Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 931-700-2 | CAS number: 66455-29-6
PBT assessment
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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
