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Draft Guidance and Review Documents/Monographs

 

Instructions for commenting on Draft Guidance and Review Documents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]

 

Draft Peer review report for the JaCVAM initiative international validation studies of the in vivo rodent alkaline comet assay for the detection of genotoxic carcinogens (PDF)

(The present document will be declassified and published in the Series on Testing and Assessment (document N° 195), together with the pre-validation report (N° 193) and the validation report (N° 194) when an addendum to the validation report has been finalized. This addendum will include further analyses and surveys conducted by the expert group to address the peer review comments and support expert decisions taken during the development of the draft Test Guideline.)

 

Draft Guidance Document on Copepod Development and Reproduction Test (PDF)
Deadline for public comments: 14 February 2014

Revised Draft Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation (PDF)
Deadline for public comments: 14 February 2014

Part 1: Draft Thyroid Scoping Document on in vitro & ex vivo Assays for Identification of Modulators of Thyroid Hormone Signalling (PDF)
Part 2: Draft Thyroid Scoping Document on in vitro & ex vivo Assays for Identification of Modulators of Thyroid Hormone Signalling (PDF)
Deadline for public comments: 7 February 2014

Draft Guidance Document on the Use of OECD Test Guidelines on Genotoxicity for Manufactured Nanomaterials (PDF)
Deadline for public comments: 31 January 2014


Draft Guidance Document for Honey Bee (Apis mellifera) Larval Toxicity Test, Repeated Exposure (PDF)
Deadline for public comments: 15 January 2014

Draft Guidance Document for Single Laboratory Validation of Quantitative Analytical Methods Used in Support of Pre- and Post-Registration Data Requirements for Plant Protection and Biocidal Products (PDF)
Deadline for public comments: 16 December 2013

Draft Validation Study Report of the Bhas 42 Cell Transformation Assay (PDF)
(Annexes are Available Below)
Deadline for public comments: 9 December 2013

Annex 1: Supplier, catalog number and lot number of test chemicals in the 6-well method validation study

Annex 2: Protocol for 6-well method validation study: 6-well method

Annex 3: Photo catalog for the judgment of foci in the Bhas 42 CTA

Annex 4: Results Submitted from Laboratories in the Validation Studyof6-Well Method

Annex 5: Supplier, catalog number and lot number of test chemicals in the 96-well method validation study

Annex 6: Protocol for the pre-validation phase of 96-well method validation study: 96-well method

Annex 7: Protocol for the phase I of 96-well method validation study: 96-well method

Annex 8: Protocol for the phase II of 96-well method validation study: 96-well method

Annex 9: Results submitted from laboratories in the pre-validation phase of 96-well method


Annex 10: Results submitted from laboratories in phase I of validation study of 96-well method


Annex 11: Results submitted from laboratories in phase II of validation study of 96-well method


Annex 12: Recommended protocol for the Bhas 42 CTA2

Annex 13: Transformation frequency of negative and positive controls

Annex 14:  Chemical properties and classes of 12 coded test chemicals and positive controls for the 6-well method validation study


Annex 15: Chemical properties and classes of test chemicals for the pre-validation phase, phase I and phase II of 96-well method
validation study


Annex 16:  Sakai et al. (2010) A Bhas 42 cell transformation assay on 98 chemicals: The characteristics and performance for the
prediction of chemical carcinogenicity. Mutat. Res., 702,100-122



Draft Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation (PDF)
Request Date for Comments: 29 November 2013

 

Part 1: In vitro & ex vivo Assays for Identification of Modulators of Thyroid Hormone Signalling (PDF)

Part 2: In vitro & ex vivo Assays for Identification of Modulators of Thyroid Hormone Signalling (PDF)
Request Date for Comments: 22 November 2013

 

 

 

 

 See also Adopted Test Guidelines, or go directly to SourceOECD or the Bookshop to order

 

 

 

 

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