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EC number: 231-850-2
CAS number: 7759-02-6
Toxicological relevance of the
The registrant is
of the opinion that the toxicity of strontium sulfate is driven by the
strontium moiety and that the sulfate anion does not contribute to the
overall toxicity of the substance strontium sulfate to any relevant
extent, for the following reasons:
are abundantly present in the human body in which they play an important
role for the ionic balance in body fluids. Sulfate is required for the
biosynthesis of 3′-phosphoadenosine-5′-phosphosulfate (PAPS) which in
turn is needed for the biosynthesis of many important sulfur-containing
compounds, such as chondroitin sulfate and cerebroside sulfate. The
Joint FAO/WHO Expert Committee on Food Additives (JECFA) concludes that
the few available studies in experimental animals do not raise any
concern about the toxicity of the sulphate ion in sodium sulphate.
Sodium sulphate is also used clinically as a laxative. In clinical
trials in humans using 2-4 single oral doses of up to 4500 mg sodium
sulphate decahydrate per person (9000 – 18000 mg per person), only
occasional loose stools were reported. These doses correspond to 2700 -
5400 mg sulphate ion per person. High bolus dose intake of sulphate ion
may lead to gastrointestinal discomfort in some individuals. No further
adverse effects were reported (JECFA 2000, 2002). This position was
adopted by the European Food Safety Authority (EFSA 2004) without
Based on the
above information, one can therefore safely assume that the sulfate
anion in strontium sulfate does not contribute to the overall toxicity
of strontium, sulfate. It is concluded that only the effect of
“strontium” is further considered in the human health hazard assessment
of strontium sulfate.
across from SrCl2 to SrSO4:
toxicity of strontium substances such as strontium sulfate can
reasonably assumed to be determined by the availability of strontium
ions in solution. As a first surrogate for bioavailability, the water
solubility of a test substance may be used. Strontium chloride is highly
water soluble with ~538 g/L at pH ~ 7, whereas strontium sulfate is
moderately soluble (~125 mg/L at pH ~ 6.5). Hence, any read across from
strontium chloride to strontium sulfate is inherently very conservative.
Evidence for neurological activity of
strontium was obtained from a number of in vitro investigations. In a
calcium-free medium, strontium ions weakly supported the generation of
excitatory postsysnaptic potentials following stimulation of guinea pig
cervical ganglia (i.e., the release of acetylcholine was less efficient
than when calcium was present) (s_McLachlan_1977). Incubation of vasa
deferentia isolated from guinea pigs showed that both strontium and
barium cations can substitute for calcium ions in the release of
noradrenaline at adrenergic nerve terminals.
It was concluded that all these
cations act through the same site at some stage in the process of
potassium induced transmitter release (s_Nakazato_1980).Perfusion
through acutely denerved cats´ adrenal glandsby
strontium in calcium-free Locke´s solution resulted in an intense
catecholamine secretion and restored the response to acetylcholine and
excess potassium (s_Douglas_1964). Findings that the stimulating effect
of strontium also persisted in glands perfused with EDTA led to the
conclusion that strontium can substitute for calcium in the secretory
process without liberation of endogeneous calcium from some
intracellular binding sites. The
sequestration of different divalent cations including strontium was
examined, in comparison to calcium, by mitochondria and smooth
endoplasmic reticulum from isolated presynaptic nerve terminals (s_Rasgado-Flores_1987).
Strontium cations were less effective (by about 50 to 60%) than calcium
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