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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The ready biodegradation of the carboxylic acid component of the registered substance (tosyl salt) was determined in a OECD 301B. The test substance is considered to not be readily biodegradable as 45% degradation was reached at the end of day 9 not meeting the 10-day window criteria. As degradation reached the pass level of 60% in the course of the test it is concluded that the substance is ultimately biodegradable, within 28 days, but not readily biodegrable. It is then concluded that the substance is not regarded as fulfilling the criteria for Persistence (P or vP).



This indicates that the formulated product demonstrates inherent biodegradability in seawater. In addition, the Log Kow of the triethanolamine component of the substance was found to be -1.75-1.32. The Log Kow of the substance is <4.5 and therefore the substance does not demonstrate the potential for bioaccumulation. Therefore, the substance does not meet the B or vB criteria.



In accordance with Annexes VII and VIII of REACH, no long-term toxicity study on the registered substance were performed for the purpose of this registration and no data on the long-term toxicity for marine/freshwater organisms was identified. Data on short-term toxicity of the registered substance to fish, aquatic invertebrates, and algae was provided. All L(E)C50 for short-term toxicity were above 1 mg/L and therefore above screening values for T properties described in Table R.11-6 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (ECHA, 2017).



The toxicity of the substance was investigated in accordance with Annexes VII and VIII of REACH. In accordance with Regulation EC No 1272/2008, it was concluded that 6-[(p-Tosyl)amino]hexanoic acid, compound with 2,2',2"- nitrilotriethanol (1:1) does not meet the criteria for classification as carcinogenic category 1A or 1B, germ cell mutagenic category 1A or 1B, toxic for reproduction category 1A, 1B or 2, or STOT RE category 1 or 2. Therefore, the substance does not meet the T criteria



6-[(p-Tosyl)amino]hexanoic acid, compound with 2,2',2"- nitrilotriethanol (1:1) does not meet the PBT and the vPvB criteria. It is not considered relevant to further investigate the PBT or vPvB properties of the substance.

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