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Testing Regulations and Guidelines




Environmental Protection Agency
Publication Date Title Notice Number
05-31-2013 EPA Office of Pesticide Programs: Use of an Alternate Testing Framework for Classification of Eye Irritation Potential of EPA Pesticide Products NA
03-01-2012 EPA Office of Pesticide Programs: Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests NA
04-01-2011 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 NA
10-01-2009 EPA Health Effects Test Guidelines: Estrogen Receptor Transcriptional Activation (Human Cell Line (HeLa- 9903)) OPPTS 890.1300
03-25-2003 Environmental Protection Agency: Revised Final Health Effects Test Guideline; Skin Sensitization; Notice of Availability EPA FR 03-7057
03-01-2003 EPA Health Effects Test Guidelines: Skin Sensitization OPPTS 870.2600
12-01-2002 EPA Health Effects Test Guidelines: Acute Toxicity Testing - Background OPPTS 870.1000
12-01-2002 EPA Health Effect Test Guidelines: Acute Oral Toxicity OPPTS 870.1100
02-25-2002 EPA Report of the FIFRA Scientific Advisory Panel Meeting (Dec. 2001) NA
07-01-2000 40 CFR 158.70: EPA Acceptable Protocols EPA 40.158.70
07-01-2000 40 CFR 157.22: EPA - Child-Resistant Packaging; When Required 40 CFR 157.22
07-01-2000 40 CFR 152.170 EPA Criteria for Restriction to use by Certified Applicators 40 CFR 152.170
07-01-2000 EPA Health Effects Test Guidelines: Repeated Dose 28-Day Oral Toxicity Study in Rodents OPPTS 870.3050
07-01-2000 EPA Health Effects Test Guideline: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test OPPTS 870.3650
07-01-2000 EPA Health Effects Test Guidelines: Reproduction/Developmental Toxicity Screening Test OPPTS 870.3550
07-01-1999 40 CFR 156: EPA Labeling Requirements for Pesticides and Devices 40 CFR 156
07-01-1999 40 CFR 152: EPA Pesticide Registration and Classification Procedures 40 CFR 152
08-01-1998 EPA Health Effects Test Guidelines; Acute Dermal Irritation OPPTS 870.2500
08-01-1998 EPA Health Effects Text Guidelines: Dermal Penetration OPPTS 870.7600
08-01-1998 EPA Health Effects Test Guidelines: Prenatal Developmental Toxicity Study OPPTS 870.3700
08-01-1998 EPA Health Effects Test Guidelines: Reproduction and Fertility Effects OPPTS 870.3800
08-01-1998 EPA Health Effects Test Guidelines: 21/28-Day Dermal Toxicity OPPTS 870.3200
08-01-1998 EPA Health Effects Test Guidelines: Acute Inhalation Toxicity OPPTS 870.1300
08-01-1998 EPA Health Effects Test Guidelines: Acute Eye Irritation OPPTS 870.2400
07-01-1997 40 CFR 160: EPA Good Laboratory Practice Standards 40 CFR 160
12-01-1996 EPA Method 1120 - Dermal Corrosion EPA 1120
08-06-1996 Environmental Protection Agency: Safe Drinking Water Act Amendments of 1996 PL 104-182
08-03-1996 Environmental Protection Agency: Food Quality Protection Act of 1996 PL 104-170
06-01-1996 EPA Health Effects Test Guidelines: Acute Dermal Toxicity OPPTS 870.1200
01-01-1995 EPA Method 9040B - pH Electrometric Measurement EPA 9040B
12-05-1991 EPA Guidelines for Developmental Toxicity Risk Assessment EPA 56FR63798



Organisation for Economic Co-operation and Development
Publication Date Title Notice Number
07-27-2017 OECD Series on Testing and Assessment No. 184: Revised Guidance Document on Developing and Assessing Adverse Outcome Pathways OECD GD 184
07-20-2017 OECD Series on Testing and Assessment No. 263: Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Serious Eye Damage and Irritation OECD GD 263
09-08-2016 OECD Test Guideline 455: Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists OECD TG 455
07-29-2016 OECD Test Guideline 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals OECD TG 458
07-29-2016 OECD Test Guideline 442E: In Vitro Skin Sensitisation OECD TG 442E
07-29-2016 OECD Test Guideline 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes OECD TG 476
07-29-2016 OECD Test Guideline 487: In Vitro Mammalian Cell Micronucleus Test OECD TG 487
07-29-2016 OECD Test Guideline 489: In Vivo Mammalian Alkaline Comet Assay OECD TG 489
07-29-2016 OECD Test Guideline 473: In Vitro Mammalian Chromosomal Aberration Test OECD TG 473
07-28-2015 OECD Test Guideline 435: In Vitro Membrane Barrier Test Method for Skin Corrosion OECD TG 435
07-28-2015 OECD Test Guideline 421: Reproduction/Developmental Toxicity Screening Test OECD TG 421
07-28-2015 OECD Test Guideline 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method OECD TG 439
07-28-2015 OECD Test Guideline 493: Performance-Based Test Guideline for Human Recombinant Estrogen Receptor (hrER) In Vitro Assays to Detect Chemicals with ER Binding Affinity OECD TG 493
07-28-2015 OECD Test Guideline 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) OECD TG 430
07-28-2015 OECD Test Guideline 492: 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
07-28-2015 OECD Test Guideline 422: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test OECD TG 422
07-28-2015 OECD Test Guideline 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 OECD TG 491
02-04-2015 OECD Test Guideline 442D: In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method OECD TG 442D
02-04-2015 OECD Test Guideline 442C: In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay OECD TG 442C
12-15-2014 OECD Guidance Document 211: Guidance Document for Describing Non-Guideline In Vitro Test Methods OECD GD 211
07-29-2014 OECD Test Guideline 431: In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method OECD TG 431
07-11-2014 OECD Series on Testing and Assessment No. 203: New Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation OECD GD 203
07-26-2013 OECD Test Guideline 437: 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
07-26-2013 OECD Test Guideline 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 OECD TG 438
10-02-2012 OECD Test Guideline 443: Extended One-Generation Reproductive Toxicity Study OECD TG 443
10-02-2012 OECD Test Guideline 405: Acute Eye Irritation/Corrosion OECD TG 405
10-02-2012 OECD Test Guideline 457: BG1Luc Estrogen Receptor Transactivation Test Method for Identifying Estrogen Receptor Agonists and Antagonists OECD TG 457
10-02-2012 OECD Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants OECD TG 460
10-25-2011 OECD Guidance Document 160: The BCOP and ICE Test Methods: Collection of Tissues for Histological Evaluation and Collection of Data on Non-severe Irritants OECD GD 160
07-28-2011 OECD Test Guideline 456: H295R Steroidogenesis Assay OECD TG456
07-22-2010 OECD Test Guideline 442B: Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA OECD TG 442B
07-22-2010 OECD Test Guideline 223: Avian Acute Oral Toxicity Test OECD TG 223
07-22-2010 OECD Test Guideline 429: Skin Sensitisation: Local Lymph Node Assay OECD TG 429
07-22-2010 OECD Test Guideline 442A: Skin Sensitization: Local Lymph Node Assay: DA OECD TG 442A
06-01-2010 OECD Guidance Document 125: Histopathology for Subacute and Subchronic Inhalation Toxicity Studies OECD GD 125
05-31-2010 OECD Series on Testing and Assessment No. 126: Short Guidance on the Threshold Approach for Acute Fish Toxicity OECD GD 126
09-07-2009 OECD Test Guideline 441: Hershberger Bioassay in Rats: A Short-term Screening Assay for (Anti)Androgenic Properties OECD TG 441
09-07-2009 OECD Test Guideline 436: Acute Inhalation Toxicity - Acute Toxic Class Method OECD TG 436
09-07-2009 OECD Test Guideline 413: Subchronic Inhalation Toxicity: 90-day Study OECD TG 413
09-07-2009 OECD Test Guideline 403: Acute Inhalation Toxicity OECD TG 403
09-07-2009 OECD Test Guideline 412: Subacute Inhalation Toxicity: 28-day Study OECD TG 412
07-21-2009 OECD Guidance Document 39: Acute Inhalation Toxicity Testing OECD GD 39
10-03-2008 OECD Test Guideline 407: Repeated 28-day Oral Toxicity Study in Rodents OECD TG 407
10-16-2007 OECD Test Guideline 440: Uterotrophic Bioassay in Rodents: A short-term screening test for oestrogenic properties OECD TG 440
03-23-2006 OECD Test Guideline 425: Acute Oral Toxicity - Up-and-Down Procedure (UDP) OECD TG 425
08-18-2005 OECD Guidance Document 34: Validation and International Acceptance of New or Updated Internationally Acceptable Test Methods for Hazard Assessment OECD GD 34
11-30-2004 OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 14 - The Application of the Principles of GLP to in vitro Studies OECD GLP14
04-13-2004 OECD Test Guideline 432: In Vitro 3T3 NRU Phototoxicity Test OECD TG 432
04-13-2004 OECD Test Guideline 428: Skin Absorption In Vitro Method OECD TG 428
04-24-2002 OECD Test Guideline 404: Acute Dermal Irritation/Corrosion OECD TG 404
12-17-2001 OECD Test Guideline 423: Acute Oral toxicity - Acute Toxic Class Method OECD TG 423
12-17-2001 OECD Test Guideline 420: Acute Oral Toxicity - Fixed Dose Procedure OECD TG 420
08-14-2001 OECD Guidance Document 33: Harmonised Integrated Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures OECD GD 33
07-23-2001 OECD Guidance Document 24: Acute Oral Toxicity Testing OECD GD 24
01-22-2001 OECD Test Guideline 414: Prenatal Development Toxicity Study OECD TG 414
11-01-2000 OECD Guidance Document 19: Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation OECD GD 19
01-26-1998 OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 1: OECD Principles on GLP OECD GD 1
10-01-1994 Final Report of the OECD Workshop on Harmonisation of Validation and Acceptance Criteria for Alternative to Toxicological Test Methods NA
07-17-1992 OECD Test Guideline 406: Skin Sensitization OECD TG 406

US Department of Agriculture
Publication Date Title Notice Number
10-08-2015 Center for Veterinary Biologics Notice No. 15-13: Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Canicola and Icterohaemorrhagiae USDA CVB 15-13
04-10-2015 Guidelines for Validation of In Vitro Potency Assays VS 800.112
12-12-2013 Exemption from Leptospira Bacterin Testing Under 9 CFR 113.101-104 and the Associated References and Studies VS 800.102
07-31-2013 Animal Safety Testing Exemption VS 800.116
07-26-2013 Changes to the Rabies Virus NIH Potency Test Validity Requirements USDA CVB 13-10
05-25-2012 Use of Humane Endpoints and Methods in Animal Testing of Biological Products USDA CVB 12-12
04-13-2012 Alternative Test Procedure for Tuberculin, PPD Bovis, Intradermic VS 800.114
07-28-2011 Supplemental Assay Method 626: In Vitro Potency Testing of Leptospira kirschneri Serogroup grippotyphosa Bacterins SAM 626
06-28-2011 Veterinary Services Memo No. 800.211: Guidelines for Master Reference Qualification and Requalification VS 800.211
02-12-2010 Supplemental Assay Method 613: In Vitro Potency Testing of Erysipelothrix rhusiopathie Bacterins SAM 613
06-03-2009 Supplemental Assay Method 627: In Vitro Potency Testing of Leptospira interrogans Serovar icterohaemorrhagiae Bacterins SAM 627
06-03-2009 Supplemental Assay Method 625: In Vitro Potency Testing of Leptospira interrogans Serovar canicola Bacterins SAM 625
06-03-2009 Supplemental Assay Method 624: In Vitro Potency Testing of Leptospira interrogans Serovar pomona Bacterins SAM 624
04-01-2004 USDA, Center for Veterinary Biologics Notice: Use of Humane Endpoints in Animal Testing of Biological Products USDA CVB 04-09
01-01-2003 9 CFR 113.110: Animal and Plant Health Inspection Service, USDA: Clostridium Botulinum Type C Bacterin-Toxoid 9 CFR 113.110
12-26-1991 Exemptions to Tests 9 CFR 113.4