| 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 |
| Jun 17, 2021 |
OECD |
In Vitro Phototoxicity - Reconstructed Human Epidermis Phototoxicity Test Method |
OECD TG 498 |
| Jun 22, 2021 |
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) |
| Feb 01, 2020 |
FDA |
Draft Guidance Document: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics - Guidance for Industry |
(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 |
| 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 |
| 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) |
| Sep 01, 2014 |
Eur Ph |
Newcastle Disease Vaccine (Inactivated) |
(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 |
| Jun 27, 2018 |
OECD |
In Vitro Skin Sensitisation |
OECD TG 442E |
| Jun 17, 2021 |
OECD |
Acute Eye Irritation/Corrosion |
OECD TG 405 |
| Jun 29, 2020 |
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 18, 2019 |
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 29, 2020 |
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 |
| Oct 09, 2017 |
OECD |
Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants |
OECD TG 460 |
| Jun 27, 2018 |
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 29, 2016 |
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 |
| Jun 29, 2020 |
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 |
| Jun 17, 2021 |
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 |
| 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 28, 2011 |
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 |
| Aug 04, 2009 |
OECD |
Final Report of the OECD Workshop on Harmonisation of Validation and Acceptance Criteria for Alternative to Toxicological Test Methods |
(none) |
| 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 |
| Jun 28, 2011 |
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 |
