Registration Dossier

Diss Factsheets

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

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 of structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. In Annex XI, entitled "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”.

Since the available data on environmental fate and aquatic toxicity of the target substance fatty acids, C14-22, C16-24-alkyl esters (CAS 92797-30-3) is limited, a read-across approach was applied and data was compiled from representative source substances to avoid unnecessary, addition animal testing. The target substance will be classified and labelled on this basis.

 

Environmental fate and pathways

Degradation

Readily biodegradable: 68.1 – 71.7% CO2 within 29 d (OECD 301 B); read-across

Partition coefficient

log Kow > 10.0 (QSAR, Vega v1.1.3)

 

Aquatic short-term toxicity

Fish

No effects up to the limit of water solubility (< 2.5 µg/L, 20 °C; OECD 203, C. carpio); read-across

Aquatic invertebrates

No effects up to the limit of water solubility (< 2.5 µg/L, 20 °C; OECD 202, D. magna); read-across

Aquatic algae

No effects up to the limit of water solubility(< 2.5 µg/L, 20 °C; OECD201, P. subcapitata); read-across

Aquatic long-term toxicity

Fish

No data available

Aquatic invertebrates

No effects up to the limit of water solubility(< 2.5 µg/L, 20 °C; OECD211, D. magna); read-across

Aquatic algae

No effects up to the limit of water solubility(< 2.5 µg/L, 20 °C; OECD201, P. subcapitata); read-across

 

Conclusion on CLP

Fatty acids, C14-22, C16-24-alkyl esters (CAS 92797-30-3) is rapidly biodegradable. Neither acute toxicity to aquatic organisms of all three trophic levels (fish, aquatic invertebrates and algae) nor chronic toxicity to aquatic algae was observed up to the limit of water solubility (< 2.5 µg/L). Based on the available data compiled above, fatty acids, C14-22, C16-24-alkyl esters (CAS 92797-30-3) is not classified and labelled for environmental hazards, according to the consolidated version of Regulation (EC) No 1272/2008 (dated: 01.06.2017) and further amendments (ATPs).

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