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EC number: 439-840-1
CAS number: 20846-91-7
In a GLP study conducted according to OECD
Guideline 415, trisodium EDDS was assessed for its ability to induce
reproductive and developmental toxicity in rats. Groups of 25
Spague-Dawley rats of each sex were given 0, 90, 250 or 700 mg/kg bw/day
of the test substance (in water) by oral gavage for 70 days before
mating, and throughout mating, pregnancy and weaning. Culling of the
offspring occurred on day 4 after birth to standardize the litters, and
the remaining offspring were killed on day 21 after delivery. The
animals were observed for mortality, clinical signs of toxicity, body
weight gain, feed consumption, changes in the estrus cycle, precoital
index, mating index, fertility, gestation index, number and sex of
offspring, litter size and viability, and lactation index. At sacrifice,
gross necropsy of the thoracic, abdominal and pelvic viscera was carried
out, the reproductive organs, brain and pituitary were weighed and sperm
evaluations were performed. The females were examined for the number and
distribution of implantation sites. Necropsies were performed on the
pups culled at 4 days for external and internal abnormalities and the
brains were sectioned to detect hydrocephaly.
No significant systemic adverse effects were
observed on the parental animals, and the reproductive and developmental
parameters examined were unremarkable. Therefore the study NOAEL was
considered to be 700 mg/kg bw/day.
In conclusion, trisodium EDDS did not affect
fertility or development in rats orally administered up to 700 mg/kg
bw/day in a one-generation reproductive toxicity study. Therefore,
according to EU CLP and DSD regulations, trisodium EDDS would not be
classified as a reproductive or developmental toxicant under the test
trisodium EDDS is considered relevant to use for understanding the
potential reproductive toxicity of EDDS acid, and is acceptable for
using as read-across information.]
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