Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
Testing of bioaccumulation in aquatic species is waived according to Column 2 of REACh Annex IX, wherein it is stated that the study need not be conducted if direct and indirect exposure of the aquatic compartment is unlikely.
Key value for chemical safety assessment
Additional information
The substance (Natural Oil Monomer) is not manufactured within the EU, and is only imported as its reacted (covalently-bound) form in polymers (i.e., polyols) having typically < 0.2% wt. residual unreacted monomer. There is no known or expected mechanism by which degradation of these polymers could result in re-formation of the monomer substance over the course of its life-cycle. Therefore, direct and indirect exposures of the environment to this substance are highly improbable.
In addition, the conduct of further testing on bioconcentration/bioaccumulation is unjustified on the following technical bases:
1) The Base-Line BCF model predicts fish bioconcentration factors (BCF) of 13 - 41 for representative components/isomers of the UVCB substance, and that this low bioaccumulation potential is influence by potential for rapid metabolism and large molecular size of these substances. For a series of five structural analogs, the the model was shown to predict BCF values which were within a factor of five of experimental values.
2) The Natural Oil Monomer substance meets OECD criteria for ready biodegradability in the Manometric Respirometry test, and is highly insoluble in water (ws < 0.03 mg/L), which further diminish its potential for emission to and persistence in water.
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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