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EC number: 212-769-1
CAS number: 868-14-4
Tartaric acid and its salts do not have significant (sub)chronic toxicity.
Table 1. Calculated intake of monosodium L(+)-tartrate and L(+)-tartaric
acid in two-year feeding study
Monosodium L(+)-tartrate was fed to rats in their diet for a total of
two years at levels of 25600, 42240, 60160 and 76800 ppm. There were no
adverse clinical signs and the investigation of the animals' eyes, blood
and urine did not reveal any reaction to treatment, nor were changes
related to treatment seen in the macroscopic pathology or organ weights
of rats killed after 104 weeks. Histological examination of the tissues
did not show evidence of toxicity or tumour induction that could be
attributed to treatment with monosodium L(+)-tartrate. Only the survival
of rats receiving 42240, 60160 or 76800 ppm was superior to that of the
controls and probably correlated with the lower food intake of these
groups and the resultant reduced bodyweight gain.
The repeated dose toxicity of tartaric acid and its salt was assessed by
oral route. According to Hunter et al. (1977), monosodium L(+) tartrate,
given to rats in their diet for a total period of two years at dose
levels of 25600, 42240, 60160 and 76800 ppm (equivalent to a tartaric
acid dietary level of 20000, 33000, 47000 or 60000 ppm, respectively),
did not cause adverse clinical effects. Moreover, the investigation of
the animals' eyes, blood and urine did not reveal any reaction to
treatment. In the same manner, no changes related to treatment were seen
in the macroscopic pathology or in organ weights of the rats killed
after 104 weeks. The histological examination of the tissues did not
show any evidence of toxicity or tumour induction that could be
attributed to treatment with monosodium L(+) tartrate.
Other studies showed adverse effects on renal function following
repeated administration of tartaric acid or disodium tartrate. However,
these effects were exclusively observed at very high doses and,
therefore, they were judged as non-significant.
Overall, it is believed that the tartaric acid and its salts possess
similar profiles of systemic toxicity, therefore, the assessment of this
endpoint may be jointly performed using all available data for these
substances. In conclusion, these substances do not deemed to be toxic
following repeated administration.
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008,
the study results indicate that the substances should not be classified
for the specific target organ toxicity - repeated exposure because data
are judged as "conclusive but not sufficient for classification".
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