ECHA gives new advice for determining dose levels in toxicity testing

On the 18th of January 2022, ECHA advises on how to determine and apply dose selection for dose and reproductive toxicity. This is in alignment with OECD guidelines. The director of ECHA for Hazard Assessment said the amended REACH annexes and the guidance instructions given by ECHA will help companies when doing toxicity tests to ensure that the correct dose level is used.

This advice is aimed at ensuring that test results reliably show whether a chemical has severe health effects or not. Furthermore, it prevents the repetition of inconclusive tests and animal suffering. REACH also has alternatives to animal testing for companies. This guidance document prepared by ECHA will be revised to consider the amended REACH annexes, therefore, the publication will be done later in the year.

Why is this guidance document important? Companies need to select the correct substance dose when doing toxicity tests of their chemicals’ safety as stipulated in the amended REACH annexes. This amendment applies from January 2022, therefore, companies will need as much guidance as possible to comply with this new rule.

According to ECHA, companies should:

(1) ensure that the data they generate from toxicity tests are suitable for hazards’ identification and risks’ assessment of chemicals.

(2) prevent the severe suffering of animals when conducting animal testing.

(3) Toxicity tests should be done at a high dose level that appropriately complies with the OECD test guideline.

The current guidance document can be accessed here.

Last Update: 2022-01-21