Betaine hydrochloride

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 MAR 1989 to 01 OCT 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed following GLP and according to EU B.10 standardized method.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Betaine

EC Number:

203-490-6

EC Name:

Betaine

Cas Number:

107-43-7

Molecular formula:

C5H11NO2

IUPAC Name:

(trimethylammonio)acetate

Details on test material:

Betaine monohydrate, >95% purity

Method

Species / strain

Species / strain / cell type:

lymphocytes: primary cells

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S-9

Vehicle / solvent:

Betaine was completely solved in culture medium: bicarbonate buffered RPMI 1640 medium containing 15% foetal bovine serum (both Gibco Europe Ltd.), 1% phytohaemagglutinin (PHA, Burroughs Wellcome) and 100 units/ml penicillin and streptomycin.

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

cyclophosphamide

Remarks:

Migrated to IUCLID6: in the presence of S-9 metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

mitomycin C

Remarks:

Migrated to IUCLID6: in the absence of S-9 metabolic activation

Evaluation criteria:

Chromatid and chromosome gaps and breaks as well as fragments and re-arrangements were all recorded on raw data sheets with the stage coordinates (vernier readings) of every cell containing aberrations.

Statistics:

Chi squared -test

Results and discussion

Test results

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

Remarks:

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative expert judgement

Based on this study betaine does not have clastogenic properties, when tested in human lymphocytes at concentrations up to a limit of 10000 microgram per millilitre.

Executive summary:

An in vitro mammalian chromosome aberration test with primary human lymphocytes was performed with the test substance according to EU Method B.10. No genotoxicity or cytotoxicity was observed during the study. The test substance does not have clastogenic properties, when tested in human lymphocytes at concentrations up to a limit of 10000 µg/mL.