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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Strontium substances have been tested in bacterial reverse mutation assays, in vitro gene mutation and chromosome aberration test.
- in-vitro gene mutation in bacteria (OECD 471): negative (no data is available for SrCO3, thus read-across from SrCl2 to SrCO3 was performed)
- in-vitro gene mutation in mammalian cells (OECD 476): negative (no data is available for SrCO3, thus read-across from SrCO3 to Sr(OH)2 was performed)
- in-vitro chromosome aberration (OECD 473): negative (no data is available for SrCO3, thus read-across from Sr(NO3)2 to SrCO3 was performed)

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included as attachment in Section 13.
Reason / purpose for cross-reference:
read-across source
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Conclusions:
Based on the read-across from SrCl2, strontium carbonate is considered to be non-mutagenic.
Endpoint:
in vitro cytogenicity / micronucleus study
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included as attachment in Section 13.
Reason / purpose for cross-reference:
read-across source
Species / strain:
lymphocytes: from humans
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Positive controls validity:
valid
Conclusions:
Based on the read-across from Sr(NO3)2, Strontium carbonate is considered to be non-genotoxic.
Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included as attachment in Section 13.
Reason / purpose for cross-reference:
read-across source
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Positive controls validity:
valid
Conclusions:
Based on the read-across from Sr(NO3)2, Strontium carbonate is considered to be non-genotoxic.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No genotoxicity study is available on Strontium carbonate itself. However, an analogue approach is used for the read-across of genotoxicity properties of strontium carbonate from strontium chloride or strontium nitrate, based on the hypothesis that properties are likely to be similar as a result of the presence of a common metal ion Sr2+. Further information on the read-across justification is included as attachment in Section 13.


The analogue approach was applied to the following endpoints:



  • Mutagenicity, in vitro gene mutation study in bacteria

  • Mutagenicity, in vitro cytogenicity study in mammalian cells or in vitro micronucleus study

  • Mutagenicity, in vitro gene mutation study in mammalian cells


It is concluded that strontium nitrate did not induce micronuclei in cultured human peripheral blood lymphocytes following treatments in the absence and presence of an Aroclor induced rat liver metabolic activation system (S-9 mix). Based on read-across the same is considered true for strontium carbonate. Concentrations were tested and analysed up to 2116 µg/mL.


It is concluded that strontium nitrate did not induce mutation at the tk locus of L5178Y mouse lymphoma cells when tested under the conditions employed in this study . Based on read-across the same is considered true for strontium carbonate.


These conditions included treatments up to precipitating concentrations in two independent experiments, in the absence and presence of a rat liver metabolic activation system (S-9 mix).


Further testing of in vivo genetic toxicity tests is not considered necessary.

Justification for classification or non-classification

Based on the read-across approach from strontium chloride or strontium nitrate, Strontium carbonate is not expected to have mutagenicity / genotoxicity potential and no classification and labelling is required.