Registration Dossier
Registration Dossier
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EC number: 202-228-8 | CAS number: 93-20-9
Toxicity to terrestrial arthropods
Administrative data
Link to relevant study record(s)
Description of key information
No toxicity to terrestrial arthropods data is available.
Key value for chemical safety assessment
Additional information
REACH Annex IX section 9.4 column 2 states that:
"These studies do not need to be conducted if direct or indirect exposure of the soil compartment is unlikely.
In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms. The choice of appropriate tests depends on the outcome of the chemical safety assessment.
In particular for substances that have high potential to absorb to soil or that are very persistent, the registrant shall consider long-term toxicity testing instead of short-term."
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 releases to the terrestrial compartment. Given the very low levels of unbound monomer and the typical use pattern of lubricant additives, it is considered that any releases to soil will be negligible and therefore significant exposure to the soil compartment is unlikely. As such further terrestrial testing is not considered necessary.
The REACH text also states that the choice of appropriate tests depends on the outcome of the chemical safety assessment. The Registration substance is a monomer imported in a polymer and does not require a 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), further terrestrial testing is not necessary.
In the absence of data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms. EC 202-228-8 is moderately soluble in that it has a water solubility of 363.4 mg/L at 22 degrees C. It is therefore soluble up to the limit of testing in the acute aquatic toxicity (100 mg/L). As such it was concluded that it is appropriate to apply the equilibrium partitioning method to assess the hazard to soil organisms. Therefore the PNEC for soil has been calculated using the equilibrium partitioning method.
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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