Testing Regulations and Guidelines

Date Agency Title Publication Number
Jan 8, 2024 EPA Framework to Assess Eye Irritation or Corrosion in New Chemicals (none)
Nov 17, 2023 FDA Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions: Guidance for Industry and FDA Staff (none)
Jul 4, 2023 OECD In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage OECD TG 496
Jul 4, 2023 OECD In Vitro Immunotoxicity OECD TG 444A
Jun 5, 2023 FDA Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals: Guidance for Industry (none)
Jan 27, 2022 CPSC Guidance for Industry and Test Method Developers: CPSC Staff Evaluation of Alternative Test Methods and Integrated Testing Approaches and Data Generated from Such Methods to Support FHSA Labeling Requirements (none)
Jun 30, 2022 OECD Rapid Androgen Disruptor Activity Reporter (RADAR) assay OECD TG 251
Jun 30, 2022 OECD Mammalian Erythrocyte Pig-a Gene Mutation Assay OECD TG 470
Jun 30, 2022 OECD Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification OECD TG 492B
Jun 30, 2022 OECD Defined Approaches for Serious Eye Damage and Eye Irritation OECD TG 467
May 1, 2021 FDA Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals - Guidance for Industry ICH S5(R3)
Jun 18, 2021 OECD EASZY assay - Detection of Endocrine Active Substances, Acting Through Estrogen Receptors, Using Transgenic tg(cyp19a1b:GFP) Zebrafish EmbrYos OECD TG 250
Jun 18, 2021 OECD Fish Cell Line Acute Toxicity - The RTgill-W1 Cell Line Assay OECD TG 249
Jul 4, 2023 OECD In Vitro Phototoxicity - Reconstructed Human Epidermis Phototoxicity Test Method OECD TG 498
Jul 4, 2023 OECD Defined Approaches on Skin Sensitisation OECD Guideline 497
Feb 1, 2020 EPA Final Guidance for Waiving Sub-Acute Avian Dietary Tests for Pesticide Registration and Supporting Retrospective Analysis (none)
Dec 31, 2020 EPA Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals and Supporting Retrospective Analysis (none)
Jan 01, 2020 FDA Guidance Document: In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry (none)
Jun 18, 2019 OECD Reactive Oxygen Species Assay for Photoreactivity OECD TG 495
Jun 17, 2021 OECD Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage OECD TG 494
Nov 3, 2023 OECD Initial Recommendations on Evaluation of Data from the Developmental Neurotoxicity (DNT) In Vitro Testing Battery OECD No. 377
Dec 8, 2021 OECD Guidance Document for the Scientific Review of Adverse Outcome Pathways OECD GD 344
Feb 3, 2021 OECD Guidance Document on the Characterisation, Validation, and Reporting of PBK Models for Regulatory Purposes OECD GD 331
Sep 03, 2018 OECD Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption OECD GD 150
Aug 29, 2018 OECD Guidance Document on Good In Vitro Methods Practices OECD GD 286
Dec 19, 2016 OECD Guidance Document for the Use of Adverse Outcome Pathways in Developing Integrated Approaches to Testing and Assessment (IATA) OECD GD 260
Apr 04, 2018 EPA Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing (none)
Nov 09, 2016 EPA Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations and Supporting Retrospective Analysis (none)
Nov 01, 2013 FDA Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products (none)
Jun 01, 2012 FDA Guidance for Industry: Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers (none)
Jan 01, 2019 FDA National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish (none)
Jan 01, 2015 FDA Photosafety Evaluation of Pharmaceuticals ICH S10
May 17, 2012 FDA Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals ICH S6(R1)
Jan 20, 2010 FDA Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals ICH M3(R2)
Jul 20, 2010 OECD Guidance Document on Using Cytotoxicity Tests to Estimate Starting Doses for Acute Oral Systemic Toxicity Tests OECD GD 129
Dec 10, 2012 CPSC Hazardous Substances and Articles; Administration and Enforcement Regulations: Revisions to Animal Testing Regulations 77 FR 73289
Feb 04, 2016 EPA Process for Evaluating and Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies for FIFRA Regulatory Use (none)
Feb 14, 2014 CPSC Final Rule: Revisions to Supplemental Definition of "Strong Sensitizer" 79 FR 8825
Dec 10, 2012 CPSC Codification of Animal Testing Policy 77 FR 73286
Jan 01, 2010 CPSC Hazardous Substances - Definitions 16 CFR 1500.3
Jan 01, 2000 CPSC Test for Eye Irritants 16 CFR 1500.42
Jan 01, 2000 CPSC Human Experience with Hazardous Substances 16 CFR 1500.4
Jan 01, 2000 CPSC Method of Testing Primary Irritant Substances 16 CFR 1500.41
May 03, 2006 DOT Special permit authorizing the use of alternative test method for corrosivity testing DOT-SP 10904
Oct 01, 2000 DOT Corrosive Label (appearance and placement) 49 CFR 172.442
Oct 01, 2000 DOT Class 8 Definitions 49 CFR 173.136
Oct 01, 2000 DOT Class 8 - Assignment of Packing Group 49 CFR 173.137
Oct 01, 2000 DOT Corrosive Placard (appearance) 49 CFR 172.558
Oct 01, 1999 DOT Assignment of Packing Group and Hazard Zones for Division 6.1 Materials 49 CFR 173.133
Oct 01, 1998 DOT Shippers - General Requirements for Shipments and Packaging 49 CFR 173
Oct 01, 1998 DOT Class 6 - Definitions 49 CFR 173.132
Mar 02, 2015 EPA Use of an Alternate Testing Framework for Classification of Eye Irritation Potential of EPA Pesticide Products (none)
Mar 01, 2012 EPA Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests for Pesticides and Pesticide Products (none)
Apr 01, 2011 EPA EPA Update on the Use of the Local Lymph Node Assay for End Use Pesticide Products and Adoption of the Reduced Dose Protocol for LLNA (none)
Oct 01, 2009 EPA EPA Health Effects Test Guidelines: Estrogen Receptor Transcriptional Activation (Human Cell Line (HeLa- 9903)) OPPTS 890.1300
Mar 01, 2003 EPA EPA Health Effects Test Guidelines: Skin Sensitization OPPTS 870.2600
Dec 01, 2002 EPA EPA Health Effects Test Guidelines: Acute Oral Toxicity OPPTS 870.1100
Dec 01, 2002 EPA EPA Health Effects Test Guidelines: Acute Toxicity Testing - Background OPPTS 870.1000
Jul 01, 2000 EPA EPA Health Effects Test Guidelines: Reproduction/Developmental Toxicity Screening Test OPPTS 870.3550
Jul 01, 2000 EPA EPA Health Effects Test Guidelines: Repeated Dose 28-Day Oral Toxicity Study in Rodents OPPTS 870.3050
Jul 01, 2000 EPA EPA Acceptable Protocols 40 CFR 158.70
Jul 01, 2000 EPA EPA Health Effects Test Guidelines: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test OPPTS 870.3650
Jul 01, 2000 EPA Child-Resistant Packaging; When Required 40 CFR 157.22
Jul 01, 2000 EPA EPA Criteria for Restriction to Use by Certified Applicators 40 CFR 152.170
Jul 01, 1999 EPA EPA Labeling Requirements for Pesticides and Devices 40 CFR 156
Jul 01, 1999 EPA EPA Pesticide Registration and Classification Procedures 40 CFR 152
Aug 01, 1998 EPA EPA Health Effects Test Guidelines: Acute Eye Irritation OPPTS 870.2400
Aug 01, 1998 EPA EPA Health Effects Test Guidelines: 21/28-Day Dermal Toxicity OPPTS 870.3200
Aug 01, 1998 EPA EPA Health Effects Test Guidelines: Acute Inhalation Toxicity OPPTS 870.1300
Aug 01, 1998 EPA EPA Health Effects Test Guidelines: Acute Dermal Irritation OPPTS 870.2500
Aug 01, 1998 EPA EPA Health Effects Test Guidelines: Dermal Penetration OPPTS 870.7600
Aug 01, 1998 EPA EPA Health Effects Test Guidelines: Reproduction and Fertility Effects OPPTS 870.3800
Aug 01, 1998 EPA EPA Health Effects Test Guidelines: Prenatal Developmental Toxicity Study OPPTS 870.3700
Jul 01, 1997 EPA EPA Good Laboratory Practice Standards 40 CFR 160
Dec 01, 1996 EPA Test Methods for Evaluating Solid Waste - Dermal Corrosion EPA 1120
Aug 06, 1996 EPA Safe Drinking Water Act Amendments of 1996 PL 104-182
Aug 03, 1996 EPA Food Quality Protection Act of 1996 PL 104-170
Jun 01, 1996 EPA EPA Health Effects Test Guidelines: Acute Dermal Toxicity OPPTS 870.1200
Nov 01, 2004 EPA Test Methods for Evaluating Solid Waste - pH Electrometric Measurement EPA 9040C
Dec 05, 1991 EPA Guidelines for Developmental Toxicity Risk Assessment (none)
Jan 01, 2005 Eur Ph Botulinum Toxin Type A for Injection (none)
Jan 01, 2005 Eur Ph Botulinum Antitoxin (none)
Apr 01, 2005 FDA FDA Definitions 21 CFR 600.3
Apr 01, 2005 FDA General Biological Products Standards: Purity 21 CFR 610.13
Apr 01, 2005 FDA FDA General Provisions: Equivalent Methods and Processes 21 CFR 610.9
Apr 01, 2005 FDA FDA Good Manufacturing Practice for Finished Pharmaceuticals: Special Testing Requirements 21 CFR 211.167
Apr 01, 2005 FDA FDA Potency 21 CFR 610.10
Nov 01, 2007 FDA FDA Guidance: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (none)
Apr 01, 2008 FDA FDA Guidance: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (none)
Apr 01, 2008 FDA FDA Guidance: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs) (none)
Apr 01, 2002 FDA FDA Good Laboratory Practice for Nonclinical Laboratory Studies 21 CFR 58
Mar 01, 1999 FDA FDA Guidance: Preparation of a Premarket Notification Application for a Surgical Mesh (none)
Jun 27, 2018 OECD Combined Chronic Toxicity/Carcinogenicity Studies OECD TG 453
Jun 27, 2018 OECD Chronic Toxicity Studies OECD TG 452
Jun 27, 2018 OECD Carcinogenicity Studies OECD TG 451
Jun 27, 2018 OECD Repeated Dose 90-Day Oral Toxicity Study in Rodents OECD TG 408
Jul 4, 2023 OECD In Vitro Skin Sensitisation OECD TG 442E
Jul 4, 2023 OECD Acute Eye Irritation/Corrosion OECD TG 405
Jul 4, 2023 OECD 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 OECD TG 491
Jun 27, 2018 OECD Subacute Inhalation Toxicity: 28-day Study OECD TG 412
Jun 27, 2018 OECD Acute Inhalation Toxicity: Fixed Concentration Procedure OECD TG 433
Jul 4, 2023 OECD Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage OECD TG 492
Jun 27, 2018 OECD Subchronic Inhalation Toxicity: 90-day Study OECD TG 413
Jul 4, 2023 OECD Bovine Corneal Opacity and Permeability Test Method i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage OECD TG 437
Oct 09, 2017 OECD Acute Dermal Toxicity OECD TG 402
Jul 4, 2023 OECD Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants OECD TG 460
Jul 4, 2023 OECD 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 OECD TG 438
Jul 27, 2017 OECD Revised Guidance Document on Developing and Assessing Adverse Outcome Pathways OECD GD 184
Jul 20, 2017 OECD Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Serious Eye Damage and Irritation OECD GD 263
May 04, 2012 OECD The Adverse Outcome Pathway for Skin Sensitisation Initiated by Covalent Binding to Proteins OECD GD 168
Jun 17, 2021 OECD Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists OECD TG 455
Jul 29, 2016 OECD In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene OECD TG 490
Jul 4, 2023 OECD In Vitro Mammalian Cell Micronucleus Test OECD TG 487
Jul 29, 2016 OECD In Vitro Mammalian Chromosomal Aberration Test OECD TG 473
Jul 29, 2016 OECD In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes OECD TG 476
Jul 29, 2016 OECD In Vivo Mammalian Alkaline Comet Assay OECD TG 489
Jul 4, 2023 OECD Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals OECD TG 458
Jun 18, 2019 OECD In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method OECD TG 431
Jul 28, 2015 OECD In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) OECD TG 430
Jul 28, 2015 OECD Reproduction/Developmental Toxicity Screening Test OECD TG 421
Jul 29, 2016 OECD Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test OECD TG 422
Jul 28, 2015 OECD Performance-Based Test Guideline for Human Recombinant Estrogen Receptor (hrER) In Vitro Assays to Detect Chemicals with ER Binding Affinity OECD TG 493
Jun 17, 2021 OECD In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method OECD TG 439
Jul 28, 2015 OECD In Vitro Membrane Barrier Test Method for Skin Corrosion OECD TG 435
Jun 27, 2018 OECD In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method OECD TG 442D
Jul 4, 2023 OECD In Chemico Skin Sensitisation: Assays Addressing the Adverse Outcome Pathway Key Event on Covalent Binding to Proteins OECD TG 442C
Dec 15, 2014 OECD Guidance Document for Describing Non-Guideline In Vitro Test Methods OECD GD 211
Oct 27, 2016 OECD Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment OECD GD 255
Aug 2, 2016 OECD Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests OECD GD 237
Jul 11, 2014 OECD New Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation OECD GD 203
Jun 27, 2018 OECD Extended One-Generation Reproductive Toxicity Study OECD TG 443
Oct 27, 2016 OECD

Guidance Document on the Reporting of Defined Approaches and Individual Information Sources to be Used Within Integrated Approaches to Testing and Assessments (IATA) for Skin Sensitisation

 OECD GD 256
Jul 06, 2018 OECD Guidance Document on the Collection of Eye Tissues for Histological Evaluation and Collection of Data OECD GD 160
Jul 4, 2023 OECD H295R Steroidogenesis Assay OECD TG 456
Jul 22, 2010 OECD Skin Sensitisation: Local Lymph Node Assay OECD TG 429
Jun 27, 2018 OECD Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA OECD TG 442B
Jul 23, 2010 OECD Avian Acute Oral Toxicity Test OECD TG 223
Jul 23, 2010 OECD Skin Sensitization: Local Lymph Node Assay: DA OECD TG 442A
Jun 01, 2010 OECD Histopathology for Subacute and Subchronic Inhalation Toxicity Studies OECD GD 125
May 31, 2010 OECD Short Guidance on the Threshold Approach for Acute Fish Toxicity OECD GD 126
Sep 08, 2009 OECD Hershberger Bioassay in Rats: A Short-term Screening Assay for (Anti)Androgenic Properties OECD TG 441
Sep 08, 2009 OECD Acute Inhalation Toxicity OECD TG 403
Sep 08, 2009 OECD Acute Inhalation Toxicity - Acute Toxic Class Method OECD TG 436
Jul 06, 2018 OECD Acute Inhalation Toxicity Testing OECD GD 39
Oct 16, 2008 OECD Acute Oral Toxicity: Up-and-Down Procedure OECD TG 425
Oct 13, 2008 OECD Repeated 28-day Oral Toxicity Study in Rodents OECD TG 407
Oct 16, 2007 OECD Uterotrophic Bioassay in Rodents: A Short-term Screening Test for Oestrogenic Properties OECD TG 440
Aug 18, 2005 OECD Validation and International Acceptance of New or Updated Internationally Acceptable Test Methods for Hazard Assessment OECD GD 34
Nov 30, 2004 OECD The Application of the Principles of GLP to In Vitro Studies OECD GLP 14
Nov 23, 2004 OECD Skin Absorption In Vitro Method OECD TG 428
Jun 18, 2019 OECD In Vitro 3T3 NRU Phototoxicity Test OECD TG 432
Jul 28, 2015 OECD Acute Dermal Irritation/Corrosion OECD TG 404
Feb 08, 2002 OECD Acute Oral Toxicity - Acute Toxic Class Method OECD TG 423
Feb 08, 2002 OECD Acute Oral Toxicity - Fixed Dose Procedure OECD TG 420
Aug 14, 2001 OECD Harmonised Integrated Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures OECD GD 33
Jul 23, 2001 OECD Acute Oral Toxicity Testing OECD GD 24
Jun 27, 2018 OECD Prenatal Development Toxicity Study OECD TG 414
Dec 21, 2000 OECD Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation OECD GD 19
Jan 26, 1998 OECD OECD Principles on GLP OECD GLP 1
Jun 17, 2021 OECD Skin Sensitization OECD TG 406
Oct 08, 2015 USDA Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Canicola and Ictero­haemorrhagiae CVB 15-13
Apr 10, 2015 USDA Guidelines for Validation of In Vitro Potency Assays VS 800.112
Dec 12, 2013 USDA Exemption from Leptospira Bacterin Testing Under 9 CFR 113.101-104 and the Associated References and Studies VS 800.102
Aug 14, 2017 USDA Animal Safety Testing Exemption VS 800.116
Apr 21, 2017 USDA Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Pomona and Gryppotyphosa CVB 17-06
Jul 26, 2013 USDA Changes to the Rabies Virus NIH Potency Test Validity Requirements CVB 13-10
May 25, 2012 USDA Use of Humane Endpoints and Methods in Animal Testing of Biological Products CVB 12-12
Apr 13, 2012 USDA Alternative Test Procedure for Tuberculin, PPD Bovis, Intradermic VS 800.114
Apr 28, 2017 USDA In Vitro Potency Testing of Leptospira kirschneri Serogroup grippotyphosa Bacterins SAM 626
Feb 8, 2023 USDA Guidelines for Master Reference Qualification and Requalification VS 800.211
May 18, 2016 USDA In Vitro Potency Testing of Erysipelothrix rhusiopathie Bacterins SAM 613
Apr 28, 2017 USDA In Vitro Potency Testing of Leptospira interrogans Serovar ictero­haemorrhagiae Bacterins SAM 627
Apr 28, 2017 USDA In Vitro Potency Testing of Leptospira interrogans Serovar canicola Bacterins SAM 625
Apr 20, 2017 USDA In Vitro Potency Testing of Leptospira interrogans Serovar pomona Bacterins SAM 624
Jan 01, 2003 USDA Clostridium Botulinum Type C Bacterin-Toxoid 9 CFR 113.110