Magnesium

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

no data available

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (not individual results reported), acceptable, well-documented publication/study report which meets basic scientific principles.

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity of metal salts in the L5178Y mouse lymphoma assay

Author:

Oberly, T.J. et al.

Year:

1982

Bibliographic source:

J. Tox. Environ. Health 9, 367-376

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)

Deviations:

no

Principles of method if other than guideline:

In vitro gene mutation test, mouse lymphoma, TK locus

GLP compliance:

not specified

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium chloride

EC Number:

232-094-6

EC Name:

Magnesium chloride

Cas Number:

7786-30-3

IUPAC Name:

magnesium dichloride

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): magnesium chloride, ACS grade.
No further details are given.

Method

Target gene:

TK

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Details on mammalian cell type (if applicable):

All cells were thawed from frozen stock and maintained in Fisher's medium for leukemic cells of mice containing 10% heat-inactivated horse serum, sodium pyruvate, penicillin G and streptomycine sulfate.

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

22, 24, 26, 28, 30, 32, 36 mg/mL

Vehicle / solvent:

distilled water

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

sterile deionised water

True negative controls:

no

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

Details on test system and experimental conditions:

Exposure: 4 hours, 2 days expression period

Evaluation criteria:

Brunswick Scientific automatic colony counter was used to determine the number of colonies per plate. Total survival was determined and the mutation frequency was calculated as the number of mutants per 10^5 colony-forming cells.

Statistics:

no data

Results and discussion

Test results

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

No increase in mutation frequency.

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Cytotoxicity observed at concentration of 28 mg/mL and above due to changes in osmotic pressure.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

no data

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test substance was non-mutagenic under the given experimental conditions.