Registration Dossier
Registration Dossier
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EC number: 205-281-5 | CAS number: 137-16-6
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
According to Regulation (EC) No. 1907/2006, a substance must fulfil all three criteria for persistence, bioaccumulation and toxicity to be considered as PBT, as listed in part 1 of Annex XIII, and it must fulfil the criteria for persistence and bioaccumulation stated in part 2 of Annex XIII to be considered vPvB.
Data for the definitive conclusion on the PBT or vPvB properties according to the criteria set in Regulation (EC) No. 1907/2006, Annex XIII, parts 1 and 2, are not available for all three criteria. Thus, the screening criteria given in the ‘Guidance on information requirements and chemical safety assessment - Chapter R.11: PBT assessment’ (ECHA, 2012) are used as surrogate information to decide whether the substance may potentially fulfil the PBT or vPvB criteria.
Persistence (P) Assessment:
A valid screening criterion to evaluate the absence of persistence (P) is the potential of a substance for ready biodegradability. Sodium N-lauroylsarcosinate (CAS 137-16-6) is considered to be readily biodegradable (82% biodegradation in 28 days). Therefore, it is not expected to be persistent in the environment and it does not meet the Persistent (P) or very Persistent (vP) criteria.
Bioaccumulation (B) Assessment:
Sodium N-lauroylsarcosinate (CAS 137-16-6) has a calculated log Kow of 0.37. Thus, the test substance does not meet the screening criterion for bioaccumulation and is not considered to be bioaccumulative (B) or very bioaccumulative (vB).
Toxicity (T) Assessment:
The chronic no-observed effect concentration (NOEC value) reported in the test conducted with algae is higher than 0.01 mg/L. Since no measured data for chronic aquatic toxicity are available for the trophic level of consumers (daphnia and fish), the assessment is additionally based on the screening criteria referring to aquatic short term data. A substance is considered to potentially meet the criteria for T when an acute E(L) C50 value from a standard E(L) C50 toxicity test is less than 0.1 mg/L. The E(L)C50 values of the acute toxicity tests are all > 10 mg/L. Therefore the substance does not fulfill the screening criteria for Toxic (T). Furthermore, the substance is neither classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to the 4th ATP of Regulation (EC) No. 1272/2008 (CLP) and Directive 67/548/EEC. Therefore, Sodium N-lauroylsarcosinate does not meet the T criterion according to Regulation (EC) No. 1907/2006, Annex XIII.
In conclusion, Sodium N-lauroylsarcosinate (CAS 137-16-6) is considered not to be PBT or vPvB.
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