National Toxicology Program

National Toxicology Program
Testing Regulations and Guidelines
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Consumer Product Safety Commission
Publication Date Title Notice Number
12-10-2012 77 FR 73289 - Hazardous Substances and Articles; Administration and Enforcement Regulations: Revisions to Animal Testing Regulations 2012-29258
12-10-2012 77 FR 73286 - Codification of Animal Testing Policy 2012-29260
01-01-2010 16 CFR 1500.3: CPSC - Hazardous Substances - Definitions 16 CFR 1500.3
01-01-2000 16 CFR 1500.4: CPSC - Human Experience with Hazardous Substances 16 CFR 1500.4
01-01-2000 16 CFR 1500.41: CPSC - Method of Testing Primary Irritant Substances 16 CFR 1500.41
01-01-2000 16 CFR 1500.42: CPSC - Test for Eye Irritants 16 CFR 1500.42


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Department of Transportation
Publication Date Title Notice Number
10-01-1998 49 CFR 173.132: DOT Class 6 - Definitions 49 CFR 173.132
10-01-2000 49 CFR 172.442: DOT - Corrosive Label (appearance and placement) 49 CFR 172.442
10-01-2000 49 CFR 172.558: DOT - Corrosive Placard (appearance) 49 CFR 172.558
10-01-1998 DOT Research and Special Programs Administration: Shippers - General Requirements for Shipments and Packaging DOT 49.173
10-01-1999 49 CFR 173.133: DOT Assignment of packing group and hazard zones for Division 6.1 materials 49 CFR 173.133
10-01-2000 49 CFR 173.136: DOT Class 8 Definitions 49 CFR 173.136
10-01-2000 49 CFR 173.137: DOT Class 8 - Assignment of Packing Group 49 CFR 173.137
05-03-2006 DOT Pipeline and Hazardous Materials Safety Administration: Special permit authorizing the use of alternative test method for corrosivity testing DOT-SP 10904


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


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European Pharmacopeia
Publication Date Title Notice Number
01-01-2008 European Pharmacopoeia: Newcastle Disease Vaccine (Inactivated) NA
01-01-2005 European Pharmacopoeia: Botulinum Toxin Type A for Injection NA
01-01-2005 European Pharmacopoeia: Botulinum Antitoxin NA


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Food and Drug Administration
Publication Date Title Notice Number
05-01-2003 FDA Guidance: Photosafety Testing 3640
04-01-2002 21 CFR 58: FDA Good Laboratory Practice for Nonclinical Laboratory Studies 21 CFR 58
04-01-2005 21 CFR 211.167: FDA Good Manufacturing Practice for Finished Pharmaceuticals: Special Testing Requirements 21 CFR 211.167
04-01-2005 21 CFR 610.13: FDA General Biological Products Standards: Purity 21 CFR 610.13
04-01-2005 21 CFR 610.9: FDA General Provisions: Equivalent methods and processes 21 CFR 610.9
04-01-2005 21 CFR 600.3: FDA Definitions 21 CFR 600.3
04-01-2005 21 CFR 610.10: FDA Potency 21 CFR 610.10
08-01-2003 FDA Guidance: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs) NA
11-01-2004 FDA Guidance: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) NA
02-01-2005 FDA Guidance: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications NA
03-01-1999 FDA Guidance: Preparation of a Premarket Notification Application for a Surgical Mesh NA


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Organisation for Economic Co-operation and Development
Publication Date Title Notice Number
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
05-31-2010 OECD Series on Testing and Assessment No. 126: Short Guidance on the Threshold Approach for Acute Fish Toxicity NA
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
07-23-2001 OECD Guidance Document 24: Acute Oral Toxicity Testing OECD GD 24
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
07-21-2009 OECD Guidance Document 39: Acute Inhalation Toxicity Testing OECD GD 39
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
07-22-2010 OECD Test Guideline 223: Avian Acute Oral Toxicity Test OECD TG 223
09-07-2009 OECD Test Guideline 403: Acute Inhalation Toxicity OECD TG 403
04-24-2002 OECD Test Guideline 405: Acute Eye Irritation/Corrosion (updated 2012) OECD TG 405
09-07-2009 OECD Test Guideline 412: Subacute Inhalation Toxicity: 28-day Study OECD TG 412
09-07-2009 OECD Test Guideline 413: Subchronic Inhalation Toxicity: 90-day Study OECD TG 413
07-22-2010 OECD Test Guideline 429: Skin Sensitisation: Local Lymph Node Assay OECD TG 429
07-26-2013 OECD Test Guideline 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) OECD TG 430
07-26-2013 OECD Test Guideline 431: In Vitro Skin Corrosion: Human Skin Model Test OECD TG 431
09-07-2009 OECD Test Guideline 436: Acute Inhalation Toxicity - Acute Toxic Class Method OECD TG 436
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
07-26-2013 OECD Test Guideline 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method OECD TG 439
09-07-2009 OECD Test Guideline 441: Hershberger Bioassay in Rats: A Short-term Screening Assay for (Anti)Androgenic Properties OECD TG 441
07-22-2010 OECD Test Guideline 442A: Skin Sensitization: Local Lymph Node Assay: DA OECD TG 442A
07-22-2010 OECD Test Guideline 442B: Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA OECD TG 442B
10-02-2012 OECD Test Guideline 443: Extended One-Generation Reproductive Toxicity Study OECD TG 443
09-07-2009 OECD Test Guideline 455: Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists (updated 2012) OECD TG 455
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
07-22-2010 OECD Test Guideline 487: In Vitro Mammalian Cell Micronucleus Test OECD TG 487
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
01-22-2001 OECD Test Guideline 414: Prenatal Development Toxicity Study OECD TG 414
12-17-2001 OECD Test Guideline 420: Acute Oral Toxicity - Fixed Dose Procedure OECD TG 420
07-27-1995 OECD Test Guideline 421: Reproduction/Developmental Toxicity Screening Test OECD TG 421
03-22-1996 OECD Test Guideline 422: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test OECD TG 422
12-17-2001 OECD Test Guideline 423: Acute Oral toxicity - Acute Toxic Class Method OECD TG 423
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
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
04-24-2002 OECD Test Guideline 404: Acute Dermal Irritation/Corrosion OECD TG 404
07-17-1992 OECD Test Guideline 406: Skin Sensitization OECD TG 406
10-03-2008 OECD Test Guideline 407: Repeated 28-day Oral Toxicity Study in Rodents OECD TG 407
03-23-2006 OECD Test Guideline 425: Acute Oral Toxicity - Up-and-Down Procedure (UDP) OECD TG 425
04-13-2004 OECD Test Guideline 428: Skin Absorption In Vitro Method OECD TG 428
04-13-2004 OECD Test Guideline 432: In Vitro 3T3 NRU Phototoxicity Test OECD TG 432
07-19-2006 OECD Test Guideline 435: In Vitro Membrane Barrier Test Method for Skin Corrosion OECD TG 435
10-16-2007 OECD Test Guideline 440: Uterotrophic Bioassay in Rodents: A short-term screening test for oestrogenic properties OECD TG 440


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US Department of Agriculture
Publication Date Title Notice Number
04-01-2004 USDA, Center for Veterinary Biologics Notice: Use of Humane Endpoints in Animal Testing of Biological Products USDA CVB 04-09
02-12-2010 Supplemental Assay Method 613: In Vitro Potency Testing of Erysipelothrix rhusiopathie Bacterins SAM 613
06-03-2009 Supplemental Assay Method 624: In Vitro Potency Testing of Leptospira interrogans Serovar pomona Bacterins SAM 624
06-03-2009 Supplemental Assay Method 624: In Vitro Potency Testing of Leptospira interrogans Serovar pomona Bacterins NA
06-03-2009 Supplemental Assay Method 625: In Vitro Potency Testing of Leptospira interrogans Serovar canicola Bacterins NA
06-03-2009 Supplemental Assay Method 625: In Vitro Potency Testing of Leptospira interrogans Serovar canicola Bacterins SAM 625
07-28-2011 Supplemental Assay Method 626: In Vitro Potency Testing of Leptospira kirschneri Serogroup grippotyphosa Bacterins SAM 626
07-28-2011 Supplemental Assay Method 626: In Vitro Potency Testing of Leptospira kirschneri Serogroup grippotyphosa Bacterins NA
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 627: In Vitro Potency Testing of Leptospira interrogans Serovar icterohaemorrhagiae Bacterins NA
01-01-2003 9 CFR 113.110: Animal and Plant Health Inspection Service, USDA: Clostridium Botulinum Type C Bacterin-Toxoid 9 CFR 113.110
06-28-2011 Veterinary Services Memo No. 800.211: Guidelines for Master Reference Qualification and Requalification VS 800.211
The NTP is administratively located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.

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