ECHA‘s Update of the Advice on Dose Level Selection for Reproductive Toxicity Studies under REACH

At the end of June, the update to the ECHA’s 2022 advice on dose selection for developmental and reproductive toxicity (DART) studies under REACH was published.
When selecting doses for DART studies, a balance must always be struck between animal welfare and the aim of generating data that can be used for classification, labelling and risk assessment. We welcome the clear recommendation that a dose of 1000 mg/kg bw/d represents the upper limit for testing.
Other aspects, which have also been the subject of intense and controversial debate in the past, remain unchanged: for instance, many questions regarding the assessment of the endpoint ‘severe suffering’ remain unanswered. Here, reference is made only to the relevant OECD Guidance from 2002, which itself has not been updated for some time.
The upper limit of 1000 mg/kg bw/d should also be adhered to if, in the absence of clear effects on systemic or reproductive toxicity endpoints in the dams, intra-uterine or postnatal mortality occurs simultaneously in the offspring and the number of offspring in a multi-generation study is clearly reduced. Whether this is appropriate for this type of study is a subject of ongoing debate. 
We are happy to advise you on any questions regarding the planning of your DART studies.