Registration Dossier

Environmental fate & pathways

Bioaccumulation: terrestrial

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
bioaccumulation: terrestrial
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Description of key information

Data on terrestrial bioaccumulation are not considered to be required for the substance.

Key value for chemical safety assessment

Additional information

Data on terrestrial bioaccumulation are not considered to be required for the substance. In accordance with REACH legislation the test does not need to be conducted if direct and indirect exposure to the terrestrial compartment is unlikely. Furthermore, this substance does not meet the B or vB criterion and it is not considered to be a PBT. ECHA Chapter R.7B guidance states that if the substance is not considered a PBT or vPvB candidate, it is not necessary to conduct further testing on the compartment. This substance is not directly applied to the terrestrial compartment and based on its intended use will not enter the terrestrial environment and therefore no testing of terrestrial arthropods is required. The indirect exposure of the terrestrial environment to this substance via sewage sludge is also of not concern based on the treatment of the sludge. In accordance with section 9.4 of REACH Annex IX and X, further tests do not need to be conducted if direct and indirect emission to, and exposure of, the terrestrial compartment is unlikely as in this case. REACH allows that certain tests may be waived based on exposure scenarios or an absent, unlikely, not relevant, or not significant exposure. In addition to the manner of use of this substance in formulated engine oils at relatively low constituent volume, during production, formulation, use and waste stages strict management measures are in place to ensure that the substance or product is not released to the environment. It is therefore considered that there should be no exposure of the substance to any soil compartments and therefore no exposure to the terrestrial arthropods nor any predators reliant upon the arthropods. It should also be noted that based on the integrated testing strategies within the EU REACH Guidance documents, tests with terrestrial organisms should only be considered as an essential requirement if exposure triggered, or if there are indications of risk.