Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sediment toxicity: long-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The waiver is submitted under the premise of exposure-based adaptation in accordance with Annex XI, Section 3.2(b) "where the substance is not incorporated in an article the manufacturer or imported demonstrates and documents for all relevant scenarios that throughout the life-cycle strictly controlled conditions as set out in REACH Article 18(4)(a) to (f) apply".

In addition to manufacturing the substance under strictly controlled conditions for on-site and transported isolated intermediate use in accordance with Article 17 and 18 of REACH, the substance is also manufactured for non-intermediate end uses that require the registration to also be compliant with Article 10 of REACH. However, these end uses are located outside the EU/EEA and as such the material is exported after manufacture, with no other interim identified uses.

Regardless of the intended end-use of the substance (intermediate or non-intermediate outside the EU/EEA), the manufacturing process is conducted in accordance with strictly controlled conditions as presented for the intermediate aspects of this registration dossier, at a single site.

The exposure-based adaptation is documented, in accordance with Annex XI, Section 3.2(b) and accompanying ECHA Guidance (ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.5 (2011)), and is presented in Sections 13.1 (Chemical Safety Report) and 13.2 (Risk Management Measures Document, in support of intermediate registration) of the technical dossier.

Exposure assessment and risk characterisation has been conducted, to support both acceptable risk conclusions for non-intermediate uses and exposure-based adaptation. Screening level predicted no-effect concentrations for the terrestrial compartment were derived using EPM methodology, as described in ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7b (2017).

This waiver applies to both short-term and long-term requirements for sediment toxicity testing.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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