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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
In the assessment of betaine hydrochloride (C5H12NO2.Cl, CAS 590-46-5), a read-across approach is followed based on the information available for betaine (C5H11NO2, CAS 107-43-7). This read-across strategy is based on the hypothesis that the betaine moiety is the driver for the ecotoxicological and toxicological effects of both substances.
The read-across hypothesis is justified by the immediate dissociation of betaine hydrochloride to betaine and hydrogen and chloride ions upon dissolution in aqueous media. Both betaine and betaine hydrochloride are highly soluble (>400 g/L). Exposure to the non-common cations (H+ and Cl-) does not influence the prediction of the (eco)-toxicity at relevant concentrations because both elements are abundantly present in natural environments and the human body and emissions from this substance do not significantly increase their overall exposure concentration.

Further information is included as attachment in section 13 of IUCLID.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Species / strain:
lymphocytes:
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Conclusions:
Interpretation of results: negative (based on expert judgement)

The substance betaine does not have clastogenic properties, when tested in human lymphocytes at concentrations up to a limit of 10000 microgram per millilitre. According to a read-across approach based on the rapid dissociation of betaine hydrochloride to betaine and hydrogen and chloride ions upon dissolution in aqueous media, it is concluded that the results for betaine are also applicable to betaine hydrochloride. Under normal physiological conditions, betaine hydrochloride will be completely dissociated. Both hydrogen and chloride ions are normally present in the body, and mammals constantly secrete gastric juices, containing hydrogen ion concentrations equivalent to 0.17 N HCl, into the stomach. Therefore, both ions released form betaine hydrochloride are not expected to show genotoxic properties and results for betaine can be used for assessing the genetic toxicity of betaine hydrochloride.
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
In the assessment of betaine hydrochloride (C5H12NO2.Cl, CAS 590-46-5), a read-across approach is followed based on the information available for betaine (C5H11NO2, CAS 107-43-7). This read-across strategy is based on the hypothesis that the betaine moiety is the driver for the ecotoxicological and toxicological effects of both substances.
The read-across hypothesis is justified by the immediate dissociation of betaine hydrochloride to betaine and hydrogen and chloride ions upon dissolution in aqueous media. Both betaine and betaine hydrochloride are highly soluble (>400 g/L). Exposure to the non-common cations (H+ and Cl-) does not influence the prediction of the (eco)-toxicity at relevant concentrations because both elements are abundantly present in natural environments and the human body and emissions from this substance do not significantly increase their overall exposure concentration.

Further information is included as attachment in section 13 of IUCLID.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Conclusions:
Interpretation of results:
negative up to 5000 micrograms, expert judgement

Betaine does not exhibit any genotoxic properties up to 5000 micrograms, when tested according to Method B14 (EEC, Annex V) and following GLP.
According to a read-across approach based on the rapid dissociation of betaine hydrochloride to betaine and hydrogen and chloride ions upon dissolution in aqueous media, it is concluded that the results for betaine are also applicable to betaine hydrochloride. Under normal physiological conditions, betaine hydrochloride will be completely dissociated. Both hydrogen and chloride ions are normally present in the body, and mammals constantly secrete gastric juices, containing hydrogen ion concentrations equivalent to 0.17 N HCl, into the stomach. Therefore, both ions released form betaine hydrochloride are not expected to show genotoxic properties and results for betaine can be used for assessing the genetic toxicity of betaine hydrochloride.
Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
In the assessment of betaine hydrochloride (C5H12NO2.Cl, CAS 590-46-5), a read-across approach is followed based on the information available for betaine (C5H11NO2, CAS 107-43-7). This read-across strategy is based on the hypothesis that the betaine moiety is the driver for the ecotoxicological and toxicological effects of both substances.
The read-across hypothesis is justified by the immediate dissociation of betaine hydrochloride to betaine and hydrogen and chloride ions upon dissolution in aqueous media. Both betaine and betaine hydrochloride are highly soluble (>400 g/L). Exposure to the non-common cations (H+ and Cl-) does not influence the prediction of the (eco)-toxicity at relevant concentrations because both elements are abundantly present in natural environments and the human body and emissions from this substance do not significantly increase their overall exposure concentration.

Further information is included as attachment in section 13 of IUCLID.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Conclusions:
Interpretation of results:
negative

The results indicate the test item betaine was negative in the L5178Y/TK+/- Mouse Lymphoma Assay, in the presence and absence of metabolic activation.
According to a read-across approach based on the rapid dissociation of betaine hydrochloride to betaine and hydrogen and chloride ions upon dissolution in aqueous media, it is concluded that the results for betaine are also applicable to betaine hydrochloride. Under normal physiological conditions, betaine hydrochloride will be completely dissociated. Both hydrogen and chloride ions are normally present in the body, and mammals constantly secrete gastric juices, containing hydrogen ion concentrations equivalent to 0.17 N HCl, into the stomach. Therefore, both ions released form betaine hydrochloride are not expected to show genotoxic properties and results for betaine can be used for assessing the genetic toxicity of betaine hydrochloride.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The substance betaine hydrochloride is not classified genetic mutagen because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008:

- Category 1 (1A; 1B): substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. Substances known to induce heritable mutations in the germ cells of humans;

- Category 2: substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.