Registration Dossier
Registration Dossier
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EC number: 701-026-1 | CAS number: -
Biodegradation in water and sediment: simulation tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: sediment simulation testing
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- Transformation products:
- no
- Endpoint:
- biodegradation in water: simulation testing on ultimate degradation in surface water
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- the study does not need to be conducted because the substance is highly insoluble in water
- other:
- Transformation products:
- no
Referenceopen allclose all
Description of key information
According to REACH Annex IX/X, column 2, item 9.2, "Further degradation testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicate the need to investigate further the degradation of the substance." Furthermore, waiving may be considered "if the substance is highly insoluble in water", or if "the substance is readily biodegradable". However, for an inorganic substance for which the chemical assessment is based on the elemental concentration, 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 can be considered as a worst-case assumption for risk assessment. Most importantly, simulation tests of biological degradation are technically not feasible with non-graphitic carbon fibre. According to REACH Annex XI, point 2, the guidance given in the test methods referred to in Article 13(3), more specifically on the technical limitations of a specific method, shall always be respected. 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, non-graphitic carbon fibre falls outside the technical feasibility domain of biological degradation testing.
Key value for chemical safety assessment
Additional information
Non-graphitic carbon fibres within the scope of this registration are regarded as inorganic and not expected to be degradable, neither by biological nor by abiotic mechanisms. Additionally, the chemically inert substance has a macromolecular size which makes crossing biological membranes unlikely.
Extracorporeal metabolism is unlikely with respect to the substance's molecular structure consisting of highly condensed carbon atoms in ring structures. Biodegradation is therefore of no relevance.
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.
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