ECHA has published an update of Section R.7.5 on repeated dose toxicity in Chapter R.7a of the Guidance on Information Requirements and Chemical Safety Assessment.
The update expands on the most appropriate route of administration for a repeated dose toxicity study. It also takes into account recent developments in the field, such as revised OECD test guidelines and updated recommendations on the use of non-testing methods. Furthermore, it reflects ECHA’s current approach to dossier evaluation by indicating, for instance, which additional specific investigations might be required. The recommended testing and assessment strategy for repeated dose toxicity has been refined accordingly.
Additionally, Section R.7.3 has also been updated to take into account the recent change in REACH Annex VII for skin sensitisation regarding the appropriateness of in vivo skin sensitisation studies carried out or initiated before the date of entry into force of this revised annex.