m-toluidine

Toxicity to terrestrial plants

Administrative data

Endpoint:

toxicity to terrestrial plants: long-term

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING

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 REACH Annex IX, Section 9.4, Column 2. No confirmatory long-term testing required for this soil hazard category 3 substance (ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7c (2017)) is deemed necessary due to exposure considerations described above.

This waiver applies to both Annex IX (short-term) and X (long-term) requirements for terrestrial toxicity testing.