Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-621-5 | CAS number: 3164-34-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- 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".
- 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.
Reference
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.
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
- 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.
Reference
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".
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.