Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-177-3 | 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).
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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
