New Advice for Determining Dose Levels in Toxicity Testing

To conclude on the safety of their chemicals, companies need to choose the correct substance dose for their toxicity tests. This was clarified in the amended REACH annexes, January 2022.  

 ECHA’s advice helps them to ensure reliable results while avoiding repeated animal tests. For identifying the hazards and assessing the risks of their chemicals, the data companies generate from toxicity tests must be adequate. Companies should also prevent severe suffering when carrying out animal tests.  

 ECHA’s advice helps them to ensure reliable results while avoiding repeated animal tests. For identifying the hazards and assessing the risks of their chemicals, the data companies generate from toxicity tests must be adequate. Companies should also prevent severe suffering when carrying out animal tests.  

1. 1. An authoritative body formally identifies the chemical as causing cancer.
2. 2. The substantiation considered by the authoritative body meets the adequacy criteria contained in the regulations.

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) prepared a draft specialized support document for proposed Public Health Pretensions (PHGs) for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) in drinking water. Download the document.

A PHG is the position of a drinking water adulterant at which adverse health goods aren’t anticipated to do from a continuance of exposure. As per the epidemiologic verified that operation of PFOA increases the threat of order cancer it’s associated with liver and vulnerable system toxin and increased total cholesterol, and there’s suggestive substantiation of an association with the threat of preeclampsia and gestation-related hypertension. PFOS is associated with vulnerable system toxins and increased total cholesterol in humans, with suggestive substantiation of an association with the threat of preeclampsia and gestation-related hypertension.

Toxicity tests must be done at an appropriately high dose level (in line with the corresponding OECD test guideline). This ensures that a test has been 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 –will be published later in 2022. 

Reference: https://echa.europa.eu/-/new-advice-for-determining-dose-levels-in-toxicity-testing