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PBT assessment

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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. Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3) 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:

According to the Guidance on information requirements and chemical safety assessment, Chapter R.11 (ECHA, 2017) substances with log Kow values ≤ 4.5 are not considered B or vB (log Pow of sodium N-methyl-N-(1-oxotetradecyl)aminoacetate = 1.35 and log D = 1.52 at the environmentally relevant pH 7).

This is supported by the estimated log BCF values obtained by (Q)SAR, using the BCFBAF model v3.01, yielding a BCF of 3.16 L/kg wet-wt (regression-based estimate) and of 1.835 L/kg wet-wt (Arnot-Gobat, including biotransformation, upper-trophic), which are clearly below the cut-off values of 2000 L/kg for bioaccumulative and 5000 L/kg for very bioaccumulative substances, as laid down by section 1 of Annex XIII to the REACH regulation (EC) No 1907/2006.

Based on the above information, the substance does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.

 

Toxicity (T) Assessment:

For Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3) the available acute effect concentrations are all > 0.1 mg/L (fish, aquatic invertebrates, algae) and the available 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. 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, Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3) is not PBT or vPvB.

 

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