Registration Dossier
Registration Dossier
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EC number: 268-130-2 | CAS number: 68003-46-3
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)”.
Persistentcy
Based on the available data, Ammonium N-methyl-N-(1-oxododecyl)glycinate (CAS 68003-46-3) 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
Ammonium N-methyl-N-(1-oxododecyl)glycinate (CAS 68003-46-3) has a log D (used for ionisable substances instead of log Kow) of 3.28 at pH 4, 0.61 at pH 7 and -0.30 at pH 9 (SPARC v4.6), indicating low lipophilicity at the environmentally relevant pH of 7 and 9. Thus, according to “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017)” the substance show values below the screening criteria for aquatic organism (log Kow > 4.5). In addition, the screening criteria for air-breathing organism is not met (log Kow > 2) as the log D is < 2 at the environmentally relevant pH of 7 and 9. Therefore, the substance is expected to have a low potential for bioaccumulation at the environmentally relevant pH of 7 and 9.
In addition, toxicokinetic considerations with regard to absorption, distribution, metabolisation and excretion of the substance provide further evidence for a low potential for bioaccumulation. Furthermore, the estimated BCF values also indicate that the potential for bioaccumulation is low. The estimated BCF values range from 3.16 to 150.7 L/kg wet-wt and are thus well below the threshold value of 2000 L/kg for bioaccumulative substances, as laid down by the REACH regulation (EC) No 1907/2006, section 1 of Annex XIII.
In conclusion, the potential for bioaccumulation is expected to be low for Ammonium N-methyl-N-(1-oxododecyl)glycinate (CAS 68003-46-3). Thus, the substance does not meet the screening criterion for bioaccumulation and it is not considered to be B or vB.
Toxicity
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, acute aquatic toxicity was not recorded < 0.1 mg/L and the substance is readily biodegradable. Thus, no further assessment is necessary according to ECHA Guidance R.10 (ECHA, 2017).
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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