Registration Dossier
Registration Dossier
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EC number: 203-471-2 | CAS number: 107-19-7
Endpoint summary
Administrative data
Description of key information
No relevant and reliable data are available.
Additional information
No relevant studies on terrestrial organisms are available for the substance.
According to Regulation (EC) 1907/2006, Annex IX, Section 9.4 (9.4.1 to 9.4.3), Column 2, and Annex X, Section 9.4 (9.4.4), Column 2, short-term and long-term studies on the toxicity to terrestrial organisms do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.
The substance is not supposed to be directly applied to soil. An indirect exposure to soil via sewage sludge transfer is unlikely since the substance is readily biodegradable (for details see IUCLID Ch. 5.2.1). For a substance being considered as „readily biodegradable“, it can be assumed that it will be biodegraded within the STP process and as a consequence a transfer to the soil compartment is not expected. In addition, adsorption to sewage sludge is not expected based on the low adsorption potential (see IUCLID Ch. 5.4.1); therefore, further reducing the risk of indirect transfer of the substance via sewage sludge.
Following the scheme for soil hazard categories and screening assessment (Table R.7.11-2, REACH Guidance R.7c, June 2017), the substance is classified as Hazard Category 1. Substances of this category do not have a high adsorption potential or a high persistence in soil. In addition they are not very toxic to aquatic organisms. According to Table R.7.11-2, the PNEC for a screening assessment can be derived using the equilibrium partitioning method.
The equilibrium partitioning method has been used for assessing the hazard to soil organisms in accordance with Annex IX, Section 9.4, Column 2 of Regulation (EC) No 1907/2006.
Consequently, no tests on soil organisms are performed.
No studies on the toxicity to birds are available for the substance.
In Annex X, Section 9.6.1, Column 2 of Regulation (EC) No 1907/2006, it is laid down that any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level. In case of diethylamine (CAS 109-89-7) a mammalian dataset is available. In addition, the hazard assessment of the substance reveals neither a need to classify the substance as hazardous according to Regulation EC 1272/2008 and its second adaptation 286/2011, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment.
In addition, indirect exposure to the soil compartment is unlikely since the substance is readily biodegradable according to OECD criteria. For substances being considered as „readily biodegradable“, it can be assumed that they will be biologically degraded within the STP-process (see IUCLID Ch. 5.2.1). Direct exposure is not intended based on the exposure assessment as the substance is not applied directly to soil. Based on the low log Kow and the low estimated BCF values, bioaccumulation in organisms is not to be expected (see IUCLID Ch. 5.3.1).
Hence, secondary poisoning is of no concern.
Therefore, and for reasons of animal welfare, no tests on birds are performed.
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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