Registration Dossier
Registration Dossier
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EC number: 947-850-7 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment of the substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistentcy
Based on the available data, Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7)is considered to be readily biodegradable. Thus, the substance does not meet the screening criterion for persistence and it is not considered to be P or vP.
Bioaccumulation
The log D values (used for ionisable substances instead of log Kow) are 5.06 - 6.06 at pH 4, 2.40 to 3.40 at pH 7 and 1.53 to 2.54 at pH 9 (SPARC v4.6, calculated for the two main constituents of the substance, Stearoyl sarcosine (CAS 142-48-3) and Palmitoyl sarcosine (CAS 2421-33-2). The estimated log BCF values yielding BCF values of 10 L/kg wet-wt (BCFBAF v.3.01, regression-based estimate), 399.9 – 421.7 L/kg wet-wt (BCFBAF v.3.01, Arnot-Gobat, including biotransformation, upper-trophic) and 11-17 (VEGA v.1.2.3, CAESAR 2.1.14) indicating a low potential for bioaccumulation. Furthermore, available data on the metabolism and excretion of sarcosinates in mammals clearly indicate extensive and rapid excretion, and reduced bioaccumulation potential. Thus, the substance does not meet the screening criterion for bioaccumulation and it is not considered to be B or vB.
Toxicity
For the substance Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7)the available chronic effect concentrations (daphnia, algae) are ≥ 0.01 mg/L. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. Therefore, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.
In conclusion, the substance is not PBT/vPvB.
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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