List of Alternative Test Methods and Strategies (or New Approach Methodologies [NAMs])
Second Update: February 4th, 2021:1
UPDATES FROM THE DECEMBER 2019 LIST
For the Second Update of the TSCA Section 4(h)(2)(C) List of NAMs [hereinafter the "List"], a
few changes were made to the List. No new Organization for Economic Cooperation and
Development (OECD) Test Guidelines (TG) were adopted this year; therefore, there were no
additions to the List. However, certain updates and corrections were made to OECD TGs on June
26, 2020; the links provided in the List are to the updated TGs. . One test, specific for endocrine
active substances (OPPTS 890.1200), was added to the List of Test Guidelines for Human Health
Effects. Two changes were incorporated into the List of EPA NAM-Related Policies Which May
Be Relevant to TSCA. including the addition of EPA's Draft Guidance for Waiving Acute
Dermal Toxicity Tests for Pesticide Technical Chemicals & Supporting Retrospective Analysis,
which was released in September 2020. The link for the Final Guidance for Waiving Sub-Acute
Avian Dietary Tests for Pesticide Registration & Supporting Retrospective Analysis, which was
released in February 2020, was also updated. In addition, OncoLogic™ version 9.0 was added to
the List of Other NAMs Used for TSCA. OncoLogic™ is an expert system that uses mechanistic
and structure-activity relationship information to predict the carcinogenicity of organic chemicals
(Version 9.0) and fibers, metals, and polymers (Version 8.0).
INTRODUCTION
The Toxic Substances Control Act (TSCA) Section 4(h)(2)(C) requires EPA to develop "a list,
which the Administrator shall update on a regular basis, of particular alternative test methods or
strategies the Administrator has identified that do not require new vertebrate animal testing and
are scientifically reliable, relevant, and capable of providing information of equivalent or better
scientific reliability and quality to that which would be obtained from vertebrate animal testing."
The New Approach Methodologies (NAMs) presented in the List are not meant to be an
exhaustive list of NAMs that could be used for TSCA decisions.2 Rather, the List provides
representative NAMs that EPA may consider. Many of the NAMs have been reviewed and
established by different organizations3 (i.e., OECD,4 EURL-ECVAM, and ICCVAM) and meet
1 The Second Update to the List replaces the First Update to the List published on December 5, 2019.
2 Consistent with Sections 4 (testing), 5 (new chemicals), and 6 (existing chemicals) of TSCA, EPA expects to
consider NAMs for the following TSCA decision contexts, among others where testing issues may arise: screening
existing chemical substances for prioritization, prioritizing existing chemical substances as low- or high-priority
substances, conducting risk evaluations on high-priority substances, informing risk determinations for both new and
existing chemical substances, assessing data gaps for the purposes of issuing test orders or requiring testing as part
of a consent order, and other risk-based decision-making activities. These contexts follow the concept of "fit-for-
purpose" which is interpreted to mean that a particular NAM may be suitable for one regulatory use and not for
others.
3 OECD = Organization for Economic Cooperation and Development; EURL-ECVAM = European Union
Reference Laboratory for Alternatives to Animal Testing; ICCVAM = Interagency Coordinating Committee for the
Validation of Alternative Methods.
4 EPA has played a key role for many years in the review and validation/vetting process for the OECD test
guidelines program, including the new performance-based and defined approach methods identified in Chapter 5 of
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the Section 4(h)(2)(C) criteria for scientific relevance {i.e., accuracy) and reliability {i.e.,
repeatability/reproducibility). The extensive test method evaluation process, developed by
EURL-ECVAM5 and ICCVAM,6 is an internationally accepted process, as described in the
OECD Guidance Document 34,7 and was designed to identify NAMs for regulatory acceptance.
In addition, there are some NAMs on the List that represent existing practices or policies within
EPA.
CONTENTS OF THE T JST/TSCA DECISION CONTEXT
Appendix A includes lists of different methods and approaches that do not use vertebrate animals
to develop new data/information. Two are based on accepted test guidelines/methods, including
those adopted by the OECD. The others represent EPA-specific NAMs. One includes EPA-
specific guidance documents/policies adopted by one or both offices within the Office of
Chemical Safety and Pollution Prevention (OCSPP) {i.e., the Office of Pesticide Programs [OPP]
and the Office of Pollution Prevention & Toxics [OPPT]). The other includes NAMs that have
been historically used for the TSCA new chemicals program in OPPT.
Appendix B includes "Other Useful Information" which are tools and approaches which may
enhance the use of NAMs for regulatory use under TSCA.
Importantly, EPA will review any potential NAM that it receives, and determine the
merits/relevance of the information based on whether it meets both the information needs and the
objectives of TSCA Section 4(h). To this end, EPA encourages all stakeholders to consult with
EPA on the development and/or use of NAMs.
EPA understands that as science progresses and as stakeholders develop new
methods/approaches, OPPT is in a unique position to inform the development of NAMs, which
may be submitted to OPPT in various stages of development to support TSCA notifications for
new chemical substances. Thus, OPPT may have early knowledge of possible NAMs that are
under development and could eventually be included on the List. EPA views this as an important
opportunity for building confidence in the understanding and use of NAMs for regulatory
purposes.
Finally, EPA expects to consider NAMs for a number of TSCA decision contexts, including
screening and prioritizing existing chemical substances and informing risk determinations for
both new and existing chemical substances. However, the NAMs will need to be considered in a
"fit-for-purpose" context because a particular NAM may be suitable for one regulatory decision
context {e.g., prioritization) but not for others {e.g., quantification of hazard or risk).
the Strategic Plan. ICCVAM has been a recognized, official partner in these OECD deliberations since 2018. The
collaboration of NICEATM, ICCVAM, and EPA is an important and strong presence in the international arena as
new NAMs are being identified, developed, and implemented for EPA's regulatory use.
5 https://ec.enropa.en/irc/en/enrl/ecvain/alteniative-methods4oxicitY4esting/validation
6 httpsi//niBJiMi!Jiiiy*oy/BMieai!ifeii^
7 http://www.oecd.org/officiaMocnments/pnblicdisplavdocnmentpdf/?cote=env/im/mono(20()5)14&doclangiiage=en
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At this time, EPA understands that the value of most of the NAMs on the List is that they
provide information that may be used as part of the weight of scientific evidence in
characterizing a mode(s) of action or a hazard(s) that can be used in risk-based decision-making
for a chemical substance. As such, EPA anticipates that each NAM will contribute to EPA's
understanding of the "fit-for-purpose" context in which it is applied (e.g., prioritization).
However, some NAMs may be combined for a specific purpose. For example, the several
defined approaches (DAs) available for evaluating skin sensitization use 2-3 separate OECD Test
Guidelines which, taken together, will result in a decision whether a chemical substance may be
considered a skin sensitizer.8
NAM CRITERIA FOR RELEVANCE AND RELIABILITY
The methods and approaches on the List meet the eight criteria for NAMs to be listed under
TSCA as described in Chapter 5 of the Strategic Plan (link) and reproduced below:
1. The decision context should be clearly defined.
2. Where possible, the NAMs should be mechanistically and/or biologically relevant to
the hazard being assessed. The chemical domain of applicability of the NAMs should
also be defined to determine relevance to the TSCA chemical landscape.
3. The criteria for selecting reference or training chemicals should be defined and
supporting information should be adequately referenced.
4. The reliability of the NAM should be considered within the context of intended use
and accepted best practices within the given field and the variability of the existing
animal model.
5. The NAMs should be transparently described and information made available to the
public (e.g., any datasets are publicly available, and its known limitations are clearly
described). Information claimed as CBI may not allow public accessibility of all
information in some cases.
6. Uncertainty should be described to the fullest extent possible, both independently and
compared to the existing animal model (if possible).
7. The NAMs should undergo an independent review in order to raise confidence in the
approach.
8. Access and use by third parties should be possible (i.e., the alternative approach must
be readily accessible commercially and/or the relevant protocols should be available).
8 See: OCSPP (2018) Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement
for Laboratory Animal Testing (hereinafter the "OCSPP Skin Sensitization Policy"), Draft for Public Comment,
April 4, 2018, EPA's Office of Chemical Safety and Pollution Prevention (OCSPP): Office of Pesticides Program
and Office of Pollution Prevention and Toxics, 13 pp., available at: https://beta.regiilations.gov/document/EPA~HO~
QPP-20.1.6-0093-0090
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rill TJST
Below is a brief description of the List in Appendix A.
Test Guidelines for Human Health Effects.
Identifies NAM Test Guidelines that have gone through the OECD Test Guidelines Programme,
the ICCVAM process, or the EURL-ECVAM process and thus meet the scientific criteria for
relevance and reliability under Section 4(h)(2)(C) of TSCA. These NAMs are all experimental
methods designed to identify/evaluate an adverse human health effect or endpoint and do not use
intact vertebrate animals. Appendix B includes "Other Useful Information" with links for how
some of these experimental methods may be combined as part of Integrated Approaches to
Testing and Assessment (IATA) or with DAs for specific regulatory use scenarios.
Test Guidelines for Effects on Biotic Systems.
Identifies NAM Test Guidelines that have gone through the OECD Test Guidelines Programme
and thus meet the scientific criteria for relevance and reliability under Section 4(h)(2)(C) of
TSCA. These NAMs are all experimental methods designed to identify/evaluate an adverse
effect or endpoint to environmental organisms. Though many of the methods in this section use
plants or invertebrate species, these data are valuable in helping to determine possible species
sensitivities/distribution and thus possibly obviate the need to perform testing in environmental
vertebrate species.
EPA NAM-Related Guidance Documents/Policies Which May Be Relevant to TSCA.
Includes EPA NAM guidance documents/policies adopted by EPA's OCSPP; four are more
relevant to OPP but may be used/relevant to OPPT (i.e., the acute dermal toxicity waiver
guidance, the acute toxicity waiver for birds, the acute toxicity waiver/bridging guidance, and the
eye irritation alternative testing framework); and one is relevant for screening for endocrine
activity under OPP's Endocrine Disruptor Screening Program. The OCSPP Skin Sensitization
Policy is currently in use by OPP/OPPT and explains OCSPP's general approach to replace
vertebrate animal tests for skin sensitization with non-animal tests. Each of the tests incorporated
under the policy are existing OECD Test Guidelines (i.e., 442C, D, and E). The OCSPP Skin
Sensitization Policy uses two DAs that the OECD is reviewing for use in a regulatory context
(see "Other Useful Information" under Appendix B).
Other NAMs Used for TSCA.
Includes NAMs (e.g., computational toxicology tools, chemical category and tiered testing
approaches, and screening methods) that have been used by OPPT in the new chemicals
program. EPA has been using (and plans to use) other models/approaches developed by other
EPA offices or by organizations external to EPA as they become available. For example, OPPT
has been using tools that are available through EPA's National Center for Computational
Toxicology (NCCT). some of which are in the early stages of deployment in the new chemicals
program. OPPT has also been using the OECD QSAR Toolbox, which contains several EPA
models and has been vetted through the OECD. The NCCT tools are presented under "Other
Useful Information" in Appendix B, and the OECD QSAR Toolbox is presented under "Other
NAMs Used for TSCA" in Appendix A.
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Appendix A - The List
Test Guidelines for Human Health Effects1
Source
Title
Information Gathered
DEC
No. 428
Skin Absorption: In Vitro Method
Provides information on absorption of a test
substance (can be from human or animal
source)
OEC
No. 430
In Vitro Skin Corrosion: Transcutaneous
Electrical Resistance Test Method (TER)
Evaluates corrosivity (rat skin as source)
OECD TG
1
In Vitro Skin Corrosion: Reconstructed
Human Epidermis (Rhe) Test Method
Evaluates corrosivity (human skin as source)
OECD TG
1
In Vitro 3T3 NRU Phototoxicity Test
Evaluates Phototoxicity to mouse cells in
culture
OECD TG
1
In Vitro Membrane Barrier Test Method for
Skin Corrosion
Evaluates corrosion using a synthetic
membrane
OECD TG
Bovine Corneal Opacity and Permeability
Test Method for Identifying i) Chemicals
Inducing Serious Eye Damage and ii)
Chemicals Not Requiring Classification for
Eye Irritation or Serious Eye Damage
Evaluates eye irritation/corrosivity in bovine
eyes
No. 438
Isolated Chicken Eye Test Method for
Identifying i) Chemicals Inducing Serious
Eye Damage and ii) Chemicals Not
Requiring Classification for Eye Irritation or
Serious Eye Damage
Evaluates eye irritation/corrosivity in chick
eyes
OEC
In Vitro Skin Irritation: Reconstructed
Human Epidermis Test Method
Evaluates irritation (human skin as source)
No. 442C
In Chemico Skin Sensitisation: Assays
addressing the Adverse Outcome Pathway
key event on covalent binding to proteins
No animal or human cells used, evaluates
simple binding of a chemical to a synthetic
peptide
No. 442D
In Vitro Skin Sensitisation: ARE-Nrf2
Luciferase Test Method
Skin sensitization evaluated - human cells
used
OECD TG
No. 442E
In Vitro Skin Sensitisation: In Vitro Skin
Sensitisation assays addressing the Key
Event on activation of dendritic cells on the
Adverse Outcome Pathway for Skin
Sensitisation
Skin sensitization evaluated - human cells
used
OEC
1
Performance-Based Test Guideline for
Stably Transfected Transactivation In Vitro
Assays to Detect Estrogen Receptor Agonists
and Antagonists
Evaluates estrogenic effects - human cells
used
No. 456
H295R Steroidogenesis Assay
Evaluates possible endocrine effects - human
cells used
5
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lost (iiiidolilies lor lliiinnn llenllh KITccls1
Source
Title
1 ii lbrinn 1 ion (i;ilhercd
OECD TG
No. 458
Stably Transfected Human Androgen
Receptor Transcriptional Activation Assay
for Detection of Androgenic Agonist and
Antagonist Activity of Chemicals
Evaluates androgenic effects using Chinese
hamster ovary cells
OEC
No. 460
Fluorescein Leakage Test Method for
Identifying Ocular Corrosives and Severe
Irritants
Evaluates eye corrosivity/severe irritation with
canine kidney cells
OEC
1
Bacterial Reverse Mutation Test
Evaluates mutagenicity in bacterial cells
OECD TG
No. 473
In Vitro Mammalian Chromosome
Aberration Test
Evaluates chromosomal effects in either
human or rodent cells
OECD TG
In Vitro Mammalian Cell Gene Mutation
Tests using the Hprt and xprt genes
Evaluates gene mutations in either human or
rodent cells
OECD TG
No. 487
In Vitro Mammalian Cell Micronucleus Test
Evaluates chromosomal effects in either
human or rodent cells
OECD TG
No. 490
In Vitro Mammalian Cell Gene Mutation
Tests Using the Thymidine Kinase Gene
Evaluates gene mutations in either human or
rodent cells
OECD TG
Short-time Exposure In Vitro Test Method
for Identifying i) Chemicals Inducing
Serious Eye Damage and ii) Chemicals Not
Requiring Classification for Eye Irritation or
Serious Eye Damage
Evaluates eye corrosivity/severe irritation with
rabbit cornea cells
No. 492
Reconstructed Human Cornea-like
Epithelium (RhCE) Test Method for
Identifying Chemicals Not Requiring
Classification and Labelling for Eye
Irritation or Serious Eye Damage
Evaluates eye irritation with reconstructed
human cells (either eye or skin)
OEC
No. 493
Performance-Based Test Guideline for
Human Recombinant Estrogen Receptor
(hrER) In Vitro Assays to Detect Chemicals
with ER Binding Affinity
Evaluates estrogenicity in human cells
OECD TG
No. 494
Vitrigel-Eye Irritancy Test Method for
Identifying Chemicals Not Requiring
Classification and Labelling for Eye
Irritation or Serious Eye Damage
Recommended to identify chemicals not
requiring classification for serious eye damage
or eye irritation
OECD TG
No. 495
Ros (Reactive Oxygen Species) Assay for
Photoreactivity
Evaluates photoreactivity in chemico
OECD TG
No. 4964
In Vitro Macromolecular Test Method for
Identifying Chemicals Inducing Serious Eye
Damage and Chemicals Not Requiring
Classification for Eye Irritation or Serious
Eye Damage
Recommended as initial step of a testing
strategy (see OECD Guidance Document [GD]
No. 263 under "Other Useful Information" in
Appendix B) to identify chemicals that induce
serious eye damage
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lost (iiiidolilies lor Human Health Effects'
Source
Title
1 n lbrina t ion Gathercd
tm:
08 fUS)2
The ToxCast Estrogen Receptor Agonist
Pathway Model
Mathematical model that combines results
from 18 assays to predict estrogen receptor
agonism
TM2004-
o ^ V
In Vitro BALB/c 3T3 Cell Transformation
Assay
Assay to measure carcinogenicity potential
TM2006-
<<_ ^ ^ )2-4
Ocular Irritection
Assay to predict potential eye irritation for
classification/labelling purposes
TM2007-
o; o ^ )2
3T3 Neutral Red Uptake Cytotoxicity Assay
Assay to specifically identify non-classified
chemicals (for classification/labelling
purposes) with a cutoff value of 2000 mg/kg-
bw (oral)
ICCVAM
Eve
Irritation
Test3
The Cytosensor Microphysiometer Test
Method
Recommended as a screening test to identify
some types of water-soluble substances that
may cause permanent or severe eye injuries,
and for a limited range of substances, to
identify chemicals and products that do not
present sufficient potential to cause eye
injuries to require eye hazard labeling
OPPTS
890.1200
Endocrine Disruptor Screening Program Test
Guidelines: Aromatase (Human
Recombinant)
Assay to identify chemicals that inhibit
aromatase activity
1 OECD Test Guidelines (Health). ICCVAM (Alternative Methods Accented bv US Aeencies: excludes methods used for
evaluating other types of substances by other agencies (e.g., biologies by the U. S. Food and Drug Administration), and EURL-
ECVAM source (filtered bv "reeulatorv acceptance/Standards" bv Stco and "finalized" bv Stco Status.
2 From EURL-ECVAM (see table note 1)
3 From ICCVAM (see table note 1).
4 In the first iiDdatc. the following EURL-ECVAM method was added - Ocular Irritection (link); however this same method was
adopted by the OECD as TG No. 496 in October of 2019.
Test Guidelines for Effects on Biotic Systems1
Source
Title
Information Gathered
OECD TG
Freshwater Alga and Cyanobacteria,
Growth Inhibition Test
Evaluates toxicity to algae
OECD TG
No. 202
Daphnia sp. Acute Immobilization test
Evaluates toxicity to freshwater invertebrates
OECD TG
Earthworm Acute, Toxicity test
Evaluates toxicity to soil invertebrates
OECD TG
Daphnia magna Reproduction Test
Evaluates reproductive effects in freshwater
invertebrates
OECD TG
Fish, Short-term Toxicity Test on Embryo
and Sac-Fry Stages
Evaluates toxicity to fish development.
OECD TG
Sediment-Water Chironomid Toxicity
Using Spiked Sediment
Evaluates toxicity to sediment-dwelling
invertebrates
7
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l ost (iiiklelines lor KITeels on IJiotio Systems'
Source
Title
1 ii lb r in ;i 1 ion (i :i 1 It ered
OECD TG
Sediment-Water Chironomid Toxicity
Using Spiked Water
Evaluates toxicity to sediment-dwelling
invertebrates
OECD TG
Lemna sp. Growth Inhibition Test
Evaluates toxicity to freshwater aquatic plants
of the genus Lemna (duckweed)
OECD TG
No 222
Earthworm Reproduction Toxicity Test
(Eisenia fetida/Eisenia andrei)
Evaluates reproductive effects in soil
invertebrates
OECD TG
No. 225
Sediment-Water Lumbriculus Toxicity
Test Using Spiked Sediment
Evaluates toxicity of sediment-associated
chemicals endobenthic living organisms
OECD TG
Sediment-Water Chironomid Life-Cycle
Toxicity Test Using Spiked Water or
Spiked Sediment
Evaluates chronic toxicity to the life-cycle of
sediment-dwelling freshwater dipteran
Chironomus species
OEC
Chironomus sp., Acute Immobilisation
test
Evaluates acute toxicity (immobilisation) to
chironomids
OECD TG
No. 236
Fish Embryo Acute Toxicity (FET)
Evaluates toxicity to fish using zebraftsh
embryos
OECD TG
No. 238
Sediment-Free Myriophyllum spicatum
Toxicity Test
Evaluates toxicity to a submerged, rooted
macrophyte species (water milfoil)
OECD TG
1
Water-Sediment Myriophyllum spicatum
Toxicity Test
Evaluates toxicity to a submerged, rooted
macrophyte species (water milfoil)
OECD TG
Potamopyrgus antipodarum Reproduction
Test
Evaluates reproductive toxicity to the mudsnail
OECD TG
Lymnaea stagnalis Reproduction Test
Evaluates reproductive toxicity to a freshwater
snail
OECD TG
No. 319A2
Determination of In Vitro Intrinsic
Clearance Using Cryopreserved Rainbow
Trout Hepatocytes (RT-HEP)
Evaluates the capacity for fish (rainbow trout)
to metabolically clear chemical via the liver.
This in vitro clearance measurement can be
applied to models to predict chemical
bioconcentration in fish (BCF). The
application is described in the guidance
document (see OECD Guidance Document
[GD] No. 280 under "Other Useful
Information" in Appendix B
OEC
No. 319B2
Determination of In Vitro Intrinsic
Clearance Using Rainbow Trout Liver S9
Sub-Cellular Fraction (RT-S9)
1 Does not include tests in terrestrial plant species.
2 The OECD includes these TGs under Section 3: Environmental Fate and Behaviour.
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KPA NA.M-Ucliilcd (iuidiincc Documents/Policies \\ hie
l Msiv lie UclcYiinl lo TSCA
li(lo
Type of NAM
1 illbrin:i 1 ion (in 1 liered
OCSPP Skin Sensitization
Policy (To be undated when
finalized)
Choice of Two Defined
Approaches (DAs)
Combination of NAMs to predict
skin sensitization in humans
Guidance for Waiving Acute
Dermal Toxicity Tests for
Pesticide Formulations &
Waiving dermal toxicity testing
for pesticide formulations; but
may be applicable to industries
considering performing these
studies for TSCA purposes
Acute dermal toxicity
Supporting Retrospective
lysis
Guidance for Waiving Acute
Dermal Toxicity Tests for
Pesticide Technical
Chemicals & Supporting
Retrospecti lysis1
Waiving dermal toxicity testing
for pesticide technical chemicals;
but may be applicable to industries
considering performing these
studies for TSCA purposes
Acute dermal toxicity
Final Guidance for Waiving
Waiving Sub-Acute Avian Dietary
Tests
Points to consider when evaluating
subacute avian dietary tests data
waivers
Sub-Acute Avian Dietary
Tests for Pesticide
Registration and Supporting
Retrospecti lysis
Guidance for Waiving or
Iging of Mammalian
Acute Toxicity Tests for
Pesticides and Pesticide
lucts (Acute Oral. Acute
Dermal. Acute Inhalation,
huaary Ey^ Pi unary
Dermal, and Dermal
Sensitization)
Waiving or the use of Bridging
(read-across)
Acute toxicity for pesticides (by route
and including irritation/sensitization)
Use irnative Testing
nework for Classification
of Eve Irritation Potential of
sticide Products
Decision tree for in vitro testing
for labeling
Eye irritation
Process for Evaluating &
Implementing Alternative
Approaches to Traditional In
Vivo Toxicity Studies for
FIFRA Regulatory Use
Alternative approaches to
evaluating acute toxicity in lieu of
an in vivo study
Documents a process to be followed
to submit to EPA (Office of Pesticide
Programs)
Use of High Throughput
Assays and Computational
Tools in the Endocrine
Disruptor Screening
Use of NAMs for endocrine
disruptor screening
Screening for tiered testing for
endocrine activity
1 Added to the List on Second Update (February 2021)
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Oilier YWIs I sod lor TSCA1
Source
Piirnuu'lcr/ 1 nTorni:ition (inlhcml
The OECD OSAR Toolbox
Compilation of models and information to predict physical-
chemical properties and hazards of chemicals. EPA has
contributed models to this tool, and it is used by scientists at
EPA to understand and evaluate new and existing chemicals
under TSCA.
OncoLogic™
Hazard2'3 - Predictive system that uses knowledge-based
rules to predict cancer concern for more than 52 classes of
organic chemicals ("Versie ). as well as fibers, metals,
and polymers (Version 8.0).
Analog Identification Methodology (AIM)
Hazard3 - Database tool to facilitate identification of
analogs for read-across
Chemical Assessment Clustering Engine
(ChemACE)
Hazard3 - Database tool to facilitate structural clustering
New Chemical Categories Document
Hazard3 - Documentation of TSCA chemical categories
Estimation Programs Interface (EPISuite™)
Physical/chemical properties and environmental fate4 - e.g.,
bi oconcentrati on/bi oaccumul ati on
Chemical Screening Tool for Exposures and
Environmental Releases (ChemSTEER)
Exposure4 - tools and models to estimate environmental
releases and worker exposures
Exposure and Fate Assessment Screening
Tool (E-FAST)
Exposure4 - tools and models to estimate consumer, general
public and environmental exposures to chemicals.
Approaches to Estimate Consumer Exposure
Exposure4 - a variety of tools and models to estimate
exposure to various consumer products and materials
1 General Guidance on all accroaches - httDs://www.eDa.eov/tsca-scree nine-tools
2 Version 9.0 added to the List on Second Update (February 2021)
3 Hazard - httDs://www.eDa.eov/tsca-screenine-tools/iisine-Dredictive-methods-assess-hazard-under-tsca#models:
4 Phvsical/Chemical Properties. Environmental Fate, and Exposure - httDs://www.eDa.gov/tsca-screening-tools/using-Dredictive-
metliods-assess-exDosure-and-fate-iiiider-tsca#fate
10
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Appendix B - Other Information or Strategies
Appendix B includes non-specific tests/experimental methods that are different from the
information presented in Appendix A. This section includes tools developed by entities outside
of OPPT, important findings reported by advisory committees formed under the Federal
Advisory Committee Act (FACA) for OCSPP evaluations/work products that use NAMs, and
OECD guidance documents (GD) considered as international consensus documents.
As with the TSCA Section 4(h)(2)(C) list above, the "Other Useful Information" below is not
meant to be exhaustive. It includes information/tools that OPPT has knowledge of and
experience with under TSCA. Links and a brief description of the source of information
identified. General information on the publications from the OECD can be found under the
OECD's Series on Testing and Assessment/Adopted Guidance and Review Documents (link).
Oilier I sel'ul Information
Source
Tille/Conlenl
>md Tox
Chemicals
Dashboard
Compilation of publicly available information on over 850,000 chemicals.
January 20131
Prioritizing the Universe of Endocrine Disruptor Screening Program (EDSP)
Chemicals Using Computational Toxicology Tools
Ut k \
November.
Continuing Development of Alternative High-Throughput Screens to Determine
Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and
Thyroid Pathways
December. 2018
Evaluation of a Proposed Approach to Refine the Inhalation Risk Assessment for
Point of Contact Toxicity: A Case Study Using a New Approach Methodology
(NAM)
OECD guidance
docume
No. 34
Guidance Document on the Validation and International Acceptance of New or
Updated Test Methods for Hazard Assessment
.
69:
Guidance Document on the Validation of (Quantitative) Structure-Activity
Relationship [(Q)SAR] Models
.
102:
Guidance Document for Using the OECD (Q)SAR Application Toolbox to Develop
Chemical Categories According to the OECD Guidance on Grouping Chemicals
.
184
Revised Guidance Document on Developing and Assessing Adverse Outcome
Pathways
.
194:
Guidance on Grouping of Chemicals, Second Edition
.
203:
New Guidance Document on an Integrated Approach on Testing and Assessment
(IATA) for Skin Corrosion and Irritation
OECD GD No.
911
w 1 1
Guidance Document for Describing Non-Guideline In Vitro Test Methods
OECD GD No.
214
Guidance Document on the In Vitro Syrian Hamster Embryo (SHE) Cell
Transformation Assay
OECD GD No.
231
Guidance Document on the In Vitro Bhas 42 Cell Transformation Assay
11
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Other Useful Information
Source
Title/Content
OECD GD No.
23 7
Guidance Document on Considerations for Waiving or Bridging of Mammalian
Acute Toxicity Tests
OECD GD No.
Guidance Document on the Reporting of Defined Approaches to be Used Within
Integrated Approaches to Testing and Assessment
.
Guidance Document on the Reporting of Defined Approaches and Individual
Information Sources to be Used Within Integrated Approaches to Testing and
Assessment (IATA) for Skin Sensitisation. Annex 1. Annex 2
OECD GD No.
260
Guidance Document for the Use of Adverse Outcome Pathways in Developing
Integrated Approaches to Testing and Assessment (IATA)
OECD GD No.
263
Guidance Document on an Integrated Approach on Testing and Assessment (IATA)
for Serious Eye Damage and Eye Irritation
OECD GD No.
280
Guidance Document on the Determination of In Vitro Intrinsic Clearance Using
Cryopreserved Hepatocytes (RT-HEP) or Liver S9 Sub-Cellular Fractions (RT-S9)
from Rainbow Trout and Extrapolation to In Vivo Intrinsic Clearance
1 FIFRA SAP = Federal Insecticide, Fungicide and Rodenticide Act, Scientific Advisory Panel. The general FIFRA SAP
website is available at (Link). Although several meetings/evaluations are presented here, interested parties are encouraged to
review the general FIFRA SAP link for other meetings related to NAMs.
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