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Toxicological information

Genetic toxicity: in vitro

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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 guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
no
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

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.