News | Jul 7, 2020
The OECD released this year’s new updates to the Test Guideline Program.
No new Test Guidelines were adopted this year; however, on June 26, 2020, the OECD Council adopted changes or corrections to the following test guidelines:
TG 437: Bovine Corneal Opacity and Permeability (BCOP) Test Method for Identifying Ocular Corrosives and Severe Irritants
TG 458: Stably Transfected Human Androgen Receptor Transcriptional Activation (ARTA) Assay
TG 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays
TG 491: Short Time Exposure (STE) In Vitro Test Method for Eye Damage for i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage
TG 405: Acute Eye Irritation/Corrosion
TG 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
TG 442C: In Chemico Skin Sensitisation
TG 471: Bacterial Reverse Mutation Test
BCOP, TG 437, was updated to allow for the use of laserlight-based opacitometers (LLBO) which perform similarly to the OP-KIT opacitometer used to validate BCOP. Other changes include an updated list of proficiency substance, including guidance on when an alternative proficiency substance is acceptable. For example, TG437 provides information on supplier variability and the acceptable use of proficiency substance 2,6-Dichlorobenzoyl chloride.
TG 458 now include two newly validated assays: the AR CALUX® test method (validated by the European Commission) and the 2Rv1/MMTV_GR-KO cell line in the ARTA method (validated by Korea). The new guideline increases the sensitivity of the AR EcoScreen™ by changing the concentration of the AR agonist, HydroxyFlutamide, to 1.0 µM. However, results obtained with the lower concentration published in 2016 are still reliable if the assay met performance criteria.
Updates to TG 491 include modifications to proficiency substances, such as the removal of n,n-dimethylguanidine sulfate. In this guideline a critical update builds upon the Integrated Approach on Testing and Assessment (IATA) for Serious Eye Damage and Eye irritation released in 2017, whereby the test guideline states the results of a STE should be considered in context to an IATA. With respect to highly volatile chemicals, the new updates expand the test guideline’s applicability (e.g., the use of mineral oil as the vehicle).
All of these updates and more can be accessed from the Test Guidelines webpage:
For more information about the OECD Test Guidelines Programme visit, http://www.oecd.org/chemicalsafety/testing/oecd-guidelines-testing-chemicals-related-documents.htm