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EC number: 202-608-3 | CAS number: 97-78-9
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
The potential for bioaccumulation is expected to be low based on all available data.
Key value for chemical safety assessment
Additional information
No experimental data on bioaccumulation are available. The high log Kow of 4.1 (KOWWIN v1.68) as an intrinsic chemical property of the substance might indicate a potential for bioaccumulation since it is above the trigger value set out in Annex IX, column 2 of Regulation (EC) No 1907/2006. However, this value might over- or under-estimate the bioaccumulation potential since the environmental fate in regard to biodegradation and metabolism and excretion of the substance are not reflected by the log Kow itself. The gathered information from QSAR-estimation in combination with data on environmental behaviour and excretion provide enough evidence (in accordance to the Regulation (EC) No 1907/2006, Annex XI General rules for adaptation of the standard testing regime set out in Annexes VII to X, 1.2), to cover the data requirements of Regulation (EC) No 1907/2006, Annex IX to state that the substance is likely to show low bioaccumulation potential.
Due to ready biodegradability and considerable potential of adsorption, the substance can be effectively removed in conventional sewage treatment plants (STPs) by biodegradation and by sorption to biomass (ECHA, 2012). If released into the aquatic environment, N-Lauroylsarcosine undergoes extensive biodegradation and sorption on organic matter. Thus, the bioavailability of the substance to aquatic organisms in the water column is reduced rapidly. The relevant route of uptake of the substance in aquatic organisms is considered predominantly by ingestion of particle bound substance.
Should the substance be taken up by fish it is not expected to be rapidly metabolized via enzymatic hydrolysis to the corresponding hydrolysis products. However, mammalian data (rats) available for one of the category members showed that after oral administration of [14C]Sodium Lauroyl Sarcosinate, 82 - 89% was excreted after 24 h in the urine and faeces (CIR, 2001), clearly indicating the capacity of mammal depuration systems to rapidly eliminate the substance from the body. Moreover, frequent oral application to rats did not cause accumulation of radiolabelled [14C]Sodium Lauroyl Sarcosinate in bone and in muscle tissue (Allison, 1994). These two studies provide strong evidence of the expected low bioaccumulation potential of the Sarcosine Category members. A validated (Q)SAR model (BCFBAF v3.01) resulted in low BCF values of 3.16 based on regression-based estimate and 150.7 L/kg based on Arnot-Gobas model (upper trophic).
Further evidence can be gathered from the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment”, in which a log Kow≤4.5 is used as a screening criterion indicating that the substance does not meet neither the B nor the vB criteria.
In conclusion the log Kow of 4.1 overestimates the true potential for bioaccumulation. Only low concentrations are expected to be found in the aquatic environment. After uptake, fast excretion and direct elimination is expected based on mammalian data reducing the bioaccumulation potential. BCF/BAF values estimated with the BCFBAF v3.01 program also indicate that the substance will not be bioaccumulative (all well below 2000 L/kg (Annex XIII criterion for Bioaccumulative (B) substances, Regulation (EC) No 1907/2006)). Taking all these information into account, it can be concluded that the bioaccumulation potential of N-lauroylsarcosine CAS 97-78-9) is expected to be low.
References
Allison JB et al. (1994). The distribution of C14 from compound 105 in the rat. Hampshire Chemical Corporation. 3: 58-66.
ECHA (2012). Guidance on information requirements and chemical safety assessment, Chapter R.7b: Endpoint specific guidance.
CIR (2001). Final Report on the Safety Assessment of Cocoyl Sarcosine, Lauroyl Sarcosine, Myristoyl Sarcosine, Oleoyl Sarcosine, Stearoyl Sarcosine, Sodium Cocoyl Sarcosinate, Sodium Lauroyl Sarcosinate, Sodium Myristoyl Sarcosinate, Ammonium Cocoyl Sarcosinate, and Ammonium Lauroyl Sarcosinate” (see IJT, 10 (Suppl.): 1-14, 2001)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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