List of Alternative Test Methods and Strategies (or New Approach Methodologies)
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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 | ||
| Source | Title | Information Gathered |
| OECD TG No. 428 | Skin Absorption: In Vitro Method | Provides information on absorption of a test substance (can be from human or animal source) |
| OECD TG No. 430 | In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER) | Evaluates corrosivity (rat skin as source) |
| OECD TG No. 431 | In Vitro Skin Corrosion: Reconstructed Human Epidermis (Rhe) Test Method | Evaluates corrosivity (human skin as source) |
| OECD TG No. 432 | In Vitro 3T3 NRU Phototoxicity Test | Evaluates Phototoxicity to mouse cells in culture |
| OECD TG No. 435 | In Vitro Membrane Barrier Test Method for Skin Corrosion | Evaluates corrosion using a synthetic membrane |
| OECD TG No. 437 | 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 |
| OECD TG 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 |
| OECD TG No. 439 | In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method | Evaluates irritation (human skin as source) |
| OECD TG 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 |
| OECD TG 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 |
| OECD TG No. 444A | NEW: In Vitro Immunotoxicity: IL-2 Luc and Il-2 Luc LTT | Evaluates immunotoxicity (human cell lines as source) |
| OECD TG No. 455 | Performance-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. 456 | H295R Steroidogenesis Assay | Evaluates possible endocrine effects – human cells used |
| 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 |
| OECD TG No. 460 | Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants | Evaluates eye corrosivity/severe irritation with canine kidney cells |
| OECD TG No. 467 | NEW: Defined Approaches for Serious Eye Damage and Eye Irritation | Evaluates eye damage and eye irritation (combines data generated in in vitro methods with information sources such as physiochemical properties) |
| OECD TG No. 471 | 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 No. 476 | 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 No. 491 | 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 |
| OECD TG 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) |
| OECD TG No. 492B | NEW: Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification | Evaluates eye hazard with reconstructed human cells |
| OECD TG 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. 496 | 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 |
| OECD TG No. 497 | NEW: Defined Approaches on Skin Sensitisation | Combinations 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. 498 | NEW: In vitro Phototoxicity - Reconstructed Human Epidermis Phototoxicity test method | Evaluates phototoxicity (3D human cell-based tissue model) |
| 890.1200 | Endocrine Disruptor Screening Program Test Guidelines: Aromatase (Human Recombinant) | Assay to identify chemicals that inhibit aromatase activity |
| 890.1300 | NEW: Endocrine Disruptor Screening Program Test Guidelines: Estrogen Receptor Transcriptional activation (Human Cell Line (HeLA-9903)) | Detects estrogenic transactivation regulated by the estrogen receptor |
| 890.1550 | NEW: Endocrine Disruptor Screening Program Test Guidelines: Steroidogenesis (Human Cell line - H295R) | Identifies xenobiotics that affect the steroidogenic pathway |
Effects on the Biotic Systems | ||
| Source | Title | Information Gathered |
| OECD TG No. 201 | 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 No. 207 | Earthworm Acute, Toxicity test | Evaluates toxicity to soil invertebrates |
| OECD TG No. 211 | Daphnia magna Reproduction Test | Evaluates reproductive effects in freshwater invertebrates |
| OECD TG No. 212 | Fish, Short-term Toxicity Test on Embryo and Sac-Fry Stages | Evaluates toxicity to fish development. |
| OECD TG No. 218 | Sediment-Water Chironomid Toxicity Using Spiked Sediment | Evaluates toxicity to sediment-dwelling invertebrates |
| OECD TG No. 219 | Sediment-Water Chironomid Toxicity Using Spiked Water | Evaluates toxicity to sediment-dwelling invertebrates |
| OECD TG No. 221 | 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 No. 233 | 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 |
| OECD TG No. 235 | 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 zebrafish embryos |
| OECD TG No. 238 | Sediment-Free Myriophyllum spicatum Toxicity Test | Evaluates toxicity to a submerged, rooted macrophyte species (water milfoil) |
| OECD TG No. 239 | Water-Sediment Myriophyllum spicatum Toxicity Test | Evaluates toxicity to a submerged, rooted macrophyte species (water milfoil) |
| OECD TG No. 242 | Potamopyrgus antipodarum Reproduction Test | Evaluates reproductive toxicity to the mudsnail |
| OECD TG No. 243 | Lymnaea stagnalis Reproduction Test | Evaluates reproductive toxicity to a freshwater snail |
| OECD TG No. 249 | NEW: Fish Cell Line Acute Toxicity - The RTgill-W1 cell line assy | Evaluates fish toxicity using the permanent cell line from Rainbow Trout |
| OECD TG No. 250 | NEW: EASZY assay - Detection of Endocrine Active Substances, acting through estrogen receptors, using transgenic tg (cyp19a1b:GFP) Zebrafish embryos | Evaluates endocrine-related activity using transgenic zebrafish embryos |
| OECD TG No. 251 | NEW: Rapid Androgen Disruption Activity Reporter (RADAR) assay | Evaluates androgen disruption using transgenic medaka embryos |
| OECD TG No. 253 | NEW: Short-term Juvenile Hormone Activity Screening Assay using Daphnia magna (JHASA) | Evaluates juvenile hormone disruption using Daphnia magna |
| OECD TG No. 319A | 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” |
| OECD TG No. 319B | Determination of In Vitro Intrinsic Clearance Using Rainbow Trout Liver S9 Sub-Cellular Fraction (RT-S9) | |
| 850.1010 | NEW: Aquatic invertebrate acute toxicity test, Freshwater Daphnids | Describes 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 |
| 850.1020 | NEW: Gammarid amphipod acute toxicity test | Describes 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 | |
| Source | Description |
| Analog Identification Methodology (AIM) | Database tool to facilitate identification of analogs for read-across |
| NEW: Androgen Receptor (AR) pathway model | AR 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: ChemExpo | ChemExpo 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 Modules | Cheminformatics 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: ECOTOX | Comprehensive, 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 model | ER 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 Hub | Generalized 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 Document | Documentation of TSCA chemical categories |
| NEW: NICEATM Alternative Methods Accepted by US Agencies | Compilation 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 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™ | 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 Frameworks | Read 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 Alerts | Use of structure-activity relationship (SAR) rules which define substructures or chemical moieties that are hypothesized to result in biological activity2 |
| NEW: ToxCast | The 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 | ||
| Title | Type of NAM | Information Gathered |
| NEW: Decision Framework for Hazard Identification of Skin Irritation and Corrosion | Prioritizes human cell-based tissue model NAMs | Decision 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 Corrosion | Prioritizes human cell-based tissue model NAMs | Decision 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 Analysis | Waiving 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 Analysis | 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 Sub-Acute Avian Dietary Tests for Pesticide Registration and Supporting Retrospective Analysis | Waiving 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 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 |
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 | |
| Source | Title/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 Dashboard | Compilation of publicly available information on over 850,000 chemicals. |
| FIFRA SAP January 2013 | Prioritizing the Universe of Endocrine Disruptor Screening Program (EDSP) Chemicals Using Computational Toxicology Tools |
| FIFRA SAP November, 20171 | Continuing Development of Alternative High-Throughput Screens to Determine Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesis, and Thyroid Pathways |
| FIFRA SAP 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 document (GD) No. 34 | Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment |
| OECD GD No. 69 | Guidance Document on the Validation of (Quantitative) Structure-Activity Relationship [(Q)SAR] Models |
| OECD GD No. 102 | Guidance Document for Using the OECD (Q)SAR Application Toolbox to Develop Chemical Categories According to the OECD Guidance on Grouping Chemicals |
| OECD GD No. 184 | Revised Guidance Document on Developing and Assessing Adverse Outcome Pathways |
| OECD GD No. 194 | Guidance on Grouping of Chemicals, Second Edition |
| OECD GD No. 203 | New Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation |
| OECD GD No. 211 | 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 |
| OECD GD No. 237 | Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests |
| OECD GD No. 255 | Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment |
| OECD GD No. 256 | 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. Although several meetings/evaluations are presented here, interested parties are encouraged to review the general FIFRA SAP link for other meetings related to NAMs. | |