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:
insufficient hazard data available (further information necessary)

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

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 PFAE mixed and branched 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: readily biodegradable: 78.1-84.7% of CO2 evolution (OECD 301B)

 

Bioaccumulation

Expert statement: Bioaccumulation is expected to be low.

 

Aquatic acute toxicity

For fish: 96 h, LL50 (Danio rerio): no effects up to the limit of water solubility

For aquatic invertebrates: 48 h, EL50 (Daphnia magna): no effects up to the limit of water solubility

For algae/aquatic plants: 72 h, ErL50 (Desmodesmus subspicatus): no effects up to the limit of water solubility

 

Aquatic chronic toxicity

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

 

CLP:

Based on the data above, Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS No. 95912-89-3) is considered to be readily biodegradable. The substance is poorly soluble in water (< 0.05 mg/L), 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 algae. No chronic effects were observed up to the limit of water solubility. Therefore, Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane 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 (< 0.05 mg/L), and no effects occurred up to its solubility limit in acute tests with fish, daphnia and algae. Therefore, Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.