Testing Regulations & Guidelines

Date	Agency	Title	Publication Number
Jul 1, 2024	EPA	EPA Report on Statutory and Regulatory Requirements for Vertebrate Animal Testing and Flexibility for Implementing New Approach Methods (NAMs)	(none)
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
Jun 25, 2025	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 25, 2025	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 25, 2025	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
Jun 25, 2025	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)
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
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
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 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 25, 2025	OECD	Repeated Dose 90-Day Oral Toxicity Study in Rodents	OECD TG 408
Jun 25, 2024	OECD	In Vitro Skin Sensitisation	OECD TG 442E
Jul 4, 2023	OECD	Acute Eye Irritation/Corrosion	OECD TG 405
Jun 25, 2025	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
Jun 25, 2025	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
Jun 25, 2025	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 25, 2019	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 25, 2025	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
Jun 25, 2025	OECD	Reproduction/Developmental Toxicity Screening Test	OECD TG 421
Jun 25, 2025	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 25, 2025	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
Jun 25, 2025	OECD	In Chemico Skin Sensitisation: Assays Addressing the Adverse Outcome Pathway Key Event on Covalent Binding to Proteins	OECD TG 442C
Apr 13, 2017	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
Apr 13, 2017	OECD	New Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation	OECD GD 203
Jun 25, 2025	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 Annex 1: Case Studies Annex 2: Information Sources Used Within the Case Studies	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
Jun 25, 2025	OECD	H295R Steroidogenesis Assay	OECD TG 456
Jul 22, 2010	OECD	Skin Sensitisation: Local Lymph Node Assay	OECD TG 429
Jun 25, 2025	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
Jun 25, 2025	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 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
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
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