Companies need to choose the correct substance dose for their toxicity tests to conclude on the safety of their chemicals. This is clarified in the amended REACH annexes, which apply as of January 2022. ECHA’s advice helps companies ensure reliable results while avoiding repeated animal tests.
The data companies generate from toxicity tests must be adequate for identifying the hazards and assessing the risks of their chemicals. Companies must also prevent severe suffering when carrying out animal tests. Toxicity tests should be done at an appropriately high dose level, in line with the corresponding OECD test guideline. This ensures that a test can be used to conclude whether the chemical is safe to use and that the test does not need to be repeated.
ECHA’s advice on how to apply dose selection for repeated dose toxicity and reproductive toxicity is aligned with OECD guidelines and guidance documents.
The ECHA guidance document on Information Requirements and Chemical Safety Assessment – Chapter R.7a will be revised to take the amended REACH annexes into account. It will be published later in 2022.