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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 for Betaines, C12-14 (even numbered)-alkyldimethyl is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2008).

Persistence

Betaines, C12-14 (even numbered)-alkyldimethyl is readily biodegradable according to an OECD 301B study (63-79% (CO2 evolution) after 28 d). Thus, the test substance does not meet the screening criterion for persistence and it is not considered to be P or vP.

Bioaccumulation

The measured Log Pow is -0.4. In the absence of study data, a BCF of 70.79 was calculated with SRC EPIWIN v4.00 (2010) based on a worst case log KOW of 2.4.

The available information indicates that Alkyl dimethyl betaines have a very low potential for bioconcentration and they will not accumulate to significant levels in aquatic organisms.

Therefore, Betaines, C12-14 (even numbered)-alkyldimethyl do not meet the B criterion.

Toxicity

From the ecotoxicity perspective the toxicity criterion is not met for Betaines, C12-14 (even numbered)-alkyldimethyl as the acute aquatic toxicity L(E)C50 is >1 mg/L. The lowest EC50 was observed in a study conducted according to OECD 201 with an EC 50 value of 1.7 mg/L for the tested substance and a NOEC of 0.38 mg/L for algae (Huntsman, 2010).

These values are above the ecologically relevant EC or NOEC triggers of less than </= 0.01 mg/L. This substance is classified as Aquatic Chronic 3 according to Regulation (EC) No. 1272/2008 (2nd ATP). This substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to Directive 67/548/EEC and Regulation (EC) No 1272/2008. 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. Therefore, Betaines, C12-14 (even numbered)-alkyldimethyl do not meet the T criterion.