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Classification & Labelling & PBT assessment

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).

Persistency

Based on the available data, N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) 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

In accordance with ECHA Guidance R.11 (ECHA, 2017) N-methyl-N-(C18-(unsaturated)alkanoyl)glycine (EC 701-177-3) is not considered to meet the screening criterion for bioaccumulation in aquatic species since the log Kow values (3.5 – 4.2) and the log D values (3.52 - 3.55) at the environmentally relevant pH value of 7 are below the trigger value of 4.5. In addition, according to ECHA Guidance R.11 (ECHA, 2017) there is low potential for accumulation in air breathing organisms. Though the calculated log Koa of 5 in combination with the log Pow > 2 might indicate a potential for biomagnification in terrestrial organisms, bioaccumulation is not expected based on the metabolisation of the substance. The evaluation of the toxicokinetic behavior indicates that the two main components of the substance sarcosine and fatty acid are expected to be metabolized and eliminated by all living organisms due to their ubiquity in biotic systems. Furthermore, due to ready biodegradability only negligible concentrations of the substance are likely to be released into the environment through the effluent of conventional STPs. The calculated BCFs obtained with the Arnot-Gobas model for the mains substance components were 95.39 – 264.5 L/kg wet-wt (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic), which is well below the screening criterion for bioaccumulation of 2000 (REACH, Annex XIII; R.7c, ECHA, 2017; R.11, ECHA, 2017). 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 N-methyl-N-[C18-(unsaturated)alkanoyl]glycine (EC 701-177-3) the available acute effect concentrations are ≥ 0.1 mg/L (fish, aquatic invertebrates, algae) and the chronic effect concentrations (aquatic invertebrates, 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. 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, the substance is not PBT/vPvB.