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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
read across to Sn compound with the same oxidation sztate and stability

Data source

Reference
Reference Type:
review article or handbook
Title:
short-term toxicity studies on some salts and oxides of tin in rats
Author:
de Groot
Year:
1973
Bibliographic source:
Fd. Comsmet. Toxicol Vol. 11, pp, 19-30
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Version / remarks:
pre-guideline studiy similar the later OECD 408
Deviations:
not applicable
Principles of method if other than guideline:
SNO2 was fed to groups of ten male and ten female rats at dietary levels of 0 (control), 0.03, 0.10, 0.30 and 1.00 % for 90 days.
GLP compliance:
not specified
Remarks:
pre-glp
Limit test:
no

Test material

Constituent 1
Reference substance name:
Tin dioxide
EC Number:
242-159-0
EC Name:
Tin dioxide
Cas Number:
18282-10-5
Molecular formula:
O2Sn
Test material form:
solid: crystalline
Details on test material:
-

Test animals

Species:
cat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Male and female weanling rats from the Institute's Wistar-derived colony were housed in groups of five in stainless steel cages with screen bottoms. The diet used for both control and treated groups was the Institute's stock diet, with the following percentage composition: soyabean-oil meal, 10; fish meal, 8; meat scraps, 4; dried whey, 2; yellow maize, 29.05; wheat, 36; grass meal, 3; brewer's yeast, 3, complete B-vitamin mixture, 0.1; vitamin-ADEK preparation, 0.6; bone meal, 0.75; trace mineral salt, 0.5; soyabean oil, 3. This diet was found to contain calcium (0.98 %), phosphorus (0.80 %), iron (205 ppm), copper (23 ppm), manganese (85 ppm) and zinc (38 ppm). Test diets were prepared by blending the stock diet and the tin compouds in a Stephan cutter. Diets and tap water were provided ad lib

Administration / exposure

Route of administration:
oral: feed
Details on route of administration:
0.0 (control), 0.03, 0.10, 0.30 and 1.00 % for 90 days.
Vehicle:
other: in diet
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
4 wks
Frequency of treatment:
with diet
Doses / concentrationsopen allclose all
Dose / conc.:
0 other: % in diet
Dose / conc.:
0.03 other: % in diet
Dose / conc.:
0.1 other: % in diet
Dose / conc.:
0.3 other: % in diet
Dose / conc.:
1 other: % in diet
Control animals:
yes, concurrent no treatment
Details on study design:
Two tin compounds, stannous oxide and stannous chloride were examined in 13-wk feeding studies. Each of these compounds was fed to groups of ten male and ten female rats at dietary levels of 0.0 (control), 0.03, 0.10, 0.30 and 1.00 % for 90 days. Individual body weights were recorded weekly. The food intake of each group was measured at weekly intervals up to wk 4 and in wk 11-12. Haematological studies were carried out at wk 12 and provided measurements of haemoglobin concentration and haematocrit value, counts of red blood cells and total and differential counts of white blood cells. Additional haematological observations were made in the study on tin chloride. These consisted of haemoglobin readings at wk 2, 4, 6 and 9, and terminal determinations of haptoglobin concentration, numbers of reticulocytes and the osmotic resistance of the erythrocytes. Serum activities of glutamic-oxalacetic and glutamic--pyruvic transaminases and of alkaline phosphatase were determined terminally in both experiments. Bilirubin concentrations were measured terminally only in the study with tin chloride.
Urine examinations, including appearance, pH, glucose, protein, occult blood, ketones and microscopy of the sediment were conducted upon pooled samples from each group in wk 13.

The rats fed the highest level of tin chloride were sacrificed after 8 wk because of poor condition and high mortality. Organs and tissues were fixed in buffered formalin. In wk 14, the remaining rats were killed by decapitation and examined for gross changes. The heart, kidneys, liver, spleen, brain, gonads, thymus, thyroid and adrenals were weighed and paraffin-wax sections of these and a wide range of other organs were stained with haematoxylin and eosin. Detailed microscopic examinations were performed on all rats fed 1% tin oxide, on those fed the two highest levels of tin chloride and on the controls. In the rats fed the intermediate levels of tin chloride, only the liver, kidneys and stomach were examined.
Positive control:
no

Examinations

Observations and examinations performed and frequency:
Individual body weights were recorded weekly. The food intake of each group was measured at weekly intervals up to wk 4 and in wk 11-12. Haematological studies were carried out at wk 12 and provided measurements of haemoglobin concentration and haematocrit value, counts of red blood cells and total and differential counts of white blood cells. Additional haematological observations were made in the study on tin chloride. These consisted of haemoglobin readings at wk 2, 4, 6 and 9, and terminal determinations of haptoglobin concentration, numbers of reticulocytes and the osmotic resistance of the erythrocytes. Serum activities of glutamic-oxalacetic and glutamic--pyruvic transaminases and of alkaline phosphatase were determined terminally in both experiments. Bilirubin concentrations were measured terminally only in the study with tin chloride.
Urine examinations, including appearance, pH, glucose, protein, occult blood, ketones and microscopy of the sediment were conducted upon pooled samples from each group in wk 13.
Sacrifice and pathology:
The rats fed the highest level of tin chloride were sacrificed after 8 wk because of poor condition and high mortality. Organs and tissues were fixed in buffered formalin. In wk 14, the remaining rats were killed by decapitation and examined for gross changes. The heart, kidneys, liver, spleen, brain, gonads, thymus, thyroid and adrenals were weighed and paraffin-wax sections of these and a wide range of other organs were stained with haematoxylin and eosin. Detailed microscopic examinations were performed on all rats fed 1 % tin oxide, on those fed the two highest levels of tin chloride and on the controls. In the rats fed the intermediate levels of tin chloride, only the liver, kidneys and stomach were examined.
Other examinations:
.a.
Statistics:
n.a.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
no effects observed
Immunological findings:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Neuropathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Other effects:
no effects observed
Details on results:
no effects in stannix oxide groups reported

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
> 100 000 ppm
Based on:
test mat.
Sex:
male/female
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity

Key result
Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
NOAEL for Sn= = 100000 ppm