Fatty acids C18-C22 (even numbered), tetraesters with pentaerythritol

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 read-across was applied for the substance, data will be generated from representative source substances to avoid unnecessary animal testing. Additionally, once the read-across approach is applied, substances will be classified and labelled on this basis.

 

Environmental fate and pathways

Degradation

Biodegradation: not readily biodegradable: 3 % after 28 days (OECD 301 F, O2 consumption) 

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.  

 

Aquatic acute toxicity

Fish
96 h, LC50 (Danio rerio, Cyprinus carpio): > 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read across

Aquatic invertebrates
48 h, EL50 (Daphnia magna): > 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read across 

Algae
72 h, EL50 (Pseudokirchneriella subcapitata): > 1000 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read across  

72 h, EL50 (Desmodesmus subspicatus): > 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read across  

Aquatic chronic toxicity

Fish: no data available

Aquatic invertebrates
21 d, NOELR (Daphnia magna): ≥ 1 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read across 

21 d, NOELR (Daphnia magna): ≥ 135 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read across 

Algae
72 h, EL10 (Pseudokirchneriella subcapitata): > 180 - < 320 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read across 

 72 h, NOELR (Desmodesmus subspicatus): ≥ 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read across  

Based on the data above, fatty acids C18-C22 (even numbered), tetraesters with pentaerythritol is considered to be not readily biodegradable. No acute aquatic toxicity was observed up to the water solubility limit (< 0.518 mg/L at 20 °C, OECD 105) for fish, algae and aquatic invertebrates. Valid chronic data are available with a NOELR (21 d) ≥ 1 mg/L (i.e. above the limit of water solubility) for aquatic invertebrates and a NOELR (72 h) ≥ 100 mg/L (i.e. above the limit of water solubility) for aquatic algae. Thus, fatty acids C18-C22 (even numbered), tetraesters with pentaerythritol does not need to be classified and labelled as environmental hazardous according to the consolidated version of Regulation (EC) No 1272/2008 and all further amendments (ATPs).