Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Biodegradation in water and sediment: simulation tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: simulation testing on ultimate degradation in surface water
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- Transformation products:
- not specified
- Endpoint:
- biodegradation in water: sediment simulation testing
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- Transformation products:
- no
Referenceopen allclose all
Description of key information
This endpoint is waived because the substance is inorganic and testing is technically not possible (see REACH Annex XI, point 2).
Most importantly, simulation tests of biological degradation are technically not feasible with "Neutralisation and reduction products of bauxite residue from refinement process".
The test guidelines relevant for biological degradation in surface water and/or water-sediment systems are OECD 308 and 309 (and their counterparts in EU Regulation 440/2008).
The applicability of these test methods is explicitly restricted to organic chemicals. Therefore, as an inorganic compound, "Neutralisation and reduction products of bauxite residue from refinement process" falls outside the technical feasibility domain of biological degradation testing.
Key value for chemical safety assessment
Additional information
This endpoint is waived because the substance is inorganic. For an inorganic substance for which the chemical safety assessment is based on the elemental concentration (i.e. pooling all inorganic speciation forms together), biotic degradation in the environment is an irrelevant process. Biotic processes may alter the speciation form of an element, but it will not eliminate the element from the environment by degradation or transformation processes. This elemental-based assessment (i.e. pooling all speciation forms together) can be considered as a worst-case assumption for risk assessment.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
