Nonanedioic acid, 1,9-bis(2-octyldodecyl) ester

Ecotoxicological Summary

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 exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

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”.

Since the group concept is applied to the category members of the PFAE linear, data will be generated from a representative category member to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.

Conclusion on classification

Classification related key information

Log Kow: > 5.7 (EU method A.8)

Water solubility: < 0.004 mg/L (OECD 105)

Biodegradation: 81.5% in 28 days (OECD 301B)

BCF: 0.89 L/kg (BCFBAF v3.01; Arnot-Gobas estimate) 

Aquatic acute toxicity:

For fish: LC50 (96h) no toxic effects up to the limit of water solubility (< 0.004 mg/L) for fish (OECD 203), read cross

For algae: EC50 (72h) no toxic effects up to the limit of water solubility (< 0.004 mg/L) for algae (OECD 201)

For crustacean: EC50 (48h) no toxic effects up to the limit of water solubility (< 0.004 mg/L) for D. magna (OECD 202)

Aquatic chronic toxicity:

For fish: no data

For algae: NOEC (72h) no toxic effects up to the limit of water solubility (< 0.004 mg/L) for algae (OECD 201)

For crustacean: NOEC (21d) no toxic effects up to the limit of water solubility (< 0.004 mg/L) for D. magna (OECD 211), read across 

Non-Classification justification according to CLP

Based on the data above, Bis(2-octyldodecyl) azelate (CAS 897626-46-9) is considered rapidly degradable. The acute aquatic toxicity L(E)C50 values are > 1 mg/L and the solubility of the substance in water for fish, algae and daphnia. Valid chronic toxicity data are available for algae and Daphnia – showing that the NOEC values are above the solubility of the substance in water. Therefore, Bis(2-octyldodecyl) azelate (CAS 897626-46-9) does not need to be classified and labelled as environmental hazard according to the Regulation (EC) No.1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2nd ATP).

Non-Classification justification according to DSD

Based on the data above, Bis(2-octyldodecyl) azelate (CAS 897626-46-9) is rapidly degradable and is considered to have a low potential for accumulation. The acute aquatic toxicity L(E)C50 is > 100 mg/L and the solubility of the substance in water for fish, algae and daphnia. Therefore, Bis(2-octyldodecyl) azelate (CAS 897626-46-9) does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.