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國際接受之已驗證替代方法-美國環保署


Test Guidelines – Health Effects
Test Guidelines – Effects on Biotic Systems
EPA NAM-Related Policies Which May Be Relevant to TSCA
Other NAMs Used for TSCA
Other Useful Information

Test Guidelines – Health Effects1


Test Guideline No.TitleInformation 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 (TER)Evaluates corrosivity (rat skin as source)
OECD TG NO. 431in vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) TestEvaluates 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 CorrosionEvaluates corrosion using a synthetic membrane
OECD TG NO. 437Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe IrritantsEvaluates eye irritation/corrosivity in bovine eyes
OECD TG NO. 438Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe IrritantsEvaluates eye irritation/corrosivity in chick eyes
OECD TG NO. 439in vitro Skin Irritation: Reconstructed Human Epidermis Test MethodEvaluates irritation (human skin as source)
OECD TG NO. 442CIn chemico Skin SensitisationNo animal or human cells used, evaluates simple binding of a chemical to a receptor
OECD TG NO. 442DIn vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test MethodEvaluates skin sensitization using human cells
OECD TG NO. 442EIn vitro Skin Sensitisation: (h-CLAT)Evaluates skin sensitization using human cells
OECD TG NO. 455Performance-based Test Guideline for Stably Transfected Transactivation in vitro Assays to Detect Estrogen Receptor Agonists and AntagonistsEvaluates estrogenic effects using human cells
OECD TG No. 456H295R Steroidogenesis AssayEvaluates possible endocrine effects using human cells
OECD TG No. 458Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of ChemicalsEvaluates androgenic effects using chinese hamster ovary cells
OECD TG No. 460Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe IrritantsEvaluates eye corrosivity/severe irritation with canine kidney cells
OECD TG No. 471Bacterial Reverse Mutation TestEvaluates mutagenicity in bacterial cells
OECD TG No. 473in vitro Mammalian Chromosome Aberration TestEvaluates chromosomal effects in either human or rodent cells
OECD TG No. 476in vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genesEvaluates 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 Thymidine Kinase Mutation TestEvaluates gene mutations in either human or rodent cells
OECD TG No. 491Short-time Exposure for the Detection of Chemicals Causing Serious Eye Damage, and Chemicals Not Requiring Classification for Serious Eye Damage or Eye IrritationEvaluates eye corrosivity/severe irritation with rabbit cornea cells
OECD TG No. 492Reconstructed Human Cornea-like Epithelium for the Detection of Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye DamageEvaluates eye irritation with reconstructed human cells (either eye or skin)
OECD TG No. 493Performance-Based Test Guideline for Human Recombinant Estrogen Receptor (hrER) in vitro AssaysEvaluates estrogenicity in human cells
OECD TG No. 494 2Vitrigel-Eye Irritancy Test Method for Identifying Chemicals not requiring Classification and Labelling for Eye Irritation or Serious Eye DamageRecommended to identify chemicals not requiring classification for serious eye damage or eye irritation.
OECD TG No. 495 2Reactive Oxygen Species (ROS) Assay for PhotoreactivityEvaluates photoreactivity in chemico
OECD TG No. 496 2In Vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye DamageRecommended 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) 2,3The ToxCast Estrogen Receptor Agonist Pathway ModelMathematical model that combines results from 18 assays to predict estrogen receptor agonism
TM2004-07 (EU) 2,3In vitro BALB/c 3T3 Cell Transformation AssayAssay to measure carcinogenicity potential
TM2009-01 (EU) 2,3Ocular Irritection®Assay to predict potential eye irritation for classification/labelling purposes
TM2008-14 (EU) 2,33T3 Neutral Red Uptake cytotoxicity assayAssay to specifically identify non-classified chemicals (for classification/labelling purposes) with a cutoff value of 2000 mg/kg-bw (oral)
ICCVAM Eye Irritation Test 4Cytosensor Michrophysiometer™ in vitro test method for eye safetyIn vitro test to evaluate eye irritation

1 OECD Test Guidelines (Health), ICCVAM (Alternative Methods Accepted by US Agencies; excludes methods used for specific purposes by other agencies (e.g., vaccines by FDA), and ECVAM source (filtered by “regulatory acceptance/Standards” by Step and “finalized” by Step Status.
2 Added to list in First Update (December 2019)
3 From ECVAM (see footnote 1)
4 From ICCVAM (see footnote 1)

Test Guidelines – Effects on Biotic Systems1


Test Guideline No.TitleInformation Gathered
OECD TG NO. 201Freshwater Alga and Cyanobacteria TestEvaluates toxicity to algae
OECD TG NO. 202Daphnia Species Acute Immobilization testEvaluates toxicity to freshwater invertebrates
OECD TG NO. 207 Earthworm Acute Toxicity testEvaluates toxicity to soil invertebrates
OECD TG NO. 211Daphnia magna Reproduction TestEvaluates reproductive effects in freshwater invertebrates
OECD TG NO. 212 2Fish Short-term Toxicity Test on Embryo and Sac-Fry StagesEvaluates toxicity to fish development.
OECD TG NO. 218 2Sediment-Water Chironomid Toxicity Using Spiked SedimentEvaluates toxicity to sediment-dwelling invertebrates
OECD TG NO. 219 2Sediment-Water Chironomid ToxicityEvaluates toxicity to sediment-dwelling invertebrates
OECD TG NO. 221Lemna species Growth Inhibition TestEvaluates toxicity to freshwater aquatic plants of the genus Lemna (duckweed).
OECD TG NO. 222Earthworm Reproduction Toxicity TestEvaluates reproductive effects in soil invertebrates
OECD TG NO. 225 2Sediment-Water Lumbriculus ToxicityEvaluates toxicity of sediment-associated chemicals endobenthic living organisms
OECD TG NO. 233 2Sediment-Water Chironomid Life-Cycle ToxicityEvaluates chronic toxicity to the life-cycle of sediment-dwelling freshwater dipteran Chironomus species.
OECD TG NO. 235 2Chironomus sp. Acute Immobilisation testEvaluates acute toxicity (immobilisation) to chironomid species.
OECD TG NO. 236Fish Embryo Acute Toxicity (FET)Evaluates toxicity to fish using zebrafish embryos
OECD TG NO. 238 2Sediment-free Myriophyllum spicatum Toxicity TestEvaluates toxicity to a submerged, rooted macrophyte species (water milfoil)
OECD TG NO. 239 2Water-Sediment Myriophyllum spicatum Toxicity TestEvaluates toxicity to a submerged, rooted macrophyte species (water milfoil)
OECD TG NO. 242 2Potamopyrgus antipodarum Reproduction TestEvaluates reproductive toxicity to a mudsnail
OECD TG NO. 243 2Lymnaea stagnalis Reproduction TestEvaluates reproductive toxicity to a freshwater snail
OECD TG NO. 319A 2,3
OECD TG NO. 319B 2,3
Determination of in vitro intrinsic clearance using rainbow trout hepatocytes (OECD TG NO. 319A)
Determination of in vitro intrinsic clearance using rainbow trout liver S9 sub-cellular fraction (RT-S9) (OECD TG NO. 319B)
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 No. 280, Other Useful Information table)

1 Does not include tests in terrestrial plant species.
2 Added to list on First Update (December 2019)
3 These Test Guidelines are classified by the OECD as evaluating Environmental Fate and Behavior.

EPA NAM-Related Policies Which May Be Relevant to TSCA


Link to PolicyType of NAMInformation 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
Waiver Guidance – Dermal ToxicityProcess for waiving dermal toxicity testing for pesticides; but may be applicable to industries considering performing these studies for TSCA purposes.Acute dermal toxicity
Waiver Guidance - Birds 1WaivingDraft policy open for public comment
Waiver Guidance - Acute Toxicity 1Waiving or the use of Bridging (read-across)Acute toxicity for pesticides (by route and including irritation/sensitization)
Alternative Testing Framework - Eye Irritation 1Decision tree for in vitro testing for labelingEye irritation
Process to Evaluate and Implement Alternative Approaches to In Vivo Acute Toxicity Studies 1Alternative approaches to evaluating acute toxicity in lieu of an in vivo studyDocuments a process to be followed to submit to EPA (Office of Pesticide Programs)
Use of NAMs for Endocrine Disruptor Screening 1Use of high throughput assays and computational tools in the endocrine disruptor screening programScreening for tiered testing for endocrine activity

1 Added to list on First Update (December 2019)

Other NAMs Used for TSCA1


NAMParameter/Information Gathered
The OECD QSAR Toolbox 2Compilation 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
Ecological Structure-Activity Relationships Program (ECOSAR)Hazard3 – In silico tool to predict aquatic hazard
OncoLogicHazard3 – In silico tool to predict potential to cause cancer in humans
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 Chemicals Program Chemical Categories DocumentHazard3 – Documentation of TSCA chemical categories
Estimation Programs Interface (EPISuiteTM)Physical/chemical properties and environmental fate3 – 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 ExposureExposure4 – 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 Added to list on First Update (December 2019)
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

Other Useful Information1


SourceContent
EPA CompTox Chemicals DashboardCompilation of publicly available information on over 850,000 chemicals.
FIFRA SAP January 2013 2Prioritizing the Universe of Endocrine Disruptor Screening Program (EDSP) Chemicals Using Computational Toxicology Tools
FIFRA SAP November, 2017Continuing 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 No. 34Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment
OECD No. 69Guidance documents on the validation of (Quantitative) structure-activity relationship [(Q)SAR] models
OECD No. 102Guidance document for using the OECD (Q)SAR application toolbox to develop chemical categories according to the OECD guidance on grouping chemicals
OECD No. 184Guidance document on developing/assessing adverse outcome pathways
OECD No. 194Guidance on grouping of chemicals, second edition
OECD No. 203Guidance document on an integrated approach on testing and assessment (IATA) for skin corrosion and irritation
OECD No. 211Guidance Document for Describing Non-Guideline In Vitro Test Methods
OECD No. 214Guidance Document on the In Vitro Syrian Hamster Embryo (SHE) Cell Transformation Assay
OECD No. 231Guidance Document on the In Vitro Bhas 42 Cell Transformation Assay (BHAS 42 CTA)
OECD No. 237Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests
OECD No. 255Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment
OECD 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 No. 260Guidance Document for the Use of Adverse Outcome Pathways in Developing Integrated Approaches to Testing and Assessment (IATA)
OECD No. 263Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Serious Eye Damage and Eye Irritation
OECD 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 Added at First Update (December 2019)
2 FIFRA SAP = Federal Insecticide, Fungicide and Rodenticide Act, Scientific Advisory Panel. Although several meetings/evaluations are presented in this table, interested parties are encouraged to review the SAP link for other meetings related to NAMs

原始檔案:https://www.epa.gov/sites/production/files/2019-12/documents/alternative_testing_nams_list_first_update_final.pdf

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

(2019.12.05更新)

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