Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

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:
PNEC soil
PNEC value:
5 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

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 group concept is applied to the category members of the LCAE, 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.

Degradation

Biodegradation: Readily biodegradable: 75.3% (BOD) after 28 d (OECD 301C); read-across

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.  

Aquatic acute toxicity

96 h, LL50 (Danio rerio): > 100 mg/L (nominal; no effects up to the limit of water solubility)

72 h, ErL50 (Desmodesmus subspicatus): > 100 mg/L (nominal; no effects up to the limit of water solubility)

Aquatic chronic toxicity

21 d, NOEC (Daphnia magna): ≥ 100 mg/L (nominal; no effects up to the limit of water solubility)

72 h, NOELR (Desmodesmus subspicatus): ≥ 100 mg/L (nominal; no effects up to the limit of water solubility)

CLP

Based on the data above, dodecyl oleate is considered to be rapidly degradable. No acute aquatic toxicity was observed up to the water solubility (< 0.05 mg/L) for fish and algae. Chronic data are available with a NOELR (72 h) ≥ 100 mg/L (nominal) for Desmodesmus subspicatus and a NOELR (21 d) ≥ 100 mg/L (nominal) for Daphnia magna. Therefore, dodecyl oleate does not need to be classified and labelled as environmental hazard according to the 2nd ATP of the Regulation (EC) No. 1272/2008 (CLP). However, since studies are still on-going for this substance (OECD 203 and OECD 211) the classification will be re-evaluated based on the outcome of these studies.

DSD

The substance is poorly soluble in water and no effects occurred up to its solubility limit in the available acute studies with fish and algae and the chronic study with daphnia. Therefore, dodecyl oleate does not need to be classified and labelled as environmental hazardous according to Directive 67/548/EEC.

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