| 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. 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. 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. 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 4 | 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 263 in Potentially Useful Information table) to identify chemicals that induce serious eye damage. |
| TM2016-08 (US) 2 | The ToxCast Estrogen Receptor Agonist Pathway Model | Mathematical model that combines results from 18 assays to predict estrogen receptor agonism |
| TM2004-07 (EU) 2 | In Vitro BALB/c 3T3 Cell Transformation Assay | Assay to measure carcinogenicity potential |
| TM2006-02 (EU) 2,4 | Ocular Irritection | Assay to predict potential eye irritation for classification/labelling purposes |
| TM2007-03 (EU) 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 Eye Irritation Test 3 | 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 Accepted by US Agencies; excludes methods used for evaluating other types of substances by other agencies (e.g., biologics by the U.S. Food and Drug Administration), and EURL-ECVAM source (filtered by “regulatory acceptance/Standards” by Step and “finalized” by Step Status.
2 From EURL-ECVAM (see table note 1)
3 From ICCVAM (see table note 1)
4 In the first update, 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.
| 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 chironomid |
| 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. 319A 2 | 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, Other Useful Information table) |
| OECD TG NO. 319B 2 | 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.
| Title | Type of NAM | Information Gathered |
|---|---|---|
| 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 1 | 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 Program | Use of NAMs for endocrine disruptor screening | Screening for tiered testing for endocrine activity |
1 Added to the List on Second Update (February 2021)
| Source | Parameter/Information Gathered |
|---|---|
| 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 |
| OncoLogicTM | Hazard2,3 – Predictive system that uses knowledge-based rules to predict cancer concern for more than 52 classes of organic chemicals (Version 9.0), 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 (EPISuiteTM) | Physical/chemical properties and environmental fate4 – e.g., bioconcentration/bioaccumulation |
| 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 approaches - https://www.epa.gov/tsca-screening-tools
2 Version 9.0 added to the List on Second Update (February 2021)
3 Hazard - https://www.epa.gov/tsca-screening-tools/using-predictive-methods-assess-hazard-under-tsca#models
4 Physical/Chemical Properties, Environmental Fate and Exposure - https://www.epa.gov/tsca-screening-tools/using-predictive-methods-assess-exposure-and-fate-under-tsca#fate
| Source | Title/Content |
|---|---|
| EPA CompTox Chemicals Dashboard | Compilation of publicly available information on over 850,000 chemicals. |
| FIFRA SAP January 2013 1 | Prioritizing the Universe of Endocrine Disruptor Screening Program (EDSP) Chemicals Using Computational Toxicology Tools |
| FIFRA SAP November, 2017 | 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 No. 34 | Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment |
| OECD No. 69 | Guidance documents on the validation of (Quantitative) structure-activity relationship [(Q)SAR] models |
| OECD 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 No. 184 | Revised Guidance Document on Developing and Assessing Adverse Outcome Pathways |
| OECD No. 194 | Guidance on grouping of chemicals, second edition |
| OECD No. 203 | New Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation |
| OECD No. 211 | Guidance Document for Describing Non-Guideline In Vitro Test Methods |
| OECD No. 214 | Guidance Document on the In Vitro Syrian Hamster Embryo (SHE) Cell Transformation Assay |
| OECD No. 231 | Guidance Document on the In Vitro Bhas 42 Cell Transformation Assay |
| OECD No. 237 | Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests |
| OECD No. 255 | Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment |
| OECD 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 No. 260 | Guidance Document for the Use of Adverse Outcome Pathways in Developing Integrated Approaches to Testing and Assessment (IATA) |
| OECD No. 263 | Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Serious Eye Damage and Eye Irritation |
| OECD 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.
關於美國環保署減少脊椎動物實驗之「替代測試方法」的更多資訊，可參考以下網站：https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce
(2021.2.18更新)
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