Hazardous Air Pollutants: Profiles of Noncancer Toxicity from Inhalation Exposures


vvEPA
            United States
            Environmental Protection
            Agency
              Office of Research and
              Development
              Washington DC 20460
EPW600/R-93/U2
September 1993
Hazardous Air
Pollutants

Profiles of Noncancer
Toxicity from Inhalation
Exposures

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                  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                       HEALTH EFFECTS RESEARCH LABORATORY
                            RESEARCH TRIANGLE PARK, NC 27711
                                                                        OFFICE OF
                                                                 RESEARCH AND DEVELOPMENT
                                   December,  1993
 To:
Recipients  of "Hazardous Air Pollutants: Profiles of Noncancer  Toxicity from
Inhalation  Exposures" (EPA  600/R-93/142).
       Enclosed for your information is a report providing information on the noncancer
health effects associated with inhalation exposure to hazardous  air pollutants.  This
information is intended to aid implementation  of the 1990 Amendments  to the Clean Air
Act and to enable identification and prioritization of research.

       Developed  from U.S. EPA, ATSDR and other data sources, this document
presents the  information both graphically and in tabular form.  The technique for
presenting  data  is similar to that developed for genetic toxicity  data.

       A personal  computer-based  system for sorting and displaying the noncancer
toxicity data  (i.e.,Toxicity Activity Profiles, "TAP") is under development and will be
available early in 1994.  Contact John  Vandenberg at the address below for a free copy
of this software.

       Currently, a personal  computer-based, system for displaying genetic toxicity data
(i.e., Genetic  Activity Profiles, "GAP") is available and  can be obtained  at no charge
from Dr. Mike Waters, U.S. EPA  MD-51A, RTF, NC 27711. Both  of these computer-
based systems will be soon be available at no charge through  the Technology Transfer
Network Bulletin Board  System (TTNBBS)  of the U.S. EPA Office of Air Quality
Planning and Standards.  Contact  Vasu Kilaru, U.S. EPA MD-13, RTP, NC 27711  for
information on obtaining this software via the TTNBBS.

       Your comments and  suggestions  regarding  this report  will be appreciated  and
helpful  to ongoing efforts to evaluate  the hazardous  air pollutants.
                                       John J. Vandenberg, Ph.D.
                                       U.S. Environmental Protection  Agency
                                       Health Effects Research  laboratory,  MD-51A
                                       Research Triangle Park, NC 27711

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                                      EPA/600/R-93/142
                                      September 1993
   Hazardous Air Pollutants:
Profiles of Noncancer Toxicity
  from Inhalation Exposures
     U.S. Environmental Protection Agency
          Office of Health Research
      Health Effects Research Laboratory
      Research Triangle Park, NC  27711
             September 1993
                                 Printed on Recycled Paper

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                                       DISCLAIMER

       The gathering of the information in this document has been funded wholly or in part by the
U.S. Environmental Protection Agency.  This text has been subject to  the Agency's  peer and
administrative review, and it has been approved for publication as an EPA document.  Mention of
trade names or commercial products does not constitute endorsement or recommendation for use.
                          For sale by the Superintendent of Documents', U.S. Government
                                 Printing Office, Washington, D.C. 20402
                                             11

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                               TABLE OF CONTENTS




LIST OF ABBREVIATIONS	v




LIST OF TABLES	 vi




PREFACE	vii




EXECUTIVE SUMMARY	 viii




1.0   INTRODUCTION ..	1




2.0   METHOD	..	2




      2.1    Overview	2




      22.    Data Sources	,	2




             2.2.1  Integrated Risk Information System (IRIS) 	3




             2.2.2  Health Assessment Documents (HADs)  	3




             2.2.3  Drinking Water Criteria Documents (DWCDs)	3




             2.2.4  ATSDR Supplemental Tables (STs) and Toxicological Profiles (TPs)	3




             2.2.5  Hazardous Substances Data Bank (HSDB)	3




             2.2.6  Health Effects Assessment Summary Tables (HEAST)	 . >.. 4



      23    Tiers	4




      2.4    Data Interpretation Precedence	.4



3.0   PROTOCOL	4




      3.1    Information Included 	4




      3.2    Definition of Toxicity Categories 	5



             3.2.1  Measures of Toxicity  	5




             3.2.2  LC5(f  	6




             3.2.3  Death  	6




             3.2.4  Qualifications 	6






                                         iii

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                        TABLE OF CX)NTENTS_ (continued)



      33   Species	8



      3.4   Route	,	,	.	8



      3.5   Physiological Systems	8



      3.6   Duration/Frequency of Exposure 	12




            3.6.1  Humans and Animals	12



            3.6.2  Definition of Exposure Duration Categories	13




            3.6.3  Default Assumptions 	13



      3.7   Number of Animals/Humans	13




      3.8   References	13




      3.9   Notes	14



4.0    QUALITY CONTROL AND QUALITY ASSURANCE  	14



5.0    DATA PRESENTATION: GRAPHIC ACTIVITY PROFILES	 14




6.0    REFERENCES	16
APPENDIX
27
                                       IV

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                             LIST OF ABBREVIATIONS
ATSDR      Agency for Toxic Substances and Disease Registry
CAA        Clean Air Act
CAS         Chemical Abstract Service
D/WK       Days per week
DWCD      Drinking Water Criteria Document
ECAO       Environmental Criteria and Assessment Office
EPA        Environmental Protection Agency
HAD        Health Assessment Document
HAP        Hazardous Air Pollutant
HEAST      Health Effects Assessment Summary Table
HERL       Health Effects Research Laboratory
H/D         Hours per day
HID        Highest  Ineffective Dose
HSDB       Hazardous Substances Data Bank
IRIS        Integrated Risk Information System
LC50        Concentration producing mortality in 50% of exposed animals
LED        Lowest Effective Dose
LOAEL      Lowest Observed Adverse Effect Level
MACT      Maximum Achievable Control Technology
NLM        National Library of Medicine
NOAEL     No Observed Adverse Effect Level
ST          Supplemental Table
TP          Toxicological Profile

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                                   OST OF TABLES






Table 1.  Secondary Reference Sources Evaluated for Noncancer Toxicity Data  	17




Table 2.  Lifespan Data for Assignment to Chronic/Subchronic Categories  	24



Table 3.  Gestation Period and Age at Weaning  	25



Table 4.  Coding System 	26
                                          VI

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PREFACE
The potential health consequences of human exposures to air pollution are estimated through
a process called health risk assessment. Risk information is coupled with legal, social, economic,
engineering and political information to support risk management decisions. Data gaps and
uncertainties exist in all of these fields, thereby making risk management decisions more difficult.
Identification and evaluation of currently available data aid recognition of data gaps, which in turn
supports identification and prioritization of research efforts to address the information needs of risk
assessors and risk managers.

The purpose of this report is to compile and present selected information on the noncancer
toxicity of hazardous air pollutants (HAPs). This information, when coupled with data on
carcinogenicity and genetic toxicity1, aids comprehension of the health concerns from inhalation
exposures to HAPs. This information is intended to aid implementation of the 1990 Amendments
to the Clean Air Act and to enable identification and prioritization of research.

Many individuals were essential to the development of this report. The protocol used to
extract and compile data was developed and implemented by Gay Goodman and Jennifer Brainard
of Gradient Corporation and Leslie Beyer and Pam DiBona of Eastern Research Group (EPA
Contract No. 68-D9-0133). Graphic presentation of the data was performed by Frank Stack of
Environmental Health Research and Testing, Inc. (EPA Contract No. 68-D1-0148), and technical
support for report production was provided by Colleen Rose Schwoerke of Research and Evaluation
Associates, Inc. (EPA Contract No. 68-D1-0122). Appreciation is also extended for support provided
during protocol development by Ken Sexton of EPA's Office of Health Research, Dan Guth of the
EPA's Environmental Criteria and Assessment Office (ECAO), and Dan Costa of the Health Effects
Research Laboratory (HERL). Mike Waters of HERL and Beth Hassett-Sipple, Dennis Pagano, and
Holly Reid of EPA's Office of Air Quality Planning and Standards provided support and helpful
comments during production of the activity profiles. Helpful comments on a draft report were
received from many of these individuals, as well as from Craig Nessel of Exxon Biomedical Sciences,
Chon Shoaf of ECAO, and Winona Victery of EPA's Region IX Office.
John J. Vandenberg
U.S. Environmental Protection Agency
Office of Health Research
Health Effects Research Laboratory, MD-51A
Research Triangle Park, NC 27711
1 Available on disk as the EPA/IARC Genetic Activity Profile data base version 3.4 for Intel 80x86
(IBM-compatible computers). Request from Michael D. Waters, U.S. EPA, HERL MD-51A, Research
Triangle Park, N.C., 27711.
Vll

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EXECUTIVE SUMMARY

Under the 1990 Amendments to the Clean Air Act (CAA), 189 substances (e.g., benzene)
or groups of substances (e.g., chromium compounds) were identified as hazardous air pollutants. The
health consequences of exposure to these chemicals will be evaluated by Federal, State and local
governments in the coming years. To support these evaluations, identify data gaps and establish
research priorities, data on the noncancer health effects of inhalation exposure to these pollutants
were identified and compiled in this report.

A variety of secondary references were used as sources of toxicity data. These are documents
and data bases from the U.S. Environmental Protection Agency (i.e., the Integrated Risk Information
System, Health Assessment Documents, and Health Effects Assessment Summary Tables), from the
Agency for Toxic Substances and Disease Registry (i.e., Toxicity Profiles and Supplemental Tables)
and from the National Library of Medicine (i.e., the Hazardous Substances Data Bank).

Data on noncancer health effects in animals and humans were identified and extracted from
the source documents and compiled in computer files. The type of effects observed (e.g.,
neurotoxicity, pulmonary toxicity), the concentrations and exposure conditions producing the effects,
and ancillary information (e.g., the number of animals exposed) were obtained. Data on exposures
which did not produce health effects were also compiled. The data files were footnoted extensively
to aid data interpretation, and extensive quality control/quality assurance procedures were employed.

The results of this compilation are presented in the Appendix to this report, using bar graphs.
These "activity profiles" are similar to displays used previously for genetic toxicity data and
developmental toxicity data. The activity profiles are accompanied by a table of the collected data
for each chemical, including information not suitable for graphic presentation.

These profiles and tables provide insights on the types of effects seen in humans and animals
from exposure to these pollutants and suggest that certain endpoints may occur more frequently or
be of potential concern during health risk assessment. Respiratory, neurological and ocular effects,
for example, are reported for the largest number of pollutants following acute exposures in humans
and animals, with more than 50% of the hazardous air pollutants associated with respiratory and
neurologic effects in humans. These same effects are reported for the largest number of chemicals,
but less frequently, for humans exposed subchronically and chronically. In animal studies, subchronic
exposures are reported to result in respiratory and neurological toxicity as well as hepatotoxicity,
developmental toxicity and systemic toxicity (generally defined here as decreased weight gain).
Respiratory toxicity appears, for many chemicals, to occur at a lower exposure concentration than
other toxicities. For many chemicals, however, data on effects from inhalation exposures are very
limited and may be inadequate for assessment of public health risks.

While limited to inhalation exposures and to specific information sources, it is anticipated that
the information contained in this report can be used to compare pollutants across several dimensions
(e.g., concordance across species and systems), to identify existing data sources and data gaps, and
to evaluate relative potencies across chemicals. Such analyses are at present underway.

This compilation of noncancer toxicity data complements data bases and information on
carcinogenicity and genetic toxicity2 as well as ambient monitoring data which have been compiled
elsewhere by EPA Together, these sources of information constitute a substantial source of
information on the health effects and exposure potential of the hazardous air pollutants.
Tbid., p. viii
Vlll

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HAZARDOUS AIR POLLUTANTS:
PROFILES OF NONCANCER TOXICTTY FROM INHALATION EXPOSURES
1.0 INTRODUCTION

Studies have suggested that emissions of hazardous air pollutants (HAPs; also known as air
toxics) are associated with risks to public health. Emissions of pollutants to the air from components
of the manufacturing sector of the U.S. economy amounted to 2.4 billion pounds in 1988 (EPA,
1990a). Approximately 464 million pounds were of chemicals suspected or known to cause cancer
in humans (EPA, 1990a). The emissions of about 90 pollutants from 60 categories of sources were
estimated by the U.S. Environmental Protection Agency (EPA) to result in up to 1700-2700 excess
cancer cases per year (EPA, 1990b). The potential for exposures to air toxics to produce health
effects other than cancer, including neurotoxicity, reproductive toxicity, developmental toxicity,
hepatotoxicity, cardiovascular system toxicity, and respiratory irritation has also been suggested but
is less well characterized (Hassett-Sipple et al, 1991).

The 1970 Amendments to the Clean Air Act required publication of a list of HAPs (defined
as pollutants reasonably anticipated to result in an increase in mortality or an increase in serious
irreversible, or incapacitating reversible, illness) and development of national emission standards for
each such pollutant (P.L. 95-95, 1970). Prior to 1990, only 8 chemicals were listed as HAPs under
these provisions, due in part to the requirement that standards be proposed within 180 days of listing
and to difficulties in determining risks to public health and the consequent standards. Difficulties
were associated with reaching consensus on the definition of an ample margin of safety, determination
of health risks, gaps in chemical-specific data, and uncertainties inherent in the risk assessment
process. These difficulties and the slow pace of air toxics regulation resulted in significant changes
to the control strategy for HAP emissions, as reflected in the 1990 Amendments to the Clean Air Act
(P.L. 101-549, 1990).

Under the 1990 Amendments to the Clean Air Act (CAA), 189 substances (e.g., benzene)
or groups of substances (e.g., chromium compounds) were listed as HAPs requiring technology-based
emission standards. Eight to nine years after promulgation of Maximum Achievable Control
Technology (MACT) standards, an evaluation of the risks remaining (i.e., residual risks) is required
to assure protection of public health. The residual risk provisions of the CAA highlight the need to
begin now to identify and perform needed research to improve the data and methods used in risk
assessment.

The purpose of this document is to describe and present a compilation of data regarding
noncancer health effects (i.e., excluding cancer and genetic toxicity) resulting from atmospheric
exposures to hazardous air pollutants. This compilation complements earlier efforts to summarize
the genetic toxicity of the HAPs (Waters et al., 1990), and it supports identification of data gaps and
research needed to improve health risk assessment. The information should be valuable as part of
ongoing efforts by the EPA and State and local agencies to evaluate potential health concerns and
to prioritize research and regulatory activities.

It is imperative for users to recognize the limitations inherent in any summary of this kind.
The procedures do not provide a comprehensive toxicological evaluation of the HAPs, but rather
focus exclusively on inhalation exposures. The analysis is based exclusively on data from selected

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secondary sources, and only selected information from individual studies was included. Although the
data are footnoted extensively, secondary sources and/or primary literature must be reviewed to
evaluate toxicity comprehensively. Additionally, data regarding human responses or lack thereof
should be considered with caution due to the typically uncertain nature of human exposure conditions
and assumptions employed in summarizing human studies herein.
2.0 METHOD

2.1 Overview

Data on noncancer toxicity were extracted from U.S. Environmental Protection Agency (EPA)
and Agency for Toxic Substances and Disease Registry (ATSDR) documents and data files and from
the Hazardous Substances Data Bank (HSDB) of the National Library of Medicine (NLM). For each
chemical evaluated, the extracted quantitative and qualitative information was compiled in a
computerized data file. Data extraction and compilation efforts were based on the protocol
summarized below. The sources of data evaluated for each HAP are identified in Table 1. In
addition to the information contained in this report, there are explanatory notes associated with
individual data entries. These notes call attention to any unusual or uncertain study conditions or
data extraction assumptions and should be carefully reviewed.

Of the 189 HAPs listed in the 1990 Amendments to the Clean Air Act, 173 are unique
substances identifiable by Chemical Abstract Services (CAS) Registry numbers; the health effects data
for only these chemicals were evaluated.

23. Data Sources

This compilation is based on data presented in secondary sources. No primary literature was
used. Seven sources of data were chosen for use in this project: EPA's Integrated Risk Information
System (IRIS); EPA's Health Assessment Documents (HADs); EPA's Drinking Water Criteria
Documents (DWCDs); ATSDR's Toxicological Profiles (TPs) and Supplemental Tables (STs);
NLM's Hazardous Substances Data Base (HSDB); and EPA's Health Effects Assessment Summary
Tables (HEAST). For some of the documents, only a draft version was available. In these cases the
draft document was used; if the source document was a draft, this information is given. Data sources
evaluated, their status (e.g., if the source document was a draft), and release date are included in the
Reference section contained in the data listing for each chemical. A brief description of the sources
and how they were used follows.

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2.2.1 Integrated Risk Information System (IRIS)

IRIS is an on-line data base, maintained by EPA, containing health risk information and EPA
regulatory information on specific chemicals. For each chemical, available pertinent information (i.e.,
toxicity data on health effects other than cancer) was extracted and entered into a data file.

2.2.2 Health Assessment Documents (HADs)

HADs are developed by the EPA Office of Health and Environmental Assessment to serve
as source documents for the Agency to use in determining potential health effects. Each presents
comprehensive data for a specific chemical. For each chemical for which this document was available,
the entire HAD was reviewed, and pertinent inhalation data were extracted and entered into a data
file.

2.2.3 Drinking Water Criteria Documents (DWCDs)

DWCDs are developed for specific, regulated chemicals by EPA's Environmental Criteria and
Assessment Office to aid the Office of Water in developing and setting health criteria and standards
under the Safe Drinking Water Act. The documents summarize existing studies obtained through
the literature and confidential reports submitted by chemical manufacturers. For each chemical,
available inhalation-exposure information contained in the Health Effects sections for humans and
animals was extracted and entered into a data file.

2.2.4 ATSDR Supplemental Tables (STs) and Toxicological Profiles (TPs)

The ATSDR develops toxicological profiles for each chemical on the Superfund list of
hazardous substances most commonly found at hazardous waste sites. To facilitate the preparation
of toxicological profiles, ATSDR develops Supplemental Tables. These chemical-specific tables list
all pertinent studies, their parameters, and observed effects in addition to LC50s (concentrations
producing mortality in 50% ,of exposed animals), Lowest Observed Adverse Effect Levels (LOAELs),
and No Observed Adverse Effect Levels (NOAELs). The tables are divided by physiological system.
For each chemical, the ST was reviewed if it was available, and pertinent inhalation data were
extracted and entered into a data file.

ATSDR develops the profiles using the Supplemental Tables to identify key studies. Studies
that are inadequate for various reasons are not used to develop the profiles. For this project,
information was extracted from the Supplemental Tables for expediency; no attempt was made to
delete any studies that were not included in the profiles. The profiles were used only to clarify
information presented in the Supplemental Tables. In the event of a discrepancy between the TP
and ST, the TP was assumed to be correct (e.g., in some cases the concentration units differed
between the TP and ST).

2.2.5 Hazardous Substances Data Bank (HSDB)

HSDB is an on-line data base maintained by the National Library of Medicine. It contains
data on more than 4,100 chemicals. Core information is derived from standard textbooks,
monographs, government documents, technical reports, and scientific journals. For each Tier 4
chemical (see below), the HSDB was reviewed when available, and pertinent inhalation data were

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extracted and entered into a data file. For this project, the HSDB sections used were the emergency
toxicology, human and nonhuman toxicity excerpts, toxicity values, human and nonhuman toxicity
values, and clinical effects.

2.2.6 Health Effects Assessment Summary Tables (HEAST)

The EPA Health Effects Assessment Summary Tables are developed as a "pointer" system to
identify literature or changes in assessment criteria for many chemicals of interest to the Superfund
program. For each Tier 4 chemical (see below), the HEAST was reviewed when available and
pertinent inhalation data were extracted and entered into a data file. Overall, very little data came
from this source.

23 Tiers

A system was developed to determine the scope of sources evaluated for each chemical.
Depending on the secondary sources available for a HAP, it was assigned to one of four tiers. In
every case, IRIS was reviewed, if available, and data were extracted and compiled in a data file.
Then, for chemicals assigned to Tier 1 (i.e., chemicals for which a HAD was available), Tier 2 (i.e.,
chemicals for which a HAD was not available but a DWCD was available) and Tier 3 (i.e., chemicals
for which neither a HAD nor DWCD were available but a TP or ST were available), the selected
documents (i.e., HAD, DWCD, TP, ST) were reviewed in a priority order, and data were extracted
and compiled. If none of these selected documents were available, the chemical was assigned to Tier
4, the HSDB and HEAST were reviewed, if available, and data were extracted and compiled. Table
1 indicates which reference sources were used for each chemical.

It should be noted that the apparent absence of toxicologic data does not necessarily mean
that none exists. First, no information on oral effects was included. Second, due to the tier approach
used, not all seven possible types of documents were reviewed, for each chemical. For example, for
a Tier 3 chemical, only IRIS and the ATSDR documents (ST and/or TP) were reviewed, even if
additional information was available from HSDB and HEAST (e.g., HSDB and HEAST were
reviewed only for Tier 4 chemicals). Third, since literature searches were not conducted for the
chemicals, other primary source information may exist.

2.4 Data Interpretation Precedence

In some cases secondary sources differed in interpretation of studies. An order of precedence
was established to consistently select an interpretation. The order of precedence was as follows:
EPA's Integrated Risk Information System > EPA Health Assessment Documents > EPA Drinking
Water Criteria Documents > ATSDR Supplemental Tables > ATSDR Toxicity Profiles > NLM
HSDB > EPA's Health Effects Assessment Summary Tables.
3.0
PROTOCOL
3.1 Information Included

Information from inhalation exposures (for ocular and dermal effects, atmospheric exposures
were also included) was reviewed and summarized (i.e., exposure routes, including oral, and
intraperitoneal and intramuscular injection, were not used to avoid route-to-route extrapolation

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uncertainties).  Among the data included in the inventory were the following categories: species
studied; response (either positive "Effects" or negative "No Effects" in each physiological system
studied); an abbreviated citation (author, year) to identify the study within the secondary source; the
number of animals studied per dose group (or number of people exposed); and information necessary
to characterize the exposure conditions, i.e., concentration, frequency (hours per day, days per week)
and duration of exposure. The exposure conditions were used to classify individual studies as acute
(exposures less than or equal to 24 hours); subchronic (exposures from 1 day through approximately
10% of species lifespan); and chronic (exposures greater than approximately 10% of species lifespan).
A reference for the secondary source was shown for each line of data, and a coding system was
consistently used  (i.e., IRIS=1, HAD=2,  DWCD=3, ST=4, TP=5, HSDB=6,  HEAST=7).
Explanatory notes also were included. These notes call attention to any unusual or uncertain study
conditions or data extraction assumptions and are essential to informed data interpretation.

3.2    Definition of Toxicity Categories

3.2.1  Measures of Toxicity

       For each study, the response (either positive  "Effects" or negative "No Effects") in each
physiological system, in each species, in each  of the exposure duration categories  (i.e., acute,
subchronic, chronic) was included in the data base. For studies with numerous dose groups, only the
lowest dose producing an effect and the  highest ineffective dose were included (the  terms Lowest
Effective Dose (LED) and Highest Ineffective Dose (HID) were used by Kavlock et al., 1991, and
these dose groups correspond to the lowest observed adverse effect level (LOAEL) and no observed
adverse effect level (NOAEL), respectively)3.

       References and authors may differ in their criteria for determining whether a response was
positive  or not.  If a secondary source  defined a LOAEL/NOAEL for  a particular effect, that
interpretation was entered into the data files as an Effect/No Effect value. It is important to keep
in mind that two secondary sources may evaluate the same observation differently (hence the data
interpretation precedence, discussed in section 2.4).

       In cases where an effect at a given concentration was listed without stating explicitly whether
it was considered as a LOAEL for the affected organ or system, an Effect for that organ/system was
entered  into the data file  (i.e., a positive response was assumed).  This situation  arose often.  In
addition, if the source did not state whether an effect was significant or not, it was assumed that it
was significant, and an Effect was entered into the data file.

        The Effect and No Effect responses are shown as "Yes" and  "No", respectively, under the
"Health Effects" column in the Appendix, and as points above the midline and below, respectively,
in the graphic activity patterns (described below).
     3For example, if a study had seven dose groups and three were reported to produce no effects while
 four produced effects for a particular physiological system, only the highest dose producing no effects and
 the lowest dose producing effects were included in the data base.

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3.2.2 LC5(f

Data for concentrations producing death in 50% of the animals (i.e., LC50s) were included.
LC50 values were preferentially entered for experiments in which the entire dose was administered
in 1 day. If only multiple-day LC50 experiments were found, the reported multiple-day LC50 was
entered along with the exposure duration. LC50 data are listed under the "acute" study type.

3.2.3 Death

Dose levels producing 2:10% excess mortality in animals were not entered into the data files
even when identified as a LOAEL by the source. Doses producing death in animals were entered
only if the result was presented as an LC50.

In order to include information on lethality in humans only, death was considered to be a
"system" for purposes of entering an Effect.

3.2.4 Qualifications

Animals and Humans

When both males and females were tested and the Effect level was different for each sex, the
lowest dose was reported, as was the number of animals corresponding to the number of males
[females] tested at each dose, not the combined number of animals tested. Such cases are shown with
a line note indicating "Effect at this level observed in males [females] only" or "Effect observed in
males [females] only," whichever applies.

When the No Effect level was different for males and females, the lowest dose was included
in the data file with the combined number of males and females tested at each dose.

If a range of doses was reported, the lowest concentration in the range was entered for an
Effect, or the highest for No Effects, with the range and average (if available) provided in a footnote.
However, if the time-weighted average concentration was reported, this value (rather than the lower
[upper] bound) was entered as the Effect [No Effect] concentration and was footnoted accordingly.
Animals

For animals, if a significant decrease in body weight gain was reported at a given
concentration, it was entered as a Systemic Effect. However, the next lowest concentration (i.e., the
highest concentration at which there was no decrease in body weight gain) was not entered as a
systemic No Effect unless some other information indicated that the animals were not experiencing
generalized systemic toxicity. Additional criteria, such as a normal clinical chemistry report or an
observation such as "Animals showed no signs of being affected," were taken to be sufficient for the
purpose of entering a systemic No Effect value. Note that this means some No Effect records are
based on very insensitive observations while others are based on very targeted and sensitive
endpoints.

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Studies for which the exposure concentration was not provided were excluded, as were studies
that were blatantly poor. A lack of dose-response was generally grounds for excluding a study.
Median lifespan studies were excluded. Also excluded were animal studies for which the total
exposure duration (e.g., days, weeks, months or years) was not reported unless no other data were
reported for a species/system/duration category. In such cases, best judgment was used to classify the
study with regard to duration (i.e., acute, subchronic or chronic). Studies in which the animals were
pretreated with another chemical (e.g., epinephrine) were included. In all cases, any assumptions
made or unusual study characteristics were noted.

Humans

Exposure-related death or specific toxic effects reported in humans were included in the data
files along with values, if given, for exposure duration and dose. Only for humans were Effects
entered, even if exposure duration and dose were unknown. Similarly, only for humans were Effects
entered, even if the route of exposure was not explicitly stated; in instances when the route of
exposure was assumed to be inhalation, this is indicated in a note. Human studies frequently have
many inherent limitations, including lack of testing at multiple dose levels. Consequently, some
observations of effects for humans entered into the data files may represent only the dose at which
an effect was found; they may not be the lowest dose that can elicit the effect. For experimental
human studies, a lack of dose-response was generally grounds for excluding a study. For human
epidemiology studies, studies were not excluded only because a dose-response was not observed.

Human information comes in several forms: epidemiologic studies (usually occupational),
experimental studies, case reports, and symptomatology information (mostly found in the HSDB).
For human epidemiological and experimental studies, all studies were entered separately.

For human case reports, if the exposure concentration or information related to the exposure
was reported, the study was entered separately. If exposure concentration or exposure-related
information was not given, the case reports were typically combined and were footnoted accordingly.

For humans, anecdotal descriptions of clinical effects with no concentration data were entered
only when better-quality information, such as epidemiologic, experimental, or case report studies, for
a given system/duration category was not provided. Anecdotal information was commonly
encountered in HSDB. When such data were included, only one entry was made for each
system/duration category. The lack of concentration data was indicated by entering "unk" (for
"unknown") in the dose column.

Exposure concentrations were required for inclusion in the graphic activity profiles, described
in Section 5. Studies in which exposure conditions were unknown are not shown on the profiles, but
they are shown on the data listing accompanying the profiles. This situation was common for
observations in humans.

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33 Species

The species and route were entered for each line of data. The data files contain data on 20
species. The species are:

baboon
cat
chicken
cow
dog
fox
gerbil
goat
guinea pig (g. pig)
hamster
human
mink
monkey
mouse
Pig
pigeon
quail
rabbit
raccoon
rat

3.4 Route

This compilation is based on studies using inhalation as the route of exposure.

For human data only, when information as to exposure route was lacking, and best judgment
indicated that the exposure route might possibly have been inhalation, the default procedure was to
assume that the exposure route was inhalation and to state this assumption in the footnotes.
However, it is possible and perhaps likely that for many chemicals the adverse health effects observed
were due to oral or dermal exposure. Because of the limited information provided in HSDB, if the
exposure route was not specified, inhalation was assumed as the route of exposure for compounds
with high vapor pressures. Although it is likely that effects on the eye resulted from direct contact
of vapor, aerosol, or liquid with the eye, ocular effects were assigned the exposure route "inhalation"
in the absence of information stating that direct contact had occurred. Thus, for effects on the eye,
"inhalation" may be interpreted as contact with vapor, aerosol, or liquid.

3.5 Physiological Systems

The physiological systems included are: behavioral, bone, cardiovascular, death, dermal,
developmental, endocrine, exocrine, gastrointestinal, hematopoietic, hepatic, immunologic, multiple
systems, muscular, neurological, ocular (eye), olfactory, pancreatic, renal, reproductive, respiratory,
splenic, and systemic. These physiological system categories are further described below.
8

-------
If an effect overlaps two systems, such as a change in acetylcholinesterase activity, which may
be considered as a neurological and a muscular effect, Effect and No Effect data were entered for
both physiological systems.

No distinction between slight and serious effects was made. For example, effects such as
headache, ataxia, and histopathological changes in the brain all were categorized as "neurological."
No distinction was made between central nervous system effects, which can be life-threatening, and
peripheral nervous system effects, which are rarely life-threatening.

The physiological system categories were defined generally. Some exceptions and guidelines
used in categorization follow. If effects were clearly identified in the source document as secondary,
they were included with the note "Secondary effect(s)."

The ATSDR Guidelines were used for guidance in sorting out effects by physiologic system
("Guidance for the Preparation of the 5th Set Toxicological Profile, Agency for Toxic Substances and
Disease Registry, US. Public Health Service, June 1990). These guidelines were particularly helpful
with regard to neurological, reproductive, developmental, and immunological effects endpoints. In
accordance with these guidelines and for the purpose of this document, a reproductive effect was
defined as occurring prior to implantation, whereas a developmental effect was defined as occurring
after implantation.

The following notes provide guidance on what effects each category encompasses and also
indicate, for certain effects, to which physiologic system they were assigned.

Acetylcholinesterase. Effects related to acetylcholinesterase were included as neurological
and muscular along with other affected systems (e.g., respiratory).

Adrenal Effects in the adrenal were considered as follows:

hypertrophy - endocrine
atrophy - endocrine or neurological, depending on the effects noted
if renal effects and adrenal effects - endocrine
if reproductive study and the type of adrenal effect is not specified - endocrine

Behavioral This category included effects like hypoactivity, hyperactivity, and effects on
grooming behavior.

Bone. This category included effects such as osteoporosis and effects on teeth. It did not
include bone marrow effects, which were included under hematopoietic.

Cardiovascular. This category included all effects to the heart and circulatory system,
including effects such as hunchback, huddling, and shivering (see below, under "hunchback").
Vascular effects (e.g., hypotension, cerebrovascular illness) were included in this system, as
was hyperemia.

Cholinesterase. Depression of cholinesterase was included as a neurological effect as well as
for any other system(s) mentioned. •

-------
Death. Death was included as a system only for human studies. If there was an LC50 for
humans, it was entered under the acute duration category, with the system listed as death.
All other deaths were entered under the appropriate time-duration category. If no duration
category was given, the default observation was an acute exposure of 1-day duration unless
it appeared to be a longer study (e.g., occupational exposure) in which case the default was
subchronic. For humans, even if the endpoint was death, other effects observed were also
included. For example, if a worker experienced eye and nose irritation and cardiovascular
effects prior to dying, ocular, respiratory, and cardiovascular effects were included in addition
to death.

DermaL This classification encompassed all effects on the skin.

Developmental. Effects after implantation were considered developmental. Examples of
developmental effects include malformations of the fetus, low birth weight, increased
number(s) of miscarriages, increased number of resorptions, and high fetal mortality. If
maternal toxicity was also reported at the lowest Effect concentration for a developmental
effect, then a separate Effect concentration for the mothers was included on a separate data
line. For example, if the mothers exhibited a decreased weight gain and the fetuses had
reduced birth weights, then Effect concentrations were included for the system categories
"systemic" (for the mothers) and "developmental" (for the fetuses).

Endocrine. This system classification included all effects related to internal secretions and
the glands that produce those internal secretions, including adrenal effects, thyroid effects,
and effects on milk production.

Exocrine. Tears and sweat were classified under exocrine. Salivation in conjunction with
neurological effects was entered as neurological; salivation in the absence of neurological
effects was considered an exocrine effect. Multiple exocrine effects (e.g., salivation, sweating)
were entered as "exocrine" regardless of whether neurological effects were also seen.
Affected exocrine functions that are controlled by the endocrine system (e.g., milk
production) were listed as "endocrine." (Milk production was not considered a reproductive
effect.)

Gastrointestinal. All stomach and intestinal effects were included in this category. In the
absence of neurological effects, nausea was listed as gastrointestinal. Multiple gastrointestinal
effects were included as gastrointestinal, regardless of whether neurological effects were also
seen.

Hematopoietic. If a test was specific for blood (e.g., red cell count), it was included as
hematopoietic. Hematopoietic was also used for effects in bone marrow; decreased leukocyte
counts; and increased leukocyte alkaline phosphatase. Blood or serum chemistry not
otherwise specified was considered systemic. Nucleic acid in blood was not considered a
hematopoietic effect, as it could indicate toxic response in an organ; this was reported as a
systemic effect in the absence of additional information.

Hepatic. This classification encompassed all effects on the liver.
10

-------
Hunchback, huddling, shivering: These symptoms are probably due to reduced blood
pressure; therefore, cardiovascular was listed as the system, especially if shock was indicated.
The system could also be neurological, but neurological was used only if adequate information
was given; the default was cardiovascular.

Hyperplasia. Because hyperplasia may, in some cases, be considered a stage in the
development of cancer, hyperplasia was not considered to be a non-cancer endpoint for the
purposes of this document. Therefore, effects based exclusively on hyperplasia were not
included.

Hyperventflation. Hyperventilation was included as a systemic effect.

Immunologic. This involved decreased immune function, or increased susceptibility to
infection. Changes in white blood cell count were classified as hematopoietic.

Multiple. The multiple No Effects category was used when a number of unspecified systems
were investigated in a relatively unspecified manner (e.g., histopathological) and no effects
were found (Note: this "system" classification was used only for No Effects, never for Effects).
It was possible to have both a systemic and a multiple No Effect. If there was no deficit in
body weight and the animals showed no toxic effects as evidenced by histopathology, blood
chemistry, etc., this was considered a systemic No Effect. If a study did not specify what
organs were examined, but did state, for example, that "no other effects were observed," then
a Multiple No Effect was assigned to the highest concentration based on the histopathology
of a number of unspecified organs. If systems were specifically named as being investigated,
the No Effects were specific to those systems.

Muscular. This category included muscular weakness and degeneration. Effects related to
acetylcholinesterase were included as neurological and muscular.

NeurologicaL This category included all effects to both the central and peripheral nervous
systems. Headache was included. Nausea in conjunction with neurological effects was
included as neurological, as were effects on reflexes, motor skills, coordination, or learning
and memory. Effects related to cholinesterase activity were included as neurological effects.

Ocular. This classification encompassed all effects on the eye.

Olfactory. Olfactory was used to account for effects on, for example, nasal olfactory
epithelium. Exceeding an odor threshold was not considered an Effect

Pancreas. Effects related to the pancreas (which serves both exocrine and endocrine
functions) were classified as "pancreatic."

RenaL Increased or high levels of blood urea nitrogen and all kidney effects were classified
as renal.

Reproductive. Effects up to the time of implantation were considered reproductive.
Examples of reproductive effects include effects on the reproductive organs and decreased
fertility.

-------
Respiratory. All effects on the respiratory system (e.g., lungs, trachea, bronchioles) were
included in this category. Asthma was considered a respiratory effect. Effects related to nasal
turbinates were also classified as respiratory.

Splenic. This classification encompassed all effects on the spleen.

Systemic. Systemic effects included effects such as lack of weight gain, decreased weight gain,
or weight loss of the animal as a whole. Weight gain or loss in specific organs (both relative
and absolute) was listed as an effect under that organ system. Example: relative increase in
weight of liver was listed as a hepatic effect. Lack of weight gain or weight loss cannot in
itself be considered a No Effect for systemic effects, however. To be conservative, a systemic
No Effect was assigned only when weight changes had not occurred and a thorough, system-
wide analysis (e.g., blood chemistry, histopathology) had been conducted. A systemic Effect
was assigned if there were any negative weight changes. Systemic also applies to overall body
effects, e.g., weakness and cyanosis. Hyperventilation was also included as a systemic effect.

Thymus. Effects in the thymus were considered as follows:

hypertrophy - endocrine
atrophy - endocrine or immunologic, depending on the effects noted

Weight loss, lack of weight gain, or decreased weight gain. See "systemic"

3.6 Duration/Frequency of Exposure

3.6.1 Humans and Animals

The exposure duration corresponds to the time effects were observed (if indicated) and not
necessarily to the entire length of the study. For exposures associated with Effects, if a range of daily
exposure was given, the shortest duration and a note indicating the range were entered into the data
file. For No Effects reported from a range of daily exposure durations and frequencies, the largest
value, not the smallest, and a note including the range were entered into the data file (e.g., if the
range was 1-7.5 hr/d, then 7.5 was included in the file with a footnote).

When animals/people were acutely exposed to several concentration/duration combinations
(e.g., 1, 3, and 10 ppm for 60, 20, and 6 min, respectively), the lowest concentration, along with its
respective duration (e.g., 1 ppm for 60 min), was entered into the data files. For longer exposure
durations, (Le., subchronic and chronic), each concentration/duration combination was included as
a separate study.

When animals/people were exposed to the same concentration but for different exposure
durations, the results were included as follows: if two groups of rats were exposed to 10 ppm for 10
and 20 weeks, respectively, and respiratory effects were observed for both durations, the results for
the shorter exposure duration and a note stating whether or not the effects were also observed in rats
exposed for 20 weeks were included in the data file. Any additional effects observed only among the
rats exposed for 20 weeks (e.g., systemic and renal effects) were also entered.
12

-------
3.6.2 Definition of Exposure Duration Categories

Assignment to an exposure duration category was based on standard toxicological definitions:
acute, 1 day or less; subchronic, <;10% of lifespan; chronic, >10% of lifespan. There was one
exception to this rule: for mice and rats, for which 10 weeks constitutes 10% of their lifespan, a 13-
week study was considered to be a subchronic study, not a chronic study. When a range of exposure
durations was reported for a given study, the study was assigned to an exposure category based on
the shortest duration and the range was entered into the duration column. The standard values for
the expected lifetime of each species are shown in Table 2.

For studies of developmental effects, the exposure duration was often described by the
secondary sources in general terms such as "exposure throughout gestation and lactation period." In
such cases the standard values for gestation and weaning shown in Table 3 were used to categorize
the exposure duration.

3.6.3 Default Assumptions

For studies in animals for which the frequency and duration of exposure were not provided,
the default assumption was 6 hrs/day, 5 days/wk. If exposure in animals was reported as 7 days or
less, however, it was assumed that exposure was for 7 days/wk. For occupational studies in humans,
the default assumption was 8 hrs/day, 5 days/wk. All assumptions are clearly indicated in the
footnotes.

3.7 Number of Animals/Humans

In general, the number of animals/humans studied at the dose corresponding to the Effect
or No Effect response is shown in the data listing for each chemical. However, for human data, this
number sometimes refers to the number of persons exposed and other times to the number of cases
reported. When available, the number of persons exposed was reported in the Number Exposed data
field column. In some cases, the source did not specify what the given number represented and a
note was included to that effect. In general, if the number is small (<10), it is likely to refer to case
reports and will therefore indicate the number of cases, not the number of persons exposed.

When both males and females were tested and the LC50 or Effect concentration was different
for each sex, the lowest dose was included in the data file and the number of animals shown
corresponds to the number of males [females] tested at each dose, not the combined number of
females and males tested at each dose. When the No Effect concentration was different for males
and females, the lowest dose was included and the number of animals corresponds to the combined
total of males and females tested at each dose.

3.8 References

All references (i.e., secondary sources) that were used to obtain data are clearly documented
in the data listing for each chemical. In addition, an abbreviated citation of the author(s) and year
for the original source (e.g., Smith and Jones, 1988) is shown for each data line. The full citation can
be located using the secondary source documents.
13

-------
Specifically excluded from the data files were all animal studies published in non-German,
Eastern Bloc journals, with the exception of a Bulgarian study on carbon disulfide by Tabacova and
coauthors, which was used because it had previously been reviewed by EPA scientists. German
studies were entered, including those published in what was formerly East Germany.

3.9 Notes

The notes contain important information on the type of study conducted, ranges reported for
doses or exposures, pretreatment, unusual conditions or outcomes, assumptions, and other pertinent
information.

4.0 QUALITY CONTROL AND QUALITY ASSURANCE

The procedures for source document review, data selection and interpretation, data extraction,
and compilation were based on a written protocol. As new substances were reviewed, new issues
were raised; this process led to a continual evolution of the protocol during the initial phase of the
project. In such cases, files completed before the protocol was finalized were revisited and revised
to conform with the final protocol.

For each of the 173 HAPs, the source document review, data selection and interpretation,
and data entry were performed by one health scientist and confirmed by a second health scientist
from an independent organization. Corrections and changes made by the second scientist were also
confirmed.

Software routines were used to sort the data files into the appropriate categories, and the data
listings were reviewed to ensure that the sorting operations were performed correctly.

5.0 DATA PRESENTATION: GRAPHIC ACTEVITY PROFILES

The individual data files were aggregated and processed to generate a computerized data file.
The data format enabled graphic presentation of information similar to displays used previously for
genetic toxicity data (Waters et al, 1988) and developmental toxicity data (Kavlock et al., 1991). Bar
graphs ("activity profiles") were used to present descriptive (positive/negative, physiological system)
and quantitative (e.g., exposure concentration) results across test systems. For each chemical, the
data are presented separately for acute, subchronic and chronic exposure durations. Within each of
these exposure groups, the toxicity data are displayed along the horizontal or x-axis, with each test
species and system being designated by a three-letter code, and a logarithmic concentration scale is
shown on the vertical or y-axis. The three-letter code (Table 4) is used to link the activity profiles
to a data listing with the code representing the species and system (e.g., rat study of respiratory
toxicity). This format, modified from that used by Kavlock et al. (1991), allows rapid visualization of
the types of species, systems and concentration levels studied and the response observed.

The type of toxicity observed in the studies (e.g., neurotoxicity, pulmonary toxicity) are labeled
along the horizontal axis. Local or portal of entry effects are presented towards the left side of each
activity profile while systemic effects are presented towards the middle and right side of each profile.
Some aggregation of endpoints was necessary due to software and plotting limitations (e.g.,
reproductive and developmental toxicity are found together under "repro/devel"). Along the top and
14

-------
bottom margins of each profile and in line with the profile lines are plotted the three-letter test
species-system codes.

To accommodate the wide range of concentrations and positive and negative test results,
concentrations were transformed logarithmically (Garrett et al., 1984). The concentration range
associated with positive responses (Effects) is from 100,000 to 0.001 mg/m3 and the concentration
range for exposures resulting in No Effects is from 100,000 to 1.0 mg/nr. Results with Effects are
plotted above a reference line and results with No Effect are plotted below the reference line. The
length of the profile line is proportional to the potency for positive results and lack thereof for
negative results.

The average of the logarithmic values of the data for each endpoint was calculated and
plotted on the profile. Individual results are indicated by hash marks along each profile line. When
results for a given test species-system endpoint were either all positive or all negative, the average
of the responses was plotted as a solid line. If conflicting data were reported for the same endpoint,
the weight of evidence was shown by the solid line to indicate the majority of the data. A dotted line
was drawn to the maximal response of the minority data. In the event that an equal amount of
positive and negative data existed, the solid line was drawn in the positive direction (Waters et al.,
1988).

The data used to generate the profiles, as well as qualitative data inadequate for presentation
in the profiles, are listed immediately following the profile(s) for each chemical. The data listing
follows the same sequence used in the profiles, with the first data listed corresponding to the profile
lines closest to the left margin and the last data listed corresponding to the profile lines closest to the
right margin.

All qualitative data (e.g., effects in humans but inadequate exposure data for quantitative
characterization) are shown in the data listing for each chemical. In cases where the exposure data
was not known, the abbreviation "unk" is shown. In such cases, the data are qualitative only and are
not plotted on the profiles-

Profiles are not included in cases where no quantitative data were identified. The activity
profiles and data listings are presented in the Appendix.
15

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6.0    REFERENCES
       Clean Air Act Amendments of 1977 - P.L. 95-95 (August 7, 1977). Section 112(a)(l).

       Clean Air Act Amendments of 1990 - P.L. 101-549 (November 15, 1990). Title HI, Section
       112.

       Garrett, N.E., Stack, H.F., Gross, M.R., Waters, M.D. (1984).  Evaluation of the genetic
       activity profiles of 65 pesticides. Mutat. Res., 168: 89-111.

       Hassett-Sipple, B., Cote I., Vandenberg, J. (1991). Toxic Air Pollutants and Noncancer Health
       Risks - United States and a Midwestern  Urban County. Morbidity  and Mortality Weekly
       Report, May 3, 1991: 278.

       Kavlock, R.J., Greene, J.A., Kimmel, G.L., et al. (1991). Activity profiles of developmental
       toxicity: design considerations and pilot implementation. Teratology 43: 159-185.

       U.S. Environmental Protection Agency (1990a).  Toxics in the Community: 1988 National and
       Local Perspectives.  Washington B.C.  EPA/560/4-90-017.

       U.S. Environmental Protection Agency (1990b). Cancer risks from outdoor exposures to air
       toxics. Washington, D.C. EPA-450/1-90/004A.

       Waters, M.D., Stack, H.F., Brady, AL., et al. (1988).  Use of computerized data listings and
       activity profiles of genetic and related effects in the review of 195 compounds. Mutat. Res.,
       205: 295-312.

       Waters, M.D., Stack, H.F., Jackson, M.A. (1990).  Genetic activity profiles of 110 hazardous
       air pollutants listed under Title III of the Clean Air Act (CAA) as  amended. October 30,
       1990, internal EPA/HERL report deliverable #3127.
                                            16

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Table 1.  Secondary Reference Sources Evaluated
          for Noncancer Toxicity Data
CAS#
75-07-0
60-35-5
75-05-8
98-86-2
53-96-3
107-02-8
79-06-1
79-10-7
107-13-1
107-05-1
92-67-1
62-53-3
90-04-0
1332-21-4
71-43-2
92-87-5
98-07-7
100-44-7
92-52-4
117-81-7
542-88-1
175-25-2
106-99-0
156-62-7
105-60-2
133-06-2
Chemical Name
Acetaldehyde
Acetamide
Acetonitrile
Acetophenone
2-Acetylaminofluorine
Acrolein
Acrylamide
Acrylic acid
Acrylonitrile
Allyl chloride
4-Aminobiphenyl
Aniline
o-Anisidine
Asbestos
Benzene (including
benzene from gasoline)
Benzidine
Benzotrichloride
Benzyl chloride
1,1-Biphenyl
Bis(2-ethylhexyl)
phthalate (DEHP)
Bis(chloromethyl)ether
Bromoform
1,3-Butadiene
Calcium cyanamide
Caprolactarri
Captan
mis
/

/
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                       17

-------
TaHe 1. (continued)
|CAS#
63-25-2
75-15-0
56-23-5
463-58-1
120-80-9
133-90-4
57-74-9
7782-50-5
79-11-8
532-27-4
I 108-90-7
510-15-6
67-66-3
I 107-30-2
126-99-8
1319-77-3
108-39-4
95-48-7
10644-5
198-82-5
94-75-7
3547-04-4
334-88-3
132-64-9
96-12-8
84-74-2
	 — 	
j 106-46-7
1 91-94-1
Chemical Name
Carbatyl
Carbon disulfide
Carbon tetrachloride
Carbonyl sulfide
Catechol
Chloramben
Chlordane
Chlorine
Chloroacetic acid
2-Chloroacetophenone
Chlorobenzene
Chlorobenzilate
Chlorofonn
Chloromethyl methyl ether
(CMME)
Chloroprene
Cresols/Cresylic acid
(isomers and mixture)
m-Cresol
o-Cresol
p-Cresol
Cumene
2,4-D, salts and esters
DDE
Diazomethane
Dibenzofurans
l,2-Dibromo-3-chloropropane
Dibutylphthalate
l,4-Dichlorobenzene(p)
3,3-Dichlorobenzidene
mis
/
/
/


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      18

-------
Table 1. (continued)
li — 	 T
CAS#
111-44-4
542-75-6
62-73-7
111-42-2
121-69-7
64-67-5
119-90-4
60-11-7
119-93-7
79-44-7

57-14-7
131-11-3
77-78-1
534-52-1
51-28-5
121-14-2
123-91-1
122-66-7
106-89-8
106-88-7
140-88-5
100-41-5
51-79-6
75-00-3
1067-93-4
107-06-2

1
Chemical Name
Dichloroethyl ether
(Bis(2-chloroethyl)ether)
1,3-Dichloropropene
Dichlorvos
Diethanolamine
N,N-Diethyl aniline
(N,N-Dimethylaniline)
Diethyl sulfate
3,3-Dimethoxybenzidine
Dimethyl aminoazobenzene
3,3' -Dimethyl benzidine
Dimethyl carbamoyl chloride
N,N-Dimethylformamide
1,1-Dimethyl hydrazine
Dimethyl phthalate
Dimethyl sulfate
4,6-Dinitro-o-cresol, and salts
2,4-Dinitrophenol
2,4-Dinitrotoluene
1,4-Dioxane
(1,4-Diethyleneoxide)
1,2-Diphenylhydrazine
Epichlorohydrin
(l,-Chloro-2,3-epoxypropane)
1,2-Epoxybutane
Ethyl acrylate
Ethyl benzene
Ethyl carbamate (Urethane)
Ethyl chloride (Chloroethane)
Ethylene dibromide
(Dibromomethane)
Ethylene dichloride
(1,2-Dichloroethane)
Ethylene glycol
— ^g
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           19

-------
. Table 1. (continued)
CAS#
I 151-56-4
II 75-21-8
I 96-45-7
Ij 	
75-34-3
	
50-00-0
76-44-8
	 — 	
118-74-1
	
87-68-3
| 77-47-4
1 67-72-1
1 822-06-0
H 680-31-9
	 — 	
110-54-3
302-01-2
7647-01-0
7664-39-3
7783-06-4
	 _ 	
IJ 123-31-9
1 78-59-1
58-89-9
| 108-31-3
J 67-56-1
I 72-43-5
74-83-9
74-87-3
71-55-6
—
1 Chemical Name
Ethylene imine (Aziridine)
Ethylene oxide
Ethylene thiourea
Ethylidene dichloride
(1,1-Dichloroethane)
Formaldehyde
Heptachlor
Hexachlorobenzene
Hexachlorobutadiene
Hexachlorocyclopentadiene
Hexachloroethane
Hexamethylene-1,6 diisocyanate
Hexamethylphosphoramide
Hexane
Hydrazine
Hydrochloric acid
Hydrogen fluoride (Hydrofluoric
acid)
Hydrogen sulfide
Hydroquinone
Isophorone
Lindane (all isomers)
Maleic anhydride
Methanol
Methoxychlor
Methyl bromide
(Bromomethane)
Methyl chloride
Methyl chloroform
(1,1,1-Trichloroethane)
mis


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20

-------
Table 1. (continued)
CAS#
78-93-3
60-34-4
74-88-4
108-10-1
624-83-9
80-62-6
1634-04-4
101-14-4
75-09-2
101-68-8
101-77-9
91-20-3
98-95-3
92-93-3
100-02-7
79-46-9
684-93-5
62-75-9
58-89-2
56-38-2
82-68-8
87-86-5
108-95-2
106-50-3
75-44-5
7803-51-2
Chemical Name
Methyl ethyl ketone
(2-Butanone)
Methyl hydrazine
Methyl iodide (lodomethane)
Methyl isobutyl ketone
(Hexone)
Methyl isocyanate
Methyl methacrylate
Methyl tert butyl ether
4,4-Methylene bis
(2-chloroaniline)
Methylene chloride
(Dichloromethane)
Methylene diphenyl
diisocyanate (MDI)
4,4'-Methylenedianiline
Naphthalene
Nitrobenzene
4-Nitrobiphenyl
4-Nitrophenol
2-Nitropropane
N-Nitroso-N-methylurea
N-Nitrosodimethylamine
N-Nitrosomorpholine
Farathion
Pentachloronitrobenzene
(Quintoben/ene)
Pentachlorophenol
Phenol
p-Phenylenediamine
Phosgene
Phosphine
IRIS
/


S
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S
S

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/

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/
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^
        21

-------
Table 1. (continued)
CAS#
7723-14-0
85-44-9
1336-36-3
1120-71-4
57-57-8
123-38-6
114-26-1
78-87-5
75-56-9
75-55-8
91-22-5
106-51-4
100-42-5
96-09-3
1746-01-6
79-34-5
127-18-4
7550-45-0
108-88-3
95-80-7
584-84-9
95-53-4
8001-35-2
120-82-1
79-00-5
Chemical Name
Phosphorus
Phthalic anhydride
Pofychlorinated biphenyls
(Aroclors)
1,3-Propane sultone
beta-Propiolactone
Propionaldehyde
Propoxur (Baygon)
Propylene dichloride
(1,2-Dichloropropane)
1,2-Propylene oxide
1,2-Propylenimine
(2-Methyl aziridine)
Quinoline
Quinone
Styrene
Styrene-7,8-oxide
2,3,7,8-Tetrachlorodibenzo-p-
dioxin
1,1,2,2-TetrachIoroethane
Tetrachloroethylene
(Perchloroethylene)
Titanium tetrachloride
Toluene
2,4-Toluene diamine
2,4-Toluene diisocyanate
o-Toluidine
Toxaphene (chlorinated
camphene)
1,2,4-Trichlorobenzene
1,1,2-Trichloroethane
IRIS
^
/
/



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       22

-------
                                          Table 1. (continued)
CAS#
79-01-6
95-95-4
88-06-2
121-44-8
1582-09-8
540-84-1
108-05-4
593-60-2
75-01-4
75-35-4
1330-20-7
108-38-3
95-47-6
106-42-3
Chemical Name
Trichloroethylene
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
Triethylamine
Trifluralin
2,2,4-Trimethylpentane
Vinyl acetate
Vinyl bromidfc
Vinyl chloride
Vinylidene chloride
(1,1-Dichloroetnane)
Xylenes (isomers and mixture)
m-Xylenes
o-Xylenes
p-Xylenes
mis
/
/
/
/
s

/


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S

/



/

s
s
s
s
s
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S


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NOTES:
IRIS        =  EPA's Integrated Risk Information System
HAD        =  EPA's Health Assessment Document
DWCD      =  EPA's Drinking Water Criteria Document
ST/TP       =  ATSDR's Supplemental Tables (STs) and Toxicological Profiles (TPs)
HSDB       =  NLM's Hazardous Substances Data Bank
HEAST     =  EPA's Health Effects Assessment Summary Tables
                                                 23

-------
           Table 2: Ufespan Data for Assignment to Chronic/Subchronic Categories8
Species
Ufespan (years)
10%of Lifespan
Human
Monkey, rhesus
Baboon
Mouse
Rat
Guinea pig
Hamster
Gerbil
Rabbit, New Zealand
Cat
Dog, beagle
Chicken
Pig
Mink
       70b
       35
       55
       2
       2
       6
       2.5
       3
       6
       15
       15
       24
       28
       8
7yrs
3.5 yrs
5.5 yrs
<:13 wksb
<:13 wksb
0.6 yr = 7.2 mos = 31.2 wks
0.25 yr = 3 mos = 13 wks
0.3 yr = 3.6 mos = 15.6 wks
0.6 yr = 7.2 mos = 31.2 wks
1.5 yrs
1.5 yrs
2.4 yrs
2.8 yrs
0.8 yr = 9.6 mos
       "Source: U.S. Environmental Protection Agency. Recommendations for and Documentation
of Biological Values for Use in Risk Assessment.  EPA/600/6-87/008,  February  1988.   NTIS
Publication No. PB88-179874.

       bNot from source.
                                          24

-------
                      Table 3.  Gestation Period and Age at Weaning
Gestation3 Weaningb
(days) (days)
Mouse
Rat
Guinea pig
Hamster
Pig
Rabbit
21 21 days
21 21 days
69
15
114 7 weeks0
31
       aSource:  Lush, J. 1945.  Animal Breeding Plans. Iowa State University Press, Ames, Iowa.

       bSource:  U.S. Environmental Protection Agency. Recommendations for and Documentation
of Biological Values for Use in Risk Assessment.  EPA/600/6-87/008,  February  1988.  NT1S
Publication No. PB88-179874.

       'Source:  National Academy of Sciences.   1971.  Swine:  Standards and Guidelines for
Breeding,  Care  and Management of Laboratory Animals.   National  Academy of Sciences,
Washington, D.C.
                                           25

-------
Table 4. Coding system used in the activity profiles to identify species and systems observed. The
first letter in each code identifies the species or species group; the second and thud letters identify
the system or system group. Grouping some species and systems was necessary due to software
limitations to enable profile display. For species and system groups (e.g., cat, cow and gerbH are all
shown in the profile as species group "X"), the data listing provides the exact species or system
studied (e.g., XKI = gerbfl renal system).
Species Codes
B Chicken
B Pigeon
B Quail
M Mouse
R Rat
G Guinea pig
L Rabbit
D Dog
X Cat
X Cow
X Gerbil
X Goat
X Hamster
P Baboon
P Monkey
H Human








System Codes
DR Dermal
EY Eye
RO Respiratory
RO Olfactory
GP Gastrointestinal
GP Pancreatic
CA Cardiovascular
HM Hematopoietic
SP Splenic
IM Immunologic
LI Hepatic
KI Renal
NB Neurological
NB Behavioral
MC Muscular
RP Reproductive
DV Developmental
MS Multiple
MS Systemic (usually weight loss)
OT Bone
OT Endocrine
OT Exocrine
LD LC50
DH Death (humans)
                                           26

-------
                                    APPENDIX

                            Hazardous Air Pollutants:
                            Graphic Activity Profiles of
                             Noncancer Toxicity from
                               Inhalation Exposures
       Graphic activity profiles for each compound (if available) are presented alphabetically and are
arranged in the order of acute, subchronic and chronic exposure. Activity profiles are followed by
data listings organized in  the same order.   No profile is presented in the cases where no
concentrations (either Effects or No Effects) are given. In these instances, only the data listings are
given (e.g., acetophenone listing on page 40).

       On the data listings, exposure concentrations expressed as mg/m3 are often converted from
the ppm values shown and have not been rounded off. The values listed under the mg/m3 column
obviously do not have the precision implied by these unrounded numbers.  See the text for a
complete discussion of activity profiles and the data presentation.
                                           27

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2.4-DINITROTOLJUENE
osure Duration Study Health Effect or No Effect Notes Ref. Short Citation
(d/wk) Type Effects Exposure Cone.
(yes/no)  (tng/m3)
5 unk Subchronic Yes unk unk 1,2,3,4,6 5 Levine et al., 1986a

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* System: hematopoeitic
HHM human 8
5 unk Subchronic No 0.023 4,5,6,7 5 Ahrenholz, 1980
Ahrenholz and Meysi, 1982
5 unk Subchronic No 0.023 4,5,6,7 5 Ahrenholz, 1980
Ahrenholz and Meysi, 1982

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COMPOUND 2,44)INITROT<
CAS NUMBER 121-14-2
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References
1 IRIS, March 1, 1991
5 ATSDR Toxicological P
4-DNT and/or technical grade DNT (76% 2,4-DNT, 19% 2,6-DNT, and other isomers).
assumed daily exposure (hr/d) and frequency (d/wk).
cal grade DNT (76% 2,4-DNT, 19% 2,6-DNT, and other isomers).
osure.
concentration range in the breathing zone was undetected to 0.023 mg/m3.
udies from Eastern European publications.

Notes
1 Mortality study.
2 Dermal exposure.
3 Exposure was to 98% 2
4 Occupational exposure
5 Exposure was to techn
6 Assumed subchronic ex|
7 Time-weighted average
8 Studied in males only
9 Sources checked; no s
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