IUCLID

REACH Chemical Safety Report (CSR)

16.08.2023; Updated CSR to include:

• The DataTox DNEL Summary (Chapter 5.11)
• The Toxicity to Reproduction DNEL Summary (Chapter 5.11)
• The Additional Information of the Carcinogenicity Endpoint Summary (Chapter 5 'Summary and discussion of carcinogenicity')

The chemical safety report documents the chemical safety assessment undertaken as part of the REACH registration process, and is the key source from which the registrant provides information to all users of chemicals through the exposure scenarios. It also forms a basis for other REACH processes including substance evaluation, authorisation and restriction.

Under the amendment to the REACH regulation (2018/1881) of 3 December 2018 to address nanoforms of substances, nanoforms of a substance need to be covered by the registration dossier. Typically, nanoform dossiers are prepared using the IUCLID assessment entity approach (see the guidance). This report shows in the first table the referenced composition(s) and endpoint summaries inside each assessment entity (section 1.10 – ‘Specific composition / form of the registered substance’). There is a new row per assessment entity document. The report shows in the second table the referenced endpoint summary information inside a single assessment entity, as well as information from the endpoint studies which are referenced by those endpoint summaries. There should be one table generated per assessment entity document, with a new row per referenced endpoint summary.