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:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.264 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

Conclusion on classification

According to Article 13 of Regulation (EC) No. 1907/2006 "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 substances. This avoids the need to test every substance for every endpoint”.

Since the group concept is applied to the category members of the Glycol Esters, data will be generated from a representative category member to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.

 

Degradation

Biodegradation: 73% of ethylene distearate (OECD 301C)

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.  

Aquatic acute toxicity

96 h, LC50 (Oncorhynchus mykiss): > 0.3 mg/L (No observed toxicological effects up to the water solubility limit), (read across)

72 h, ErL50 (Scenedesmus subspicatus): > 3 mg/L (No observed toxicological effects up to the water solubility limit), (read across)

48 h, EL50 (Daphnia magna): > 2.4 mg/L (No observed toxicological effects up to the water solubility limit), (read across)

Aquatic chronic toxicity

21 d, NOELR (Daphnia magna): ≥ 0.02 mg/L (No observed toxicological effects up to the water solubility limit), (read across)

CLP

The substance is poorly soluble in water and no effects occurred up to its solubility limit in acute tests for fish, algae and aquatic invertebrates. Therefore, ethylene distearate does not need to be classified and labelled as environmental hazardous according to Directive 67/548/EEC. Based on the data above, ethylene distearate is considered to be rapidly degradable. No acute aquatic toxicity was observed up to the water solubility limit (4.24E-012 mg/L) for fish, algae and daphnids. Valid chronic data are available with a NOELR (21 d) ≥ 0.02 mg/L (i.e. above the limit of water solubility) for Daphnia magna. Therefore, ethylene distearate does not need to be classified and labelled as environmental hazardous according to the Regulation (EC) No 1272/2008 and the Regulation (EU) No 286/2011 (2nd ATP).

DSD

The substance is poorly soluble in water and no effects occurred up to its solubility limit in acute tests for fish, algae and aquatic invertebrates. Therefore, ethylene distearate does not need to be classified and labelled as environmental hazardous according to Directive 67/548/EEC.