Section 4: Health Effects

Go to:
- Draft Test Guidelines open for comment
- Draft Test Guidelines closed for comment (awaiting approval or publication)
- OECD Series on Testing and Assessment (Guidance Documents/Monographs)

 

Adopted Test Guidelines

OECD Test Guidelines are free of charge from the OECD Bookshop or Source OECD.  Click here for information on how to order.

 

401 Acute Oral Toxicity (Deleted Guideline, date of deletion: 20th December 2002)


402 Acute Dermal Toxicity (Updated Guideline, adopted 24th February 1987)


403 Acute Inhalation Toxicity (Original Guideline, adopted 12th May 1981)


404 Acute Dermal Irritation/Corrosion (Updated Guideline, adopted 24th April 2002)


405 Acute Eye Irritation/Corrosion (Updated Guideline, adopted 24th April 2002)


406 Skin Sensitisation (Updated Guideline, adopted 17th July 1992)


407 Repeated Dose 28-day Oral Toxicity Study in Rodents (Updated Guideline, adopted 27th July 1995)


408 Repeated Dose 90-Day Oral Toxicity Study in Rodents (Updated Guideline, adopted 21st September 1998)


409 Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents (Updated Guideline, adopted 21st September 1998)


410 Repeated Dose Dermal Toxicity: 21/28-day Study (Original Guideline, adopted 12th May 1981)


411 Subchronic Dermal Toxicity: 90-day Study (Original Guideline, adopted 12th May 1981)


412 Repeated Dose Inhalation Toxicity: 28-day or 14-day Study (Original Guideline, adopted 12th May 1981)


413 Subchronic Inhalation Toxicity: 90-day Study (Original Guideline, adopted 12th May 1981)


414 Prenatal Developmental Toxicity Study (Updated Guideline, adopted 22nd January 2001)


415 One-Generation Reproduction Toxicity Study (Original Guideline, adopted 26th May 1983)


416 Two-Generation Reproduction Toxicity Study (Updated Guideline, adopted 22nd January 2001)


417 Toxicokinetics (Updated Guideline, adopted 4th April 1984)


418 Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure (Updated Guideline, adopted 27th July 1995)


419 Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study (Updated Guideline, adopted 27th July 1995)


420 Acute Oral Toxicity - Fixed Dose Method (Updated Guideline, adopted 20th December 2001)


421 Reproduction/Developmental Toxicity Screening Test (Original Guideline, adopted 27th July 1995)


422 Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (Original Guideline, adopted 22nd March 1996)


423 Acute Oral toxicity - Acute Toxic Class Method (Updated Guideline, adopted 20th December 2001)


424 Neurotoxicity Study in Rodents (Original Guideline, adopted 21st July 1997)

 

425 Acute Oral Toxicity: Up-and-Down Procedure (Updated Guideline, adopted 20th December 2001) [Statistical Software]

 

426 Developmental Neurotoxicity Study (Original Guideline, adopted 16th October 2007)

 

427 Skin Absorption: In Vivo Method (Original Guideline, adopted 13th April 2004)


428 Skin Absorption: In Vitro Method (Original Guideline, adopted 13th April 2004)


429 Skin Sensitisation: Local Lymph Node Assay (Updated Guideline, adopted 24th April 2002)


430 In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) (Original Guideline, adopted 13th April 2004)


431 In Vitro Skin Corrosion: Human Skin Model Test (Original Guideline, adopted 13th April 2004)


432 In Vitro 3T3 NRU Phototoxicity Test (Original Guideline, adopted 13th April 2004) [Software: Phototox Version 2.0]

 

435 In Vitro Membrane Barrier Test Method for Skin Corrosion (Original Guideline, adopted 19th July 2006)

 

440 Uterotrophic Bioassay in Rodents: a short-term screening test for oestrogenic properties (Original Guideline, adopted 16th October 2007)


451 Carcinogenicity Studies (Original Guideline, adopted 12th May 1981)


452 Chronic Toxicity Studies (Original Guideline, adopted 12th May 1981)


453 Combined Chronic Toxicity/Carcinogenicity Studies (Original Guideline, adopted 12th May 1981)


471 Bacterial Reverse Mutation Test (Updated Guideline, adopted 21st July 1997)


473 In vitro Mammalian Chromosomal Aberration Test (Updated Guideline, adopted 21st July 1997)


474 Mammalian Erythrocyte Micronucleus Test (Updated Guideline, adopted 21st July 1997)


475 Mammalian Bone Marrow Chromosomal Aberration Test (Updated Guideline, adopted 21st July 1997)


476 In vitro Mammalian Cell Gene Mutation Test (Updated Guideline, adopted 21st July 1997)


477 Genetic Toxicology: Sex-Linked Recessive Lethal Test in Drosophila melanogaster (Updated Guideline, adopted 4th April 1984)


478 Genetic Toxicology: Rodent Dominant Lethal Test (Updated Guideline, adopted 4th April 1984)


479 Genetic Toxicology: In vitro Sister Chromatid Exchange Assay in Mammalian Cells (Original Guideline, adopted 23rd October 1986)


480 Genetic Toxicology: Saccharomyces cerevisiae, Gene Mutation Assay (Original Guideline, adopted 23rd October 1986)


481 Genetic Toxicology: Saacharomyces cerevisiae, Miotic Recombination Assay (Original Guideline, adopted 23rd October 1986)


482 Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells in vitro (Original Guideline, adopted 23rd October 1986)


483 Mammalian Spermatogonial Chromosome Aberration Test (Original Guideline, adopted 21st July 1997)


484 Genetic Toxicology: Mouse Spot Test (Original Guideline, adopted 23rd October 1986)


485 Genetic Toxicology: Mouse Heritable Translocation Assay (Original Guideline, adopted 23rd October 1986)


486 Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo (Original Guideline, adopted 21st July 1997)

 

Draft Test Guidelines

 

WARNING: Draft Test Guidelines are not part of Mutual Acceptance of Data.  Please consult with national authorities before using draft Test Guidelines

 

Draft Test Guidelines open for comment

Instructions for Commenting on Draft Test Guidelines
Template for submission of comments (optional)

 

Draft Extended One-Generation Reproductive Toxicity Test Guideline PDF
Deadline for public comments: 4 September 2008

 

Draft Test Guideline on In Vitro Skin Irritation: Human Skin Model Test PDF
Validation information for the Human Skin Model Test Zip
Deadline for public comments on the draft TG: 15 August 2008

 

Draft Test Guideline for the Stably Transfected Human Estrogen Receptor-α Transcriptional Activation Assay for Detection of Estrogenic Agonist-Activity of Chemicals PDF
Deadline for public comments: 3 July 2008

 

412 Draft Proposal for a Revised Guideline 412: Subacute Inhalation Toxicity (Version 3, March 2008) PDF
Deadline for public comments: 12 May 2008

 

413 Draft Proposal for a Revised Guideline 413: Subchronic Inhalation Toxicity (Version 2.5, March 2008) PDF
Deadline for public comments: 12 May 2008

 

Draft Test Guideline for the Stably Transfected Human Estrogen Receptor-α Transcriptional Activation Assay for Detection of Estrogenic Agonist-Activity of Chemicals PDF

Deadline for public comments: 8 February 2008

 

487 Draft Proposal for a New Guideline 487: In Vitro Mammalian Cell Micronucleus Test (MNvit) (Version 3, 13 December 2007) PDF

Deadline for public comments: 1 February 2008 

 

407 Draft Updated Test Guideline 407: Repeated Dose 28-Day Oral Toxicity Study in Rodents; Updated with Parameters for Endocrine Effects (December 2007 version)  PDF

Deadline for public comments: 8 February 2008

 

Draft Test Guidelines awaiting approval or publication

 

The following draft Test Guidelines are being revised/finalised and are no longer available for comment.

 

*** Acute Inhalation Toxicity
Draft New Guideline (October 2002) PDF
Deadline for public comments passed: 20 January 2003

 

433 Acute Inhalation Toxicity-Fixed Dose Procedure
Draft Revised Guideline (June 2004) PDF 
Deadline for public comments passed: 30 July 2004

 

434 Acute Dermal Toxicity-Fixed Dose Procedure
Draft New Guideline (May 2004) PDF
Deadline for public comments passed: 16 July 2004

 

436 Acute Inhalation Toxicity - Acute Toxic Class (ATC) Method
Draft New Guideline (December 2004) PDF
Deadline for public comments passed: 28 January 2005

 

Software to be used with TG432: Phototox Version 2.0

To install the software download phototox.zip to the hard drive of your computer and then open the zip folder and click on the setup.exe file. The software will install itself on your computer.

For instructions on how to use the PHOTOTOX Application please read the How-to-get-started document (WordPDF) and the PHOTOTOX Application Help in the phototox.hlp file contained in the phototox.zip file.

Other documentation for the software:

  • Phase II.PXP and Phase III.PXP (PXP project files containing all the validation data) (ZIP file)
  • In Vitro Phototoxicity Testing: Development and Validation of a New Concentration Response Analysis Software and Biostatistical Analyses Related to the Use of Various Prediction Models (PDF)

 

Statistical Software to be used with TG425: Acute Oral Toxicity: Up and Down Procedure

User documentation 329k- PDF for the AOT425StatPgm Program
! Users should read this file before downloading the AOT425 Statistical Program file!

Next, download the AOT 425Statistical Program.This is a self-extracting zip file which will install the program on your computer in two steps (right click on link, then "Save target as...") 1.84mb- execute file

Questions or comments? Email AOT425@epa.gov
Note: This is to confirm that the use of the computer program, AOT425StatPgm, developed by Westat for the US EPA, is freely given and there are no licensing restrictions in connection with its use. The user is cautioned to read the User Documentation regarding any limitations on applicability and hardware requirements.

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