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EC number: 212-769-1
CAS number: 868-14-4
The following organs were weighed at autopsy: adrenals, bladder, brain,
heart, kidneys, liver, lung, prostate, spleen, stomach, testes, and
thyroid. The histologic changes observed in the experimental groups were
similar to those seen in the control group. Mild focal pyelonephritis,
moderate congestion, mild hyperplasia of tubular epithelium, and
occasionai protein casts and hyaline droplet' degeneration were noted in
the kidneys, while livers of rabbits in ali groups exhibited
pericholangitis, bile duct proliferation, and dilatation as well as
moderate congestion. These changes are not unusual in rabbits and are
not to be attributed to the experimental feeding.
Examination of the testes revealed that the seminiferous tubules, the
interstitial cells, and spermatogenesis were normal in all groups.
Slight peritubular fibrosis and mild stromal hyalinization were observed
in each group after 150 days of feeding.
The effects of sodium tartrate when fed to rabbits for 150 days at
concentrations equivalent to 5.0% of the organic acid in the diet were
investigated. Particular attention was given to the possible appearance
of testicular toxicity. No significant gross or histopathologic changes
attributable to the experimental feeding could be found in any case.
Tartaric acid was investigated for its toxicity to the fertility in
rabbits, mice, rats and hamsters. The substance did not affect the
parameters related to the reproductive performance.
Based on the chemical structure, it is considered that the toxicity to
reproduction of tartaric acid is the same of that ones of its salts
(i.e. monosodium, monopotassium, sodium potassium, sodium, potassium and
calcium tartrate) and, therefore, the assessment of this endpoint may be
jointly performed using all available data for these substances.
Overall, tartaric acid and its salts do not have toxicity to
Tartaric acid and its salts do not have developmental toxicity.
at 274 mg/kg the results were the following:
total: 22, died before day 17°: 0, to term: 22
total: 243, average/dam: 11.1
total: 18, dams with one or more site resorbed: 8, dams with all sites
resorbed: 1, partial resorptions: 36.4%, total resorptions: 4.55%
total: 222, average/dam: 10.1, sex ratio (M/F): 0.87
total: 3, dams with one or more dead: 3, dams with all dead: -, partial
dead: 13.6%, all dead: -, average fetus weight: 0.91.
Skeletal findings (fetuses affected/litters affected):
Live fetuses examined (at term): 155/21
Sternebrae: incomplete oss.: 32/17, bipartite: 4/3, missing: 6/4
Ribs: More than 13: 37/16
Extremities: incomplete oss: 2/2
Miscellaneous: Hyoid missing: 26/11, Hyoid reduced: 11/9
Soft tissue abnormalities:
1 pups Gastroschisis
The administration of up to 274 mg/Kg (body weight) of the test material
to pregnant mice for 10 consecutive days had no clearly discernible
effect on nidation or on maternal or fetal survival. The number of
abnormalities seen in either soft or skeletal tissues of the test groups
did not differ from the number occuring spontaneously in the
Tartaric acid was investigated for its developmental toxicity in mice,
rats and rabbits. The substance did not cause significant increases in
skeletal abnormalities, fetal survival or in other parameters, compared
with the controls.
Based on the chemical structure, it is considered that the toxicity of
tartaric acid is the same of that ones of its salts (i.e. monosodium,
monopotassium, sodium potassium, sodium, potassium and calcium tartrate)
and, therefore, the assessment of this endpoint may be jointly performed
using all available data for these substances.
Overall, tartaric acid and its salts do not have developmental toxicity.
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008,
the substances should not be classified for the toxicity to
reproduction/development because the data are judged as "conclusive but
not sufficient for classification".
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