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Ltd. and New Jersey Laboratories, Inc. 5 p.
46700700 I-Ching Chemical Company, Ltd. (2005) Submission of Product Chemistry Data in
Support of the Application for Registration of I-Ching Naphthalene Moth Balls.
Transmittal of 2 Studies.
46700701 Chang, S. (2005) I-Ching Naphthalene Moth Balls - Product Chemistry. Unpublished
study prepared by I-Ching Chemical Company Ltd. 17 p.
46700702 Chang, S. (2005) I-Ching Naphthalene Moth Balls - Product Chemistry. Project
Number: 051260. Unpublished study prepared by I-Ching Chemical Company, Ltd. 37
P-
46706900 I-Ching Chemical Company Ltd. (2005) Submission of Product Chemistry Data in
Support of the Application for Registration of I-Ching Naphthalene Moth Balls.
Transmittal of 1 Study.
46706901 Chang, S. (2005) Physical/Chemical Properties of I-Ching Naphthalene Moth Balls.
Unpublished study prepared by I-Ching Chemical Company, Ltd. 7 p.
46746900 Dr. T's Nature Products, Inc. (2006) Submission of Efficacy Data in Support of the
Registration of the Registration of Dr. T's Snake-A-Way Snake Repellent. Transmittal
of 1 Study.
46746901 Lillywhite, H. (1989) Dr. T's Original Snake-A-Way: Final Report. Project Number:
C1/1989. Unpublished study prepared by University of Florida. 22 p.
46778300 IMS Trading, LLC (2006) Submission of Product Chemistry Data in Support of the
Application for Registration of IMS Old Fashion Moth Balls. Transmittal of 1 Study.
46778301 Conti, J. (2006) Groups A & B - Product Chemistry: Naphthalene. Project Number:
983/002/02. Unpublished study prepared by Acta Group, L.L.C. 27 p.
46862000 Oxford & Hill Home Products, LLC (2006) Submission of Product Chemistry Data in
Support of the Application for Registration of Moth-Be-Gone Moth Balls 2. Transmittal
of 1 Study.
46862001 Brookman, D. (2006) Product Properties - Group A: Moth-Be-Gone Moth Balls 2.
Unpublished study prepared by Genesis Engineering & Redevelopment LLC. 17 p.
46880900 U.S. Environmental Protection Agency (2006) Submission of Exposure and Risk Data.
Transmittal of 5 Studies.
46880903 Adgate, J.; Barr, D.; Clayton, C.; et al. (2001) Measurement of Children's Exposure to
Pesticides: Analysis of Urinary Metabolite Levels in a Probability-Based Sample.
Environmental Health Perspectives 109(6): 583-590.
46905000 I-Ching Chemical Company (2006) Submission of Product Chemistry Data in Support
of the Registration of I-Ching Naphthalene Moth Balls. Transmittal of 1 Study.
46905001 Chang, S. (2005) Volume 5: Physical/Chemical Properties of I-Ching Naphthalene
Moth Balls (Storage Stability Study: Final Report): Compilation of 3 Month, 6 Month,
9 Month and 12 Month Storage Stability Data. Project Number: 061263, 060001,
052033. Unpublished study prepared by I-Ching Chemical Company, Ltd. 62 p.
47104500 Recochem, Inc. (2007) Submission of Toxicity Data in Support of the Reregistration of
Naphthalene Technical. Transmittal of 1 Study.
69
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47104501 Tedesco, J. (2006) Naphthalene: In Vitro Dermal Absorbtion Rate Testing. Project
Number: DUPONT/17707, 15939, 1623. Unpublished study prepared by Dupont
Haskell Laboratory. 50 p.
47165200 Recochem, Inc. (2007) Submission of Efficacy Data in Support of the Registration of
Naphthalene Technical. Transmittal of 1 Study.
47165201 Daisy, B.; Strobel, G.; Castillo, U.; et. al. (2002) Naphthalene, An Insect Repellant, is
Produced by Muscodor vitigenus, a Novel Endophytic Fungus. Microbiology 148:
3737-3741
47183900 Recochem (2007) Submission of Efficacy Data in Support of the Reregistration of
Naphthalene Technical. Transmittal of 1 Study.
47183901 Small, G. (2006) Laboratory Bioassays to Assess the Efficacy of a Naphthalene
Repellent Against the Clothes Moth, Tineola bisselliella. Project Number: NAPH/6/04,
06/07. Unpublished study prepared by Insect Investigations Ltd. 22 p.
47464900 I-Ching Chemical Company Ltd. (2008) Submission of Toxicity Data in Support of the
Application for Registration of I-Ching Naphthalene Moth Balls. Transmittal of 9
Studies.
47464901 Chang, S. (2008) Toxicology of I-Ching Naphthalene Moth Balls Prenatal
Developmental Toxicity (Referenced Data). Unpublished study prepared by I-Ching
Chemical Company, Ltd. 7 p.
47464902 Chang, S. (2008) Toxicology of I-Ching Naphthalene Moth Balls Reproduction and
Fertility Effects (Referenced Data). Unpublished study prepared by I-Ching Chemical
Company, Ltd. 7 p.
47464903 Chang, S. (2008) Toxicology of I-Ching Naphthalene Moth Balls Bacterial Reverse
Mutation Assay (Referenced Data) . Unpublished study prepared by I-Ching Chemical
Company, Ltd. 6 p.
47464904 Chang, S. (2008) Toxicology of I-Ching Naphthalene Moth Balls Genotoxicity in
Human Lymphoblasts by Atmospheric Reaction Products of Naphthalene and
Phenanthrene, Mutat Res 393(l-2):23-35. Unpublished study prepared by I-Ching
Chemical Company, Ltd. 5 p.
47464905 Chang, S. (2008) Toxicology of I-Ching Naphthalene Moth Balls in Vitro Mammalian
Cytogenetics (Referenced Data). Unpublished study prepared by I-Ching Chemical
Company, Ltd. lip.
47464906 Chang, S. (2008) Toxicology of I-Ching Naphthalene Moth Balls Naphthalene Induced
Chromosomal Aberrations in the Bone Marrow of the Test Species (Referenced Data).
Unpublished study prepared by I-Ching Chemical Company, Ltd. 7 p.
47464907 Chang, S. (2008) Toxicology of I-Ching Naphthalene Moth Balls. The Ability of
Naphthalene to Induce Micronuclei in Polychromatic Erythrocytes (Referenced Data).
Unpublished study prepared by I-Ching Chemical Company, Ltd. 8 p.
47464908 Chang, S. (2008) Toxicology of I-Ching Naphthalene Moth Balls Subchronic
Neurotoxicity (Referenced Data). Unpublished study prepared by I-Ching Chemical
Company, Ltd. 6 p.
47464909 Chang, S. (2008) Toxicology of I-Ching Naphthalene Moth Balls Immunotoxicity of
70
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Naphthalene (Referenced Data). Unpublished study prepared by I-Ching Chemical
Company, Ltd. 5 p.
47466300 United States Environmental Protection Agency (2008) Submission of Fate, Residue,
Exposure and Risk, Efficacy, and Toxicity Data in Support of Risk Assessment.
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