Registration Dossier
Registration Dossier
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EC number: 446-220-4 | CAS number: 365411-50-3
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
Description of key information
No studies on the toxicity of Nebulone to soil macro-organisms are available and are not needed for a REACH Annex VIII dossier. Based on the available calculated value of Koc value of 6760 the substance will have some potential to adsorb to soil. Therefore a risk characterisation for soil organism is presented to assess their risk. In view of the log Kow of 4.29, the screening approach is justified, in which soil risks are estimated using aquatic toxicity data using the equilibrium partitioning method, because the log Kow is not exceeding 5.Using the available information for the substance a PNECsoil derived by equilibrium partitioning.
Key value for chemical safety assessment
Additional information
The Spanish CA has required an acute earthworm test under 67/548/EEC (29 May 2008) based on their risk assessment. ECHA has sent reminders on 30 November and on 22 July 2013. Now REACH has come into practice and the risk assessment has been updated according to the new legislation and guidance. According to the REACH regulation an acute earthworm test is not required when a substance is registered under Annex VIII.
To assess the hazards for soil organisms the equilibrium partition method can be applied to assess this hazard when the adsorption to soil is not to strong. Based on the available Koc value of 6760 the substance will have some adsorption potential to soil. The screening approach for assessing soil organism hazard is justified, in which the acute aquatic data are used as a surrogate, because the log Kow is < 5
In addition, such a study would not add information on classification and labelling and PBT assessment. For the risk characterisation for soil organisms such an acute earthworm test cannot be used either because it is only a single acute test. For a PNECsoil derived from soil organisms at least 3 tests from different trophic levels are needed. An acute earthworm test is not needed because the acute and long-term terrestrial toxicity can be well estimated using the acute aquatic toxicity data and the equilibrium approach. The latter being suitable in view of the log Kow, being 4.29 and not exceeding 5, of the substance. Based on these data an adequate PNEC for soil organisms (including earthworms) has been derived and a risk characterisation has been performed to assess the risk to soil organisms.
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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