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:
insufficient hazard data available (further information necessary)

Additional information

Conclusion on classification

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. In Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X”, it is stated 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 this substance and data was compiled from representative source substances to avoid unnecessary animal testing. The target substance will be classified and labelled on this basis.

Environmental fate and pathways

Degradation

Readily biodegradable (82.2% in 28 d, OECD 301 B)                        

Bioaccumulation

Log Pow >10

 

Aquatic short-term toxicity

Fish

No effects up to the limit of water solubility (OECD 203, C. variegatus); read-across

Aquatic invertebrates

Data waiving: a long-term aquatic study on invertebrates is available.

Algae

No effects up to the limit of water solubility(ISO 8692, S. subspicatus); read-across

 

Aquatic long-term toxicity

Fish

No data available

Aquatic invertebrates

No effects up to the limit of water solubility (OECD 211, D. magna); read-across

Algae

No effects up to the limit of water solubility(OECD 201, S. subspicatus); read-across

Conclusion on CLP

The substance Fatty acids, C18-unsaturated, 1,6 Hexanediol Diester (EC 947-912-3) is readily biodegradable. No toxic effects were observed at the limit of water solubility (EC(L) > 1 mg/L for fish, aquatic invertebrates and algae). Thus, the substance 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).