Regulatory Guidance
 
ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) Guidelines
 
Carcinogenicity Studies
 
S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074911.pdf
 
The tripartite harmonized ICH guideline was finalized (Step 4) in November 1995. This document provides a consistent definition of the circumstances under which it is necessary to undertake carcinogenicity studies on new drugs. These recommendations take into account the known risk factors as well as the intended indications and duration of exposure.
 
 
The tripartite harmonized ICH guideline was finalized (Step 4) in July 1997. This document provides guidance on the need to carry out carcinogenicity studies in both mice and rats, and guidance is also given on alternative testing procedures which may be applied without jeopardizing safety.
 
S1C(R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals and Limit Dose: http://www.ich.org/LOB/media/MEDIA491.pdf
 
S1C(R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals This second revision has been approved by the ICH Steering Committee directly under Step 4 without further public consultation in March 2008. Note 2 of the parent guideline has been deleted, and the text referring to the Notes has been revised. The title has been changed by deleting "& Limit Dose". The Addendum has been integrated in the text. This document addresses the criteria for the selection of the high dose to be used in carcinogenicity studies on new therapeutic agents to harmonise current practices and improve the design of studies. In this revision, the pharmacokinetic endpoint of 25 is declared to be applicable also for pharmaceuticals with positive genotoxicity signals. This change has implications on "Refinement" (one of the 3R's) in enhancing the welfare, i.e., reducing the pain or discomfort of the animals at the MTD.
 
S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use Use: http://www.ich.org/LOB/media/MEDIA4474.pdf
 
This guideline has been released for consultation under Step 2 of the ICH process on 6 March 2008. 
This guidance replaces and combines these ICH S2A and S2B guidelines:
 
S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074925.pdf
 
The tripartite harmonized ICH guideline was finalized (Step 4) in July 1995. This document provides specific guidance and recommendations for in vitro and in vivo tests and on the evaluation of test results. It includes a glossary of terms related to genotoxicity tests to improve consistency in applications.
 
S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074929.pdf
 
The tripartite harmonized ICH guideline was finalized (Step 4) in July 1997. This document addresses two fundamental areas of genotoxicity testing: the identification of a standard set of assays to be conducted for registration, and the extent of confirmatory experimentation in any particular genotoxicity assay in the standard battery.
 
Toxicokinetics and Pharmacokinetics
 
S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129279.pdf
 
The tripartite harmonized ICH guideline was finalized (Step 4) in October 1994. This document gives guidance on developing test strategies in toxicokinetics and the need to integrate pharmacokinetics into toxicity testing, in order to aid in the interpretation of the toxicology findings and promote rational study design development.
 
S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129281.pdf
 
The tripartite harmonised ICH guideline was finalised (Step 4) in October 1994. This document gives guidance on circumstances when repeated dose tissue distribution studies should be considered (i.e., when appropriate data cannot be derived from other sources). It also gives recommendations on the conduct of such studies.
 
Toxicity Testing
 
S4A: Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity testing): http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129213.pdf
 
A tripartite, harmonized ICH guideline was finalized (Step 4) in September 1998. The recommendations are unchanged from those in the consultation draft issued in July 1997. The text incorporates the guidance for repeat-dose toxicity tests that was agreed at the time of ICH 1, in 1991 (reduction of the duration of repeat dose toxicity studies in the rat from 12 to 6 months).
 
Reproductive Toxicity
 
S5(R2) Detection of Toxicity to Reproduction for Medicinal Products   Toxicity to Male Fertility
Note: In November 2005, the ICH incorporated the S5B addendum with S5A and retitled the combined S5 document. The contents of the two guidances were not revised.
 
Biotechnological Products
 
S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129171.pdf
 
The tripartite harmonized ICH guideline was finalized (Step 4) in July 1997. This document covers the pre-clinical safety testing requirements for biotechnological products. It addresses the use of animal models of disease, determination of when genotoxicity assays and carcinogenicity studies should be performed, and the impact of antibody formation on duration of toxicology studies.
 
S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals: http://www.ich.org/LOB/media/MEDIA5784.pdf
 
This guideline has been released for consultation under Step 2 of the ICH process on 29 October 2009. 
The purpose of the addendum is to provide clarification on S6 and an update of the following topics discussed in the original ICH S6 guidance: species selection, study design, immunogenicity, reproductive and developmental toxicity and assessment of carcinogenic potential. Scientific advances and experience gained since publication of the original ICH S6 guidance call for this addendum.
This harmonised addendum will provide further complementary guidance to the S6 guideline and will help to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.
 
Pharmacology Studies
 
S7A: Safety Pharmacology Studies for Human Pharmaceuticals: http://www.fda.gov/RegulatoryInformation/Guidances/ucm129150.htm  
 
The ICH guideline reached Step 4 of the ICH process in November 2000. This document addresses the definition, objectives and scope of safety pharmacology studies. It also addresses which studies are needed before initiation of Phase 1 clinical studies as well as information needed for marketing.
 
S7B: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization: (QT Interval Prolongation) By Human Pharmaceuticals: http://www.fda.gov/RegulatoryInformation/Guidances/ucm129121.htm
 
The Guideline reached Step 4 of the ICH process on 12 May 2005.
This guideline describes a non-clinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization.
This guideline includes information concerning non-clinical assays and integrated risk assessments.
 
Immunotoxicity
 
S8: Immunotoxicology Studies for Human Pharmaceuticals:  http://www.ich.org/LOB/media/MEDIA1706.pdf
 
The Guideline reached Step 4 of the ICH process on 15 September 2005. This guideline addresses the recommendations on nonclinical testing for immunosuppression induced by low molecular weight drugs (non-biologicals). It applies to new pharmaceuticals intended for use in humans, as well as to marketed drug products proposed for different indications or other variations on the current product label in which the change could result in unaddressed and relevant toxicologic issues. In addition, the guideline might also apply to drugs in which clinical signs of immunosuppression are observed during clinical trials and following approval to market. The term immunotoxicity in this guideline will primarily refer to immunosuppression, i.e. a state of increased susceptibility to infections or the development of tumors. It is beyond the scope of this guideline to provide specific guidance on how each immunotoxicity study should be performed. General guidance is provided in Appendix 1.
 
Testing Antineoplastic Agents
 
S9: Nonclinical Evaluation for Anticancer Pharmaceuticals
http://www.ich.org/LOB/media/MEDIA5785.pdf
 
The Guideline reached Step 4 of the ICH process on 29 October 2009.
This guideline provides information for pharmaceuticals that are only intended to treat cancer in patients with late stage or advanced disease regardless of the route of administration, including both small molecule and biotechnology-derived pharmaceuticals. It describes the type and timing of nonclinical studies in relation to the development of anticancer pharmaceuticals and references other guidance as appropriate.
 
Joint Safety/Efficacy (Multidisciplinary) Topic
 
M3(R2): Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals: http://www.fda.gov/RegulatoryInformation/Guidances/ucm129520.htm
 
The recommendations of this revised guidance further harmonise the nonclinical safety studies to support the various stages of clinical development among the regions of European Union (EU), Japan, and the United States. The present guidance represents the consensus that exists regarding the type and duration of nonclinical safety studies and their timing to support the conduct of human clinical trials and marketing authorization for pharmaceuticals.
 
U.S. Environmental Protection Agency 
 
Toxic Substances Control Act Test Guidelines; Final Rule:  http://www.epa.gov/fedrgstr/EPA-TOX/1997/August/Day-15/t21413.htm
 
Guidelines for Reproductive Toxicity Risk Assessment:  Guidelines for Reproductive Toxicity Risk Assessment (PDF)
 
The Guidelines for Reproductive Toxicity Risk Assessment discuss the scientific basis for concern about exposure to agents that cause reproductive toxicity and describe the principles and procedures to be followed in conducting risk assessments for reproductive toxicity. They include the female (non-pregnant and pregnant) and male reproductive systems. Together with the Agency Guidelines for Developmental Toxicity Risk Assessment, developing young are covered. The Guidelines will promote consistency in the Agency's assessment of toxic effects on the male and female reproductive systems, including outcomes of pregnancy and lactation, and inform others of approaches that the Agency will use in assessing those risks. They identify and discuss the use of default assumptions, present summaries of the standardized testing protocols used to generate information on reproductive toxicity, discuss the various types of information that may be encountered in evaluations of reproductive toxicity, and specify the approaches that are appropriate for quantitative risk assessment, and exposure assessment. Although specific program policies and procedures are still evolving, these Guidelines discuss attributes of the Agency's risk characterization policy as it applies to reproductive toxicity.
 
Proposed Guidelines for Carcinogen Risk Assessment: http://oaspub.epa.gov/eims/eimscomm.getfile?p_download_id=439797
 
In an effort to update key scientific risk assessment methodologies, EPA has published revised Guidelines for Carcinogen Risk Assessment EPA/630/P-03/001F (PDF, 166p, 461K). The Guidelines provide a framework to EPA scientists for assessing possible cancer risks from exposures to pollutants or other agents in the environment. They will also inform Agency decision makers and the public about these recommended procedures. Revisions to the Cancer Guidelines are intended to make greater use of the increasing scientific understanding of processes of cancer development. Major issues considered in finalizing revisions to the Cancer Guidelines were:
  • beginning with an analysis of available information, and invoking defaults if needed to address uncertainty or the absence of critical information;
  • emphasizing key events and processes, starting with the interaction of an agent with a cell, through functional and anatomical changes, that may result in adverse health consequences ("modes of action");
  • considering that certain subpopulations, and childhood and other lifestages, may be associated with higher susceptibilities to risk; and
  • summarizing the full range of available evidence and describing any conditions associated with conclusions about an agent's hazard potential using a weight-of-evidence narrative and accompanying descriptors.
 
OPPTS Harmonized Test Guidelines
 
Series 870 Health Effects Test Guidelines
The FINAL guidelines on this page are part of a series of test guidelines that have been developed by the Office of Prevention, Pesticides and Toxic Substances (OPPTS) for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency.
 
Group A – Acute Toxicity Test Guidelines
Group B – Subchronic Toxicity Test Guidelines
870.3050 - Repeated Dose 28-Day Oral Toxicity Study in Rodents (July 2000) (PDF) (17 pp, 29K)
870.3100 - 90-Day Oral Toxicity in Rodents (August 1998) (PDF) (13 pp, 33K)
870.3150 - 90-Day Oral Toxicity in Nonrodents (August 1998) (PDF) (12 pp, 30K)
870.3200 - 21/28-Day Dermal Toxicity (August 1998) (PDF) (15 pp, 36K)
870.3250 - 90-Day Dermal Toxicity (August 1998) (PDF) (14 pp, 34K)
870.3465 - 90-Day Inhalation Toxicity (August 1998) (PDF) (17 pp, 40K)
870.3550 - Reproduction/Developmental Toxicity Screening Test (July 2000) (PDF) (13 pp, 89K)
870.3650 - Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (July 2000) (PDF) (17 pp, 89K)
870.3700 - Prenatal Developmental Toxicity Study (August 1998) (PDF) (11 pp, 126K)
870.3800 - Reproduction and Fertility Effects (August 1998) (PDF) (14 pp, 35K)
Group C – Chronic Toxicity Test Guidelines
Group D – Genetic Toxicity Test Guidelines
870.5100 - Bacterial Reverse Mutation Test (August 1998) (PDF) (13 pp, 36K)
870.5140 - Gene Mutation in Aspergillus nidulans (August 1998) (PDF) (7 pp, 18K)
870.5195 - Mouse Biochemical Specific Locus Test (August 1998) (PDF) (7 pp, 19K)
870.5200 - Mouse Visible Specific Locus Test (August 1998) (PDF) (6 pp, 16K)
870.5250 - Gene Mutation in Neurospora crassa (August 1998) (PDF) (6 pp, 17K)
870.5275 - Sex-linked Recessive Lethal Test in Drosophila melanogaster (August 1998) (PDF) (6 pp, 16K)
870.5300 - In vitro Mammalian Cell Gene Mutation Test (August 1998) (PDF) (14 pp, 37K)
870.5375 - In vitro Mammalian Chromosome Aberration Test (August 1998) (PDF) (13 pp, 33K)
870.5380 - Mammalian Spermatogonial Chromosomal Aberration Test (August 1998) (PDF) (11 pp, 28K)
870.5385 - Mammalian Bone Marrow Chromosomal Aberration Test (August 1998) (PDF) (11 pp, 28K)
870.5395 - Mammalian Erythrocyte Micronucleus Test (August 1998) (PDF) (12 pp, 31K)
870.5450 - Rodent Dominant Lethal Assay (August 1998) (PDF) (6 pp, 15K)
870.5460 - Rodent Heritable Translocation Assays (August 1998) (PDF) (7 pp, 17K)
870.5500 - Bacterial DNA Damage or Repair Tests (August 1998) (PDF) (7 pp, 18K)
870.5550 - Unscheduled DNA Synthesis in Mammalian Cells in Culture (August 1998) (PDF) (7 pp, 18K)
870.5575 - Mitotic Gene Conversion in Saccharomyces cerevisiae (August 1998) (PDF) (6 pp, 16K)
870.5900 - In vitro Sister Chromatid Exchange Assay (August 1998) (PDF) (7 pp, 18K)
870.5915 - In vivo Sister Chromatid Exchange Assay (August 1998) (PDF) (6 pp, 15K)
Group E – Neurotoxicity Test Guidelines
Group F – Special Studies Test Guidelines
Group G – Health Effects Chemical-Specific Test Guidelines
Series 890 - Endocrine Disruptor Screening Program Test Guidelines
U.S. Food and Drug Administration (FDA) 
Guidance for Industry and Other Stakeholders
Toxicological Principles for the Safety Assessment of Food Ingredients
Redbook 2000: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
July 2000; Updated  July 2007
Note to reader: Individual chapters/sections of this internet version of "Redbook" are available as linked documents via the Table of Contents. The date of revision for each chapter and /or chapter section is provided in the Table of Contents and the individual documents. These revisions supersede previous versions of Redbook 
Table of Contents
I. Introduction1 (July 2007)
II. Agency Review of Toxicology Information Submitted in Support of the Safety Assessment of Food Ingredients (available in 1993 Draft "Redbook II"2)
IV. Guidelines for Toxicity Studies
A. Introduction4 (November 2003)
B. General Recommendations for Toxicity Studies
5. Diets for Toxicity Studies (available in 1993 Draft "Redbook II"9)
C. Guidelines for Specific Toxicity Studies
2. Acute Oral Toxicity Tests (available in 1993 Draft "Redbook II"16)
3. Short Term Toxicity Studies
4. Subchronic Toxicity Studies
5. Chronic Toxicity Studies
9. Reproduction and Developmental Toxicity Studies
10.               Neurotoxicity Studies28 (July 2000)
V. Additional Studies (available in 1993 Draft "Redbook II"29)
A. Introduction
B. Metabolism and Pharmacokinetic Studies
C. Immunotoxicity Studies
VI. Human Studies
A. Clinical Evaluation of Food Ingredients (available in 1993 Draft "Redbook II"30)
B. Epidemiology Studies31 (October 2001)
1This guidance has been prepared by the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.
2Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food (also known as Redbook I), U.S. Food and Drug Administration, Bureau of Foods (now CFSAN), 1982. May be purchased from: National Technical Information Services (NTIS), 5285 Port Royal Road, Springfield, VA 22161, Telephone (703) 605-6000, NTIS Order Number PB83-170696.
3Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food 1993 Draft "Redbook II" Table of Contents33
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International Conference on Harmonization (ICH) Guidance Documents
 
·   ---------------------------------------------
Veterinary International Conference on Harmonization (VICH) Guidance Documents
 
 
Pharmacology/Toxicology
 

 

Developing Medical Imaging Drug and Biological Products  

 

 

OECD

 

 

 

 

This document is intended to provide guidance on methodological aspects, interpretation of data and strategy for testing of chemicals for potential human and other mammalian reproductive toxicity. The document constitutes an essential supplement to existing OECD Test Guidelines that can be used to obtain information on the potential reproductive toxicity of chemicals. Specific OECD Test Guidelines include the one- and two-generation toxicity study (TG 415 and 416), prenatal developmental toxicity study (TG 414), developmental neurotoxicity study (TG 426) and the reproduction/developmental toxicity screening tests (TG 421 and 422). However, data from other toxicity studies e.g., repeated dose toxicity studies for systemic toxicity (TG 407, 408 and 409) may indicate potential reproductive toxicity and should be considered in the assessment as well as existing human data.
 
OECD Guidelines for the Testing of Chemicals
 
 
Section 2: Effects on Biotic Systems
 
 
Test No. 201: Alga, Growth Inhibition Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 202: Daphnia sp. Acute Immobilisation Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 203: Fish, Acute Toxicity Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 204: Fish, Prolonged Toxicity Test: 14-Day Study
OECD Guidelines for the Testing of Chemicals
 
Test No. 205: Avian Dietary Toxicity Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 206: Avian Reproduction Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 207: Earthworm, Acute Toxicity Tests
OECD Guidelines for the Testing of Chemicals
 
 
Test No. 209: Activated Sludge, Respiration Inhibition Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 210: Fish, Early-Life Stage Toxicity Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 211: Daphnia magna Reproduction Test
OECD Guidelines for the Testing of Chemicals
 
 
Test No. 213: Honeybees, Acute Oral Toxicity Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 214: Honeybees, Acute Contact Toxicity Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 215: Fish, Juvenile Growth Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 216: Soil Microorganisms: Nitrogen Transformation Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 217: Soil Microorganisms: Carbon Transformation Test
OECD Guidelines for the Testing of Chemicals
 
 
 
Test No. 220: Enchytraeid Reproduction Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 221: Lemna sp. Growth Inhabition Test
OECD Guidelines for the Testing of Chemicals
 
 
 
 
 
Test No. 227: Terrestrial Plant Test: Vegetative Vigour Test
OECD Guidelines for the Testing of Chemicals
 
 
Test No. 229: Fish Short Term Reproduction Assay
OECD Guidelines for the Testing of Chemicals
 
 
Test No 231: Amphibian Metamorphosis Assay
OECD Guidelines for the Testing of Chemicals
 
Test No. 232: Collembolan Reproduction Test in Soil
OECD Guidelines for the Testing of Chemicals
 
Series: OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring
 
OECD Principles on Good Laboratory Practice
OECD Guidelines for the Testing of Chemicals
 
 
 
Quality Assurance and GLP
OECD Guidelines for the Testing of Chemicals
 
Compliance of Laboratory Suppliers with GLP Principles
OECD Guidelines for the Testing of Chemicals
 
The Application of the GLP Principles to Field Studies
OECD Guidelines for the Testing of Chemicals
 
The Application of the GLP Principles to Short Term Studies
OECD Guidelines for the Testing of Chemicals
 
The Role and Responsibilities of the Study Director in GLP Studies
OECD Guidelines for the Testing of Chemicals
 
Guidance for the Preparation of GLP Inspection Reports
OECD Guidelines for the Testing of Chemicals
 
The Application of the Principles of GLP to Computerised Systems
OECD Guidelines for the Testing of Chemicals
 
 
 
 
The Application of the Principles of GLP to in vitro Studies
OECD Guidelines for the Testing of Chemicals
 
 
Section 4: Health Effects
 
 
Test No. 401: Acute Oral Toxicity
OECD Guidelines for the Testing of Chemicals
 
Test No. 402: Acute Dermal Toxicity
OECD Guidelines for the Testing of Chemicals
 
Test No. 404: Acute Dermal Irritation/Corrosion
OECD Guidelines for the Testing of Chemicals
 
Test No. 405: Acute Eye Irritation/Corrosion
OECD Guidelines for the Testing of Chemicals
 
Test No. 406: Skin Sensitisation
OECD Guidelines for the Testing of Chemicals
 
Test No. 407: Repeated Dose 28-day Oral Toxicity Study in Rodents
OECD Guidelines for the Testing of Chemicals
 
Test No. 408: Repeated Dose 90-Day Oral Toxicity Study in Rodents
OECD Guidelines for the Testing of Chemicals
 
 
Test No. 410: Repeated Dose Dermal Toxicity: 21/28-day Study
OECD Guidelines for the Testing of Chemicals
 
Test No. 411: Subchronic Dermal Toxicity: 90-day Study
OECD Guidelines for the Testing of Chemicals
 
Test No. 412: Subacute Inhalation Toxicity: 28-Day Study
OECD Guidelines for the Testing of Chemicals
 
Test No. 413: Subchronic Inhalation Toxicity: 90-day Study
OECD Guidelines for the Testing of Chemicals
 
Test No. 414: Prenatal Development Toxicity Study
OECD Guidelines for the Testing of Chemicals
 
Test No. 415: One-Generation Reproduction Toxicity Study
OECD Guidelines for the Testing of Chemicals
 
Test No. 416: Two-Generation Reproduction Toxicity
OECD Guidelines for the Testing of Chemicals
 
Test No. 417: Toxicokinetics
OECD Guidelines for the Testing of Chemicals
 
 
 
Test No. 420: Acute Oral Toxicity - Fixed Dose Procedure
OECD Guidelines for the Testing of Chemicals
 
Test No. 421: Reproduction/Developmental Toxicity Screening Test
OECD Guidelines for the Testing of Chemicals
 
 
Test No. 423: Acute Oral toxicity - Acute Toxic Class Method
OECD Guidelines for the Testing of Chemicals
 
Test No. 424: Neurotoxicity Study in Rodents
OECD Guidelines for the Testing of Chemicals
 
Test No. 425: Acute Oral Toxicity: Up-and-Down Procedure
OECD Guidelines for the Testing of Chemicals
 
Test No. 426: Developmental Neurotoxicity Study
OECD Guidelines for the Testing of Chemicals
 
Test No. 427: Skin Absorption: In Vivo Method
OECD Guidelines for the Testing of Chemicals
 
Test No. 428: Skin Absorption: In Vitro Method
OECD Guidelines for the Testing of Chemicals
 
Test No. 429: Skin Sensitisation: Local Lymph Node Assay
OECD Guidelines for the Testing of Chemicals
 
 
Test No. 431: In Vitro Skin Corrosion: Human Skin Model Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 432: In Vitro 3T3 NRU Phototoxicity Test
OECD Guidelines for the Testing of Chemicals
 
 
 
Test No. 452: Chronic Toxicity Studies
OECD Guidelines for the Testing of Chemicals
 
Test No. 453: Combined Chronic Toxicity/Carcinogenicity Studies
OECD Guidelines for the Testing of Chemicals
 
Test No. 471: Bacterial Reverse Mutation Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 473: In vitro Mammalian Chromosome Aberration Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 474: Mammalian Erythrocyte Micronucleus Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 475: Mammalian Bone Marrow Chromosome Aberration Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 476: In vitro Mammalian Cell Gene Mutation Test
OECD Guidelines for the Testing of Chemicals
 
 
Test No. 478: Genetic Toxicology: Rodent Dominant Lethal Test
OECD Guidelines for the Testing of Chemicals
 
 
 
 
 
Test No. 483: Mammalian Spermatogonial Chromosome Aberration Test
OECD Guidelines for the Testing of Chemicals
 
Test No. 484: Genetic Toxicology: Mouse Spot Test
OECD Guidelines for the Testing of Chemicals
 
 
 
Test No. 403: Acute Inhalation Toxicity
OECD Guidelines for the Testing of Chemicals
 
Test No. 436: Acute Inhalation Toxicity - Acute Toxic Class Method
OECD Guidelines for the Testing of Chemicals
 
 
 
 
Test No. 451: Carcinogenicity Studies
OECD Guidelines for the Testing of Chemicals