Lithium tetrafluoroborate, anhydrous

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / micronucleus study

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)

GLP compliance:

yes (incl. QA statement)

Type of assay:

in vitro mammalian cell micronucleus test

Test material

Test material information

Constituent 1

Reference substance name:

Lithium tetrafluoroborate, anhydrous

EC Number:

238-178-9

EC Name:

Lithium tetrafluoroborate, anhydrous

Cas Number:

14283-07-9

Molecular formula:

BF4.Li

IUPAC Name:

lithium tetrafluoroborate, anhydrous

Test material form:

solid: particulate/powder

Method

Species / strain

Species / strain / cell type:

lymphocytes:

Remarks:

human

Metabolic activation:

with and without

Metabolic activation system:

liver S9 mix from male rats, treated with Aroclor 1254

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

cyclophosphamide

mitomycin C

other: Colchicine

Results and discussion

Test results

Species / strain:

other: human lymphocytes

Metabolic activation:

with and without

Genotoxicity:

ambiguous

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

In experiment I without metabolic activation, two test item concentrations (5 and 2.5 mM) showed values lying above the historical control data (also above the 95.5% control limits) for the concurrent solvent control MCM. Additionally, the value of binucleated cells with micronuclei was statistically significantly (p < 0.5) increased at the concentration 2.5 mM.
In experiment I with metabolic activation, all three test item concentrations (10, 5 and 2.5 mM) showed values lying above the historical control data (also above the 95.5% con-trol limits) for the concurrent solvent control MCM. Additionally, the values of binucleate cells with micronuclei were statistically significantly increased at the concentrations 5mM (p < 0.01) and 2.5 mM (p < 0.05).

Applicant's summary and conclusion

Conclusions:

In conclusion, the result of the in vitro micronucleus test with Lithium Tetrafluoroborateis considered as “equivocal” under the conditions of the test, with a distinct indication towards a positive result.