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:
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 read-across was applied for the substance, data will be generated from representative source substances to avoid unnecessary animal testing. Additionally, once the read-across approach is applied, substances will be classified and labelled on this basis.

Degradation

Biodegradation:Readily biodegradable: 89.9% after 29 d (OECD 301B); read-across

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

 

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.  

Aquatic acute toxicity

Fish: 96 h, LL50 (Danio rerio): > 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read-across

Aquatic invertebrates: no data; chronic data are available instead

Aquatic algae: 72 h, ErL50 (Scenedesmus subspicatus): > 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read-across

Aquatic chronic toxicity

Fish: no data available

Aquatic invertebrates: 21 d, NOEC (Daphnia magna): ≥ 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read-across
21 d, NOELR (Daphnia magna): ≥ 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read-across

Aquatic algae: 72 h, NOELR (Scenedesmus subspicatus): ≥ 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read-across



CLP

Based on the data above, tetradecyl stearate is considered to be rapidly degradable. No acute aquatic toxicity was observed up to the water solubility limit (0.5-1 µg/L at 20 °C, pH 6) for fish, algae and daphnids. Valid chronic data are available with a NOELR (72 h) ≥ 100 mg/L for the algae Scenedesmus subspicatus and a NOELR (21 d) ≥ 100 mg/L for Daphnia magna. Therefore, tetradecyl stearate does not need to be classified and labelled as environmental hazard according to the 5th ATP of the Regulation (EC) No 1272/2008 (CLP). 

DSD

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. Therefore, tetradecyl stearate does not need to be classified and labelled as environmental hazardous according to Directive 67/548/EEC.