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EC number: 212-769-1
CAS number: 868-14-4
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 tarataric 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 mey be excluded for
both tartaric acid and its salts.
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008,
the substances should not be classified for the genetic toxicity because
the available data are judged as "conclusive but not sufficient for
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.
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