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EC number: 231-302-2 | CAS number: 7488-55-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: publication from EFSA
- Justification for type of information:
- Datawaiving from SnCl_2 to SnSO_4, Sn^(2+)-ion is responsible for adverese effects
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to the Tolerable Upper Intake Level of Tin
- Author:
- European Food Safety Authority
- Year:
- 2 005
- Bibliographic source:
- The EFSA Journal (2005) 254, 1-25
- Report date:
- 2005
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- toxicokinetics
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Tin sulphate
- EC Number:
- 231-302-2
- EC Name:
- Tin sulphate
- Cas Number:
- 7488-55-3
- Molecular formula:
- O4S.Sn
- IUPAC Name:
- λ²-tin(2+) sulfate
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 113Sn
Test animals
- Species:
- other: rat, mice, strain and sex see free text
- Strain:
- other: see free text
Administration / exposure
- Route of administration:
- other: see free text
- Duration and frequency of treatment / exposure:
- see free text
Doses / concentrations
- Remarks:
- Doses / Concentrations:
see free text
- No. of animals per sex per dose / concentration:
- see free text
- Control animals:
- other: see free text
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- It has been reported that gastrointestinal absorption of tin by the rat is extremely low. In one study, groups of 8 male Wistar rats (approximately 250 g) were fasted for 17 hours after which a dose of radiolabelled 113SnCl2 (50 mg/kg body weight; 0.5 μCi/mg tin) was administered by gavage in either: (1) water; or with (2) aqueous sucrose at 5 g/kg body weight; (3) aqueous ascorbic acid at 0.5 g/kg body weight; (4) aqueous potassium nitrate 0.1 g/kg body weight; (5) an aqueous solution of all three compounds at the same dose; or in (6) 20% alcohol solution, equivalent to 2 g ethanol/kg body weight; or (7) a solution of albumin at 2.5 g/kg body weight; or (8) 1:1 (v/v) sunflower oil-1% Tween 20 emulsion at 10 mL/kg body weight. Rats were placed in metabolic cages, fasted for another 6 hours and then received a basal diet ad libitum. Urine and faeces were collected from 0-24 and 24-48 hours. Animals were then sacrificed and excreta and selected organs and tissues analysed for radioactivity. Group mean values of the proportion of the administered dose excreted in the faeces within 48 hours or remaining in the gastrointestinal tract ranged from 98.7-99.8%. The mean percentage of the 113Sn dose detected in the urine was less than 1.1% and in the organs
and tissues examined was less than 0.005% (Fritsch et al., 1977a; WHO, 1980; ATSDR, 1992 and 2002).
The effect of the anion and oxidation state on the gastrointestinal absorption of inorganic tin salts, labelled with 113Sn, was studied in the rat. Following a 24-hour fast, groups of 10 female rats (Charles River, 200-225 g) were given a single 20 mg Sn/kg body weight oral dose of Sn2+ citrate, fluoride or pyrophosphate or Sn4+ citrate or fluoride. Changing the anion from citrate to fluoride did not alter the absorption of either oxidation state and approximately 2.8% and 0.6% of the Sn2+ and Sn4+, respectively, were absorbed. With pyrophosphate as the anion, absorption of Sn2+ was significantly lower than with the citrate or fluoride, an observation which the author ascribed to the greater tendency of pyrophosphate to form insoluble complexes with tin as compared to the citrate and fluoride anions (Hiles, 1974). In a 28-day study in which groups of 6 weanling female rats were fed with the Sn2+ and Sn4+fluoride salts (20 mg Sn/kg body weight, on 6 days/week) the steady state urinary excretion was circa 0.35% and 0.12% of the total dose of tin from the Sn2+ and Sn4+ salts, respectively, confirming the greater absorption of the Sn2+ ion (Hiles, 1974). In a comparative study of the absorption of tin, tracer dose of 113SnCl2 (2.6-4.4 mg Sn) were administered intravenously, intraperitoneally and by gavage to female RF mice, male Sprague-Dawley rats, male African white-tailed rats, male rhesus monkeys and male beagle dogs. In all species more than 95% of the oral gavage dose was excreted via the faeces within 3 days, whereas a greater percentage (15.9-62.8%) of the parenteral doses was excreted via the urine during the same time (Furchner and Drake, 1976). Orange juice containing 540 mg Sn/kg derived from corrosion of the can or a solution of tin citrate (1200 mg Sn) was administered to Wistar rats (gender not given), and faeces and urine were collected over 48 hours or 18 hours respectively. No tin was detected in the urine collections whereas the faecal excretion of tin was 99% or 94-98% respectively (Benoy et al., 1971). - Details on distribution in tissues:
- When expressed as a percentage of a dose administered orally to rats, tissue distributions for Sn2+ and Sn4+, respectively were skeleton, 1.02% and 0.24%, liver, 0.08% and 0.02%; and kidneys 0.09% and 0.02% (Hiles, 1974). When radioactive stannous chloride was administered by stomach tube to anaesthetised rats the bulk of the dose was excreted in faeces, and there was highly variable distribution of the absorbed fraction in the internal organs as measured for periods of up to 21 days (Kutzner and Brood, 1971).
Tin concentrations were measured in the liver, kidneys and femur of groups of 6 male weanling Wistar rats administered 0, 0.3, 1.0 and 3.0 mg Sn2+/kg body weight orally every 12 hours for a period of 90 days. There was a clear dose-related increase in femur concentration with statistical significance achieved at the 1.0 mg Sn2+/kg body weight dose. In the highest dose group the femur concentrations were 10-fold higher than the control values of 2.05 ± 0.41 μg/g wet tissue and these were associated with significant reductions of the diaphysis and epiphysis concentrations of calcium. The concentrations of tin in the livers of control rats were 0.24 ± 0.01 μg/g wet tissue and the levels were significantly increased by 58% at the highest dose. There were no significant increases in the kidney concentrations of 0.22 ± 0.41 μg/g wet tissue (Yamaguchi et al., 1980).
Male Wistar rats were given SnCl2.2H2O in their drinking water for 1-18 weeks at concentrations of 100 mg/L (0.44mM), 250 mg/L (1.11 mM) or 500 mg/L (2.22 mM). Tin accumulated in the brain at the highest concentration (2.22 mM) throughout the experiment, but elevated tin concentrations in brain were found only after 15 and 18 weeks at 1.11 mM and tin did not increase in the brains of rats given 0.44 mM. Blood tin increased after one week at the highest dose (2.22 mM) without further accumulation, whereas blood tin levels did not differ from controls at the 2 lower doses. Tin exposure caused a dose-dependent increase in the cerebral and muscle acetylcholinesterase activity at the two highest doses (Savolainen and Valkonen, 1986).
Transfer into organs
- Transfer type:
- secretion via gastric mucosa
- Observation:
- slight transfer
- Remarks:
- in rat, mice, human
- Details on excretion:
- The absorption of inorganic compounds of tin from the gastrointestinal tract in humans and animals is reported to be low with as much as 98% being excreted directly in the faeces. The nature of the inorganic tin compound and its oxidation state appears to determine the extent of absorption (Calloway and McMullen, 1966; Hamilton et al., 1972b; Tipton et al., 1966 and 1969; Fritsch et al., 1977a; WHO, 1980; ATSDR, 1992 and 2002).
Toxicokinetic parameters
- Toxicokinetic parameters:
- half-life 1st: 29d in mice
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- The methylation of inorganic tin compounds by a mechanism involving the oxidation of a stannous compound to the Sn (III) radical and the reaction of this with the cobalt-carbon bond of vitamin B12 to give a methylated tin derivative have been described. However, it is probable that this can only occur in anaerobic conditions (Ridley et al., 1977 a and b; Wood et al., 1978; ATSDR, 1992 and 2002).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: no bioaccumulation potential based on study results
There is no bioaccumulatiom based on inorganic Sn^2+ compounds, but an effect on other trace elements (e.g. on iorn and so to the hemoglobin level).
Occasional high intakes of tin are associated with high consumption of canned foods, and regulatory limits of tin content in canned foods (200 mg/kg) and beverages (100 mg/kg) have been established to protect against possible local acute effects on the gastrointestinal tract.
Short-term human studies indicate that high intakes of tin (about 30-50 mg tin/day or per meal) may reduce the absorption of zinc, but not other minerals such as iron, copper, manganese or magnesium. However, the possible long-term effects, if any, of such intake levels on status of zinc or other minerals have not been investigated. The current mean daily intake of tin in EU countries (e.g. ranging up to about 6 mg/day in the UK) appears to be well below the lowest intakes reported to cause adverse effects on zinc
absorption.
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