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  2. Assessing and Managing Chemicals under TSCA

List of Alternative Test Methods and Strategies (or New Approach Methodologies)

On this page:

  • Introduction
  • List of NAMs
  • NAMs Nomination Process
  • June 2026 List of NAMs

Introduction 

The Toxic Substances Control Act (TSCA) directs EPA to use modern, non-animal "new approach methodologies" (NAMs) whenever scientifically appropriate when evaluating chemicals, and to reduce, refine, or replace vertebrate animal testing. Using NAMs, like human cell models and advanced computer methods, helps EPA identify hazards and exposures faster and often with results that are more relevant to people. These tools can cut costs and time, reduce animal use, and provide clearer insight into how a chemical works in the body. The result is quicker, more transparent safety decisions that better protect families, workers, and communities while giving businesses clear, up-to-date expectations 

TSCA also requires EPA to maintain and regularly update a list of NAMs. This list is not exhaustive, and EPA may consider additional NAMs, on a case-by-case basis.

Learn more about using NAMs in EPA's chemical safety decisions.

List of NAMs

The list contains several categories of methods and approaches that generate new data or information without the use of vertebrate animals. These categories include methods based on internationally accepted test guidelines, such as those adopted by the Organisation for Economic Co-operation and Development (OECD), as well as EPA-specific NAMs. 

The NAMs presented in this list are not meant to be an exhaustive list of NAMs that could be used for TSCA decisions. Rather, the list provides representative NAMs that EPA may consider. Many of the NAMs have been reviewed and established by different organizations (e.g., OECD, ICCVAM, and ICATM) and meet 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-ECVAM and ICCVAM is an internationally accepted process that was designed to identify NAMs for regulatory acceptance, and is considered scientifically robust. In addition, there are some NAMs on the list that represent existing practices or policies within EPA. 

The "Other Useful Information" section provides tools, resources, and approaches that can support or enhance the application of NAMs for TSCA regulatory decision-making. These materials include tools developed outside of EPA's Office of Pollution Prevention and Toxics (OPPT), relevant findings from advisory committees, and internationally recognized OECD guidance documents. 

NAMs Nomination Process

Stakeholders can submit NAMs and related data to EPA through the agency's NAMs Nomination Process (LINK). EPA reviews these methods to make sure they are scientifically sound, looking at transparency of the approach, relevance to human biology, reliability and reproducibility of results, and whether the method is fit for its intended purpose. 

Receiving NAMs from stakeholders helps EPA make faster, more reliable chemical safety decisions that better reflect human biology. Stakeholders bring cutting-edge scienced, real-world data, and fit-for-purpose methods tailored to specific chemicals and use patterns, which can fill data gaps and improve accuracy. High-quality NAMs can reduce the need for animal testing, lower costs, and speed timelines, benefits that align with TSCA's direction to use scientifically appropriate non-animal approaches. Submitting NAMs also increases transparency and predictability by showing how companies generate evidence, supporting clearer, more consistent regulatory decisions and encouraging innovation across the sector. 

As described in the NAMs Nomination Process (LINK), when a NAM is submitted to EPA, the agency considers three main factors: context of use, biological relevance, and reliability. Context of use focuses on how the NAM will support a specific TSCA risk decision context (such as screening new chemicals, prioritizing existing chemicals, or conducting risk evaluations) and the type of endpoint it addresses (e.g. physicochemical properties, fate, exposure, ecological effects, or human health). EPA also evaluates whether the NAM is fit-for-purpose, meaning the information it provides is adequate for the intended regulatory application. For biological relevance, EPA examines the scientific basis of the method, including biological or mechanistic understanding, and the reference chemicals used to evaluate and anchor the NAM. For reliability, EPA considers factors such as quality assurance practices, applicability domain, predictivity and statistical performance, reproducibility within and across laboratories, and whether the method has undergone independent review. 

EPA anticipates considering nominated NAMs across multiple TSCA decision contexts, such as prioritization, screening, and informing risk determinations for new or existing chemicals, while applying a fit-for-purpose approach, recognizing that a method is suitable for one context may not be appropriate for another. Most NAMs currently on the List are expected to contribute as part of a weight of scientific evidence framework for characterizing modes of action or hazards, though some may be combined to meet specific regulatory needs, such as OECD defined approaches that integrate results from multiple methods 

June 2026 List of NAMs

The table of NAMs below are organized into three categories: OECD test guidelines and EPA test guidelines; non-OECD methods, computational tools and models; and policy related documents that might be relevant to TSCA. This structure highlights the distinction between internationally harmonized OECD methods and all other approaches. Within each table, all newly added NAMs are denoted with "NEW" so stakeholders can easily see what has changed and where new content has been incorporated. 

OECD/EPA Test Guidelines

Health Effects

SourceTitleInformation Gathered
OECD TG No. 428Skin Absorption: In Vitro MethodProvides information on absorption of a test 
substance (can be from human or animal 
source)
OECD TG No. 430In Vitro Skin Corrosion: Transcutaneous 
Electrical Resistance Test Method (TER)
Evaluates corrosivity (rat skin as source)
OECD TG No. 431In Vitro Skin Corrosion: Reconstructed 
Human Epidermis (Rhe) Test Method
Evaluates corrosivity (human skin as source)
OECD TG No. 432In Vitro 3T3 NRU Phototoxicity TestEvaluates Phototoxicity to mouse cells in 
culture
OECD TG No. 435In Vitro Membrane Barrier Test Method for 
Skin Corrosion
Evaluates corrosion using a synthetic 
membrane
OECD TG No. 437Bovine 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
OECD TG No. 438Isolated 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
OECD TG No. 439In Vitro Skin Irritation: Reconstructed 
Human Epidermis Test Method
Evaluates irritation (human skin as source)
OECD TG No. 442CIn 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
OECD TG No. 442DIn Vitro Skin Sensitisation: ARE-Nrf2 
Luciferase Test Method
Skin sensitization evaluated – human cells 
used
OECD TG No. 442EIn 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
OECD TG No. 444ANEW: In Vitro Immunotoxicity: IL-2 Luc and Il-2 Luc LTTEvaluates immunotoxicity (human cell lines as source)
OECD TG No. 455Performance-Based Test Guideline for 
Stably Transfected Transactivation In Vitro
Assays to Detect Estrogen Receptor Agonists 
and Antagonists
Evaluates estrogenic effects – human cells 
used
OECD TG No. 456H295R Steroidogenesis AssayEvaluates possible endocrine effects – human 
cells used
 
OECD TG No. 458Stably 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
OECD TG No. 460Fluorescein Leakage Test Method for 
Identifying Ocular Corrosives and Severe 
Irritants
Evaluates eye corrosivity/severe irritation with 
canine kidney cells
OECD TG No. 467NEW: Defined Approaches for Serious Eye Damage and Eye IrritationEvaluates eye damage and eye irritation (combines data generated in in vitro methods with information sources such as physiochemical properties)
OECD TG No. 471Bacterial Reverse Mutation TestEvaluates mutagenicity in bacterial cells
OECD TG No. 473In Vitro Mammalian Chromosome 
Aberration Test
Evaluates chromosomal effects in either 
human or rodent cells
OECD TG No. 476In Vitro Mammalian Cell Gene Mutation 
Tests using the Hprt and xprt genes
Evaluates gene mutations in either human or 
rodent cells
OECD TG No. 487In Vitro Mammalian Cell Micronucleus TestEvaluates chromosomal effects in either 
human or rodent cells
OECD TG No. 490In Vitro Mammalian Cell Gene Mutation 
Tests Using the Thymidine Kinase Gene
Evaluates gene mutations in either human or 
rodent cells
OECD TG No. 491Short-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
OECD TG No. 492Reconstructed 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)
OECD TG No. 492BNEW: Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard IdentificationEvaluates eye hazard with reconstructed human cells
OECD TG No. 493Performance-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. 494Vitrigel-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. 495Ros (Reactive Oxygen Species) Assay for 
Photoreactivity
Evaluates photoreactivity in chemico
OECD TG No. 496In 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
 
OECD TG No. 497NEW: Defined Approaches on Skin SensitisationCombinations of OECD validated in chemico and in vitro test data, in some cases along with in silico information, to identify potential dermal sensitization hazard, dermal sensitization potency, and a quantitative point-of-departure
OECD TG No. 498NEW: In vitro Phototoxicity - Reconstructed Human Epidermis Phototoxicity test methodEvaluates phototoxicity (3D human cell-based tissue model)
890.1200Endocrine Disruptor Screening Program Test 
Guidelines: Aromatase (Human 
Recombinant)
Assay to identify chemicals that inhibit 
aromatase activity
890.1300NEW: Endocrine Disruptor Screening Program Test Guidelines: Estrogen Receptor Transcriptional activation (Human Cell Line (HeLA-9903))Detects estrogenic transactivation regulated by the estrogen receptor
890.1550NEW: Endocrine Disruptor Screening Program Test Guidelines: Steroidogenesis (Human Cell line - H295R)Identifies xenobiotics that affect the steroidogenic pathway

Effects on the Biotic Systems

SourceTitleInformation Gathered
OECD TG No. 201Freshwater Alga and Cyanobacteria, 
Growth Inhibition Test
Evaluates toxicity to algae
OECD TG No. 202Daphnia sp. Acute Immobilization testEvaluates toxicity to freshwater invertebrates
OECD TG No. 207Earthworm Acute, Toxicity testEvaluates toxicity to soil invertebrates
OECD TG No. 211Daphnia magna Reproduction TestEvaluates reproductive effects in freshwater 
invertebrates
OECD TG No. 212Fish, Short-term Toxicity Test on Embryo and Sac-Fry StagesEvaluates toxicity to fish development.
OECD TG No. 218Sediment-Water Chironomid Toxicity 
Using Spiked Sediment
Evaluates toxicity to sediment-dwelling invertebrates
OECD TG No. 219Sediment-Water Chironomid Toxicity
Using Spiked Water
Evaluates toxicity to sediment-dwelling invertebrates
OECD TG No. 221Lemna sp. Growth Inhibition TestEvaluates toxicity to freshwater aquatic plants of the genus Lemna (duckweed)
OECD TG No. 222Earthworm Reproduction Toxicity Test (Eisenia fetida/Eisenia andrei)Evaluates reproductive effects in soil 
invertebrates
OECD TG No. 225Sediment-Water Lumbriculus Toxicity
Test Using Spiked Sediment
Evaluates toxicity of sediment-associated chemicals endobenthic living organisms
OECD TG No. 233Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked SedimentEvaluates chronic toxicity to the life-cycle of sediment-dwelling freshwater dipteran Chironomus species
OECD TG No. 235Chironomus sp., Acute Immobilisation 
test
Evaluates acute toxicity (immobilisation) to chironomids
OECD TG No. 236Fish Embryo Acute Toxicity (FET)Evaluates toxicity to fish using zebrafish embryos
OECD TG No. 238Sediment-Free Myriophyllum spicatum Toxicity TestEvaluates toxicity to a submerged, rooted macrophyte species (water milfoil)
OECD TG No. 239Water-Sediment Myriophyllum spicatum Toxicity TestEvaluates toxicity to a submerged, rooted macrophyte species (water milfoil)
OECD TG No. 242Potamopyrgus antipodarum Reproduction TestEvaluates reproductive toxicity to the mudsnail
OECD TG No. 243Lymnaea stagnalis Reproduction TestEvaluates reproductive toxicity to a freshwater snail
OECD TG No. 249NEW: Fish Cell Line Acute Toxicity - The RTgill-W1 cell line assyEvaluates fish toxicity using the permanent cell line from Rainbow Trout
OECD TG No. 250NEW: EASZY assay - Detection of Endocrine Active Substances, acting through estrogen receptors, using transgenic tg (cyp19a1b:GFP) Zebrafish embryosEvaluates endocrine-related activity using transgenic zebrafish embryos
OECD TG No. 251NEW: Rapid Androgen Disruption Activity Reporter (RADAR) assayEvaluates androgen disruption using transgenic medaka embryos
OECD TG No. 253NEW: Short-term Juvenile Hormone Activity Screening Assay using Daphnia magna (JHASA)Evaluates juvenile hormone disruption using Daphnia magna
OECD TG No. 319ADetermination 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” 
OECD TG No. 319BDetermination of In Vitro Intrinsic Clearance Using Rainbow Trout Liver S9 Sub-Cellular Fraction (RT-S9)
850.1010NEW: Aquatic invertebrate acute toxicity test, Freshwater DaphnidsDescribes an acute toxicity test in which daphnids (Daphnia magna or Daphnia pulex) are exposed to a test substance in static, static-renewal, or flow-through systems
850.1020NEW: Gammarid amphipod acute toxicity testDescribes an acute toxicity test in which freshwater, gammarid amphipods are exposed to a test substance in static, static-renewal, or flow-through systems

Data Integration Tools, Predictive Models, and Assessment Frameworks

SourceDescription
Analog Identification Methodology (AIM)Database tool to facilitate identification of analogs for read-across
NEW: Androgen Receptor (AR) pathway modelAR pathway model based on the full 11-assay ToxCast/Tox21 battery
Chemical Assessment Clustering Engine (ChemACE)Database tool to facilitate structural clustering
Chemical Screening Tool for Exposures and Environmental Releases (ChemSTEER)Tools and models to estimate environmental releases and worker exposures
NEW: ChemExpoChemExpo is a new, publicly accessible data search and visualization tool for exploring chemical data relevant to exposure assessment that has been curated from public documents. 
NEW: Cheminformatics ModulesCheminformatics analysis modules provide information on chemicals including high-quality chemical structures, experimental and predicted physicochemical properties, environmental fate and transport information, and appropriately linked toxicity data. 
NEW: Developmental Neurotoxicity in vitro battery (DNT-IVB) The assays in this battery are designed to detect changes in a number of important neurodevelopmental processes at the cellular level that are regulated by multiple signalling pathways at the molecular level.
NEW: ECOTOXComprehensive, publicly available application that provides information on adverse effects of single chemical stressors to ecologically relevant aquatic and terrestrial species
NEW: ECVAM Tracking System for Alternative Methods (TSAR)Compilation of alternative methods indicating the stages methods have reached in terms of acceptance
Estimation Programs Interface (EPISuiteTM)Physical/chemical properties and environmental fate4 – e.g., bioconcentration/bioaccumulation
Estrogen Receptor (ER) Pathway modelER pathway model based on the full 18-assay ToxCast/Tox21 battery
Exposure and Fate Assessment Screening Tool (E-FAST)Tools and models to estimate consumer, general public and environmental exposures to chemicals.
NEW: GenRA Resource HubGeneralized Read-Across Hub: algorithmic approach to permit objective and reproducible read-across predictions of in vivo toxicity and in vitro bioactivity. 
High-throughput toxicokinetics R package (httk)The R package can be used to estimate chemical concentrations in humans
New Chemical Categories DocumentDocumentation of TSCA chemical categories
NEW: NICEATM Alternative Methods Accepted by US AgenciesCompilation of methods for chemical safety testing that are accepted by U.S. and international regulatory authorities as replacement, reduction, or refinement alternatives to required animal tests
The OECD QSAR ToolboxCompilation 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™Predictive system that uses knowledge-based rules to predict cancer concern for more than 52 classes of organic chemicals (Version 9.4), as well as fibers, metals, and polymers (Version 8.0). 
NEW: Read-Across FrameworksRead across frameworks infer hazard assessment for data-poor chemicals by using data-rich analogues of the target chemical based on structural, toxicokinetic, and toxicodynamic similarity1
NEW: SeqAPASS Sequence Alignment to Predict Across Species Susceptibility (SeqAPASS) is a fast, online screening tool that allows researchers and regulators to extrapolate toxicity information across species. 
NEW: Structural AlertsUse of structure-activity relationship (SAR) rules which define substructures or chemical moieties that are hypothesized to result in biological activity2
NEW: ToxCastThe Toxicity Forecaster (ToxCast) program makes in vitro medium- and high-throughput screening assay data publicly available for prioritization and hazard characterization of thousands of chemicals. 
NEW: Toxicity Estimation Software Tool (TEST)Allows users to easily estimate the toxicity of chemicals using Quantitative Structure Activity Relationships (QSARs) methodologies

1Lizarraga LE, Suter GW, Lambert JC, Patlewicz G, Zhao JQ, Dean JL, Kaiser P. Advancing the science of a read-across framework for evaluation of data-poor chemicals incorporating systematic and new approach methods. Regul Toxicol Pharmacol. 2023 Jan;137:105293. doi: 10.1016/j.yrtph.2022.105293

2Cronin MTD, Bauer FJ, Bonnell M, Campos B, Ebbrell DJ, Firman JW, Gutsell S, Hodges G, Patlewicz G, Sapounidou M, Spînu N, Thomas PC, Worth AP. A scheme to evaluate structural alerts to predict toxicity - Assessing confidence by characterising uncertainties. Regul Toxicol Pharmacol. 2022 Nov;135:105249. doi: 10.1016/j.yrtph.2022.105249.

EPA NAM-Related Guidance Documents/Policies Which May Be Relevant to TSCA

TitleType of NAMInformation Gathered
NEW: Decision Framework for Hazard Identification of Skin Irritation and CorrosionPrioritizes human cell-based tissue model NAMsDecision framework for identification of skin irritation or corrosion hazards for new chemical substances based on reproducible, human-relevant data
NEW: Decision Framework for Hazard Identification of Eye Irritation and CorrosionPrioritizes human cell-based tissue model NAMsDecision framework for identification of eye irritation or corrosion hazards for new chemical substances based on reproducible, human-relevant data
OCSPP Skin Sensitization Policy (To be updated 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 & Supporting Retrospective AnalysisWaiving dermal toxicity testing 
for pesticide formulations; but 
may be applicable to industries
considering performing these 
studies for TSCA purposes
Acute dermal toxicity
Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals & Supporting Retrospective AnalysisWaiving 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 Sub-Acute Avian Dietary Tests for Pesticide Registration and Supporting Retrospective AnalysisWaiving Sub-Acute Avian Dietary 
Tests
Points to consider when evaluating subacute avian dietary tests data waivers
Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests for Pesticides and Pesticide Products (Acute Oral, Acute Dermal, Acute Inhalation, Primary Eye, Primary Dermal, and Dermal Sensitization)Waiving or the use of Bridging 
(read-across)
Acute toxicity for pesticides (by route and including irritation/sensitization)
Use of An Alternative Testing Framework for Classification of Eye Irritation Potential of EPA Pesticide ProductsDecision tree for in vitro testing 
for labeling
Eye irritation
Process for Evaluating & Implementing Alternative Approaches to Traditional In Vivo Toxicity Studies for FIFRA Regulatory UseAlternative 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 ScreeningUse of NAMs for endocrine 
disruptor screening
Screening for tiered testing for endocrine activity

Description of Categories

OECD/EPA Test Guidelines: Identifies both OECD and EPA Test Guidelines that have gone through their respective Test Guidelines Programs and therefore met the relevance and reliability criteria specified under TSCA Section 4(h)(2)(C). The included Health Effects NAMs consist of experimental methods that identify or evaluate adverse human health effects or endpoints and do not use intact vertebrate animals. The Other Information or Strategies section also provides links illustrating how some may be combined with Integrated Approaches to Testing and Assessment (IATA) or used with Defined Approaches (DAs) for specific regulatory applications. The Biotic Systems NAMs similarly encompass experimentally based methods designed to evaluate adverse effects or endpoints in environmental organisms; while many rely on plants or invertebrate species, these data help inform species' sensitivity and distribution and can, in some cases, reduce or eliminate the need for vertebrate testing in ecological assessments.

Non-Test Guidelines, Data Integration Tools, Predictive Models, and Assessment Frameworks: This includes NAMs such as computational toxicology tools, chemical category approaches, tiered testing strategies, and screening methods of relevance to OPPT. EPA has been using, and will continue to use, models and approaches developed both within the Agency and by external organizations as they become available and are considered appropriate for TSCA decision-making. OPPT, for example, applies tools available through internationally recognized platforms such as the OECD QSAR Toolbox, which includes several EPA-developed models that have been evaluated through the OECD. Links to two comprehensive compilations of alternative methods maintained and regularly updated by ECVAM and NICEATM are also provided.

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 sue 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 OECD accepted for use in a regulatory context (see "Other Useful Information"). This update includes two Decision Frameworks for Hazard Identification of Eye and Skin Irritation and Corrosion. 

Other Information or Strategies

This section includes non-specific tests/experimental methods and 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. 

Other Useful Information
SourceTitle/Content
NEW: Adverse Outcome Pathways Knowledge Base (AOP-KB)The AOP-KB is the primary repository for all AOPs developed either as part of the OECD AOP Development Programme or by the broader scientific community
EPA Comp Tox Chemicals DashboardCompilation of publicly available information on over 850,000 chemicals.
FIFRA SAP January 2013Prioritizing the Universe of Endocrine Disruptor Screening Program (EDSP) 
Chemicals Using Computational Toxicology Tools
FIFRA SAP November, 20171Continuing Development of Alternative High-Throughput Screens to Determine 
Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and 
Thyroid Pathways
FIFRA SAP December, 2018Evaluation 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 document (GD) No. 34Guidance Document on the Validation and International Acceptance of New or 
Updated Test Methods for Hazard Assessment
OECD GD No. 69Guidance Document on the Validation of (Quantitative) Structure-Activity 
Relationship [(Q)SAR] Models
OECD GD No. 102Guidance Document for Using the OECD (Q)SAR Application Toolbox to Develop 
Chemical Categories According to the OECD Guidance on Grouping Chemicals
OECD GD No. 184Revised Guidance Document on Developing and Assessing Adverse Outcome 
Pathways
OECD GD No. 194Guidance on Grouping of Chemicals, Second Edition
OECD GD No. 203New Guidance Document on an Integrated Approach on Testing and Assessment 
(IATA) for Skin Corrosion and Irritation
OECD GD No. 211Guidance Document for Describing Non-Guideline In Vitro Test Methods
OECD GD No. 214Guidance Document on the In Vitro Syrian Hamster Embryo (SHE) Cell 
Transformation Assay
OECD GD No. 231Guidance Document on the In Vitro Bhas 42 Cell Transformation Assay
OECD GD No. 237Guidance Document on Considerations for Waiving or Bridging of Mammalian 
Acute Toxicity Tests
OECD GD No. 255Guidance Document on the Reporting of Defined Approaches to be Used Within 
Integrated Approaches to Testing and Assessment
OECD GD No. 256Guidance 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. 260Guidance Document for the Use of Adverse Outcome Pathways in Developing 
Integrated Approaches to Testing and Assessment (IATA)
OECD GD No. 263Guidance Document on an Integrated Approach on Testing and Assessment (IATA) 
for Serious Eye Damage and Eye Irritation
OECD GD No. 280Guidance 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. Although several meetings/evaluations are presented here, interested parties are encouraged to review the general FIFRA SAP link for other meetings related to NAMs.

Assessing and Managing Chemicals under TSCA

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  • Prioritizing Existing Chemicals for Risk Evaluation
  • Risk Evaluations for Existing Chemicals under TSCA
  • Risk Management for Existing Chemicals under TSCA
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