Registration Dossier
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EC number: 814-433-5 | CAS number: 926622-96-0
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No experimental data available.
Key value for chemical safety assessment
Additional information
In Annex IX of Regulation (EC) No 1907/2006, section 9.1.5, it is laid down that a chronic study on aquatic invertebrates shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on aquatic vertebrates. 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 Directive 1999/45/EC 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, the risk assessment results in Risk Characterisation Ratios far below 1 for the freshwater compartment.
According to Regulation (EC) No 1907/2006 Annex XI sections 3.1 and 3.2(b) (as amended by Regulation 134/2009) testing in accordance with Annex IX (incl. section 9.1.5, Long-term toxicity testing on aquatic invertebrates) may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (CSR), when the substance is not incorporated in an article and the manufacturer can demonstrate and document for all relevant scenarios that throughout the life cycle strictly controlled as well as rigorously contained conditions as set out in Article 18(4) (a) to (f) Regulation (EC) No 1907/2006 apply.On the basis of the present process conditions, as described in the attached justification document ‘926622-96-0_Long-term invertebrates testing_exposure-based waiving_2018-05-25’, the criteria of exposure-based adaptation of information requirements are met due to the lack of environmental exposure of aquatic invertebrates to the substance.
Therefore, testing of 2-Propanamine, N-[2-[2-(2-methoxyethoxy)ethoxy]ethyl]-2-methyl- (CAS 926622-96-0) in a long-term toxicity study on aquatic invertebrates was not performed.
Supporting this conclusion, the ACR approach according to ECETOC (2003, Report no. 91) results in NOECs greater than 1 mg/L based on the effect data of the acute toxicity study (BASF SE, 2018; report no. 170907BH / DAI17942).
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