Registration Dossier
Registration Dossier
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EC number: 614-144-2 | CAS number: 67800-94-6
Biodegradation in soil
Administrative data
Link to relevant study record(s)
Description of key information
The substance is an UVCB substance. In accordance with Annex IX, Section 9.3.2 and Section 9.2.1.2 the assessment of bioaccumulation or bioconcentration and biodegradation of each constituent and impurity present in concentrations at or above 0.1% (w/w) must be performed. Experimental testing of the degradation behaviour of registration item itself is not technically possible due to the complex UVCB nature of the substance and the large number of constituents. Furthermore, any potential breakdown products of the components are themselves also likely components of the target substance, so tracking the degradation products and identifying their source would be technically impossible. Therefore, QSAR approaches have been applied to investigate the degradation behaviour of the registration item.
Since the substance is a reaction product with ethoxylated and propoxylated components, there is no unique molecular structure of the registration item existing. Therefore, three representative chemical structures (large, medium and small) covering the molecular size range and structural differences of the UVCB were selected. Results obtained for these three substructures are considered representative of the entire UVCB substance and therefore allow for the assessment of the registration item:
Constituent 1 (CC(O)CNc1ccc(C)cc1NCCO), small size
Constituent 2 (CC(CN(CCOCC(C)O)c1ccc(C)cc1N(CCOCC(C)O)CCOCC(C)OCC(C)O)OCC(C)O), medium size
Constituent 3 (CC(CN(CCOCC(C)OCC(C)O)c1ccc(C)cc1N(CCOCC(C)OCC(C)O)CC(C)OCC(C)OCC(C)O)OCC(C)OCC(C)O), large size
These structures do not exist separately and cannot be synthesized or isolated with justifiable effort. Therefore, due to the lack of the experimental data for the constituents, the assessment of biodegradation is based on two QSAR models of CATALOGIC and one QSAR model of BIOWIN. The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment.
Biodegradation in soil
Degradation testing of Benzenediamine, ar-methyl-, polymer with methyloxirane and oxirane in simulation tests is not technically possible due to the complex UVCB nature of the substance and the large number of constituents. In addition, because a part of the potential breakdown products of the components are themselves also likely to be components of the target substance, tracking the degradation products and identifying their source would be technically impossible. Therefore, in line with REACH Annex XI, section 2, experimental simulation testing on the registration item is omitted.
However, to allow for a PBT assessment of the registration item and its relevant metabolites, QSAR analyses on the three representative structures (defined above) using different tools have been performed. The information obtained from those analyses demonstrate that all potential breakdown products occurring at relevant levels at or above 0.1% have log KOWs below 4.5, i.e. are not fulfilling the B criterion. This result is taken into account during the PBT assessment of Benzenediamine, ar-methyl-, polymer with methyloxirane and oxirane.
Key value for chemical safety assessment
Additional information
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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