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:
insufficient hazard data available (further information necessary)

Sediment (marine water)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
100 mg/kg soil dw
Assessment factor:
10

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 secondary 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 related key information

- Biodegradation: Not readily biodegradable: < 10% - 24% degradation (OECD 301 D, 301 F, DGXI/400/84 EEC 19984, L251, 1984.09.19, Part C, EEC 1984)

- Bioaccumulation: BCF = 0.89 L/kg whole body w.w.(QSAR; Arnot Gobas) and 3.16 L/kg whole body w.w. (BCF regression based); log Pow > 5.7 (EU Method A.8, HPLC method)

Aquatic acute data

Fish: LC50 (96 h) >1000 mg/L (EU Method C.1, Poecilia reticulate, nominal)

Aquatic invertebrates: EC50 (48 h) > 100 % v/v of a saturated solution (OECD 202, Daphnia magna, nominal)

Aquatic algae: ErC50 (72 h) >100% v/v of a saturated solution (OECD 201, Pseudokirchneriella subcapitata, nominal)

Aquatic chronic data

Aquatic algae: NOEC (72 h): 100 mg/L (OECD 201, Pseudokirchneriella subcapitata, nominal)

Classification justification according to CLP

Based on the data above, the substance is not considered to be rapidly degradable in the environment. The substance is characterized by a low water solubility and high log Koc leading to a low bioavailability. Due to its higher molecular weight, no extensive metabolism of the substance is expected but rather direct elimination. In conclusion, a bioaccumulation or biomagnification through the food chain of the substance is not expected. It can hence be concluded that the high log Kow, which indicates a potential for bioaccumulation, overestimates the bioaccumulation potential of the substance.

Since the test substance did not caused any statistically significant effect up to a saturated solution of 100% v/v the substance do not has to be classified and labelled according to the Regulation (EC) No 1272/2008 (CLP) and the Regulation (EU) No 1297/2014 (7th ATP).

Classification justification according to CLP:

Based on the ecotoxicological data, the substance does not pose a risk to organisms in regard to bioaccumulation; the substance is not readily biodegradable. Short term toxicity data of analogue substances towards fish, daphnia and algae give a NOEC greater than the water solubility of (Z)-N-octadecyldocos-13-enamide (CAS No. 10094-45-8). No toxicity could be observed in any test. Therefore, no classification is required for (Z)-N-octadecyldocos-13-enamide (CAS No. 10094-45-8) 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, the substance (Z)-N-octadecyldocos-13-enamide (CAS No. 10094-45-8) does not pose a risk to organisms in regard to bioaccumulation; the substance is not readily biodegradable. The substance is poorly soluble in water and no effects occurred up to its limit of solubility in acute tests for fish, algae and aquatic invertebrates. Therefore, no classification is required for (Z)-N-octadecyldocos-13-enamide (CAS No. 10094-45-8) according to the Directive 67/548/EEC.