Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.44 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.44 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
20 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

For all members of the SCAE C2-8 category (short chain alcohol ester) no intrinsic effects at the range of water solubility were observed (water solubility < 1 mg/L). In some studies physical effects, well above the limit of water solubility, were observed, when unfiltered test substance was present. Therefore, no PNEC derivation for the aquatic compartment was conducted.

For the category of SCAE C2-8 two valid short term studies on the marine invertebrate Corophium volutator are available, hence a PNEC sediment (marine water) was derived. Applying an assessment factor of 1000, a PNEC of 1.44 mg/kg sediment dw was derived (LC50(10d) > 1439.41 mg/kg sediment dw).

No studies on the toxicity of sediment dwelling organisms in freshwater are available. Considering the absence of aquatic ecotoxicity effects on marine and freshwater organisms, the results of marine studies can been used to derive a PNECsediment (freshwater). Two short-term sediment toxicity tests in marine conditions are available, with the key result of LC50(10d)>1439 mg/kg sediment dw. Using an assessment factor of 1000 a PNECsediment freshwater of 1.44 mg/kg sediment dw was derived.

The PNEC soil was derived using an assessment factor of 1000 based on the short-term study available on Eisenia fetida with an LC50(14d) value of >20000 mg/kg soil dw.

A PNEC oral was not derived for the members of the SCAE C2 -8 category due to: a) the ready biodegradability in water, sediments and soils and b) the acknowledged rapid metabolisation in fatty acids and their respective alcohol component.

Conclusion on classification

Justification for classification

According to Article 13 "General Requirements for Generation of Information on Intrinsic Properties of substances", Information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met.

Annex XI, “General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substance. This avoids the need to test every substance for every endpoint”.

Since the group concept is applied to the members of the SCAE C2-C8 category, data will be generated from representative category members to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.

Brief description of the data relevant for classification

Degradation

Biodegradation: 86.8% of CO2 evolution (OECD 301B)

Bioaccumulation

Expert statement: Bioaccumulation is expected to be low.

Aquatic acute toxicity

For fish: 96 h, LC50 (Danio rerio): no effects up to the limit of water solubility; read-across

For aquatic invertebrates: 48 h, EC50 (Daphnia magna): no effects up to the limit of water solubility

For algae/aquatic plants: 72 h, ErC50 (Desmodesmus subspicatus): no effects up to the limit of water solubility

Aquatic chronic toxicity

For fish: no data available

For aquatic invertebrates: 21 d, NOEC (Daphnia magna): no effects up to the limit of water solubility

For algae/aquatic plant: 72 h, NOErC (Scenedesmus subspicatus): no effects up to the limit of water solubility

Conclusion on classification

CLP:

Based on the data above, 2-ethylhexyl oleate (CAS No. 26399-02-0) is considered to be readily biodegradable. The substance is poorly soluble in water, and no effects occurred up to its water solubility limit in acute tests with fish, algae and daphnia. Valid chronic toxicity data are available for daphnia and algae. No chronic effects were observed up to the limit of water solubility. Therefore, 2-ethylhexyl oleate does not need to be classified and labelled as environmental hazard according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).

DSD:

The substance is poorly soluble in water, and no effects occurred up to its solubility limit in acute tests with for fish, algae and daphnia. Therefore, 2-ethylhexyl oleate does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.