Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
13 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
130 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
1.3 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1.31 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
28 µg/kg sediment dw

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
2.8 µg/kg sediment dw

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
2.31 µg/kg soil dw

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
3.33 mg/kg food
Assessment factor:
300

Additional information

All assessment and conversion factors used in the above PNEC calculations were taken from the ECHA guidance document "Guidance on information requirements and chemical safety assessment; Chapter R.10: Characterisation of dose [concentration]-response for environment" along with appropriate equations and methodologies.

The aquatic ecotoxicity testing, and thus PNEC derivations, were based on Water Accommodated Fractions (WAFs) of nominal concentrations of the substance. The test substance has water solubility in excess of the highest loading rates used in the WAF preparation, therefore the nominal loading rates were used to derive PNECs.

No additional long term aquatic toxicity testing is proposed for the registration substance, justification for waiving these studies is provided below.

The provision for long-term toxicity testing on aquatic organisms 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 in the, 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.

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. No terrestrial toxicity is proposed for the registration substance, justification for waiving is provided below.

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 terrrestial 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.

 

Conclusion on classification

Using the criteria set out in CLP Regulation (EC) No 1272/2008 Part 4: Environmental Hazards (as amended) the material will be classified as H411 Aquatic Chronic Category 2. The basis of this is that EC 202-228-8 was found to be not readily biodegradable in an OECD 301F as only 11% biodegradation was observed after 28 days and is therefore considered not rapidly biodegradable. And the material has an algal chronic NOEC (growth rate) value of 1 mg/L when tested in an OECD 201 study.