2-ethyl-2-[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)

Ecotoxicological Summary

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:

no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

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 TMP esters of the polyol esters category, 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: readily biodegradable (91% after 28 d, OECD 301B)

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.

Aquatic acute toxicity

No observed toxicological effects up to the limit of water solubility (< 0.05 mg/L)

Fish: Brachydanio rerio LC50 (96 h): > 48 mg/L (OECD 203)

Aquatic invertebrates: Daphnia magna EC50 (48 h): > 7.6 mg/L (OECD 202)

Algae: Scenedesmus subspicatus EC50 (72 h): > 3.7 mg/L (ISO 8692)

Aquatic chronic toxicity

No observed toxicological effects up to the limit of water solubility (< 0.05 mg/L).

Fish: no data available

Aquatic invertebrates: Daphnia magna NOELR (21 d) ≥ 0.11 g/L (nominal, WAF; OECD 211); read across

Algae: no data available

 

CLP:

2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis (isooctadecanoate) (CAS 68541-50-4) (CAS 68541-50-4) is readily biodegradable and has a low potential to bioaccumulate. The substance is considered to be not acutely toxic to fish, aquatic invertebrates or algae since not toxic effects were observed up to the limit of water solubility (<0.05 mg/L). Data on chronic toxicity indicate no toxicological effects up to the limit of water solubility. Therefore, 2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis (isooctadecanoate) (CAS 68541-50-4) 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:

2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis (isooctadecanoate) (CAS 68541-50-4) is readily biodegradable and has a low potential to bioaccumulate. The substance is poorly soluble in water and is considered to be not acutely or chronically toxic to aquatic organisms up to the limit of water solubility. Therefore, 2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis (isooctadecanoate) (CAS 68541-50-4) does not need to be classified and labelled as environmental hazardous according to Directive 67/548/EEC.