Registration Dossier
Registration Dossier
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EC number: 258-007-1 | CAS number: 52558-73-3
Endpoint summary
Administrative data
Description of key information
Additional information
N-(1-oxotetradecyl)sarcosine (CAS 52558-73-3) is a mono-constituent acid characterized by a water solubility of 0.9 g/L (25 °C, pH 5, EU A.6, flask method), a calculated vapour pressure of 0.174 Pa (25 °C, MPBPWIN v1.43), and a calculated log D of 1.52 at pH 7 and 0.63 at pH 9 (SPARC v4.6). Furthermore, the substance is readily biodegradable (85.2% in 28 d, OECD 301 B, activated sludge) based on a standard biodegradation study with the corresponding salt (Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate, CAS 30364-51-3). The estimated log Koc (Franco, Fu & Trapp model for ionisable substances, 2013) is 2.45 – 4.32 at pH 7, indicating a potential for adsorption to particles present in soil and sediment. Thus, if released into the environment, the substance is expected to distribute into the aquatic and sediment compartments based on the available data. However, it will not persist in these compartments due to ready biodegradability. According to the Guidance on information requirements and chemical safety assessment, Chapter R.7b, readily biodegradable substances can be expected to undergo rapid and ultimate degradation in both aquatic and terrestrial environments, including biological sewage treatment plants (ECHA, 2016). Therefore, in accordance with Regulation (EC) No. 1907/2006, Annex IX, Column 2, 9.2.1.2 – 9.2.1.4, further simulation testing for biodegradation in water and sediment or soil is not required. Abiotic degradation via hydrolysis or phototransformation in air is not a relevant environmental fate pathway based on the ready biodegradability and low vapour pressure of the substance, respectively.
N-(1-oxotetradecyl)sarcosine (CAS 52558-73-3) has calculated log D (considered for ionisable substances instead of log Kow) of 1.52 at pH 7 and 0.63 at pH 9 (SPARC v4.6), indicating low lipophilicity at environmentally relevant pH ranges of 7 and above. According to REACh regulation (EC) No 1907/2006 a substance has a low potential for bioaccumulation when the log D is ≤ 3.0. Furthermore, the predicted BCF values provide evidence that the potential for bioaccumulation in aquatic organisms is likely low. The calculated BCF values range from 10 – 306.9 L/kg wet-wt (BCFBAF v3.01) and are thus well below the threshold value of 2000 L/kg for bioaccumulative substances, as laid down by the REACH regulation (EC) No 1907/2006, section 1 of Annex XIII.
Moreover, the substance is readily biodegradable and will therefore not persist in the environment. Hence, its bioavailability to aquatic organisms is expected to be low due to low discharge into the environment (owing to extensive biodegradation in conventional STPs as a result of adsorption properties) on the one hand and minimal persistence due to ready biodegradability on the other hand. In addition, toxicokinetic considerations with regard to absorption, distribution, metabolisation and excretion of the substance provide further evidence for a low bioaccumulation potential. While absorption after oral uptake is considered likely, systemic distribution, accumulation and metabolisation of the substance is not anticipated and urinary excretion is expected to be an important and rapid excretion pathway based on experimental mammalian studies with structurally similar substances (for further details, please refer to the toxicokinetic statement in IUCLID section 7.1). In conclusion, the potential for bioaccumulation is expected to be low for N-(1-oxotetradecyl)sarcosine (CAS 52558-73-3).
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