Section 4: Health Effects

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Adopted Test Guidelines

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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

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

 

Draft Guidance Document on the Supplement to Test Guidelines 437 and 438: The Bovine Corneal Opacity and Permeability and Isolated Chicken Eye Test Methods: Collection of Tissues for Histopathological Evaluation and Collection of Data on Non-severe Irritants
PDF

Deadline for comments: 23 April 2010

 

Draft Proposal For a New Guideline 4xx The H295R Steroidogenesis Assay
PDF
Deadline for comments: 15 February 2010

 

Draft Proposal For A New Test Guideline Skin Sensitisation: Local Lymph Node Assay: DA Version
PDF
Deadline for comments: 27 January 2010

 

Draft Proposal For A New Test Guideline Skin Sensitisation: Local Lymph Node Assay: BrdU-ELISA
PDF
Deadline for comments: 27 January 2010

 

Draft Proposal For An Updated Test Guideline 429 Skin Sensitisation: Local Lymph Node Assay
PDF
Deadline for comments: 27 January 2010

 

Draft Proposal for a new Guideline in Vitro Skin Irritation: Reconstructed Human Epidermis (RHE) Test Method
PDF
Deadline for comments: 26 January 2010


Draft Proposal for a Revised TG 417

PDF

Deadline for comments: 22 January 2010

 

Draft Proposal for a New Guideline 487: In Vitro Mammalian Cell Micronucleus Test (MNVIT)
PDF
(Draft Approved by the Working Group of National Coordinators of the Test Guidelines Programme. Final adoption is expected in 2010.)

 

Draft Test Guideline for the Extended One Generation Reproductive Toxicity Study
PDF
Deadline for comments: 9 December 2009


Draft Guidance Document on Histopathology for inhalation toxicity studies, Supporting TG 412
(Subacute Inhalation Toxicity: 28-Day) and TG 413 (Subchronic Inhalation Toxicity: 90-Day)
PDF
Deadline for comments: 15 November 2009
 

 

Draft Test Guideline (version 7.6) on “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”
PDF
Deadline for public comments: 23 October 2009

 

Draft Guidance Document on “Using Cytotoxicity Tests to estimate Starting Doses for Acute Oral Systemic Toxicity Tests
PDF
Deadline for public comments: 4 September 2009

 

Draft revised versions of the Local Lymph Node Assay (LLNA) Test Guideline 429
PDF DA Version
PDF BrdU-ELISA version
PDF Local Lymph Node Assay version   (revised version posted the 17/07/09)
Please click here to download the ICCVAM/NICEATM Peer Review Panel Report
Please click here to download the ICCVAM/NICEATM Recommended Performance Standards for the LLNA
Deadline for public comments: 28 August 2009

 

Draft revised Test Guidelines on “In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test No. 430 and the “In Vitro Skin Corrosion: Reconstructed Human Epidermis Test Method” No. 431
PDF TG 430
PDF TG 431
Deadline for public comments: 21 August 2009

Draft Guidance Document on Toxicokinetic supporting TG 417
PDF
Deadline for public comments: 20 August 2009

 

Draft Test Guideline for the In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method 
PDF
Deadline for public comments: 8 May 2009

 

Draft Test Guideline for the Bovine Corneal Opacity and Permeability (BCOP) Test Method for Identifying Ocular Corrosives and Severe Irritants PDF
Draft Test Guideline for the Isolated Chicken Eye (ICE) Test Method for Identifying Ocular Corrosives and Severe Irritants PDF
Annex 2: Proficiency Standards for the ICE and BCOP Test Methods PDF 
Deadline for public comments: 6 February 2009

 

Draft Test Guideline 403: Acute Inhalation Toxicity PDF
Draft Test Guideline 436: Acute Inhalation Toxicity - Acute Toxic Class (ATC) Method PDF
Deadline for public comments: 23 January 2009

 

Draft Test Guideline 451 : Carcinogenicity studies PDF
Draft Test Guideline 452: Chronic Toxicity Studies PDF
Draft Test Guideline 453: Combined Chronic Toxicity\Carcinogenicity Studies PDF
Deadline for public comments: 16 January 2009

 

Draft Test Guideline for the Hershberger Bioassay in rats PDF
Deadline for public comments: 16 January 2009

 

Draft Test Guideline for the Stably Transfected Human Estrogen Receptor-α Transcriptional Activation Assay for Detection of Estrogenic Agonist-Activity of Chemicals PDF
No longer open for public comments

 

Draft Proposal for a Revised TG 417: Toxicokinetics PDF
Deadline for public comments: 30 January 2009

 

Draft Proposal for a Revised Guideline 412: Subacute Inhalation Toxicity: 28-Day Study PDF
Draft Proposal for a Revised Guideline 413: Subchronic Inhalation Toxicity: 90-Day Study PDF
Deadline for public comments: 28 November 2008

 

The Bovine Corneal Opacity and Permeability Test Guideline PDF
The Isolated Chicken Ice Test Guideline PDF
Deadline for public comments: 31 October 2008

 

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

 

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 

 

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

 

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...and also Guidance Document 1