Registration Dossier
Registration Dossier
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EC number: 202-228-8 | CAS number: 93-20-9
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No long-term toxicity to aquatic invertebrate's data is available.
Key value for chemical safety assessment
Additional information
The provision for long-term toxicity testing on aquatic invertebrates is contained within Column 1 of Annexes VIII and IX of REACH. Column 2 of each of these Annexes, describing the Specific Rules for Adaptation from Column 1, states:
"Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms."
The Registration substance (EC 202-228-8) is a monomer imported in a polymer and does not require full chemical safety assessment (comprising hazard assessment, exposure assessment, and risk characterisation) under REACH. Ipso facto, in accordance with the Standard Information Requirements laid down by REACH (Annexes VII to X), long-term toxicity testing in aquatic invertebrates is not necessary.
Furthermore, as the registration substance 2-(2-naphthyloxy)ethanol is a monomer in an imported polymer, the life cycle of this monomer ends outside of the EU. The polymer is imported into the EU diluted in base oil, the amount of unbound 2-(2-naphthyloxy)ethanol monomer in the polymer/base oil mixture is approximately 0.05%. This mixture is then formulated (diluted) into additive packages, the typical polymer concentration in additive packages is approximately 15%, which would result in unbound monomer concentrations of approximately 0.0075%. These additive packages are then formulated (diluted) into finished lubricant oils for use in engines, the typical polymer concentrations is approximately 1%, which would result in unbound monomer concentrations of approximately 0.0005%.The typical use of these lubricant additives does not involve contact with water and given the very low levels of unbound monomer present in the products used, it is considered that any releases to water will be negligible and therefore significant exposure to the aquatic compartment is unlikely. As such further long-term aquatic toxicity testing is not considered necessary.
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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