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”.

Since the analogue concept is applied to the primary fatty amides, data will be generated from a representative member to avoid unnecessary animal testing. Additionally, once the analogue concept is applied, substances will be classified and labelled on this basis.

Classification justification according to CLP:

Based on the ecotoxicological data, docosanamide (CAS No. 3061-75-4) does not pose a risk to organisms in regarding bioaccumulation since, the substance is readily biodegradable. Short term toxicity data of the analoque substances towards fish, daphnia and algae give a NOEC greater than the water solubility of docosanamide (CAS No. 3061-75-4). No toxicity could be observed in any test. Additionally, long term test with the structural related (Z)-Docos-13-enamide are conducted. The available study report on long-term toxicity of (Z)-Docos-13-enamide to fish conducted according to OECD 215 demonstrate no effect up to the limit of the water solubility of the tested substance. The same applies for a long term daphnia study according to OECD 202 for (Z)-Docos-13-enamide, detecting no effects up to the limit of the water solubility of the tested substance. Therefore, no classification is required for docosanamide (CAS No. 3061-75-4) 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 ecotoxicological data for read across substances, docosanamide (CAS No. 3061-75-4) does not pose a risk to organisms regarding bioaccumulation since, the substance is readily biodegradable. The substance is poorly soluble in water and no effects occurred up to its solubility limit in acute tests for fish, algae and aquatic invertebrates. Additionally, long term test with the structural related (Z)-Docos-13-enamide are conducted. The available study report on long-term toxicity of (Z)-Docos-13-enamide to fish conducted according to OECD 215 demonstrats no effect up to the limit of the water solubility of the tested substance. The same applies for a long term daphnia study according to OECD 202 for (Z)-Docos-13-enamide, detecting no effects up to the limit of the water solubility of the tested substance. Therefore, no classification is required for docosanamide (CAS No. 3061-75-4) according to or the Directive 67/548/EEC.