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EC number: 215-710-8
CAS number: 1344-95-2
investigations on fertility to current standards are not available for
synthetic amorphous calcium silicate.
one-generation study conducted with a hydrophilic SAS type is not
adequate to contribute reliable information for biostatistical
given the inherent physico-chemical properties and ubiquitous nature of
this class of compounds, there is no structural
to indicate a potential for reproductive and developmental toxicity.
Therefore, based on the
weight of evidence, prolonged exposure to synthetic amorphous calcium silicate,
applied before and
during pregnancy at high
doses, is not expected to produce harmful effects on the reproductive
performance or embryonic/foetal development in experimental animals
(see: SIAR 2004).
Hence, further testing is
not justified. Waiving
of this toxicological endpoint is in line with REACH Regulation
Annex VIII, 8.7.1, Annexes IX and X, 8.7.
of the result of the reproduction study:
one-generation study on Wistar rats gave no evidence of any adverse
effects arising from long-term feeding of Aerosil
mg/(kg bw*d)] to both genders for a premating period of 4.5
months and continued up to 6 months [Leuschner
pregnant test females and four pregnant untreated control females
delivering 45 and 37 pups, respectively, were included
this test. The
study had shortcomings with respect to the low number of pregnant
animals used and the mating ratio of
1(m):5(f), which was too low according to current standards.
No adverse maternal and embryo-/foetotoxic effects in three species (mouse, rat, and hamster) following oral doses of up to 1600 mg/(kg bw*d) during gestation. The NOAEL of calcium silicate corresponds to the highest dose tested of 1600 mg/(kg*d).
experimental data on intra-uterine development produced in three animal
species by a synthetic amorphous calcium silicate
that there is no potential for adverse effects on embryonal/foetal
development arising from exposure to this type of substances:
is in line with the negative results obtained with synthetic amorphous
silica and aluminum sodium silicate.
Summary of test results
the scope of a comprehensive and valid testing programme, calcium
silicate (CS) was examined for embryotoxic and
effects during the gestation phase in various animals species, rat,
mouse, and hamster at oral doses up to
mg/(kg bw*d). There were no significant signs of maternal or
embryotoxic/developmental toxic effects in any species tested.
number of abnormalities seen in either soft or skeletal tissues of the
test groups did not differ from the untreated control groups.
Therefore, the top dose of 1600 mg/(kg bw*d) corresponds to
the NOAEL for maternal and developmental toxicity.
No classification required.
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