National Toxicology Program

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Regulations and Statutes

U.S. Consumer Product Safety Commission

• Federal Hazardous Substances Act (U.S.C. Title 15, Chapter 30, Sections 1261-1278) [PDF]
• Definitions - Federal Hazardous Substances Act
  Code of Federal Regulations: 16 CFR 1500.3 [PDF]

U.S. Environmental Protection Agency

• Toxic Substances Control Act (U.S.C. Title 15, Chapter 53) [PDF]
• Federal Insecticide, Fungicide, and Rodenticide Act (U.S.C. Title 7, Chapter 6) [PDF]
• Toxicology Data Requirements Table
  Code of Federal Regulations 40 CFR 158.500 [View on U.S. Government Printing Office web site ]
• Toxic Substances Control Act: Health and Safety Data Reporting
  Code of Federal Regulations: 40 CFR 716 [View on U.S. Government Printing Office web site ]
• Toxic Substances Control Act: Health Effects Testing Guidelines
  Code of Federal Regulations: 40 CFR 798 [View on U.S. Government Printing Office web site ]

U.S. Food and Drug Administration (FDA)/Center for Drug Evaluation and Research

• Federal Food, Drug, and Cosmetic Act (U.S.C. Title 21, Chapter 9)
  View on FDA web site
• Public Health Service Act (U.S.C. Title 42, Chapter 6A)
  View on FDA web site
• Investigational New Drug Applications
  Code of Federal Regulations 21 CFR 312 [View on U.S. Government Printing Office web site ]
• Applications for FDA Approval to Market a New Drug
  Code of Federal Regulations 21 CFR 314 [View on U.S. Government Printing Office web site ]

U.S. Occupational Safety and Health Administration

• Occupational Safety and Health Act of 1970 (U.S.C. Title 29, Chapter 15) [PDF]
• Hazard Communication
  Code of Federal Regulations 29 CFR 1910.1200 [View on U.S. Government Printing Office web site ]

European Union

European Union documents not directly linked here may be found on the Eur-Lex Web site

• Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 [PDF]
• Annex V to Directive 67/548/EEC of 27 June 1967
• Directive 91/414/EEC of the European Parliament and of the Council of 15 July 1991

United Nations

• GHS Part 3: Health Hazards [PDF]
  Chapter 3.4, Respiratory or Skin Sensitization

Guidances, Guidelines, and Recommendations

U.S. Environmental Protection Agency

• Office of Prevention, Pesticides and Toxic Substances (OPPTS) Health Effects Test Guidelines, OPPTS 870.2600: Skin Sensitization (March 2003) [PDF]
• June 2011 Update on the Use of the Local Lymph Node Assay for End Use Pesticide Products and Adoption of the Reduced Dose Protocol for LLNA (rLLNA): View on EPA web site

U.S. Food and Drug Administration/Center for Drug Evaluation and Research

• Guidance for Industry Immunotoxicology Evaluation of Investigational New Drugs (2002) [PDF]

Organisation for Economic Co-operation and Development (OECD)

• OECD Guideline for the Testing of Chemicals Number 406: Skin Sensitization (July 1992) [PDF]
• OECD Guideline for the Testing of Chemicals Number 429: Skin Sensitization - Local Lymph Node Assay (updated July 2010) [PDF]
• OECD Guideline for the Testing of Chemicals Number 442A: Skin Sensitization - Local Lymph Node Assay: BrdU-DA (July 2010) [PDF]
• OECD Guideline for the Testing of Chemicals Number 442B: Skin Sensitization - Local Lymph Node Assay: BrdU-ELISA (July 2010) [PDF]

International Organization for Standardization

• ISO 10993-10: Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization
  Available for purchase on the ISO web site

Relevant documents may also be found via the Agency Guidelines and Regulations Search Page