Registration Dossier
Registration Dossier
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EC number: 258-007-1 | CAS number: 52558-73-3
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).
Persistence (P) Assessment:
A valid screening criterion to evaluate the absence of persistency (P) is the potential of a substance for ready biodegradability. N-(1-oxotetradecyl)sarcosine (CAS 52558-73-3) is readily biodegradable (85.2% biodegradation in 28 days). Therefore, the substance does not meet the Persistent (P) or very Persistent (vP) criteria.
Bioaccumulation (B) Assessment:
The substance is considered to be readily biodegradable indicating no persistence. The substance has a low potential for bioaccumulation based on a log D of 1.52 at pH 7 and 0.63 at pH 9 (SPARC v4.6). This conclusion is supported by the estimated log BCF values ranging from 10-306.9 L/kg (BCFBAF v3.01), well below the value considered as criterion to define a substance as Bioaccumulative (B) according to Annex XIII of Regulation (EC) No. 1907/2006. Furthermore, available data on the metabolism and excretion of sarcosinates in mammals clearly indicate extensive and rapid excretion, and reduced bioaccumulation potential. Based on the available information, low bioaccumulation potential of N-(1-oxotetradecyl)sarcosine (CAS 52558-73-3) is expected and the substance does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.
Toxicity (T) Assessment:
For the substance N-(1-oxotetradecyl)sarcosine (CAS 52558-73-3) the available acute effect concentrations are > 0.1 mg/L (fish, aquatic invertebrates and algae) and the chronic effect concentration (algae) is > 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. Moreover, the substance is readily biodegradable and has a low potential for bioaccumulation. 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, N-(1-oxotetradecyl)sarcosine (CAS 52558-73-3) is not PBT or vPvB.
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