Registration Dossier
Registration Dossier
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EC number: 267-023-8 | CAS number: 67762-55-4
Biodegradation in soil
Administrative data
Link to relevant study record(s)
Description of key information
Under Section 2 of Annex XI, and with respect to Article 13(3), it is considered that it is not technically possible to run the simulation test. According to OECD 307, prior to running this study, it is necessary to know the solubility in water (according to OECD 305) and the n-octanol/water partition coefficient (Kow) (according to OECD 107 or 117). However, the substance is highly insoluble in water, and the water solubility cannot be analytically determined with any level of accuracy or reliability. Equally, the Log Kow has been determined to be >10, and no reference standard is currently available to allow a more precise determination. However, the log Kow value would indicate that the substance is likely to adsorb to incubation vessels and associated laboratory equipment, such that it will not be possible to distinguish loss of material due to binding to sediment as non-extractable residues (NER) (which may indicate P or vP), or sorption to analytical equipment (which would only indicate experimental limitations and cannot be used to infer any information on degradation kinetics). OECD 307 states that it is applicable to slightly volatile, non-volatile, soluble and poorly water-soluble compounds. The guidance does not include highly insoluble compounds within the scope of applicable substances. Therefore, it is considered that soil simulation testing methods are not appropriate to this substance based on water solubility. It should be considered that OECD 307 does allow for the use of solvents for the addition of test substance into the system, provided such solvents do not inhibit microbial activity. It was necessary to investigate the use of solvents/dispersants an OECD 301B (see relevant dossier entry). In this study, it was necessary to use chloroform as a solvent to obtain a meaningful result. However, chloroform is specifically named in OECD 307 as a solvent that should be avoided as it inhibits microbial activity. Therefore, the use of solvents is not appropriate in this case. As such, it is considered that the study is not technically feasible.
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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