OECD invites comments (by 13 October) on a draft test guideline (TG) on the human cell line activation test (h-CLAT), a novel in vitro procedure for determining skin sensitisation potential. The test addresses dendritic cell activation, a key event in the adverse outcome pathway (AOP) for skin sensitisation, by quantifying changes in cell surface marker expression.

Comments are also requested on draft updates for the following TGs:

  • TG 421 (reproduction/developmental toxicity screening test)
  • TG 422 (combined repeated dose toxicity study with the reproduction/developmental toxicity screening test)

A Danish draft feasibility study for the ‘minor enhancements’ in TGs 421 and 422 is also available.

Organisation for Economic Co-operation and Development.

Draft proposal for a new test guideline. In vitro skin sensitisation: human cell line activation test (h-CLAT). July 2014. http://www.oecd.org/chemicalsafety/testing/Draft-new-Test-Guideline-Skin-Sensitisation-h-CLAT-July-2014.pdf

Draft updated OECD guideline for testing of chemicals. TG 421. Reproduction/developmental toxicity screening test. August 2014. http://www.oecd.org/chemicalsafety/testing/Draft-updated-TG-421-August-2014.pdf

Draft updated OECD guideline for testing of chemicals. TG 422. Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test. August 2014. http://www.oecd.org/chemicalsafety/testing/Draft-updated-TG-422-August-2014.pdf

Danish National Food Institute (DTU Food). Feasibility study for minor enhancements of TG 421/422 (reproduction/developmental toxicity screening test) / (combined repeated dose toxicity study with the reproduction/developmental toxicity screening test) with ED-relevant endpoints. Draft. 28 August 2014. http://www.oecd.org/chemicalsafety/testing/Review-of-TGs-421-422-28-August-2014-and-Appendix-1-2a-2b-3.pdf

 

The above items were taken from the October 2014 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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