Registration Dossier
Registration Dossier
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EC number: 203-049-8 | CAS number: 102-71-6
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
Description of key information
No data available.
Key value for chemical safety assessment
Additional information
No relevant studies on terrestrial organisms are available for the substance.
According to Regulation (EC) 1907/2006, Annex IX, Section 9.4.1 to 9.4.3, Column 2, studies on the toxicity to terrestrial organisms do not need to be conducted as the substance is considered to be readily biodegradable. The test 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, the substance is expected to rapidly degrade in soil, as indicated by a half-life of 1.8 d determined in a degradation test in soil (see IUCLID Ch. 5.3.3).
In Annex X Section 9.4 of Regulation (EC) No 1907/2006, it is laid down that tests on terrestrial organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on terrestrial organisms. 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 Directive 67/548/EEC or Regulation EC 1272/2008 or is assessed to be a PBT or vPvB.
The hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. Based on the low log Kow and the low measured and estimated BCF values, bioaccumulation in aquatic organisms is not to be expected (see IUCLID Ch. 5.3.1).
In Annex XI Section 3, it is laid down that testing in accordance with sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). However, no risk assessment is required as the substance holds no relevant classification for toxicity or environmental effects. In addition, short-term and long-term hazards are not expected (L(E)C50 > 100 mg/L; NOEC/EC10 > 1 mg/L).
Consequently, no tests on soil organisms are performed. The equilibrium partitioning method has been used for assessing the hazard to soil organisms in accordance with Annex IX and X, Section 9.4, Column 2 of Regulation (EC) No 1907/2006.
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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