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 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. A report on read across is added to this dossier.

Degradation

Biodegradation: readily biodegradable: 67% of the analogue tetradecyl myristate (OECD 301C)

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.  

Aquatic acute toxicity of fatty alkyl esters:

96 h, LC50 (Danio rerio): > 100 mg/L (nominal) and > 0.189 µg/L (measured) (No observed toxicological effects up to the water solubility limit)

72 h, ErL50 (Pseudokirchnerella subcapitata): > 100 mg/L (nominal) and > 1.465 µg/L (measured) (No observed toxicological effects up to the water solubility limit)

48 h, EL50 (Daphnia magna): > 100 mg/L (nominal) and > 0.128 µg/L (measured) (No observed toxicological effects up to the water solubility limit)

Aquatic chronic toxicity

72 h, NOELR (Pseudokirchnerella subcapitata): ≥ 100 mg/L (nominal) and ≥ 1.465 µg/L (measured) (No observed toxicological effects up to the water solubility limit)

21 d, NOELR (Daphnia magna): ≥ 10 mg/L (nominal) (No observed toxicological effects up to the water solubility limit); read-across

Based on the data above, tetradecyl laurate is considered to be rapidly degradable. No acute aquatic toxicity is expected up to the water solubility limit (< 0.01 mg/L) for fish, algae and daphnids. Valid chronic data are available for the analogue tetradecyl myristate

with a NOELR (72 h) ≥ 1.465 µg/L (i.e. above the limit of water solubility) for Pseudokirchneriella subcapitata and a NOELR (21 d) ≥ 10 mg/L for Daphnia magna (i.e. above the limit of water solubility).

Therefore, tetradecyl laurate, as its analogue tetradecyl myristate and other analogues of thelong-chain aliphatic ester (LCAE) category,does not need to be classified and labelled as environmental hazard according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).