Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional 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.

Short 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.
Additional 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 the EU Directive 67/548/EEC and 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.