Essais des produits chimiques

Draft Guidance and Review Documents/Monographs

 

Instructions for commenting on Draft Guidance and Review Documents
Template for submission of comments (optional) [word file]

 * Comments should be sent to the Secretariat by National Coordinators by that date. Anyone who would like to contribute to a commenting round is invited to contact their National Coordinator beforehand and discuss together of a timeframe for comment submission.

 

Draft Guidance Document on Medaka Histopathology:
Part 1
Part 2
Part 3
Part 4


Draft Guidance Document on Amphibian Histopathology

Deadline for public comments*: 6 February 2015

Draft Performance Standards for the Human Recombinant Estrogen Receptor Binding Assay
Deadline for public comments*: 5 February 2015

Integrated Summary Report: Validation of Two Binding Assays Using Human Recombinant Estrogen Receptor Alpha (hrERa)

Appendix B - ICCVAM Evaluation of In Vitro Test Methods for Dectecting Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor Binding and Transcriptional Activation Assays

Appendix C - PRISM Fit Parameters for Competitive Binding Data: All Runs Conducted

Appendix D - Chemical Approval Board (CAB) Report

Appendix E - Final Report: Analysis of Saturation Binding Data From Six Laboratories and Two Protocols for the Human Recombinant ER alpah (hrERa) Binding Assay Validation

Appendix F - Analysis of Competitive Binding Data from Six Laboratories and Two Protocols for the Human Recombinant ER (hrERa) Binindg Assay Validation Effort - Data Handling and Statisical Analysis Methods and Results

Appendix G - Follow-up Data Analysis Support for Human Recombinant Estrogen Receptor Validation Study - Statistical Analysis

Appendix H - Additional Statistical Analyses for Human Recombinant Estrogen Receptor (hrER) Validation

Appendix I - Statistical Report: Follow-up Analysis, Competitive Binding Data: Data analysis of CERI and FW hrER binding parameter summary data: Evaluation of r2 values to assess intra- and inter-laboratory reproducibility

Appendix J - Protocol for In Vitro Estrogen Receptor (ER) Binding Assay Using the CERI Human Recombinant ERa Ligand Binding Domain Protein

Appendix K - Freyberger-WIlson Assay Protocol for the In Vitro Estrogen Receptor-a (ERa) Saturation and Competitive Binding Assays Using Human Recombinant Full Length Estrogen Receptor-a

Appendix L - Data Analysis Reported in Tables

Appendix M - Peer Review of hrER Binding Assay Validation Studies

Appendix N - Data Supporting the Assessment of Reliability and Accuracy of the FW and CERI In Vitro hrER Binding Assays in the Validation Studies




Deadline for public comments*: 5 February 2015

Draft Guidance Document: In Vitro Syrian Hamster Embryo (SHE) Cell Transformation Assay

Deadline for public comments*: 30 January 2015

OECD Draft Guidance Document on Crop Field Trials
Deadline for public comments*: 31 October 2014

 

Feasibility Study for Minor Enhancements of TG 421/422 with Endocrine Disrupter-relevant Endpoints
Deadline for public comments*: 13 October 2014

 

Draft Guidance Document for Pesticide Terrestrial Field Dissipation (TFD) Studies and Crosswalk between North America and European Ecoregions 
Deadline for public comments*: 30 September 2014

 

Draft Guidance Document for In Vitro Syrian Hamster Embryo (SHE) Cell Transformation Assay
Deadline for public comments*: 22 September 2014

 

Assessment of the Performance Characteristics of proposed In Vitro Membrane Barrier Test Method for Skin Corrosion
Deadline for public comments*: 15 September 2014

 

Performance Standards for Assessment of proposed similar or modified In Vitro transcutaneous electrical Resistance (TER) Test Methods for Skin Corrosion
Deadline for public comments*: 15 September 2014

 

Performance Standards for Assessment of proposed similar or modified In Vitro Reconstructed Human Epidermis (RHE) Test Methods for Skin Corrosion (in relation to TG 431)
Deadline for public comments*: 15 September 2014

 

Performance Standards for Assessment of proposed similar or modified In Vitro reconstructed Human Epidermis (RhE) Test Methods for Skin Irritation (in relation to TG 439)
Deadline for public comments*: 15 September 2014

 

Statistical Issues related to OECD In Vitro Gene Mutation Tests Test Guidelines (TG 476)
Deadline for public comments*: 12 September 2014

Draft Guidance for Describing Non-guideline in vitro Test Methods (PDF)
Deadline for public comments*: 1 September 2014
 

Draft Validation Report of the Human Estrogen Receptor (ER) Mediated Reporter Gene Assay to Detect ER Antagonist Activity (PDF)
Draft Updated Performance Standards for Stably Transfected Transactivation in vitro Assays to Detect Estrogen Receptor Antagonists (PDF)
Deadline for public comments*: 1 September 2014
For Information: Draft Validation Report of Pre-validation and Inter-laboratory Validation for STTA Assay to Detect Estrogenic Activity

 

Draft Guidance Document for Storage Stability Testing - Guidance Used in Support of Pre-registration Data Requirements for Plant Protection and Biocidal Products (PDF)
Deadline for public comments*: 1 August 2014

Performance Standards for Assessment of Proposed Similar or Modified in vitro Skin Sensitisation ARE-Nrf2 Luciferase Test Methods (PDF)
Deadline for public comments*: 30 June 2014

 

 See also Adopted Test Guidelines.

 

 

 

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