Registration Dossier
Registration Dossier
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EC number: 926-191-9 | CAS number: 1181221-96-4
Endpoint summary
Administrative data
Description of key information
Additional information
No experimental data on the terrestrial toxicity of the submission item are available.
However, the submission item is used in the coatings industry under controlled conditions. Companies of this industry sector are typically equipped to meet the requirements of the Solvent Emissions Directive (1999/13/EC), i.e. have on-site treatment of off-air in place. This, together with the extremely low vapour pressure of the submission item, makes emissions of the submission item via the air very unlikely. Furthermore, also emissions to wastewater are considered negligible. Most of the processes operated in the coatings industry do not generate wastewater at all, for the remaining ones effective measures prevent significant releases to the environment. The particularly low water solubility of the submission item further contributes to the conclusion that emissions via wastewater are not relevant for the submission item. Moreover, also direct releases to soil are not intended and there is no deposition to soil from the manufacture and application processes in the coatings industry. For the reasons stated above, also indirect exposure of the soil compartment is considered not significant. According to column 2 of Annex IX of Regulation (EC) No 1907/2006, studies relating to effects on terrestrial organisms do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.
In addition, studies on aquatic organisms suggest a low toxicity potential of the submission item. This is in line with the assumption of a reduced bioavailability of the submission item. According to the Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment, an average maximum diameter (Dmax aver) of greater than 1.7 nm and a molecular weight of greater than 1100 g/mol influence the uptake and distribution of substances. The submisson item has a molecular weight of 1316 g/mol and a Dmax of at least 3 nm. Therefore, it is very likely that the submission item has a limited potential to cross biological membranes and deploy toxic action. Taking the available information on exposure, toxicity and bioavailability into account, studies on the terrestrial toxicity of the submission item are not deemed necessary.
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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