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EC number: 215-252-9
CAS number: 1315-01-1
A 90- day repeated dose toxicity study in
rats daily dosed with Tin sulfide at doses of 100, 300 and
1000 mg/kg bw per day resulted in a slight
increase in food consumption, associated with slight increases
in body weight and serum glucose
concentrations in females dosed at 1000 mg/kg, as well as slight
decreases in serum Na and Cl. Except for the
above mentioned changes, Tin sulfide did not cause any
other changes. Therefore Tin sulfide was
considered safe and well tolerated up to the dose of
1000 mg/kg bw/day. The NOAEL was defined at
1000 mg/kg and the NOEL at 300 mg/kg.
key 90- day repeated dose toxicity study in rats daily dosed with Tin
sulfide was available (Slais, 2010). Four groups of rats (male/female
Wistar rats) were daily administered with the test item suspension in
0.5% Carboxymethylcellulose (CMC) orally by gavage for 90 days.Three
treated groups were administered with doses of 100, 300 and 1000 mg/kg
bw per day. Dosing resulted in a slight increase in food consumption,
associated with slight increases in body weight and serum glucose
concentrations in females dosed at 1000 mg/kg. These were however not
considered as adverse effects. Slight dose dependent decreases in serum
Na and Cl, varying within physiological range, were observed. Except for
the above mentioned changes, Tin sulfide did not cause any negative
effect on body weight, food consumption, ophthalmoscopy, hematology and
clinical chemistry parameters and organ weights. Tin sulfide further did
not cause any organ weight changes nor gross or histopathological
changes in the liver, kidneys, gastrointestinal tract or other organs of
survived animals indicative of a toxic effect. Under the test conditions
used, 90 - day administration of the test item Tin sulfide to rats was
safe and well tolerated up to the dose of 1000 mg/kg bw/day. The NOAEL
was defined at 1000 mg/kg and the NOEL at 300 mg/kg.
on the similar structural and physicochemical properties of Tin
disulfide (target chemical) and tin sulfide (source chemical), as well
as the comparable and low toxicological profiles for acute toxicity,
local tolerance and genetic toxicity, the results of the 90-day repeated
dose toxicity study with Tin sulfide are considered valid as read-across
to Tin disulfide. Therefore no new study has been conducted and current
study is considered key study for repeated dose toxicity of Tin
disulfide. Further argumentation is provided in a separate document on
read-across argumentation under Section 13.
for selection of repeated dose toxicity via oral route - systemic
effects endpoint: Key
study with read across substance. Argumentation on the adequacy of read
across between target and source chemical has been documented in a
separate document (see Section 13).
classification and labelling is needed for repeated dose toxicity for
Tin disulfide according to EU labelling regulations Commission Directive
93/21/EEC and CLP regulation (No. 1272/2008 of 16 December 2008).
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