^«^EZDy% United States
LhI Environmental Protection Agency
Office of Chemical Safety and
Pollution Prevention
Proposed Designation of
lr3?4,6,7,8-Hexahydro-4,6,6,7,8,8-
Hexamethylcyclopenta [y] -2-Benzopyran
(HHCB; CASRN 1222-05-5)
as a High-Priority Substance
for Risk Evaluation
August 23,2019
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Table of Contents
List of Tables iii
Acronyms and Abbreviations iv
1. Introduction 1
2. Production volume or significant changes in production volume 3
Approach 3
Results and Discussion 3
3. Conditions of use or significant changes in conditions of use 4
Approach 4
CDR Summary and Additional Information on Conditions of Use 7
4. Potentially exposed or susceptible subpopulations 8
Approach 8
Results and Discussion 8
5. Persistence and bioaccumulation 10
Approach 10
Physical and Chemical Properties and Environmental Fate Tables 10
Results and Discussion 13
6. Storage near significant sources of drinking water 13
Approach 13
Results and Discussion 14
7. Hazard potential 14
Approach 14
Potential Human Health and Environmental Hazard Tables and Additional Information on
Hazards 14
8. Exposure potential 18
Approach 18
Results and Discussion 18
9. Other risk-based criteria that EPA determines to be relevant to the designation of the
chemical substance's priority 22
10. Proposed designation and Rationale 22
11. References 23
ii
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List of Tables
Table 1. 1986-2015 National Aggregate Production Volume Data (Production Volume in
Pounds) 3
Table 2. HHCB (1222-05-5) Categories and Subcategories of Conditions of Use (2016 CDR
Reporting Cycle) 4
Table 3. HHCB (1222-05-5) Categories and Subcategories of Conditions of Use (2012 CDR
Reporting Cycle) 6
Table 4. Uses in Children's Products Information 9
Table 5. Physical and Chemical Properties of HHCB 10
Table 6. Environmental Fate Characteristics of HHCB 12
Table 7. Potential Human Health Hazards Identified for HHCB 15
Table 8. Potential Environmental Hazards Identified for HHCB 16
Table 9. Exposure Information for Consumers 20
Table 10. Exposure Information for the Environment and General Population 21
in
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Acronyms and Abbreviations
Term
Description
ACGM
American Conference of Governmental Industrial Hygienists
AT SDR
Agency for Toxic Substances and Disease Registry
Biomon.
Biomonitoring
BOD
Biochemical oxygen demand
BP
Boiling point
CAA
Clean Air Act
CASRN
Chemical Abstracts Service Registry Number
CBI
Confidential Business Information
CDR
Chemical Data Reporting
CERCLA
Comprehensive Environmental Response, Compensation, and Liability Act
CFR
Code of Federal Regulations
Concen.
Concentration
CWA
Clean Water Act
ECOTOX
Ecotoxicology Database
EPA
U.S. Environmental Protection Agency
EPCRA
Emergency Planning and Community Right-to-Know Act
FDA
U.S. Food and Drug Administration
FR
Federal Register
GC
Gas chromatography
HPLC
High performance liquid chromatography
IRIS
Integrated Risk Information System
IUR
Inventory Update Rule
K
Thousand
Koc
Organic carbon-water partition coefficient
Kow
Octanol-water partition coefficient
M
Million
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MITI
Ministry of International Trade and Industry
MP
Melting point
NAICS
North American Industry Classification System
NIH
National Institute of Health
NIOSH
National Institute for Occupational Safety and Health
NR
Not reported
OECD
Organisation for Economic Co-operation and Development
OH
Hydroxyl radical
OPPT
Office of Pollution Prevention and Toxics
OSHA
Occupational Safety and Health Administration
PEL
Permissible Exposure Limit
POTW
Publicly owned treatment works
PPE
Personal protective equipment
PPM
Parts per million
RCRA
Resource Conservation and Recovery Act
REL
Recommended Exposure Limit
RY
Reporting Year
SOP
Standard Operating Procedure
SMILES
Simplified Molecular-Input Line-Entry System
T1/2
Half-life
TBD
To be determined
TG
Test guidance
TLV
Threshold Limit Value
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
TWA
Time weighted average
USGS
United States Geological Survey
VP
Vapor pressure
WS
Water solubility
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1. Introduction
In section 6(b)(1)(B) of the Toxic Substances Control Act (TSCA), as amended, and in the U.S.
Environmental Protection Agency's implementing regulations (40 CFR 702.3)1, a high-priority
substance is defined as a chemical substance that the U.S. Environmental Protection Agency
(EPA) determines, without consideration of costs or other non-risk factors, may present an
unreasonable risk of injury to health or the environment because of a potential hazard and a
potential route of exposure under the conditions of use, including an unreasonable risk to
potentially exposed or susceptible subpopulations identified as relevant by EPA.
Before designating prioritization status, under EPA's regulations at 40 CFR 702.9 and pursuant
to TSCA section 6(b)(1)(A), EPA will generally use reasonably available information to review
the candidate chemical substance under its conditions of use against the following criteria and
considerations:
• the hazard and exposure potential of the chemical substance;
• persistence and bioaccumulation;
• potentially exposed or susceptible subpopulations;
• storage near significant sources of drinking water;
• conditions of use or significant changes in the conditions of use of the chemical
substance;
• the chemical substance's production volume or significant changes in production volume;
and
• other risk-based criteria that EPA determines to be relevant to the designation of the
chemical substance's priority.
This document presents the review of the candidate chemical substance against the criteria and
considerations set forth in 40 CFR 702.9 for a may present risk finding. The information sources
used are relevant to the criteria and considerations and consistent with the scientific standards of
TSCA section 26(h), including, as appropriate, sources for hazard and exposure data listed in
Appendices A and B of the TSCA Work Plan Chemicals: Methods Document (February 2012)
(40 CFR 702.9(b)). Final designation of the chemical substance as a high-priority chemical
substance would immediately initiate the risk evaluation process as described in the EPA's final
rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control
Act (40 CFR 702).
l,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[y]-2-benzopyran (HHCB) is one of the
40 chemical substances initiated for prioritization as referenced in the March 21, 2019 notice (84
FR 10491)2. EPA has determined that HHCB is a suitable candidate for the proposed designation
as a high-priority chemical substance. The proposed designation is based on the results of the
review against the aforementioned criteria and considerations as well as review of the reasonably
available information on HHCB, including relevant information received from the public and
other information as appropriate.
1 For all 40 CFR 702 citations, please refer to:
https://www.govinfo.gov/content/pkg/CFR-2018-tifle40-vol33/xml/CFR-2018-title40-vol33-part702-xml and
https://www.re gulations.gov/document?D=EPA-HO-OPPT-2Q .1.6-06
2 https://www.federalregister.gov/docnments/2019/03/21/2019-05404/initiation-of-prioritization-niider-the-toxic-
substances-control-act-tsca
1
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EPA will take comment on this proposed designation for 90 days before finalizing its designation
of HHCB. The docket number for providing comments on this chemical is EPA-HQ-OPPT-
2018-0430 and is available at www.regulations.gov.
The information, analysis and basis used for the review of the chemical is organized as follows:
• Section 1 (Introduction): This section explains the requirements of the amended TSCA
and implementing regulations - including the criteria and considerations — pertinent to
the prioritization and designation of high-priority chemical substances.
• Section 2 (Production volume or significant changes in production volume): This section
presents information and analysis on national aggregate production volume of the
chemical substance.
• Section 3 (Conditions of use or significant changes in conditions of use): This section
presents information and analysis regarding the chemical substance's conditions of use
under TSCA.
• Section 4 (Potentially exposed or susceptible subpopulations): This section presents
information and analysis regarding potentially exposed or susceptible subpopulations,
including children, women of reproductive age, and workers, with respect to the chemical
substance.
• Section 5 (Persistence and bioaccumulation): This section presents information and
analysis regarding the physical and chemical properties of the chemical substance and the
chemical's fate characteristics.
• Section 6 (Storage near significant sources of drinking water): This section presents
information and analysis considered regarding the risk from the storage of the chemical
substance near significant sources of drinking water.
• Section 7 (Hazardpotential): This section presents the hazard information relevant to the
chemical substance.
• Section 8 (Exposurepotential): This section presents information and analysis regarding
the exposures to the chemical substance.
• Section 9 (Other risk-based criteria): This section presents the extent to which EPA
identified other risk-based criteria that are relevant to the designation of the chemical
substance's priority.
• Section 10 (Proposed designation): Based on the results of the review performed and the
information and analysis presented, this section describes the basis used by EPA to
support the proposed designation.
2
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2. Production volume or significant changes in production volume
Approach
EPA considered current volume or significant changes in volume of the chemical substance
using information reported by manufacturers (including importers). EPA assembled reported
information for years 1986 through 2015 on the production volume for HHCB reported under the
Inventory Update Reporting (IUR) rule and Chemical Data Reporting (CDR) rule3.
Results and Discussion
The national aggregate production volume is presented in Table 1 as a range to protect individual
site production volumes that are confidential business information (CBI).
Table 1.1986-2015 National Aggregate Production Volume Data (Production Volume in
Pounds)
Chemical
ID
1986
1990
1994
1998
2002
2006
2011
2012
2013
2014
2015
HHCB
>500K
>1M
>1M
>1M
>1M
>1M
3,126,728
>1M
>1M
>1M
>1M
(1222-05-5)
to 1M
to
to
to
to
to
to
to
to
to
10M
10M
10M
10M
10M
10M
10M
10M
10M
Note: K = thousand; M = million
Reference: U.S. EPA (20.1.3) and U.S. EPA (20.1.7)
The aggregate production volume of HHCB in 2015, as reported to EPA during the 2016 CDR
reporting period, was between 1 and 10 million pounds. The exact aggregate production volume
is available for one year, 2011, in which 3.1 million pounds of HHCB was produced or imported.
Production volume of HHCB as reported to EPA has remained stable from 1986-2016 (Table 1).
According to public comments received, HHCB is imported into the United States consistently at
between 1 and 10 million pounds a year (EPA-HQ-OPPT-2018-0430-0004).
3 Over time, the requirements for reporting frequency, production volume thresholds, and chemical substances under
the Chemical Data Reporting (CDR) rule have changed. CDR was formerly known as the Inventory Update Rule
(IUR). The first IUR collection occurred in 1986 and continued every four years through 2006. As part of two
rulemakings in 2003 and 2005, EPA made a variety of changes to the IUR, including to change the reporting
frequency to every five years to address burdens associated with new reporting requirements. Additional changes to
reporting requirements were made in 2011, including to suspend and replace the 2011 submission period with a
2012 submission period, return to reporting every four years, and require the reporting of all years beginning with
2011 production volumes. The reporting of production volumes for all years was added because of the mounting
evidence that many chemical substances, even larger production volume chemical substances, often experience wide
fluctuations in production volume from year to year. In addition, also as part of the 2011 IUR Modifications final
rule (76 FR 50816, Aug 16, 2011), EPA changed the name of the regulation from IUR to CDR to better reflect the
distinction between this data collection (which includes exposure-related data) and the TSCA Inventory itself (which
only involves chemical identification information).
3
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3. Conditions of use or significant changes in conditions of use
Approach
EPA assembled information to determine conditions of use or significant changes in conditions
of use of the chemical substance. TSCA section 3(4) defines, the term "conditions of use" to
mean the circumstances, as determined by the Administrator, under which a chemical substance
is intended, known, or reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.
A key source of reasonably available information that EPA considered for determining the
conditions of use for HHCB was submitted by manufacturers (including importers) under the
2012 and 2016 CDR reporting cycles. CDR requires manufacturers (including importers) to
report information on the chemical substances they produce domestically or import into the
United States greater than 25,000 pounds per site, except if certain TSCA actions apply (in
which case the reporting requirement is greater than 2,500 pounds per site). CDR includes
information on the manufacturing, processing, and use of chemical substances. Based on the
known manufacturing, processing and uses of this chemical substance, EPA assumes distribution
in commerce. CDR may not provide information on other life-cycle phases such as distribution
or chemical end-of-life after use in products (i.e., disposal). While EPA may be aware of
additional uses, CDR submitters are not required to provide information on chemical uses that
are not regulated under TSCA.
HHCB is not included on the TRI chemical list. For purposes of this proposed prioritization
designation, EPA assumed end-of-life pathways that include releases to air, wastewater, and
solid and liquid waste based on the conditions of use.
CDR and TRI Tables
Based on the publicly available4 manufacturing information, industrial processing and use
information, and consumer and commercial use information reported under CDR, EPA
developed a list of conditions of use for the 2016 and 2012 reporting cycles (Tables 2 and 3,
respectively).
Table 2. HHCB (1222-05-5) Categories and Subcategories of Conditions of Use (2016 CDR
Reporting Cycle)
Life-Cycle
Stage
Category
Subcategory
Reference
Manufacturing
Domestic manufacture/Import
CBI5
019)
Import
Import
U.S. EPA (2019)
Processing
Processing - incorporating into
formulation, mixture, or reaction
product
Odor agent in:
- all other chemical product and
preparation manufacturing;
U.S. EPA (2019)
4 Some specific chemical uses reported by CDR submitters are confidential business information (CBI) under
section 14 of TSCA. In these cases, EPA has indicated that the information is CBI.
5 At this time, "CBI" indicates that a data element has been claimed CBI by the information submitter; it does not
reflect the result of an EPA substantiation review.
4
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Life-Cycle
Stage
Category
Subcategory
Reference
- miscellaneous manufacturing;
- soap, cleaning compound, and
toilet preparation manufacturing;
- other: fragrance mixtures
Processing
Processing - incorporating into
articles
Odor agent in plastics material
and resin manufacturing
U.S. EPA (2019)
Processing
Repackaging
Odor agent in all other chemical
product and preparation
manufacturing
U.S. EPA (2019)
Processing
Recycling
CBI4
U.S. EPA (2019)
Distribution in
commerceab
Distribution in commerce
Distribution in commerce
Industrial use
Surface active agents
Wholesale and retail trade
019)
Commercial
use
Air care products
Air care products
U.S. EPA (2019)
Cleaning and furnishing care
products
Cleaning and furnishing care
products
U.S. EPA (2019)
Laundry and dishwashing
products
Laundry and dishwashing
products
U.S. EPA (2019)
Personal care products
Personal care products
U.S. EPA (2019)
Plastic and rubber products not
covered elsewhere
Plastic and rubber products not
covered elsewhere
U.S. EPA (2019)
Other: aroma chemicals
Other: aroma chemicals
019)
Consumer use
Air care products
Air care products
U.S. EPA (2019)
Cleaning and furnishing care
products
Cleaning and furnishing care
products
U.S. EPA (2019)
Laundry and dishwashing
products
Laundry and dishwashing
products
U.S. EPA (2019)
Paper products
Paper products
U.S. EPA (2019)
Personal care products
Personal care products
019)
Plastic and rubber products not
covered elsewhere
Plastic and rubber products not
covered elsewhere
U.S. EPA (2019)
Consumer
uses
Other: aroma chemicals
Other: aroma chemicals
U.S. EPA (2019)
Non-TSCA use
Non-TSCA use
U.S. EPA (201'
Disposal
Disposal
5
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Life-Cycle
Stage
Category
Subcategory
Reference
Note: CBI = confidential business information; TSCA = Toxic Substances Control Act
a CDR includes information on the manufacturing, processing, and use of chemical substances. CDR may not
provide information on other life-cycle phases such as distribution or chemical end-of-life after use in products
(i.e., disposal). The table row is highlighted in gray to indicate that no information is provided for this life-cycle
stage.
b EPA is particularly interested in information from the public on distribution in commerce.
Table 3. HHCB (1222-05-5) Categories and Subcategories of Conditions of Use (2012 CDR
Reporting Cycle)
Life-Cycle
Stage
Category
Subcategory
Reference
Manufacturing
Domestic Manufacture/Import
CBI6
U.S. EPA (2019)
Import
Import
U.S. EPA (2019)
Processing
Processing - incorporating into
formulation, mixture, or
reaction product
Odor agent in:
- all other chemical product and
preparation manufacturing;
- soap, cleaning compound, and
toilet preparation
manufacturing;
- other: fragrance raw material
U.S. EPA (2019)
Processing
Processing - incorporating into
articles
Odor agent in plastics material
and resin manufacturing
019)
Processing
Repackaging
Odor agent in all other chemical
product and preparation
manufacturing
0.1.9)
Processing
Recycling
CBI5
0.1.9)
Distribution in
commerce
Dislnliulion in commerce
Commercial use
Air care products
Air care products
U.S. EPA (20.1.9)
Cleaning and furnishing care
products
Cleaning and furnishing care
products
U.S. EPA (20.1.9)
Laundry and dishwashing
products
Laundry and dishwashing
products
U.S. EPA (20.1.9)
Personal care products
Personal care products
U.S. EPA (20.1.9)
Plastic and rubber products not
covered elsewhere
Plastic and rubber products not
covered elsewhere
0.1.9)
6 At this time, "CBI" indicates that a data element has been claimed CBI by the information submitter; it does not
reflect the result of an EPA substantiation review.
6
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Life-Cycle
Stage
Category
Subcategory
Reference
Consumer use
Air care products
Air care products
U.S. EPA (2019)
Cleaning and furnishing care
products
Cleaning and furnishing care
products
U.S. EPA (2019)
Laundry and dishwashing
products
Laundry and dishwashing
products
U.S. EPA (2019)
Personal care products
Personal care products
U.S. EPA (2019)
Plastic and rubber products not
covered elsewhere
Plastic and rubber products not
covered elsewhere
0.1.9)
Non-TSCA use
Non-TSCA use
U.S. EPA (20.1.m
Disposal
Disposal
Note: CBI = confidential business information; TSCA = Toxic Substances Control Act
11 CDR includes information on the manufacturing, processing, and use of chemical substances. CDR may not
provide information on other life-cycle phases such as distribution or chemical end-of-life after use in products
(i.e., disposal). The table row is highlighted in gray to indicate that no information is provided for this life-cycle
stage.
b EPA is particularly interested in information from the public on distribution in commerce.
CDR Summary and Additional Information on Conditions of Use
According to the 2016 CDR reports, HHCB was imported into the United States. However, due
to CBI7, EPA cannot disclose whether HHCB was manufactured in the United States. HHCB is
processed in several ways: incorporated into formulation, mixture, or reaction products;
incorporated into articles; and repackaged. Due to CBI6, EPA cannot disclose whether HHCB is
recycled. The functional use reported for HHCB is as odor agent that is used in several industrial
sectors (e.g., miscellaneous manufacturing; soap, cleaning compound, and toilet preparation
manufacturing; plastics material and resin manufacturing; and all other chemical product and
preparation manufacturing).
The only industrial use reported in the 2016 CDR is as surface active agent for wholesale and
retail trade. The 2016 CDR includes several reports of commercial and consumer uses of HHCB
in air care products, cleaning and furnishing care products, laundry and dishwashing products,
personal care products, plastic and rubber products, and as aroma chemicals. The consumer uses
reported also include uses in paper products and non-TSCA uses. Consumer uses were also
identified in additional databases, which are included in the Exposure Potential section (Section
8). Based on CDR reporting, the reported processing of HHCB in 2016 was similar to the
reported processing in 2012.
According to public comments received, HHCB is manufactured outside the United States and
nine sites import CDR-reportable quantities of HHCB. The only TSCA use is as fragrance
ingredient in commercial and consumer products, and this use has not change significantly in
7 At this time, "CBI" indicates that a data element has been claimed CBI by the information submitter; it does not
reflect the result of an EPA substantiation review.
7
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recent years (EPA-HQ-OPPT-2018-0430-0004). Another public comment provided information
regarding the use of HHCB in consumer products, such as air fresheners, shampoos, and soaps,
however, a complete list was not provided given the difficulty to search for ingredients in
databases provided by the manufacturers (EPA-HQ-OPPT-2018-0430-0005). Similarly, another
commenter indicated that HHCB is a fragrance commonly used in detergents and other consumer
and personal care products (EPA-HQ-OPPT-2019-0131-0009). One other comment indicates
that HHCB is found as an impurity in amounts less than 0.1 percent in paints, coatings, sealants,
and adhesives (EPA-HQ-OPPT-2018-0430-0003).
Should the Agency decide to make a final decision to designate this chemical substance as a
high-priority substance, further characterization of relevant TSCA conditions of use will be
undertaken as part of the process of developing the scope of the risk evaluation.
4. Potentially exposed or susceptible subpopulations
Approach
In this review, EPA considered reasonably available information to identify potentially exposed
or susceptible subpopulations, such as children, women of reproductive age, workers, consumers
or the elderly. EPA analyzed processing and use information included on the CDR Form U that
indicates whether the chemical substance is used in products and articles subject to TSCA and
are intended for children. These data provide an indication about whether children or other
susceptible subpopulation may be potentially exposed (e.g., workers, women of reproductive
age). EPA also used human health hazard information to identify potentially exposed or
susceptible subpopulations.
Results and Discussion
At this stage, EPA identified children, women of reproductive age, consumers and workers as
subpopulations who may be potentially exposed or susceptible subpopulations for HHCB.
Children
EPA used data reported to the 2012 and 2016 CDR to identify uses in products and articles
intended for children over time for HHCB. According to the 2016 CDR, one site reported use of
HHCB in personal care products intended for children (Table 4). In the 2012 CDR, no uses in
children's products were reported.
Existing assessments reviewed lacked discussion on the susceptibility of children to HHCB
within children's products (U.S. EPA. 2014. U.S. EPA. 2008. EU. 20081 EPA also identified
potential developmental hazards that would impact any stage of children's development. A
public comment provided information regarding studies indicating the placental transfer of
HHCB in utero. According to the comment, these studies indicate that infants and fetuses are
vulnerable populations to consider with respect to HHCB exposure (EPA-HQ-OPPT-2018-0430-
0005).
8
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Table 4. Uses in C
lildren's Products Information
Chemical
Year
Product Category (Product
Concentration, Number of Workers)
Consumer or
Commercial
Used in Products
Intended for
Children
HHCB
(1222-05-5)
2012
Air care products (1% to <30% conc. by
wt.; 50-499 workers)
Consumer and
Commercial
No or NKRA
Cleaning and furnishing care products
(<1% to <30% conc. by wt.; 50-499
workers)
Consumer and
Commercial
No or NKRA
Laundry and dishwashing products (<1%
to <30% conc. by wt.; 50-499 workers)
Consumer and
Commercial
No or NKRA
Personal care products (<1% to <30%
conc. by wt.; 50-499 workers)
Consumer and
Commercial
NKRA
Plastic and rubber products not covered
elsewhere (<1% conc. by wt.; workers
NKRA)
Consumer and
Commercial
NKRA
Non-TSCA use (l%to <30% conc. by
wt.; workers NKRA)
Consumer
NKRA
2016
Air care products (<1% to <60% conc. by
wt.; <10-999 workers)
Consumer and
Commercial
No or NKRA
Cleaning and furnishing care products
(<1% to <30% conc. by wt.; <10-999
workers)
Consumer and
Commercial
No or NKRA
Laundry and dishwashing products (<1%
to <30% conc. by wt.; <10-499 workers)
Consumer and
Commercial
No or NKRA
Paper products (NKRA conc. by wt.; 100-
499 workers)
Consumer
NKRA
Personal care products (<1% to <30%
conc. by wt.; 50-499 workers)
Consumer and
Commercial
Yes or NKRA
Plastic and rubber products not covered
elsewhere (<1% conc. by wt.; workers
NKRA)
Consumer and
Commercial
No
Other: aroma chemicals (NKRA conc. by
wt.; workers NKRA)
Consumer and
Commercial
NKRA
Non-TSCA use (l%to <30% conc. by
wt.; workers NKRA)
Consumer
NKRA
TSCA = Toxic Substances Control Act; NKRA = not known or reasonably ascertainable
Reference: U.S. EPA (20.1.9)
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Women of reproductive age (e.g., pregnant women per TSCA statute)
EPA identified studies that observed developmental effects following exposure to HHCB
(Section 7, Table 7). No reproductive hazards were identified. EPA considers women of
reproductive age as a potentially exposed susceptible subpopulation. During the scoping and risk
evaluation process, reproductive hazards will be considered again following a systematic search
of the relevant scientific literature.
Consideration of women of reproductive age as a potentially exposed or susceptible
subpopulation was also based on exposure because women of reproductive age are potential
workers in the manufacturing, processing, distribution in commerce, use, or disposal of the
chemical substance.
Workers
Please refer to the Exposure Potential section (Section 8) for a summary of potential
occupational exposures, which EPA indicates that workers are potentially exposed or susceptible
subpopulations based on greater exposure.
Consumers
Please refer to the Exposure Potential section (Section 8) for a summary of potential consumer
exposures which EPA indicates that consumers are potentially exposed or susceptible
subpopulations based on greater exposure.
5. Persistence and bioaccumulation
Approach
EPA reviewed reasonably available data, such as physical and chemical properties and
environmental fate characteristics, to understand HHCB's persistence and bioaccumulation.
Physical and Chemical Properties and Environmental Fate Tables
Table 5 and Table Table 6 summarize the physical and chemical properties of HHCB, and
environmental fate characteristics of HHCB, respectively.
Table 5. Physical and Chemical Properties of HHCB
Property or
Endpoint
Value3
Reference
Molecular Formula
Ci8H260
PhvsProp Database (U.S. EPA. 2012b);
HSDB (2007)
Molecular Weight
258.41
PhvsProp Database (U.S. EPA. 2012b);
HSDB (2007)
Physical Stateb
Liquid
OECD (2009); EU (2008)
Physical Form
Colorless crystals
HSDB (2007) citing O'Neil (2013)
Purity
Purity: >95% w/w (sum of isomers)
EU12008)
10
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Property or
Endpoint
Value3
Reference
Diluents typically added to HHCB
include diethyl phthalate, benzyl
benzoate, or isopropyl myristate
Melting Pointb
-5 °C
PhvsProp Database (U.S. EPA. 2012b)
<-20"Cat 101,325 Pa
EU (2008)
(4S,7R) and (4R,7S) isomers 77-78
°C
(4R, 7R) and (4S, 7S) isomers 52-
58 °C
HSDB (2007) citina O'Neil (2013)
57-58 °C
HSDB (2007) citina O'Neil (2013)
Boiling Point
325°C
PhvsProp Database (U.S. EPA, 2012b)
318 "Cat 101,325 Pa
EU f'2008)
128 °C at 0.8 mm Hg
HSDB (2007) citina O'Neil (2013)
Density/Specific
gravity
1.0054 at 20 °C/4 °C
HSDB (2007) citina O'Neil (2013)
Vapor Pressure
5.45 x 10"4 mm Hg at °C
HSDB (2007) citina Balk and Ford (1999)
7.27 x 10"2 Pa at 25 °C
OECD (2009): EU (2008)
Vapor Density
TBD
TBD
Water Solubility
1.75 mg/L at 25 °C
HSDB (2007) citina Balk and Ford (1999)
1.65-1.99 mg/L
EU (2008)
Log Kow
5.9
EU (2008) citina Rudio (1993)
5.3
OECD (2009): EU (2008) citina Artola-
Garicanoa (2002)
Henry's Law
Constant
1.32 x 10"4 atm-m3/mol
Betterton and Hoffman (1988)
3.60 x 10 4 atm-m3/mol
EU (2008)
Flash Point
>100 °C (closed cup)
IFF (2001)
Auto Flammability
Not a flammable liquid; it is a
combustible liquid that can burn; no
pyrophoric properties
IFF (2001)
Viscosity
12,914 mPa second
HSDB (2007) citina ECHA (2018)
Refractive Index
1.53 at 20 °C
HSDB (2007) citina O'Neil (2013)
Dielectric Constant
TBD
TBD
Surface Tension
39.3 dyn/cm
EU (2008) citina IFF (2001)
aMeasured unless otherwise noted
11
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bHHCB is a mixture of various isomers that typically is a viscous liquid at room temperatures; the solid with higher
melting points represent isolated isomers
TBD = to be determined, if reasonably available. EPA is particularly interested in information from the
public on these properties or endpoints.
Table 6. Environmental Fate Characteristics of HHCB
Property or
Endpoint
Value8
Reference
Direct
Photodegradation
Direct photolysis is not expected to be an
important fate process because HHCB does
not contain chromophores that absorb at
wavelengths >290 nm
HSDB (2007)
Direct photolysis by sunlight and gas-phase
reaction with -OH radicals are considered to
be the major degradation routes for HHCB
in the atmosphere
OECD (2009)
Indirect
Photodegradation
ti/2 = 5 days (based on -OH reaction rate
constant of 2.6 x 10"11
cm3/molecules-second 25 °C and an -OH
concentration of 1.5 x 106 -OH/cm"3)
OECD (2009)
Hydrolysis
Stable; HHCB is not expected to undergo
hydrolysis in the environment due to its
chemical structure, which lacks functional
groups known to undergo hydrolysis under
environmental conditions
HSDB (2007): OECD (2009)
Biodegradation
0%/28 days CO2 evolution test (OECD test
guideline 301 B) (aerobic water)
HSDB (2007): EU (20081
18%/200 days activated sludge; by-
products identified were Galaxolide-lactone
and Galaxolide hydroxy acid
HSDB (2007) citing Balk and Ford
(1999)
Wastewater
Treatment
92% total removal (0.76% by
biodegradation, 91% by sludge and 0.14 by
volatilization to air; estimated)13
U.S. EPA (2012b)
91.5% removal activated sludge plant
EU (2008) citing Simonich et al. (2000)
Bioconcentration
Factor
1,584 (whole fish, wet weight) bluegill
sunfish (Lepomis macrochirus) OECD Test
guideline 305E
HSDB (2007) citina Balk and Ford
(1999)
624 (fresh weight) 33,200 (lipid) zebrafish
(Brachydanio rerio), OECD Test guideline
305E
EU (2008) citina Butte and Ewald
(1999)
Bioaccumulation
Factor
52,370 (crucian carp), 66,030 (common
carp), 39,400 (silver carp)
Hu (2011)
Soil Organic
Carbon:Water
4.87
EU (2008) citina MacGillivrav (1996)
3.6-3.9
EU (2008) citina Muller (2002)
12
-------
Property or
Endpoint
Value8
Reference
Partition
Coefficient
(Log Koc)
3.8
EU (2008) citine Artola-Garicanoa
(2002)
"Measured unless otherwise noted
bEPI Suite™ physical property inputs: Log Kow = 5.90, BP = 325.00 °C, MP = -5.00 °C, VP = 0.000545 mm Hg,
•OH = hydroxyl radical, WS = 1.75 mg/L, BIOP = 10,000, BioA = 10,000 and BioS = 10,000, SMILES:
0(CC(c(clcc(c2C(C3C)(C)C)C3(C)C)c2)C)Cl
Results and Discussion
HHCB, in a mixture of stereoisomers, is a liquid at room temperature (with melting points from
<-20 to -5 °C); however, purified isomers of HHCB are solids at room temperature with melting
points of 52-78 °C. HHCB has moderate water solubility (1.75 mg/L). Given its measured
Henry's Law constant (1.32 x 10"4 atm-m3/mol) and vapor pressure (5.45 x 10"4 mm Hg), HHCB
is expected to be moderately persistent in surface water and soil. In the air, HHCB may react
with photochemically produced hydroxyl radicals at a rate corresponding to a half-life of 5 days.
HHCB is not susceptible to direct photolysis because it does not absorb light at wavelengths
>290 nm. Similarly, HHCB is not expected to hydrolyze due to a lack of hydrolyzable functional
groups.
In aerobic aquatic environments, HHCB was not observed to be readily biodegradable, having
only achieved 0 percent degradation over 28 days in an OECD 301B CO2 evolution test. HHCB
degraded 18 percent in activated sludge over 200 days, with HHCB-lactone and HHCB-hydroxy
acid being the major by-products. HHCB is expected to persist in subsurface environments,
groundwater, or enclosed pipes based on these data. HHCB has a bioconcentration factors of
1,584 in Lepomis macrochirus and 624 Brachydanio rerio. Additionally, bioaccumulation
factors of 52,370, 66,030, and 39,400 were measured crucian carp, common carp, and silver
carp, respectively. The measured bioaccumulation factor and bioconcentration factor values
suggest that the potential for HHCB to bioaccumulate is high.
6. Storage near significant sources of drinking water
Approach
To support the proposed designation, EPA screened each chemical substance under its conditions
of use with respect to the seven criteria in TSCA section 6(b)(1)(A) and 40 CFR 702.9. The
statute specifically requires the Agency to consider the chemical substance's storage near
significant sources of drinking water, which EPA interprets as direction to focus on the chemical
substance's potential human health hazard and exposure.
EPA reviewed reasonably available information, specifically looking to identify certain types of
existing regulations or protections for the proposed chemical substances. EPA considered the
chemical substance's potential human health hazards, including to potentially exposed or
susceptible subpopulations, by identifying existing National Primary Drinking Water
Regulations under the Safe Drinking Water Act (SDWA; 40 CFR Part 141) and regulations
under the Clean Water Act (CWA; 40 CFR 401.15). In addition, EPA considered the
consolidated list of chemical substances subject to reporting requirements under the Emergency
13
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Planning and Community Right-to-Know Act (EPCRA; Section 302 Extremely Hazardous
Substances and Section 313 Toxic Chemicals), the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA; Hazardous Substances), and the Clean Air Act
(CAA) Section 112(r) (Regulated Chemicals for Accidental Release Prevention). Regulation by
one of these authorities is an indication that the substance is a potential health or environmental
hazard which, if released near a significant source of drinking water, could present an
unreasonable risk of injury to human health or the environment.
Results and Discussion
EPA has not established a Maximum Contaminant Level (MCL) or Maximum Contaminant
Level Goal (MCLG) for HHCB under SDWA. HHCB is not considered a priority pollutant
under the CWA. HHCB is also not subject to regulations under EPCRA, CERCLA, or CAA.
According to public comments received, HHCB is an extremely high-value industrial ingredient
that is stored indoors, at manufacturing facilities, in structurally sound, non-leaking tanks and
containers (EPA-HQ-OPPT-2018-0430-0004).
7. Hazard potential
Approach
EPA considered reasonably available information from peer-reviewed assessments and databases
to identify potential human health and environmental hazards for HHCB (Tables 7 and Table 8,
respectively).
Because there are few publicly available assessments for HHCB with cited environmental hazard
data, EPA uses the infrastructure of ECOTOXicology knowledgebase (ECOTOX) to identify
single chemical toxicity data for aquatic and terrestrial life ( .). It uses a
comprehensive chemical-specific literature search of the open literature that is conducted
according to the Standard Operating Procedures (SOPs)8. The environmental hazard information
was populated in ECOTOX and is available to the public. In comparison to the approach used to
survey human health hazard data, EPA also used a read-across approach to identify additional
environmental hazard data for isomers of HHCB, if available, to fill in potential data gaps when
there were no reported observed effects for specific taxa exposed to the HHCB (Table 8).
Potential Human Health and Environmental Hazard Tables and Additional Information on
Hazards
EPA identified potential human health and environmental hazards based on a review of the
reasonably available information for HHCB (Tables 7 and 8, respectively). In addition, EPA
received comments with references to studies identifying potential human health and
environmental concerns (EPA-HQ-OPPT-2018-0430-0005 and EPA-HQ-OPPT-2018-0430-
0006).
8 The ECOTOX SOPs can be found at https://cfpub.epa. gov/ecotox/help.cfm?helptabs=tab4
14
-------
Table 7. Potential Human Health Hazards Identified for HHCB
Human Health Hazards
Tested for
Specific Effect
Effect
Observed
Data Source
Acute Toxicity
X
U.S. EPA (2014). U.S. EPA (2008). EU
(2008)
Repeated Dose Toxicity
X
U.S. EPA (2014). U.S. EPA (2008). EU
(2008)
Genetic Toxicity
X
U.S. EPA (2014). U.S. EPA (2008). EU
(2008)
Reproductive Toxicity
X
U.S. EPA (2014). U.S. EPA (2008). EU
(2008)
Developmental Toxicity
X
X
U.S. EPA (2014). U.S. EPA (2008). EU
(2008)
Toxicokinetic
X
U.S. EPA (2014). EU (2008)
Irritation/Corrosion
X
U.S. EPA (2014). EU (2008)
Dermal Sensitization
X
U.S. EPA (2014). EU (2008)
Respiratory Sensitization
U.S. EPA (2014). EU (2008)
Carcinogenicity
U.S. EPA (2014). U.S. EPA (2008). EU
(2008)
Immunotoxicity
Neurotoxicity
X
U.S. EPA (2014). EU (2008)
Epidemiological Studies
or Biomonitoring Studies
X
U.S. EPA (2014). EU (2008)
Note: The "X" in the "Effect Observed" column indicates when a hazard effect was reported by one or more of the
referenced studies. Blank rows indicate when information was not identified during EPA's review of reasonably
available information to support the proposed designation.
15
-------
Table 8. Potential Environmental Hazards Identified for HHCB
Media
Study
Duration
Taxa Groups
High-Priority
Chemical Candidate
1,3,4,6,7,8-
Hexahydro-
4,6,6,7,8,8-
hexamethylcyclopent
a[y ]-2 benzopyran
(CASRN 1222-05-5)
Number of
Studies
Observed
Effects
Isomers of
1,3,4,6,7,8-
Hexahydro-
4,6,6,7,8,8-
hexamethylcyclopent
a[y]-2 benzopyran
(CASRN 1222-05-5)
NO^
Number of
Studies
E
Observed
Effects
Data Sources
Aquatic
Acute
exposure
Vegetation
1
X
Balk and Ford (1999)
Invertebrate
X
Artola-Garicano et al. (2003);
Chen et al. (2015); Gooding et al.
(2006); Parolini et al. (2015);
Wollenberger et al. (2003)
Fish
12
X
Carlsson and Norrgren (2004);
Fernandes et al. (2013); Fernandez
et al. (2013); Ribalta and Sole
(2014); Schnell et al. (2009);
Yamauchi et al. (2008); Zhang et al.
(2012)
Non-Fish Vertebrates
(i.e., amphibians, reptiles, mammals)
Chronic
exposure
Vegetation
Invertebrate
X
Artola-Garicano et al. (2003),
Balk and Ford (1999),
Breitholtz et al. (2003),
Parolini et al. (2015),
Wollenberger et al. (2003)
Fish
X
Balk and Ford (1999); Chen et al.
(2012); Lefebvre et al. (2017); Van
Dijk (1996); Zhang et al. (2012)
Non-Fish Vertebrates
(i.e., amphibians, reptiles, mammals)
X
Pablos et al. (2015)
16
-------
Media
Study
Duration
Taxa Groups
High-Priority
Chemical Candidate
1,3,4,6,7,8-
Hexahydro-
4,6,6,7,8,8-
hexamethylcyclopent
a[y ]-2 benzopyran
(CASRN 1222-05-5)
Number of
Studies
Observed
Effects
Isomers of
1,3,4,6,7,8-
Hexahydro-
4,6,6,7,8,8-
hexamethylcyclopent
a[y]-2 benzopyran
(CASRN 1222-05-5)
NO]\
Number of
Studies
E
Observed
Effects
Data Sources
Terrestrial
Acute
exposure
Vegetation
Invertebrate
Vertebrates
X
Chen et al. (2011); Liu et al. (2011);
Liu et al. (2012); Mori et al. (2006)
Chronic
exposure
Vegetation
Invertebrate
Vertebrates
X
Chen and Cai (2015); Chen et al.
(2014); Wang et al. (2013)
X
Balk and Ford (1999); Chen et al.
(2011); Liu etal. (2011)
The dash indicates that no studies relevant for environmental hazard were identified during this initial review and thus the "Observed Effects" column is left
blank.. The "X" in the "Observed Effects" column indicates when a hazard effect was reported by one or more of the referenced studies. The "N/A" in the
"Observed Effects" column indicates when a hazard effect was not reported by one of the referenced studies' abstract (full reference review has not been
conducted).
17
-------
8. Exposure potential
Approach
EPA considered reasonably available information to identify potential environmental,
worker/occupational, consumer, and general population exposures for HHCB.
Release potential for environmental and human health exposure
HHCB (CAS RN 1222-05-5) is not included on the TRI chemical list. EPA considered
information from existing assessments (U. S. EPA. 2 '008). conditions of use reported in
CDR and the physical and chemical properties to inform the release potential of HHCB.
Worker/Occupational and consumer exposure
EPA approach for assessing exposure potential was to review the physical and chemical
properties, conditions of use reported in CDR, and information from existing assessments (U.S.
W) for 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-Hexamethylcyclopenta[y]-2-
Benzopyran to inform occupational and consumer exposure potential. The results of this review
is detailed in the following tables.
General population exposure
EPA identified environmental concentration and human biomonitoring data to inform HHCB's
exposure potential to the general population (Table 10).
Results and Discussion
Release potential for environmental and human health exposure
In 2014, EPA noted that HHCB is produced solely outside of the United States (l_Js
2014). EPA anticipates releases of HHCB into the environment due to activities at import sites
where HHCB is diluted and compounded onsite after import, disposal, or waste treatment
activities, activities related to the blending of fragrance oils, as well as from the use of
commercial and consumer products ( 38). HHCB release into the environment from
industrial sources would be dependent upon frequency of specific processes. Cleaning of HHCB
mixing vessels in compounding operations that do not collect and incinerate remaining wash
solution may result in discharge to waste water; this waste water may or may not be further
treated, depending on the size of the processing plant and its capabilities, with the smaller
facilities having less strictly controlled treatment of emissions (ELI. 2008). The Ell assessment
noted HHCB releases to the environment through consumer product use would be primarily
through detergents, rather than cosmetics, and release from disposal of residue in empty
containers is expected to be minor (ELI. 2008).
HHCB was reported in water, soil/sediment environmental concentrations, as well as in human
blood. In 2014, EPA reported HHCB measurements in filtered and non-filtered drinking water,
wastewater influent and effluent, wastewater sludge, municipal sewage treatment effluent
streams, surface and groundwater located near wastewater discharge areas, bottom material from
top bed deposits within bodies of water, downstream surface water sediment of streams and
lakes, wastewater treatment biosolids subsequently disposed of through landfill/incineration or
known to be used for agricultural land application, agricultural, and suburban soil (
2014). Measured concentrations within biota were also reported and included sampling of
18
-------
aquatic organisms, aquatic mammals, birds, and higher trophic level aquatic organisms (U.S.
ID-
Research suggests moderate-range (regional) atmospheric transport of HHCB may occur;
however, long-range transport is unlikely (U.S. EPA. 2014). HHCB is considered to be of low to
moderate concern for bioaccumulation, with aquatic food-chain modeling indicating it is not
subject to biomagnification ( 014. EU. 2008).
When chemical substances are used as reactants and as intermediates, the industrial releases may
be a relatively low percentage of the production volume. Lower percentage releases occur when
a high percentage of the chemical reacts without excess loss during its use as an intermediate.
The actual percentages, quantities, and media of releases of the reported chemical associated
with this processing or use are unknown.
When chemical substances are repackaged, the industrial releases may be a relatively low
percentage of the production volume. Lower percentage releases occur when a high percentage
of the chemical is repackaged without significant process losses during its repackaging. The
actual percentages, quantities, and media of releases of the reported chemical associated with this
processing or use are unknown.
When chemical substances have commercial or consumer use as cleaning products, the releases
during end use may be a relatively high percentage of the production volume. Higher percentage
releases occur when the product containing the chemical is used in a way that is often disposed
to aqueous media. The actual percentage and quantity of release of the reported chemical
associated with this category are unknown but could be high.
Worker/occupational exposure
Worker exposures to this chemical may be affected by many factors, including but not limited to
volume produced, processed, distributed, used and disposed of; physical form and concentration;
processes of manufacture, processing, and use; chemical properties such as vapor pressure,
solubility, and water partition coefficient; local temperature and humidity; and exposure controls
such as engineering controls, administrative controls, and the existence of a personal protective
equipment (PPE) program.
HHCB does not have an Occupational Safety and Health Administration (OSHA) Permissible
Exposure Limit (PEL)9, a National Institute for Occupational Safety and Health (NIOSH)
Recommended Exposure Limit (REL)10, or the Threshold Limit Value (TLV) set by American
Conference of Governmental Industrial Hygienists (ACGIH).
HHCB has a vapor pressure of 5.45x 10"4 mm Hg at 25 °C/77 °F. EPA assumes that inhalation
exposure is negligible when vapors are generated from liquids or solids with vapor pressures
below 0.001 mm Hg at ambient room temperature conditions. Some handling activities of HHCB
9 OSHA, 2009. Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs).
https://www.osha.gov/cisg/anin3fated-peis/tablez-l.html
10 NIOSH, 2005. NIOSH Pocket Guide to Chemical Hazards, https://www.cdc.gov/niosli/npg/npgdcas.html
19
-------
may generate dust, particularly, when handled as a dry powder. Workers may be exposed to
aerosolized particles.
Consumer exposure
According to EPA ( ), HHCB is present in a multitude of consumer products (Table 9).
TSCA uses for HHCB include as an ingredient in detergents, fabric softeners, dishwashing
detergents, and commercial and consumer general purpose cleaners. Non-TSCA uses include
cosmetics and personal care products, which are regulated under the Federal Food, Drug, and
Cosmetic Act (U.S. EPA. 2014). The main route of exposure to consumers was assumed as
dermal, with some inhalation exposures and no oral exposures ( 14) ¦
Table 9. Exposure Information for Consumers
Chemical
Identity
Consumer Uses (List)
HHCB
(1222-05-5)
Absorbent, adsorbent, air fresheners, air treatment, automotive care, automotive
cleaner, candle, cleaner, detergent, detergent fragrance, dishwashing detergent,
dry cleaning, floor cleaner, fluid property modulator, fragrance, furniture
cleaner, paint, plastic, polish, propellant, soap, soap fragrance, textile cleaner,
toilet cleaner
Reference: U.S. EPA 2014
The estimated exposure to HHCB on the skin from the use of a combination of all classes of
consumer products on a daily basis was calculated by a European Union (EU) assessment to
result in a "worst case situation" of 0.85 mg/kg body weight per day (EU. 2008). The inhalation
exposure of consumers to HHCB in household cleaning products and air fresheners was
estimated as lower, in total 0.0085 mg/kg body weight per day (EU. 2008). The 2008 EU
assessment concluded there was no need for further information and/or testing and no need for
risk reduction measures beyond those already being applied for consumers (EU. 2008).
General population exposure
HHCB was reported in water, and soil/sediment environmental concentrations, as well as in
human blood.
Releases of HHCB from specific conditions of use, such as consumer and industrial use product
processing through fragrance compounding and end-product formulation, disposal, or waste
treatment activities may result in general population exposures due to ingestion of contaminated
drinking water near industrial processing sites (U.S. EPA. 2014. ELI 2008). HHCB was reported
in water, soil/sediment environmental concentrations, and in human blood. In the 2014
assessment EPA reported HHCB measured in filtered and non-filtered drinking water,
wastewater influent and effluent, wastewater sludge, municipal sewage treatment effluent
streams, surface and groundwater located near wastewater discharge areas, bottom material from
top bed deposits within bodies of water, downstream surface water sediment of streams and
lakes, wastewater treatment biosolids subsequently disposed of through landfill/incineration or
known to be used for agricultural land application, agricultural and suburban soil (
2014). Measured concentrations within biota were also reported in the 2014 assessment
20
-------
describing sampling of aquatic organisms, aquatic mammals, birds, and higher trophic level
aquatic organisms (U.S. EPA.: ) Research suggests moderate-range (regional) atmospheric
transport of HHCB may occur, however long-range transport is unlikely (U.S. EPA. 2014).
Table 10. Exposure Information for the Environment and Genera
Population
Database Name
Environmental
Concen. Data
Present?3
Human
Biomon.
Data
Present?b
Ecological
Biomon.
Data
Present? b
Reference
California Air Resources Board
no
no
no
CARB (2005)
Comparative Toxicogenomics Database
no
no
no
MDI (2002)
EPA Ambient Monitoring Technology
Information Center - Air Toxics Data
no
no
no
U.S. EPA
0]
EPA Discharge Monitoring Report Data
no
no
no
U.S. EPA
(2007)
EPA Unregulated Contaminant Monitoring
Rule
no
no
no
U.S. EPA
6)
FDA Total Diet Study
no
no
no
Great Lakes Environmental Database
no
no
no
U.S. EPA
(2018b)
Information Platform for Chemical
Monitoring Data
no
no
no
EC (2018)
International Council for the Exploration of
the Sea
no
no
no
ICES (2018)
OECD Monitoring Database
no
yes
no
OECD (2018)
Targeted National Sewage Sludge Survey
no
no
no
U.S. EPA
The National Health and Nutrition
Examination Survey
no
no
no
CDC (2013)
USGS Monitoring Data -National Water
Quality Monitoring Council
yes
no
no
USGS
USGS Monitoring Data -National Water
Quality Monitoring Council, Air
no
no
no
USGS
USGS Monitoring Data -National Water
Quality Monitoring Council, Ground Water
yes
no
no
USGS
USGS Monitoring Data -National Water
Quality Monitoring Council, Sediment
yes
no
no
USGS
USGS Monitoring Data -National Water
Quality Monitoring Council, Soil
yes
no
no
USGS
USGS Monitoring Data -National Water
Quality Monitoring Council, Surface Water
yes
no
no
use.
USGS Monitoring Data -National Water
Quality Monitoring Council, Tissue
no
no
no
USGS
a Concen.= concentration
b Biomon.= biomonitoring
21
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Human exposure through ingestion of water and food including fish, root crops, and mother's
milk was noted in the 2014 assessments as the main route of exposure to humans, as exposure by
the inhalation route to the general population was considered to be negligible ( 14).
A EU assessment concluded there was no need for further information and/or testing and no need
for risk reduction measures beyond those already applied for the general population exposed via
the environment (EU. 2008).
9. Other risk-based criteria that EPA determines to be relevant to the designation of
the chemical substance's priority
EPA did not identify other risk-based criteria relevant to the designation of the chemical
substance's priority.
10. Proposed designation and Rationale
Proposed designation: High-priority substance
Rationale: EPA identified and analyzed reasonably available information for exposure and
hazard and is proposing to find that HHCB may present an unreasonable risk of injury to health
and/or the environment, including potentially exposed or susceptible subpopulations, (e.g.,
workers, consumers, women of reproductive age, children). This is based on the potential hazard
and potential exposure of HCCB under the conditions of use described in this document to
support the prioritization designation. Specifically, EPA expects that the manufacturing,
processing, distribution, use and disposal of HHCB may result in presence of the chemical in
surface water and groundwater, ingestion of the chemical in drinking water, exposure to workers,
exposure to consumers and exposure to the general population, including exposure to children. In
addition, EPA identified potential environmental (e.g., aquatic toxicity, terrestrial toxicity) and
human health hazards (e.g., developmental toxicity).
22
-------
11. References
*Note: All hyperlinked in-text citations are also listed below *
Artola-Garicano, E. (2002). Distribution behaviour of polycyclic musks in sewage treatment
plants and in biota. Interpretation of data using free and total concentration measurements.
Utrecht, The Netherlands: Institute for Risk Assessment Sciences IRA.
Artola-Garicano, E; Sinnige, TL; van Holsteijn, I; Vaes, WHJ; Hermens, JL. (2003).
Bioconcentration and acute toxicity of polycyclic musks in two benthic organisms (Chironomus
riparius and Lumbriculus variegatus). Environmental Toxicology and Chemistry 22: 1086-1092.
https://www.ncbi.nlm.nih.eoY/pubmed/1272.92.18
Balk, F; Ford, RA. (1999). Environmental risk assessment for the polycyclic musks AHTN and
HHCB in the EU. I. Fate and exposure assessment. Toxicology Letters 111: 57-79.
https://www.ncbi.nlm.nih.gov/piibmed/106307Q3
Balk, F; Ford, RA. (1999). Environmental risk assessment for the polycyclic musks, AHTN and
HHCB. II. Effect assessment and risk characterisation. Toxicology Letters 111: 81-94.
https://www.ncbi.nlm .nih. eov/pubmed/1063 0704
Betterton, EA; Hoffmann, MR. (1988). Henry's law constants of some environmentally
important aldehydes. Environmental Science and Technology 22: 1415-1418.
http://dx.doi. ore ;s00177a004
Breitholtz, M; Wollenberger, L; Dinan, L. (2003). Effects of four synthetic musks on the life
cycle of the harpacticoid copepod Nitocra spinipes. Aquatic Toxicology 63: 103-118.
https://www.ncbi.nlm.nih.eov/piibmed/12657486
Butte, W; Ewald, F. (1999). Kinetics of accumulation and clearance of the polycyclic musk
compounds Galaxolide (HHCB) and Tonalide (AHTN). Germany: University Oldenburg.
CARB (California Air Resources Board). (2005). California Air Resources Board (CARB):
Indoor air pollution in California [Database], Retrieved from
https://www.arb.ca.eov/research/apr/reports/13041.pdf
Carlsson, G; Norrgren, L. (2004). Synthetic musk toxicity to early life stages of zebrafish (Danio
rerio). Archives of Environment Contamination and Toxicology 46: 102-105.
https://www.ncbi.nlm.nih.eov/pubmed/15025169
CDC (Centers for Diseases Control and Prevention). (2013). National Health and Nutrition
Examination Survey Data (NHANES) [Database], Atlanta, GA: CDC, National Center for
Health Statistics. Retrieved from https://www.cdc.eov/nchs/nhan.es/in.dex.htm.
Chen, C; Cai, Z. (2015). Physiological and antioxidant responses in wheat (Triticum aestivum) to
HHCB in soil. Bulletin of Environmental Contamination and Toxicology 95: 272-277.
http://dx.doi.ore 00128-015-1565-x
23
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Chen, C; Xue, S; Zhou, Q; Xie, X. (2011). Multilevel ecotoxicity assessment of polycyclic musk
in the earthworm Eisenia fetida using traditional and molecular endpoints. Ecotoxicology 20:
1949-1958. https://www.ncbi.nlm.nih.eov/pubmed/21789675
Chen, C; Zhou, Q; Cai, Z. (2014). Effect of soil HHCB on cadmium accumulation and
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