| DRAFT DOCUMENTS IN A COMMENTING ROUND |
Instructions for Commenting on Draft Guidance and Review Documents
Template for submission of comments (optional)
Draft Document of the the Threshold Approach for Acute Fish Toxicity Testing PDF
Template for comments Word
Attachment 1 PDF
Attachment 2 PDF
Deadline for public comments: 29 September 2008
DRP Draft Detailed Review Paper on Transgenic Rodent Mutation Assays (May Version 2008) PDF
Table of Contents PDF
Chapter 1- Executive SummaryPDF
Chapter 2- Introduction to Transgenic Rodent Mutation models and assays PDF
Chapter 3- Existing Genotoxicity Assays PDF
Chapter 4- Existing Data and Factors Influencing Performance PDF
Chapter 5- The Predictive Ability of Transgenic Rodent Mutation Assays PDF
Chapter 6- Recommendations PDF
References PDF
Appendix A- Experimental data sorted by chemical PDF
Appendix B- Genotoxicity and Carcinogenicity data sorted by chemical PDF
Appendix C- Transgenic rodent mutagenicity data on carcinogens in target issues PDF
Appendix D- DNA sequence confirmation of phenotypic mutant data PDF
Deadline for public comments: 18 August 2008
Draft Guidance Notes for the Estimation of Dermal Absorption Values PDF
Deadline for public comments: 15 July 2008
GD for Histopathologic Evaluation of Endocrine and Reproductive Tests
Part 1: Guidelines for dissection and trimming of endocrine tissues
Part 2: Male reproductive system [PDF1] [PDF2] [PDF3] [PDF4] [PDF5] [PDF6] [PDF7]
Part 3: Female reproductive system (parts 3a, 3b and 3c can be grouped under this title) [PDF3a] [PDF3b] [PDF3c]
Part 4: Mammary gland
Part 5: Preparation, reading and reporting of vaginal smears
Part 6: Pituitary gland
Deadline for public comments: 4 July 2008
GD The Draft Guidance for a Single Dose Study for the Derivation of an Acute Reference Dose PDF
Deadline for public comments: 15 January 2008
DRP The Use of Metabolising Systems for In Vitro Testing of Endocrine Disrupters - A Detailed Review Paper PDF (Document replaced on 29 August due to an error in the original source used in Figure 4).
Deadline for public comments: 10 September 2007
| DRAFT DOCUMENTS FOR WHICH COMMENTING PERIOD HAS EXPIRED AND WHICH ARE BEING REVISED OR FINALISED |
DRP Draft Detailed Review Paper on Avian 2-Generation Toxicity (version June 2006) PDF
2nd version - deadline for public comments passed: 27 August 2006
1st version - deadline for public comments passed: 1st September 2003
DRP Draft Detailed Review paper on the Use of Metabolising Systems for in vitro Testing of Endocrine Disrupters (version March 2006) PDF
Deadline for public comments passed: 28 April 2006
DRP Draft Detailed Review Paper on Transgenic Rodent Mutation Assays (February 2005 version) PDF (3.5MB)
Deadline for public comments passed: 29 April 2005
For your convenience the document has been divided into separate chapters:
Table of Contents
Executive Summary
Chapter 1 - Description of Transgenic Rodent Models and Overview of the Transgenic Rodent Mutation Experiment
Chapter 2 - Existing Genotoxicity Assays
Chapter 3 - Transgenic Rodent Mutation Assays: Existing Data and Current Level of Understanding of Factors Influencing Performance
Chapter 4 - Predictive Ability of Transgenic Rodent Mutation Assays
Chapter 5 - Recommendations for the conduct of Transgenic Rodent Mutation Assays
Appendix 1 - Experimental Data sorted by Chemical
Appendix 2 - Genotoxicity and Carcinogenicity Data sorted by Chemical
Appendix 3 - TGR Mutagenicity Data of Carcinogens in Target Tissues
References
DRP No. 31 Detailed Review Paper on Non-genotoxic carcinogens detection: the Performance of in-vitro cell transformation assays (May 2001 version) PDF
Deadline for public comments passed: 1st October 2001
GD No. 39 Draft Guidance Document on Acute Inhalation Toxicity (October 2002 version) PDF and Draft New Test Guideline 433 on Acute Inhalation Toxicity
Deadline for public comments passed: 20 January 2003
GD No. 39B Draft Guidance Document on Acute Inhalation Toxicity Testing (December 2004 version) PDF
Deadline for public comments passed: 28 January 2005
DRP Draft Detailed Review Paper on Steroidogenesis (split in 2 due to large file size) PDF1 PDF2
Deadline for public comments passed: 1st August 2003
DRP Draft Detailed Review Paper on Aromatase PDF
Deadline for public comments passed: 1st August 2003
DRP Draft Detailed Review Paper on Fish Two-Generation (March 2003 version) PDF and Proposal for a Fish Two-Generation Test Guideline (March 2003 version) PDF
Deadline for public comments passed: 24th April 2003
GD Draft Guidance Document on Testing Avian Avoidance Behaviour (Pen Test)
Deadline for public comments passed: 15th May 2003
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