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Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records
Reference
Endpoint:
genetic toxicity in vitro, other
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Justification for type of information:
Important considerations for the read-across were:
- calcium tartrate (the target chemical) has similar physico-chemical properties as the others members of the Category "Tartaric acids and its salts" (the source chemicals), these properties include molecular weight; logKow and solubility
- there are structural similarities between all the chemicals of the Category
- tartaric acid; potassium hydrogen tartrate; sodium hydrogen tartrate and disodium tartrate have been tested for mutagenicity; neither chemical is genotoxic.
Key result
Remarks on result:
other: The mutagenic/clastogenic activity may be excluded for calcium tartrate based on the evaluation of the category "tartaric acid and its salts".

The assessment of the potential genetic toxicity of Calcium tartrate was performed by means a read across based on grouping of substances (category approach). The name Category use is "Tartaric acid and its salts".

 

Tartaric acid was tested in several mutagenicity and clostogenicity tests both in vitro and in vivo. In particular, it was assayed by means of host-mediated assays, in vitro and in vivo mammalian chromosome aberration tests, bacterial reverse mutation assays (e.g. Ames test) and a in vitro DNA damage/repair assay (unscheduled DNA synthesis in mammalian cells in vitro). The substance was found non-mutagen/non-clastogenic in almost all tests, except for a positive result from a host-mediated assay on Saccharomyces D3 and an ambiguous result from a dominant lethal assay. However, in both cases, the replication of these tests gave negative results.

 

Also data available for the tartaric acid salts confirm the absence of mutagenicity/clastogenicity of this category of substances. In particular, (i) a series of bacterial reverse mutation assays and an in vitro mammalian chromosome aberration test showed negative results for potassium hydrogen tartrate; (ii) a single negative result from a Ames test is available for sodium hydrogen tartrate; (iii) a negative result from Ames test is available for disudium tartrate which, instead, was found to be positive in an in vitro mammalian chromosome aberration test. (iv) This positive result has been undermined by the absence of clastogenicity registered in in vivo micronucleus tests performed through both single-dose and repeated-dose administration.

Overall, the mutagenic/clastogenic activity may be excluded of calcium tartrate.

Conclusions:
The mutagenic/clastogenic activity may be excluded for calcium tartrate based on the evaluation of the category "tartaric acid and its salts".
Executive summary:

The assessment of the potential genetic toxicity of Calcium tartrate was performed by means a read across based on grouping of substances (category approach). The name Category use is "Tartaric acid and its salts". Tartaric acid was tested in several mutagenicity and clostogenicity tests both in vitro and in vivo, with negative results. Also data available for the tartaric acid salts confirm the absence of mutagenicity/clastogenicity of this category of substances. Overall, the mutagenic/clastogenic activity may be excluded of calcium tartrate.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

Available data on "Tartaric acid and its salts" confirm the absence of mutagenicity/clastogenicity for this category of substances.

Link to relevant study records
Reference
Endpoint:
genetic toxicity in vivo, other
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Justification for type of information:
Important considerations for the read-across were:
- calcium tartrate (the target chemical) has similar physico-chemical properties as the others members of the Category "Tartaric acids and its salts" (the source chemicals), these property include molecular weight; logKow and solubility
- there are structural similarities between all the chemicals of the Category
- tartaric acid; potassium hydrogen tartrate; sodium hydrogen tartrate and disodium tartrate have been tested for mutagenicity; neither chemical is genotoxic.
Key result
Remarks on result:
other: The mutagenic/clastogenic activity may be excluded for calcium tartrate based on the evaluation of the category "Tartaric acid and its salts".
Conclusions:
The mutagenic/clastogenic activity may be excluded for calcium tartrate based on the evaluation of the category "Tartaric acid and its salts".
Executive summary:

The assessment of the potential genetic toxicity of Calcium tartrate was performed by means a read across based on grouping of substances (category approach). The name Category use is "Tartaric acid and its salts". Tartaric acid was tested in several mutagenicity and clostogenicity tests both in vitro and in vivo, with negative results. Also data available for the tartaric acid salts confirm the absence of mutagenicity/clastogenicity of this category of substances. Overall, the mutagenic/clastogenic activity may be excluded of calcium tartrate.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

The assessment of the potential genetic toxicity of Calcium tartrate was performed by means a read across based on grouping of substances (category approach). The name Category used is "Tartaric acid and its salts".

 

Tartaric acid was tested in several mutagenicity and clostogenicity tests both in vitro and in vivo. In particular, it was assayed by means of host-mediated assays, in vitro and in vivo mammalian chromosome aberration tests, bacterial reverse mutation assays (e.g. Ames test) and a in vitro DNA damage/repair assay (unscheduled DNA synthesis in mammalian cells in vitro). The substance was found non-mutagen/non-clastogenic in almost all tests, except for a positive result from a host-mediated assay on Saccharomyces D3 and an ambiguous result from a dominant lethal assay. However, in both cases, the replication of these tests gave negative results.

 

Also data available for the tartaric acid salts confirm the absence of mutagenicity/clastogenicity of this category of substances. In particular, (i) a series of bacterial reverse mutation assays and an in vitro mammalian chromosome aberration test showed negative results for potassium hydrogen tartrate; (ii) a single negative result from a Ames test is available for sodium hydrogen tartrate; (iii) a negative result from Ames test is available for disudium tartrate which, instead, was found to be positive in an in vitro mammalian chromosome aberration test. (iv) This positive result has been undermined by the absence of clastogenicity registered in in vivo micronucleus tests performed through both single-dose and repeated-dose administration.

Overall, the mutagenic/clastogenic activity may be excluded of calcium tartrate.

Justification for classification or non-classification

According to Regulation (EC) n. 1272/2008, the substance should not be classified for the genetic toxicity because the available data are judged as "conclusive but not sufficient for classification".