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September, 2014
SCREENING-LEVEL HAZARD CHARACTERIZATION
Heavy Fuel Oils Category
SPONSORED CHEMICALS
(See Table 1)
SUPPORTING CHEMICALS
(See Table 1)
The High Production Volume (HPV) Challenge Program1 was conceived as a voluntary initiative aimed
at developing and making publicly available screening-level health and environmental effects information
on chemicals manufactured in or imported into the United States in quantities greater than one million
pounds per year. In the Challenge Program, producers and importers of HPV chemicals voluntarily
sponsored chemicals; sponsorship entailed the identification and initial assessment of the adequacy of
existing toxicity data/information, conducting new testing if adequate data did not exist, and making both
new and existing data and information available to the public. Each complete data submission contains
data on 18 internationally agreed to "SIDS" (Screening Information Data Set1'2) endpoints that are
screening-level indicators of potential hazards (toxicity) for humans or the environment.
The Environmental Protection Agency's Office of Pollution Prevention and Toxics (OPPT) is evaluating
the data submitted in the HPV Challenge Program on approximately 1400 sponsored chemicals by
developing hazard characterizations (HCs). These HCs consist of an evaluation of the quality and
completeness of the data set provided in the Challenge Program submissions. They are not intended to be
definitive statements regarding the possibility of unreasonable risk of injury to health or the environment.
The evaluation is performed according to established EPA guidance2,3 and is based primarily on hazard
data provided by sponsors; however, in preparing the hazard characterization, EPA considered its own
comments and public comments on the original submission as well as the sponsor's responses to
comments and revisions made to the submission. In order to determine whether any new hazard
information was developed since the time of the HPV submission, a search of the following databases was
made from one year prior to the date of the HPV Challenge submission to the present: (ChemID to locate
available data sources including Medline/PubMed, Toxline, HSDB, IRIS, NTP, ATSDR, IARC,
EXTOXNET, EPA SRS, etc.), STN/CAS online databases (Registry file for locators, ChemAbs for
toxicology data, RTECS, Merck, etc.), Science Direct and ECHA4. OPPT's focus on these specific
sources is based on their being of high quality, highly relevant to hazard characterization, and publicly
available.
1 U.S. EPA. High Production Volume (HPV) Challenge Program; http://www.epa.gov/chemrtk/index.htm.
2 U.S. EPA. HPV Challenge Program - Information Sources; http://www.epa.gov/chemrtk/pubs/general/guidocs.htm.
3 U.S. EPA. Risk Assessment Guidelines; http://cfpub.epa.gov/ncea/raf/rafguid.cfm.
4European Chemicals Agency, http://echa.europa.eu
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OPPT may not develop HCs for those HPV chemicals which have recently been assessed and published
internationally through the HPV program of the Organization for Economic Cooperation and
Development (OECD) and for which Screening Initial Data Set (SIDS) Initial Assessment Reports
(SIAR) and SIDS Initial Assessment Profiles (SIAP) are available. These documents are presented in an
international forum that involves review and endorsement by governmental authorities around the world.
OPPT is an active participant in these meetings and accepts these documents as reliable screening-level
hazard assessments. HCs may be created if new data suggest a need to update the case work where the
OECD document will be used as key support documentation.
These hazard characterizations are technical documents intended to inform subsequent decisions and
actions by OPPT. Accordingly, the documents are not written with the goal of informing the general
public. However, they do provide a vehicle for public access to a concise assessment of the raw technical
data on HPV chemicals and provide information previously not readily available to the public.
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TABLE OF CONTENTS
List of Tables 4
Heavy Fuel Oils Category Summary 5
Category Identification/Justification 11
Justification for Supporting Chemicals 12
1. Chemical Identity 16
2. General Information on Exposure 27
Conclusion 36
3. Human Health Hazard 37
Acute Oral Toxicity 37
Acute Inhalation Toxicity 39
Acute Dermal Toxicity 39
Repeated-Dose Toxicity 41
Reproductive Toxicity 57
Developmental Toxicity 57
Genetic Toxicity - Gene Mutation 86
Genetic Toxicity - Chromosomal Aberrations 88
Genetic Toxicity - Other Information 89
Skin Irritation 90
Eye Irritation 93
Sensitization 94
Carcinogenicity 97
Conclusion 98
4. Hazard to the Environment 115
Acute Toxicity to Fish 115
Acute Toxicity to Aquatic Invertebrates 115
Toxicity to Aquatic Plants 115
Chronic Toxicity to Aquatic Invertebrates 115
Conclusion 115
5. References 115
Appendix 116
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LIST OF TABLES
TABLE 1. Heavy Fuel Oils CA Index Names, CAS Numbers and Subcategories for Health Effects
Endpoints 13
TABLE 2. Physical-Chemical Properties of Heavy Fuel Oils 16
TABLE 3. Environmental Fate Characteristics of Heavy Fuel Oils 28
TABLE 4. Summary Table of the Screening Information Data Set as submitted under the U.S. HPV
Challenge Program - Human Health Data 103
TABLE 5. Summary Table of the Screening Information Data Set as submitted under the U.S. HPV
Challenge Program - Aquatic Toxicity Data 115
LIST OF APPENDICES
APPENDIX A. Description of Process Streams 117
APPENDIX B. Representative Structures and TSCA Description of Heavy Fuel Oils Category 121
APPENDIX C. Cracking Processes 140
APPENDIX D. Poly-Aromatic Contents (PAC) Analytical Profile of Heavy Fuel Oils 141
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Category Name
Heavy Fuel Oils
Chemical Abstract Service Registry
Number (CASRN)
See Table 1
Chemical Abstract Index Name
Structural Formula
See Appendix
Summary
Heavy fuel oils are viscous liquid blends of the residues and distillates that are derived from
various refinery distillations, cracking, and reforming processes. These heavy fuel oils are
complex mixtures which may boil in the range of 121 to 600°C and consist of aromatic,
aliphatic, and naphthenic hydrocarbons, generally having carbon numbers in the range of C7 to
C50, together with asphaltenes and smaller amounts of heterocyclic compounds containing
sulfur, nitrogen, and oxygen. The lower molecular weight components of these complex
mixtures possess low to moderate water solubility while higher molecular weight fractions have
negligible solubility in water. The lower molecular weight components of the heavy fuel oil
category have moderate to high vapor pressure while higher molecular weight fractions tend to
possess negligible to low vapor pressure. The components of the heavy fuel oils category will
have low mobility in soil. Volatilization is expected to be moderate to high for most constituents
of the heavy fuel oils. The rate of hydrolysis is negligible since paraffins, naphthenes, and the
aromatic hydrocarbons contained in this category do not possess functional groups that
hydrolyze under environmental conditions. The rate of atmospheric photooxidation is expected
to be slow to rapid for most components of the heavy fuel oils. The components of this category
are not expected to be readily biodegradable. The components of heavy fuel oils are expected to
possess low (PI) to high (P3) persistence and low (Bl) to high (B3) bioaccumulation potential.
Human Health Hazard
Subcategory I: Residual Fuel Oils
The acute oral toxicity to rats and acute dermal toxicity to rabbits of CASRN 68553-00-4 is low,
while the acute inhalation toxicity to rats for CASRN 68476-33-5 is moderate. In a 28-day
repeated-dose dermal toxicity study in rats with CASRN 68476-33-5, the following systemic
effects were observed at the lowest tested dose of 480 mg/kg-day: increased liver and spleen
weights and decreased hemoglobin and hematocrit values. The NOAEL is not established. No
data are available for reproductive and developmental toxicity. CASRN 68553-00- 4 was not
mutagenic in bacteria but was mutagenic in mammalian cells in vitro. CASRN 68553-00-4
induced chromosomal aberrations in rat bone marrow cells in vivo. CASRN 68553-00-4 was
irritating to rabbit skin and eyes and sensitizing to guinea pigs skin.
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For Subcategory I, the reproductive and developmental toxicity endpoints were identified as data
gaps under the HPV Challenge Program.
Subcategory II: Atmospheric Residual
The acute oral toxicity to rats and acute dermal toxicity to rabbits of CASRN 64741-45-3 is low.
Following a 4-week dermal exposure of rats to CASRN 64741-45-3, no systemic effects were
noted. The NOAEL is 940 mg/kg-day (highest dose tested). Data for reproductive toxicity are
not available. The prenatal developmental toxicity study in rats, via the dermal route with
CASRN 64741-45-3, was conducted with fewer rats (10-15/dose) than recommended by the
guidelines; but the study is acceptable. The study provided LOAELs of 1000 mg/kg-day and
NOAELs of 333 mg/kg-day for both maternal and developmental toxicity. The maternal effects
include a significant decrease in gestational body weights and significantly increased gestational
length. The developmental effects include significantly decreased pup body weights. No data
are available for gene mutation or chromosomal aberrations endpoints. CASRN 64741-45-3 was
irritating to rabbit skin, not irritating to rabbit eyes and not-sensitizing to guinea pig skin.
For Subcategory II, the reproductive toxicity, gene mutation and chromosomal aberrations
endpoints were identified as data gaps under the HPV Challenge Program.
Subcategory III: Atmospheric Distillate
The acute dermal toxicity of CASRN 68476-34-6 (supporting chemical stream) to rabbits is low.
A 13-week dermal toxicity study conducted in rats with CASRN 68915-97-9 (supporting
chemical stream), showed a LOAEL of 125 mg/kg-day based on effects on clinical chemistry
(increased BUN, cholesterol, sorbitol dehydrogenase, total protein, globulin and decreased A/G
ratio) and hematology (decreased RBC, hemoglobin, hematocrit and platelets) parameters and
relative organ weights (liver, thymus, adrenals, heart, kidney, spleen). The NOAEL is 30 mg/kg-
day. No reproductive toxicity data are available.
A total of five pre-natal developmental toxicity studies were performed using both sponsored
chemicals and on one supporting chemical; all studies used the dermal route of exposure. In a
prenatal dermal developmental toxicity study of CASRN 68410-00-4 in rats (25/dose), the
LOAEL for maternal toxicity is 250 mg/kg-day based on significantly decreased body weights
and body weight gains; the NOAEL is 50 mg/kg-day. No developmental effects were seen in
this study; the NOAEL for developmental toxicity is 500 mg/kg-day (highest dose tested).
In two other prenatal dermal developmental toxicity studies with CASRN 68410-00-4 using
fewer animals (12-19/dose) and having different compositions of polyaromatic compounds
(PACs), the range for LOAELs for maternal toxicity is 250 to 500 mg/kg-day and that for
developmental toxicity is 125 to 150 mg/kg-day. The maternal effects include decreased body
weight, body weight gain and food consumption. The developmental effects include decreased
pup weights. The NOAELs for maternal toxicity range from 125 to 150 mg/kg-day and
NOAELs for developmental toxicity range from "not established" to 50 mg/kg-day. In another
prenatal dermal developmental toxicity study of CASRN 68783-08-4 in rats, conducted using
fewer animals (12-19/dose),the LOAEL for both maternal and developmental toxicity is 250
mg/kg-day. The maternal effects include significant decreases in body weights, body weight
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gains and food consumption and developmental effects include significantly decreased number
of total and live pups delivered, decreased pup body weights and incomplete ossification. The
NOAEL for maternal and developmental toxicity is 50 mg/kg-day. For the supporting chemical
stream CASRN 68915-97-9, the LOAEL for maternal and developmental toxicity is 125 mg/kg-
day; the NOAEL is 30 mg/kg-day. The maternal effects include decreased body weight, body
weight gains and food consumption. Developmental effects include decreased total and live
pups delivered, decreased pup body weights and incomplete ossification. No data are available
for gene mutation or chromosomal aberrations endpoints. CASRN 68476-34-6 (supporting
chemical stream) was irritating to rabbit skin.
For Subcategory III, the reproductive toxicity, gene mutation and chromosomal aberrations
endpoints were identified as data gaps under the HPV Challenge Program.
Subcategory IV: Vacuum Residual
There were no data available on either of the two sponsored chemicals. The acute oral toxicity
to rats and acute dermal toxicity to rabbits of CASRN 64741-56-6 (supporting chemical stream)
is low; and the acute inhalation toxicity to rats is moderate. In the 4-week repeated-dose dermal
toxicity study of CASRN 64741-56-6 (supporting chemical stream) in rabbits, the LOAEL of
2000 mg/kg-day is based on decreased body weight gains and decreased alkaline phosphatase
activity in male rabbits. The NOAEL is 1000 mg/kg-day. No reproductive or developmental
toxicity data are available. CASRN 64741-56-6 (supporting chemical stream) was mutagenic in
bacteria in vitro. No data for chromosomal aberrations are available. CASRN 64741-56-6
(supporting chemical stream) was irritating to rabbit skin but not to rabbit eyes. CASRN 68512-
62-9 was not sensitizing to guinea pig skin.
For Subcategory IV, the reproductive and developmental toxicity and chromosomal aberrations
endpoints were identified as data gaps under the HPV Challenge Program.
Subcategory V: Vacuum Distillate
The acute oral toxicity to rats and acute dermal toxicity to rabbits of CASRN 64741-57-7 is low.
A 13-week dermal toxicity study in rats with CASRN 64741-57-7 showed a LOAEL of 125
mg/kg-day based on effects on hematological parameters (decreased RBC count, hemoglobin,
hematocrit and platelets). The NOAEL is 30 mg/kg-day. No reproductive toxicity data are
available. A number of prenatal developmental toxicity studies were conducted via dermal
exposure to CASRN 64741-57-7. In one study in rats (25/dose), CASRN 64741-57-7 showed a
LOAEL of 75 mg/kg-day for maternal toxicity based on significantly decreased body weights
and body weight gains; the NOAEL is not established. The developmental toxicity LOAEL is
75 mg/kg-day based on significantly decreased pup body weight, increased incidence of
microphthalmia and delayed ossifications; the NOAEL is not established. In another study in
rats (25/dose), CASRN 64741-57-7 showed a LOAEL of 100 mg/kg-day for maternal toxicity
based on significantly decreased body weights and body weight gains; a NOAEL of 50 mg/kg-
day. The developmental toxicity LOAEL is 250 mg/kg-day based on significantly decreased pup
body weight, and increased variations in fetal skeletal ossifications; the NOAEL is 100 mg/kg-
day. Several similar studies with CASRN 64741-57-7 using fewer animals
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(10-20/dose) and varying compositions of PACs showed similar effects with LOAELs ranging
from 150 to 500 mg/kg-day for both maternal and developmental toxicity. The range for
NOAELs is 1 to 125 mg/kg-day. Additional maternal effects in these studies were vaginal red
discharge, effects on thymus and decreased numbers of implantation sites. In a prenatal
developmental toxicity study in rats via the dermal route with CASRN 64742-86-5 conducted
with fewer animals (12-15/dose), the LOAEL for maternal and developmental toxicity is 333
mg/kg-day based on significantly decreased body weights and body weight gains for maternal
toxicity and significantly decreased pup body weight and dead pups delivered for developmental
toxicity. The NOAEL is 50 mg/kg-day. No data for gene mutation are available; CASRN
65741-57-7 did not induce micronuclei when tested in vivo. CASRNs 64741-57-7 and 64742-
86-5 were irritating to rabbit skin and eyes and CASRN 64741-57-7 was non-sensitizing to
guinea pig skin.
For Subcategory V, the reproductive toxicity and gene mutation endpoints were identified as
data gaps under the HPV Challenge Program.
Subcategory VI: Cracked Residual
The acute oral toxicity to rats and acute dermal toxicity to rabbits of CASRN 64741-62-4 is low.
There were several repeated-dose toxicity studies in rats via the dermal route with CASRN
64741-62-4. In a 13-week study, a LOAEL of 8 mg/kg-day was based on effects on the liver and
thymus (increased liver weights and decreased thymus weight and histopathological findings),
body weight and body weight gains, and/or effects on hematology and clinical chemistry
parameters. The NOAEL was not established. Similar effects were seen in several 28-day
studies with a lowest LOAEL of 10 mg/kg-day and NOAEL not established. One of the 28-day
studies also showed microscopic changes in the skin (sub-acute acanthotic dermatitis, minimal to
severe early multifocal papillomatosis (skin surface elevation caused by hyperplasia and
enlargement of contiguous dermal papillae)) at 2000 mg/kg-day. For CASRN 64741-75-9, a 28-
day dermal toxicity study in rats resulted in a NOAEL of 210 mg/kg-day, the highest dose tested.
A 13-week dermal toxicity study with CASRN 64741-80-6 showed a LOAEL of 60 mg/kg-day
based on effects on liver, adrenals and alanine amino transferase; the NOAEL is not established.
No reproductive toxicity data are available. A dominant lethal assay in rats (treated male rats
mated with untreated females) showed no effects. In a prenatal developmental toxicity study of
CASRN 64741-62-4 in rats (24/dose) via the dermal route, the LOAEL for maternal toxicity is
1.0 mg/kg-day based on increased vaginal red discharge, significantly decreased body weights
and food consumption; the NOAEL is 0.05 mg/kg-day. The LOAEL for developmental toxicity
is 1.0 mg/kg-day; the effects include increased resorptions, decreased number of live fetuses,
decreased body weights and increased incidence of fetal variations (moderate dilation of renal
pelvis, slight dilation of lateral ventricle of brain, bifid thoracic vertebral centrum and decreased
average number of ossified caudal vertebrae). The NOAEL for developmental toxicity is 0.05
mg/kg-day. Several other studies are conducted using fewer animals (10-15/dose) than
recommended by guidelines. For CASRN 64741-62-4 with varying compositions of PACs, the
range of LOAEL values for maternal toxicity is 4 to 100 mg/kg-day. The effects include
decreased body weights and body weight gains, food consumption, increased vaginal discharge,
increased gestational length, and/or thymus atrophy. The range for LOAEL values for
developmental toxicity in these studies is 4 to 250 mg/kg-day. The effects include decreased pup
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body weights, decreased number of pups delivered per litter, increased resorptions, decreased
number of male pups, decreased crown-rump length and/or fetal alterations. The range for
NOAELs for maternal toxicity and developmental toxicity is 'not established' to 10 mg/kg-day.
CASRN 64741-62-4 was not mutagenic in mammalian cells in vitro and did not induce
chromosomal aberrations in vivo; however, it induced sister chromatid exchanges in vitro and
unscheduled DNA synthesis in vitro and in vivo. CASRN 64741-62-4 did not induce dominant
lethal mutation in rat germ cells. CASRN 64741-62-4 was irritating to rabbit skin and eyes and
was not sensitizing to guinea pigs skin. CASRNs 64741-62-4 and 68187-58-6 increased tumor
incidences in mice.
For Subcategory VI, the reproductive toxicity endpoint was identified as a data gap under the
HPV Challenge Program.
Subcategory VII: Cracked Distillate
The acute oral toxicity to rats and acute dermal toxicity to rabbits of CASRN 64741-81-7 is low.
Among several 13-week repeated-dose dermal toxicity studies in rats conducted with CASRN
64741-81-7 with varying composition of PACs, the range of LOAEL values is 30 to 125 mg/kg-
day. The systemic effects include decreased body weights, increased relative testes weights,
decreased epididymis weights and/or decreased hematocrit and MCH values. The range of
NOAEL values is 'not established' to 30 mg/kg-day. In two 28-day repeated-dose dermal
toxicity studies in rats with CASRN 64741-81-7, the LOAEL range is 93 - 930 mg/kg-day based
on effects on liver and hematology parameters. The NOAEL range is 9.3 to 93 mg/kg-day. A
28-day repeated-dose dermal toxicity study of CASRN 64741-61-3 in rats showed a LOAEL of
99 mg/kg-day based on effects on liver weights and hematology parameters. The NOAEL is 9.9
mg/kg-day. No data are available on reproductive toxicity. All developmental toxicity studies
for this subcategory are conducted via dermal route and using fewer animals (10-15/dose) than
that recommended by the guidelines. For CASRN 64741-81-7 with varying compositions of
PACs, the range of LOAEL values for maternal toxicity is 8 to 250 mg/kg-day. The effects
include decreased body weights and body weight gains, increased vaginal discharge, effects on
clinical chemistry parameters, and/or increased absolute and decreased relative liver and thymus
weights. The range of NOAEL values for maternal toxicity is 'not established' to 125 mg/kg-
day. The range for LOAEL values for developmental toxicity is 8 to 125 mg/kg-day. The
effects include decreased pup body weights, decreased number of pups delivered per litter,
increased resorptions, decreased litter size and/or fetal anomalies and skeletal variations. The
range of NOAEL values for developmental toxicity is 'not established' to 30 mg/kg-day. No data
are available for gene mutation and chromosomal aberrations. CASRN 64741-81-7 was
irritating to rabbit skin and eyes; it was not sensitizing to guinea pigs skin. CASRNs 64741-61-3
increased tumor incidences in mice.
For Subcategory VII, the reproductive toxicity, gene mutation and chromosomal aberration
endpoints were identified as data gaps under the HPV Challenge Program.
Subcategory VIII: Reformer Residual
There were no data for any endpoints for this subcategory.
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For Subcategory VIII, the repeated-dose, reproductive and developmental toxicity, gene
mutation and chromosomal aberration endpoints were identified as data gaps under the HPV
Challenge Program.
Hazard to the Environment
No adequate data are available for the sponsored substances. Based on the supporting chemicals
(CASRNs 90622-56-3, 1120-36-1 and 629-73-2), the 96-h LCso for fish is 0.11 mg/L, the 48-h
ECso for aquatic invertebrates is 0.9 mg/L, and the 72-h EC50 for aquatic plants is 0.4 mg/L for
biomass. Based on the supporting chemical (CASRN 64742-49-0), the 21-d chronic NOEC and
LOEC for aquatic invertebrates is 0.17 mg/L and 0.32 mg/L, respectively. Based on CASRNs
1120-36-1 and 629-73-2 there are no aquatic toxicity effects at saturation for chemicals in this
category with a carbon chain of fourteen or greater.
No data gaps for Aquatic toxicity were identified under the HPV Challenge Program.
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Hazard Characterization Document
The sponsor, American Petroleum Institute, submitted a Test Plan and Robust Summaries to EPA for
heavy fuel oils on June 17, 2004. EPA posted the submission on the ChemRTK HPV Challenge website
on July 2, 2004. (http://www.epa.gov/oppt/chemrtk/pubs/summaries/heavvfos/cl5368tc.htm). EPA
comments on the original submission were posted to the website on December 8, 2005. Public comments
were also received and posted to the website. On July 12, 2011, the sponsor submitted the interim final
category analysis document and several revised robust summaries which were posted to the ChemRTK
website on November 30, 2011.
Category Identification/Justification
The sponsor proposed a category that covered two groups: finished residual fuels (or, heavy fuels) that
are marketed commercially (consisting of two CASRNs, 68476-33-5 and 68553-00-4) and the 30 refinery
process streams from which they are blended. The 30 petroleum process streams are complex mixtures of
hydrocarbons in the C7 - C50 range that boil between 121 and 600 °C. However, the more typical heavy
fuel oils are mixtures of hydrocarbons in the C20 - C50 range, whereas fuel oils with lower carbon
numbers and boiling temperatures are associated with lighter weight streams (CONCAWE, 1998). All of
the category members are complex mixtures, containing variable amounts of alkanes, cycloalkanes,
aromatics, olefins, asphaltenes and heteromolecules containing sulfur, oxygen, nitrogen and
organometals. The residual fuels are low-grade fuels primarily used in industrial boilers and other direct-
source heating applications (e.g., blast furnaces) and as a fuel for large marine diesel engines. The
finished heavy fuels (residual fuels) consist primarily of residuum of the refining process after virtually all
of the higher-quality hydrocarbons have been removed from crude oil feedstock. Residual fuels are
blended from a variety of different residual and distillate materials, and the exact blend for a specific
residual fuel is determined largely by the desired viscosity of the finished fuel (see figure 1). To produce
a residual fuel of a specified viscosity, the high viscosity of the residual streams is reduced by adding a
diluent that is typically a lower quality distillate stream. As a result, the composition of residual fuel oils
can vary widely and will depend on the refinery configuration, the crude oils being processed and the
overall refinery demand.
Owing to the inherent variability in petroleum materials, category members are not defined by detailed
compositional information, but rather by process history, physical properties and product use
specifications. The category includes both residual fuel oils and seven refinery streams divided into eight
subcategories: Subcategory I, Residual Fuel Oils; Subcategory II, Atmospheric Residual; Subcategory
III, Atmospheric Distillate; Subcategory IV, Vacuum Residual; Subcategory V, Vacuum Distillate;
Subcategory VI, Cracked Residual; Subcategory VII, Cracked Distillate; and Subcategory VIII, Reformer
Residual (see Table 1)..
The sponsor justified the grouping of the category members on the basis of production streams. EPA
agreed with the rationale for the heavy fuel oils category and subdivision of the refinery streams into
seven subcategories, reflecting their processing history. EPA accepted the sponsor's category definition
and justification. The read-across approach is acceptable within subcategories, but not between
subcategories.
For aquatic toxicity, sub categorizing these substances is not necessary. Categorizing these substances in
one single category is justified because they have similar structure profiles, and therefore they have
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similarities in physico-chemical and environmental fate properties. A read-across approach to treat all
sponsored substances as one broad category is adequate.
Furthermore, high-molecular-weight organometallic and other heteroatom compounds in some of the
higher-boiling category members are not expected to interfere with the chemicals' toxicity to aquatic
organisms because they are not expected to be bioavailable based on their extremely high molecular
weights and low water solubility.
Justification for Supporting Chemicals
For health effects endpoints, the sponsor proposed the use of data from other HPV categories (i.e., Gas
Oils, Asphalt and Aromatic Extracts) to read across to the lightest heavy fuel oil streams. Petroleum
streams in the heavy fuel oil category generally consist of hydrocarbon molecules having 20 - 50 carbon
atoms, although some streams in this category have low-end carbon atoms from 7-15. Heavy fuel oils
also may be blended with gas oils or similar low viscosity fuels to meet market specifications. Although
not explicitly stated, for the vacuum distillate subcategory (subcategory III), the sponsor proposed the use
of diesel fuel No. 2 (fuel oil No. 2-D; CASRN 68476-34-6) to address acute dermal toxicity, skin and eye
irritation endpoints. In addition, heavy atmospheric gas oil, CASRN 68915-97-9 (also included in the
Gas Oils Category) which is compositionally similar to the CASRN 68783-08-4 is also used as a
supporting chemical for subcategory III to address repeated-dose and developmental toxicity endpoints.
For the vacuum residues subcategory (subcategory IV) the sponsor proposed, although not explicitly
stated, the use of residues (petroleum), vacuum (CASRN 64741-56-6) to address acute oral, dermal and
inhalation and repeated-dose toxicity and gene mutation, skin and eye irritation endpoints). EPA agrees
that these substances adequately support their respective subcategories for the evaluation of human health
effects endpoints.
For aquatic toxicity endpoints, EPA is using the following supporting chemicals to address this category:
Naphtha (petroleum) hydrotreated light (CASRN 64742-49-0),
C7-C10 iso-alkanes (CASRN 90622-56-3),
1-tetradecene (CASRN 1120-36-1) and
1-hexadecene (CASRN 629-73-2)
These chemicals have similar structures, and physical/chemical properties, and they have the same mode
of toxic action (non-polar narcosis).
The C7-C9 aliphatic hydrocarbons (CASRNs 64742-49-0 and 90622-56-3) have been assessed in the
OECD HPV program (SIAM 30; http://webnet.oecd.org/hpv/UI/SIDS Details.aspx?Kev=d3906311-
a0e0-4fe8-a66b-7159b864a557&idx=0Y
1-Tetradecene (CASRN 1120-36-1: SIAM 11) has been assessed in the OECD HPV program as a
member of the alpha olefins category
(http://www.chem.unep.ch/irptc/sids/OECDSIDS/AOalfaolefins.pdf).
1-Hexadecene (CASRN 629-73-2: SIAM 19) has been assessed in the OECD HPV program as a member
of the higher olefins category (http ://www. chem .unep. ch/irptc/ sids/OECD SID S/Hi gherOlefins. pdf).
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Table 1. CA Index Names and CASRNs for Heavy Fuel Oils Subcategories for
Human Health Effects Endpoints
CASRN
CA Index Name
Subcategory I. Residual Fuel Oils
68476-33-5
Fuel Oil, residual
68553-00-4
Fuel oil, No. 6
Subcategory II. Atmospheric Residual
64741-45-3
Residues (petroleum), atm. tower
64742-78-5
Residues (petroleum), hydrosulfurized atmospheric
68333-22-2
Residues (petroleum), atmospheric
68607-30-7
Residues (petroleum), topping plant, low-sulfur
70592-79-9
Residues (petroleum), atm. tower, light
68476-32-4
Fuel oil, residues-straight-run gas oils, high sulfur
Subcategory III. Atmospheric Distillate
68410-00-4
Distillates (petroleum) crude oil
68783-08-4
Gas oils (petroleum), heavy atmospheric
Subcategory III. Supporting Chemicals
68476-34-6
Diesel fuels No.2 {used to support acute dermal toxicity, skin irritation
endpoints)
68915-97-9
Gas oils (petroleum), heavy atmospheric {used to support repeated-dose
and developmental toxicity endpoints)
Subcategory IV. Vacuum Residual
68512-62-9
Residues (petroleum), light vacuum
70913-85-8
Residues (petroleum), solvent-extd. Vacuum distilled
Subcategory IV. Supporting Chemical
64741-56-6
Residues (petroleum), vacuum {used to support acute oral, dermal and
inhalation and repeated-dose toxicity, gene mutation, skin and eye
irritation endpoints)
Subcategory V. Vacuum Distillates
64741-57-7
Residues (petroleum), heavy vacuum
64742-59-2
Gas oils (petroleum), hydrotreated vacuum
13
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 1. CA Index Names and CASRNs for Heavy Fuel Oils Subcategories for
Human Health Effects Endpoints
CASRN
CA Index Name
64742-86-5
Gas oil (petroleum), hydrosulfurized heavy vacuum
68955-27-1
Distillates (petroleum), petroleum residues vacuum
70592-76-6
Distillates (petroleum), intermediate vacuum
70592-77-7
Distillates (petroleum), light vacuum
70592-78-8
Distillates (petroleum), vacuum
Subcategory VI. Cracked Residual
64741-62-4
Clarified oils(petroleum), catalytic cracked
64741-75-9
Residues (petroleum), hydrocracked
64741-80-6
Residues (petroleum), thermal cracked
68187-58-6
Pitch, petroleum, arom
68478-17-1
Residues (petroleum), heavy coker gas oil and vacuum gas oil
68783-13-1
Residues (petroleum), coker scrubber condensed-ring-aromatic-
containing
Subcategory VII. Cracked Distillate
64741-61-3
Distillates (petroleum), heavy catalytic cracked
64741-81-7
Distillates (petroleum), heavy thermal cracked
68333-26-6
Distillates (petroleum), hydrosulfurized catalytic cracked
68333-27-7
Distillates (petroleum), hydrosulfurized intermediate catalytic cracked
70955-17-8
Aromatic hydrocarbons, C12 - 20
Subcategory VIII. Reformer Residua1
64741-67-9
Residues (petroleum), catalytic reformer fractionator
68478-13-7
Residues (petroleum), catalytic reformer fractionators residue distn.
14
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U.S. Environmental Protection Agency
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September, 2014
Figure 1, HFO Process Diagram
Crude O I
Atmolpheric
Vacuum
Distillation
Distillation
Catalytic Cracking
Thermal Cracking
Coking
Hydrocracking
Residual Distillate Residual Distillate
64741-45-3
64742-78-5
68333-22-2
68476-32-4
68607-30-7
70592-79-9
68512-62-'
70913-85-
68410-00-4
68783-08-4
1
64741-57-7
64742-59-2
64742-86-5
68955-27-1
70592-76-6
70592-77-7
70592-78-8
Residual
64741-62-4
64741-75-9
64741-80-6
68187-58-6
68478-17-1
68783-13-1
Reformer
Distillate
Residual
64741-61-3
64741-81-7
68333-26-6
68333-27-7
70955-17-8
64741-67-9
68478-13-7
Residual Fuel Oils
68476-33-5 68553-00-4I
15
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1. Chemical Identity
1.1 Identification and Purity
The chemicals in this category are refinery streams containing the same classes of hydrocarbon
and heterocyclic compounds. The proportion of these compounds vary with boiling temperature
range of a stream; the higher the molecular weight of the oil's components, the higher the levels
of Polyaromatic content (PAC), polycycloparaffins and hetero-atoms (N, O, S and metals) and
the lower the levels of paraffins. The cracking processes further modify the composition of the
streams. Composition of extractable PAC contents in the samples that were tested are provided
in sponsor's the category assessment document and in robust summary where appropriate. The
composition of extractable PAC contents is also provided in Appendix E.
1.2 Physical-Chemical Properties
The physical-chemical properties of the sponsored substances and supporting chemicals in the
Heavy Fuel Oils category are summarized in Table 2. The representative chemical structures of
the sponsored chemicals and supporting chemicals are provided in the Appendix.
Table 2. Physical-Chemical Properties of the Heavy Fuel Oils Category1
Property
Subcategory I: Residual Fuel Oils
SPONSORED CHEMICAL
Fuel oil, residual
SPONSORED CHEMICAL
Fuel oil, No. 6
CASRN
68476-33-5
68553-00-4
Molecular Weight
Complex mixture of aromatic, aliphatic and naphthenic hydrocarbons
Physical State
Liquid
Melting Point
-1°C (measured pour point)
-1°C (measured pour point)
Boiling Point
160-600°C (measured)
204-649°C (measured)2
Vapor Pressure
<0.75 mmHg at 37.8°C (measured)
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 2. Physical-Chemical Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory II: Atmospheric Residual
SPONSORED
CHEMICAL
Residues
(petroleum), atm.
tower
SPONSORED
CHEMICAL
Residues (petroleum),
hydrodcsulfuri/ed
atmospheric
SPONSORED
CHEMICAL
Residues
(petroleum),
atmospheric
SPONSORED
CHEMICAL
Residues (petroleum),
topping plant,
low-sulfur
SPONSORED
CHEMICAL
Residues
(petroleum), atm.
tower, light
SPONSORED
CHEMICAL
Fuel oil, rcsiducs-
straight-run gas
oils, high sulfur
CASRN
64741-45-3
64742-78-5
68333-22-2
68607-30-7
70592-79-9
68476-32-4
Molecular Weight
Complex mixture of aromatic, aliphatic, and naphthenic hydrocarbons, generally having carbon numbers in the range of C7 to C50
Physical State
Liquid
Melting Point
18°C (measured
pour point)
No data. Typical pour point values for heavy fuel oils are <30°C.
Boiling Point
>350°C
(measured)2
>350°C
(measured)2
>200°C
(measured)2
181.2-266.7°C
(estimated)45
>200°C
(measured)2
181.2-266.7
(estimated)3-4
Vapor Pressure
<1.0xl0"10 to
0.003 mmHg
(estimated)4,5
<1.0xlO_10to 0.003 mm
Hg (estimated)4-5
<1.0xl010 to 1.2 mm
Hg (estimated)3-4
<1.0xl010 to 1.2 mm
Hg (estimated)3-4
<1.0xl0"10 to 1.2
mmHg
(estimated)3-4
0.0035 to 1.2 mm
Hg (estimated)3,4
Dissociation Constant (pKa)
Not applicable
Henry's Law Constant
7.0 xlO-5 to 372 atm-
m3/mol
(estimated)4,5
7.0xlO-5 to 372 atm-
m3/mol (estimated)4-5
7.0xl0 5 to 9.35 atm-
m3/mol (estimated)3-4
7.0xl0 5 to 9.35 atm-
m3/mol (estimated)3 4
7.0 xlO"5 to
9.35 atm-m3/mol
(estimated)3-4
0.00035 to
9.35 atm-m3/mol
(estimated)3-4
Water Solubility
<1.0xl0"10 to
2.9><10"5 mg/Lat
25°C (estimated)45
<1.0xl0"10 to2.9xl0"5
mg/L at 25°C
(estimated)4,5
<1.0xl0"10 to 12.9
mg/L at 25 °C
(estimated)34
<1.0xl0"10 to 12.9
mg/L at 25°C
(estimated)34
<1.0xl0"10 to 12.9
mg/L at 25°C
(estimated)3-4
0.11 to 12.9 mg/L at
25°C (estimated)3,4
Log Kow
9.6-19.3
(estimated)4-5
9.6-19.3
(estimated)45
4.26-19.3
(estimated)3,4
4.26-19.3 (estimated)3-4
4.26-19.3
(estimated)3-4
4.26-6.73
(estimated)3-4
1 American Petroleum Institute, Petroleum HPV Testing Group. 2004. Robust Summary and Test Plan for the Heavy Fuel Oils. Available online at
http://www.epa.gov/chemrtk/pubs/summaries/heavvfos/cl5368tc.htm as of December 15,2010.
2 Boiling ranges obtained from the TSCA CAS definition.
3 Data range presented for representative structures provided the Appendix.
4U.S. EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC. Available online at
http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of December 15,2010.
17
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Table 2. Physical-Chemical Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory III: Atmospheric Distillate
SPONSORED
CHEMICAL
Distillates (petroleum),
erude oil
SPONSORED
CHEMICAL
Gas oils (petroleum),
heavy atmospheric
SUPPORTING
CHEMICAL
Fuels, diesel
SUPPORTING
CHEMICAL
Fuel oil no. 2
SUPPORTING
CHEMICAL
Fuel oil no. 4
SUPPORTING
CHEMICAL
Fuels, diesel, no. 2
CASRN
68410-00-4
68783-08-4
68334-30-5
68476-30-2
68476-31-3
68476-34-6
Molecular Weight
Complex mixture of aromatic, aliphatic, and naphthenic hydrocarbons, generally having carbon numbers in the range of C7 to C50
Physical State
Liquid
Melting Point
No data. Typical pour
point values for heavy
fuel oils are <30°C.
No data. Typical pour
point values for heavy
fuel oils are <30°C.
-5°C (measured pour
point)2;
0°C (measured pour
point)3;
-6°C (measured pour
point)4;
-50 to -14°C
(measured pour
point)5
No data. Typical
pour point values for
heavy fuel oils are
<30°C.
-5°C (measured pour
point)2;
0°C (measured pour
point)3;
-6°C (measured pour
point)4;
-50 to -14°C
(measured pour
point)5
-5°C (measured
pour point)2;
0°C (measured pour
point)3;
-6°C (measured
pour point)4;
-50 to -14°C
(measured pour
point)5
Boiling Point
205-495°C (measured)6
121-510°C (measured)6
160-390°C
(measured)2;
160^100oC
(measured)3;
141-388°C
(measured)5
160-390°C
(measured)2;
160-400°C
(measured)3;
141-388°C
(measured)5
160-390°C
(measured)2;
160^100oC
(measured)3;
141-388°C
(measured)5
160-390°C
(measured)2;
160^t00°C
(measured)3;
141-388°C
(measured)5
Vapor Pressure
<1.0xl0"10 to 3.3 mmHg
(estimated)7,8
<1.0xl0"10 to 62.2 mm
Hg (estimated)7,8
3.0 mmHg
(measured)2,3;
15.0 mmHg
(measured)5
15.0 mmHg
(measured);
2.12-26.4 mmHg
(measured)9
3.0 mmHg
(measured)2,3;
15.0 mmHg
(measured)5
3.0 mmHg
(measured)2,3;
15.0 mmHg
(measured)5;
2.12-26.4 mmHg
(measured)9
Dissociation Constant (pKa)
Not applicable
Henry's Law Constant
7.0xl0 5 to 7.4 atm-
m3/mol (estimated)7,8
1.9xl0"7 to 2.8 atm-
m3/mol (estimated)7,8
0.14 to 90.2 atm-
m3/mol (estimated)7,8
0.14 to 90.2 atm-
m3/mol (estimated)7-8
2.8xl0 8to 90.2 atm-
m3/mol (estimated)7-8
0.14 to 90.2 atm-
m3/mol
(estimated)7-8
18
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Table 2. Physical-Chemical Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory III: Atmospheric Distillate
SPONSORED
CHEMICAL
Distillates (petroleum),
erude oil
SPONSORED
CHEMICAL
Gas oils (petroleum),
heavy atmospheric
SUPPORTING
CHEMICAL
Fuels, diesel
SUPPORTING
CHEMICAL
Fuel oil no. 2
SUPPORTING
CHEMICAL
Fuel oil no. 4
SUPPORTING
CHEMICAL
Fuels, diesel, no. 2
Water Solubility
<1.0xl0"10to 2.5 mg/L at
25°C (estimated)7 8
3.7xl0"9to 28.4 mg/L
at 25°C (estimated)7,8
1.9xl0-5 to 3.9 mg/L
at 25°C (estimated)7,8
1.9xl0"5 to 3.9 mg/L
at 25°C
(estimated)7,8
l.OxlO-6 to 3.9 mg/L
at 25°C (estimated)7,8
1.9x10-5 to
3.9 mg/L at 25°C
(estimated)7,8
Log Kow
4.6-19.3
(estimated)7,8
3.6-12.3
(estimated)7,8
4.5-9.9
(estimated)7,8
4.5-9.9
(estimated)7,8
4.5-9.9
(estimated)7,8
4.5-9.9
(estimated)7,8
1 American Petroleum Institute, Petroleum HPV Testing Group. 2004. Robust Summary and Test Plan for the Heavy Fuel Oils. Available online at
http://www.epa.gov/chemrtk/pubs/summaries/heavvfos/cl5368tc.htm as of December 15,2010.
2 Measured value obtained for an automotive gas oil.
3 Measured value for a heating oil.
4 Measured value for a marine oil.
5 Measured values obtained for diesel fuel oil from various locations.
6 Boiling ranges obtained from the TSCA CAS definition.
7 Data range presented for representative structures provided the Appendix.
8 U.S. EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC. Available online at
http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of December 15,2010.
9 Agency for Toxic Substances and Disease Registry. 2005. Toxicological Profile for Fuel Oils/Kerosene. Available online at http://www.atsdr.cdc.gov/ToxProfiles/tp.asp?id=516&tid=91
as of December 15, 2010.
19
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Table 2. Physical-Chemical Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory IV: Vacuum Residual
SPONSORED
CHEMICAL
Residues (petroleum),
light vaeuum
SPONSORED
CHEMICAL
Residues (petroleum),
solvent-extd. vaeuum
distilled residuum
SUPPORTING
CHEMICAL
Residues (petroleum),
vaeuum
CASRN
68512-62-9
70913-85-8
64741-56-6
Molecular Weight
Complex mixture of aromatic, aliphatic, and naphthenic hydrocarbons, generally
having carbon numbers in the range of C7 to C50
Physical State
Liquid
Melting Point
No data. Typical pour point
values for heavy fuel oils
are <30°C.
No data. Typical pour point
values for heavy fuel oils
are <30°C.
No data. Typical pour
point values for heavy fuel
oils are <30°C.
Boiling Point
>230°C (measured)2
>300°C (estimated)3,4
>495°C (measured)2
Vapor Pressure
<1.0xl010 to 0.16 mmHg
(estimated)3,4
<1.0><10"10 to 0.16 mmHg
(estimated)3-4
<1.0xl0"10 to
4.2xlO_7mmHg
(estimated)3-4
Dissociation Constant (pKa)
Not applicable
Henry's Law Constant
7.0xl0 5 to 38.5 atm-
m3/mol (estimated)3,4
7.0xl0 5to 38.5 atm-m3/mol
(estimated)3-4
0.001 to 6,320 atm-
m3/mol (estimated)3 4
Water Solubility
<1.0><10"10to 0.02 mg/L at
25°C (estimated)3-4
<1.0xl0_10to 0.02 mg/L at
25°C (estimated)3 4
<1.0xlO"10mg/L at25°C
(estimated)3-4
Log Kow
6.8-19.3 (estimated)3-4
6.8-19.3 (estimated)3 4
13.6-16.9 (estimated)3,4
1 American Petroleum Institute, Petroleum HPV Testing Group. 2004. Robust Summary and Test Plan for the Heavy Fuel Oils.
Available online at http://www.epa.gov/chemrtk/pubs/summaries/heavvfos/cl5368tc.htm as of December 15,2010.
2 Boiling ranges obtained from the TSCA CAS definition.
3 Data range presented for representative structures provided the Appendix.
4 U.S. EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental Protection
Agency, Washington, DC. Available online at http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of December 15,
2010.
20
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Hazard Characterization Document
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Table 2. Physical-Chemical Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory V: Atmospheric Distillate
SPONSORED
CHEMICAL
Residues
(petroleum),
heavy vacuum
SPONSORED
CHEMICAL
Gas oils (petroleum),
hydrotrcatcd vaeuum
SPONSORED
CHEMICAL
Gas oils (petroleum),
hydrodcsulfurizcd
heavy vacuum
SPONSORED
CHEMICAL
Distillates
(petroleum),
petroleum residues
vacuum
SPONSORED
CHEMICAL
Distillates
(petroleum),
intermediate vacuum
SPONSORED
CHEMICAL
Distillates
(petroleum), light
vacuum
SPONSORED
CHEMICAL
Distillates
(petroleum),
vacuum
CASRN
64741-57-7
64742-59-2
64742-86-5
68955-27-1
70592-76-6
70592-77-7
70592-78-8
Molecular
Weight
Complex mixture of aromatic, aliphatic, and naphthenic hydrocarbons, generally having carbon numbers in the range of C7 to C50.
Physical State
Liquid
Melting Point
31-35°C (measured
pour point)
No data. Typical pour
point values for heavy
fuel oils are <30°C.
13°C (measured pour
point)
No data. Typical pour
point values for heavy
fuel oils are <30°C.
No data. Typical pour
point values for heavy
fuel oils are <30°C.
No data. Typical pour
point values for heavy
fuel oils are <30°C.
27°C (measured
pour point)
Boiling Point
350-600°C
(measured)2
230-600°C
(measured)2
350-600°C
(measured)2
>300°C (estimated)3,4
250-545°C
(measured)2
250-545°C
(measured)2
270-600°C
(measured)2
Vapor Pressure
<1.0xlO-10to
0.003 mmHg
(estimated)3,4
<1.0xlO_10to 0.48 mm
Hg (estimated)3,4
<1.0xlO_10to 0.003 mm
Hg (estimated)3,4
<1.0xl0"10to
0.003 mmHg
(estimated)3,4
<1.0xlO_10to 0.19 mm
Hg (estimated)3,4
<1.0xl010to 3.3 mm
Hg (estimated)3,4
<1.0xl0"10to
0.13 mmHg
(estimated)3,4
Dissociation
Constant (pKa)
Not applicable
Henry's Law
Constant
7.0><10"5 to 372 atm-
m3/mol
(estimated)3,4
7.0xl0-5 to 372 atm-
m3/mol (estimated)3,4
7.0xlO-5 to 372 atm-
m3/mol (estimated)3,4
7.0xlO-5 to 372 atm-
m3/mol (estimated)3,4
2.6xl0_6to 372 atm-
m3/mol (estimated)3,4
1.9xl0-7 to 372 atm-
m3/mol (estimated)3,4
7.0 xlO"5 to
21.9 atm-m3/mol
(estimated)3,4
Water Solubility
<1.0xl0"10to
1.4><10"4mg/L at
25°C (estimated)3,4
<1.0xl0_1°to 0.26 mg/L
at 25°C (estimated)3,4
<1.0xl0"10to 1.4xl0"4
mg/L at 25 °C
(estimated)3,4
<1.0xl0-10to 1.4xl0"4
mg/L at 25 °C
(estimated)3,4
<1.0xl0"10to
0.10 mg/L at 25°C
(estimated)3,4
3.6xl0 9to 2.5 mg/L at
25°C (estimated)3,4
<1.0xl0-10to
0.04 mg/L at 25°C
(estimated)3,4
Log Iv
8.8-19.3
(estimated)3,4
5.6-19.3
(estimated)3,4
8.8-19.3 (estimated)3,4
8.8-19.3 (estimated)3,4
6.0-15.6 (estimated)3,4
5.6-12.6 (estimated)3,4
6.4-19.3
(estimated)3,4
1 American Petroleum Institute, Petroleum HPV Testing Group. 2004. Robust Summary and Test Plan for the Heavy Fuel Oils. Available online at
http://www.epa.gov/chemrtk/pubs/summaries/heavvfos/cl5368tc.htm as of December 15, 2010.
2 Boiling ranges obtained from the TSCA CAS definition.
3 Data range presented for representative structures provided the Appendix.
4 U.S. EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC. Available online at
http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of December 15, 2010.
21
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Table 2. Physical-Chemical Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory VI: Cracked Residual
SPONSORED CHEMICAL
Clarified oils (petroleum),
catalytie cracked
SPONSORED
CHEMICAL
Residues (petroleum),
hyd roc racked
SPONSORED
CHEMICAL
Residues
(petroleum), thermal
cracked
SPONSORED
CHEMICAL
Pitch, petroleum,
arom.
SPONSORED
CHEMICAL
Residues (petroleum),
heavy cokcr <;as oil
and vacuum gas oil
SPONSORED
CHEMICAL
Residues (petroleum),
cokcr scrubber
condcnscd-rinjj-
aromatic-containinii
CASRN
64741-62-4
64741-75-9
64741-80-6
68187-58-6
68478-17-1
68783-13-1
Molecular
Weight
Complex mixture of aromatic, aliphatic, and naphthenic hydrocarbons, generally having carbon numbers in the range of C7 to C50
Physical State
Liquid
Melting Point
1.7°C (measured pour point);
-13 to -1°C (measured pour point)2
No data. Typical pour
point values for heavy
fuel oils are <30°C.
No data. Typical pour
point values for heavy
fuel oils are <30°C.
No data. Typical pour
point values for heavy
fuel oils are <30°C.
No data. Typical pour
point values for heavy
fuel oils are <30°C.
No data. Typical pour
point values for heavy
fuel oils are <30°C.
Boiling Point
150-600°C (measured)2;
202-511°C (measured)2
>350°C (measured)3
>350°C (measured)3
>300°C (estimated)4 5
>230°C (measured)3
>350°C (measured)3
Vapor Pressure
<1.0xl010to 0.003 mmHg
(estimated)45
<1.0><10"10to 0.003 mm
Hg (estimated)4,5
<1.0xl0"10to
0.003 mmHg
(estimated)4,5
<1.0xl0"10to
1.7xl05mmHg
(estimated)4-5
<1.0xlO_10to 0.16 mm
Hg (estimated)4-5
<1.0xlO_10to 0.003 mm
Hg (estimated)4 5
Dissociation
Constant (pKa)
Not applicable
Henry's Law
Constant
7.0 xlO 5 to 372 atm-m3/mol
(estimated)45
7.0xlO-5 to 372 atm-
m3/mol (estimated)4-5
7.0xlO-5 to 372 atm-
m3/mol (estimated)4-5
7.0xl0-5to5.9xl0"5
atm-m3/mol
(estimated)4,5
7.0xlO-5 to 372 atm-
m3/mol (estimated)4 5
7.0xlO-5 to 372 atm-
m3/mol (estimated)4 5
Water
Solubility
<100 mg/L at 20°C (measured)2
<1.0xl0"10to
2.9xlO"5mg/L at 25°C
(estimated)4,5
<1.0xl0"10to
2.9xlO"5mg/L at 25°C
(estimated)4,5
<1.0xl0-10to
0.03 mg/L at 25°C
(estimated)4,5
<1.0xl0"10to 0.02 mg/L
at 25°C (estimated)4,5
<1.0xlO-10to2.9xlO"5
mg/L at 25°C
(estimated)4,5
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Log Iv
9.6-19.3
9.6-19.3
9.6-19.3
5.8-19.3
6.8-19.3 (estimated)4,5
9.6-19.3 (estimated)4,5
(estimated)45
(estimated)4,5
(estimated)4,5
(estimated)4,5
1 American Petroleum Institute, Petroleum HPV Testing Group. 2004. Robust Summary and Test Plan for the Heavy Fuel Oils. Available online at
http://www.epa.gov/chemrtk/pubs/summaries/heawfos/cl5368tc.htm as of December 15, 2010.
2 ECB. 2000. European Chemical Substances Information System (ESIS), IUCLID Dataset, Residual Fuel Oils (CAS No. 64741-62-4). Available online at
http://ecb.irc.ec.europa.eu/esis/ as of January 12, 2011.
3 Boiling ranges obtained from the TSCA CAS definition.
4 Data range presented for representative structures provided the Appendix.
5 U.S. EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC. Available online at
http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of December 15, 2010.
23
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 2. Physical-Chemical Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory VII: Cracked Distillate
Subcategory VIII: Reformer
Residual
SPONSORED
CHEMICAL
Distillates
(petroleum),
heavy eatalvtie
cracked
SPONSORED
CHEMICAL
Distillates
(petroleum), heavy
thermal cracked
SPONSORED
CHEMICAL
Clarified oils
(petroleum),
hydro-
(lesu It'll ri/ed
catalytic cracked
SPONSORED
CHEMICAL
Distillates
(petroleum),
hydro-
desu Ifu ri/ed
intermediate
catalytic cracked
SPONSORED
CHEMICAL
Aromatic
hydrocarbons,
C12 - 20
SPONSORED
CHEMICAL
Residues
(petroleum),
catalytic reformer
fractionator
SPONSORED
CHEMICAL
Residues
(petroleum),
catalytic reformer
fractionator
residue distn.
CASRN
64741-61-3
64741-81-7
68333-26-6
68333-27-7
70955-17-8
64741-67-9
68478-13-7
Molecular Weight
Complex mixture of aromatic, aliphatic, and naphthenic hydrocarbons, generally having carbon numbers in the range of C7 to C50
Physical State
Liquid
Melting Point
No data. Typical
pour point values
for heavy fuel oils
are <30°C.
16-35°C
(measured pour point)
No data. Typical
pour point values
for heavy fuel oils
are <30°C.
No data. Typical
pour point values
for heavy fuel oils
are <30°C.
No data.
Typical pour
point values for
heavy fuel oils
are <30°C.
No data. Typical
pour point values for
heavy fuel oils are
<30°C.
No data. Typical
pour point values
for heavy fuel oils
are <30°C.
Boiling Point
260-500°C
(measured)2
260^80°C
(measured)2
>350°C
(measured)2
205-405°C
(measured)2
282^t27°C
(measured)2
160-400°C
(measured)2
>399°C
(measured)2
Vapor Pressure
<1.0xl0-10to
0.13 mmHg
(estimated)4,5
<1.0xlO"10to 0.13 mm
Hg (estimated)4,5
<1.0xl0"10to
0.003 mmHg
(estimated)4,5
<1.0xl0"10to
1.24 mmHg
(estimated)4,5
2.3xl0"6to
0.26 mmHg
(estimated)4,5
<1.0xl010 to 3.2 mm
Hg (estimated)4,5
<1.0xl0"10 to
0.003 mmHg
(estimated)4,5
Dissociation Constant
(pKa)
Not applicable
Henry's Law Constant
1.9xl0"7to
372 atm-m3/mol
(estimated)4,5
2.6xl0 7to 372 atm-
m3/mol (estimated)4,5
7.0 xlO-5 to
372 atm-m3/mol
(estimated)4,5
2.8xl0"7to
372 atm-m3/mol
(estimated)4,5
2.4 xlO"4 to
0.05 atm-m3/mol
(estimated)4,5
2.2xl0_7to 372 atm-
m3/mol (estimated)4,5
7.0xlO-5 to 372 atm-
m3/mol
(estimated)4,5
Water Solubility
3.7xlO"9 to 0.04 to
mg/L at25°C
(estimated)4,5
1.3xl0 9to 0. mg/L at
25°C (estimated)4,5
<1.0xl0"10to
2.9xlO_5mg/L at
25°C (estimated)4,5
2.9xl0"8 to 0.94
mg/L at 25 °C
(estimated)4,5
0.001 to
12.9 mg/L at
25°C at 25°C
(estimated)4,5
2.9xl0"8to 6.5 mg/L
(estimated)4,5
<1.0xl0"10to
1.4xlO_4mg/L at
25°C (estimated)4,5
24
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U.S. Environmental Protection Agency
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September, 2014
Table 2. Physical-Chemical Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory VII: Cracked Distillate
Subcategory VIII: Reformer
Residual
SPONSORED
CHEMICAL
Distillates
(petroleum),
heavy eatalvtie
cracked
SPONSORED
CHEMICAL
Distillates
(petroleum), heavy
thermal cracked
SPONSORED
CHEMICAL
Clarified oils
(petroleum),
hydro-
(lesu It'll ri/ed
catalytic cracked
SPONSORED
CHEMICAL
Distillates
(petroleum),
hydro-
desu Ifu ri/ed
intermediate
catalytic cracked
SPONSORED
CHEMICAL
Aromatic
hydrocarbons,
C12 - 20
SPONSORED
CHEMICAL
Residues
(petroleum),
catalytic reformer
fractionator
SPONSORED
CHEMICAL
Residues
(petroleum),
catalytic reformer
fractionator
residue distn.
Log Kow
6.4-12.3
(estimated)34
6.4-12.7
(estimated)3,4
9.6-19.3
(estimated)4-5
5.0-12.6
(estimated)4-5
4.3-7.2
(estimated)4-5
4.2-12.6
(estimated)4-5
8.8-19.3
(estimated)4-5
1 American Petroleum Institute, Petroleum HPV Testing Group. 2004. Robust Summary and Test Plan for the Heavy Fuel Oils. Available online at
http://www.epa.gov/chemrtk/pubs/summaries/heawfos/cl5368tc.htm as of December 15, 2010.
2 Boiling ranges obtained from the TSCA CAS definition.
3 Data range presented for representative structures provided the Appendix.
4U.S.EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC. Available online
at http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of December 15, 2010.
25
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Conclusion: Heavy fuel oils are viscous liquid blends of the residues and distillates that are
derived from various refinery distillations, cracking, and reforming processes. These heavy fuel
oils are complex mixtures which may boil in the range of 121 to 600°C and consist of aromatic,
aliphatic, and naphthenic hydrocarbons, generally having carbon numbers in the range of C7 to
C50, together with asphaltenes and smaller amounts of heterocyclic compounds containing
sulfur, nitrogen, and oxygen. The lower molecular weight components of these complex
mixtures possess low to moderate water solubility while higher molecular weight fractions have
negligible solubility in water. The lower molecular weight components of the heavy fuel oil
category have moderate to high vapor pressure while higher molecular weight fractions tend to
possess negligible to low vapor pressure.
2. General Information on Exposure
2.1 Production Volume and Use Pattern
The C Heavy Fuel Oils category chemicals had an aggregated production and/or import volume
in the United States greater than 24 billion 200 million pounds in calendar year 2005.
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
CASRN
68476-33-5
68553-00-4
64741-45-3
68333-22-2
68607-30-7
70592-79-9
68410-00-4
68783-08-4
68512-62-9
70913-85-8
64741-57-7
64742-59-2
64742-86-5
68955-27-1
70592-76-6
70592-77-7
70592-78-8
64741-62-4
64741-75-9
64741-80-6
68187-58-6
68478-17-1
64741-61-3
64741-81-7
64741-67-9
68478-13-7
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
100 million to <
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
1 billion pounds
100 million to <
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
500 million
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
and greater;
500 million
26
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
CASRNs 64742-78-5, 68476-32-4, 68783-13-1, 68333-26-6, 68333-27-7 and 70955-17-8 were
not reported in the 2006 IUR.
CASRNs 68476-33-5, 64741-45-3, 68333-22-2, 68607-30-7, 70592-79-9, 68410-00-4, 68512-
62-9, 70913-85-8, 64742-59-2, 64742-86-5, 68955-27-1, 70592-76-6, 70592-77-7, 70592-78-8,
64741-75-9, 64741-80-6, 68187-58-6, 64741-61-3, 64741-81-7, 64741-67-9 and 68478-13-7:
No industrial processing and uses, and commercial and consumer uses were reported for these
chemicals.
CASRN 68553-00-4:
Non-confidential information in the IUR indicated that the industrial processing and uses for the
chemical include pulp mills as fuels. Commercial and consumer uses of this chemical are
claimed confidential.
CASRN 68783-08-4 and 68478-17-1:
Non-confidential information in the IUR indicated that the industrial processing and uses for the
chemicals include petroleum refineries as fuels. Non-confidential commercial and consumer
uses of these chemicals include "other."
CASRN 64741-57-7:
Industrial processing and uses, and commercial and consumer uses of this chemical are claimed
confidential.
CASRN 64741-62-4:
Non-confidential information in the IUR indicated that the industrial processing and uses for the
chemical include other basic organic chemical manufacturing as other; and petroleum refineries
as fuels. Non-confidential commercial and consumer uses of this chemical include "other."
2.2 Environmental Exposure and Fate
The environmental fate properties are provided in Table 3.
27
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 3. Environmental Fate Properties of the Heavy Fuel Oils Category1
Property
Subcategory I: Residual Fuel Oils
SPONSORED CHEMICAL
Fuel oil, residual
SPONSORED CHEMICAL
Fuel oil, No. 6
CASRN
68476-33-5
68553-00-4
Photodegradation Half-life
0.7-5.0 hours (estimated)2,3
0.7-5.0 hours (estimated)2,3
Hydrolysis Half-life
Stable
Biodegradation
No data
No data
Bioaccumulation Factor
0.9 to 1.7xlO6 (estimated)2,3
0.9 to 1.7xlO6 (estimated)2,3
Log Koc
5.6-13.2 (estimated)2,3
5.6-13.2 (estimated)2,3
Fugacity
(Level III Model)2'3
Air (%)
Water (%)
Soil (%)
Sediment (%)
<0.1-6.1
6.2-84.1
7.6-93.8
<0.1-31.6
<0.1-6.1
6.2-84.1
7.6-93.8
<0.1-31.6
Persistence4
PI (low) to P3 (high)
PI (low) to P3 (high)
Bioaccumulation4
B1 (low) to B3 (high)
B1 (low) to B3 (high)
1 American Petroleum Institute, Petroleum HPV Testing Group. 2004. Robust Summary and Test Plan for the
Heavy Fuel Oils. Available online at http://www.epa.gov/chemrtk/pubs/summaries/heawfos/cl5368tc.htm as of
December 15, 2010.
2 Data range presented for representative structures provided the Appendix.
3U.S. EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental
Protection Agency, Washington, DC. Available online at
http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of December 15, 2010.
4Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Federal
Register 64, Number 213 (November 4, 1999) pp. 60194-60204.
28
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September, 2014
Table 3. Environmental Fate Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory II: Atmospheric Residual
SPONSORED
CHEMICAL
Residues
(petroleum), atm.
tower
SPONSORED
CHEMICAL
Residues (petroleum),
hyd rodesu Ifu rized
atmospheric
SPONSORED
CHEMICAL
Residues
(petroleum),
atmospheric
SPONSORED
CHEMICAL
Residues (petroleum),
topping plant,
low-sulfur
SPONSORED
CHEMICAL
Residues
(petroleum), atm.
tower, light
SPONSORED
CHEMICAL
Fuel oil, rcsiducs-
straight-run gas
oils, high sulfur
CASRN
64741-45-3
64742-78-5
68333-22-2
68607-30-7
70592-79-9
68476-32-4
Photodegradation Half-life
0.7-4.8 hours
(estimated)2,3
0.7-4.8 hours
(estimated)23
0.7-8.9 hours
(estimated)2,3
0.7-8.9 hours
(estimated)2,3
0.7-8.9 hours
(estimated)2-3
0.7-8.9 hours
(estimated)2-3
Hydrolysis Half-life
Stable
Biodegradation
No data
No data
No data
No data
No data
No data
Bioaccumulation Factor
0.9 to 1.2xl05
(estimated)2-3
0.9 to 1.2xl05
(estimated)2,3
0.9 to3.9xl04
(estimated)23
0.9 to3.9xl04
(estimated)23
0.9 to 3.9xl04
(estimated)2-3
0.9 to3.9xl04
(estimated)2-3
Log Koc
5.6-13.2
(estimated)2-3
5.6-13.2
(estimated)23
3.6-13.2
(estimated)2,3
3.6-13.2
(estimated)2,3
3.6-13.2
(estimated)2-3
3.6-13.2
(estimated)2-3
Fugacity
(Level III Model)2 3
Air (%)
Water (%)
Soil (%)
Sediment (%)
<0.1-3.9
6.2-89.2
4.3-93.8
<0.1-31.6
<0.1-3.9
6.2-89.2
4.3-93.8
<0.1-31.6
<0.1-18.8
6.2-71.6
1.6-93.8
<0.1-8.6
<0.1-18.8
6.2-71.6
1.6-93.8
<0.1-8.6
<0.1-18.8
6.2-71.6
1.6-93.8
<0.1-8.6
<0.1-18.8
6.2-71.6
1.6-93.8
<0.1-8.6
Persistence4
PI (low) to P3
(high)
PI (low) to P3 (high)
PI (low) to P3 (high)
PI (low) to P3 (high)
PI (low) to P3
(high)
PI (low) to P3
(high)
Bioaccumulation4
B1 (low) to B3
(high)
B1 (low) to B3 (high)
B1 (low) to B3 (high)
B1 (low) to B3 (high)
B1 (low) to B3
(high)
B1 (low) to B3
(high)
1 American Petroleum Institute, Petroleum HPV Testing Group. 2004. Robust Summary and Test Plan for the Heavy Fuel Oils. Available online at
http://www.epa.gov/chemrtk/pubs/summaries/heawfos/cl5368tc.htm as of December 15, 2010.
2 Data range presented for representative structures provided the Appendix.
3U.S.EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC. Available online
at http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of December 15, 2010.
4 Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Inderal Register 64. Number 213 (November4, 1999)pp.
60194-60204.
29
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Table 3. Environmental Fate Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory III: Atmospheric Distillate
SPONSORED
CHEMICAL
Distillates (petroleum),
crude oil
SPONSORED
CHEMICAL
Gas oils (petroleum),
heavy atmospheric
SUPPORTING
CHEMICAL
Fuels, diesel
SUPPORTING
CHEMICAL
Fuel oil, no. 2
SUPPORTING
CHEMICAL
Fuel oil, no. 4
SUPPORTING
CHEMICAL
Fuels, diesel, no. 2
(Fuel oil No. 2-D)
CASRN
68410-00-4
68783-08-4
68334-30-5
68476-30-2
68476-31-3
68476-34-6
Photodegradation Half-life
0.7-9.8 hours
(estimated)2,3
0.8-18.0 hours
(estimated)2-3
5.0-9.4 hours
(estimated)2-3
5.0-9.4 hours
(estimated)23
1.0-9.4 hours
(estimated)2-3
5.0-9.4 hours
(estimated)23
Hydrolysis Half-life
Stable
Biodegradation
No data
No data
60% in 28 days
(not readily
biodegradable)4;
57.5% in 28 days
(not readily
biodegradable)4
60% in 28 days
(not readily
biodegradable)4;
57.5% in 28 days
(not readily
biodegradable)4;
A mixed culture of
estuarine bacteria
was observed to
degrade fuel oil
no. 2 by 55% in
28 days5;
86-90% degradation
in 1 year5
60% in 28 days
(not readily
biodegradable)4;
57.5% in 28 days
(not readily
biodegradable)4
60% in 28 days
(not readily
biodegradable)4;
57.5% in 28 days
(not readily
biodegradable)4
Bioaccumulation Factor
0.9 to 3.9><104
(estimated)2-3
39.4 to 3.9><104
(estimated)2-3
867 to 3.9><104
(estimated)2,3
867 to 3.9><104
(estimated)2-3
867 to 3.9xl04
(estimated)2,3
867 to 3.9xl04
(estimated)2-3
Log Koc
3.3-13.2
(estimated)2,3
2.3-9.5
(estimated)2-3
2.9-5.6
(estimated)2-3
2.9-5.6
(estimated)2-3
2.9-8.3
(estimated)2-3
2.9-5.6
(estimated)2-3
Fugacity
(Level III Model)2,3
Air (%)
Water (%)
Soil (%)
Sediment (%)
<0.1-21.2
6.2-72.6
1.5-93.8
<0.1-8.6
<0.1-30.7
4.6-72.0
1.0-77.8
0.7-17.7
3.4-20.8
19.7-87.4
3.6-54.1
2.0-22.7
3.4-20.8
19.7-87.4
3.6-54.1
2.0-22.7
<0.1-20.8
2.5-87.4
3.6-54.1
2.0-61.3
3.4-20.8
19.7-87.4
3.6-54.1
2.0-22.7
30
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Table 3. Environmental Fate Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory III: Atmospheric Distillate
SPONSORED
CHEMICAL
Distillates (petroleum),
crude oil
SPONSORED
CHEMICAL
Gas oils (petroleum),
heavy atmospheric
SUPPORTING
CHEMICAL
Fuels, diesel
SUPPORTING
CHEMICAL
Fuel oil, no. 2
SUPPORTING
CHEMICAL
Fuel oil, no. 4
SUPPORTING
CHEMICAL
Fuels, diesel, no. 2
(Fuel oil No. 2-D)
Persistence6
PI (low) to P3 (high)
PI (low) to P3 (high)
PI (low) - P2
(moderate)
PI (low) - P2
(moderate)
PI (low) - P2
(moderate)
PI (low) - P2
(moderate)
Bioaccumulation6
B1 (low) to B3 (high)
B1 (low) to B3 (high)
B1 (low) to B3 (high)
B1 (low) to B3
(high)
B1 (low) to B3
(high)
B1 (low) to B3
(high)
1 American Petroleum Institute, Petroleum HPV Testing Group. 2004. Robust Summary and Test Plan for the Heavy Fuel Oils. Available online at
http://www.epa.gov/chemrtk/pubs/summaries/heawfos/cl5368tc.htm as of December 15, 2010.
2 Data range presented for representative structures provided the Appendix.
3 U.S. EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC. Available online
at http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of December 15, 2010.
4 American Petroleum Institute. Revised Robust Summary and Test Plan for the Gas Oils Category available online at
http://www.epa.gov/oppt/chemrtk/pubs/summaries/gasoilct/cl4835tc.htm as of December 15, 2010.
5 Agency for Toxic Substances and Disease Registry. 2005. Toxicological Profile for Fuel Oils/Kerosene. Available online at
http://www.atsdr.cdc. gov/ToxProfiles/tp.asp?id=516&tid=91 as of December 15, 2010.
6 Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Inderal Register 64. Number 213 (November4, 1999)pp.
60194-60204.
31
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Table 3. Environmental Fate Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory IV: Vacuum Residual
SPONSORED
CHEMICAL
Residues (petroleum),
light vacuum
SPONSORED
CHEMICAL
Residues (petroleum),
solvent-cxtd. vacuum
distilled residuum
SUPPORTING
CHEMICAL
Residues (petroleum),
vacuum
CASRN
68512-62-9
70913-85-8
64741-56-6
Photodegradation Half-life
0.7-7.5 hours
(estimated)2,3
0.7-7.5 hours
(estimated)2-3
0.7-2.2 hours
(estimated)2-3
Hydrolysis Half-life
Stable
Biodegradation
No data
No data
No data
Bioaccumulation Factor
0.9-6.5 xlO4 (estimated)2,3
0.9-6.5xlO4 (estimated)2,3
0.9-20.9 (estimated)2,3
Log Koc
4.0-13.2 (estimated)2,3
4.0-13.2 (estimated)23
9.2-9.3 (estimated)2,3
Fugacity
(Level III Model)2'3
Air (%)
Water (%)
Soil (%)
Sediment (%)
<0.1-11.1
6.2-78.4
2.1-93.8
<0.1-16.9
<0.1-11.1
6.2-78.4
2.1-93.8
<0.1-16.9
<0.1-0.6
6.1-36.7
62.6-93.0
<0.1-0.9
Persistence4
PI (low) to P3 (high)
PI (low) to P3 (high)
PI (low) to P3 (high)
Bioaccumulation4
B1 (low) to B3 (high)
B1 (low) to B3 (high)
B1 (low)
1 American Petroleum Institute, Petroleum HPV Testing Group. 2004. Robust Summary and Test Plan for the
Heavy Fuel Oils. Available online at http://www.epa.gov/chemrtk/pubs/summaries/heawfos/cl5368tc.htm as of
December 15, 2010.
2 Data range presented for representative structures provided the Appendix.
3 U.S. EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental
Protection Agency, Washington, DC. Available online at
http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of December 15, 2010.
4Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Federal
Register 64, Number 213 (November 4, 1999) pp. 60194-60204.
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Table 3. Environmental Fate Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory V: Atmospheric Distillate
SPONSORED
CHEMICAL
Residues
(petroleum),
heavy vaeuum
SPONSORED
CHEMICAL
Gas oils (petroleum),
hydrotrcatcd
vaeuum
SPONSORED
CHEMICAL
Gas oils
(petroleum),
hydrodcsulfuri/cd
heavy vaeuum
SPONSORED
CHEMICAL
Distillates
(petroleum),
petroleu m
residues vaeuum
SPONSORED
CHEMICAL
Distillates
(petroleum),
intermediate
vacuum
SPONSORED
CHEMICAL
Distillates
(petroleum),
light vacuum
SPONSORED
CHEMICAL
Distillates
(petroleum),
vacuum
CASRN
64741-57-7
64742-59-2
64742-86-5
68955-27-1
70592-76-6
70592-77-7
70592-78-8
Photodegradation
Half-life
0.7-4.8 hours
(estimated)2,3
0.7-8.0 hours
(estimated)2-3
0.7-5.0 hours
(estimated)2-3
0.7-4.8 hours
(estimated)2,3
0.7-7.4 hours
(estimated)23
0.8-9.8 hours
(estimated)23
0.7-6.8 hours
(estimated)2-3
Hydrolysis Half-life
Stable
Biodegradation
No data
No data
No data
No data
No data
No data
No data
Bioaccumulation
Factor
0.9 to 1.2xl05
(estimated)2-3
0.9 to 3.9><104
(estimated)2-3
0.9 to 1.7xl06
(estimated)2-3
0.9 to 1.2x10s
(estimated)23
1.2 to 2.5x10s
(estimated)2,3
39.4 to 2,719
(estimated)2,3
0.9 to 8.1x10s
(estimated)2-3
Log Koc
5.6-13.2
(estimated)2-3
3.8-13.2
(estimated)2-3
5.6-13.2
(estimated)2-3
5.6-13.2
(estimated)2,3
4.1-11.2
(estimated)23
3.3-9.4
(estimated)23
4.3-13.2
(estimated)2-3
Fugacity
(Level III Model)2 3
Air (%)
Water (%)
Soil (%)
Sediment (%)
<0.1-3.9
6.2-89.2
4.3-93.8
<0.1-31.6
<0.1-16.1
6.2-70.0
1.8-93.8
<0.1-14.6
<0.1-6.1
6.2-84.1
7.6-93.8
<0.1-31.6
<0.1-3.9
6.2-89.2
4.3-93.8
<0.1-31.6
<0.1-12.9
6.2-69.0
2.0-93.7
<0.1-20.6
<0.1-21.2
4.6-72.6
1.5-77.7
0.1-17.7
<0.1-6.9
6.2-65.5
1.3-93.8
<0.1-43.1
Persistence4
PI (low) to P3 (high)
PI (low) to P3 (high)
PI (low) to P3
(high)
PI (low) to P3
(high)
PI (low) to P3
(high)
PI (low) to P3
(high)
PI (low) to P3
(high)
Bioaccumulation4
B1 (low) to B3 (high)
B1 (low) to B3 (high)
B1 (low) to B3
(high)
B1 (low) to B3
(high)
B1 (low) to B3
(high)
B1 (low) to B2
(moderate)
B1 (low) to B3
(high)
1 American Petroleum Institute, Petroleum HPV Testing Group. 2004. Robust Summary and Test Plan for the Heavy Fuel Oils. Available online at
http://www.epa.gov/chemrtk/pubs/summaries/heawfos/cl5368tc.htm as of December 15, 2010.
2 Data range presented for representative structures provided the Appendix.
3U.S.EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC. Available online
at http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of December 15, 2010.
4 Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Inderal Register 64. Number 213 (November4, 1999)pp.
60194-60204.
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Table 3. Environmental Fate Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory VI: Cracked Residual
SPONSORED
CHEMICAL
Clarified oils
(petroleum), eatalvtie
cracked
SPONSORED
CHEMICAL
Residues (petroleum),
hydroc racked
SPONSORED
CHEMICAL
Residues (petroleum),
thermal cracked
SPONSORED
CHEMICAL
Pitch, petroleum, arom.
SPONSORED
CHEMICAL
Residues (petroleum),
heavy cokcr j»as oil and
vacuum gas oil
SPONSORED
CHEMICAL
Residues
(petroleum), cokcr
scrubber
condcnscd-rinjj-
aromatic-containinii
CASRN
64741-62-4
64741-75-9
64741-80-6
68187-58-6
68478-17-1
68783-13-1
Photodegradation
Half-life
0.7-4.8 hours
(estimated)2,3
0.7-4.8 hours
(estimated)2,3
0.7-4.8 hours
(estimated)2,3
0.7-1.3 hours
(estimated)2,3
0.7-7.5 hours
(estimated)2,3
0.7-4.8 hours
(estimated)2,3
Hydrolysis Half-life
Stable
Biodegradation
<20% degradation in
soil after 1 year4
No data
No data
No data
No data
No data
Bioaccumulation
Factor
0.9 to 1.2xl05
(estimated)2,3
0.9 to 1.2x10s
(estimated)2,3
0.9 to 1.2x10s
(estimated)2,3
0.9 to 1,727
(estimated)2,3
0.9 to 6.5 xlO4
(estimated)2,3
0.9 to 1.2x10s
(estimated)2,3
Log Koc
5.6-13.2
(estimated)2,3
5.6-13.2
(estimated)2,3
5.6-13.2
(estimated)2,3
5.9-13.2
(estimated)2,3
4.0-13.2 (estimated)2,3
5.6-13.2
(estimated)2,3
Fugacity
(Level III Model)2,3
Air (%)
Water (%)
Soil (%)
Sediment (%)
<0.1-3.9
6.2-89.2
4.3-93.8
<0.1-31.6
<0.1-3.9
6.2-89.2
4.3-93.8
<0.1-31.6
<0.1-3.9
6.2-89.2
4.3-93.8
<0.1-31.6
<0.1-0.1
6.2-8.4
56.9-93.8
<0.1-34.6
<0.1-11.1
6.2-68.4
2.1-93.8
<0.1-16.9
<0.1-3.9
6.2-89.2
4.3-93.8
<0.1-31.6
Persistence5
PI (low) to P3 (high)
PI (low) to P3 (high)
PI (low) to P3 (high)
PI (low) to P3 (high)
PI (low) to P3 (high)
PI (low) to P3 (high)
Bioaccumulation5
B1 (low) to B3 (high)
B1 (low) to B3 (high)
B1 (low) to B3 (high)
B1 (low) to B2 (moderate)
B1 (low) to B3 (high)
B1 (low) to B3 (high)
1 American Petroleum Institute, Petroleum HPV Testing Group. 2004. Robust Summary and Test Plan for the Heavy Fuel Oils. Available online at
http://www.epa.gov/chemrtk/pubs/summaries/heavvfos/cl5368tc.htm as of December 15,2010.
2 Data range presented for representative structures provided the Appendix.
3 U.S. EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC. Available online at
http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of December 15,2010.
4 ECB. 2000. European Chemical Substances Information System (ESIS), IUCLID Dataset, Residual Fuel Oils (CAS No. 64741 -62-4). Available online at http://ecb.irc.ec.europa.eu/esis/
5 Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Federal Register 64, Number 213 (November 4, 1999) pp. 60194-60204.
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Table 3. Environmental Fate Properties of the Heavy Fuel Oils Category1 (continued)
Property
Subcategory VII: Cracked Distillate
Subcategory VIII: Reformer Residual
SPONSORED
CHEMICAL
Distillates
(petroleum),
heavy eatalytie
cracked
SPONSORED
CHEMICAL
Distillates
(petroleum), heavy
thermal cracked
SPONSORED
CHEMICAL
Clarified oils
(petroleum),
hydro-
(lesu It'll ri/ed
catalytic cracked
SPONSORED
CHEMICAL
Distillates
(petroleum),
hydro-
desu Ifu ri/cd
intermediate
catalytic cracked
SPONSORED
CHEMICAL
Aromatic
hydrocarbons,
C12 - 20
SPONSORED
CHEMICAL
Residues
(petroleum),
catalytic reformer
fractionator
SPONSORED
CHEMICAL
Residues
(petroleum),
catalytic reformer
fractionator
residue distn.
CASRN
64741-61-3
64741-81-7
68333-26-6
68333-27-7
70955-17-8
64741-67-9
68478-13-7
Photodegradation
Half-life
0.8-6.8 hours
(estimated)2,3
0.8-6.8 hours
(estimated)2,3
0.7-4.8 hours
(estimated)2,3
1.0-8.9 hours
(estimated)2,3
1.2-10.9 hours
(estimated)2,3
0.8-11.0 hours
(estimated)2,3
0.7-5.0 hours
(estimated)2,3
Hydrolysis Half-life
Stable
Biodegradation
No data
No data
No data
No data
No data
No data
No data
Bioaccumulation
Factor
39 to 8><105
(estimated)2,3
39 to 8xl05
(estimated)2,3
0.9 to 1.2xl05
(estimated)2-3
368.6 to l.OxlO4
(estimated)2,3
425 to 2.9xl04
(estimated)2-3
368.6 to 1,881
(estimated)2,3
0.9 to 1.7xl06
(estimated)23
Log Koc
4.3-9.4
(estimated)2-3
4.3-9.7
(estimated)23
5.6-13.2
(estimated)2-3
3.6-8.3
(estimated)23
3.6-5.6
(estimated)2-3
3.0-7.1
(estimated)23
5.6-13.2
(estimated)2,3
Fugacity
(Level III Model)2 3
Air (%)
Water (%)
Soil (%)
Sediment (%)
<0.1-6.9
4.6-65.5
1.3-77.7
0.1-43.0
<0.1-6.9
5.0-65.5
1.3-82.3
0.1-43.0
<0.1-3.9
6.2-89.2
4.3-93.8
<0.1-31.6
<0.1-18.8
2.5-71.6
1.6-36.3
7.9-61.1
<0.1-9.2
5.0-32.8
43.1-86.4
2.6-51.9
<0.1-23.3
1.0-73.0
1.3-43.7
0.1-55.2
<0.1-6.1
6.2-84.1
7.6-93.8
<0.1-31.6
Persistence4
PI (low) to P3
(high)
PI (low) to P3 (high)
PI (low) to P3
(high)
PI (low) to P3
(high)
PI (low) to P3
(high)
PI (low) to P3 (high)
PI (low) to P3
(high)
Bioaccumulation4
B1 (low) to B3
(high)
B1 (low) to B3 (high)
B1 (low) to B3
(high)
B1 (low) to B3
(high)
B1 (low) to B3
(high)
B1 (low) to B2
(moderate)
B1 (low) to B3
(high)
1 American Petroleum Institute, Petroleum HPV Testing Group. 2004. Robust Summary and Test Plan for the Heavy Fuel Oils. Available online at
http://www.epa.gov/chemrtk/Dubs/summaries/heavvfos/cl5368tc.htm as of December 15,2010.
2 Data range presented for representative structures provided the Appendix.
3 U.S. EPA. 2010. Estimation Programs Interface Suite™ for Microsoft® Windows, v4.00. U.S. Environmental Protection Agency, Washington, DC. Available online at
http://www.epa.gov/opptintr/exposure/pubs/episuitedl.htm as of December 15,2010.
4Federal Register. 1999. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances. Federal Register 64, Number 213 (November 4, 1999) pp. 60194-60204.
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The components of the heavy fuel oils category are expected to possess low mobility in soil.
Based on data from supporting chemicals, the components of this category are not expected to be
readily biodegradable. Microbial degradation in soils is expected to be greatest for the lower
molecular weight aromatic fractions, while the biodegradation of the aliphatic and naphthenic
hydrocarbons decreases with increasing carbon chain length and degree of branching. Aromatics
with one, two or three aromatic rings are efficiently biodegraded; however, those with four or
more aromatic rings and the high molecular weight asphaltenes are quite resistant to
biodegradation. A single application of approximately 21, 14, or 13 g/kg soil of home fuel oil,
no. 2 to outdoor plots in Pennsylvania (silt loam), Oklahoma (sandy loam), and Texas (clay
loam) was degraded by 86, 90, and 86%, respectively, after 1 year, with degradation being
independent of temperature differences. The degradation of hydrocarbons fractions of fuel oil,
no. 2 was studied using a marine microcosm under different temperature, light and biological
activity regimes. Levels of heavy fuel oils were found to decrease exponentially under all
conditions, with temperature having the greatest effect on the half-lives of the component
hydrocarbons. In cold water, the half-life for total hydrocarbons was greater than 10 days, while
in warmer water (17-21°C), the half-life decreased to approximately 30 hours. In cold water,
saturated hydrocarbons were removed more rapidly than aromatic hydrocarbons, but in warmer
water, the half-lives of the fractions were similar. For the saturated hydrocarbons, the half-life
increased with increasing molecular weight or with branched or cyclic moieties, i.e., small n-
alkanes (C-12) had the shortest half-life in both warm and cold water. A Bunker C fuel oil
biodegraded 11% in 28 days using an inoculum of a mixed culture of bacteria obtained from a
estuarine creek known to be exposed to low levels of oil contamination. Volatilization of the
components of heavy fuel oils is expected to be moderate to high. The rate of hydrolysis is
expected to be negligible since the substances in this category do not possess functional groups
that hydrolyze under environmental conditions. The components of the heavy fuel oils category
are expected to possess low (PI) to high (P3) persistence and low (Bl) to high (B3)
bioaccumulation potential.
Conclusion: Heavy fuel oils are viscous liquid blends of the residues and distillates that are
derived from various refinery distillations, cracking, and reforming processes. These heavy fuel
oils are complex mixtures which may boil in the range of 121 to 600°C and consist of aromatic,
aliphatic, and naphthenic hydrocarbons, generally having carbon numbers in the range of C7 to
C50, together with asphaltenes and smaller amounts of heterocyclic compounds containing
sulfur, nitrogen, and oxygen. The lower molecular weight components of these complex
mixtures possess low to moderate water solubility while higher molecular weight fractions have
negligible solubility in water. The lower molecular weight components of the heavy fuel oil
category have moderate to high vapor pressure while higher molecular weight fractions tend to
possess negligible to low vapor pressure. The components of the heavy fuel oils category will
have low mobility in soil. Volatilization is expected to be moderate to high for most constituents
of the heavy fuel oils. The rate of hydrolysis is negligible since paraffins, naphthenes, and the
aromatic hydrocarbons contained in this category do not possess functional groups that
hydrolyze under environmental conditions. The rate of atmospheric photooxidation is expected
to be slow to rapid for most components of the heavy fuel oils. The components of this category
are not expected to be readily biodegradable. The components of heavy fuel oils are expected to
possess low (PI) to high (P3) persistence and low (Bl) to high (B3) bioaccumulation potential.
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3. Human Health Hazard
A summary of health effects data submitted for SIDS endpoints is provided in Table 4. The table
also indicates where data for tested category members are read-across (RA) to untested members
of the category.
Acute Oral Toxicity
Subcategory I: Residual Fuel Oils
Fuel oil, No. 6 (CASRN 68553-00-4)
(1) In four separate studies, Sprague-Dawley rats (5/sex/dose) were administered CASRN
68553-00-4 (Fuel oil, No. 6, API 78-6, API-78-7, API 78-8 and API 79-2) via gavage at 25
mL/kg (23,750 mg/kg based on density of 950 kg/m3 [or mg/mL] reported in CONCAWE, 1998)
and observed for 14 days after dosing. No mortalities were observed.
LDso > 23,750 mg/kg
(2) Male Wistar rats (5/dose) were administered CASRN 68553-00-4 (Residual Fuel oil, No. 6)
via the oral route at 1.0, 1.47, 2.15, 3.16, 4.64, 6.81 and 10 g/kg and were observed for 14 days.
Mortality was seen at > 3160 mg/kg as follows: 1/5 each at 3.16 and 4.64 g/kg, 3/5 at 6.81 g/kg
and 5/5 at 10 g/kg. Additional details are from TSCATS (OTS0536024).
LD50 = 5880 mg/kg
Subcategory II: Atmospheric Residual
Residues (petroleum), atm. tower (CASRN 64741-45-3)
Sprague-Dawley rats (5/sex) were administered CASRN 64741-45-3 (residues (petroleum), atm.
tower sample F-132) via gavage at 5000 mg/kg and were observed for 14 days after dosing. No
mortalities were observed.
LD50 > 5000 mg/kg
Subcategory III: Atmospheric Distillate
No data.
Subcategory IV: Vacuum Residual
Residues (petroleum), vacuum (CASRN 64741-56-6, supporting chemical)
Sprague-Dawley rats (5/sex) were administered CASRN 64741-56-6 (residues (petroleum)
vacuum (API sample 81-13)) in corn oil via gavage at 5000 mg/kg. No mortalities were
observed. This study summary was reported in the HPV Hazard Characterization for Gas Oils.
LD50 > 5000 mg/kg
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Subcategory V: Vacuum Distillate
Residues (petroleum), heavy vacuum (CASNo. 64741-57-7)
Sprague-Dawley rats were administered residues (petroleum), heavy vacuum via gavage at 5000
mg/kg-bw and were observed for 14 days after dosing. No mortalities were observed.
LDso > 5000 mg/kg-bw
Subcategory VI: Cracked Residual
Clarified oils (petroleum), catalytic cracked (CASRN 64741-62-4)
(1) Sprague-Dawley rats (10/sex/dose) were administered CASRN 64741-62-4 (Clarified oils
(petroleum), catalytic cracked (API 81-15))) via gavage at 3.2, 4.0, 5.0, 6.25 or 7.81 g/kg and
were observed for 14 days after dosing. Mortality was seen at all doses as follows: 1 male and 1
female at 3.2 g/kg, 1 male and 3 females at 4.0 g/kg, 2 males and 2 females at 5.0 g/kg, 3 males
and 5 females at 6.25 g/kg and 10 males and 10 females at 7.81 g/kg.
LD50 (males) = 5270 mg/kg
LD50 (females) = 4320 mg/kg
(2) Sprague-Dawley rats (10/sex/dose) were administered CASRN 64741-62-4 (Clarified oils
(petroleum), catalytic cracked; Cracked residual Carbon Black Oil; F-73-01)) via gavage at 4.0,
5.1, 6.2 or 8.4 g/kg and were observed for 14 days. Mortality was seen at > 5.1 g/kg as follows:
2 males and 0 female at 4.0 g/kg, 3 males and 3 females at 5.1 g/kg, 9 males and 7 females at 6.2
g/kg, and 10 males and 10 females at 8.4 g/kg. Additional details are from TSCATS
(OTS0546268).
LD50 (males) = 5230 mg/kg
LD50 (females) = 5820 mg/kg
Subcategory VII: Cracked Distillate
Distillates (petroleum), heavy thermal cracked (CASRN 64741-81-7)
(1) Sprague-Dawley rats (5/sex) were administered CASRN 64741-81-7 (Distillates (petroleum),
heavy thermal cracked (Coker heavy gas oil, sample F-97))) via gavage at 5000 mg/kg and were
observed for 14 days after dosing. No mortalities were observed.
LD50 > 5000 mg/kg
(2) Sprague-Dawley rats (5/sex) were administered four samples of CASRN 64741-81-7
separately (residues (petroleum), heavy vacuum—F-97-01, Visbreaker HGO, Vis gas oil
VIBRA, and VB Mittelol) via gavage at 5000 mg/kg and were observed for 14 days after dosing.
No mortalities were observed.
LD50 > 5000 mg/kg
Subcategory VIII: Reformer Residual
No data.
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Acute Inhalation Toxicity
Subcategory I: Residual Fuel Oils
Fuel oil, residual (CASRN 68476-33-5)
Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 68476-33-5 (Fuel oil, residual;
Heavy Fuel Oil; F-74-01) as an aerosol via whole-body inhalation at 2.1, 3.3 or 4.8 mg/L for 4
hours and were observed for 14 days. Mortality was seen at the highest exposure concentration
(9 males and 6 females). Additional details are from TSCATS (OTS0544092).
LCso (males) = 4.1 mg/L
LC50 (females) = 4.5 mg/L
Subcategory IV: Vacuum Residual
Residues (petroleum), vacuum (CASRN 64741-56-6), supporting chemical
Wistar rats (5/sex/dose) were exposed to CASRN 64741-56-6 (Residues (petroleum), vacuum)
aerosol via inhalation at 2.3 mg/L (94.4 mg/m3) for 4.5 hours and were observed for 14 days. No
mortalities were observed.
LCso> 2.3 mg/L (converted from 94.4 mg/m3 based on molecular weight of 600 [Asphalt
MSDS]). These data are from the HPV submission for Asphalt.
Acute Dermal Toxicity
Subcategory I: Residual Fuel Oils
Fuel oil, No. 6 (CASRN 68553-00-4)
New Zealand White rabbits (4/sex) were administered undiluted CASRN 68553-00-4 (Fuel oil,
No. 6 (API 78-6)) via the dermal route at 5 mL/kg (4874 mg/kg based on density of 950 mg/mL
reported in CONCAWE, 1998) under occluded conditions for 24 hours and were observed for 14
days after dosing. In three other studies using the same protocol, the Fuel oil, No. 6 blends tested
included API-78-7, API 78-8 and API 79-2. No mortalities were observed.
LD50 > 4874 mg/kg
Subcategory II: Atmospheric Residual
Residues (petroleum), atm. tower (CASRN 64741-45-3)
New Zealand White rabbits (5/sex/dose) were administered undiluted CASRN 64741-45-3
(Residues (petroleum), atm. tower (F-132)) via the dermal route at 2 g/kg under occluded
conditions for 24 hours and were observed for 14 days after dosing. No mortalities were
observed.
LD50 > 2000 mg/kg
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Subcategory III: Atmospheric Distillate
Diesel fuel No. 2 (CASRN 68476-34-6, supporting chemical)
In a 4-week study, Sprague-Dawley rats (10/sex/dose) were administered undiluted CASRN
68476-34-6 (Diesel fuel No. 2 (F-75-01) via the dermal route under occluded conditions at 0,
0.5, 2 or 5 mL/kg-day (0, -500, 2000 or 5000 mg/kg-day) once daily, 5 days/week. No
mortalities were observed. This study summary was reported in the HPV Hazard
Characterization for Gas Oils.
LDso (estimated) > 5000 mg/kg
Subcategory IV: Vacuum Residual
Residues (petroleum), vacuum (CASRN 64741-56-6, supporting chemical)
New Zealand White rabbits (5/sex) were administered undiluted CASRN 64741-56-6 (Residues
(petroleum), vacuum) via the dermal route at 2 g/kg under occluded conditions for 24 hours and
were observed for 14 days after dosing. No mortalities were observed. This study summary was
reported in the HPV Hazard Characterization for Gas Oils.
LD50 > 2000 mg/kg
Subcategory V: Vacuum Distillate
Residues (petroleum), heavy vacuum (CASRN 64741-57-7)
New Zealand White rabbits (3/sex) were administered undiluted CASRN 64741-57-7 (Residues
(petroleum), heavy vacuum; Vacuum distillate HVGO)) via the dermal route at 2000 mg/kg
under occluded conditions for 24 hours and were observed for 14 days after dosing. In three
other studies using the same protocol, tested substances included Visbreaker HGO, Vis gas oil
VIBRA, and VB Mittelol. No mortalities were observed.
LD50 > 2000 mg/kg
Subcategory VI: Cracked Residual
Clarified oils (petroleum), catalytic cracked (CASRN 64741-62-4)
New Zealand White rabbits (4/sex) were administered undiluted CASRN 64741-62-4 (Cracked
clarified oils (petroleum), catalytic cracked; Cracked residue (API 81-15)) via the dermal route at
2000 mg/kg under occluded conditions for 24 hours and were observed for 14 days after dosing.
No mortalities were observed.
LD50 > 2000 mg/kg
Subcategory VII: Cracked Distillate
Distillates (petroleum), heavy thermal cracked (CASRN 64741-81-7)
(1) New Zealand White rabbits (5/sex) were administered undiluted CASRN 64741-81-7
(distillates (petroleum), heavy thermal cracked;F-97-01; Coker heavy gas oil) via the dermal
route at 2000 mg/kg under occluded conditions for 24 hours and were observed for 13 days after
dosing. No mortalities occurred.
LD50 > 2000 mg/kg
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September, 2014
(2) New Zealand White rabbits (3/sex) were administered undiluted CASRN 64741-81-7
(distillates (petroleum), heavy thermal cracked; Visbreaker Gas Oils) via the dermal route at
2000 mg/kg under occluded conditions for 24 hours and were observed for 13 days after dosing.
In three other studies using the same protocol, tested substances included Vis gas oil VIBRA,
and VB Mittelol and Heavy Vacuum Gas Oil. No mortalities occurred.
LDso > 2000 mg/kg
Repeated-Dose Toxicity
All repeated-dose toxicity studies were conducted by a dermal route since the sponsor claims it is
the primary route of human exposure. The sponsor conducted a study on clarified slurry oil
(CASRN 64741-62-4; Subcategory VI)) in male mice to compare dermal and oral routes of
exposure. The conclusion is: "Based on mortality, body weights, liver weights, and liver and
bone marrow pathology, CSO is more toxic to mice when it is administered subchronically by
the dermal route than by the oral route. After 10 weeks of oral administration, mice exhibited
only slight morphologic changes in the liver. The observed liver changes were suggestive of the
healing of an earlier toxicological insult rather than of on-going toxicity. It would therefore
appear that mice exposed orally to CSO developed or manifested, in fewer than 10 weeks, a form
of acclimation or adaptation that was profoundly effective in repairing or protecting the liver
from the hepatotoxic effects of CSO. Mice exposed dermally to CSO at a dose of 1000
mg/kg/day for 10 weeks had a mortality of 50%, severe skin irritation, slightly decreased body
weights, significantly increased liver and reduced thymus weights, reduced megakaryocytes in
sterna bone marrow, and severe liver necrosis and fibrosis. Based on a previous study in rats it
appears that mice are less sensitive to the skin effects of CSO than rats".
Subcategory I: Residual Fuel Oils
Fuel oil, residual (CASRN 68476-33-5)
(1) In a 28-day study, Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 68476-33-5
(F-92-01) via the dermal route at 0 (sham-exposed), 0.5, 1.0 or 2.0 mL/kg-day (0, 480, 960 or
1920 mg/kg-day 6 hour/day, 5 days/week on to the previously clipped backs of the animals. The
application sites were occluded during the exposure period; the skin was then wiped to remove
residual test substance. Clinical signs and dermal irritation observations, hematology and
clinical chemistry evaluations, organ weights (liver, kidneys, testes, ovaries, spleen, brain and
adrenals), necropsy observations and histopathological examination (control and high-dose
groups) were performed.
There were no mortalities and treatment-related clinical signs. A significant decrease (p<0.05) in
body weight gains was seen in males at 1920 mg/kg-day and at 960 mg/kg-day (not significant).
No dermal irritation was seen. Liver weights (absolute and relative to body and brain weights)
were significantly increased (p<0.05) at all doses in both sexes (except for the males at 960
mg/kg-day for absolute liver weights). The absolute and relative spleen weights were
significantly increased at all doses. Hematological parameters showed changes suggestive of
anemia (significantly lower (p<0.05) erythrocytes count and hematocrit and hemoglobin levels)
at all doses. Absolute kidney weights were significantly lower (p<0.05) than controls in males
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September, 2014
atl920 mg/kg-day; however, they were within the normal ranges. No treatment-related changes
were seen during histopathology examination. Testes and ovaries were normal. Dermal lesions
(acanthosis and hyperkeratosis—trace or mild severity) were noted at the application sites in two
rats animals at 1920 mg/kg-day. Additional details are from TSCATS (OTS0534754).
LOAEL = 480 mg/kg-day (based on increased liver and spleen weights and decreased
erythrocytes, hemoglobin and hematocrit values)
NOAEL = Not established
(2) In a 28-day study, Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 68476-33-5
(F-92-01) via the dermal route at 0 (sham-exposed), 0.5, 1.0 or 2.5 mL/kg-day (0, 496, 992 or
2480 mg/kg-day, respectively, 6 hours/day,5 days/week on to the shorn dorsal skin of the
animals. The application sites were occluded during the exposure period; the skin was then
wiped to remove the residual test substance. Clinical signs and dermal irritation observations,
hematology and clinical chemistry evaluations, body weights, organ weights (liver, kidneys,
testes, ovaries, brain and spleen), necropsy observations and histopathological examination
(control and high-dose groups) were performed.
No mortality or treatment-related clinical signs were noted. A minimal, reversible dermal
irritation was seen at all doses. Several statistically significant parameters for hematology (lower
eosinophil count in mid- and high-dose males, lower hemoglobin concentration in high-dose
males) and clinical chemistry (lower SGOT levels in low- and high-dose females and high-dose
males, higher glucose levels in mid- and high-dose females and high-dose males and lower total
protein levels in low dose males) were within normal limits and did not exhibit any clear dose-
related trends. Relative liver weights were higher for females in all dose groups and for males in
the high-dose group. Liver/body weight and liver/brain weight ratios were higher at all doses.
Higher spleen/body weight ratios (in low and mid-dose females and high-dose males) and higher
spleen/brain weight (in low-dose females and high-dose males) ratios were not considered to be
treatment-related by the study director. Treatment-related histopathology results were eosinophil
casts in the kidneys of control and high-dose rats (considered to be spontaneous in the Sprague-
Dawley rats by the study director), hepatic inflammation in a high-dose male and hyperkeratosis
at the application site in the high-dose rats (minimal severity).
LOAEL = 496 mg/kg-day (based on effects on liver weight, spleen weight and liver/body
weight ratio and liver/brain weight ratio)
NOAEL = Not established
Subcategory II: Atmospheric Residual
Residues (petroleum), atm. tower (CASRN 64741-45-3)
In a 4-week study, Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 64741-45-3
(residues (petroleum), atm. tower; Atmospheric Tower Bottoms (F-132)) via the dermal route at
0, 0.01, 0.25 or 1.0 mL/kg-day (0, 9.4, 235 or 940 mg/kg-day, respectively) 6 hours/day, 5
days/week, on to the previously clipped backs of the animals, under occluded conditions.
Mortality, clinical signs, dermal irritation, body weights were recorded. Hematology and clinical
chemistry parameters were evaluated. Necropsy observations, organ weights and histopathology
(control and high dose animals) examination were conducted. There were no treatment-related
effects on body weights, organ weights, organ/body weight ratios, hematological changes,
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U.S. Environmental Protection Agency September, 2014
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clinical chemistry or clinical observations or histopathology. Testes and ovaries were normal.
Skin irritation was none to very minimal at all doses.
NOAEL = 940 mg/kg-day (highest dose tested)
Subcategory III: Atmospheric Distillate
Gas oils (petroleum), heavy atmospheric (CASRN 68915-97-9)
The study is conducted on heavy atmospheric gas oil, CASRN 68915-97-9, which is
compositionally similar to heavy fuel CASRN 68783-08-4, and also included in the Gas oils
category.
In a 13-week study, Sprague-Dawley rats (10/sex/dose) were exposed to CARN 68915-97-9
(heavy atmospheric gas oil) via the dermal route at 0, 30, 125 or 500 mg/kg-day once daily, 5
days/week. The application sites were not occluded during the exposure period; the animals
were fitted with Elizabethan collars to prevent oral ingestion of the test substance. At the end of
each week, any residual test substance was removed by wiping the skin. Mortality, clinical
signs, dermal irritation, body weights were recorded. Hematology, clinical chemistry and
urinalysis parameters were evaluated. At necropsy, organ weights were recorded and
histopathology examination was conducted.
Two animals became moribund and were sacrificed. One of the animals was a male from the
500 mg/kg-day group and the effects were considered to be treatment related. The other was a
male at 30 mg/kg-day and it death was considered incidental. Except for a slight skin irritation
(due to Elizabethan collars) there were no other treatment-related clinical signs. Body weight
gains were significantly (10%, significance not indicated) decreased in the males of the high-
dose group. Serum chemistry values were different from controls in the at 125 and 500 mg/kg-
day (increased BUN (27-35%), cholesterol (39-117%), sorbitol dehydrogenase (68-106%)) and
at 500 mg/kg-day (increased total protein (11%) and globulin {21%) and decreased A/G ratio
(20%))). Hematological parameters indicated differences from controls in males at 125 and 500
mg/kg-day males and in females at 500 mg/kg-day (decreased RBC count 8-30%), hemoglobin
(9-31%>) and hematocrit (8-30%>) and platelets (23-48%). At necropsy, treatment-related effects
included increased liver size, decreased thymus size, thickening of the limiting ridge between the
non-glandular and glandular sections of the stomach and enlarged and reddened lymph nodes.
There were some relative organ weight differences at > 125 mg/kg-day (adrenals, heart, kidney,
liver, spleen and thymus). Treatment-related effects observed at histopathological examination
in the 500 mg/kg-day dose group included severe reduction in hematopoiesis in the bone
marrow, liver hypertrophy and connective tissue formation. There were also increased areas of
hematopoiesis, focal necrosis and cell death in the liver and a reduction in the numbers of
lymphocytes in the thymus glands. There were no treatment-related effects on the epididymal
sperm or testicular spermatid parameters (weight of cauda epididymis, number of sperms/gram
of cauda, testes weight, number of spermatid/gram of testis, and number of sperm/testis.
LOAEL = 125 mg/kg-day (based effects on serum chemistry and hematological parameters,
organ weight)
NOAEL = 30 mg/kg-day
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Subcategory IV: Vacuum Residual
Residues (petroleum), vacuum (CASRN 64741-56-6, supporting chemical)
In a 4-week study, New Zealand White rabbits (5/sex/dose) were administered residues
(petroleum), vacuum (API sample 81-13) via the dermal route at 0, 200, 1000 or 2000 mg/kg-day
to clipped dorsal skin under occluded conditions for 6 hours/day, 3 days/week, for total of 12
applications. The application sites were occluded. The residual test substance was then wiped
off the skin. All animals were observed for signs of toxicity and dermal irritation; body weights
and food consumption were recorded; clinical chemistry and hematology parameters were
evaluated and at necropsy, organ weights were taken. Histopathology examination was
conducted on tissues and organs from the control and high-dose groups.
Two animals died and two were sacrificed moribund during the study - the identity of the dose
groups for these mortalities were not reported in the robust summary; however the full report is
available in TSCATS (OTS 0000186-1) and shows that one control female and one high dose
male were found dead, and one control male and a mid-dose female were sacrificed in moribund
condition during the study. This supports the conclusion that these deaths were not likely
treatment-related. Treatment-related clinical signs observed in survivors included thin
appearance, decreased food intake, flaking skin and wheezing (doses not stated). All animals
treated with residues (petroleum), vacuum exhibited slight edema. Decreased body weight gain
was observed in males at 2000 mg/kg-day. There were no treatment-related changes in the
hematology parameters. Alkaline phosphatase was reduced by 50% in males at 2000 mg/kg-day.
Changes in absolute and/or relative organ weights were observed at 2000 mg/kg-day (adrenals,
kidney, pituitary and spleen), but were not considered to be treatment-related. Treatment-related
gross necropsy and microscopic findings were confined to the skin. The skin of females
appeared to be more severely affected. Effects in females were limited to the point of contact
with the test substance. Incidental findings were observed and were consistent with
Encephalitozoon infection. Additional details are from the HPV test submission for asphalt
category and TSCATS OTS0000186-1.
LOAEL (systemic) = 2000 mg/kg-day (based on decreased body weight gain and reduced
alkaline phosphatase in males)
NOAEL (systemic) = 1000 mg/kg-day
Subcategory V: Vacuum Distillate
Residues (petroleum), heavy vacuum (CASRN 64741-57-7)
(!)
Sample
CRU No.
85244
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.00
0.06
2.48
1.86
1.24
0.50
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
n a 13-week study, Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 64741-57-7
(Heavy Vacuum Gas Oil (CRU No. 85244)) daily via the dermal route at 0, 30, 125, 500 or 2000
mg/kg-day, 6hr/day, 5 days/week, on to previously clipped sites on the trunk of the animals. The
application sites were not occluded; the animals were fitted with Elizabethan collars to minimize
ingestion of the test substance. At 24 hours after the 5th dose, the residual test substance was
wiped off. Mortality, clinical signs, skin irritation and body weights were monitored. Clinical
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Hazard Characterization Document
chemistry and hematology parameters were evaluated. At necropsy, organ weights were taken.
Histopathological examinations were conducted on tissues from the control and high-dose
groups. Sperm head morphology was evaluated in the control and at 2000 mg/kg-day.
Two males and one female at 2000 mg/kg-day died during the study. The male deaths were
considered to be treatment-related but the female death was incidental. Body-weight gains in
both sexes were reduced at 2000 mg/kg-day (males weighed 20% less and females weighed 15%
less than controls). Erythrocytes and platelets were reduced in males and females at 2000
mg/kg-day and in females at 500 mg/kg-day during weeks 5 and 13. At 125 mg/kg-day,
erythrocytes count, hemoglobin, hematocrit and platelets were decreased in both sexes. Clinical
chemistry changes included increased sorbitol dehydrogenase (two fold increase), increased
cholesterol (two fold) and decreased uric acid (50%) in males and females at 2000 mg/kg-day
and decreased glucose in females and increased cholesterol in males at 500 mg/kg-day. At gross
necropsy, relative thymus weights and relative liver weights were reduced in both sexes at > 500
mg/kg-day. Histopathological examination revealed decreased erythropoeisis and fibrosis of the
bone marrow in males at 2000 mg/kg-day and a marked reduction in thymic lymphocytes in
males and moderate decrease in females at 2000 mg/kg-day and slightly in both sexes at 500
mg/kg-bw/day. No effects were seen on sperm morphology.
LOAEL = 125 mg/kg-day (based on decreased hematological parameters)
NOAEL = 30 mg/kg-day
(2) In a 28-day study, Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 64741-57-7
(heavy paraffinic vacuum distillate, F-128) via the dermal route at 0, 0.1, 1.0 or 2.5 mL/kg-day
(0, 94, 940 or 2350 mg/kg-day) 6 hours/day, 5 days/week on to the previously clipped sites on
the back of animals. The application sites were occluded and after the exposure period, the
residual test substance was wiped off. Mortality, clinical signs, skin irritation and body weights
were monitored. Clinical chemistry and hematology parameters were evaluated. At necropsy,
organ weights were taken. Histopathological examinations were conducted on tissues from the
control and high-dose groups.
No mortality or treatment-related clinical signs were observed. There were no significant
differences in body weights between control and treatment groups. Very slight and sporadic
dermal irritation (slight erythema, slight eschar and slightly dried skin) was seen at all doses.
The severity was not dose dependent. A significantly lower (p<0.01) and dose dependent
decrease (p<0.05) in mean hematocrit and hemoglobin values were seen in females at 2350
mg/kg-day. A significant increase (p<0.01) in cholesterol values was seen females of the high-
dose. Treatment-related increase in mean absolute and/or relative (to body weight and brain
weight) liver weight were noted in males and females at 940 and 2350 mg/kg-day. At necropsy,
multiple red foci in thymus and yellow discoloration of kidney were seen in females at 2350
mg/kg-day. No treatment-related changes were observed during the histopathlogical
examination. No effects were seen on testes and ovaries. Additional details are also from
TSCATS (OTS0555147).
LOAELfemaies = 940 mg/kg-day (based on effects on hematocrit, hemoglobin, cholesterol values
and increased absolute and relative liver weights)
NOAELfemaies = 94 mg/kg-day
NOAELmaies = 2350 mg/kg-day (highest dose tested)
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(3) In a 28-day study, Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 64741-57-7
(heavy vacuum gas oil stock, F-l 13-01) via the dermal route at 0, 0.01, 0.1 or 1.0 mL/kg-day (0,
9.3, 93 or 930 mg/kg-day, respectively) 6 hours/day, 5 days/week on to previously clipped sites.
The application sites were occluded during the exposure period. The skin was then wiped off to
remove residual test substance. Mortality, clinical signs, skin irritation and body weights were
monitored. Clinical chemistry and hematology parameters were evaluated. At necropsy, organ
weights were taken. Histopathological examinations were conducted on tissues from the control
and high-dose groups.
No mortality or treatment-related clinical signs were observed. Slight skin irritation was
observed in females at 930 mg/kg-day. Body weight and body weight gain were decreased in
females at 930 mg/kg-day. Increased liver weight (relative to body weight (10-16%) and brain
weight (8%)) and decreased absolute and relative kidney weights (14 and 10%, respectively) in
females at 930 mg/kg-day were not considered treatment related or biologically relevant by the
study director. Treatment-related decreases in hematocrit (8-10%) and hemoglobin (5-6%) were
seen at 930 mg/kg-day in both sexes. A significant increase in cholesterol values (47%) was seen
in females at 930 mg/kg-day. No treatment-related changes were observed during the
histopathlogical examination. No effects were seen on testes and ovaries.
LOAEL = 930 mg/kg-day (based on effects on hematocrit, hemoglobin in both sexes and
cholesterol values and increased liver weights in females)
NOAEL = 93 mg/kg-day
Subcategory VI: Cracked Residual
Clarified oils (petroleum), catalytic cracked (CASRN 64741-62-4)
(!)
Sample
CRUNo.
86484
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.0
0.98
9.76
19.52
9.76
4.88
0.98
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
n a 13-week study, Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 64741-62-4
(clarified oils (petroleum), catalytic cracked; Clarified Slurry Oil, (CSO)) via the dermal route at
0, 8, 30, 125 or 500 mg/kg-day daily, 5 days/week under non-occluded conditions. There were
two groups of untreated control animals. Animals were fitted with Elizabethan collars to
minimize ingestion of the test substance. Mortality, clinical signs, skin irritation and body
weights were monitored. Clinical chemistry, hematology and urinalysis parameters were
evaluated. At necropsy, organ weights were taken. Histopathological examinations were
conducted on tissues from the control and 125 and 500 mg/kg-day dose groups.
All rats in the highest dose group and males treated at 125 mg/kg-day, died or were sacrificed in
a moribund condition prior to necropsy. In addition, 8 females treated at 125 mg/kg-day and 2
males at 30 mg/kg-day died or were sacrificed prior to scheduled necropsy. Body weight gains
were reduced at > 30 mg/kg-day. Erythema (slight) and thickened, leathery skin were observed
in four rats at 500 mg/kg-day. Hematological parameters were changed in comparison to the
controls at dose levels > 30 mg/kg-day (decreased hematocrit, hemoglobin, RBC count, and
platelets). Serum chemistry was also changed at dose levels > 30 mg/kg-day (increased BUN,
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decreased uric acid, increased alkaline phosphatase, decreased LDH). Increased frequency of
elevated glucose levels were seen urine of rats at > 30 mg/kg-day. Liver weights were increased
at all dose levels. There was a dose-related decrease in thymus weights. At necropsy, epidermal
hyperplasia and trace to slight chronic inflammation in the superficial dermis. In the liver,
microsystes, cholangiolitis/cell degeneration/disarray and altered focus of hepatocytes were
observed at doses > 8 mg/kg-day. Necrosis and fibrosis were also observed in liver at doses > 30
mg/kg-day. Hepatocellular degeneration, hypertrophy of hepatocytes, multinucleated large
hepatocytes and vacuolation were observed at doses > 125 mg/kg-day. Erythroid hypoplasia of
the bone marrow was observed at doses > 125 mg/kg-day with slight changes found at 30 mg/kg-
day. Hypoplasia and atrophy of thymus was seen at > 8 mg/kg-day.
LOAEL = 8 mg/kg-day (based on effects on liver and thymus)
NOAEL = Not established
2)
Sample
CRUNo.
86001
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.0
2.57
25.68
19.26
6.42
3.21
0.64
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
n a 13-week study, Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 64741-62-4
(clarified oils (petroleum), catalytic cracked; Clarified Slurry Oil, (CSO)) via the dermal route at
0, 8, 30, 125, 500 or 2000 mg/kg-bw/day daily, 5 days/week on to previously clipped sites on the
back of animals. The application sites were not occluded; the animals were fitted with
Elizabethan collars to minimize ingestion of the test substance. At 24 hour after the fifth dose of
the week, the residual test substance was wiped off. Mortality, clinical signs, skin irritation and
body weights were monitored. Clinical chemistry, hematology and urinalysis parameters were
evaluated. At necropsy, organ weights were taken. Histopathological examinations were
conducted on selected tissues and gross lesions.
All rats at 2000 and 85% rats at 500 mg/kg-day died or sacrificed in moribund condition. At 125
mg/kg-day, 5/10 males and 1/10 females died or sacrificed in moribund condition prior to
scheduled necropsy. Body weight gains were reduced at > 30 mg/kg-day. Skin irritation was not
seen at 8, 30 or 125 mg/kg-day. Hematological parameters were decreased compared control
values in both sexes at 125 mg/kg-day (decreased hematocrit, hemoglobin, and RBC count).
Hematocrit values were also decreased at 30 mg/kg/day in both sexes. Several clinical chemistry
values were changed compared to controls. At 125 mg/kg-day, males showed increased glucose
(26%), A/G ratio (14%), total bilirubin (146%), aspartate aminotransferase (200%), alkaline
phosphatase (72%), and calcium (7%) values. Males at 30 mg/kg/day showed decreased uric
acid (33%>) and LDH (52%) values. In females, at 125 mg/kg-day, increased A/G ratio (18%),
and decreased LDH {19%) values were seen. Females at 30 mg/mg-day showed increased
alkaline phosphatase (58%) values and those at 8 mg/kg-day showed increased cholesterol (43%)
values. Absolute liver weights were increased (21 %)in females at 8 mg/kg-day and relative liver
weight were increased in both sexes (13 and 23%, respectively for males and females. In males,
absolute (43%) and relative (39%) thymus weights at 30 mg/kg-day and relative spleen weight
(25%) were increased at 30 mg/kg-day. In females at 125 mg/kg-day, absolute (67%) and
relative (38%) thymus weights were decreased. Histopathology showed microcysts,
cholangiolitis/cell degeneration and altered focus of hepatocytes at >8 mg/kg-day. Necrosis was
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observed at > 30 mg/kg-day. Erythroid hypoplasia of bone marrow was observed at > 30 mg/kg-
day. Hypoplasia and atrophy of thymus was seen at > 8 mg/kg-day. No treatment-related effects
were seen on testes and ovaries.
LOAEL = 8 mg/kg-day (based on effects on liver and thymus)
NOAEL = Not established
(3) In a 13-week study, Fisher 344 rats (10/sex/dose) were exposed to CASRN 64741-62-4
(clarified oils (petroleum), catalytic cracked (API 81-15)) via the dermal route at 0 (sham-
exposed), 40, 200 or 400 mg/kg-day, 6 hours/day, 5 days/week for a total of 65 applications.
The application sites were not occluded; the rats were fitted with Elizabethan collars to prevent
ingestion of the test substance. Mortality, clinical signs, skin irritation and body weights were
monitored. Clinical chemistry, hematology and urinalysis parameters were evaluated. At
necropsy, organ weights were taken. Histopathological examinations were conducted on tissues
from the control and low- and mid-dose animals.
All rats at 400 mg/kg-day died or were killed in a moribund condition. Seven rats in the 200
mg/kg-day group died or were killed in a moribund condition. One male died at 40 mg/kg-day;
however, the death was not considered treatment related. Clinical signs observed in the 200 and
400 mg/kg-day groups included thinness, hunched posture, lethargy and prostration. No
erythema or edema was observed. Dose-related and statistically significant (p<0.05) decreases
were observed in body weights throughout the study duration. Statistically significant (p<0.05)
hematological changes (decreased RBC, hemoglobin and hematocrit) occurred in both sexes at
40 and 200 mg/kg-day. Serum chemistry evaluation showed statistically significant changes in
both sexes (increases in BUN, SGOT, SGPT, and ALP values and decreases in total protein
values) at 200 mg/kg-day and at increased alkaline phosphatase values in both sexes at 40
mg/kg-day. A statistically significant increase in absolute and relative liver weights were seen in
males and females at 40 mg/kg-day and in females at 200 mg/kg-day. At necropsy, gross
findings in males of the 200 mg/kg-day group included small thymus, reddened and/or enlarged
lymph nodes, discoloration of the liver and congested and/or dark testes. Histological changes in
rats from the 200 mg/kg-day group included minimal to severe multifocal centrilobular
degeneration of hepatic lobules, vacuolation, pigmentation and/or accumulations of neutrophils
and absent thymic tissue (severe atrophy). In many of the female rats at 200 mg/kg-day, the
hepatic changes were accompanied by secondary treatment-related changes in the kidneys (,
adrenals, ovaries and uterus. Similarly, in male rats at this dose level, secondary changes were
present in the kidneys and adrenals. Skin lesions characterized by hyperplasia and/or
hyperkeratosis were observed in all of the dose groups. Additional details are from TSCATS
(OTS0539134).
LOAEL = 40 mg/kg-day (based on changes in hematology, clinical chemistry parameters,
decreased body weight and organ weights)
NOAEL = Not established
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(4)
Sample
091645
(F-179)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.00
0.70
10.00
30.00
20.00
6.00
0.00
Wt. % of PACs (polyaromatic compounds) that have 1-7 aromatic rings in the Aromatic Ring Class
n a 13-week study, Sprague-Dawley rats (20/sex/dose) were exposed to CASRN 64741-62-4
(Catalytic-Cracked Slurry Oil, F-179) via the dermal route at 0, 0.001, 0.01, 0.05, 0.1 or 0.5
mL/kg-day (0, 1.06, 10.6, 53, 106, and 530 mg/kg-day, respectively) daily, 6 hours/day, 5
days/week under occluded conditions. The skin was then wiped to remove residual material.
Mortality, clinical signs, skin irritation, body weights and food consumption were monitored.
Clinical chemistry and hematology parameters were evaluated. At necropsy, organ weights were
taken. Histopathological examinations were conducted on tissues from the control and high-dose
animals.
Mortality occurred at 530 mg/kg-day; in males (35%) and females (10%). At 530 mg/kg-day, a
decrease (12%) in terminal body weights was seen in males. At >53 mg/kg-day, hematology
parameters showed decreases in RBC count (9-30%), hematocrit (9-36%), hemoglobin (7-28%)
and at >10.6 mg/kg-day, in platelets (20-43%). The affected serum chemistry parameters at >
53included increased BUN (31-85%), creatinine (8-14%), SGOT (9-111%)), cholesterol (61-
87%>), and alkaline phosphatase ((93% in females only at 530 mg/kg-day). Absolute liver
weights were significantly increased in males and females at >53 mg/kg-day (19-45%) and
relative liver weights (to body weight) were increased (11-37%) at all doses in both sexes except
at 1.06 mg/kg-day. Kidney, spleen, thymus, lungs and heart weights were also affected by
treatment. The decreases (43-56%) in absolute and relative thymus weights at 530 mg/kg-day
and increases (12-23%) in absolute and relative lungs weights at 53, 106 and 530 mg/kg-day
were treatment-related. Histopathological examination revealed the following changes:
increased incidence of bone marrow cellular depletion at > 106 mg/kg-day in both sexes; liver
congestion/necrosis/vacuolar changes at > 53 mg/kg-day in both sexes; thymus atrophy in males
at > 10.6 mg/kg-day and at >106 mg/kg-day in females and thyroid chronic inflammation
(lymphocytic thyroiditis) at> 53 mg/kg-day in both sexes.
LOAEL = 10.6 mg/kg-day (based on increased absolute and relative liver weight, lungs weight,
decreased platelets, thymic atrophy)
NOAEL = 1.06 mg/kg-day
(5) In a 28-day study, albino Sprague-Dawley rats (10/sex/dose) were exposed to CASRN
64741-62-4 (clarified oils (petroleum), catalytic cracked (Carbon Black Oil (CBO) F-l 15-01),
FCCU Clarified Oil) via the dermal route at 0 (untreated), 1, 10 or 50 mg/kg-day (neat) and 0
(acetone), 0.1, 1.0, 10 or 50 mg/kg-day as a 10% solution in acetone 6 hours/day, 5 days/week on
to previously clipped sites under occluded conditions. Following a 6-hour exposure period, the
test sites were wiped to remove residual test substance. Mortality, clinical signs, skin irritation
and body weights were monitored. Clinical chemistry and hematology parameters were
evaluated. At necropsy, organ weights were taken. Histopathological examinations were
conducted on tissues from the control and high-dose animals.
A statistically significant decrease in RBC counts (males), hematocrit and hemoglobin values
(both sexes) were seen at 50 mg/kg-day groups and in males receiving 10 mg/kg-day CBO in
acetone. Clinical chemistry parameters showed significantly higher BUN in both sexes at 50
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September, 2014
mg/kg-day, higher cholesterol and glucose levels than controls. Higher cholesterol values were
seen in females at 10 mg/kg-day. Absolute and relative liver weights were elevated over controls
in the high-dose acetone group and in the neat 10 mg/kg-day groups. Absolute and relative
thymus weights and absolute kidney weights were lower than controls among high-dose rats.
Except for changes in skin (acanthosis and hyperkeratosis) in both sexes at 50 mg/kg-day, there
were no other treatment-related histopathological findings. Additional details are from TSCATS
(OTS0546268).
LOAEL = 10 mg/kg-day (based on increased liver weights and changes in hematology and
clinical chemistry)
NOAEL = 1 mg/kg-day
(6) In a 28-day study, Sprague-Dawley rats (10/se/dose) received CASRN 64741-62-4 (clarified
oils (petroleum), catalytic cracked (carbon Black Oil, F-73-01) via the dermal route at 0, 0.5, 1.0,
or 2.5 mL/kg-day (0, 542, 1084 or 2710 mg/kg-day, 6 hours/day, 5 days/week onto previously
clipped backs of the animals. The application sites were occluded during the exposure period.
The application sites were then wiped to remove residual test substance. Mortality, clinical
signs, skin irritation and body weights were monitored. Clinical chemistry and hematology
parameters were evaluated. At necropsy, organ weights were taken. Histopathological
examinations were conducted on tissues from the control and high-dose animals.
Body weights were decreased statistically (p<0.05) at all doses for males and in the high-dose
group for females. Body weight gain was also affected in all animals; to a lesser extent in
females. Absolute and relative liver weights were higher than controls at all doses and kidney
and ovary weights were significantly (p<0.05) lower in the mid- and high-dose groups. Changes
in hematological (decreased eosinophils, hemoglobin and hematocrit in both sexes at all doses)
and biochemical (decreased SGPT in males, increased alkaline phosphatase in females, increased
glucose in both sexes and decreased total protein in females) parameters were observed. All
these changes were not considered to be treatment-related and/or biologically relevant by the
study director. Histopathology revealed no treatment-related effects except acanthosis and
hyperkeratosis in high-dose animals. Additional details are from TSCATS (OTS0534753).
LOAEL = 542 mg/kg-day (based on decreased body weights body weight gains, and increased
liver weights, effect on hematology parameters)
NOAEL = Not established
(7) In a 28-day study, New Zealand White rabbits (5/sex/dose) were exposed to CASRN 64741-
62-4 (clarified oils (petroleum), catalytic cracked (API 81-15)) via the dermal route at 0, 200,
1000 or 2000 mg/kg-day, 6 hours/day, 3 times/week on to previously clipped backs of the
animals for a total of 12 applications under occluded conditions. At the end of the exposure
period, the application sites were wiped off to remove residual test substance. Mortality, clinical
signs, skin irritation and body weights were monitored. Clinical chemistry and hematology
parameters were evaluated. At necropsy, organ weights were taken. Histopathological
examinations were conducted on tissues from the control and high-dose animals.
Treatment-related deaths occurred in mid-dose (1 male) and high-dose rabbits (two males and
one female) during the exposure period. Clinical signs in surviving rabbits included cracked or
flaking skin, thin appearance, necrotic tissue around the dosing area, decreased food intake,
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moderate to severe erythema outside of the dosed area, edema and skin ulceration at the test site.
Statistically significant (p<0.05) decreases in were observed among males from all doses and
high-dose females. Overall body weight gains were lower in males of the mid- and high-dose
groups and high-dose females. No treatment-related trends were seen in hematology parameter.
Statistically significant (p<0.05) serum chemistry changes (increase in SGOT activity in high-
dose males and females, decreased total protein in mid-and high-dose females and mid-dose
males) were observed. Absolute and relative liver weights were increased significantly (p<0.05)
over controls in females of all dose groups and males of the mid- and high-dose groups. Gross
examination revealed thickened skin among all treatment groups. Microscopic changes in high-
dose animals included skin (sub-acute acanthotic dermatitis, minimal to severe early multifocal
papillomatosis (skin surface elevation caused by hyperplasia and enlargement of contiguous
dermal papillae) in high-dose males and females), hepatic (slight to moderate diffuse mid-zonal
hepatocellular hypertrophy, minimal to severe necrosis), thymus (involution of the thymus) and
mesenteric lymph nodes (slight to moderate lymphoid depletion). Additional details are from
TSCATS (OTS0000901H7).
LOAEL = 200 mg/kg-bw/day (based on decreased body weights, increased liver weights and
microscopic changes in skin)
NOAEL = Not established
Residues (petroleum), hydrocracked (CASRN 64741-75-9)
In a 28-day study, Sprague-Dawley rats (10/se/dose) received CASRN 64741-75-9
(Hydrocracker Recycle Oil (F-127)) via the dermal route at 0, 0.01, 0.05, or 0.25 mL/kg-day (0,
8.4, 42 or 210 mg/kg-day, respectively) 6 hours/day, 5 days/week on previously clipped sites on
the backs of the animals under occluded conditions. The skin was wiped to remove residual test
substance. Mortality, clinical signs, skin irritation and body weights were monitored. Clinical
chemistry and hematology parameters were evaluated. At necropsy, organ weights were taken.
Histopathological examinations were conducted on tissues from the control and high-dose
animals. There was no mortality. Very slight to moderate skin irritation was observed. There
were no effects on body weights, organ weights, hematology or conical chemistry parameters.
There were no treatment-related changes observed during the histopathological examination.
NOAEL = 210 mg/kg-day (highest dose tested)
Residues (petroleum), thermal cracked (CASRN 64741-80-6)
In a 13-week study, male and female Sprague-Dawley rats (number/dose not stated) were
exposed to 67% mix of CASRN 64741-80-6 (67% mix of Visbreaker residue in Stock 141) via
the dermal route at 0 (sham exposed), 0 (vehicle, Stock 141) 60, 250 or 1000 mg/kg-day daily, 5
days/week onto previously clipped sites on the backs of the animals. The animals were fitted
with Elizabethan collars to minimize ingestion of the test substance. At 24 hours after the fifth
dose, residual test substance was wiped off as thoroughly as possible. Mortality, clinical signs,
skin irritation, body weights and food consumption were monitored. Clinical chemistry,
hematology and urinalysis parameters were evaluated. At necropsy, organ weights were taken.
Histopathological examinations were conducted on tissues from the control and high-dose
animals. Sperm morphology and count were also performed.
There were no treatment-related clinical signs or skin irritation. Decreased body weight gain
(17%>) was seen in males at 1000 mg/kg-day. Decreased RBC count (8%>), hemoglobin (11%>)
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and hematocrit (9%) were noted in males at 1000 mg/kg-day. Decreased BUN, total protein and
albumin and increased sorbitol dehydrogenase in males and increased BUN, sorbitol
dehydrogenase and cholesterol values in females were seen at 1000 mg/kg-day. At 250 mg/kg-
day, increased sorbitol dehydrogenase in females and decreased alanine amino transferase in
males were seen. At 60 mg/kg-day, a decrease in ALT activity (12%) was seen in males.
Absolute and relative liver weights were increased in both sexes at 1000 mg/kg-day; at 250
mg/kg-day, increased absolute liver weight in males and a slight increase in relative liver weights
in females were noted. At 60 mg/kg-day, increase (2-12%) in absolute liver weights in both
sexes were noted. In males, relative spleen weight, absolute and relative adrenals weights and
relative kidney weights were increased at 1000 mg/kg-day. Absolute adrenals weights were also
increased in males at 250 and 60 mg/kg-day (26%). No treatment-related effects were seen
during the histopathological examination or sperm evaluation.
LOAEL = 60 mg/kg-day (based on effects on ALT, absolute and relative liver weight and
absolute adrenals weights)
NOAEL = not established
Subcategory VII: Cracked Distillate
Distillates (petroleum), heavy thermal cracked (CASRN 64741-81-7)
(!)
Sample
86181
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.25
2.48
12.40
7.44
2.48
0.500
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
In a 13-week study, male and female Sprague-Dawley rats (number/dose not indicated) were
exposed to CASRN 64741-81-7 (Distillates (petroleum), heavy thermal cracked, (Joliet Heavy
Coker Gas Oil, CRU 86181)) via the dermal route at 0 (sham-exposed), 8, 30 or 125 mg/kg-day,
5 days/week. The test substance was applied to previously clipped sites on the backs of the
animals. The application sites were not occluded; the rats were fitted with Elizabethan collars to
prevent ingestion of the test substance. Mortality, clinical signs, skin irritation and body weights
were monitored. Clinical chemistry, hematology and urinalysis parameters were evaluated. At
necropsy, organ weights were taken. Histopathological examinations were conducted on tissues
from the control and high-dose animals. Sperm morphology and sperm count were evaluated.
No mortality was reported. Skin irritation was moderate in all treated groups. Body weight gain
was decreased in males at 125 mg/kg-day (17%). Absolute and relative liver weights were
increased (24-36%) in both sexes at 125 mg/kg-day and relative liver weights were increased (9-
16%>) in both sexes at 30 mg/kg-day. Absolute thymus weights were decreased (52-56%>) in
males and females at 125 mg/kg-day. Relative heart weights were increased (14%>) in males at
125 mg/kg-day. Absolute weights for epididymis were decreased (13%>) in males at 30 mg/kg-
day. Hematology changes included decreased RBC count (12%>), hemoglobin (15-16%>), and
platelets (30-31%>) in both sexes at 125 mg/kg-day. Hematocrit and MCH were decreased (13
and 4%>, respectively) in females at 125 mg/kg-day and in males (5 and 4%>, respectively) at 30
mg/kg-day; MCV was decreased in males (4%>) and MCHC was decreased in females at 125
mg/kg-day. Clinical chemistry changes included increased BUN in the mid-dose males, sorbitol
dehydrogenase glucose, creatinine, cholesterol, triglycerides in females at 125 mg/kg-day;
decreased calcium at 30 mg/kg-day in males and potassium in females at 125 mg/kg-day.
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Histopathology examination revealed decreased lymphoid tissue in thymus of males and females
at 125 mg/kg-day.
LOAEL = 30 mg/kg-day (based on decreased epididymes weights, decreased hematocrit, MCH,
calcium and increased BUN values.)
NOAEL = 8 mg/kg-day
fi)
Sample
83366
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.10
2.50
5.10
2.50
1.30
0.90
0.10
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
n a 13-week study, Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 64741-81-7
(Distillates (petroleum), heavy thermal cracked, (Paulsboro Heavy Coker Gas Oil, CRU 83366)
via the dermal route at 0 (sham-exposed), 30, 125, 500 or 2000 mg/kg-day, 5 days/week. The
test substance was applied to previously clipped sites on the backs of the animals. The
application sites were not occluded; the rats were fitted with Elizabethan collars to prevent
ingestion of the test substance. At 24 hours after the fifth dose each week, the residual test
substance was wiped off. Mortality, clinical signs, skin irritation and body weights were
monitored. Clinical chemistry, hematology and urinalysis parameters were evaluated. At
necropsy, organ weights were taken. Histopathological examinations were conducted on tissues
from the control and high-dose (125 mg/kg-day) animals. Sperm count and morphology was
evaluated.
All animals from 500 and 2000 mg/kg-day groups were terminated early. One male and one
female died at 125 mg/kg-day. Skin irritation was moderate in all treatment groups. Body
weights were decreased in males and females at 30 mg/kg-day and at in males at 125 mg/kg-day.
Decreases in RBC count (9-13%), hemoglobin (10-11%), and hematocrit (10-12%) were seen in
males and females at 125 mg/kg-day and platelets were decreased in females (25%) at 125
mg/kg-day. Sorbitol dehydrogenase activity was decreased (38%) in males and BUN was
increased (44%) in females at 125 mg/kg-day. Absolute and relative thymus weights were
decreased (42-48%) and liver weights were increased (24-50%) in males and females and
relative spleen weights were increased (36%) in males at 125 mg/kg-day. Relative testes weights
were increased at 30 (6%) and 125 mg/kg-day (16%). Histopathology examination revealed
lymphoid reduction in thymus in both sexes at 125 mg/kg-day; fibrous foci in spleens of males
and focal fibrosis in bone marrow in one male and in 2 females at 125 mg/kg-day. Sperm
morphology was unremarkable.
LOAEL = 30 mg/kg-day (based on decreased body weights in both sexes and increased relative
testes weights in males)
NOAEL = not established
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(3)
Sample
86272
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.32
4.86
8.10
1.62
0.32
0.16
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
n a 13-week study, Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 64741-81-7
(Distillates (petroleum), heavy thermal cracked, (Heavy Coker Gas Oil, Sample 86272) via the
dermal route at 0 (sham-exposed), 8, 30, or 125 mg/kg-day, 5 days/week. The test substance was
applied to previously clipped sites on the backs of the animals. The application sites were not
occluded; the rats were fitted with Elizabethan collars to prevent ingestion of the test substance.
Mortality, clinical signs, skin irritation and body weights were monitored. Clinical chemistry,
hematology and urinalysis parameters were evaluated. At necropsy, organ weights were taken.
Histopathological examinations were conducted on tissues from the control and high-dose
animals. Sperm count and morphology was evaluated.
Limited signs of intoxication were seen in several animals (dose not indicated). Moderate to
severe skin irritation was seen. Body weights were decreased ((20%) in males at 125 mg/kg-day.
Decreases in RBC count (13%), hemoglobin (11%), hematocrit (10%) and platelets (32%) were
seen in males and hemoglobin ((8%), platelets ((18%) and lymphocytes (13%) were in females at
125 mg/kg-day. WBC count (31%) and a number of segmented neutrophils (94%) were
increased in females at 125 mg/kg-day. Increased BUN (43-57%) in both sexes and sorbitol
dehydrogenase (60%) in females and decreased potassium (13%) were seen in females at 125
mg/kg-day. Absolute and relative liver weights in females (18 and 26%) and relative liver
weights in males (24%) were increased at 125 mg/kg-day. Absolute and relative thymus weights
in females (36 and 32% respectively) and absolute thymus weights in males (35%) were
decreased at 125 mg/kg-day. Histopathology examination revealed reduction in thymocytes in
thymus and increased granulocytes in bone marrow at 125 mg/kg-day. Sperm morphology was
unremarkable.
LOAEL = 125 mg/kg-day (based on decreased body weights, effect on hematology and clinical
chemistry parameters, organ weights and histopathology findings in thymus and bone marrow)
NOAEL = 30 mg/kg-day
(4)
Sample
86193
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.84
2.94
0.38
0.00
0.00
0.00
0.00
Wt. % of PACs (polyaromatic compounds) that have 1-7 aromatic rings in the Aromatic Ring Class
n a 13-week study, male and female Sprague-Dawley rats (number/dose not indicated) were
exposed to CASRN 64741-81-7 (Distillates (petroleum), heavy thermal cracked, (Visbreaker Gas
Oil, CRU 86193 (V.B. Mittelol) via the dermal route at 0 (sham-exposed), 8, 30, or 125 mg/kg-
day, 5 days/week. The test substance was applied to previously clipped sites on the backs of the
animals. The application sites were not occluded; however, the rats were fitted with Elizabethan
collars to minimize ingestion of the test substance. AT 24 hours after the fifth dose each week,
residual test substance was wiped off. Mortality, clinical signs, skin irritation and body weights
were monitored. Clinical chemistry, hematology and urinalysis parameters were evaluated. At
necropsy, organ weights were taken. Histopathology examinations were conducted on tissues
from the control and high-dose animals. Sperm morphology and count were evaluated.
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There was no mortality. No other treatment-related clinical signs were seen except for skin
irritation (erythema , edema and chronic deterioration of the skin) at all doses. There were no
effects on body weights, hematology, clinical chemistry, urinalysis. There was a reduction in
uterus weight at 30 mg/kg-day—this was not observed in any other group. Histopathology
findings pertained to skin (thickening of epidermis with parakeratosis, chronic inflammation,
ulcers and increased mitosis in the epidermal basal cells). The skin changes were more severe in
females. Lymph nodes were enlarged predominantly in the high-dose animals and microscopic
examination revealed non-specific reactive hyperplasia in lymph nodes in most instances. There
were no effects on sperm morphology.
NOAEL = 125 mg/kg-day (highest dose tested)
(5) In a 4-week study, Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 64741-81-7
(Distillated (petroleum), heavy thermal cracked (Cocker Heavy Gas Oil (F-97-01) via dermal
route at 0 (acetone), 0.001, 0.1 or 1.0 mL/kg-day ( 0, 0.93, 93 or 930 mg/kg-day, respectively) 6
hours/day, 5 days/week for under occluded conditions. The test substance was applied to
previously clipped sites on the backs of the animals. Following the 6-hour exposure period, the
skin was wiped to remove residual test substance. Mortality, clinical signs, skin irritation, body
weights and food consumption were monitored. Clinical chemistry and hematology parameters
were evaluated. At necropsy, organ weights were taken. Histopathological examinations were
conducted on tissues from the control and high-dose animals.
No treatment-related mortality was seen. The terminal body weight was decreased (9%) in
females at 930 mg/kg-day. At 930 mg/kg-day, there was an increase in absolute spleen weights
in males (24%), relative spleen weights (to body weight) in both sexes (21 and 17% respectively,
for males and females), absolute liver weights in males (24%) and relative liver weights in both
sexes (12-23%)). Relative liver weights (to body weight) were increased (8%) in males at 93
mg/kg-day. Hematology changes included decreased RBC count (6-9%, males and females at
930 mg/kg-day and females at 93 mg/kg-day), hematocrit (5-11%) and hemoglobin (7-13%)
(males and females at 930 mg/kg-day and males at 93 mg/kg-day). Clinical chemistry was
unremarkable. Histopathology on two control groups and high-dose animals revealed no
treatment-related changes. Testes and ovaries showed no treatment-related effects.
LOAEL = 93 mg/kg-day (based on increased relative liver weights and decreased RBC count,
hemoglobin and hematocrit)
NOAEL = 9.3 mg/kg-day
(6) In a 4-week study, Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 64741-81-7
(Distillated (petroleum), heavy thermal cracked (Cocker Heavy Gas Oil (F-136)) via dermal
route at 0, 0.01, 0.1 or 1 mL/kg-day (0, 9.3, 93 or 930 mg/kg-day 6 hours/day, 5 days/week under
occluded conditions. The test substance was applied to previously clipped sites on the backs of
the animals. Following the 6-hour exposure period, the skin was wiped to remove residual test
substance. Mortality, clinical signs, skin irritation, body weights and food consumption were
monitored. Clinical chemistry and hematology urinalysis parameters were evaluated. At
necropsy, organ weights were taken. Histopathological examinations were conducted on tissues
from the control and high-dose animals.
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There was no treatment-related mortality during this study. Dose-related increased incidence
with very slight to slight dermal irritation was seen. Body weights were not affected by
treatment. Hematology changes were noted in males and females at 930 mg/kg-day (slightly
decreased hematocrit, 4%) and females (9%) and hemoglobin in females (6%). BUN was
increased at all doses in males (18, 21, and 19%, respectively). Cholesterol levels were elevated
in females at 930 mg/kg-day (59%). Absolute and relative liver weights were increased elevated
in both sexes at 930 mg/kg-day (30-32%) and in females at 93 mg/kg-day (11%).
Histopathology on control and high-dose rats revealed no treatment-related changes. Additional
details are from TSCATS (OTS0544095).
LOAEL = 930 mg/kg-day (based on increased liver weights, hematology parameters and
increased cholesterol and BUN)
NOAEL = 93 mg/kg-day
Distillates (petroleum), heavy catalytic cracked (CASRN 64741-61-3)
(1) In a 28-day study, Sprague-Dawley rats (10/sex/dose) were exposed to CASRN 64741-61-3
(distillates (petroleum), heavy catalytic cracked or Heavy Cycle Oil or Heavy Thermo-cracked
Distillate (F-134)) via the dermal route at 0, 0.01, 0.1 or 1 mL/kg-day (0, 9.9, 99 or 990 mg/kg-
day) for 6 hours/day, 5 days/week under occluded conditions. The test substance was applied to
previously clipped sites on the backs of the animals. Following the 6-hour exposure period, the
skin was wiped to remove residual test substance. Mortality, clinical signs, skin irritation, body
weights and food consumption were monitored. Clinical chemistry, hematology and urinalysis
parameters were evaluated. At necropsy, organ weights were taken. Histopathological
examinations were conducted on tissues from the control and high-dose animals.
Dose-related and very slight to moderate irritation was observed. Body weight was decreased
(11%) and relative brain weight (11%) was increased in males at 990 mg/kg-day. Absolute liver
weights were increased (28%) in females at 990 mg/kg-day and relative liver weights (to body
weight) were increased in both sexes (19 and 33% in males and females, respectively). Relative
liver weight (to brain) was increased in females at 99 and 990 mg/kg-day, 11 and 30%,
respectively. Hematology changes included decreases in RBC count, hemoglobin hematocrit in
males at 990 mg/kg-day and in females at 99 and 990 mg/kg-day at 99 and 990 mg/kg-day.
Platelets were decreased (33%) in females at 990 mg/kg-day. At this dose, females also showed
increased SGOT (24%) and cholesterol (60%) levels. Histopathological examination revealed no
treatment-related changes. No treatment-related effects were seen on testes and ovaries.
LOAELmaies = 990 mg/kg-day (based on decreased body weight, liver weights RBC count,
hematocrit and hemoglobin levels)
NOAELmaies = 99 mg/kg-bw/day
LOAELfemaies = 99 mg/kg-day (based on decreased liver weights, RBC count, hematocrit and
hemoglobin)
NOAELfemaies = 9.9 mg/kg-day
Subcategory VIII: Reformer Residual
No data.
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Reproductive Toxicity
Subcategories I to V and VII and VIII
No data.
Developmental Toxicity
Subcategory I: Residual Fuel Oils
No data.
Subcategory II: Atmospheric Residual
Residues (petroleum), atm. tower (CASRN 64741-45-3)
Sample
091691;
(F-228)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.10
0.30
2.00
2.00
2.00
0.60
0.10
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
Pregnant Sprague-Dawley rats were administered CASRN 64741-45-3 (residues (petroleum),
atm. Tower; Atmospheric Tower Bottom (ATB); F-228) at 0, 50, 333 or 1000 mg/kg-day for 6
hours/day on shaved backs on gestation days 0 - 20. There were 15, 12, 10 and 11 pregnant
females in the control, 50, 333 and 1000 mg/kg-day groups, respectively. The application sites
were not occluded; the animals were fitted with Elizabethan collars during the exposure period.
The excess test substance was wiped from the application sites after the 6-hour exposure period.
For each dam, viability and clinical signs of toxicity were monitored and body weight and food
consumption measurements were taken. Observations in pups included signs of toxicity,
mortality, body weight on lactation days 0 and 4 and sex ratio. At necropsy, gross observations
were made; numbers of resorptions and implantation sites were recorded; and external
examinations of pups were conducted.
Treatment related mortalities were not observed among dams. Body weights were significantly
decreased (p<0.05) at 1000 mg/kg-day between gestation days 16 - 20. There were no
treatment-related effects on either absolute or relative food consumption in dams. The gestation
length was significantly increased (p<0.01) at 1000 mg/kg-day. At necropsy, no lesions related
to treatment were observed in dams of any of the dose groups. Significantly decreased (p<0.05)
pup body weights were observed at 1000 mg/kg-day. A Significantly decreased (p<0.05)
number of implantation sites was observed only at 333 mg/kg-day, but not at the higher dose and
was not considered to be treatment related. No significant difference was noted for the total pups
per litter, proportion dead on lactation day 0, proportion surviving on lactation day 4, fetal sex
ratio, or external pup alterations.
LOAEL (maternal toxicity) = 1000 mg/kg-day (based on decreased gestational body weights
and increased gestational length)
NOAEL (maternal toxicity) = 333 mg/kg-day
LOAEL (developmental toxicity) = 1000 mg/kg-day (based on decreased pup body weights)
57
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NOAEL (developmental toxicity) = 333 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
Subcategory III: Atmospheric Distillate
Distillates, Crude Oil (DCO); VDF Diesel (CASRN 68410-00-4)
(!)
Sample
091681
(F-215)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.20
4.00
4.00
0.00
0.00
0.00
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats (25/dose) were administered CASRN 68410-00-4 (Distillate
Crude Oil (DCO; VDF Diesel (DCO, F-215)) at 0 (acetone), 50, 250 or 500 mg/kg-day for 6
hours/day on shaved backs of the animals on gestation days 0-19. The application sites were
not occluded; the animals were fitted with Elizabethan collars during the exposure period. The
excess test substance was wiped from the application sites after the 6-hour exposure period. For
each dam, viability and clinical signs of toxicity were monitored and body weight and food
consumption measurements were taken. Observations in pups included signs of toxicity,
mortality, body weight on lactation days 0 and 4 and sex ratio. At necropsy, gross observations
were made; numbers of resorptions and implantation sites were recorded; and external
examinations of pups were conducted.
There were no treatment-related mortalities. Slight to extreme irritation was noted at all doses at
the application sites. Body weights and body weight gains were significantly lower (p<0.05
and/or p<0.01) at 250 and 500 mg/kg-day at various points during gestation and postnatal
periods. Absolute and/or relative food consumption in dams was significantly (p<0.05) lower at
500 mg/kg-day during gestation and lactation. All litter parameters were unaffected by
treatment. Implantation sites and sex ratio were comparable to controls. The number of dams
with viable fetuses was comparable among the four dose groups. There were no biologically
significant effects on corpora lutea, implantations, litter sizes, live fetuses, early and late
resorptions, fetal body weights, percent resorbed conceptuses and sex ratio. No treatment-related
gross external soft tissue or skeletal alterations in fetuses were seen.
LOAEL (maternal toxicity) = 250 mg/kg-day (based on decreased body weights, body weight
gains)
NOAEL (maternal toxicity) = 50 mg/kg-day
NOAEL (developmental toxicity) = 500 mg/kg-day (highest dose tested)
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(2)
Sample
091647
(F-194)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.1
4.0
4.0
0.0
0.0
0.0
0.0
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats were administered CASRN 68410-004 (Distillates Crude Oil
(DCO); F-194)) at 0, 125, 250 or 1000 mg/kg-day for 6 hours/day on shaved backs of the
animals. Animals from the 125 and 250 mg/kg-day groups were administered the test substance
during gestation days 0-20; and those from the 1000 mg/kg-day were administered the test
substance during gestation days 5-9 (due to severe skin irritation). There were , 19, 15, 15, and
14 pregnant females in the control, 125, 250 and 1000 mg/kg-day groups, respectively. The
control group was shared with another study, possibly conducted simultaneously (ATX-91-
0129). The application sites were not occluded; the animals were fitted with Elizabethan collars
during the exposure period. The excess test substance was wiped from the application sites after
the 6-hour exposure period. For each dam, viability and clinical signs of toxicity were monitored
and body weight and food consumption measurements were taken. Observations in pups
included signs of toxicity, mortality, body weight on lactation days 0 and 4 and sex ratio. At
necropsy, gross observations were made; numbers of resorptions and implantation sites were
recorded; and external examinations of pups were conducted.
There were no mortalities. Slight to extreme irritation was noted at all doses at the application
sites. Alopecia and yellow staining in the perineal region were seen at 1000 mg/kg-day. Body
weights were significantly decreased (p<0.05) at 250 and 1000 mg/kg-day at various time points
during gestation and postnatal periods. Absolute food consumption in dams was significantly
(p<0.05) lower at 250 mg/kg-day and absolute and relative food consumption was significantly
(p<0.01) lower at 1000 mg/kg-day. There were no effects on gestation length, number of
implantation sites, a number of dead pups on lactation day 0 and proportion of surviving pups to
lactation day 4 or sex ratio. At necropsy, no treatment-related lesions were observed in dams of
any of the dose groups. Significantly decreased (p<0.05 to p<0.01) pup body weights were
observed at 250 and 1000 mg/kg-day on lactation days 0 and 4. A significant decrease (p<0.05)
in pup body weights were also observed at 125 mg/kg-day on lactation days 0. There were no
external pup alterations at any dose.
LOAEL (maternal toxicity) = 250 mg/kg-day (based on decreased body weights, body weight
changes and food consumption)
NOAEL (maternal toxicity) = 125 mg/kg-day
LOAEL (developmental toxicity) = 125 mg/kg-day (based on decreased pup body weights)
NOAEL (developmental toxicity) = not established
[Note: Although in this study, fewer animals/dose are used than recommended by the guidelines,
and the dosing periodfor the 1000 mg/kg-day group animals is shorter (due to skin irritation,
gestation days 5-9 instead of 0-20), the study generated sufficient information to assess maternal
and developmental toxicity. Therefore, it is considered adequate to include in this hazard
assessment. ]
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(3)
Sample
091681
(F-215)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.20
4.00
4.00
0.00
0.00
0.00
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats were administered CASRN 68410-00-4 (Distillates Crude Oil
(DCO); F-215)) at 0, 50, 150 or 500 mg/kg-day for 6 hours/day on shaved backs on gestation
days 0 - 20. There were 15, 12, 12, and 12 pregnant females in the control, 50, 150 and 500
mg/kg-day groups, respectively. The application sites were not occluded; the animals were fitted
with Elizabethan collars during the exposure period. The excess test substance was wiped from
the application sites after 6-hour exposure period. For each dam, viability and clinical signs of
toxicity were monitored and body weight and food consumption measurements were taken.
Observations in pups included signs of toxicity, mortality, body weight on lactation days 0 and 4
and sex ratio. At necropsy, gross observations were made; numbers of resorptions and
implantation sites were recorded; and external examinations of pups were conducted.
There were no mortalities. Slight to extreme irritation was noted at all doses at the application
sites. Alopecia, yellow, yellow/brown, yellow/red staining in the perineal and abdominal regions
were seen at 500 mg/kg-day. Body weight gains were significantly lower (p<0.05 to p<0.01) at
500 mg/kg-day at various time points during gestation and postnatal periods. Absolute and/or
relative food consumption in dams was significantly (p<0.05) higher at 150 mg/kg-day and 500
mg/kg-day during gestation and lactation. Pup body weights at 150 and 500 mg/kg-day were
lower (not significant) than that of the controls on lactation day 0 (6.10 and 5.56 grams,
respectively, versus 6.55 grams in the control group) and day 4 (8.41 and 6.94 grams, respective,
versus 9.89 grams in the control group). At 500 mg/kg-day, the proportion of pups surviving to
lactation day 4 was significantly decreased (p<0.01) than controls. There were no effects on
gestation length, number of implantation sites, a number of total and live pups on lactation day 0
and proportion of dead pups on lactation day 0 or sex ratio. There were no external pup
alterations at any dose.
LOAEL (maternal toxicity) = 500 mg/kg-day (based on decreased body weights, body weight
gains)
NOAEL (maternal toxicity) = 150 mg/kg-day
LOAEL (developmental toxicity) = 150 mg/kg-day (based on decreased pup body weights on
lactation days 0 and 4)
NOAEL (developmental toxicity) = 50 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
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Gas oils (petroleum), heavy atmospheric (CASRN 68783-08-4)
(!)
Sample
094626
(F-275)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.70
4.00
1.00
0.70
0.50
0.00
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats (12/dose; 15/control) were administered CASRN 68783-08-4
(Full Range Gas Oil (FRGO, F-275)) at 0, 50, 250 or 500 mg/kg-day for 6 hours/day on shaved
backs of the animals on gestation days 0 - 20. The application sites were not occluded; the
animals were fitted with Elizabethan collars during the exposure period. The excess test
substance was wiped from the application sites after 6-hour exposure period. For each dam,
viability and clinical signs of toxicity were monitored and body weight and food consumption
measurements were taken. Observations in pups included signs of toxicity, mortality, body
weight on lactation days 0 and 4 and sex ratio. At necropsy, gross observations were made;
numbers of resorptions and implantation sites were recorded; and external examinations of pups
were conducted.
There were no mortalities. Slight to extreme irritation was noted at all doses at the application
sites. Body weights and body weight gains were significantly lower (p<0.05 to p<0.01) at 250
and 500 mg/kg-day at various time points during gestation and postnatal periods. Absolute
and/or relative food consumption in dams was significantly (p<0.05) lower at 250 and 500
mg/kg-day during gestation and lactation. Slight dermal irritation was noted at all doses. Early
resorption sites were seen in uteri of two females at 500 mg/kg-day. Total number of pups per
litter and live pups per litter were significantly decreased (p<0.05 to p<0.01) at 250 and 500
mg/kg-day. Four females at 500 mg/kg-day did not deliver litters. Two of these females
delivered only one pup each that were found dead on lactation day 0. The third female that
delivered only two pups was noted to have very small nipples on lactation day 3. On lactation
day 4, these two pups were found dead with no milk in their stomach. The proportion of dead
pups in the 500 mg/kg-day group was significantly greater than that of the control. The
proportion of male pups in the 500 mg/kg-day group was significantly greater than in the control
group. Pup body weights at 250 and 500 mg/kg-day were significantly lower than that of the
controls on lactation days 0 and 4. External examination of pups revealed sporadic occurrances
of hematoma, tip of tail black, left eye slightly swollen and dark red, eschar, missing tail-
considered to be incidental in nature.
LOAEL (maternal toxicity) = 250 mg/kg-day (based on decreased body weights, body weight
changes and food consumption)
NOAEL (maternal toxicity) = 50 mg/kg-day
LOAEL (developmental toxicity) = 250 mg/kg-day (based on decreased number of total and
live pups delivered and pups body weights on lactation days 0 and 4)
NOAEL (developmental toxicity) = 50 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
(2) The following study was conducted on heavy atmospheric gas oil, CASRN 68915-97-9,
which is compositionally similar to heavy fuel CASRN 68783-08-4, and also included in the Gas
oils category.
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Pregnant Sprague-Dawley rats (12/dose) were administered CASRN 68915-97-9 (Heavy
Atmospheric Gas Oil that is compositionally similar to Heavy Fuel; 68783-08-4) at 0 (sham
control), 8, 30, 125, and 500 mg/kg-day for 6 hours/day on shorn dorsal skin on gestation days
0-19. The application sites were not occluded; the animals were fitted with Elizabethan collars
during the exposure period. The excess test substance was wiped from the application sites after
6-hour exposure period. Two additional groups (postnatal groups) at 0 (sham control) and 125
mg/kg-day were included in the study—dams and their litters were observed on post partum days
0 to 4 for clinical signs. Body weights and food consumption were recorded. Offspring were
weighed according to gender. The pups were examined for external malformations and daily for
the presence/absence of milk in the stomach. For each female, reproductive organs were
examined; liver and thymus were weighed; the number of corpora lutea per ovary and number of
implantations for each dam were recorded. At necropsy, blood samples were collected for
hematology and clinical chemistry evaluations. Fetuses were examined for soft tissue
abnormalities and skeletal examination.
Skin irritation which ranged from slight to moderate was noted at all doses. A red vaginal
discharge was seen in 7/11 animals at 500 mg/kg-day and 1/12 animals at 125 mg/kg-day. Body
weight, weight gain (p<0.05 to p<0.01) and food consumption (p<0.01) were significantly
reduced at 125 and 500 mg/kg-day. At 500 mg/kg-day, other statistically significant changes
(p<0.05 to p<0.01) included decreased absolute and relative thymus weight, increased relative
liver weight, decreased platelets, segmented neutrophils, decreased triglycerides, and increased
total protein, albumin, calcium, BUN and alkaline phosphatase. Pre-implantation losses were
seen at 125 and 500 mg/kg-day. There was a significant increase in the mean number/percent
resorptions in the 500 mg/kg-day group. Mean fetal body weights were significant decreased
(significance not provided) for all viable fetuses at 500 mg/kg-day and in male pups at 125
mg/kg-day. A significant increase (significance not provided) in incomplete ossification of a
number of skeletal structures (nasal bones, thoracic centra, caudal centra, sternebrae, metatarsal
and pubis) at 125 and 500 mg/kg-day. No treatment-related abnormalities were seen in the soft
tissues.
LOAEL (maternal toxicity) = 125 mg/kg-day (based on decreased body weights, body weight
changes and food consumption)
NOAEL (maternal toxicity) = 30 mg/kg-day
LOAEL (developmental toxicity) = 125 mg/kg-day (based on decreased number of total and
live pups delivered and pups body weights, incomplete ossification)
NOAEL (developmental toxicity) = 30 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
Subcategory IV: Vacuum Residual
No data.
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September, 2014
Subcategory V: Vacuum Distillate
Residues (petroleum), heavy vacuum (CASRN 64741-57-7)
(!)
Sample
091650
(F-197)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.00
0.40
4.00
2.00
0.60
0.20
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
n a prenatal developmental toxicity study, pregnant Sprague-Dawley rats (25/dose) were
administered 64741-57-7 (Heavy Vacuum Gas Oil (VDF Gas Oil, F-197) at 0, 50, 100 or 250
mg/kg-day in acetone, for 6 hours/day on to previously clipped intact sites on the backs, on
gestation days 0-19. The application sites were not occluded; the animals were fitted with
Elizabethan collars during the exposure period. The excess test substance was wiped from the
application sites after 6-hour exposure period. For each dam, viability and clinical signs of
toxicity were monitored; body weight and food consumption were measured and the number of
corpora lutea, implantation sites, early/late resorptions, and live and dead fetuses were recorded.
Observations in pups included signs of toxicity, mortality, body weight on lactation days 0 and 4
and sex ratio. Gross observations were made and external examinations of pups were conducted.
No mortality occurred. Body weights and body weight gains were decreased (significant for
body weight gain, p<0.01) at 100 and 250 mg/kg-day. Absolute and/or relative food
consumption in dams was significantly (p<0.05 to p<0.01) lower at 50, 100 and 250 mg/kg-day
during gestation at various time points. Slight irritation was noted at all doses at the application
sites. At 250 mg/kg-day, litter sizes and the mean number of live fetuses were significantly
reduced (p<0.05); litter averages for total resorptions, early resorptions and percent resorbed
conceptuses and the number of dams with resorptions were increased. Live fetal body weights
and female fetal body weight were significantly reduced (p<0.01) at 250 mg/kg-day. There were
no significant or biologically relevant differences in the litter averages for corpora lutes,
implantations and sex ratios. There were no late resorptions and no dam resorbed all
conceptuses; the number of dams with viable fetuses was comparable among the four dose
groups. Skeletal observations at 250 mg/kg-day showed significantly reduced (p<0.01) the
average number of caudal vertebral ossification sites per fetus. There was an increased tendency
toward fetal and litter incidences of bifid thoracic vertebral centra and incompletely ossified
sternebrae at 250 mg/kg-day.
LOAEL (maternal toxicity) = 100 mg/kg-day (based on decreased body weights, body weight
gains)
NOAEL (maternal toxicity) = 50 mg/kg-day
LOAEL (developmental toxicity) = 250 mg/kg-day (based on decreased fetal body weights,
increased variations in fetal skeletal ossifications)
NOAEL (developmental toxicity) = 100 mg/kg-day
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(2)
Sample
091649
(F-196)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.10
0.30
3.00
2.00
2.00
0.70
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats (25/dose) were administered 64741-57-7 (Heavy Vacuum Gas Oil
(VDF Gas Oil, F-196) at 0 (acetone), 75, 150 or 300 mg/kg-day (in acetone), for 6 hours/day on
to previously clipped intact sites on the backs, on gestation days 0-19. The application sites
were not occluded; the animals were fitted with Elizabethan collars during the exposure period.
The excess test substance was wiped from the application sites after 6-hour exposure period. For
each dam, viability and clinical signs of toxicity were monitored; body weight and food
consumption were measured and the number of corpora lutea, implantation sites, early/late
resorptions, and live and dead fetuses were recorded. Observations in pups included signs of
toxicity, mortality, body weight on lactation days 0 and 4 and sex ratio. Gross observations were
made and external examinations (soft tissue and skeletal alterations) of pups were conducted.
No mortality occurred. Body weights and body weight gains were significantly lower (p<0.05 to
p<0.01) at all doses at various time points during dosing period. Absolute and/or relative food
consumption in dams was significantly (p<0.05 to p<0.01) lower at all doses during dosing
period. At 150 and 300 mg/kg-day, significant reductions (p<0.01) in litter sizes and live fetuses
and increases (p<0.01) in resorptions (total and/or early resorptions) were seen. The number of
dams with any resorptions was also significantly increased (p<0.01) at 300 mg/kg-day. There
was an increased tendency for the percentage of resorbed conceptuses per litter at 150 mg/kg-day
and a significant increase (p<0.01) at 300 mg/kg-day. Fetal body weights were decreased at 75
mg/kg-day achieving a statistical significance (p<0.01) at 150 and 300 mg/kg-day. No
biologically significant differences were seen in litter averages for corpora lutea, implantations,
late resorptions and sex ratio. The number of dams with viable fetuses was comparable among
all groups. The fetal incidences of microphthalmia and bifid thoracic vertebral centra were
significantly increased (p<0.01) at all doses. There was a reduction in average number of
ossified caudal vertebrae per fetus at 300 mg/kg-day (significance not provided).
LOAEL (maternal toxicity) = 75 mg/kg-day (based on decreased body weights, body weight
gains and food consumption)
NOAEL (maternal toxicity) = not established
LOAEL (developmental toxicity) = 75 mg/kg-day (based on decreased fetal body weights,
increased incidences of microphthalmia and delayed ossification)
NOAEL (developmental toxicity) = not established
(3)
Sample
091689
(F-225)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.0
0.4
4.0
1.0
0.4
0.1
0.0
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats were administered CASRN 64741-57-7 (Heavy Vacuum Gas Oil
(HVGO F-225)) at 0, 50, 150 or 500 mg/kg-day for 6 hours/day on previously clipped backs
(intrascapular and lumbar regions) on gestation days 0 - 20. There were 15, 12, 12, and 12
pregnant females in the control, 50, 150 and 500 mg/kg-day groups, respectively. The
application sites were not occluded; the animals were fitted with Elizabethan collars during the
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exposure period. The excess test substance was wiped from the application sites after 6-hour
exposure period. For each dam, viability and clinical signs of toxicity were monitored and body
weight and food consumption measurements were taken. Observations in pups included signs of
toxicity, mortality, body weight on lactation days 0 and 4 and sex ratio. At necropsy, gross
observations were made; numbers of resorptions and implantation sites were recorded; and
external examinations of pups were conducted.
There were no mortalities. Slight to extreme irritation was noted at all doses at the application
sites. At 500 mg/kg-day, the incidence of vaginal discharge was higher than that of the control
group. Gestation length was significantly increased (p<0.01) at 500 mg/kg-day compared to
controls. Body weights were significantly lower ( p<0.01) at 500 mg/kg-day at various time
points during gestation and lactation periods. Body weight gains were significantly lower at 150
mg/kg-day (p<0.05) and 500 mg/kg-day (p<0.01). Absolute and/or relative food consumption in
dams was significantly (p<0.05) lower at 150 mg/kg-day and 500 mg/kg-day during gestation
and lactation except for females at 500 mg/kg-day during gestation days 16-20. At necropsy,
one female at 500 mg/kg-day had red vaginal discharge and a dead fetus in the uterus. Another
female in this group had thickened uterine walls and one early resorption in the uterus. Pup body
weights at 150 and 500 mg/kg-day were significantly lower (p<0.01) than that of the controls on
lactation days 0 and 4. At 500 mg/kg-day, the proportion of pups surviving to lactation day 4
was significantly decreased (p<0.01) than controls. There were no effects on gestation length,
number of implantation sites, a number of total and live pups on lactation day 0 and proportion
of dead pups on lactation day 0 or sex ratio. There were no external pup alterations at any dose.
LOAEL (maternal toxicity) = 150 mg/kg-day (based on decreased body weights, body weight
gains and food consumption)
NOAEL (maternal toxicity) = 50 mg/kg-day
LOAEL (developmental toxicity) = 150 mg/kg-day (based on decreased pup body weights on
lactation days 0 and 4)
NOAEL (developmental toxicity) = 50 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
(4)
Sample
094627
(F-276)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
9.00
9.00
0.20
0.00
0.00
0.00
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats were administered 64741-57-7 (Heavy Vacuum Gas Oil;
Hydrocracker Feed Oil (F-276)) at 0 (sham control), 1.0, 250 or 500 mg/kg-day for 6 hours/day
on to previously clipped intact sites on the backs on gestation days 0 - 20. (Actual
administration of the test substance was from day -7 (premating) to gestation day 20.) There
were 15, 11, 12, and 11 pregnant females in the control, 1.0, 250 and 500 mg/kg-day groups,
respectively. The application sites were not occluded; the animals were fitted with Elizabethan
collars during the exposure period. The excess test substance was wiped from the application
sites after 6-hour exposure period. For each dam, viability and clinical signs of toxicity were
monitored and body weight and food consumption measurements were taken. Observations in
pups included signs of toxicity, mortality, body weight on lactation days 0 and 4 and sex ratio.
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At necropsy, gross observations were made; numbers of resorptions and implantation sites were
recorded; and external examinations of pups were conducted.
There were no mortalities. Body weights and body weight gains were significantly lower
(p<0.05 to p<0.01) at 250 and 500 mg/kg-day at various time points during gestation and
lactation periods. Absolute and/or relative food consumption in dams was significantly (p<0.05)
lower at 250 and 500 mg/kg-day during gestation and lactation. Slight to moderate irritation was
noted at all doses at the application sites. The enlargement of axillary lymph nodes at 250 and
500 mg/kg-day and the cervical lymph nodes at 500 mg/kg-day were considered to be secondary
to the dermal irritation. The number of implantation sites for the 250 and 500 mg/kg-day groups
was significantly lower (p<0.05) than that of the control group. Total number of pups per litter
and live pups per litter were significantly reduced at 250 (P<0.05) and 500 mg/kg-day (p<0.01).
The number of pups surviving to lactation day 4 was significantly decreased (p<0.05) at 500
mg/kg-day. Average pup body weights at 250 mg/kg-day on lactation day 0 and at 500 mg/kg-
day on lactation days 0 to 4 were decreased significantly (p<0.01).
LOAEL (maternal toxicity) = 250 mg/kg-day (based on decreased body weights, body weight
changes and food consumption)
NOAEL (maternal toxicity) = 1 mg/kg-day
LOAEL (developmental toxicity) = 250 mg/kg-day (based on decreased number of
implantation sites, total and live pups and decreased pup body weights on lactation day 0)
NOAEL (developmental toxicity) = 1 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
(5)
Sample
091649
(F-196)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.10
0.30
3.00
2.00
2.00
0.70
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats (15/dose; 20/control) were administered 64741-57-7 (Heavy
Vacuum Gas Oil (F-196) at 0 (sham control), 1.0, 250 or 1000 mg/kg-day for 6 hours/day on to
previously clipped intact sites on the backs on gestation days 0 - 20. (Actual administration of
the test substance was from day -7 (pre-mating) to gestation day 20.) The application sites were
not occluded; the animals were fitted with Elizabethan collars during the exposure period. The
excess test substance was wiped from the application sites after the 6-hour exposure period. For
each dam, viability and clinical signs of toxicity were monitored and body weight and food
consumption measurements were taken. Observations in pups included signs of toxicity,
mortality, body weight on lactation days 0 and 4 and sex ratio. At necropsy, gross observations
were made; numbers of resorptions and implantation sites were recorded; and external
examinations of pups were conducted.
One female at 1000 mg/kg-day died on gestation day 22. Treatment-related increased incidence
of vaginal discharge was seen at 250 and 1000 mg/kg-day. Body weights and body weight gains
were significantly lower (p<0.05 to p<0.01) at 250 and 1000 mg/kg-day at various time points
during gestation and lactation periods. Absolute and/or relative food consumption in dams was
significantly (p<0.05) lower at 250 and 1000 mg/kg-day during gestation and/or lactation
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periods. Slight and sporadic irritation was noted at all doses at the application sites. At
necropsy, decreased thymus size was noted in 1, 2, 3, and 6 females at 0, 1, 250 and 1000 mg/kg-
day, respectively. At 1000 mg/kg-day, none of the pregnant females delivered a litter; although
the implantation sites at this dose were comparable to the control group. At 250 mg/kg-day, the
number of total and live pups at lactation day 0 were significantly lower (p<0.01) than those for
the control group. Average pup body weights at 250 mg/kg-day on lactation day 0 and 4 were
decreased significantly (p<0.05 and p<0.01, respectively). There were no significant differences
in gestation length, number of implantation sites, external pup alterations, proportion of pups
dead on lactation day 0, proportion of pups surviving on lactation day 4 or proportion of male
pups on lactation days 0 and 4, compared to controls.
LOAEL (maternal toxicity) = 250 mg/kg-day (based on vaginal discharge, decreased body
weights, body weight gains, food consumption and decreased thymus size)
NOAEL (maternal toxicity) = 1 mg/kg-day
LOAEL (developmental toxicity) = 250 mg/kg-day (based on decreased total and live pups on
lactation day 0 and decreased pup body weights on lactation day 0 and 4)
NOAEL (developmental toxicity) = 1 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
(6)
Sample
091650
(F-197)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.00
0.40
4.00
2.00
0.60
0.20
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats (15/dose; 20/control) were administered CASRN 64741-57-7
(Heavy Vacuum Gas Oil (VDF Gas Oil, F-197) at 0 (sham control), 1.0, 250 (241 corrected
dose) or 1000 (965 corrected dose) mg/kg-day for 6 hours/day on to previously clipped intact
sites on the backs, on gestation days 0 - 20. (Actual administration of the test substance was
from day -7 pre-mating, mating through gestation day 20.) The control group was shared with
another study possibly conducted simultaneously (ATX-91-0127). The application sites were
not occluded; the animals were fitted with Elizabethan collars during the exposure period. The
excess test substance was wiped from the application sites after the 6-hour exposure period. For
each dam, viability and clinical signs of toxicity were monitored and body weight and food
consumption measurements were taken. Observations in pups included signs of toxicity,
mortality, body weight on lactation days 0 and 4 and sex ratio. At necropsy, gross observations
were made; numbers of resorptions and implantation sites were recorded; and external
examinations of pups were conducted.
There were no mortalities. Treatment-related increased in the incidence of vaginal discharge was
seen at 250 and 1000 mg/kg-day. Body weights and body weight gains were significantly lower
(p<0.05 to p<0.01) at 241 and 965 mg/kg-day at various points during gestation and lactation
periods. Absolute and/or relative food consumption in dams was significantly (p<0.01) lower at
241 and 965 mg/kg-day during gestation and/or lactation periods. Slight to moderate irritation
was noted at all doses at the application sites. At necropsy, a late resorption was noted in one
female at 965 mg/kg-day. At 965 mg/kg-day, none of the pregnant females delivered a litter;
although the implantation sites at this dose were comparable to the control group. A statistically
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significant decrease was noted in the number of total and live pups (p<0.05); the proportion of
pups surviving to lactation day 4 (p<0.01) and pup body weights on lactation day 0 and 4
(p<0.05) at 241 mg/kg-day. There were no significant differences in gestation length, number of
implantation sites, external pup alterations, or proportion of male pups on lactation days 0 and 4
among all groups.
LOAEL (maternal toxicity) = 241 mg/kg-day (based on vaginal discharge, decreased body
weights, body weight gains and food consumption)
NOAEL (maternal toxicity) = 1 mg/kg-day
LOAEL (developmental toxicity) = 241 mg/kg-day (based on decreased total and live pups,
proportion of pups surviving to lactation day 4 and decreased pup body weights on lactation day
0 and 4)
NOAEL (developmental toxicity) = 1 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
(Z)
Sample
091654
(F-201)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.10
0.40
4.00
3.00
0.90
0.40
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats (15/dose; 20/control) were administered 64741-57-7 (Heavy
Vacuum Gas Oil (hydrocracker Fresh Feed, F-201) at 0 (sham control), 1.0, 250 or 1000 mg/kg-
day for 6 hours/day on to previously clipped intact sites on the backs, on gestation days 0 - 20.
(Actual administration of the test substance was from day -7 (pre-mating) to gestation day 20.)
There were 16, 10, 9 and 12 pregnant females in the control, 1.0, 250 and 500 mg/kg-day groups,
respectively. The application sites were not occluded; the animals were fitted with Elizabethan
collars during the exposure period. The excess test substance was wiped from the application
sites after 6-hour exposure period. For each dam, viability and clinical signs of toxicity were
monitored and body weight and food consumption measurements were taken. Observations in
pups included signs of toxicity, mortality, body weight on lactation days 0 and 4 and sex ratio.
At necropsy, gross observations were made; numbers of resorptions and implantation sites were
recorded; and external examinations of pups were conducted.
One female at 1000 mg/kg-day was sacrificed in a moribund condition. Treatment-related
increased incidence of vaginal discharge was seen at 250 and 1000 mg/kg-day. Ocular and nasal
discharge was also seen at 1000 mg/kg-day. Body weights and body weight gains were
significantly lower (p<0.05 to p<0.01) at 250 and 1000 mg/kg-day at various time points during
gestation and lactation periods. Absolute and/or relative food consumption in dams was
significantly (p<0.05) lower at 250 and 1000 mg/kg-day during gestation and/or lactation
periods. Slight irritation was noted at all doses at the application sites. At necropsy, decreased
thymus size (significance not provided) was noted at 250 and 1000 mg/kg-day. At 250 mg/kg-
day, six out of nine females delivered. At 1000 mg/kg-day, none of the pregnant females
delivered a litter and the number of implantation sites at this dose were decreased (significance
not provided) compared to the control group. At 250 mg/kg-day, the number of implantation
sites was significantly lower (p<0.01) than that of the control group suggesting increased pre-
implantation loss. At this dose, the number of total and live pups on lactation day 0 were
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significantly lower (p<0.01) than those for the control group. Average pup body weights at 250
mg/kg-day on lactation day 0 and 4 were decreased significantly (significance not provided).
There were no significant differences at 250 mg/kg-day in gestation length, external pup
alterations, proportion of dead pups on lactation day 0, proportion of pups surviving on lactation
day 4 or proportion of male pups on lactation days 0 and 4.
LOAEL (maternal toxicity) = 250 mg/kg-day (based on decreased body weights, body weight
gains and decreased thymus size)
NOAEL (maternal toxicity) = 1 mg/kg-day
LOAEL (developmental toxicity) = 250 mg/kg-day (based on decreased implantation sites,
total and live pups on lactation day 0 and decreased pup body weights on lactation days 0 and 4)
NOAEL (developmental toxicity) = 1 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
(8)
Sample
85244
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.00
0.06
2.48
1.86
1.24
0.50
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
n a developmental toxicity screen, pregnant Sprague-Dawley rats (10/dose) were administered
CASRN 64741-57-7 (Heavy Vacuum Gas Oil (CRUNo. 85244) at 0, 30, 125, 500 or 1000
mg/kg-day, for 6 hours/day on to previously clipped intact sites on the backs, on gestation days 0
-19. The application sites were not occluded; the animals were fitted with Elizabethan collars
during the exposure period. For each dam, viability and clinical signs of toxicity were
monitored; body weight and food consumption were measured and the number of corpora lutea,
implantation sites, early/late resorptions, and live and dead fetuses were recorded. At necropsy,
blood samples were collected for evaluation of clinical chemistry parameters. Observations in
pups included signs of toxicity, mortality, body weight on lactation days 0 and 4 and sex ratio.
Gross observations were made and external examinations of pups were conducted.
No mortality occurred. Dose-related decrease in mean body weights and body weight gains was
seen at > 500 mg/kg-day at various time points during gestation period. Absolute and/or relative
food consumption in dams was lower at >500. Thymus was smaller in dams at 1000 mg/kg-day.
Lungs were pale in color in the treated groups; however, the significance of this finding is not
known. Relative liver weights were significantly increased (p<0.05) at >500 mg/kg-day. The
number of implantation sites and percent pre-implantation loss were not affected by treatment.
The number of dams with resorptions was significantly increased (p<0.05 to p<0.01) and the
litter size was significantly decreased (p<0.05 to p<0.01) at > 500 mg/kg-day. No significant
differences were seen in serum chemistry parameters. At the time of necropsy all fetuses were
viable. Fetal body weights were significantly reduced (p<0.05) at > 500 mg/kg-day. External
examination showed one fetus at 1000 mg/kg-day was edematous (accumulation of serum in
cellular tissues) and pale in color; both hind paws were malformed; digits were reduced in size
with subcutaneous hematoma located at the distal most aspect of each the digits. Skeletal
variations included increased incidence of mostly unossified or incompletely ossified bones at
>500 mg/kg-day. Fetuses with vertebral malformations were seen among the litters of dams
given 500 mg/kg-day. Visceral malformations were restricted to two fetuses from the 500
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September, 2014
mg/kg-day—one fetus had microphthalmia and another one had a diaphragmatic hernia
(protrusion of liver into the thoracic cavity).
LOAEL (maternal toxicity) = 500 mg/kg-day (based on decreased body weights, body weight
gains and food consumption)
NOAEL (maternal toxicity) = 125 mg/kg-day
LOAEL (developmental toxicity) = 500 mg/kg-day (based on decreased fetal body weights,
increased resorptions, unossified/incomplete ossification, vertebral/visceral malformations)
NOAEL (developmental toxicity) = 125 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
Gas Oils (petroleum), hydrodesulfurized heavy vacuum (CASRN 64742-86-5)
Sample
091690
(F-227)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.10
0.70
3.00
2.00
1.00
0.30
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
Pregnant Sprague-Dawley rats (12/dose; 15/control) were administered CASRN 64742-86-5
(Hydrodesulfurized Heavy Vacuum Gas Oil (HHVGO, F-227) at 0, 50, 33 or 1000 mg/kg-day
for 6 hours/day on to previously clipped intact sites on the backs, on gestation days 0 - 20. The
application sites were not occluded; the animals were fitted with Elizabethan collars during the
exposure period. The excess test substance was wiped from the application sites after 6-hour
exposure period. For each dam, viability and clinical signs of toxicity were monitored and body
weight and food consumption measurements were taken. Observations in pups included signs of
toxicity, mortality, body weight on lactation days 0 and 4 and sex ratio. At necropsy, gross
observations were made; numbers of resorptions and implantation sites were recorded; and
external examinations of pups were conducted.
One female at 1000 mg/kg-day died on gestation day 16. Treatment-related increased incidence
of vaginal discharge was seen at 333 and 1000 mg/kg-day. Red-black stained coat in the
perineal region was noted for two females at 1000 mg/kg-day. Body weights and body weight
gains were significantly lower (p<0.05 to p<0.01) at 333 and 1000 mg/kg-day at various time
points during gestation period. Absolute and relative food consumption in dams was
significantly (p<0.05 to p<0.01) lower at 333 and 1000 mg/kg-day during gestation period.
Slight to extreme skin irritation was noted at 333 and 1000 mg/kg-day. At 1000 mg/kg-day,
none of the pregnant females delivered a litter; however, the number of implantation sites at this
dose were comparable to the control group. One female delivered dead pups at 333 mg/kg-day.
At 333 mg/kg-day, the number of total and live pups on lactation day 0 were significantly lower
(p<0.01) than those for the control group. Average pup body weights at 333 mg/kg-day were
decreased significantly on lactation day 0 (p<0.05) and 4 (p<0.01). There were no significant
differences in gestation length, a number of implantation sites, proportion of dead pups on
lactation day 0, proportion of pups surviving on lactation day 4 or proportion of male pups on
lactation day 4 and external pup alterations.
LOAEL (maternal toxicity) = 333 mg/kg-day (based on decreased body weights, body weight
gains and food consumption)
NOAEL (maternal toxicity) = 50 mg/kg-day
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LOAEL (developmental toxicity) = 333 mg/kg-day (based on decreased total and live pups on
lactation day 0 and decreased pup body weights on lactation days 0 and 4 and dead pups
delivered by one female)
NOAEL (developmental toxicity) = 50 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
Subcategory VI: Cracked Residual
Clarified oils (petroleum), catalytic cracked (CASRN 64741-62-4)
(1) In a study described above, separate groups of pregnant Sprague-Dawley rats (24/dose) were
administered CASRN 64741-62-4 (Clarified Slurry Oil) daily at 0 (sham control), 0.05, 1.0, 50
or 250 mg/kg-day, for 6 hours/day, on to previously shaved backs of the animals during gestation
days 0-19. The application sites were not occluded; the animals were fitted with Elizabethan
collars during the exposure period. For each dam, viability and clinical signs of toxicity were
monitored and body weight and food consumption measurements were taken. Animals were
sacrificed on GD 20. At necropsy, gravid uterus was weighed, gross observations were made;
numbers of resorptions and implantation sites were recorded; and external examinations were
conducted. Observations in pups included signs of toxicity, mortality, body weight on lactation
days 0 and 4 and sex ratio.
There were no mortalities. Red vaginal discharge was seen at all doses (p<0.05 and /or p<0.01).
Body weights and food consumption was reduced >1.0 mg/kg-day. Gravid uterine weights were
also significantly reduced in a dose -related manner. Early resorptions and total resorptions were
significantly increased (p<0.05) in a dose related manner at >1.0 mg/kg-day. The number of live
fetuses were also significantly decreased (p<0.05) in a dose-related manner at >1.0 mg/kg-day;
all fetuses died at 250 mg/kg-day. A percent of dead or resorbed conceptuses per litter was
increased significantly (p<0.05) at 1.0 to 50 mg/kg-day. Fetal body weights were significantly
decreased (p<0.05) at lto 50 mg/kg-day. Increased incidences of fetal variations were noted in
fetuses from 1 to 50 mg/kg-day and included moderate dilation of the renal pelvis, slight dilation
of lateral ventricle of brain, bifid thoracic vertebral centrum and decreased average numbers of
ossified caudal vertebrae.
LOAEL (maternal toxicity) = 1.0 mg/kg-day (based on increased red vaginal discharge,
decreased body weight, food consumption)
NOAEL (maternal toxicity) = 0.05 mg/kg-day
LOAEL (developmental toxicity) = 1.0 mg/kg-day (based on increased resorptions, decreased
live fetuses, decreased body weights and increased incidence of fetal variation)
NOAEL (developmental toxicity) = 0.05 mg/kg-day
fi)
Sample
091645
(F-179)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.00
0.70
10.00
30.00
20.00
6.00
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
n a developmental toxicity study, pregnant Sprague-Dawley rats (15/dose; 20/control) were
administered CASRN 64741-62-4 (Clarified Slurry Oil; CSO; F-179)) at 0 (sham control) , 0.05,
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10, or 250 mg/kg-day for 6 hours/day on to previously clipped intact sites on the backs, on
gestation days 0 - 20. (Actual administration of the test substance was from day -7 (pre-mating)
to gestation day 20.) The application sites were not occluded; the animals were fitted with
Elizabethan collars during the exposure period. The excess test substance was wiped from the
application sites after 6-hour exposure period. For each dam, viability and clinical signs of
toxicity were monitored and body weight and food consumption measurements were taken.
Observations in pups included signs of toxicity, mortality, body weight on lactation days 0 and 4
and sex ratio. At necropsy, gross observations were made; numbers of resorptions and
implantation sites were recorded; and external examinations of pups were conducted.
There were no mortalities. A higher incidence of vaginal discharge was noted in females at 250
mg/kg-day. Body weights and body weight gains were significantly lower (p<0.05 to p<0.01) at
10 and 250 mg/kg-day at various time points during gestation and lactation periods. Absolute
and/or relative food consumption in dams was significantly (p<0.05) lower at 10 and 250 mg/kg-
day during gestation and lactation. Thymus size was decreased at 250 mg/kg-day. None of the
females in the 250 mg/kg-day group delivered a litter. There were no differences between the
dose groups that delivered a litter and the control group with respect to gestation length, total and
live pups delivered, external pup alterations, pup body weights and proportion of dead pups on
lactation day 0, proportion of pups surviving to lactation day 4 or the proportion of males on
days 0 and 4. There was no significant difference in the number of implantation sites between
the control and the dosed groups.
LOAEL (maternal toxicity) = 10 mg/kg-day (based on decreased body weights, body weight
gains and food consumption)
NOAEL (maternal toxicity) = 0.05 mg/kg-day
LOAEL (developmental toxicity) = 250 mg/kg-day (based on 100% resorption rate—none of
females delivered)
NOAEL (developmental toxicity) = 10 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment.]
(3)
Sample
091692
F-229
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.00
3.00
20.00
30.00
10.00
4.00
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
n a developmental toxicity study, pregnant Sprague-Dawley rats (12/dose; 15/control) were
administered CASRN 64741-62-4 (FCCU Clarified Oil; Carbon Black Oil (CBO-F-229)) at 0
(sham control), 0.05, 10, or 50 mg/kg-day for 6 hours/day on to previously clipped intact sites on
the backs on gestation days 0 - 20. There were 15, 8, 11, and 10 pregnant females in the control,
0.05, 10 and 50 mg/kg-day groups, respectively. The application sites were not occluded; the
animals were fitted with Elizabethan collars during the exposure period. The excess test
substance was wiped from the application sites after 6-hour exposure period. For each dam,
viability and clinical signs of toxicity were monitored and body weight and food consumption
measurements were taken. Observations in pups included signs of toxicity, mortality, body
weight on lactation days 0 and 4 and sex ratio. At necropsy, gross observations were made;
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numbers of resorptions and implantation sites were recorded; and external examinations of pups
were conducted.
There were no mortalities. A higher incidence of vaginal discharge was noted in females at 50
mg/kg-day. The gestation length was significantly longer (p<0.01) than that of the control
group. Body weights and body weight gains were significantly lower (p<0.05 to p<0.01) at 50
mg/kg-day at various time points during gestation and lactation periods. Absolute and/or relative
food consumption in dams was significantly (p<0.01) lower at 50 mg/kg-day during gestation.
At 50 mg/kg-day, the total number of pups delivered per litter on day 0 and the total number of
live pups delivered/litter were significantly lower (p<0.01) than the control group. The
proportion of male pups was significantly lower (p<0.05) on lactation day 0 and 4 than the
control group. On day 0, the body weight of live pups from was significantly lower (p<0.01) at
50 mg/kg-day on lactation day 0. There were no significant differences for the number of
implantation sites, proportion of surviving pups on lactation day 0 or external pup alterations.
LOAEL (maternal toxicity) = 50 mg/kg-day (based on decreased body weights, body weight
changes increased incidence of vaginal discharge and increase in gestation length)
NOAEL (maternal toxicity) = 10 mg/kg-day
LOAEL (developmental toxicity) = 50 mg/kg-day (based decreased total and live pups per
litter, increased proportion of dead pups on lactation day 0, decreased proportion of males on
lactation days 0 and 4 and decrease in pup body weights on lactation day 0)
NOAEL (developmental toxicity) = 10 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment.]
(4)
Sample
86001
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.0
2.57
25.68
19.26
6.42
3.21
0.64
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
n a developmental toxicity study, pregnant Sprague-Dawley rats were administered CASRN
64741-62-4 (Clarified Slurry Oil (CRUNo. 86001)) at 0 (sham control), 10, 100 or 1000 mg/kg-
day daily on to shaved intact sites on the backs on gestation days 9 - 12. There were 20, 20, 15,
and 15 pregnant females in the control (sham), 10, 100 and 1000 mg/kg-day groups, respectively.
The application sites were not occluded; the animals were fitted with Elizabethan collars during
the exposure period. For each dam, viability and clinical signs of toxicity were monitored and
body weight and food consumption measurements were taken. Blood was collected at necropsy
for evaluation of clinical chemistry parameters. Observations in pups included signs of toxicity,
mortality, body weight on lactation days 0 and 4 and sex ratio. At necropsy, gross observations
were made; numbers of resorptions and implantation sites were recorded; and external
examinations of pups were conducted.
There were no mortalities. In dams, there was a dose-related decrease in mean body weights and
body weight gains in the treated groups achieving a statistical significance (p<0.05 to P<0.01) at
100 and 1000 mg/kg-day. Liver weights were significantly increased (p<0.01) and thymus
weights were significantly decreased (p<0.01) at 1000 mg/kg-day. At 1000 mg/kg-day, a
number of resorptions and dams with resorptions were increased (p<0.01) and litter size was
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decreased (p<0.01). All fetuses were viable at necropsy; however, there was an increase in in
utero death at 1000 mg/kg-day. Fetal body weights were significantly reduced (p<0.01) at 1000
mg/kg-day. Edema and paw malformations were increased at >100 mg/kg-day, achieving a
statistical significance at 1000 mg/kg-day. Cleft palate was observed at 1000 mg/kg-day at a
litter incidence of 40% and a fetal incidence of 14%.
LOAEL (maternal toxicity) = 100 mg/kg-day (based on decreased body weights, body weight
changes and food consumption)
NOAEL (maternal toxicity) = 10 mg/kg-day
LOAEL (developmental toxicity) = 100 mg/kg-day (based on external fetal alterations)
NOAEL (developmental toxicity) = 10 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
and the dosing periodfor the 1000 mg/kg-day group animals is shorter (due to irritation,
gestation days 9-12 instead of 0-20), the study generated sufficient information to assess
maternal and developmental toxicity. Therefore, it is considered adequate to include in this
hazard assessment. ]
(5)
Sample
86484
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.0
0.98
9.76
19.52
9.76
4.88
0.98
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
n a developmental toxicity study, pregnant Sprague-Dawley rats (15/dose) were administered
CASRN 64741-62-4 (Syntower Bottom (STB, CRUNo. 86484)) at 0 (sham control), "4", 8, 30,
125, 500 mg/kg-day daily on to shaved intact sites on shaved backs on gestation days 0 - 19.
The "4" mg/kg-day group animals were administered the test substance at 8 mg/kg-day on
alternate days during gestation. The 500 mg/kg-day group animals were exposed to the test
substance only during gestation days 10-12. The application sites were not occluded; the
animals were fitted with Elizabethan collars during the exposure period. For each dam, viability
and clinical signs of toxicity were monitored and body weight and food consumption
measurements were taken. Blood samples were collected for evaluation of clinical chemistry
parameters. Observations in pups included signs of toxicity, mortality, body weight on lactation
days 0 and 4 and sex ratio. At necropsy, gross observations were made; numbers of resorptions
and implantation sites were recorded; and external examinations of pups were conducted.
There were no mortalities. Vaginal bleeding was noted in animals at >8 mg/kg-day. The mean
body weight for the 30 and 125 mg/kg-day groups were significantly reduced (p<0.01)
throughout most of the gestation period and at 500 mg/kg-day during gestation days 10-12.
Body weight gain was also reduced at these doses. Food consumption was lower at all doses. At
all doses, thymus weights were lower achieving a statistical significance (p<0.01) at 125 and 500
mg/kg-day. Absolute liver weights were significantly (p<0.01) reduced at 125 mg/kg-day The
number and percent resorptions were increased >8 mg/kg-day, statistically significant (p<0.01) at
>30 mg/kg-day. Liter size was significantly decreased at > 8 mg/kg-day. A significant decrease
in mean fetal body weight was seen in male fetuses at >4 mg/kg-day. Two fetuses at 500 mg/kg-
day (GD 10-12) were edematous and one fetus had a kinked tail. The total number of affected
fetuses in this group was significantly greater than that from the control group. One fetus at 30
mg/kg-day had hyper flexion of both forelimbs. A significant increase in total rib malformation
was seen at 500 mg/kg-day (GD 10-12). A dose-related increase in the incidence of incomplete
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ossifications of the nasal bones, vertebrae and sternebrae was seen. At 500 mg/kg-day, there was
a significant (p<0.01) increase in fetuses having cleft palate.
LOAEL (maternal toxicity) = 4 mg/kg-day (based on decreased body weights, body weight
changes)
NOAEL (maternal toxicity) = not established
LOAEL (developmental toxicity) = 4 mg/kg-day (based on decreased body weights, increased
mean percent resorptions and decreased in litter size)
NOAEL (developmental toxicity) = not established
[Note: In this study, although fewer animals/dose are used than those recommended by the
guidelines, the study generated sufficient information to assess maternal and developmental
toxicity. Therefore, it is considered adequate to include in this hazard assessment. ]
(6)
Sample
091645
(F-179)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.00
0.70
10.00
30.00
20.00
6.00
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
n a developmental toxicity study, pregnant Sprague-Dawley rats were administered CASRN
64741-62-4 (Clarified Slurry Oil; CSO; Cat Cracked Clarified Oil; F-179) at 0 (acetone), 0.05,
1.0, 50 or 250 mg/kg-day, for 6 hours/day, on to previously shaved backs. The test substance
was administered to animals (25/dose) from control and 0.05 mg/kg-day groups on gestation
days 0 - 19. The remaining three groups were divided into seven subgroups (10/dose/duration)
and received the test substance according to their assigned seven subgroups each on GD 0-2, GD
3-5, GD 6-8, GD 9-11, GD 12-14, GD 15-17 and GD 18-19. The study was designed to
determine the critical period effect of dermal administration of CSO (F-179) on major
organogenesis in the developing rat conceptus. The application sites were not occluded; the
animals were fitted with Elizabethan collars during the exposure period. The excess test
substance was wiped from the application sites after 6-hour exposure period. For each dam,
viability and clinical signs of toxicity were monitored and body weight and food consumption
measurements were taken. Observations in pups included signs of toxicity, mortality, body
weight on lactation days 0 and 4 and sex ratio. At necropsy, gross observations were made;
numbers of resorptions and implantation sites were recorded; and external examinations of pups
were conducted.
There were no mortalities. Body weights, body weight gains and absolute and relative food
consumption were not affected at 0.05 mg/kg-day. Body weights for the 1, 50 and 250 mg/kg-
day groups were unaffected. However, the body weight gain was significantly lower (p<0.05 to
p<0.01) in these group s during their assigned gestation periods compared to controls. Absolute
and relative food consumption in dams for these groups was also significantly lower (p<0.05 to
p<0.01). At 50 and 250 mg/kg-day, early resorptions were increased during gestation days 6
through 8. At 250 mg/kg-day, increased early resorptions were occurred during gestation days 9
through 11. There was an increased tendency of percent of resorbed conceptuses per litter at 50
mg/kg-day achieving a statistical significance (p<0.05) at 250 mg/kg-day. Fetal alterations were
not considered to be treatment-related (not significant compared to controls, no dose response, or
were within the historical control ranges). Fetal sex ratio, body weights, gross external, soft
tissue or skeletal morphology were not affected by the treatment when administered on days 0
through 19 or gestation or days 0-2, 3-5, 6-8, 9-11, 12-14, 15-17 or 18 and 19. At 0.05 mg/kg-
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day, the test substance did not adversely affect the offspring (embryo- fetal viability, sex, body
weight or external soft and skeletal morphology).
[The study did not follow the full dosing regimen; therefore, NOAEL/LOAEL values were not
determinedfor this hazard characterization.]
(J)
Sample
86001
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.0
2.57
25.68
19.26
6.42
3.21
0.64
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats (10/dose) were administered CASRN 64741-62-4 (Clarified
Slurry Oil; CSO; Cat Cracked Clarified Oil; CRUNo. 86001) at 0 (sham control), "4", 8, 30,
125, 250 mg/kg-day daily on to shaved intact sites on shaved backs on gestation days 0 - 19.
The "4" mg/kg-day group animals were administered the test substance at 8 mg/kg-day on
alternate days during gestation. The application sites were not occluded; the animals were fitted
with Elizabethan collars during the exposure period. For each dam, viability and clinical signs of
toxicity were monitored and body weight and food consumption measurements were taken.
Blood samples were collected for evaluation of clinical chemistry parameters. Observations in
pups included signs of toxicity, mortality, body weight on lactation days 0-4 and sex. At
necropsy, gross observations were made; numbers of resorptions and implantation sites were
recorded; and external examinations were conducted.
Two dams exposed to 4 mg/kg-day showed skin irritation. One dam exposed to 125 mg/mg-day
was found dead on GD 18. Vaginal bleeding was noted in animals at >8 mg/kg-day. The mean
body weights and body weight gains were significantly reduced (p<0.01) throughout most of the
gestation period at >8 mg/kg-day. Food consumption was lower at > 8 mg/kg-day. Thymus
weights were lower than control at > 8 mg/kg-day, achieving a statistical significance (p<0.05) at
250 mg/kg-day. Absolute and relative liver weights were increased (p<0.05) at 250 mg/kg-day.
Treatment-related seven clinical chemistry parameters (not stated in the robust summary) were
affected in a dose-related manner and those associated with liver toxicity (cholesterol and
alkaline phosphatase) were increased. The number of implantation sites and percent
preimplantation losses was not affected by the treatment. At > 30 mg/kg-day, the number of
dams with all resorptions and number of resorptions were increased (p<0.01) and litter size was
decreased. Fetuses at 30 and 125 mg/kg-day were smaller (decreased body weight and crown-
rump length) than those from the control groups. Abnormal external fetal development
(microganthia, kinked tail and edema) was observed in fetuses at > 8 mg/kg-day. Visceral
anomalies included enlarged ventricles of the brain, displacement of esophagus and development
of heart.
LOAEL (maternal toxicity) = 8 mg/kg-day (based on vaginal discharge, decreased body
weights, body weight changes, decreased food consumption and atrophy of thymus)
NOAEL (maternal toxicity) = not established
LOAEL (developmental toxicity) = 8 mg/kg-day (based on increased number and percent
resorptions and decreased fetal body weight, crown-rump length and litter size, and increased
fetal anomalies)
NOAEL (developmental toxicity) = not established
[Note: In this study, although fewer animals/dose are used than those recommended by the
guidelines, the study generated sufficient information to assess maternal and developmental
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toxicity. Therefore, it is considered adequate to include in this hazard assessment. Since "4"
mg/kg-day group did not receive the full regimen of doses and it did not show any maternal or
developmental effects, it was not considered when assigning the NOAEL/LOAEL values. ]
(8)
Sample
86001
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.00
2.57
25.68
19.26
6.42
3.21
0.64
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats (12/dose) were administered single doses of CASRN 64741-62-4
(Clarified Slurry Oil; CSO; Cat Cracked Clarified Oil; CRU No. 86001) via gavage at 0 (water),
125, 500 or 2000 mg/kg on a designated day during specific periods of organogenesis (see
below), during which the developing conceptus is believed to be sensitive to the teratogenic
insult of a chemical.
Group 1: tap water (control) dosed through GD 11 to 14
Group 2: at 2000 mg/kg on GD 11
Group 3: at 125 mg/kg on GD 12
Group 4: at 500 mg/kg on GD 12
Group 5: at 2000 mg/kg on GD 12.
Group 6: at 2000 mg/kg on GD 13
Group 7: at 2000 mg/kg on GD 14
For each dam, viability and clinical signs of toxicity were monitored and body weight and food
consumption measurements were taken. Each dam was sacrificed on day 20 of its presumed
gestation. Thoracic and abdominal organs were examined and reproductive organs were
examined grossly. Thymus and liver weights were taken. The number of corpora lutea and
uterus weights was recorded. Observations in pups included signs of toxicity, mortality, body
weight on lactation days 0 and 4 at necropsy, gross observations were made; numbers of
resorptions and implantation sites were recorded; and external examinations of pups were
conducted.
No treatment-related mortality was seen. Treatment-related clinical signs included vaginal
bleeding, perianal staining and decreased stool. One female at 2000 mg/kg (GD 14) had severe
red vaginal discharge and was sacrificed moribund on GD 19; her entire litter was found to be
dead. The mean body weights for dams at 500 and 2000 mg/kg were significantly reduced
(p<0.01) during the later part of gestation. A significant reduction in overall maternal body
weight (GD 0-20) and net body weight change was also seen in these groups. There was a dose-
response on GD 12. Food consumption was reduced at 500 and 2000 mg/kg. At these doses, the
absolute and relative thymus weights were significantly lower (p<0.01) than controls. Relative
liver weights were significantly increased at 2000 mg/kg (GD 13). The number of percent
resorptions was increased at 2000 mg/kg on GD 11, 12 and 13; achieving a statistical
significance on GD 11 and 12. Litter size at 2000 mg/kg (GD 11 and 12) was decreased
significantly (p<0.01) and the fetal sex ratio was significantly altered at 2000 mg/kg (GD 11).
Mean male fetal body weight was significantly decreased at >500 mg/kg and in all viable fetuses
in the 2000 mg/kg groups. A significant increase in fetal malformations was observed for all
2000 mg/kg groups. The most common malformations were cleft palate, hind and forepaws
brachydactyly (short and stubby toes) and tail (kinked, fleshy tab at the tip). One fetus at 500
mg/kg (GD 12) had hind-paw malformations; one fetus had syndactyly (fused toes) and one fetus
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September, 2014
had brachydactyly. A significant increase in skeletal malformations was noted at >500 mg/kg
and included misshapen cervical and caudal vertebrae, misshapen clavicle and costal cartilage
and fore- and hind paw phalanges absent, misshapen or fused and incompletely ossified skeletal
structures. In 2000 mg/kg groups, significant increase was seen cleft palate. This malformation
was seen at 125 and 500 mg/kg. In addition, diaphragmatic hernia was seen at 2000 mg/kg (GD
11, 12,and 13) and ectopic esophagus at 2000 mg/kg (GD 13).
[The study did not follow the full dosing regimen (single doses administered), therefore,
NOAEL/LOAEL values were not determinedfor this hazard characterization.]
(9)
Sample
86484
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.0
0.98
9.76
19.52
9.76
4.88
0.98
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats (11/dose) were administered single doses of CASRN 64741-62-4
(Syntower Bottoms CRU No. 86484) via gavage at 0 (water), 125, 500 or 2000 mg/kg on
designated day (see below) during specific periods of organogenesis (GD 11-15) during which
the developing conceptus is believed to be sensitive to the teratogenic insult of a chemical.
Group 1: tap water (control) dosed through GD 11 to 15
Group 2: at 2000 mg/kg on GD 11
Group 3: at 125 mg/kg on GD 12
Group 4: at 500 mg/kg on GD 12
Group 5: at 2000 mg/kg on GD 12.
Group 6: at 2000 mg/kg on GD 13
Group 7: at 2000 mg/kg on GD 14
Group 8: at 2000 mg/kg on GD 15
For each dam, viability and clinical signs of toxicity were monitored and body weight and food
consumption measurements were taken. Each dam was sacrificed on day 20 of its presumed
gestation. Thoracic and abdominal organs were examined and reproductive organs were
examined grossly. Thymus and liver weights were taken. The number of corpora lutea and
uterus weights were recorded. Observations in pups included signs of toxicity, mortality, body
weight on lactation days 0-4 at necropsy, gross observations were made; numbers of resorptions
and implantation sites were recorded; and external examinations were conducted.
No treatment-related mortality was seen. Treatment-related clinical signs included vaginal
bleeding, perineal staining and decreased stool. The females with red vaginal discharge had
large numbers of resorptions. The mean body weights for dams at 2000 mg/kg were
significantly reduced (p<0.01) during the later part of gestation. A significant reduction
(p<0.01) in overall maternal body weight (GD 0-20) and net body weight change were seen at
2000 mg/kg. Food consumption was significantly reduced at 2000 mg/kg. Gravid uterine
weights were significantly less (p<0.01) at > 500 mg/kg. At these doses, the absolute and
relative thymus weights were significantly reduced (p<0.01) than controls. There was no
adverse effect on liver weight. The number of percent resorptions was increased at 2000 mg/kg
on GD 11,12 and 15. The litter size was reduced and correspondingly resorptions were
increased in all treatment groups achieving a statistical significance (p<0.01) at 125 and 2000
mg/kg (GD 11 and 12). The number of dams with resorptions were significantly (p<0.01)
increased at 500 and 2000 mg/kg (GD 11 and 12). A decrease in fetal body weights was seen at
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September, 2014
> 500 mg/kg; significant (p<0.01) at 2000 mg/kg. Fetal external malformations were
significantly increased at 2000 mg/kg and generally included cleft palate, brachydactyly
(shortness of fingers or toes) and adactyly (one or more fingers or toes missing) and fleshy tab at
the tip of the tail and shortened tail. The brachydactyly and adactyly was also seen at 500 mg/kg.
Other fetal variations such as edema and malrotated hindlimb also occurred in fetuses of exposed
dams. Skeletal malformations were observed >500 mg/kg (GD 11-14) and included misshapen
cervical transverse process, shortened tail, hind-paw phalanges fused, misshapen or missing. In
complete ossification was noted in many skeletal structures at 2000 mg/kg (GD 11-15). A
significant increase in visceral malformations was seen at 2000 mg/kg regardless of the gestation
day of test substance administration. Among the findings were small and/or lobular lungs (GD
11, 12, 13), small spleen (GD 11, 15), ectopic and small kidneys (GD 11 and 14), cleft palate
(GD 12, 13, 14), right-sided esophagus (GD 12 and 13), heart abnormalities (GD 12 13) and
diaphragmatic hernia (GD 12, 13). Some of these findings were also seen at 500 mg/kg.
Variations of the urinary tract (dilation of renal pelvis and distended ureters) were seen
significantly more often at 125, 500 and 2000 (GD15) mg/kg than in the controls.
[The study did not follow the full dosing regimen (single doses administered); therefore,
NOAEL/LOAEL values were not determinedfor this hazard characterization.]
Subcategory VII: Cracked Distillate
Distillates (petroleum), heavy catalytic cracked (CASRN 64741-61-3)
Sample
091686
(F-222)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.00
4.00
40.00
4.00
0.60
0.00
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
Pregnant Sprague-Dawley rats were administered CASRN 64741-61-3 (FCCU Heavy Cycle
Oil(HCO);(F-222)) at 0 (sham control), 50, 150 or 500 mg/kg-day for 6 hours/day on to
previously clipped intact sites on the backs to alternating sites (intrascapular and lumbar regions)
of the animals on gestation days 0 - 20. There were 14, 10, 12, and 10 pregnant females in the
control, 50, 150 and 500 mg/kg-day groups, respectively. The application sites were not
occluded; the animals were fitted with Elizabethan collars during the exposure period. The
excess test substance was wiped from the application sites after 6-hour exposure period. For
each dam, viability and clinical signs of toxicity were monitored and body weight and food
consumption measurements were taken. Observations in pups included signs of toxicity,
mortality, body weight on lactation days 0 and 4 and sex. At necropsy, gross observations were
made; numbers of resorptions and implantation sites were recorded; and external examinations of
pups were conducted.
One female from the 150 mg/kg-day group was found dead on GD 16 and two other females
from this group were sacrificed in a moribund condition on GD 15 or 16. Slight to moderate
skin irritation was seen at all doses. A higher incidence of vaginal discharge was noted in
females at all doses. Red, red/black or yellow staining in the perineal region was seen in several
females at >150 mg/kg-day. Body weights and body weight gains were significantly lower
(p<0.05 to p<0.01) at >50 mg/kg-day at various time points during gestation and lactation
periods. Absolute and/or relative food consumption in dams was significantly (p<0.01) lower at
>50 mg/kg-day during gestation. At 50 mg/kg-day, the gestation length was significantly longer
(p<0.01). The number of total and live pups on lactation day 0 was significantly lower (p<0.01)
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and adjusted mean pup weight on lactation day 0 was significantly decreased (p<0.05) compared
to the control group. At this dose, seven of 10 pregnant females delivered a litter. At 150
mg/kg-day, one of 12 pregnant females delivered a litter. The number of total and live pups on
lactation day 0 was significantly lower (p<0.01) and although not statistically significant, the
adjusted mean pup weight on lactation day 0 was decreased compared to the control group. At
500 mg/kg-day, none of the 10 pregnant females delivered a litter. At this dose, the number of
implantation sites was significantly lower (p<0.01) than controls, suggesting increased pre-
implantation loss. At 50 and 150 mg/kg-day, there were no significant differences in number of
implantation sites, proportion of dead pups on lactation day 0, proportion of pups surviving to
lactation day 4, proportion of male pups on lactation days 0 and 4 or external pup alterations.
LOAEL (maternal toxicity) = 50 mg/kg-day (based on decreased body weights, body weight
changes and food consumption, increased incidence of vaginal discharge)
NOAEL (maternal toxicity) = not established
LOAEL (developmental toxicity) = 50 mg/kg-day (based decreased number of total and live
pups on lactation day 0, decreased pup body weights on lactation day 0)
NOAEL (developmental toxicity) = not established
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
Distillates (petroleum), heavy thermal cracked (CASNo. 64741-81-7)
(!)
Sample
094625
(F-274)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
7.00
9.00
7.00
5.00
2.00
0.00
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats were administered CASRN 64741-81-7 (Heavy Coker Gas Oil,
Heavy Thermal Cracked Distillate (HGCO (F274)) at 0 (sham control), 1.0, 50 or 250 mg/kg-
day, for 6 hours/day, on to previously clipped intact site on the backs on gestation days 0 - 20.
The application sites were not occluded; the animals were fitted with Elizabethan collars during
the exposure period. The excess test substance was wiped from the application sites after 6-hour
exposure period. There were 15, 10, 12, and 10 pregnant females in the control, 1, 50 and 250
mg/kg-day groups, respectively. For each dam, viability and clinical signs of toxicity were
monitored and body weight and food consumption measurements were taken. Observations in
pups included signs of toxicity, mortality, body weight on lactation days 0-4 and sex. At
necropsy, gross observations were made; numbers of resorptions and implantation sites were
recorded; and external examinations of pups were conducted.
There were no mortalities. Slight skin irritation was seen at >50 mg/kg-day. Body weights and
body weight gains were significantly lower (p<0.05 to p<0.01) than controls at >1 mg/kg-day at
various time points during gestation and lactation periods. Absolute and/or relative food
consumption in dams was significantly reduced (p<0.05 to p<0.01) at >1 mg/kg-day during
gestation. At necropsy, early resorption sites were noted in two females at 250 mg/kg-day with a
red fluid filling the uterus; the uterus of another female was filled with a clear fluid. The
gestation length at 50 mg/kg-day was significantly longer (p<0.01) than that of the sham
controls. No females from the 250 mg/kg-day group delivered a litter. The number of
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September, 2014
implantation sites were significantly less (p<0.01) at 250 mg/kg-day than controls. Total pups
per litter and live pups per litter were significantly less (p<0.05) at 50 mg/kg-day than the
controls. Average pup body weights were not significantly different at 1 and 50 mg/kg-day
compared to controls.
LOAEL (maternal toxicity) = 50 mg/kg-day (based on decreased body weight gain, food
consumption)
NOAEL (maternal toxicity) = 1 mg/kg-day
LOAEL (developmental toxicity) = 50 mg/kg-day (based on decreased number of total and
live pups delivered per litter)
NOAEL (developmental toxicity) = 1 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment.]
2)
Sample
091653
(F-200)
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.00
0.90
20.00
5.00
0.00
0.00
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats (15/dose; 20/control) were administered CASRN 64741-81-7
(Heavy Coker Gas Oil, Heavy Thermal Cracked Distillate (HGCO (F200)) at 0 (sham control),
0.1(diluted in acetone), 50 (neat) or 250 (neat) mg/kg-day, for 6 hours/day, on to previously
clipped intact site on the backs on gestation days 0 - 20. (Actual administration of the test
substance was from day -7 (pre-mating) to gestation day 20.) The application sites were not
occluded; the animals were fitted with Elizabethan collars during the exposure period. The
excess test substance was wiped from the application sites after 6-hour exposure period. For
each dam, viability and clinical signs of toxicity were monitored and body weight and food
consumption measurements were taken. Observations in pups included signs of toxicity,
mortality, body weight on lactation days 0 and 4 and sex ratio. At necropsy, gross observations
were made; numbers of resorptions and implantation sites were recorded; and external
examinations of pups were conducted.
One female in the 250 mg/kg-day group was found dead on GD 18. Slight to severe skin
irritation was seen at all doses. There was an increased incidence of vaginal discharge in females
at 250 mg/kg-day. Body weights and body weight gains were significantly lower (p<0.05 to
p<0.01) at >50 mg/kg-day at various time points during gestation and lactation periods.
Absolute and/or relative food consumption was significantly lower (p<0.05 to p<0.01) than
controls at 250 mg/kg-day during gestation and pre-mating periods. At necropsy, thymus size
was decreased at 250 mg/kg-day (weight data not included). Two females showed resorptions.
The total number of live pups and pup body weights were significantly lower (p<0.01) at 50
mg/kg-day. At 250 mg/kg-day, only one female delivered a litter. The number of implantation
sites in females of this group were significantly lower (p<0.01) than the controls suggesting
increased pre-implantation loss. At 50 mg/kg-day, the number of total and live pups on lactation
day 0 was decreased (p<0.01) and pup body weights were lower (p<0.05) than that of the
controls on lactation days 0 and 4. None of the pups from the only litter that was delivered,
survived to lactation day 4 at 250 mg/kg-day. There were no differences in gestation length,
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external pup alterations or the proportion of males on lactation day 0 and 4 among all doses and
the controls.
LOAEL (maternal toxicity) = 50 mg/kg-day (based on decreased body weights and body
weight changes)
NOAEL (maternal toxicity) = 0.1 mg/kg-day
LOAEL (developmental toxicity) = 50 mg/kg-day (based on decreased number of total and
live pups and decreased pup body weights)
NOAEL (developmental toxicity) = 0.1 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
(3)
Sample
83366
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.10
2.50
5.10
2.50
1.30
0.90
0.10
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
Pregnant Sprague-Dawley rats (10/dose) were administered CASRN 64741-81-7 (Heavy Coker
Gas Oil (HCGO); Heavy Thermal Cracked Distillate (CRUNo. 83366)) at 0, 8, 30, 125, 250
mg/kg-day daily on to shaved intact sites on clipped backs on gestation days 0-19. The
application sites were not occluded; the animals were fitted with Elizabethan collars during the
exposure period. Each female was sacrificed on day 20. For each dam, viability and clinical
signs of toxicity were monitored and body weight and food consumption measurements were
taken. Blood samples were collected for evaluation of clinical chemistry parameters.
Observations in pups included signs of toxicity, mortality, body weight on lactation days 0 and 4
and sex ratio. At necropsy, gross observations were made; numbers of resorptions and
implantation sites were recorded; and external examinations of pups were conducted.
There were no mortalities. Moderate to severe skin irritation was seen at all doses. Vaginal
bleeding was noted in animals at >30 mg/kg-day. Mean body weights, body weight gains,
uterine weights and net body weights were decreased in a dose-related manner at > 30 mg/kg-
day throughout most of the gestation period. Food consumption was decreased at > 125 mg/kg-
day. At > 125 mg/kg-day, thymus weights were lower achieving a statistical significance
(p<0.05). Pale lungs were seen in treated animals. Absolute liver weights were significantly
(p<0.05) reduced at 250 mg/kg-day. The relative liver weights were higher (p<0.01) at > 125
mg/kg-day. The gravid uterine weights were decreased in a dose-related manner at > 30 mg/kg-
day achieving a statistical significance at >125 mg/kg-day. The number of dams with all
resorptions, the number of resorptions and litter size were adversely affected in a dose-related
manner at >125 mg/kg-day. There was an indication of dose-related hepatotoxicity as
characterized by increases in serum aspartate amino transferase and sorbitol dehydrogenase
activities. A significant decrease (p<0.05 to p<0.01) in mean fetal body weight was seen at >125
mg/kg-day. At these doses, crown-rump length was significantly reduced in female fetuses.
External fetal examination showed a slight increase in anomalies at >125 mg/kg-day on a fetal
basis only (one fetus with edema, one fetus with a slightly reduced lower jaw and one dead fetus
with microganthia). The soft tissue examination did not reveal any statistically significant
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increase in anomalies. Some skeletal variations, mostly unossified or incompletely ossified
bones, were seen at a higher incidence at >125 mg/kg-day.
LOAEL (maternal toxicity) = 30 mg/kg-day (based on vaginal bleeding, decreased body
weights and food consumption)
NOAEL (maternal toxicity) = 8 mg/kg-day
LOAEL (developmental toxicity) = 125 mg/kg-day (based on increased number and percent
resorptions, decreased fetal body weight and crown-rump length, increased fetal anomalies)
NOAEL (developmental toxicity) = 30 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
(4)
Sample
CRU No.
86181
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.25
2.48
12.4
7.44
2.48
0.50
0.0
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats (15/dose) were administered CASRN 64741-81-7 (Heavy Coker
Gas Oil (HCGO); Heavy (CRU No. 86181)) at 0, 8, 30, 125, 250 mg/kg-day daily on to shaved
intact sites on clipped backs on gestation days 0-19. The application sites were not occluded;
the animals were fitted with Elizabethan collars during the exposure period. For each dam,
viability and clinical signs of toxicity were monitored and body weight and food consumption
measurements were taken. Each female was sacrificed on day 20. Blood samples were collected
for evaluation of clinical chemistry and hematology parameters. Gross examination of organs
was conducted; thymus and liver were weighed; the number of corpora lutea per ovary and
gravid uterus weight were recorded. Observations in pups included signs of toxicity, mortality,
body weight on lactation days 0 and 4 and sex ratio. At necropsy, gross observations were made;
numbers of resorptions and implantation sites were recorded; and external examinations of pups
were conducted.
There were no mortalities. Slight to severe skin irritation was seen at all doses. Vaginal red
discharge was noted in animals at >30 mg/kg-day with increasing incidence. One female dosed
at 250 mg/kg-day was sacrificed in a moribund condition on GD 16 with severe vaginal red
discharge. Mean body weights (at all doses), body weight gains and net body weights were
decreased in a dose-related manner throughout most of the gestation period achieving a statistical
significance at >30 mg/kg-day. Food consumption was decreased at all doses with the amount of
reduction increased with the increasing dose. Absolute thymus weights were significantly
decreased at all doses achieving a statistical significance at > 30 mg/kg-day (p<0.05 to p<0.01)
and relative thymus weights were decreased in a dose-related manner; achieving a statistical
significance at >125 mg/kg-day. Absolute liver weights were significantly decreased (p<0.01) at
250 mg/kg-day; mean relative liver weights were significantly increased (p<0.05 to p<0.01) at
>125 mg/kg-day. The gravid uterine weights were decreased in a dose-related manner at > 30
mg/kg-day achieving a statistical significance at >125 mg/kg-day. The number of dams with
resorptions, the mean percent resorptions and litter size were adversely affected at all doses,
significantly (p<0.01) at >125 mg/kg-day. Some of the hematological parameters were affected
(segmented neutrophils, lymphocytes and monocytes). The changes in clinical chemistry
parameters were comparable with the normal range of non-pregnant animals. Fetal body weights
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Hazard Characterization Document
were significantly decreased (p<0.05 to p<0.01) at >125 mg/kg-day. There were no significant
findings following the gross examinations of fetuses. Fetal skeletal examinations showed a
statistically significant increase in incompletely ossified or unossified sternebrae at 8 mg/kg-day.
Isolated incidences of variations and malformations—not dose-related—were seen during the
fetal visceral evaluations.
LOAEL (maternal toxicity) = 8 mg/kg-day (based on decreased body weights, body weight
gain and food consumption)
NOAEL (maternal toxicity) = not established
LOAEL (developmental toxicity) = 8 mg/kg-day (based on increased mean number and
percent resorptions, skeletal variations)
NOAEL (developmental toxicity) = not established
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
(5)
Sample
86193
1-ARC
(%)
2-ARC
(%)
3-ARC
(%)
4-ARC
(%)
5-ARC
(%)
6-ARC
(%)
7-ARC
(%)
0.84
2.94
0.38
0.00
0.00
0.00
0.00
Wt. % of PACs (polyaromatic compounds) that have 1 -7 aromatic rings in the Aromatic Ring Class
3regnant Sprague-Dawley rats (15/dose; 14/control) were administered CASRN 64741-81-7
(Heavy Coker Gas Oil; Visbreaker Gas Oil (VGO); V B Mittelol (CRU No. 86193)) at 0, 30,
125, 250 mg/kg-day daily on to shaved intact sites on clipped backs on gestation days 0 - 19.
The application sites were not occluded; the animals were fitted with Elizabethan collars during
the exposure period. For each dam, viability and clinical signs of toxicity were monitored and
body weight and food consumption measurements were taken. Each female was sacrificed on
day 20. Gross examination of organs was conducted; the number of corpora lutea per ovary and
gravid uterus weight were recorded. Observations in pups included signs of toxicity, mortality,
body weight on lactation days 0 and 4 and sex ratio. At necropsy, gross observations were made;
numbers of resorptions and implantation sites were recorded; and external examinations were
conducted.
There were no mortalities. Slight to severe skin irritation was seen at all doses. Mean body
weights were not affected by treatment; however, body weight gains were significantly
decreased (p<0.05) at 250 mg/kg-day. No significant differences in food consumption values at
any dose and there were no treatment-related, significant findings at necropsy of females.
Although not statistically significant, there was a dose-related increase in resorptions. Dams
with resorptions and percent pre-implantation loss were higher at 250 mg/kg-day when compared
with controls. There were no differences in fetal body weights from the exposed animals and the
controls. There were isolated incidence of variations and malformations during external
examination of fetuses; Fleshy tab tip of tail (in one fetus at 125 and one at 250 mg/kg-day,
protruding tongue in one fetus at 250 mg/kg-day). Based on low incidence and no dose
response, these observations were considered not to be treatment related.
LOAEL (maternal toxicity) = 250 mg/kg-day (based on decreased body weight gains)
NOAEL (maternal toxicity) = 125 mg/kg-day
NOAEL (developmental toxicity) = 250 mg/kg-day (highest dose tested)
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[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
(6) Pregnant Sprague-Dawley rats (15/dose) were administered CASRN 64741-81-7 (Coker
Heavy Gas Oil) at 0 (sham control), 8, 30, 125, 250 mg/kg-day daily on to the shorn sites on
gestation days
0-19. The application sites were not occluded; the animals were fitted with Elizabethan collars
during the exposure period. For each dam, viability and clinical signs of toxicity were monitored
and body weight and food consumption measurements were taken. Each female was sacrificed
on day 20. Blood samples were collected for evaluation of clinical chemistry parameters. Gross
examination of organs was conducted; thymus and liver were weighed; the number of corpora
lutea per ovary and gravid uterus weight were recorded. The number and location of
implantations and live and dead fetuses were recorded. Observations in pups included signs of
toxicity, mortality, body weight on lactation days 0 and 4 and sex ratio. Skeletal examinations
and examination of soft tissue abnormalities for pups were conducted.
There were no mortalities. Slight to severe skin irritation was seen at all doses. Vaginal red
discharge was noted in animals at >30 mg/kg-day with increasing incidence. The net body
weights were decreased at >30 mg/kg-day achieving a statistical significance at >125 mg/kg-day.
Food consumption was decreased at >125 mg/kg-day. Clinical chemistry parameters were
affected only at 250 mg/kg-day as follows: decreased triglycerides (52%), increase albumin,
(36%), A/G ratio (33%), inorganic phosphorus (43%) and iron (2.5 times the control). At
necropsy, absolute thymus weights were significantly decreased at all doses achieving a
statistical significance at > 125 mg/kg-day. Absolute liver weights were increased and relative
liver weights were decreased. The number of dams with all resorptions were increased (50%) at
250 mg/kg-day (50%) and the number of resorptions were increased at 125 mg/kg-day. There
were decreases in litter size, fetal body weights and crown-rump length at >125 mg/kg-day. The
external examinations of pups showed anomalies at >125 mg/kg-day. The anomalies included
reduced (shortened) lower jaw and edema. Displacement of esophagus and distension of the
uterus were also observed. Isolated incidences of variations and malformations were seen during
the fetal visceral evaluations.
LOAEL (maternal toxicity) = 125 mg/kg-day (based on decreased body weights, body weight
gain, decreased liver and thymus weights and effects on clinical chemistry parameters)
NOAEL (maternal toxicity) = 30 mg/kg-day
LOAEL (developmental toxicity) = 125 mg/kg-day (based on decreased pup body weight,
litter size; increased number and percent resorptions, external anomalies)
NOAEL (developmental toxicity) = 30 mg/kg-day
[Note: In this study, although fewer animals/dose are used than recommended by the guidelines,
the study generated sufficient information to assess maternal and developmental toxicity.
Therefore, it is considered adequate to include in this hazard assessment. ]
Subcategory VIII: Reformer Residual
No data.
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Genetic Toxicity - Gene Mutation
In vitro
Subcategory I: Residual Fuel Oils
Fuel oil, No. 6 (CASRN 68553-00-4)
(1) In an Ames assay, Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and
TA100 were exposed to CASRN 68553-00-4 (Fuel Oil No.6; also called as Jet Fuel A) at
concentrations of 20,000 and 40,000 |ig/plate with and without metabolic activation. Both
positive and negative controls were included in the assay. Controls responded appropriately.
Cytotoxicity information is unclear. Under the conditions of the assay, Jet Fuel A did not exhibit
a positive response in any strain with or without metabolic activation. Additional details are
from TSCATS (OTS0536509).
CASRN 68553-00-4 was not mutagenic in this assay.
(2) In a forward mutation assay, mouse lymphoma cells (L5178Y) were exposed to CASRN
68553-00-4 (Fuel Oil No.6; also called as Jet Fuel A) at concentrations ranging from 25 to 200
|ig/mL with metabolic activation and from 100 to 2400 |ag/m L without metabolic activation.
Positive controls responded appropriately. Cytotoxicity information is unclear. Fuel oil No. 6 or
Jet Fuel A was mutagenic with metabolic activation. Additional details are from TSCATS
(OTS0536509).
CASRN 68553-00-4 was mutagenic in this assay.
Subcategory II: Atmospheric Residual
No data.
Subcategory III: Atmospheric Distillate
No data.
Subcategory IV: Vacuum Residual
Residues (petroleum), vacuum (CASRN 64741-56-6, supporting chemical)
(1) In an in vitro gene mutation test, Mouse lymphoma cells (L5178Y) were exposed to CASRN
64741-56-6 (Residues (petroleum), vacuum) was tested in at concentrations of 0, 62.5, 125, 250,
500 or 1000 nL/mL with and without metabolic activation. There was no evidence of mutagenic
activity under non-activation conditions. However, with metabolic activation there was an
indication of weak activity. This study summary was reported in the HPV Hazard
Characterization for the Asphalt Category.
CASRN 64741-56-6 was mutagenic in this assay.
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Subcategory V: Vacuum Distillate
No data.
Subcategory VI: Cracked Residual
Clarified oils (petroleum), catalytic cracked (CASRN 64741-62-4)
(1) In an in vitro gene mutation test, Mouse lymphoma L5178Y cells were exposed to CASRN
64741-62-4 (Clarified oils (petroleum), catalytic cracked (API 81-15)) n at concentrations of
0.061 - 1000 nL/mL. The test substance appeared miscible in the assay medium without
activation from 0.061 -31.3 nL/mL but a brown precipitate was noted at the top concentrations
from 62.5 to 100 nL/mL. Under non-activation conditions, weak mutagenic activity was noted.
In the presence of metabolic activation, a dose-dependent increase in the mutant frequency was
observed at concentrations > 0.977 nL/mL. Both positive and negative controls responded
appropriately.
CASRN 64741-62-4 was mutagenic in this assay.
(2) In a forward mutation assay, Chinese hamster ovary cells were exposed to CASRN 64741-
62-4 (Clarified oils (petroleum), catalytic cracked (Clarified slurry oil)) at concentrations of 0.1,
1, 3, 10 and 30 |ig/mL without S-9 activation and 0.1, 1, 10, 100 and 200 |ig/mL with S-9
activation. No dose-dependent increase in the mutant frequencies was noted. Both positive and
negative controls responded appropriately.
CASRN 64741-62-4 was not mutagenic in this assay.
Subcategory VII: Cracked Distillate
No data.
Subcategory VIII: Reformer Residual
No data.
In vivo
Subcategory VI: Cracked Residual
No data.
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Genetic Toxicity - Chromosomal Aberrations
In vitro
Subcategory I to VIII
No data.
In vivo
Subcategory I: Residual Fuel Oils
Fuel oil, No. 6 (CASRN 68553-00-4)
In a bone marrow cytogenetic assay, male albino Sprague-Dawley rats (5/dose) were exposed to
CASRN 68553-00-4 (Fuel Oil No.6; also called as Jet Fuel A) via inhalation at 0, 400 or 1000
ppm 6 hours/day, 5 days/week for up to a total of 20 exposures (only 5 exposures for the 400
ppm group). Under the conditions of the study, Jet Fuel A showed the ability to produce
structural aberrations in bone marrow cells in rats. Additional details are from TSCATS
(OTS0536509).
CASRN 68553-00-4 induced chromosomal aberrations in this assay.
Subcategory V: Vacuum Distillate
Residues (petroleum), heavy vacuum (CASRN 64741-57-7)
In a micronucleus assay, rats (10/sex, train not specified) were exposed to CASRN 64741-57-7
(Residues (petroleum), heavy vacuum; Heavy Vacuum Gas Oil) via the dermal route at 30, 125,
500 or 2000 mg/kg-bw/day daily, 5 days/week for 13 weeks. At the end of 14 weeks exposure,
the animals were killed and bone marrow cells from femurs were taken from 5 animals/sex/dose
(except for females treated at 125 mg/kg-day and males treated at 2000 mg/kg-day). There were
no difference between the control values and the treated groups for polychromatic erythrocytes
(PCEs)/normochromatic erythrocytes (NCEs) ratios, percent micronucleated PCEs or percent
micronucleated NCEs.
CASRN 64741-57-7 did not induce micronuclei in this assay.
Subcategory VI: Cracked Residual
Clarified oils (petroleum), catalytic cracked (CASRN 64741-62-4)
In mammalian bone marrow chromosome aberration test, Sprague-Dawley rats (10/sex/dose)
were exposed to CASRN 64741-62-4 (Clarified oils (petroleum) catalytic cracked (API 81-15))
via gavage at 0.1, 0.3 or 1 g/kg-day for 5 days. After the exposure and an intraperitoneal
injection of colchicine, the animals were killed, bone marrow smears were prepared, stained and
chromosomal aberrations were scored. At all doses the number of bone marrow cells with
chromosomal aberrations did not differ from those for the negative control. The positive control
responded appropriately.
CASRN 64741-62-4 did not induce chromosomal aberrations in this assay.
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Other Information
Subcategory VI: Cracked Residual
Clarified oils (petroleum), catalytic cracked (CAS No. 64741-62-4)
(1) In a sister chromatid exchange assay, mouse embryo cells were exposed to
CASRN 64741-62-4 (Clarified oils (petroleum), catalytic cracked (API 81-15)) at 1, 2, 6 or
9 [ig/mL without metabolic activation and 10, 30, 100 or 300 |ag/mL with metabolic activation.
Both positive and negative controls were run. Positive controls responded appropriately. Sister
chromatid exchanges were increased in the presence of metabolic activation, but not in the
absence of activation.
CASRN 64741-62-4 induced sister chromatid exchange in this assay.
(2) In an in vitro unscheduled DNA synthesis (UDS) assay, primary hepatocytes cultures (from
F-344 rats) were exposed to CASRN 64741-62-4 (Clarified Slurry Oil; Clarified oils
(petroleum), catalytic cracked)) at 0.5 to 100 |ig/mL. Cytotoxicity was seen at 500 and 1000
|ig/mL, Unscheduled DNA synthesis was elevated compared to that in the solvent control.
CASRN 64741-62-4 induced UDS in this assay.
(3) In another in vitro UDS assay, primary rat hepatocyte cultures were exposed to
CASRN 64741-62-4 [Clarified Slurry Oil; Clarified oils (petroleum), catalytic cracked)] at
concentrations ranging from 1 x 10"6 to 1000 |ig/mL. Both positive and negative controls were
run. Positive controls responded appropriately. The presence of a dose-response, positive net
grain count and increased number of cells in repair indicate that the test substance is genotoxic.
CASRN 64741-62-4 induced UDS in this assay.
(4) In an unscheduled DNA synthesis assay, Fischer 344 male rats were exposed to
CASRN 64741-62-4(clarified oils (petroleum), catalytic cracked) via gavage at 50, 200 or
1000 mg/kg at 2 and 12 hours prior to sacrifice. Primary hepatocyte cultures were obtained from
the livers of treated rats. Unscheduled DNA synthesis was elevated above that in the solvent
control.
CASRN 64741-62-4 induced UDS in this assay.
(5) In the dominant lethal assay, male Crl:CD(SD)BR VAF/Plus rats (10/dose) were
administered percutaneous doses of CASRN 64741-62-4 (Clarified slurry oil) at 0, 0.1, 1.0, 10,
50 and 250 mg/kg-day for 70days before a seven-day cohabitation period with untreated virgin
female rats. Two female rats were assigned with each male rat. The female rats were not
administered the test substance. The male rats were observed for viability and clinical signs of
toxicity, signs of irritation; and body weight and food consumption were recorded. The male rats
were sacrificed after completion of the cohabitation period. The testes, epididymides, seminal
vesicles, prostate gland, pituitary gland and brain were weighed. The left testis and epididymis
were used for evaluation of the spermatozoa, testicular spermatid count and concentration, and
cauda epididymal spermatozoa count, concentration and motility, and evaluation of the
epididymal fluid for debris and unexpected cell types. The right testis, epididymis, seminal
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vesicle, prostate gland, pituitary gland and gross lesions were processed for histopathological
examination.
The females were examined for viability and clinical signs of toxicity. Body weight and food
consumption were recorded. On day 14 of gestation, the females were sacrificed and a gross
necropsy was performed; the uterus was examined for pregnancy, number and distribution of
implantations, early resorptions and live and dead embryos. The number of corpora lutea in each
ovary was recorded for the non-pregnant females.
No deaths and no skin reactions were caused by the test substance. An increase in a number of
pale rats was seen a 50 and 250 mg/kg-day. One rat at 250 mg/kg-day had small, pale seminal
vesicles and prostate and small pituitary. Decreased absolute prostate weights were seen at
>10 mg/kg-day. There was a reduced body weight gain at >10 mg/kg-day. Absolute and relative
food consumption was reduced (p<0.05 to p<0.01) at >50 mg/kg-day. Mating and fertility
parameters were unaffected by the treatment. The females assigned to cohabitation with male
rats were unaffected by treatment in relation to clinical signs, necropsy observations or average
body weights, body weight gains or food consumption values. Litter averages for corpora lutea,
implantations and live embryos; resorptions were not significantly different among the dose
groups. There were no dead embryos and no dams resorbed all conceptuses. .
CASRN 64741-62-4 did not induce dominant lethal mutation in this assay.
Additional Information
Skin Irritation
Subcategory I: Residual Fuel Oils
Fuel oil, No. 6 (CASRN 68553-00-4)
New Zealand White rabbits (3/sex) were administered four different samples of undiluted
(0.5 mL each) CASRN 68553-00-4 (Heavy Fuel oil, No. 6 (API 78-6, 78-7, 78-8, 79-2;) to the
intact and abraded skin of each rabbit under occluded conditions for 24 hours. After 24 hours,
any excess test substance was removed by wiping. Erythema and edema was minimal for three
samples (API 78-6, 78-7 and 78-8). Sample API 79-2 caused severe erythema in one rabbit that
was resolved by 72 hours. In another animal, API 79-2 caused minimal erythema at 24 hours but
its severity increased by 72 hours. The average primary irritation scores were 0.35, 0.73, 0.27
and 1.54 for API 78-6, 78-7, 78-8 and 79-2, respectively.
CASRN 68553-00-4 was irritating to rabbit skin in this study.
Subcategory II: Atmospheric Residual
Residues (petroleum), atm. tower (CASRN 64741-45-3)
New Zealand rabbits (6, sex not indicated) were administered 0.5 mL of undiluted
CASRN 64741-45-3 (Residues (petroleum), atm. Tower; Atmospheric residue) to the intact skin
under occluded conditions for 24 hours and observed for 7 days after application. After
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24 hours, any excess test substance was removed by wiping. Edema was observed in all animals
after 24 hours. Erythema was observed after 72 hours; however, it could not be assessed
properly due to the staining nature of the test substance. The primary irritation score was 3.5.
CASRN 64741-45-3 was irritating to rabbit skin in this study.
Subcategory III: Atmospheric Distillate
Diesel fuel No. 2 (CASRN 68476-34-6, supporting chemical)
In the 4-week study in Sprague-Dawley rats, described previously in the acute dermal toxicity
section, skin irritation occurred at >0.5 mL/kg-day.
CASRN 68476-34-6 was irritating to rat skin in this study.
Subcategory IV: Vacuum Residual
Residues (petroleum) vacuum (CASRN 64741-56-6, supporting chemical)
Six New Zealand rabbits (sex not reported) were administered 0.5 mL for undiluted
CASRN 64741-56-6 (Residues (petroleum) vacuum) to intact and abraded skin under occluded
conditions for 24 hours and observed for 7 days. At 24 and 72 hours after application, erythema
was seen. However, due to dark staining of the skin at the application site, it was difficult to
assess erythema properly. The primary irritation index was 0.18. Edema was not observed at
either abraded or intact skin sites. Signs of irritation had resolved by day 4.
CASRN 64741-56-6 was irritating to rabbit skin in this study.
Subcategory V: Vacuum Distillate
Residues (petroleum), heavy vacuum (CASRN 64741-57- 7)
Rabbits (3/sex, unspecified strain) were administered 0.5 mL of undiluted CASRN 64741-57-7
(Residues (petroleum), heavy vacuum gas oil) to six sites on the right and left flanks of each
under occluded (4 hours and 24 hours) and non-occluded (24 hours) conditions. After 24 hours,
any excess test substance was removed by wiping. Animals were observed for 7 days after
application. At 24 hours, irritation scores ranged from 2.2 for occluded sites and 2.7 for non-
occluded sites.
CASRN 64741-57-7 was irritating to rabbit skin in this study.
Gas oils (petroleum), hydrodesulfurized heavy vacuum (CASRN 64742-86-5)
New Zealand White rabbits (3/sex) were administered 0.5 mL of undiluted CASRN 64742-86-5
(Hydrosulfurized heavy vacuum gas oil) to the intact and abraded skin of each rabbit under
occluded conditions for 24 hours. Animals were observed for up to 6 days after application.
Very slight to well-defined erythema was observed during the course of the study. By day 6, all
irritation scores were zero. The average primary irritation index was 0.17. Additional details are
from TSCATS (OTS0513402).
CASRN 64742-86-5 was irritating to rabbit skin in this study.
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Subcategory VI: Cracked Residual
Clarified oils (petroleum), catalytic cracked (CASRN 64741-62-4)
Six rabbits (unspecified strain) were administered 0.5 mL of undiluted CASRN 64741-62-4
(Clarified oils (petroleum), catalytic cracked (API 81-15)) to intact and abraded skin of each
rabbit under occluded conditions for 24 hours; animals were observed for 7 days after
application. After 24 hours the treated skin was wiped to remove any residue of the test
substance. The primary irritation index based on 24 and 72 hours scores was 0.2. The irritation
increased gradually on the later observation days. It is concluded in the robust summary that the
tar-like nature of the test substance, it was not all removed from the application sites following
the 24-hour exposure period. The remaining test substance was probably responsible for the
increased dermal irritation observed at the 7 day observation period.
CASRN 64741-62-4 was irritating to rabbit skin in this study.
Subcategory VII: Cracked Distillate
Cracked distillate (CASRN 64741-81-7)
(1) Six New Zealand White rabbits (sex not reported) were administered 0.5 mL of undiluted
CASRN 64741-81-7 (Cracked distillates) to intact and abraded skin of each rabbit under
occluded conditions for 24 hours. After 24 hours the treated skin was wiped to remove any
residue of the test substance. The primary irritation index was 5.1 for intact skin and 5.6 for
abraded skin. Erythema and edema were observed for both intact and abraded skin immediately
following exposure.
CASRN 64741-81-7 was irritating to rabbit skin in this study.
(2) Six rabbits (3/sex; strain not reported) were administered 0.5 mL of undiluted
CASRN 64741-81-7 (Visbreaker Gas Oils, 3 samples—Visbreaker HGO, Vis gas oil VIBRA and
VB Mittelol) to intact and abraded skin sites (total six sites on each rabbit). The three sites on
the right flank were abraded and the three sites on the left flank remained intact. The anterior
and middle test sites were occluded and the posterior sites were left unoccluded. Following a
4-hour exposure period, the anterior sites were wiped to remove excess test substance and after
24 hours, the middle and posterior sites were wiped of excess test substance and were evaluated
for irritation. Average 4-hour (occluded) erythema and edema scores were 1.3 to 1.9 and 1.0 to
1.2, respectively. Average 24-hour (occluded) primary irritation index was 2.4 to 3.6.
CASRN 64741-81-7 was irritating to rabbit skin in this study.
(3) Six New Zealand White rabbits (sex not reported) were administered 0.5 mL of undiluted
CASRN 64741-81-7 (Vacuum tower bottoms) to intact and abraded skin of each rabbit under
occluded conditions for 24 hours. After 24 hours the treated skin was wiped to remove any
residue of the test substance. It was difficult to read erythema due to the staining of the skin at
the application sites; the erythema was scored adjacent to the patch test site. The primary
irritation index was 0.18.
CASRN 64741-81-7 was not irritating to rabbit skin in this study.
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Eye Irritation
Subcategory I: Residual Fuel Oils
Fuel oil, No. 6 (CASRN 68553-00-4)
Nine New Zealand rabbits were instilled 0.1 mL of undiluted CASRN 68553-00-4 (Heavy fuel
oil) on the everted lower eyelid of the right eye. The test eyes of three rabbits were rinsed with
warm distilled water for lminutes following 30 seconds exposure. The test eyes of other rabbits
remained unwashed. Ocular irritation was observed at 24, 48 and 72 hours after treatment. Four
different samples (API 78-6, 78-7, 78-8 and 79-2) were tested following the same protocol; for
two samples the observation period was extended until no irritation was seen. Irritation was
scored by the method of Draize. The average 24-hour irritation scores ranged from 2.67 to 7.67
for washed eyes and 4.0 to 7.33 for unwashed eyes.
CASRN 68553-00-4 was irritating to rabbit eyes in this study.
Subcategory II: Atmospheric Residual
Residues (petroleum), atmospheric (CASRN 64741-45-3)
Three male New Zealand White rabbits were instilled undiluted (0.1 mL) CASRN64741-45-3
(Residues (petroleum), atmospheric) in the conjunctival sac of the right eye and ocular irritation
was observed at 1, 24, 48 and 72 hours. There was no evidence of damage to the iris. Average
eye irritation scores at 24 and 72 hours were 0.
CASRN64741-45-3 was not irritating to rabbit eyes in this study.
Subcategory IV: Vacuum Residual
Residues (petroleum), vacuum (CASN 64741-56-6)
Twelve New Zealand White rabbits were instilled undiluted (0.1 mL) CASRN 64641-56-6
(Residues (petroleum), vacuum) onto the corneal surface of the right eye and ocular irritation
was observed at 1, 24, 48 and 72 hours after treatment and again at 4, 7, 10 and 14 days after
treatment. Half of the treated eyes were flushed with water 20-30 seconds after instillation of
the test substance. Irritation was scored by the method of Draize. Conjunctival redness and
swelling were observed. No corneal opacity or iritis was observed. The test substance was non-
irritating in unrinsed eyes and minimally irritating in rinsed eyes.
64641-56-6 was not irritating to rabbit eyes in this study.
Subcategory V: Vacuum Distillate
Residues (petroleum), heavy vacuum (CASRN 64741-57-7)
Six rabbits (3/sex; strain not reported) were instilled 0.1 mL of undiluted CASRN 64741-57-7
(Heavy vacuum gas oil)) into the conjunctival sac of the left eye and ocular irritation was
observed at 1, 24, 48 and 72 hours after treatment. Irritation was scored by the method of
Draize. Conjunctival redness and swelling were observed. No corneal opacity or iritis was seen.
The Irritation score for heavy vacuum gas oil at 24 hours was 10.3.
CASRN 64741-57-7 was irritating to rabbit eyes in this study.
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Gas oils (petroleum), hydrodesulfurized heavy vacuum (CASRN 64742-86-5)
Six New Zealand White rabbits were instilled 0.1 mL of CASRN 64742-86-5 (Hydrosulfurized
heavy vacuum gas oil) in to the right eyes; the left eyes served as controls. Test eyes remained
unwashed and rabbits were observed for up to 7 days. Positive ocular responses were observed
at 1 and 24 hours, but all symptoms resolved by 72 hours. The average Draize score at 24 hours
was 12.6. Additional details are from TSCATS (OTS0513402).
CASRN 64742-86-5 was irritating to rabbit eyes in this study.
Subcategory VI: Cracked Residual
Clarified oils (petroleum), catalytic cracked (CASRN 64741-62-4)
Nine rabbits (sex and strain not noted) were instilled 0.1 mL of undiluted CASRN 64741-62-4
(Clarified oils (petroleum), catalytic cracked (API 81-15)) to the corneal surface of one eye and
ocular irritation was observed at 1, 24, 48 and 72 hours and 7 days after treatment. After
30 seconds, the treated eyes of three rabbits were washed with water for 1 minute. Eyes of the
other 6 rabbits were not washed. Irritation was scored by the method of Draize. The presence of
brown or light brown test material was noticeable at the observation and scoring. Signs of
irritation abated by 24 hours, after which time, eyes were normal.
CASRN 64741-62-4 was irritating to rabbit eyes in this study.
Subcategory VII: Cracked Distillate
Cracked distillate (CASRN 64741-81-7)
(1) Twelve New Zealand White rabbits (sex not noted) were instilled 0.1 mL of undiluted
CASRN 64741-81-7 (Cracked distillates; F97-01) onto the corneal surface of the right eye and
ocular irritation was observed at 1, 24, 48 and 72 hours and 7 days after treatment. In half of the
rabbits, the treated eyes were flushed for 1 minute with lukewarm water. Conjunctival redness
and swelling were observed. All signs of irritation cleared by 72 hours.
CASRN 64741-81-7 was not irritating to rabbit eyes in this study.
(2) Six rabbits (3/sex; strain not reported) were instilled 0.1 mL of undiluted
CASRN 64741-81-7 (Visbreaker gas oils, 3 samples—Visbreaker heavy gas oil, Vis gas oil
VIBRA and VB Mittelol) into the conjunctival sac of the left eye and ocular irritation was
observed at 1, 24, 48 and 72 hours after treatment. Irritation was scored by the method of
Draize. Conjunctival redness and swelling were observed. No corneal opacity or iritis was seen.
Irritation scores at 24 hours were 1.7 to 5.3.
CASRN 64741-81-7 was irritating to rabbit eyes in this study.
Sensitization
Subcategory I: Residual Fuel Oils
Fuel oil, No. 6 (CASRN 68553-00-4)
(1) Ten Guinea pigs (sex not indicated) were administered 0.5 mL of undiluted
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CASRN 68553-00-4 (four different heavy fuel oil samples (API 78-6, API 78-7, API 78-8 and
API 79-2)) to shorn skin for 6 hours/day, once a week for 3 weeks under occluded conditions
(Induction phase). After a 2-week rest period, the treated animals were challenged with 0.5 mL
of undiluted heavy fuel oils on different application sites. Dinitrochlorobenzene (DNCB) in
ethanol was used a positive control. Skin reactions were graded for erythema and edema 24
hours after each dose. Three of the samples (API 78-6, API 78-8 and API 79-2) were not skin
sensitizers since the degree of response to the challenge dose was less than that for the positive
controls. One sample (API 78-7) was mildly sensitizing.
CASRN 68553-00-4 was sensitizing to guinea pigs in this study.
(2) Six Guinea pigs (sex not indicated) were administered 0.5 mL of undiluted
CASRN 68553-00-4 (heavy fuel oil (F-74-01) to the shaved skin, for 6 hours/day, once a week
for 3 weeks, under occluded conditions (Induction phase). After a 2-week rest period, the treated
animals were challenged with 0.5 mL of undiluted heavy fuel oils on different application sites.
DNCB in ethanol was used a positive control. Skin reactions were graded for erythema and
edema 24 and 48 hours after each induction and challenge dose. During the induction phase,
only 4 out of 10 animals had severity of 0 - 0.4 compared to 10 out of 10 positive control animals
with severity 2.3-3.1. Treated animals did not show any signs of irritation during the challenge
phase.
CASRN 68553-00-4 was not sensitizing to guinea pigs in this study.
Subcategory II: Atmospheric Residual
Residues (petroleum), atm. tower (CASRN 64741-45-3)
Ten guinea pigs (sex not reported) were administered 0.5 mL of undiluted CASRN 64741-45-3
(Atmospheric residues (petroleum), atm. Tower, F-132) to shaved skin for 6 hours/day, once a
week for 3 weeks under occluded conditions (Induction phase). After a 2-week rest period, the
treated animals were challenged with 0.5 mL of undiluted heavy fuel oils on different application
sites. DNCB in ethanol was used a positive control. Skin reactions were graded for erythema
and edema 24 and 48 hours after each induction and challenge dose. None of the test animals
became sensitized following treatment. A positive control responded appropriately.
CASRN 64741-45-3 was not sensitizing to guinea pigs in this study.
Subcategory IV: Vacuum Residual
Residues (petroleum), light vacuum (CASRN 68512-62-9)
Ten guinea pigs (sex not reported) were administered 0.5 mL of undiluted CASRN 68512-62-9
(vacuum tower bottoms or vacuum residues) to shaved skin for 6 hours/day, once a week for 3
weeks under occluded conditions (Induction phase). After a 2-week rest period, the treated
animals were challenged with 0.5 mL of undiluted heavy fuel oils on different application sites.
DNCB in ethanol was used a positive control. Skin reactions were graded for erythema and
edema 24 and 48 hours after each induction and challenge dose. None of the test animals
became sensitized following treatment. A positive control responded appropriately.
CASRN 68512-62-9 was not sensitizing to guinea pigs in this study.
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Subcategory V: Vacuum Distillate
Residues (petroleum), heavy vacuum (CASRN 64741-57-7)
Ten guinea pigs (sex not reported) were administered 0.5 mL of undiluted CASRN 64741-57-7
(Heavy Vacuum Gas Oil, HVGO) to shaved skin for 6 hours/day, once a week for 3 weeks under
occluded conditions (Induction phase). After a 2-week rest period, the treated animals were
challenged with 0.5 mL of undiluted heavy fuel oils on different application sites. DNCB in
ethanol was used a positive control. Skin reactions were graded for erythema and edema 24 and
48 hours after each induction and challenge dose. None of the test animals became sensitized
following treatment. A positive control responded appropriately.
CASRN 64741-57-7 was not sensitizing to guinea pigs in this study.
Subcategory VI: Cracked Residual
Clarified oils (petroleum), catalytic cracked (CAS No. 64741-62-4)
Ten male Guinea pigs were administered 0.4 mL of undiluted CASRN 64741-62-4 (Cracked
residue, API 81-15) to shaved skin for 6 hours/day, once a week for 3 weeks under occluded
conditions (Induction phase). After a 2-week rest period, the treated animals were challenged
with 0.4 mL of undiluted heavy fuel oils on different application sites. DNCB in ethanol was
used a positive control. Skin reactions were graded for erythema and edema 24 and 48 hours
after each induction and challenge dose. None of the test animals became sensitized following
treatment. A positive control responded appropriately.
During the induction phase of the study, dermal irritation included very slight edema and very
slight to well defined erythema. No dermal irritation was exhibited by either the test group or
naive controls following challenge application. A positive control responded appropriately.
CASRN 64741-62-4 was not sensitizing to guinea pigs in this study.
Subcategory VII: Cracked Distillate
Distillates (petroleum), heavy thermal cracked (CASRN 64741-81-7)
Ten male Guinea pigs were administered 0.5 mL of undiluted CASRN 64741-81-7 (Cracked
distillate) to shaved skin for 6 hours/day, once a week for 3 weeks under occluded conditions
(Induction phase). After a 2-week rest period, the treated animals were challenged with 0.5 mL
of undiluted heavy fuel oils on different application sites. DNCB in ethanol was used a positive
control. Skin reactions were graded for erythema and edema 24 and 48 hours after each
induction and challenge dose. None of the test animals became sensitized following treatment.
A positive control responded appropriately.
CASRN 64741-81-7 was not sensitizing to guinea pigs in this study.
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Carcinogenicity
Subcategory VI: Cracked Residual
Clarified oils (petroleum), catalytic cracked (CAS No. 64741-62-4)
(1) In a Lifetime Dermal Carcinogenicity/Chronic Toxicity Screening Bioassay, 50 [j,L CASRN
64741-62-4 (Clarified oils (petroleum), catalytic cracked (API 81-15)), diluted in toluene, was
applied to the shaved backs of C3H mice (50 males/dose) at 0, 0.1, 1 or 10% twice/week for their
lifetime. Vehicle (toluene) and positive controls (benzo-a-pyrene in toluene) were also tested.
By week 52, ninety-four percent of the high-dose mice died. Neoplasms occurred in all
treatment groups and toluene controls. Several neoplastic legions were observed in the non-
dermal tissues of mice. Six types of neoplasms were observed at the dermal test sites in mice of
the treated groups. These included fibromas, papillomas, hemangiomas, fibrosarcomas,
squamous cell carcinomas and malignant melanomas; the first three being benign neoplasms.
Metastatic tumors (squamous cell carcinoma and fibrosarcoma) were observed at > 1% groups.
Additional details are from TSCATS (OTS0000426-8).
CASRN 64741-62-4 - increased tumor incidence in this study.
(2) During a 28-week dermal tumorigenicity bioassay (to assess the initiation/promotion
potential), 50 [j,L 1% (diluted in toluene) CASRN 64741-42-4 (Clarified oils (petroleum),
catalytic cracked (API 81-15)) (was applied to the shaved back of 30 male CD-I mice twice
weekly for 25 weeks following a pre-treatment with 1 mg/mL dimethyl benzantahracene
(DMBA) for 1 week and a 2-week rest period. Negative, vehicle and positive controls were also
tested. Time to first tumor appearance was significantly reduced in treated mice, but the
incidence and total number of clinically observed masses increased. However, the incidence of
histologically confirmed neoplasms was comparable to controls. Additional details are from
TSCATS (OTS0000547-1).
CASRN 64741-62-4 - increased tumor incidence in this study.
Pitch, petroleum, arom (CAS No. 68187-58-6)
In a mouse skin-painting assay, CASRN 68187-58-6 (pitch petroleum, aromatic) was applied in
toluene to the shaved backs of 40 male C3H mice at 1850 mg/kg, twice/week for 109 weeks. A
group of 40 additional rats served as vehicle controls and another group of 20 rats received
similar treatment with a positive control (~ 5.5 mg/kg benzo(a)pyrene /week). Based on gross
pathology, treated rats exhibited a greater incidence of malignant tumors than controls. The
study histopathology characterized the benign tumors primarily as papillomas and
keratoacanthomas, and the malignant tumors as squamous cell carcinomas. Less predominant
neoplastic lesions in the treated animals were a hemangioma, a fibrosarcoma and a basal cell
carcinoma. Additional details are from TSCATS (OTS204860).
CASRN 68187-58-6 - increased tumor incidence in this study.
Subcategory VII: Cracked Distillate
Distillates (petroleum), heavy catalytic cracked (CAS No. 64741-61-3)
(1) In a mouse skin painting test, one hundred female CD-I mice received 20 mg of
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CASRN 64741-61-3 (distillates (petroleum), heavy catalytic cracked) dermally 3 times/week for
up to 193 days (sacrificed because moribund). Treated mice (81%) developed a greater number
of skin tumors (squamous cell carcinoma, papilloma, basal cell carcinoma) than controls (0.5%).
Additional details are from TSCATS (OTS200438).
CASRN 64741-61-3 - increased tumor incidence in this study.
(2) In a mouse skin painting test, CD-I mice (25/sex) received 20 mg CASRN 64741-61-3 (of
distillates (petroleum), heavy catalytic cracked) dermally 3 times/week for up to 11 months
sacrificed because moribund). Treated mice (80% males and females) developed a greater
number of skin tumors (squamous cell carcinoma, papilloma) than controls (1.3% males,
0% females). Additional details are from TSCATS (OTS200438).
CASRN 64741-61-3 - increased tumor incidence in this study.
Conclusion:
Subcategory I: Residual Fuel Oils
The acute oral toxicity to rats and acute dermal toxicity to rabbits of CASRN 68553-00-4 is low,
while the acute inhalation toxicity to rats for CASRN 68476-33-5 is moderate. In a 28-day
repeated-dose dermal toxicity study in rats with CASRN 68476-33-5, the following systemic
effects were observed at the lowest tested dose of 480 mg/kg-day: increased liver and spleen
weights and decreased hemoglobin and hematocrit values. The NOAEL is not established. No
data are available for reproductive and developmental toxicity. CASRN 68553-00- 4 was not
mutagenic in bacteria but was mutagenic in mammalian cells in vitro. CASRN 68553-00-4
induced chromosomal aberrations in rat bone marrow cells in vivo. CASRN 68553-00-4 was
irritating to rabbit skin and eyes and sensitizing to guinea pigs skin.
Subcategory II: Atmospheric Residual
The acute oral toxicity to rats and acute dermal toxicity to rabbits of CASRN 64741-45-3 is low.
Following a 4-week dermal exposure of rats to CASRN 64741-45-3, no systemic effects were
noted. The NOAEL is 940 mg/kg-day (highest dose tested). Data for reproductive toxicity are
not available. The prenatal developmental toxicity study in rats, via the dermal route with
CASRN 64741-45-3, was conducted with fewer rats (10-15/dose) than recommended by the
guidelines; but the study is acceptable. The study provided LOAELs of 1000 mg/kg-day and
NOAELs of 333 mg/kg-day for both maternal and developmental toxicity. The maternal effects
include a significant decrease in gestational body weights and significantly increased gestational
length. The developmental effects include significantly decreased pup body weights. No data
are available for gene mutation or chromosomal aberrations endpoints. CASRN 64741-45-3 was
irritating to rabbit skin, not irritating to rabbit eyes and not-sensitizing to guinea pig skin.
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Subcategory III: Atmospheric Distillate
The acute dermal toxicity of CASRN 68476-34-6 (supporting chemical stream) to rabbits is low.
A 13-week dermal toxicity study conducted in rats with CASRN 68915-97-9 (supporting
chemical stream), showed a LOAEL of 125 mg/kg-day based on effects on clinical chemistry
(increased BUN, cholesterol, sorbitol dehydrogenase, total protein, globulin and decreased A/G
ratio) and hematology (decreased RBC, hemoglobin, hematocrit and platelets) parameters and
relative organ weights (liver, thymus, adrenals, heart, kidney, spleen). The NOAEL is 30 mg/kg-
day. No reproductive toxicity data are available.
A total of five pre-natal developmental toxicity studies were performed using both sponsored
chemicals on one supporting chemical; all studies used the dermal route of exposure. In a
prenatal dermal developmental toxicity study of CASRN 68410-00-4 in rats (25/dose), the
LOAEL for maternal toxicity is 250 mg/kg-day based on significantly decreased body weights
and body weight gains; the NOAEL is 50 mg/kg-day. No developmental effects were seen in
this study; the NOAEL for developmental toxicity is 500 mg/kg-day (highest dose tested).
In two other prenatal dermal developmental toxicity studies with CASRN 68410-00-4 using
fewer animals (12-19/dose) and having different compositions of polyaromatic compounds
(PACs), the range for LOAELs for maternal toxicity is 250 to 500 mg/kg-day and that for
developmental toxicity is 125 to 150 mg/kg-day. The maternal effects include decreased body
weight, body weight gain and food consumption. The developmental effects include decreased
pup weights. The NOAELs for maternal toxicity range from 125 to 150 mg/kg-day and
NOAELs for developmental toxicity range from "not established" to 50 mg/kg-day. In another
prenatal dermal developmental toxicity study of CASRN 68783-08-4 in rats, conducted using
fewer animals (12-19/dose), the LOAEL for both maternal and developmental toxicity is 250
mg/kg-day. The maternal effects include significant decreases in body weights, body weight
gains and food consumption and developmental effects include significantly decreased number
of total and live pups delivered, decreased pup body weights and incomplete ossification. The
NOAEL for maternal and developmental toxicity is 50 mg/kg-day. For the supporting chemical
stream CASRN 68915-97-9, the LOAEL for maternal and developmental toxicity is 125 mg/kg-
day; the NOAEL is 30 mg/kg-day. The maternal effects include decreased body weight, body
weight gains and food consumption. Developmental effects include decreased total and live
pups delivered, decreased pup body weights and incomplete ossification. No data are available
for gene mutation or chromosomal aberrations endpoints. CASRN 68476-34-6 (supporting
chemical stream) was irritating to rabbit skin.
Subcategory IV: Vacuum Residual
There were no data available on either of the two sponsored chemicals. The acute oral toxicity to
rats and acute dermal toxicity to rabbits of CASRN 64741-56-6 (supporting chemical stream) is
low; and the acute inhalation toxicity to rats is moderate. In the 4-week repeated-dose dermal
toxicity study of CASRN 64741-56-6 (supporting chemical stream) in rabbits, the LOAEL of
2000 mg/kg-day is based on decreased body weight gains and decreased alkaline phosphatase
activity in male rabbits. The NOAEL is 1000 mg/kg-day. No reproductive or developmental
toxicity data are available. CASRN 64741-56-6 (supporting chemical stream) was mutagenic in
bacteria in vitro. No data for chromosomal aberrations are available. CASRN 64741-56-6
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(supporting chemical stream) was irritating to rabbit skin but not to rabbit eyes. CASRN 68512-
62-9 was not sensitizing to guinea pig skin.
Subcategory V: Vacuum Distillate
The acute oral toxicity to rats and acute dermal toxicity to rabbits of CASRN 64741-57-7 is low.
A 13-week dermal toxicity study in rats with CASRN 64741-57-7 showed a LOAEL of 125
mg/kg-day based on effects on hematological parameters (decreased RBC count, hemoglobin,
hematocrit and platelets). The NOAEL is 30 mg/kg-day. No reproductive toxicity data are
available. A number of prenatal developmental toxicity studies were conducted via dermal
exposure to CASRN 64741-57-7. In one study in rats (25/dose), CASRN 64741-57-7 showed a
LOAEL of 75 mg/kg-day for maternal toxicity based on significantly decreased body weights
and body weight gains; the NOAEL is not established. The developmental toxicity LOAEL is 75
mg/kg-day based on significantly decreased pup body weight, increased incidence of
microphthalmia and delayed ossifications; the NOAEL is not established. In another study in
rats (25/dose), CASRN 64741-57-7 showed a LOAEL of 100 mg/kg-day for maternal toxicity
based on significantly decreased body weights and body weight gains; a NOAEL of 50 mg/kg-
day. The developmental toxicity LOAEL is 250 mg/kg-day based on significantly decreased pup
body weight, and increased variations in fetal skeletal ossifications; the NOAEL is 100 mg/kg-
day. Several similar studies with CASRN 64741-57-7 using fewer animals
(10-20/dose) and varying compositions of PACs showed similar effects with LOAELs ranging
from 150 to 500 mg/kg-day for both maternal and developmental toxicity. The range for
NOAELs is 1 to 125 mg/kg-day. Additional maternal effects in these studies were vaginal red
discharge, effects on thymus and decreased numbers of implantation sites. In a prenatal
developmental toxicity study in rats via the dermal route with CASRN 64742-86-5 conducted
with fewer animals (12-15/dose), the LOAEL for maternal and developmental toxicity is 333
mg/kg-day based on significantly decreased body weights and body weight gains for maternal
toxicity and significantly decreased pup body weight and dead pups delivered for developmental
toxicity. The NOAEL is 50 mg/kg-day. No data for gene mutation are available; CASRN
65741-57-7 did not induce micronuclei when tested in vivo. CASRNs 64741-57-7 and 64742-
86-5 were irritating to rabbit skin and eyes and CASRN 64741-57-7 was non-sensitizing to
guinea pig skin.
Subcategory VI: Cracked Residual
The acute oral toxicity to rats and acute dermal toxicity to rabbits of CASRN 64741-62-4 is low.
There were several repeated-dose toxicity studies in rats via the dermal route with CASRN
64741-62-4. In a 13-week study, a LOAEL of 8 mg/kg-day was based on effects on the liver and
thymus (increased liver weights and decreased thymus weight and histopathological findings),
body weight and body weight gains, and/or effects on hematology and clinical chemistry
parameters. The NOAEL was not established. Similar effects were seen in several 28-day
studies with a lowest LOAEL of 10 mg/kg-day and NOAEL not established. One of the 28-day
studies also showed microscopic changes in the skin (sub-acute acanthotic dermatitis, minimal to
severe early multifocal papillomatosis (skin surface elevation caused by hyperplasia and
enlargement of contiguous dermal papillae)) at 2000 mg/kg-day. For CASRN 64741-75-9, a 28-
day dermal toxicity study in rats resulted in a NOAEL of 210 mg/kg-day, the highest dose tested.
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A 13-week dermal toxicity study with CASRN 64741-80-6 showed a LOAEL of 60 mg/kg-day
based on effects on liver, adrenals and alanine amino transferase; the NOAEL is not established.
No reproductive toxicity data are available. A dominant lethal assay in rats (treated male rats
mated with untreated females) showed no effects. In a prenatal developmental toxicity study of
CASRN 64741-62-4 in rats (24/dose) via the dermal route, the LOAEL for maternal toxicity is
1.0 mg/kg-day based on increased vaginal red discharge, significantly decreased body weights
and food consumption; the NOAEL is 0.05 mg/kg-day. The LOAEL for developmental toxicity
is 1.0 mg/kg-day; the effects include increased resorptions, decreased number of live fetuses,
decreased body weights and increased incidence of fetal variations (moderate dilation of renal
pelvis, slight dilation of lateral ventricle of brain, bifid thoracic vertebral centrum and decreased
average number of ossified caudal vertebrae). The NOAEL for developmental toxicity is 0.05
mg/kg-day. Several other studies are conducted using fewer animals (10-15/dose) than that is
recommended by guidelines. For CASRN 64741-62-4 with varying compositions of PACs, the
range of LOAEL values for maternal toxicity is 4 to 100 mg/kg-day. The effects include
decreased body weights and body weight gains, food consumption, increased vaginal discharge,
increased gestational length, and/or thymus atrophy. The range for LOAEL values for
developmental toxicity in these studies is 4 to 250 mg/kg-day. The effects include decreased pup
body weights, decreased number of pups delivered per litter, increased resorptions, decreased
number of male pups, decreased crown-rump length and/or fetal alterations. The range for
NOAELs for maternal toxicity and developmental toxicity is 'not established' to 10 mg/kg-day.
CASRN 64741-62-4 was not mutagenic in mammalian cells in vitro and did not induce
chromosomal aberrations in vivo; however, it induced sister chromatid exchanges in vitro and
unscheduled DNA synthesis in vitro and in vivo. CASRN 64741-62-4 did not induce dominant
lethal mutation in rat germ cells. CASRN 64741-62-4 was irritating to rabbit skin and eyes and
was not sensitizing to guinea pigs skin. CASRNs 64741-62-4 and 68187-58-6 increased tumor
incidences in mice.
Subcategory VII: Cracked Distillate
The acute oral toxicity to rats and acute dermal toxicity to rabbits of CASRN 64741-81-7 is low.
Among several 13-week repeated-dose dermal toxicity studies in rats conducted with CASRN
64741-81-7 with varying composition of PACs, the range of LOAEL values is 30 to 125 mg/kg-
day. The systemic effects include decreased body weights, increased relative testes weights,
decreased epididymis weights and/or decreased hematocrit and MCH values. The range of
NOAEL values is 'not established' to 30 mg/kg-day. In two 28-day repeated-dose dermal
toxicity studies in rats with CASRN 64741-81-7, the LOAEL range is 93 - 930 mg/kg-day based
on effects on liver and hematology parameters. The NOAEL range is 9.3 to 93 mg/kg-day. A
28-day repeated-dose dermal toxicity study of CASRN 64741-61-3 in rats showed a LOAEL of
99 mg/kg-day based on effects on liver weights and hematology parameters. The NOAEL is 9.9
mg/kg-day. No data are available on reproductive toxicity. All developmental toxicity studies
for this subcategory are conducted via dermal route and using fewer animals (10-15/dose) than
recommended by the guidelines. For CASRN 64741-81-7 with varying compositions of PACs,
the range of LOAEL values for maternal toxicity is 8 to 250 mg/kg-day. The effects include
decreased body weights and body weight gains, increased vaginal discharge, effects on clinical
chemistry parameters, and/or increased absolute and decreased relative liver and thymus weights.
The range of NOAEL values for maternal toxicity is 'not established' to 125 mg/kg-day. The
101
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
range for LOAEL values for developmental toxicity is 8 to 125 mg/kg-day. The effects include
decreased pup body weights, decreased number of pups delivered per litter, increased
resorptions, decreased litter size and/or fetal anomalies and skeletal variations. The range of
NOAEL values for developmental toxicity is 'not established' to 30 mg/kg-day. No data are
available for gene mutation and chromosomal aberrations. CASRN 64741-81-7 was irritating to
rabbit skin and eyes; it was not sensitizing to guinea pigs skin. CASRNs 64741-61-3 increased
tumor incidences in mice.
Subcategory VIII: Reformer Residual
There were no data for any endpoints for this subcategory.
102
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 4. Summary of Screening Information Data Set under the U.S. HPV Challenge Program - Human Health Data
Subcategory I: Residual Fuel Oils
Subcategory II: Atmospheric Residual
Endpoint
SPONSORED
CHEMICAL
Fuel oil, residual
(68476-33-5)
SPONSORED
CHEMICAL
Fuel oil, No. 6
(68553-00-4)
SPONSORED
CHEMICAL
Residues
(petroleum),
atm. tower
(64741-45-3)
SPONSORED
CHEMICAL
Residues
(petroleum),
hvdro-
dcsulfurizcd
atmospheric
(64742-78-5)
SPONSORED
CHEMICAL
Residues
(petroleum),
atmospheric
(68333-22-2)
SPONSORED
CHEMICAL
Residues
(petroleum),
topping plant,
low-sulfur
(68607-30-7)
SPONSORED
CHEMICAL
Residues
(petroleum),
atm. tower, light
(70592-79-9)
SPONSORED
CHEMICAL
Fuel oil,
residues-
straight-run gas
oils, high sulfur
(68476-32-4)
Acute Oral Toxicity
LDso (mg/kg)
No Data
5880
(RA)
5880
>5000
No Data
>5000
(RA)
No Data
>5000
(RA)
No Data
>5000
(RA)
No Data
>5000
(RA)
No Data
> 5000
(RA)
Acute Inhalation
Toxicity
LC50 (mg/L)
4.1-4.5
No Data
4.1-4.5
(RA)
-
-
-
-
-
-
Acute Dermal Toxicity
LD50 (mg/kg)
No Data
>4874
(RA)
>4874
>2000
No Data
>2000
(RA)
No Data
>2000
(RA)
No Data
>2000
(RA)
No Data
>2000
(RA)
No Data
>2000
(RA)
Repeated-Dose Toxicity
NOAEL/LOAEL
Dermal (mg/kg-day)
NOAEL = NE
LOAEL = 480
No Data
NOAEL = NE
LOAEL = 480
(RA)
NOAEL = 940
(Highest dose
tested)
No Data
NOAEL = 940
(RA)
No Data
NOAEL = 940
(RA)
No Data
NOAEL = 940
(RA)
No Data
NOAEL = 940
(RA)
No Data
NOAEL = 940
(RA)
Reproductive Toxicity
NOAEL/LOAEL
Oral (mg/kg-day)
No Data
No Data
No Data
No Data
No Data
No Data
No Data
No Data
103
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 4. Summary of Screening Information Data Set under the U.S. HPV Challenge Program - Human Health Data
Subcategory I: Residual Fuel Oils
Subcategory II: Atmospheric Residual
Endpoint
SPONSORED
CHEMICAL
Fuel oil,
residual
(68476-33-5)
SPONSORED
CHEMICAL
Fuel oil, No. 6
(68553-00-4)
SPONSORED
CHEMICAL
Residues
(petroleum),
atm. tower
(64741-45-3)
SPONSORED
CHEMICAL
Residues
(petroleum),
hvdro-
dcsulfurizcd
atmospheric
(64742-78-5)
SPONSORED
CHEMICAL
Residues
(petroleum),
atmospheric
(68333-22-2)
SPONSORED
CHEMICAL
Residues
(petroleum),
topping plant,
low-sulfur
(68607-30-7)
SPONSORED
CHEMICAL
Residues
(petroleum),
atm. tower, light
(70592-79-9)
SPONSORED
CHEMICAL
Fuel oil,
residues-
straight-run gas
oils, high sulfur
(68476-32-4)
Developmental Toxicity
NOAEL/LOAEL
Dermal (mg/kg-day)
Maternal Toxicity
Developmental Toxicity
No Data
No Data
NOAEL = 3331
LOAEL= 1000
NOAEL = 3331
LOAEL= 1000
No Data
NOAEL = 333
LOAEL= 1000
NOAEL = 333
LOAEL= 1000
(RA)
No Data
NOAEL = 333
LOAEL= 1000
NOAEL = 333
LOAEL= 1000
(RA)
No Data
NOAEL = 333
LOAEL= 1000
NOAEL = 333
LOAEL= 1000
(RA)
No Data
NOAEL = 333
LOAEL= 1000
NOAEL = 333
LOAEL= 1000
(RA)
No Data
NOAEL = 333
LOAEL= 1000
NOAEL = 333
LOAEL= 1000
(RA)
Genetic Toxicity -
Gene Mutation
In vitro
No Data
Positive
(RA)
Positive
No Data
No Data
No Data
No Data
No Data
No Data
Genetic Toxicity -
Chromosomal Aberrations
In vitro
No Data
No Data
No Data
No Data
No Data
No Data
No Data
No Data
Genetic Toxicity -
Chromosomal Aberrations
In vivo
No Data
Positive
(RA)
Positive
Additional Information
Skin Irritation
Eye Irritation
Skin Sensitization
Carcinogenicity
-
Irritating
Irritating
Sensitizing
Irritating
Not irritating
Not sensitizing
-
-
-
-
-
104
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 4. Summary of Screening Information Data Set under the U.S. H PV Challenge Program - Human Health Data
Subcategory III: Atmospheric Distillate
Subcategory IV: Vacuum Residual
Endpoint
SPONSORED
CHEMICAL
Distillates
(petroleum),
crude oil
(68410-00-4)
SPONSORED
CHEMICAL
Gas oils
(petroleum),
heavy
atmospheric
(68783-08-4)
SUPPORTING
CHEMICAL
Heavy
atmospheric gas
oil
(68915-97-9)
SUPPORTING
CHEMICAL
Diesel fuel No. 2
(Fuel oil No. 2-D)
(68476-34-6)
SPONSORED
CHEMICAL
Residues
(petroleum), light
vacuum
(68512-62-9)
SPONSORED
CHEMICAL
Residues
(petroleum),
solvent-extd.
vacuum distilled
atm residuum
(70913-85-8)
SUPPORTING
CHEMICAL
Residues (petroleum),
vacuum
(64741-56-6)
Acute Oral Toxicity
LDso (mg/kg)
No Data
No Data
No Data
> 5000
(RA)
No Data
> 5000
(RA)
>5000
Acute Inhalation
Toxicity
LC50 (mg/L)
No Data
No Data
No Data
>2.3
(RA)
No Data
>2.3
(RA)
>2.3
Acute Dermal Toxicity
LDso (mg/kg)
No Data
>5000
(RA)
No Data
> 5000
(RA)
>5000
No Data
>2000
(RA)
No Data
>2000
(RA)
>2000
Repeated-Dose
Toxicity
NOAEL/LOAEL
Dermal (mg/kg-day)
No Data
NOAEL = 30
LOAEL = 125
(RA)
No Data
NOAEL = 30
LOAEL = 125
(RA)
NOAEL = 303
LOAEL =125
No Data
NOAEL = 1000
LOAEL = 2000
(RA)
No Data
NOAEL = 1000
LOAEL = 2000
(RA)
NOAEL = 1000
LOAEL = 2000
Reproductive Toxicity
NOAEL/LOAEL
Oral (mg/kg-day)
No Data
No Data
No Data
No Data
105
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 4. Summary of Screening Information Data Set under the U.S. HPV Challenge Program - Human Health Data
Subcategory III: Atmospheric Distillate
Subcategory IV: Vacuum Residual
Endpoint
SPONSORED
CHEMICAL
Distillates
(petroleum), crude
oil
(68410-00-4)
SPONSORED
CHEMICAL
Gas oils
(petroleum), heavy
atmospheric
(68783-08-4)
SUPPORTING
CHEMICAL
Heavy
atmospheric gas
oil
(68915-97-9)
SUPPORTING
CHEMICAL
Diesel fuel No. 2
(Fuel oil No.
2-D)
(68476-34-6)
SPONSORED
CHEMICAL
Residues
(petroleum),
light vacuum
(68512-62-9)
SPONSORED
CHEMICAL
Residues
(petroleum),
solvent-extd.
vacuum
distilled atm
residuum
(70913-85-8)
SUPPORTING
CHEMICAL
Residues
(petroleum),
vacuum
(64741-56-6)
Developmental Toxicity
NOAEL/LOAEL
Dermal (mg/kg-day)
Maternal Toxicity
NOAEL = 502
LOAEL = 250
NOAEL = 501
LOAEL = 250
NOAEL = 301
LOAEL = 125
No Data
No Data
Developmental Toxicity
NOAEL = 500
(highest dose tested)
NOAEL = -50!
LOAEL =125-250
NOAEL = 301
LOAEL = 125
Maternal Toxicity
NOAEL =125-150!
LOAEL = 250-500
Developmental Toxicity
NOAEL = NE-501
LOAEL =125-150
Genetic Toxicity -
Gene Mutation
In vitro
No Data
No Data
-
-
No Data
Positive
(RA)
No Data
Positive
(RA)
Positive
Genetic Toxicity -
Chromosomal Aberrations
In vitro
No Data
No Data
-
-
No Data
No Data
-
Additional Information
Skin Irritation
Eye Irritation
Skin Sensitization
Carcinogenicity
-
-
-
Irritating
Not sensitizing
-
Irritating
Not irritating
106
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 4. Summary of Screening Information Data Set under the U.S. HPV Challenge Program - Human Health Data
Subcategory V: Vacuum Distillate
Endpoint
SPONSORED
CHEMICAL
Residues
(petroleum),
heavy vacuum
(64741-57-7)
SPONSORED
CHEMICAL
Gas oils
(petroleum),
hvdrotreated
vacuum
(64742-59-2)
SPONSORED
CHEMICAL
Gas oils
(petroleum),
hvdrodcsulfurizcd
heavy vacuum
(64742-86-5)
SPONSORED
CHEMICAL
Distillates
(petroleum),
petroleum
residues vacuum
(68955-27-1)
SPONSORED
CHEMICAL
Distillates
(petroleum),
intermediate
vacuum
(70592-76-6)
SPONSORED
CHEMICAL
Distillates
(petroleum), light
vacuum
(70592-77-7)
SPONSORED
CHEMICAL
Distillates
(petroleum),
vacuum
(70592-78-8)
Acute Oral Toxicity
LDso (mg/kg)
>5000
No Data
>5000
(RA)
No Data
>5000
(RA)
No Data
>5000
(RA)
No Data
> 5000
(RA)
No Data
> 5000
(RA)
No Data
> 5000
(RA)
Acute Inhalation Toxicity
LCso (mg/L)
-
-
-
-
-
-
-
Acute Dermal Toxicity
LDso (mg/kg)
>2000
No Data
>2000
(RA)
No Data
>2000
(RA)
No Data
>2000
(RA)
No Data
>2000
(RA)
No Data
>2000
(RA)
No Data
>2000
(RA)
Repeated-Dose Toxicity
NOAEL/LOAEL
Dermal (mg/kg-day)
(13-wk)
NOAEL = 30
LOAEL = 125
(28-d)
NOAEL = 93
LOAEL = 930
No Data
(13-wk)
NOAEL = 30
NOAEL = 125
(28-d)
NOAEL = 93
LOAEL = 930
(RA)
No Data
(13-wk)
NOAEL = 30
NOAEL = 125
(28-d)
NOAEL = 93
LOAEL = 930
(RA)
No Data
(13-wk)
NOAEL = 30
NOAEL = 125
(28-d)
NOAEL = 93
LOAEL = 930
(RA)
No Data(13-wk)
NOAEL = 30
NOAEL = 125
(28-d)
NOAEL = 93
LOAEL = 930
(RA)
No Data
(13-wk)NOAEL =
30
NOAEL = 125
(28-d)
NOAEL = 93
LOAEL = 930
(RA)
No Data(13-wk)
NOAEL = 30
NOAEL = 125
(28-d)
NOAEL = 93
LOAEL = 930
(RA)
Reproductive Toxicity
NOAEL/LOAEL
Oral (mg/kg-day)
No Data
107
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 4. Summary of Screening Information Data Set under the U.S. HPV Challenge Program - Human Health Data
Subcategory V: Vacuum Distillate
Endpoint
SPONSORED
CHEMICAL
Residues
(petroleum),
heavy vacuum
(64741-57-7)
SPONSORED
CHEMICAL
Gas oils
(petroleum),
hvdrotreated
vacuum
(64742-59-2)
SPONSORED
CHEMICAL
Gas oils
(petroleum),
hydrodesult'urized
heavy vacuum
(64742-86-5)
SPONSORED
CHEMICAL
Distillates
(petroleum),
petroleum residues
vacuum
(68955-27-1)
SPONSORED
CHEMICAL
Distillates
(petroleum),
intermediate
vacuum
(70592-76-6)
SPONSORED
CHEMICAL
Distillates
(petroleum), light
vacuum
(70592-77-7)
SPONSORED
CHEMICAL
Distillates
(petroleum),
vacuum
(70592-78-8)
Developmental Toxicity
NOAEL/LOAEL
Dermal (mg/kg-day)
Maternal Toxicity
Developmental Toxicity
Maternal Toxicity
Developmental Toxicity
NOAEL = NE2
LOAEL = 75
NOAEL = NE
LOAEL = 75
NOAEL =1-125!
LOAEL = 150-500
NOAEL =1-125
LOAEL = 150-500
No Data
NOAEL = NE
LOAEL = 75
NOAEL = NE
LOAEL = 75
(RA)
NOAEL = 501
LOAEL = 333
NOAEL = 50
LOAEL = 333
No Data
NOAEL = NE
LOAEL = 75
NOAEL = NE
LOAEL = 75
(RA)
No Data
NOAEL = NE
LOAEL = 75
NOAEL = NE
LOAEL = 75
(RA)
No Data
NOAEL = NE
LOAEL = 75
NOAEL = NE
LOAEL = 75
(RA)
No Data
NOAEL = NE
LOAEL = 75
NOAEL = NE
LOAEL = 75
(RA)
Genetic Toxicity -
Gene Mutation
In vitro
No Data
Genetic Toxicity -
Chromosomal
Aberrations
In vitro
No Data
Genetic Toxicity -
Chromosomal
Aberrations
In vivo
Negative
No Data
Negative
(RA)
Additional Information
Skin Irritation
Eye Irritation
Skin Sensitization
Carcinogenicity
Irritating
Irritating
Not sensitizing
-
Irritating
Irritating
-
-
-
-
108
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 4. Summary of Screening Information Data Set under the U.S. HPV Challenge Program - Human Health Data
Subcategory VI: Cracked Residual
Endpoint
SPONSORED
CHEMICAL
Clarified oils
(petroleum),
catalytic cracked
(64741-62-4)
SPONSORED
CHEMICAL
Residues
(petroleum),
hvdrocracked
(64741-75-9)
SPONSORED
CHEMICAL
Residues
(petroleum),
thermal cracked
(64741-80-6)
SPONSORED
CHEMICAL
Pitch, petroleum,
arom
(68187-58-6)
SPONSORED
CHEMICAL
Residues
(petroleum), heavy
cokcr gas oil and
vacuum gas oil
(68478-17-1)
SPONSORED
CHEMICAL
Residues
(petroleum), cokcr
scrubber
condensed-ring-
aromatic-
containing
(68783-13-1
Acute Oral Toxicity
LDso (mg/kg)
4320-5270
No Data
4320 - 5270
(RA)
No Data
4320 - 5270
(RA)
No Data
4320 - 5270
(RA)
No Data
4320 - 5270
(RA)
No Data
4320 - 5270
(RA)
Acute Dermal Toxicity
LD50 (mg/kg)
>2000
No Data
>2000
(RA)
No Data
>2000
(RA)
No Data
>2000
(RA)
No Data
>2000
(RA)
No Data
>2000
(RA)
Repeated-Dose Toxicity
NOAEL/LOAEL
Dermal (mg/kg-day)
(13-wk)
NOAEL = NE
LOAEL = 8
(28-d)
NOAEL = NE-1
LOAEL = 10 - 542
(28-d)
NOAEL = 210
(highest dose
tested)
(13-wk)
NOAEL = NE
LAOEL = 60
No Data
NOAEL = NE
LOAEL = 8
(RA)
No Data
NOAEL = NE
LOAEL = 8
(RA)
No Data
NOAEL = NE
LOAEL = 8
(RA)
Reproductive Toxicity
NOAEL/LOAEL
(mg/kg-day)
No Data
Developmental Toxicity
NOAEL/LOAEL
Dermal (mg/kg-day)
Maternal Toxicity
NOAEL = 0.052
LOAEL = 1.0
No Data
NOAEL = 0.05
LOAEL = 1.0
No Data
NOAEL = 0.05
LOAEL = 1.0
No Data
NOAEL = 0.05
LOAEL = 1.0
No Data
NOAEL = 0.05
LOAEL = 1.0
No Data
NOAEL = 0.05
LOAEL = 1.0
Developmental Toxicity
Maternal Toxicity
NOAEL = 0.052
LOAEL = 1.0
NOAEL = NE-101
LOAEL = 4 - 100
NOAEL = 0.05
LOAEL = 1.0
(RA)
NOAEL = 0.05
LOAEL = 1.0
(RA)
NOAEL = 0.05
LOAEL = 1.0
(RA)
NOAEL = 0.05
LOAEL = 1.0
(RA)
NOAEL = 0.05
LOAEL = 1.0
(RA)
Developmental Toxicity
NOAEL = NE -101
LOAEL = 4-250
109
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 4. Summary of Screening Information Data Set under the U.S. HPV Challenge Program - Human Health Data
Subcategory VI: Cracked Residual
Endpoint
SPONSORED
CHEMICAL
Clarified oils
(petroleum),
catalytic cracked
(64741-62-4)
SPONSORED
CHEMICAL
Residues
(petroleum),
hvdrocracked
(64741-75-9)
SPONSORED
CHEMICAL
Residues
(petroleum),
thermal cracked
(64741-80-6)
SPONSORED
CHEMICAL
Pitch, petroleum,
arom
(68187-58-6)
SPONSORED
CHEMICAL
Residues
(petroleum), heavy
cokcr gas oil and
vacuum gas oil
(68478-17-1)
SPONSORED
CHEMICAL
Residues
(petroleum), cokcr
scrubber
condensed-ring-
aromatic-
containing
(68783-13-1
Genetic Toxicity -
Gene Mutation
In vitro
Positive
No Data
Positive
(RA)
No Data
Positive
(RA)
No Data
Positive
(RA)
No Data
Positive
(RA)
No Data
Positive
(RA)
Genetic Toxicity -
Chromosomal Aberrations
In vitro
-
-
-
-
-
-
Genetic Toxicity -
Chromosomal Aberrations
In vivo
Negative
No Data
Negative
(RA)
No Data
Negative
(RA)
No Data
Negative
(RA)
No Data
Negative
(RA)
No Data
Negative
(RA)
Genetic Toxicity - Other
Information
In vitro
Sister Chromatid Exchange
Unscheduled DNA
Synthesis
In vivo
Dominant Lethal Assay
Positive
Positive
Negative
-
-
-
-
-
Additional Information
Skin Irritation
Eye Irritation
Skin Sensitization
Carcinogenicity
Irritating
Irritating
Negative
Positive
—
—
Positive
—
—
110
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 4. Summary of Screening Information Data Set under the U.S. HPV Challenge Program - Human Health Data
Subcategory VII: Cracked Distillate
Subcategory VIII:
Reformer Residual
Endpoints
SPONSORED
CHEMICAL
Distillates
(petroleum), heavy
catalytic cracked
(64741-61-3)
SPONSORED
CHEMICAL
Distillates
(petroleum), heavy
thermal cracked
(64741-81-7)
SPONSORED
CHEMICAL
Clariticd oils
(petroleum),
hvdrodcsulfurizcd
catalytic cracked
(68333-26-6)
SPONSORED
CHEMICAL
Distillates
(petroleum),
hvdrodesulfurized
intermediate
catalytic cracked
(68333-27-7)
SPONSORED
CHEMICAL
Aromatic
hydrocarbons,
C12-20
(70955-17-8)
SPONSORED
CHEMICAL
Residues
(petroleum),
catalytic
reformer
fractionator
(64741-67-9)
SPONSORED
CHEMICAL
Residues
(petroleum),
catalytic reformer
fractionator
residue distn.
(68478-13-7)
Acute Oral Toxicity
LDso (mg/kg)
No Data
>5000
(RA)
>5000
No Data
>5000
(RA)
No Data
> 5000
(RA)
No Data
>5000
(RA)
No Data
No Data
Acute Inhalation Toxicity
LC50 (mg/L)
-
-
-
-
-
-
-
Acute Dermal Toxicity
LD50 (mg/kg)
No Data
>2000
(RA)
>2000
No Data
>2000
(RA)
No Data
>2000
(RA)
No Data
>2000
(RA)
Repeated-Dose Toxicity
NOAEL/LOAEL
Oral (mg/kg-day)
-
-
-
-
-
No Data
No Data
Repeated-Dose Toxicity
NOAEL/LOAEL
Dermal (mg/kg-day)
(28-d)
NOAEL = 9.9
LOAEL = 99
(13-wk)
NOAEL = NE-30
LOAEL = 30-125
(28-d)
NOAEL = 9.3-93
LOAEL = 93-930
No Data
NOAEL = NE - 125
LOAEL = 30 - 125
(RA)
No Data
NOAEL = NE - 125
LOAEL = 30 - 125
(RA)
No Data
NOAEL = NE - 125
LOAEL = 30 - 125
(RA)
No Data
No Data
111
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Table 4. Summary of Screening Information Data Set under the U.S. HPV Challenge Program - Human Health Data
Subcategory VII: Cracked Distillate
Subcategory VIII: Reformer
Residual
Endpoint
SPONSORED
CHEMICAL
Distillates
(petroleum), heavy
catalytic cracked
(64741-61-3)
SPONSORED
CHEMICAL
Distillates
(petroleum), heavy
thermal cracked
(64741-81-7)
SPONSORED
CHEMICAL
Clarified oils
(petroleum),
hydrodcsulfurizcd
catalytic cracked
(68333-26-6)
SPONSORED
CHEMICAL
Distillates
(petroleum),
hvd rodcsulfu rized
intermediate
catalytic cracked
(68333-27-7)
SPONSORED
CHEMICAL
Aromatic
hydrocarbons,
C12-20
(70955-17-8)
SPONSORED
CHEMICAL
Residues
(petroleum),
catalytic reformer
fractionator
(64741-67-9)
SPONSORED
CHEMICAL
Residues
(petroleum),
catalytic reformer
fractionator
residue distn.
(68478-13-7)
Developmental Toxicity
NOAEL/LOAEL
Dermal (mg/kg-day)
Maternal Toxicity
NOAEL = NE3
LOAEL = 50
NOAEL = NE-1251
LOAEL = 8 - 250
No Data
NOAEL = NE-125
LOAEL = 8-250
No Data
NOAEL = NE-125
LOAEL = 8-250
No Data
NOAEL = NE-125
LOAEL = 8-250
-
-
Developmental Toxicity
NOAEL = NE
LOAEL = 50
NOAEL = NE-301
LOAEL = 8 - 125
NOAEL = NE-30
LOAEL = 8-125
(RA)
NOAEL = NE-30
LOAEL = 8-125
(RA)
NOAEL = NE-30
LOAEL = 8-125
(RA)
Genetic Toxicity -
Gene Mutation
In vitro
No Data
No Data
No Data
No Data
No Data
No Data
No Data
Genetic Toxicity -
Chromosomal
Aberrations
In vitro
No Data
No Data
No Data
No Data
No Data
No Data
No Data
Additional Information
Skin Irritation
Eye Irritation
Skin Sensitization
Carcinogenicity
Positive
Irritating
Irritating
Non-sensitizing
-
-
-
-
-
NE = not established; Measured data in bold text; (RA) = Read Across; - indicates that endpoint was not evaluated for this substance; 'fewer animals were used than
recommended by guidelines; 2used adequate number of animals in these studies; 3CASRN 68915-97-9 and 68783-08-4 have similar composition; 4Male mediated reproductive
toxicity (Dominant Lethal assay)
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4. Hazard to the Environment
No adequate data were submitted for the sponsored chemicals. A summary of aquatic toxicity
data for supporting chemicals for SIDS endpoints is provided in Table 5. The table also
indicates where test data are read-across (RA) from the supporting chemicals of the Kerosene/Jet
Fuel category.
Acute Toxicity to Fish
C7-C10 Isoalkane Hydrocarbons (CASRN 90622-56-3, supporting chemical)
Rainbow trout (Oncorhynchus mykiss) were exposed to Water Accommodated Fractions (WAFs)
of CASRN 90622-56-3 at nominal loading rates of 0, 0.9, 2.0, 10.0, 22.0 or 50.0 mg/L under
static-renewal conditions for 96 hours. Corresponding time-weighted mean measured
concentrations were 0, 0.05, 0.12, 0.33, 0.36 and 0.47 mg/L.
96-h LCso = 0.11 mg/L
C8-C9 Cyclic Hydrocarbons (CASRN 64742-48-9, supporting chemical)
Rainbow trout (Oncorhynchus mykiss) were exposed to WAFs of 64742-48-9 at nominal loading
rates of 1.0, 2.3, 5.1, 11.0 or 25.0 mg/L under static-renewal conditions for 96 hours.
Corresponding time-weighted mean measured concentrations were 0, 0.05, 0.12, 0.33, 0.36 and
0.47 mg/L.
96-h LCso = 0.3 mg/L
/- Tetradecene (CASRN 1120-36-1, supporting chemical)
http://www.chem.unep.ch/irptc/sids/OECDSIDS/AOalfaolefins.pdf
96-h EC50 = No effects at saturation (0.0004 mg/L-calculated)
1-Hexadecene (CASRN 629-73-2, supporting chemical)
http://www.chem.unep.ch/irptc/sids/OECDSIDS/Higher01efins.pdf
96-h LC50 > Predicted Solubility limit (0.00144 mg/L)
Acute Toxicity to Aquatic Invertebrates
C9-C 10 Hydrocarbons, n-alkanes, isoalkanes, cyclics, <2% aromatics (CASRN 64742-49-0,
supporting chemical)
Water fleas (Daphnia magna) were exposed to CASRN 64742-49-0 at nominal loading rates of
0, 1, 2.2, 4.6, 10, 22, 46 or 100 mg/L for 48 hours under static conditions. The corresponding
measured concentrations were 0, 0.11, 0.22, 0.18, 0.25, 0.44, 0.47 and 0.56 mg/L, respectively,
based upon the geometric mean of the 0 and 48 hour samples.
48-h EC50 = 0.9 mg/L
1-Tetradecene (CASRN 1120-36-1, supporting chemical)
http://www.chem.unep.ch/irptc/sids/OECDSIDS/AOalfaolefins.pdf
48-h EC50 = No effects at saturation (0.0004 mg/L-calculated)
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1-Hexadecene (CASRN 629-73-2, supporting chemical)
http://www.chem.unep.ch/irptc/sids/0ECDSIDS/Higher01efins.pdf
96-h LCso > Predicted Solubility limit (0.00144 mg/L)
Toxicity to Aquatic Plants
C9-C 10 Hydrocarbons, n-alkanes, isoalkanes, cyclics, <2% aromatics (CASRN 64742-49-0,
supporting chemical)
Green algae (Pseudokirchneriella subcapitata) were exposed to CASRN 64742-49-0 at nominal
loading rates of 0, 1,3, 10, 30, 100, 300 or 1000 mg/L for 72-hours under static conditions.
Corresponding mean measured concentrations were <0.02, 0.13, 0.11, 0.31, 0.33, 0.36, 0.37 and
0.40 mg/L.
72-h EC50 (biomass) = 0.4 mg/L
72-h EC50 (growth rate) > 0.4 mg/L
1-Tetradecene (CASRN 1120-36-1)
http://www.chem.unep.ch/irptc/sids/OECDSIDS/AOalfaolefins.pdf
48-h LC50 = No effects at saturation (0.0004 mg/L-calculated)
1-Hexadecene (CASRN 629-73-2, supporting chemical)
http://www.chem.unep.ch/irptc/sids/OECDSIDS/Higher01efins.pdf
72-h EC50 (biomass) > Predicted Solubility limit (0.00144 mg/L)
72-h EC50 (growth rate) > Predicted Solubility limit (0.00144 mg/L)
Chronic Toxicity to Aquatic Invertebrates
C9-C 10 Hydrocarbons, n-alkanes, isoalkanes, cyclics, <2% aromatics (CASRN 64742-49-0,
supporting chemical)
Water fleas (D. magna) were exposed to CASRN 64742-49-0 at nominal loading rates of 0, 1, 4,
8 or 10 mg/L for 21-days under static-renewal conditions. Corresponding mean measured
concentrations were 0, 0.17, 0.32, 0.79, 1.1 and 1.2 mg/L.
21-d NOEC = 0.17 mg/L
21-d LOEC = 0.32 mg/L
1-Tetradecene (CASRN 1120-36-1)
http://www.chem.unep.ch/irptc/sids/OECDSIDS/AOalfaolefins.pdf
ChV = No effects at saturation (0.0004 mg/L-calculated)
Conclusion: No adequate data are available for the sponsored substances. Based on the
supporting chemicals (CASRNs 90622-56-3, 1120-36-1 and 629-73-2), the 96-h LC50 for fish is
0.11 mg/L, the 48-h EC50 for aquatic invertebrates is 0.9 mg/L, and the 72-h EC50 for aquatic
plants is 0.4 mg/L for biomass. Based on the supporting chemical (CASRN 64742-49-0), the 21-
d chronic NOEC and LOEC for aquatic invertebrates is 0.17 mg/L and 0.32 mg/L, respectively.
Based on CASRNs 1120-36-1 and 629-73-2, there is no aquatic toxicity at saturation for
chemicals in this category with a carbon chain of fourteen or greater.
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Table 5. Summary of Screening Information Data Set under the U.S. HPV Challenge
Program - Aquatic Toxicity Data
Endpoint
SPONSORED
CHEMICAL
Fuel oil, residual*
(68476-33-5;
SUPPORTING
CHEMICAL
C7-C10 Isoalkane
Hydrocarbons
(90622-56-3)
SUPPORTING
CHEMICAL
C9-C10 Hydrocarbons,
n-alkanes, isoalkanes,
cyclics,
(64742-49-0)
SUPPORTING
CHEMICALS
1-Tetradecene, C14
(1120-36-1)
1-Hexadecene, C16
(629-73-2)
Fish
96-h LCso or LLso (mg/L)
No Adequate Data
0.11
(RA)
0.11
-
NES
Aquatic Invertebrates
48-h ECso or ELso (mg/L)
No Adequate Data
0.09
(RA)
-
0.09
NES
Aquatic Plants
72-h ECso or EC50 (mg/L)
Growth
Biomass
No Adequate Data
0.4
(RA)
-
0.4
NES
Chronic Toxicity to
Invertebrates
21-d ECso (mg/L) 21-d
NOEC/ LOEC (mg/L)
No Data
0.17
0.32
(RA)
-
0.17
0.32
NES
Bold = experimental data (derived from testing), RA = read across, - indicates that endpoint was not addressed for this
chemical, NES = No Effects at Saturation (the water solubility limit f the substance), * represents all category substances.
5. References
CONCAWE. 1998. Heavy fuel oils. Product dossier No. 98/109. Brussels. 48 pp.
115
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Hazard Characterization Document
APPENDIX
The Appendix contains:
Appendix A Description of Process Streams
Appendix B Process Streams, CASRN, and Description of the Heavy Fuel Oils Category
Appendix C Cracking Processes
Appendix D PAC Analytical Profile of Heavy Fuel Oils
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Appendix A
1.1.1 Process Streams
Because the process history of a refinery stream determines rts chemical composition, it is
expected that streams thai have undergone similar processing will have similar
physicalfchemical/hnlogic properties and environmental fate and transport: characteristics. The
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streams that are produced by catalytic cracking have high levels of aromatics. In contrast,
hydrocracked streams have relatively low amounts of aromatics, since hydrocracking introduces
hydrogen into the cracking process resulting in saturation of aromatic compounds. As shown in
Figure 1, there are eleven refinery streams in the heavy fuel oils category that are produced by
cracking (five distillate and six residual streams). See Appendix A for a more detailed
description of each of these streams.
Reforming
Catalytic reforming employs a catalyst to facilitate the structural rearrangement of hydrocarbon
molecules in order to increase the aromatic content of a refinery stream, ultimately producing
higher octane gasoline blending stocks. During reforming, olefins are saturated to form
paraffins, which are then converted to shorter paraffins, isoparaffiiis, and naphthenes. The
naphthenes are converted to aromatics by dehydrogenation (Gary and Handwerk, 1S34}. As
shown in Figure 1, there are two refinery streams in the heavy fuel oils category that are
produced as residuals of reforming. See Appendix A for a more detailed description of each of
these streams.
1,1,2, Residual Fuel Oils
In addition to the process streams discussed above, the heavy fuel oil category also includes two
blended residual fuel oils. Residual Fuel Oil (CAS 68476-33-5) and No. 6 Fuel Oil {CAS 68553-00-
4). These two fuel oil's are most often produced by blending any combination of the distillate and
residual streams so that the finished fuel meets the appropriate product specifications. The
residual fuels can also be blended with petroieum distillates (cutter stocks) covered in other API
HPV Categories [e.g. kerosene, gas oils]. See Appendix A for a more detailed description of each
of these two residual fuel oils.
In describing some of the SIDS endpoints for this category (e.g.. particularly physical-chemical and
environmental fate end points) data on Bunker C fuel oil has been cited and used as a supporting
material that is representative of a no. 6 fuel oil. Bunker fuel gets its name from the containers on
ships and in ports in which it is stored {i.e., "storage bunkers™!. While there are several cfasses of
bunker fuel (e.g.. classes "A" and "B", etc.], Bunker C is a term that as commonly used as a generic
synonym equivalent to residual fuel oil, no. 6 fuel o;1, or heavy fuel oil (Irwin et ai.. ^ 997;
CONCAWE, 1999). Therefore, the composition of Bunker C fuels is expected to be similar to other
substances m this category, and any differences may be explained by the variability in the streams
from which these products are made and the characteristics of the original crude oil. For this
reason, Bunker C fuel oil is a valid supporting substance to this category that provides valuable
data for characterizing SIDS endpoints. Furthermore, much of the data on the fate and effects of
heavy fuel oils are derived from studies on oil spilled at sea. of which Bunker C fuel has been
reported m a number of studies {Keizer et al., 1978; Jezequel et al., 2003; Lee. et ai.. 2003).
Analytical data for representative materials in this category are shown in Table 1.
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carbon ranges for streams in this category are directly related to physical/chemical properties and
the potential for environmental effects. See Appendix A for a more detailed description of each of
these streams. Knowledge of refining processes, in addition to carbon range and physical/chemical
properties, coupled with tests of representative substances can be useful in evaluating human
health effects. As shown in Figure 1, the major processes used to produce the refinery streams
included in the heavy fuel oils category are:
Atmospheric distillation
Heavy fuel oil related streams produced by atmospheric distillation comprise fractions of crude
oil separated by heating (650-7005F [346-3740C]) at atmospheric pressure. They include
atmospheric distillates (heavy gas oils} and the heavier residual materials. The distillate HFO
streams are similar to some of the refinery streams covered in the API HPV Gas Oils category,
albeit of higher molecular weight. Some of these streams may be further hydrotreated or
desulfurized to remove sulfur, nitrogen, and other impurities. Most atmospheric distillates
undergo further processing in order to convert them into higher value fuels (diesel, kerosene).
Vacuum distillation
The residuum from the atmospheric distillation unit is distilled under vacuum to farther separate
heavier molecules without the use of high temperatures. This is done under reduced pressure
to prevent thermal cracking. In addition to producing lube oils, various vacuum distillates
(vacuum gas oils) and vacuum residuals are produced. Similar to the atmospheric: distillates,
some of the vacuum distillates may be hydrotreated or desulfurized to remove sulfur, nitrogen,
and other impurities. Most vacuum distillates undergo further processing in order to convert
them into higher value fuels (diesel, kerosene)
Portions of the heavier atmospheric or vacuum distillate streams may be used as blending
stocks to reduce the viscosity of other residual streams. The atmospheric and vacuum residual
refinery streams, each comprise a heterogeneous group of poorly defined, viscous, high boiling
hydrocarbon streams that usually contain suspensions of resin/asphaltene complexes. These
streams often have high levels of heterocyclic aromatic and naphthenic compounds. Varying
percentages of sulfur, nitrogen, oxygen, and other elements are present as heterocyclic
inclusions, primarily in the aromatics fraction. These residual streams often have a PAC content
over 5%.
Cracking
Many of the distillate and residual streams used to blend heavy fuel o-ils are derived from
cracking processes. Cracking is a process that breaks ("cracks") the heavier, higher bo-ting
petroleum streams produced by atmospheric or vacuum, distillation into fighter molecular weight
materials such as gasoline, diesei fuel, jet fuel and kerosene.
There are two basic types of cracking processes, those using heat (thermal cracking) to break
molecular bonds, and those using a catalyst and heat (catalytic cracking) to facilitate the
cracking process. Both thermal and catalytic cracking are used to produce refiner/ streams that
are used for blending heavy fuel oils. Cracking processes are described in Appendix B.
The refinery streams produced by the various cracking processes represent a continuum in the
severity of the cracking process. All the cracking processes produce refinery streams that are
similar from a physical-chemical perspective, being differentiated from each other primarily by
the ratio of their unsaturated and saturated hydrocarbon content. The saturated and aromatic
hydrocarbons species are similar but may vary in ratio between streams. For instance, refinery
119
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Figure 1, HFG Process Diagram
C rude OH
Hmvv Fuel
Atmospheric &
Yacuum Distillation
64 "41—5-3
i C23:
Si3S3-22-2
i C131
63476-32-J
>NDt
.5Sd,r-3C-T
tNDi
"i"15P2-7?-9
! c;; ¦
6^:C-K>-4
i C1 l-C?C'i
63 'S3-0S-4
fC7-C 35;
6SJ;2-f2-P
i C!3!
64^:-57-7
iC20-C5(n
65955-27-:
CQi
705?2-7c-e
fC 14-C 42'
70592-^.7
iCll-C35;
"05P2-7S-S
IC15-C5D'.
1
64742-7S-"1
i €20)
64742-59-2
(C13-C50'
64742-S6-5
(CIO-CJi
70913-S5-5
'ISTC
C ntalytic C racking
Thermal Cracking
6~^:-t2-
« C20<
,5,741-80-6
i. C2u)
s8LS~-58-S
iND)
6s--g-:7-:
« C i 3 •
«s"83-::-:
(- C 2 U •
6-1 '4!-c':-3
iC15-C35i
S474;-S:-7
C15-C361
08333-26-6 i C20-
6S533-::-- «C11-C30.
Hvchoci .ifking
C aiahtic
Reforming
64741-7:"-9 •" C20)
t4741-(r~-9 C10-C25'
70955-1 ~-S •C12-C2Z;
Kfulun! Fn*l.
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Appendix B
Process Streams, CASRN, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Subcategory I: Residual Fuel Oils
Fuel oil,
residual
68476-33-5
h3c
h3c\CH3
h3c\ k/CH3
H3C' I' 1
H3C 1 rn
ch3 r^r^i
^jQO
h3cYCH3
ch3
Fuel oil, No. 6
68553-00-4
h3c
H3c\CH3
H3c\ k/CH3
H3C I"' 1
H3C 1 ri\
ch3
Ch3 °H* XJCQ
h3c\ch3
h3c^J
ch3
A distillate oil having a minimum viscosity of 900 SUS at 37.7°C (100°F) to a
maximum of 9000 SUS at 37.7°C (100°F).
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Process Streams, CASRN, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Subcategory II: Atmospheric Residual
Residues
(petroleum),
atm. tower
64741-45-3
h3c.
HsC'Y'01-13
kxH3
H3C^,CH3 L
/L-CHs J.
r^Tj rrr
ch3 ch3 ^YVY^
ch3 S
h^c T
ch3
A complex residuum from the atmospheric distillation of crude oil. It consists
of hydrocarbons having carbon numbers predominantly greater than C20 and
boiling above approximately 350°C (662°F). This stream is likely to contain
5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
Residues
(petroleum),
hydrodesulfur-
ized
atmospheric
64742-78-5
h3c.
HsC'Y'01-13
H3C^,CH3 L
/L-CHs J.
r^Tj rrr
ch3 ch3 ^YVY^
ch3 S
h3c T
ch3 a
complex combination of hydrocarbons obtained by treating an atmospheric
tower residuum with hydrogen in the presence of a catalyst under conditions
primarily to remove organic sulfur compounds. It consists of hydrocarbons
having carbon numbers predominantly greater than C20 and boiling above
approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more
of 4- to 6-membered condensed ring aromatic hydrocarbons.
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Process Streams, CASRIV
, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Residues
(petroleum),
atmospheric
68333-22-2
h3c.
h r-^v-CH3
ch3 h3c T
r TH3
CH3 CH3
ch3
ch3 ^
ch3
A complex residuum from atmospheric distillation of crude oil. It consists of
hydrocarbons having carbon numbers predominantly greater than CI 1 and
boiling above approximately 200°C (392°F). This stream is likely to contain
5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
Residues
(petroleum),
topping plant,
low-sulfur
68607-30-7
h3c.
h r-^VCH3
ch3 h3c T
r nr^i TH3
CH3 CH3
ch3 ^yv
H3C^^ (fYj
CH3 k
h3c^J
ch3
A low-sulfur complex combination of hydrocarbons produced as the residual
fraction from the topping plant distillation of crude oil. It is the residuum after
the straight-run gasoline cut, kerosene cut, and gas oil cut have been removed.
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Process Streams, CASRIV
, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Residues
(petroleum),
atm. tower,
light
70592-79-9
h3c.
h r-^Y-^3
ch3 h3c T
r TH3
CH3 CH3
ch3
ch3 k
H3c\CH3
h3c^J
ch3
A complex residuum from the atmospheric distillation of crude oil. It consists
of hydrocarbons having carbon numbers predominantly greater than CI 1 and
boiling above approximately 200°C (392°F). This stream is likely to contain
5 wt % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
Fuel oil,
residues-
straight-run gas
oils, high-sulfur
68476-32-4
h3c.
pX/CH3
ch3 h3c T
r TH3
CHa \KJ ^
ch3 ch3
ch3
ch3 k
H3c\CH3
ch3
No description
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Process Streams, CASRN, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Subcategory III: Atmospheric Distillate
Distillates
(petroleum),
crude oil
68410-00-4
h3c
H3CJyCH3
k/CH3
m nV
h3c^y-^_^-ch3 IIJ
ch3 I ^ j if
CH3
H3c\CH3
ch3
A complex combination of hydrocarbons produced by distillation of crude oil.
It consists of hydrocarbons having carbon numbers predominantly in the range
of CI 1 through C50 and boiling in the range of approximately 205 to >495°C
(401 to >923 °F).
Gas oils
(petroleum),
heavy
atmospheric
68783-08-4
H3C^/CH3
ch3 ch3
6 QX^
| CH3
ch3
A complex combination of hydrocarbons obtained by the distillation of crude
oil. It consists of hydrocarbons having carbon numbers predominantly in the
range of C7 through C35 and boiling in the range of approximately 121 to
510°C (250 to 950°F).
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Process Streams, CASRN, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Supporting Chemicals1
Fuels, diesel
68334-30-5
ch3 ch3
ch3
.ch3
1 ch3 ch3
ch3
A complex combination of hydrocarbons produced by the distillation of crude
oil. It consists of hydrocarbons having carbon numbers predominantly in the
range of C9 through C20 and boiling in the range of approximately 163 to
357°C.
Fuel oil, no. 2
68476-30-2
ch3 ch3
ch3
.ch3
J. ch3 ch3 n^j
ch3
A distillate oil having a minimum viscosity of 32.6 SUS at 37.7°C to a
maximum of 37.9 SUS at 37.7°C.
Fuel oil, no. 4
68476-31-3
ch3 ch3
ch3
/ch3 ^X)
X CH3 CH3 rf%
CHs XJ
A distillate oil having a minimum viscosity of 45 SUS at 37.7°C to a maximum
of 125 SUS at 37.7°C.
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Process Streams, CASRIV
, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Fuels, diesel,
no. 2
68476-34-6
ch3 ch3
ch3
.ch3
1 ch3 ch3
ch3
A distillate oil having a minimum viscosity of 32.6 SUS at 37.7°C to a
maximum of 40.1 SUS at 37.7°C.
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Process Streams, CASRN, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Subcategory I V: Vacuum Residual
Residues
(petroleum),
light vacuum
68512-62-9
h3c.
H3CJyCH3
k/CH3
H3C Y CH3 I rh JL
ch3 h3c^Ych3 f)
}
h3c^J
ch3
A complex residuum from the vacuum distillation of the residuum from the
atmospheric distillation of crude oil. It consists of hydrocarbons having carbon
numbers predominantly greater than C13 and boiling above approximately
230°C.
Residues
(petroleum),
solvent-extd.
vacuum
distilled atm.
residuum
70913-85-8
h3c
H3C-VH3
k^CH3
^ ^ ch3 i
H3C CH3 JL ru JL
CH3 H3cVCH3
i >>
h3c ch3 ch3 ^
H3C-VCH3
h3c^J
ch3
A complex residuum produced by the solvent extraction of the vacuum
distillate of the complex residuum from the atmospheric distillation of crude oil.
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Process Streams, CASRN, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Supporting Chemicals
Residues
(petroleum),
vacuum
64741-56-6
/CH3
h3c^JCH3
CH3 HsC^S
h3cvJ h3c^J
CH3 CH3 CH3 CH3 CH3
ch3 ch3 ch3 ch3 r"CH
"-yv
f CH3
h3c^
Vch3
Vch3
h3c
A complex residuum from the vacuum distillation of the residuum from
atmospheric distillation of crude oil. It consists of hydrocarbons having carbon
numbers predominantly greater than C34 and boiling above approximately
495°C (923°F).
Subcategory V: Vacuum Distillate
Gas oils
(petroleum),
heavy vacuum
64741-57-7
h3c.
h3c\-CH3
k/CH3
h3c^,ch3 L
ch3 3
ch3 S
H3° CH3 h3c^T
ch3
A complex combination of hydrocarbons produced by the vacuum distillation
of the residuum from atmospheric distillation of crude oil. It consists of
hydrocarbons having carbon numbers predominantly in the range of C20
through C50 and boiling in the range of approximately 350 to 600°C (662 to
1,112°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered
condensed ring aromatic hydrocarbons.
129
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Process Streams, CASRIV
, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Gas oils
(petroleum),
hydrotreated
vacuum
64742-59-2
h3c.
H3c\CH3
?h3 >
ch3
HsC^^rCHs CO cue
h,c\-ch'
ch3
A complex combination of hydrocarbons obtained by treating a petroleum
fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons
having carbon numbers predominantly in the range of C13 through C50 and
boiling in the range of approximately 230 to 600°C (446 to 1,112°F). This
stream is likely to contain 5 wt % or more of 4- to 6-membered condensed ring
aromatic hydrocarbons.
Gas oils
(petroleum),
hydrodesulfur-
ized heavy
vacuum
64742-86-5
h3c.
h3c-VCH3
k/CH3
h3c^,ch3 L
cH3 3 ^Yx^n
ch3 S
H3° CH3 h3c^T
ch3
A complex combination of hydrocarbons obtained from a catalytic
hydrodesulfurization process. It consists of hydrocarbons having carbon
numbers predominantly in the range of C20 through C50 and boiling in the
range of approximately 350 to 600°C (662 to 1,112°F). This stream is likely to
contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic
hydrocarbons.
130
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Process Streams, CASRIV
, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Distillates
(petroleum),
petroleum
residues
vacuum
68955-27-1
h3c.
h3c\CH3
k/CH3
h3c^ch3 L
ch3 3 WyY^
ch3 S
h^c T
ch3
A complex combination of hydrocarbons produced by the vacuum distillation
of the residuum from the atmospheric distillation of crude oil.
Distillates
(petroleum),
intermediate
vacuum
70592-76-6
ch3
H3CN
CH3 I
PH3 ^ 1 (i\\
pi coL
ch3 T T T 1
H1 CH>
h3c
A complex combination of hydrocarbons produced by the vacuum distillation
of the residuum from atmospheric distillation of crude oil. It consists of
hydrocarbons having carbon numbers predominantly in the range of C14
through C42 and boiling in the range of approximately 250 to 545°C (482 to
1,013°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered
condensed ring aromatic hydrocarbons.
131
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Process Streams, CASRIV
, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Distillates
(petroleum),
light vacuum
70592-77-7
H3CX.CH3
ch3
h3c. /\/Ch3 r^r^i ^ 1 1
V0 CXX^
ch3 T y 1 1
^-ch3
ch3
A complex combination of hydrocarbons produced by the vacuum distillation
of the residuum from atmospheric distillation of crude oil. It consists of
hydrocarbons having carbon numbers predominantly in the range of CI 1
through C35 and boiling in the range of approximately 250 to 545°C (482 to
1,013°F).
Distillates
(petroleum),
vacuum
70592-78-8
h3c^
H3CJyCH3
CH3 \
(Y) cxY^
CH3 CH3 1 IN N
ch3
H30^"^ 3 /L^CH3
h30 T
H3C,J
ch3
A complex combination of hydrocarbons produced by the vacuum distillation
of the residuum from atmospheric distillation of crude oil. It consists of
hydrocarbons having carbon numbers predominantly in the range of CI5
through C50 and boiling in the range of approximately 270 to 600°C (518 to
1,112°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered
condensed ring aromatic hydrocarbons.
132
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Process Streams, CASRN, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Subcategory VI: Cracked Residual
Clarified oils
(petroleum),
catalytic
cracked
64741-62-4
h3c.
HsC'Y'01-13
kxH3
H3C^,CH3 L
/L-CHs J.
r^Tj rrr
ch3 ch3 ^YVY^
ch3 S
h^c T
ch3
A complex combination of hydrocarbons produced as the residual fraction from
distillation of the products from a catalytic cracking process. It consists of
hydrocarbons having carbon numbers predominantly greater than C20 and
boiling above approximately 350°C (662°F). This stream is likely to contain
5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
Residues
(petroleum),
hydrocracked
64741-75-9
H3c.
H3c\CH3
h3c ch3 L
X/H3 L
ch3 ch3 ch3 H3C T [ ]
H3Cr^W^^^ Ci)fn
ch3 S
h3c T
ch3
A complex combination of hydrocarbons produced as the residual fraction from
distillation of the products of a hydrocracking process. It consists of
hydrocarbons having carbon numbers predominantly greater than C20 and
boiling above approximately 350°C (662°F).
133
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Process Streams, CASRIV
, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Residues
(petroleum),
thermal cracked
64741-80-6
h3c.
HsC'Y'01-13
kxH3
H3C^,CH3 L
/L-CHs J.
r^Tj rrr
ch3 ch3 ^YVY^
ch3 S
h^c T
ch3
A complex combination of hydrocarbons produced as the residual fraction from
distillation of the product from a thermal cracking process. It consists
predominantly of unsaturated hydrocarbons having carbon numbers
predominantly greater than C20 and boiling above approximately 350°C
(662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered
condensed ring aromatic hydrocarbons.
Pitch,
petroleum,
arom.
68187-58-6
h3c.
h3cV3
H3C.-CH3 \^\
H3cXrCH3
ch3
The residue from the distillation of thermal cracked or steam-cracked residuum
and/or catalytic cracked clarified oil with a softening point from 40 to 180°C.
Composed primarily of a complex combination of 3 or more membered
condensed ring aromatic hydrocarbons.
134
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Process Streams, CASRIV
, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Residues
(petroleum),
heavy coker gas
oil and vacuum
gas oil
68478-17-1
h3c^
CH3
H3° J3
Q yWJ
ch3 N
H3C'JYCH3
h3c ch3 H3C^J
ch3
A complex combination of hydrocarbons produced as the residual fraction from
the distillation of heavy coker gas oil and vacuum gas oil. It predominantly
consists of hydrocarbons having carbon numbers predominantly greater than
C13 and boiling above approximately 230°C (446°F).
Residues
(petroleum),
coker scrubber,
condensed-ring-
arom.-contg.
68783-13-1
h3c.
h3c^V'CH3
k/CH3
h3c^,ch3 L
^vCH3
ch3 ch3
ch3 S
ch3
A very complex combination of hydrocarbons produced as the residual fraction
from the distillation of vacuum residuum and the products from a thermal
cracking process. It consists predominantly of hydrocarbons having carbon
numbers predominantly greater than C20 and boiling above approximately
350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to
6-membered condensed ring aromatic hydrocarbons.
135
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Process Streams, CASRN, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Subcategory VII: Cracked Distillate
Distillates
(petroleum),
heavy catalytic
cracked
64741-61-3
H3Cv/CH3
ch3 N
r^cH3 f\\
-Y—cpccc^
ch3 ch3 I 1
CH3
I ch3
ch3
A complex combination of hydrocarbons produced by the distillation of
products from a catalytic cracking process. It consists of hydrocarbons having
carbon numbers predominantly in the range of CI5 through C35 and boiling in
the range of approximately 260 to 500°C (500 to 932°F). This stream is likely
to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic
hydrocarbons.
Distillates
(petroleum),
heavy thermal
cracked
64741-81-7
h3c^.ch3
Lch3
ch3 y
£ OSL.
ch3 ch3 T
CH3
^—ch3
A complex combination of hydrocarbons from the distillation of the products
from a thermal cracking process. It consists predominantly of unsaturated
hydrocarbons having carbon numbers predominantly in the range of C15
through C36 and boiling in the range of approximately 260 to 480°C (500 to
896°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered
condensed ring aromatic hydrocarbons.
136
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Process Streams, CASRIV
, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Clarified oils
(petroleum),
hydrodesulfur-
ized catalytic
cracked
68333-26-6
h3c.
HsC'Y'01-13
kxH3
H3C^,CH3 L
/L-CHs J.
r^Tj rrr
ch3 ch3 ^YVY^
ch3 S
h^c T
ch3
A complex combination of hydrocarbons obtained by treating catalytic cracked
clarified oil with hydrogen to convert organic sulfur to hydrogen sulfide which
is removed. It consists of hydrocarbons having carbon numbers predominantly
greater than C20 and boiling above approximately 350°C (662°F). This stream
is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring
aromatic hydrocarbons.
Distillates
(petroleum),
hydrodesulfur-
ized
intermediate
catalytic
cracked
68333-27-7
h3c.
ch3 JL
H3C^J^CH3 (V) QfT
Th3
A complex combination of hydrocarbons obtained by treating intermediate
catalytic cracked distillates with hydrogen to convert organic sulfur to hydrogen
sulfide which is removed. It consists of hydrocarbons having carbon numbers
predominantly in the range of CI 1 through C30 and boiling in the range of
approximately 205 to 450°C (401 to 842°F). It contains a relatively large
proportion of tricyclic aromatic hydrocarbons.
137
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Process Streams, CASRIV
, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Aromatic
hydrocarbons,
C12-20
70955-17-8
u ^ h3c^ch3
h3c ch3 y
[ ^ch3
h3c^S lh3 I
fS CT] PTlj
ch3
A complex combination of hydrocarbons obtained from the distillation of
biphenyl and naphthalene feedstocks. It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of C12
through C20, such as alkylbenzenes, alkylnaphthalenes, indans, fluorenes,
acenaphthalenes, phenanthrenes, and anthracenes, and boiling in the range of
approximately 282 to 427 °C.
Subcategory VIII: Reformer Residual
Residues
(petroleum),
catalytic
reformer
fractionator
64741-67-9
h3c
CO rr^
CH3
CH3
A complex combination of hydrocarbons produced as the residual fraction from
distillation of the product from a catalytic reforming process. It consists of
predominantly aromatic hydrocarbons having carbon numbers predominantly in
the range of CIO through C25 and boiling in the range of approximately 160 to
400°C (320 to 725°F). This stream is likely to contain 5 wt. % or more of 4- or
6-membered condensed ring aromatic hydrocarbons.
138
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Process Streams, CASRIV
, and Description of the Heavy Fuel Oils Category
Name
CASRN
TSCA Description
Residues
(petroleum),
catalytic
reformer
fractionator
residue distn.
68478-13-7
h3c.
HsC'Y'01-13
kxH3
H3C^,CH3 L
ch3 3
ch3 S
h^c T
ch3
A complex residuum from the distillation of catalytic reformer fractionator
residue. It boils approximately above 399°C (750°F).
1 Fuels, diesel (CASRN 68334-30-5), Fuel oil, no. 2 (CASRN 68476-30-2), and Fuels, diesel no. 2 (CASRN 68476-
34-6) are distillate fuel oils and generally have lower molecular weight hydrocarbons than Fuel oil, residual
(CASRN 68476-33-5) and Fuel oil, no 6 (CASRN 68553-00-4). Fuel oil, no. 4 is a mix of distillate and residual oils
and may contain some higher molecular weight constituents as compared to the distillate fuels.
139
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U.S. Environmental Protection Agency
Hazard Characterization Document
September, 2014
Appendix C
Cracking Processes
Thermal Cracking
Visbreaking, coking and steam cracking are types of thermal cracking. In visbreaking, the heavy
feedstock is heated under pressure to crack the molecules in the stream. Coking is a severe
method of thermal cracking. In steam cracking, the hydrocarbon stream is diluted with steam and
then briefly heated (>900 °C) in a furnace. Light hydrocarbon feeds produce streams rich in the
lighter alkenes, including ethylene, propylene and butadiene. Heavier hydrocarbon feeds give
some of these, but also give products rich in aromatic hydrocarbons. Petroleum pitch, sold as a
product for various applications, is a high aromatic residual material produced from either
thermal cracking or catalytic cracking.
Catalytic Cracking
Catalytic cracking and hydrocracking are two types of catalytic cracking. Catalytic cracking is
similar to thermal cracking except a catalyst facilitates conversion of the heavier to lighter
products and requires less severe operating conditions than thermal cracking. Catalytic cracking
converts heavy paraffins to light paraffins and olefins, heavy naphthenes to light naphthenes and
olefins, and heavy aromatics to light aromatics, naphthenes and olefins. As noted above,
petroleum pitch is a high aromatic residual material from either catalytic cracking or thermal
cracking.
Hydrocracking
Hydrocracking is a combination of catalytic cracking and hydrogenation, using high pressure,
high temperature, a catalyst, and hydrogen. It is typically used for feedstocks that are difficult to
process by either catalytic cracking or reforming. When the feedstock has high paraffin content,
the primary function of hydrogen is to prevent formation of PACs. Hydrocracking converts
sulfur and nitrogen compounds to hydrogen sulfide and ammonia.
140
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U.S. Environmental Protection Agency September, 2014
Hazard Characterization Document
Appendix D
PAC Analytical Profile of Heavy Fuel Oils
(as presented in Sponsor's Category Assessment Document)
Table 12, PAC Analytical Profile of Heavy Fuel Oils
CAS RN
Sample
DM SO
ARC I3
ARC 2
ARC 3
ARC 4
ARCS
ARC IS
>ARC 7
No,
wt V
fM
m
(°»)
(%)
fo)
64741-45-3 Atmospheric Tower Residuals
64741—5-3
070904
5.6
0.0
0.5
* ¦
M
1.1
1.1
0.5
8474 "M 5-3
070907
V3
0.0
0.2
0 6
0.6
0.4
0.2
0.1
64741-45-3
060905
2.6
0.0
00
0 5
0.8
0.5
05
0,1
64741-45-3
060917
3.0
0.0
0 0
0 6
• ">
0.9
0.6
0.1
64741-^5-3
00*691
0.1
0.3
-0
2.0
2.0
0.6
0.1
64741-57-7 Heavy Vacuum Gas Ois
64741-57-7
085244
6.2
0.0=
0 1
2 5
1.9
1.2
0.5
0.0
64741-5 7-7
065289
7.1
0.0
0.0
:i.4
'.4
1.4
I «
0 7
64741-57-7
066010
6.4
0.0
0 1
" 3
'.9
1.9
1 3
0.0
64741-57-7
066269
12.6
0.0
0.6
5 0
;
2.5
" :
0.0
64741-57-7
0862-31
11.9
0.0
0.6
60
3 6
1.2
"I
0.0
64741-57-7
086239
16.6
0.0
0.7
» 0
" 1.6
1.7
C.6
0.0
64741-57-7
09*649
0.1
03
30
2.0
2.0
' ¦-
0.0
64741-57-7
09*650
0.0
04
40
2.0
0,6
n "s
0.0
64741-57-7
09' 6-54
0.1
04
40
3 0
0.9
C 4
0.0
64741-57-7
09*689
0.0
0 4
4 0
-.0
0.4
2 *
0.0
64741-57-7
094627
9.0
9.3
0 2
0.0
0.0
3 0
0.0
64741-57-7
060906
4.3
0.0
f> "
0.4
.3
1,3
q
0.3
64741-57-7
060916
3.7
0.0
a'.C
04
' 1
1,1
¦ -
.. !¦
0.3
64741-57-7
060922
5.4
0.0
C.I
i 6
! .0
1.1
e:
0.1
64741-57-7
066178
6.5
0.0
0.6
0 9
2.6
1.7
: 9
1.7
141
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Hazard Characterization Document
September, 2014
CAS RN
Sample
DM SO
ARC 12
ARC 2
ARC 3
ARC 4
ARC 5
ARC 6
£ ARC 7
No.
Wt®b'
(%)
(•>)
f.'6»
pc4
IN
029
5'.4
0.0
: :
33 4
'• 3.9
0.5
a 0
0.0
84741-61-3
09*030
50.8
0.0
¦ ¦
33 0
*3.2
1.5
e o
0.0
64741-6 •-?•
09-68*5
0.0
4.0
40 0
4.0
0.6
C 0
0.0
64741-62-4 Catalytic Cracked Clarified Oi's
84741-52-4
086001
64.2
0
2.6
25 7
'.9.3
6.4
: 2
0,6
64741-£2-4
087277
*9 1
0.0
u,4
3,8
5.7
5.7
3 8
0.3
64741-62-^
067278
30.3
0.0
- :
q •
9.1
6.1
? 0
a.9
64741-62-4
087279
20.2
0.0
r q
wu-
6.:.
6.1
4.0
20
0.6
64741-t 2-»
091645
0.0
D.7
<0 0
30.0
2 j :
€ 0
0.0
64741-52-4
0*0923
43.2
0.0
1.3
*3 0
*3,0
8 6
- :¦
1.7
64741 -6 2-s
0 "0924
V 0
0.Q
r n
6 2
'2.4
6.2
\ <
1.6
64741-62-4
0 • 0929
52.0
0.0
1 c
'.5.8
*5 6
10.-
c 7
2.6
64741-52-4
066002
6: .7
0.0
1.5
*2 3
24.7
12 ,
r ^
1.2
64741-62-^
066015
3 *.2
0.0
C.3
6 2
"2.5
9.4
8 2
-j i
64741-52-4
086066
52.6
0,0
0.5
*05
21.0
10.5
5 3
1.6
64741-62-4
086'25
'3.4
0.1
4.0
4 0
2.7
-f 7
1 2
0.3
64741-E2-—
066:80
63.5
0.0
1.3
127
25.4
12.7
5.4
1.3
64741-C 2-4
086!85
63.7
0.0
1 ?
25 5
59.1
12.7
-
0.6
64741-62-4
086"96
74.9
a.o
1 5
22 5
30 0
15.C
7 5
1.5
64741-S2--
0864.34
46.3
a.o
1 S
9.8
'9.5
9,2
a 9
1.0
64741-52-4
091692
0.0
" 1
20 0
30.0
10.u
a 0
0.0
64741-67-9 Catalytic Reformer Fraction atoi Residuals
64741-67-9
060949
49.0
3.9
44,1.
2 3
00
0.0
0 0
0.0
64741-75-9 Hydrocracked Residuals
64741-75-&3
060946
0.2
0,0
0.0
0.0
0.0
0.0
0.0
0.0
64741 -80-8 Thermal Cracked Residuals
64741-50-6
060915
4.4
0.0
" c
1,3
- -
0.9
: 2
0.0
64741-?:-?
07'021
63.0
0.0
: ?
44 1
6.3
4.4
: o
0.0
64741-51-7
066*96
9.4
5.6
_ ;
0.6
0 1
0.0
a 0
a.o
64741-5 '-7
094625
7.0
7.0
5.0
2.0
2 0
0.0
64741-81-7 Heavy Therroai Cracked Dfslilfates
64741-5*-7
063366
"2.7
0.1
:
5.1
2.5
1.3
Z 9
0.1
64741-9'-7
0&6J. 61
*4.9
0.0
*
6 0
4.5
3.0
1 5
0.3
64741-6*-7
086*61
24,9
0.2
_ t
T24
7.4
2.5
0.0
64741-5 "--7
086'93
4.2
0.8
_ ;
0.4
0.0
00
; c
0.0
64741-8'-7
056"94
".6.0
0.0
0,5
3 2
4,6
4.8
1 6
0.5
64741-5*.-7
086230
6.8
0.3
2,0
2.7
1.4
0.4
U:. .
0.0
64741-?;-7
066.272
'6.2
0.3
4.9
8.1
" .6
0.3
0,2
0.0
64741-5 5-7
091653
0.0
09
20.0
5.0'
0.0
0 0
0.0
64742-59-2 Hydro-Created Vacuum Gns Oils
64742-59-2
071017
2 9
a.o
0.6
0.9
0.6
0 6
0.3
0,0
64742-59-2
07"026
5.8
0.0
0.5
1.7
1.7
1.2
0.6
0.1
64742-78-5 Hydropic sulfunzed Atmospheric Residuals
64742-75-5
07*030
"3,0
0.0
3.9
5.2
1.2
1.0
1.0
0.5
64742-66-5 H^cirodiesulfurized Heavy Vacuum Gas Oils
64742-56-5
09 * 690
0 1
0.7
3.D
2.0
1.0
03
00
142
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Hazard Characterization Document
September, 2014
CAS RN
Sample
DMSO
ARC I2
ARC 2
ARC 3
ARC 4
ARC 5
ARC 6
>ARt 7
No.
Wt "a'
(%}
fS|
(%S
{%)
68333-22-2 Atmospheric Residuals
66333-22-:
07'016
6.2
0,0'
0.1
19
18
1 2
0.8
0.1
88410-00-4 Crude O
il Distillates
684*0-00-4
030932
3.2
0.0
1.0
1.3
0.6
0.2
0 0
0.0
684 "0-30-4
030933
5.5
0.1
4.4
1.1
0.0
0.0
0.0
0.0
664'0-3 0-4
030934
5.5
0.0
1.7
17
f.1
0.6
0 2
0,0
664'G-: 0-
09:647
0.1
4.0
4.0
0.0
0,0
0.0
0.0
664*0-00-4
09"681
0.2
4.0
4..D
0.0
0.0
0.0
0.0
86478-33-5 Residual Fuel Oils
68476-3 3-5
066'04
:4,*3
0.0
1.5
7,3
2.9
1.3
0.6
0.1
66476-23-5
066119
8,3
0.0
2.6
2.6
t.3
0.9
0 6
0.2
68476-33-5
070903
6.0
0.2
1 °
1.2
~ Ti
1.2
0.5
0.1
66476-33-5
086:, 08
9.0
0.3
Z 7
2.7
0.9
0.9
0.7
0.3
68478-17-1 Heavy Coker Gas Oil and Vacuum Gas Oil Residuals
68478-17-1
07'012
"8.0
0,0
c
u .
5.4
5.4
3,6
1.8
0.4
66478-17-1
07-031
20.0
0.0
r ->
W..*£
4.0
6.0
4.0
4 0
0.3
88513-62-9 Lkiht Vacuum Residuals
665 "2-52-5
092009
3.3
0.0
0.7
0.7
0.7
1.0
0.7
665 "2-62-9
06-022
3.1
0.1
2 I
0.9
0.0
0.0
0.0
0.0
685S3-00-4 Fuel Oil.
ffc, 6
68553-C0-4
070908
21.0
0.0
2 1
8.4
6.3
2.1
1.3
0.2
6855 3-3 0-4
030936
36.1
0.0
1.6
14.4
50.3
3.6
29
0.7
68553-D 0-4
030937
32.6
0.0
2.3
13.0
9.6
6.5
3.3
1.0
68553-30—
09'034
42.4
0.0
2 5
IP 1
(4.0
6.3
2.5
0.0
68553-30-4
09*035
42 7
0.0
5 i
*.7 r
:3.7
6 0
Z 6
0.0
66553-C0-4
09 "036
43.3
0.0
£ J
'6 5
- 3 9
6.1
28
0.0
6855 3-3 0-4
09'674
•3.1
0.1
I i
5 2
».3
1.3
1.3
0.9
88783-08-4 Heavy Atmospheric Gas Oils
68763-D 6-4
07!020
3.0
0.0
0.0
1.2
0.9
0.6
0.3
0.0
68783-38-4
07-025
5.8
0.1
35
1 7
0.0
0.0
0.0
0.0
66763-: 6-4
08:009
5 8
0.0
0.5
2.3
*'.7
o.e
0.2
0.0
68783-38-4
08*010
5.7
0.0
0 5
2.3
1.7
0.6
0.2
0.0
66763-: 6-4
06*011
5 8
0.0
24
2 9
*7
0.6
0.2
0.0
66783-D 8-4
08-.012
5.9
0.0
: -
3 0
t.8
0.6
0 2
0.0
66763-D8-4
06-013
2.4
0.0
1 3
¦ 0
0.2
0.1
0.1
0.0
667634 8-4
094626
0.7
4 3
• 0
0.7
0.5
0 0
0.0
70592-76-6 Intermediate Vacuum Distillates
70592-76-6
07'011
5.3
0.0
0.1
1.7
* 7
1.2
0.6
0.2
70592-76-6
07<018
5.0
0.0
2,0
3.0
0.1
0.0
0.0
0.0
70592-76-6
07'029
5.8
0.0
1 2
2.9
* 9
0.5
0.2
0.0
70592-76-6
07:032
6.1
0,0
0.6
2.4
1.8
1.2
0.4
0.0
76592-77-7 Light Vacuum Disti
(ates
70592-77-7
07:015
t «.0
0.0
I 2
7 7
i.l
0.0
GO
0.0
70592-77-7
07'022
6.3
0.0
0 3
25
1.9
0.6
3 6
0,0
70592-77-7
07:023
8.2
0.0
c 6
4."
2.5
0.8
J 5
0.0
70592-77-7
07'027
8 3
0.0
1 7
5.0
,« T
0.5
0.2
0.0
70592-78-8 Vacuum Distillates
70592-78-5
07'014
9.3
0.0
at
0.9
3.7
2.3
1.9
0.2
70592-78-5
07'019
5.2
0,0
0.1
1.0
1.0
1.0
1.0
1.0
70592-78-5
07-024
7 "Ts
f
0.0
W.'u
; 4
2.2
2.2
1.4
0.7
70913-85-8 Solvent Extracted, Vacuum Distilled Atmospheric Residuals
709n 3-85-6
070905
'.9
0.0
Lf.w
0 0
0.0
0.2
: 5
0.3
709'3-65-8
060904
2.0
0.0
.n ,r»
U-VUf
0.0
0.2
0.4
0.6
0.6
1 - Percent of DMSO-e*TactaWe OACs as Astern red by PAC-2 MetNic as described by Roth e; al, 2D11 [IniotJuctary
PAC paper for publication], Ttie DMSO wt % nam not contain the total PACs for eacti sample; DMSO does not extract
Wgrty slfcstated PACs. DMSO wt * does not correlate witti modeling'. PDR1Q is based upon the PAC Profile onfy.
References for imriiwiiJusl sample PAC Profiles are presented separately
2 - ARC is "-aromatic ring class". ARC 1 (%) is fie weight percent of PACs that .have 1 aromatic ring within the total
sample: "ARC 2 (%} is the percent of PACs with 2 aromatic rings, and so forth to 7 aromatic rims determined bv tie
PAC-2 method.
143
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