Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: no glp, only similar to guideline
Justification for type of information:
or the 4 weeks study no data waiving, For the 13 weeks study data waiving form SnCl2 to SnSO4, because in the GI-tract: dissoziation form SnCl2 in Sn^2+ and Cl- (SnSO4 in Sn^2+ and SO4^2-).

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 guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SnCl_2 * 2aq

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
4 and 13 weeks
Frequency of treatment:
daily with diet
Doses / concentrationsopen allclose all
Dose / conc.:
0 other: w/w % in diet
Dose / conc.:
0.03 other: w/w % in diet
Dose / conc.:
0.3 other: w/w % in diet
Dose / conc.:
1 other: w/w % in diet
No. of animals per sex per dose:
10 animals per sex per dose per timeframe.
Control animals:
yes

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
see section any other information on materials and methodes
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
see section any other information on materials and methodes
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
see section any other information on materials and methodes
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
see section any other information on materials and methodes
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
see section any other information on materials and methodes
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
see section any other information on materials and methodes
Histopathological findings: neoplastic:
effects observed, treatment-related
Description (incidence and severity):
see section any other information on materials and methodes
Other effects:
effects observed, treatment-related
Description (incidence and severity):
see section any other information on materials and methodes
Details on results:
see section any other information on materials and methodes

Effect levels

Key result
Dose descriptor:
NOEL
Effect level:
> 22 - < 33 other: mg Sn /kg bw day
Based on:
element
Sex:
male/female
Remarks on result:
other: not relevant

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Severe growth retardation,
decreased food efficiency, slight anaemia and slight histological changes in the liver were
observed with 39 mg SnSO_4 / kg bw /day or more of stannous sulphate.

As NOAL a value of 22-33 mg Sn/kg bw day was determined, no LOAEL was fouind.