Fatty acids, C16-18, esters with diethylene glycol

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:

insufficient hazard data available (further information necessary)

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Conclusion on classification

The hazard assessment is based on the data currently available. New studies with the registered substance will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

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.

 

Degradation

Biodegradation: readily biodegradable: 95% after 28 d (OECD 301B, CO2 evolution)

 

Bioaccumulation

Weight of evidence: Bioaccumulation is assumed to be low.  

 

Aquatic acute toxicity

Fish
96 h, LC50 (Oncorhynchus mykiss): > 0.3 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)

 

Aquatic algae
72 h, ErL50 (Pseudokirchneriella subcapitata): > 160 mg/L (nominal; no observed toxicological effects up to the water solubility limit)

 

Aquatic chronic toxicity

72 h, ErL10 (Pseudokirchneriella subcapitata): > 160 mg/L (nominal; no observed toxicological effects up to the water solubility limit)

 

CLP

Based on the data above, Fatty acids, C16-18, esters with diethylene glycol (CAS 85116-97-8) is considered to be readily degradable. No acute aquatic toxicity was observed up to the water solubility limit (< 1 µg/L at 20 °C, pH=6.3 (OECD 105)) for fish, algae and daphnids. Valid chronic data are available with an ErL10 (72 h) > 160 mg/L for the algae Pseudokirchneriella subcapitata. Therefore, the substance does not need to be classified and labelled as environmental hazard according to Regulation (EC) No 1272/2008 (CLP) and further amendments.