Registration Dossier
Registration Dossier
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EC number: 203-631-1 | CAS number: 108-94-1
Endpoint summary
Administrative data
Description of key information
In Annex IX of Regulation (EC) No 1907/2006, it is laid down that toxicity testing on soil species shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on soil organisms. In chapter 9 and 10 of the attached CSR it is shown that the substance does not pose any threat to the environment. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Regulation EC 1272/2008 or is assessed to be a PBT or vPvB. The hazard assessment of cyclohexanone reveals neither a need to classify the substance as dangerous to the environment, nor it is a PBT or vPvB substance, nor there are further indications that the substance may be hazardous to the environment. Cyclohexanone is readily biodegradable fulfilling the 10 -day window criterion. However, as the logKoc and LogPow is below 3 and no cationic and surface active properties are given a low adsorption potential is indicated. Hence, an adsorption to activated sludge, suspended matter or soil particles is unlikely and as a consequence a transfer to the soil compartment is not expected. As a consequence, no tests on soil organisms are provided.
Additional information
In Annex X of the Regulation (EC) No 1907/2006 REACH concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), it is suggested, that "in the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms. The choice of the appropriate tests depends on the outcome of the chemical safety assessment. In particular for substances that have a high potential to adsorb to soil or that are very persistent, the registrant shall consider long-term toxicity testing instead of short-term. These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely."
For Cyclohexanone there are no appropriate data on terrestrial toxicity available for a derivation of PNECsoil. The substance however, exhibits a low potential for adsorption, is not bioaccumulative and readily biodegradable. Furthermore, results of aquatic tests revealed no harmful effects of Cylcohexanone, and by thereby suggesting little hazardous potential towards soil organisms. Therefore, the equilibrium partitioning method has been used to assess the hazard potential of Cylcohexanone towards soil organisms.
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