Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 203-490-6 | CAS number: 107-43-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Based on the properties which betaine has exhibited, there has not been any indication that might cause concern for it being toxic for reproduction or teratogenicity. According to genetic toxicity testing betaine is not genotoxic and no toxic properties have been indicated in repeated dose toxicity testing (sub-acute, sub-chronic, chronic). Betaine did not indicate any carcinogenicity or adverse effects for reproductive organs. Betaine was also tested by QSAR-modelling for its ability to bind to Estrogen Receptor-B, a major target for endocrine disruptors. According to this valid and applicable model betaine was determined not to bind this receptor.
Effects on developmental toxicity
Description of key information
Based on the properties which betaine has exhibited, there has not been any indication that might cause concern for it being toxic for reproduction or teratogenicity. According to genetic toxicity testing betaine is not genotoxic and no toxic properties have been indicated in repeated dose toxicity testing (sub-acute, sub-chronic, chronic). Betaine did not indicate any carcinogenicity or adverse effects for reproductive organs. Betaine was also tested by QSAR-modelling for its ability to bind to Estrogen Receptor-B, a major target for endocrine disruptors. According to this valid and applicable model betaine was determined not to bind this receptor.
Justification for classification or non-classification
Not classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. Based on the testing performed on betaine and its known metabolic functions within the human body, nothing indicates toxicity against fertility. Betaine can be found in the human body as a naturally occurring substance. It is involved in one-carbon metabolism and methylation processes. Humans can consume betaine from normal food stuffs such as vegetables and it is metabolized mainly by the liver. Betaine has been found safe in nutritional studies, and emphasis of studies has been mostly to investigate how betaine improves health by donating methyl groups for biological processes. Betaine was also tested by QSAR-modelling for its ability to bind to Estrogen Receptor-B, a major target for endocrine disruptors. According to this valid and applicable model betaine was determined not to bind this receptor.
Additional information
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.
