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:
no hazard identified

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”.

A read-across approach was applied to Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid (EC 948-383-1) for ready biodegradability and aquatic toxicity. Once the read-across approach is applied, substances will be classified and labelled on this basis.

Environmental fate and pathways

Degradation

Readily biodegradable: 66.4% after 28 d

Bioaccumulation

Negligible due to ready biodegradability.

Aquatic acute toxicity

Fish, short-term:

LC50 (96 h) > 0.704 mg/L

Aquatic invertebrates, short-term:

EL50 (48h) > 100 mg/L

Aquatic chronic toxicity

Aquatic invertebrates, long-term:

NOEC (21 d)1 mg/L (immobility, reproduction)

Aquatic algae and cyanobacteria:

EL50 (72 h) > 100 mg/L

NOELR (72 h)100 mg/L

CLP

Based on the data above, the substance is predicted to be readily biodegradable, and neither short-term nor long-term toxic effects towards aquatic organisms of all three trophic levels are expected up to the limit of the water solubility ( < 165 µg/L). Therefore, Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid (EC 948-383-1) does not need to be classified and labelled as environmentally hazardous, according to the consolidated version of Regulation (EC) No 1272/2008 and further amendments (ATPs).