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Ecotoxicological information

Ecotoxicological Summary

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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

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 "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 the group concept is applied to the category members of the Dimerised Fatty Acids and it Derivatives (sub-category 1 predominantly monomers) data will be generated from a representative sub-category member to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.

Classification related key information for Isooctadecanoic acid, as a member of Sub-category 1 of the Dimerised Fatty Acids and its derivatives:

Biodegradation in water: 62 % after 28d (OECD 301B), rapidly biodegradable

LogKow: >4 (expert judgement)

Acute toxicity:

- to fish: LC50 (48h) (Cyprinus carpio) = 13.4 mg/L nominal. No observed toxicological effects up to the water solubility limit (0.24 mg/L)

- to algae ErL50 (72h) (Scenedesmus subspicatus). No observed toxicity up to the water solubility limit (0.24 mg/L), based on read across.

- to crustacea EL50 (48h) (Daphnia magna) = No observed toxicological effects up to the water solubility limit (0.24 mg/L), based on read across.

Chronic toxicity:

- to algae (72 h) NOELR (Scenedesmus subspicatus) = No chronic toxicity to algae up to the limit of water solubility (0.24 mg/L), based on read across.

- to crustacea (21d) NOELR (Daphnia magna, reproduction) = No chronic toxicity to up to the limit of water solubility (0.24 mg/L), based on read-across

Classification justification according to CLP

Based on the data above, Isooctadecanoic acid and all members of sub-category 1 of the dimerised fatty acids and its derivatives are considered to be rapidly degradable. No acute aquatic toxicity was observed up to the water solubility limit (0.24 mg/L) for fish, algae and Daphnia. The long-term NOELR based on the reproduction of Daphnia magna was above 1 mg/L. Therefore, no classification is required for Isooctadecanoic acid is required according to the Regulation (EC) No.1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2nd ATP).

Classification justification according to DSD

Based on the data above, Isooctadecanoic acid and all sub-category 1 of the dimerised fatty acids and its derivatives do not pose a risk with regard to bioaccumulation due to their expected general low bioavailability, ready biodegradability and their metabolic fate in organisms. No acute aquatic toxicity was observed up to the water solubiltiy limit (0.24 mg/L). The long-term NOELR based on the reproduction of Daphnia magna was above 1 mg/L.

Therefore no classification is required for Isooctadecanoic acid, according to or the Directive 67/548/EEC.