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EC number: 212-414-0
CAS number: 814-94-8
Sinkeldam (1979) investigated the
reproductive effect of tin dichloride dihydrate in rats in a multi-generation
study. The dose levels tested were 10, 20, and 40 mg tin/kg bw (nominal)
administered via diet. Adverse effects were not observed in the dams.
According to the authors there was no indications of any effects on the
reproductive performance of rats, which could be regarded as
deleterious. Therefore, the NOAEL was considered to be greater than 40
mg tin/kg bw (nominal).
NOAEL (teratogenicity; rabbit) > 41.5 mg tin dichloride/kg diet (nominal; NOAEL for tin only: 26 mg/kg bw /day)NOAEL (maternal toxicity; rabbit) > 41.5 mg tin dichloride/kg diet (nominal; NOAEL for tin only: 26 mg/kg bw /day)
dichloride was tested in pregnant mice, rats, and hamsters for
developmental toxicity (Anonymous, 1972). All three species were treated
with 0.5, 2.3, 11.0, and 50.0 mg/kg (nominal) of the test material for 5
or 10 consecutive days (gestation day 6 through day 10 for hamsters;
gestation day 6 through day 15 for mice and
rats) by gavage. In addition to the groups treated with the test
substance, a sham-exposed control group and a positive control group
(aspirin) were also run. According to the author(s), the administration
of up to 50 mg/kg bw of the test material (31 mg tin/kg bw/day) had no
clearly discernible effect on nidation or on maternal or foetal
survival. The number of abnormalities seen in either soft or skeletal
tissues of the test groups did not differ from the number occurring
spontaneously in the sham-treated controls. Therefore, the NOAEL for
maternal toxicity and teratogenicity is greater than 50 mg/kg bw.
Effects on maternal toxicity are poorly described, and there are minimal
effects on maternal body weight. However, results relevant for foetal
survival and visceral as well as skeletal effects are reasonably well
documented, so that the studies are considered reliable with
another study of similar design, developmental effects of tin dichloride
were investigated in pregnant rabbits (Anonymous, 1974). The rabbits
were treated with 0.42, 1.90, 8.90, and 41.5 mg/kg (nominal) of the test
item for 13 consecutive days (gestation days 6 through day 18) by
gavage. A vehicle control group (water) and a positive control group
(6-aminonicotinamide) were also run. According to the author(s), the
administration of up to 41.5 mg/kg
bw of the test material (26 mg tin/kg bw/day) had no clearly discernible
effect on nidation or on maternal or foetal survival. The number of
abnormalities seen in either soft
or skeletal tissues of the test groups did not differ from the number
occurring spontaneously in the sham-treated controls. Therefore, the
NOAEL for maternal toxicity and teratogenicity is greater than 41.5
mg/kg bw. Effects on maternal toxicity are poorly described, and there
are minimal effects on maternal body weight. However, results relevant
for foetal survival and visceral as well as skeletal effects are
reasonably well documented, so that the studies are considered reliable
addition to the above mentioned studies, several supporting studies were
Sinkeldam (1979) described “a
reproduction study in rats with an incorporated developmental toxicity
study with dose levels of 0, 200, 400 and 800 mg stannous chloride in
the diet revealed transient adverse effects only at specific stages.
These were a decrease in body weight gain during lactation, decreased
haemoglobin in pups prior to weaning, and microscopic changes in the
liver and spleen of pups of the F3b generation at weaning. The iron
content in the diet for these pregnant rats was, respectively, 70 and
140 mg/kg feed, greater than the minimal adequate level of iron for
adult non-pregnant rats (35 mg/kg feed). At the higher iron content in
the feed the effects were less in the suckling pups. This led the
investigators to the conclusion that the 70 mg iron/kg feed is a
sub-optimal content for pregnant dams. No adverse effects were observed
in the dams. Visceral and skeletal examination did not reveal any
tin-related teratogenic effects (Sinkeldam et al, 1979a). As the effects
in the pups seen in this study were transient and disappeared after the
animals were weaned, the NOAEL can be established at 800 mg stannous
chloride/kg feed which is equivalent to 40 mg/kg body weight
(as also derived by the Scientific Committee on Food, Scientific Panel
on Dietetic Products, Nutrition and Allergies February 2006, European
Food Safety Authority, p. 470.).
- Theuer (1971)
studied the developmental effects of tin fluoride in rats. Doses of 110
to 625 ppm tin were given to the animals via feed. The duration of
treatment was 20 days ad libitum. A group receiving plain diet was used
as control. According to the author, no effects were observed on the
numbers of litters, resorptions, live foetuses per litter, mean
placental and foetal weights.
- Lastly, Ridgway
and Karnofsky (1952) tested the effect of tin dichloride on chicken
embryos (White Leghorn chickens) by injections into the yolk or onto the
chorioallantoic membrane (CAM). The embryos were eight days old.
According to the authors, effects on teratogenicity were not observed.
This reference is however considered not relevant for risk assessment,
since the test system is considered unsuitable for the investigation of
further references relating to the developmental toxicity of tin
compounds are regarded as unreliable and have been disregarded from the
further assessment: Grin et al, 1988; El-Makawy, 2008; Wu et al. 1990.
Please refer to the technical dossier for the rationales for
disregarding these references.
potential for developmental toxicity of inorganic tin (II) salts was
investigated with stannous chloride in four different species: mice,
rats, golden hamsters and rabbits (FDRL, 1972 and 1974). The oral
administration of up to 50 mg/kg bw of stannous chloride to pregnant
females of all four species mice did not have any significant
effect on fetal weight, number of live or dead fetuses and the incidence
of skeletal or
visceral malformations in the fetuses. Despite a lack of recording
maternal toxicity in these studies, the upper range of doses used has
been reported to elicit mild toxicity in adult rats such as reduced body
weight (de Groot et al., 1973; Janssen et al., 1985) and reduced enzyme
levels (Pfaff et al., 1980).
multi-generation reproduction feeding study with stannous chloride in
rats incorporating a developmental toxicity study, the maximum dietary
level corresponding to a dose of 40 mg tin/kg bw/d did not elicit any
adverse effects in the dams, and there were no significant visceral or
skeletal malformations (Sinkeldam, 1979).
another, poorly documented study the administration
of up to approximately 56 mg tin/kg/day (as tin fluoride) to rats on Gds
0–20 had no significant effect on average fetal weight or the number of
live fetuses per litter (Theuer et al. 1971).
the observed deviations in these studies from current guidelines for
developmental toxicity testing, the overall absence of any adverse
developmental effects in four different species is considered by
weight-of-evidence to adequately justify no classification of inorganic
tin(II) substances for developmental toxicity.
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