Registration Dossier
Registration Dossier
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EC number: 203-556-4 | CAS number: 108-16-7
Endpoint summary
Administrative data
Description of key information
Additional information
Terrestrial waiver:
No studies on terrestrial organisms are available for 1-(dimethylamino)propan-2-ol. 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 IX and X, the choice of the appropriate tests depends on the outcome of the chemical safety assessment. 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. 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. As the log Koc and log Kow of the substance are below 3, a low adsorption potential is indicated (see IUCLID Ch. 5.4.1). Hence, an adsorption to activated sludge is unlikely. Based on the low log Kow and the low 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”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 9, 10). 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, Section 9.4, Column 2 of Regulation (EC) No 1907/2006.
Birds-Waiver:
No studies on the toxicity to birds are available for 1-(dimethylamino)propan-2-ol. In Annex X Section 9.6.1 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 1-(dimethylamino)propan-2-ol a mammalian dataset is available. In addition, 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. 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). 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).
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 may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 9, 10). Consequently, 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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