Registration Dossier
Registration Dossier
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EC number: 226-956-0 | CAS number: 5578-42-7
Endpoint summary
Administrative data
Description of key information
Additional information
PNECsoil has been calculated from the aquatic data using the Equilibrium Partitioning Method. The risk characterisation ratios (RCR) based on the PNECsoil are <1.
In accordance with Column 2 of REACH Annex IX, there is no need to further investigate the effects of this substance in a 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 (RCR) is 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 used under highly controlled conditions due to the very rapid hydrolysis and corrosive nature of the substance. The highest RCR is for the sewage treatment plant (STP). However, there is no application of the STP sludge on to agricultural soil. This is implemented as a risk management measure. Therefore, exposure to soil is unlikely and, according to ECHA 2017, guidance part R7(c), R.7.11.6.3, Figure R.7.11—2, no further assessment of the soil is required.
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 moderate 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 80, 215 and 100 mg/l for fish, Daphnia and algae, respectively) would be considered unlikely.
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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