Cerium dioxide

Toxicity to terrestrial arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to non-target arthropods on natural substrate (NTA other than pollinators)

Data waiving:

other justification

Justification for data waiving:

other:

Description of key information

Data waiving (other justification):

Acute data of terrestrial ecotoxicity are available on earthworms, plants and soil micro-organisms; all showing an absence of adverse effects with NOEC >= 1000 mg/kg dry soil. ECHA Guidance on Dossier and Substance Evaluation (June 2007) indicates that a testing proposal must be submitted when:

- The available information on an endpoint is inconclusive,

- Further testing is triggered by suspicion based on structural similarities with substances of concern,

- The CSR indicates there is a risk and therefore the PNEC needs to be refined,

- The classification and labelling needs to be refined,

- There is a need to improve the PBT/vPvB assessment.

In the case of cerium dioxide, data available on terrestrial ecotoxicity are fully reliable and conclude to an absence of adverse effect on the tested organisms. Furthermore, endpoints relative to terrestrial ecotoxicity do not play a role in classsification and labelling or in PBT/vPVB assessment. At last, as a non classified substance, cerium dioxide does not require a risk assessment, and thus, the PNEC does not need to be refined to improve the risk characterisation ratio. As a result, none of the conditions above-mentionned is fulfilled. On this basis and according to column 2 of REACH Annex X, the long-term toxicity test on terrestrial arthropods is not required.