Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

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.