Registration Dossier
Registration Dossier
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EC number: 224-221-9 | CAS number: 4253-34-3
Endpoint summary
Administrative data
Description of key information
Additional information
In accordance with Column 2 of REACH Annex IX, there is no need to further investigate the effects of this substance in a long-term terrestrial toxicity to invertebrates/higher plants study because, as indicated in guidance R.7.11.6 (ECHA 2017), the quantitative chemical safety assessment (conducted according to Annex I of REACH) indicates that the Risk Characterisation Ratio is well below 1, even with due consideration of contributing uncertainties, and therefore the risk is already adequately controlled and further testing is not justifiable.
The substance is not readily biodegradable but has low potential for bioaccumulation, low potential for adsorption, has low bioavailability (based on log Kow <3) and no toxicity was observed in short-term aquatic tests, and there is no reason to expect any specific mechanism of toxicity beyond narcosis. Therefore, the occurrence of more severe toxic effects in the terrestrial compartment that were not expressed in the aquatic studies (conducted at concentrations up to 500 mg/l) would be considered unlikely.
The soil hazard category 1 (ECHA 2017, guidance part R7(c) Table R.7.11—2) has been derived for the category. In accordance with the screening assessment for soil hazard category 1 substances, a PNECsoil has been calculated from the aquatic data on the basis of the equilibrium partitioning method. The PNEC calculated by Equilibrium Partitioning has been derived for the purpose of chemical safety assessment and the risk characterisation ratios are below 1.
Overall it is concluded that the risk characterisation conclusion is sufficiently conservative in respect of any uncertainties and therefore further in vivo testing is not considered necessary.
Details on how the PNEC and the risk characterisation ratio have been derived can be found in IUCLID Section 6.0 and Chapters 9 and 10 of the Chemical Safety Report, respectively.
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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