Four test guidelines (TGs) have recently been finalised and adopted by the OECD.

  • TG 433 has been adopted to assess acute inhalation toxicity by the fixed concentration procedure (FCP). This new method allows GHS classification whilst generally using fewer experimental animals, since lethality is not the principle endpoint being assessed.
  • The guidelines for the 28-day and 90-day inhalation toxicity studies (TGs 412 and 413, respectively) have been revised to enable the characterisation and testing of nanomaterials.
  • TG 442E for testing the activation of dendritic cells, as part of the Adverse Outcome Pathway (AOP) for skin sensitisation, has now been updated to incorporate the Interleukin-8 reporter gene assay (IL-8 Luc assay) and the U937 cell line activation test (U-SENS).

In addition, the following guidelines or updated guidelines have been proposed:

  • BrdU-ELISA or -FCM local lymph node assay (update to TG 442B)
  • In vitro skin sensitisation assays addressing keratinocyte activation (update to TG 442D)
  • Reconstructed human cornea-like epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage (update to TG 492).
  • Repeated-dose 90-day oral toxicity study in rodents (update to TG 408)
  • ROS (reactive oxygen species) assay for photosafety

Organisation for Economic Cooperation and Development (2016-2017). Guidelines for the testing of chemicals. Accessible via: http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-4-health-effects_20745788

Draft guidelines and proposals. Accessible via: http://www.oecd.org/env/ehs/testing/section4-health-effects.htm

 

The above items were taken from the November 2017 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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