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EC number: 206-108-6 | CAS number: 301-10-0
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Pre-chronic study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: NTP protocol
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Tin dichloride
- EC Number:
- 231-868-0
- EC Name:
- Tin dichloride
- Cas Number:
- 7772-99-8
- Molecular formula:
- Cl2Sn
- IUPAC Name:
- Tin dichloride
- Details on test material:
- Tin Dichloride [CAS No. 7772-99-8]; anhydrous, food grade ~98.5% purity, source: M&T Chemicals, Inc.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Frederick Cancer Research Center, Frederick, Maryland
- Age at study initiation: 4 weeks
- Weight at study initiation: male: 84.3 to 90.4 g; female: 77.3 to 85.4 g
- Housing: 5/polycarbonate cage covered with disposable filters
- Diet (e.g. ad libitum): ad libitum; Wayne Lab Blox meal
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 10 days
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily, continuous in diet
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
500, 1000, 1900, 3800, or 7500 ppm
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
48, 94, 187, 360, 887 mg/kg bw/day
Basis:
other: actual ingested males
- Remarks:
- Doses / Concentrations:
46, 98, 187, 376, 863 mg/kg bw/day
Basis:
other: actual ingested females
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- Animals were checked for mortality and signs of moribundity twice daily. Each animal was given a clinical examination weekly, including palpation for tissue masses or swelling. Body weight and feed consumption data were recorded weekly.
- Sacrifice and pathology:
- Those animals that were judged moribund were killed and necropsied. At the end of the 13-week study, all survivors and all animals found dead, unless precluded in whole or in part by autolysis or cannibalism, were necropsied.
Examinations performed in the control and high dose groups included: gross lesions, tissue masses, abnormal lymph nodes, skin, mandibular lymph nodes, mammary gland, salivary gland, thigh muscle, bone marrow, thymus, trachea, lungs and bronchi, heart, thyroid, parathyroid, esophagus, stomach, duodenum, jejunum, ileum, colon, mesenteric lymph nodes, liver, pancreas, spleen, kidneys, adrenals, bladder, seminal vesicles/prostate/testes or ovaries/uterus, brain, and pituitary.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- There were no mortalities during the 13-week study period.
Mean body weight gain was reduced more than 10% in animals receiving the 7500 ppm diet, relative to control animals. However, average daily feed consumption at 7500 ppm was higher than that of the control group.
Seventy-100% of rats receiving the 3800 or 7500 ppm diets had gross distention of the cecum and reddened gastric mucosa, although no compound-related histopathologic effects were observed in the cecum, stomach, or any other tissues examined.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 187 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: gross pathology stomach and caecum
- Dose descriptor:
- NOEL
- Effect level:
- 1 900 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: gross pathology stomach and caecum
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Based on the results of the 13-week study, doses of 1000 and 2000 ppm stannous chloride in feed were selected for the chronic, 105-week study.
Applicant's summary and conclusion
- Conclusions:
- In a 13-week repeated dose study with F344/N rats, 70-100% of rats receiving the 3800 or 7500 ppm diets had gross distention of the cecum and reddened gastric mucosa, although no compound-related histopathologic effects were observed in the cecum, stomach, or any other tissues examined. A NOEL of 1900 ppm (187 mg/kg bw/day) was determined based on the effects seen at 3800 ppm.
Based on the results of the 13-week study, doses of 1000 and 2000 ppm stannous chloride in feed were selected for the chronic, 105-week study. - Executive summary:
A thirteen-week study was conducted to evaluate the cumulative toxicity of stannous chloride and to determine the concentrations of stannous chloride to be used in chronic studies. Male and female F344/N rats were fed diets containing 0, 500, 1000, 1900, 3800 or 7500 ppm. Seventy to 100% of rats receiving the 3800 or 7500 ppm diets had gross distention of the cecum and reddened gastric mucosa, although no compound-related histopathologic effects were observed in the cecum, stomach, or any other tissues examined. A NOEL of 1900 ppm (187 mg/kg bw/day) was determined based on the effects seen at 3800 ppm.
Based on the results of the 13-week study, doses of 1000 and 2000 ppm stannous chloride in feed were selected for the chronic, 105-week study.
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