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EC number: 483-270-6 | CAS number: 54068-28-9
- 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:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- no guideline available at the timeframe of the test, no glp information, well documented study; only examination of 14C, The hydrolysis in the stomach of rat is not clarified, it seems plausible that the solubility of the dichloride compond ist 1000 times higher in the stomach of rat than the hydrolysis product (oxide) from diacetylacetone compound.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
- Objective of study:
- distribution
- excretion
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Tissue distribution studies
The tissue distribution of radioactivity was determined in male rats
weighing 80--100 g following a single i.v. or oral (by gavage) administration
of 1.2 and 6.3 mg [~C]DOTC/kg body weight, respectively. Groups of 3
animals were killed by decapitation at 1, 2, 4 and 7 days after the administration,
and blood was collected in heparinized tubes. The animals were
dissected immediately to sample and weigh the organs and tissues. Duplicate
or triplicate 50--100-mg samples of most organs and tissues were cut,
weighed, and transferred to liquid scintillation vials to examine their content
of radioactivity. For the smaller organs, e.g. adrenal, pituitary glands etc. the
radioactivity of the total organ was measured. To each vial 1 ml of the
tissue solubilizer Soluene 350 (Packard Instruments, Packard Dekker
B.V., The Netherlands) was added and allowed to stand for one night at
50--60°C. After solubilization, samples of liver, kidney, heart, lung and
blood were decolourized by adding 0.5 ml of isopropanol followed by 0.5
ml of a 30% solution of H202, to reduce colour quenching. After adding
10 ml scintillation fluid to each vial the content of radioactivity was determined
in a Mark II (Nuclear Chicago) liquid scintillation counter and corrected
for background. Counting efficiency was determined by the external
standard technique. The tissue radioactivity was expressed in dpm/mg tissue.
From these data the relative accumulation index of radioactivity in each of
the organs and tissues was calculated according to the equation: R t = (Ct/Ht).
In this equation R t stands for the relative accumulation of radioactivity at
time t (days); C t for radioactivity in dpm/mg tissue at time t, and H t for the
radioactivity in dpm/mg tissue which was calculated by dividing the total
radioactivity in the sampled organs and tissues by their total weight at time
t (see Table I and III). The weights of blood, muscle and fat tissues were
estimated to contribute to 8, 45 and 8% of the total body weight, respectively
[19].
Excretion studies
Groups of 3 male rats weighing 100--120 g were given a single i.v. or a
single p.o. dose (by gavage) of 1.2 mg and 2 mg [14C] DOTC/kg body weight,
respectively. Then for 25 days urine and feces of each animal were dally
collected separately and their r a d i o a c t i v i t i e s were measured. Triplicate
50-pl aliquots of urine from the individual animals were transferred to
s c i n t i l l a t i o n vials and 1 ml Soluene-350 was added. The fecal samples of the
individual animals were dried at 50--60°C, weighed, and ground to a fine
powder with a mortar and pestle. Then t r i p l i c a t e 10--20-mg samples from
the individual animals were transferred to s c i n t i l l a t i o n vials and rehydrated
with 0.1 ml water (1 h) before adding 1 ml Soluene-350. The vials of urine
and fecal samples were closed and incubated overnight at 50--60°C. To reduce - GLP compliance:
- not specified
Test material
- Reference substance name:
- di-n-octyltin dichloride
- IUPAC Name:
- di-n-octyltin dichloride
- Test material form:
- solid - liquid: suspension
- Remarks:
- migrated information: dispersion
- Details on test material:
- 14C-labeled di-n-octyltin dichloride from Schering AG, Berlin.
Chemical purity > 98% , contaminated with about 1%
monooctyltintrichloride
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
Administration / exposure
- Route of administration:
- other: i.v. and oral (gavage)
- Vehicle:
- other: ethanol, Tween 80 and phosphate buffered physiological saline
- Duration and frequency of treatment / exposure:
- Duration and frequency of treatment:
Frequency: 1 time dose
Duration:
Experiment 1 – distribution:
1, 2, 4 and 7 days
Experiment 2 – Excretion / absorption
25 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Experiment 1 – distribution:
a) i.V., 1.2 mg / kg bw
b) oral (gavage), 6.3 mg / kg bw
Experiment 2 – Excretion / absorption
a) i.V., 1.2 mg / kg bw
b) oral (gavage), 2 mg / kg bw
- No. of animals per sex per dose / concentration:
- 3 male animals per dose / administration / timeframe
- Control animals:
- yes, concurrent no treatment
Results and discussion
- Preliminary studies:
- n.a.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- From the oral dose 84.5 ± 5.1 % (6.3 mg/ kg bw dose) and 79.6 + 4.5% (2 mg / kg bw dose) of the radioactivity was recovered from the feces in the first two days. So there was an absorption of 15.5 respective 20.4 % of the radioactive labeled 14C. Assuming the fetal excretion is approximately identical in the oral and in die i.v. experiment (values form i.v.: 12.1 and 9.6 %; mean ) 10.9) there can calculate an absorption between 17.4 and 22.9 % via absorption = administered oral dose - fecal excretion + 10.9%.
- Details on distribution in tissues:
- The highest concentration of radioactivity in tissue was found in liver and kidney. Also in the endocrine organs adrenals, thyroid glands and pituitary gland, the radioactivity tissue was somewhat higher than in the other organs and tissues determined. Although thymic atrophy is the most sensitive criterion of DOTC toxicity in rats, as it is also shown by the decrease in relative thymus weight in this study low levels of radioactivity were observed in this organ.
Transfer into organsopen allclose all
- Test no.:
- #2
- Transfer type:
- blood/brain barrier
- Observation:
- slight transfer
- Test no.:
- #1
- Transfer type:
- secretion via gastric mucosa
- Observation:
- distinct transfer
- Test no.:
- #3
- Transfer type:
- secretion via gastric mucosa
- Observation:
- distinct transfer
- Details on excretion:
- see details on absorption
Toxicokinetic parametersopen allclose all
- Test no.:
- #3
- Toxicokinetic parameters:
- half-life 1st: 8.3 d (i.v.)
- Test no.:
- #4
- Toxicokinetic parameters:
- half-life 1st: 8.9 d (oral)
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- n.a.
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- -
Any other information on results incl. tables
see attachment in due to publication by ECHA and copyright
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
Only 20% of 14C in DOTC was absorbed, Half life time between 8.3 and 8.9 days,
Slight increase of 14C accumulation in brain and adipose tissue in due to rate constant; decrease of thymus weight.
DOTC induced thymus atropy is not caused by selective accumulation of this compound in the thymus. - Executive summary:
"Absorption and distribution
In orally treated rats (Wistar derived) only a small part of the dioctyltindichloride (DOTC)
was absorbed as approximately 80 % of the 14C-labelled DOTC radioactivity was already
excreted in the feces during the first day after administration. This is in accordance with the
observation that after i.v. administration of 1.2 mg 14C-labelled DOTC/kg b.w./day the tissue
radioactivity was about 3 - 4 times higher than after oral administration with 6.3 mg 14CDOTC/
kg b.w./day. Absorption was calculated to be approximately 20 % of the dose.
The highest amount of radioactivity was found in liver and kidney, and to a lesser degree in
adrenal, pituitary and thyroid glands. The lowest activity was recovered from blood and brain.
No selective accumulation was observed in the thymus, although thymus atrophy is the most
sensitive parameter of DOT toxicity in rats. It was suggested that DOT is rapidly distributed
and diffuses poorly into the brain
Excretion
After a single oral dose of 14C-labelled DOTC (6.3 mg/kg b.w./day) a time dependent
decrease in radioactivity was found for all tissues investigated, except for the kidney. At day
25 after exposure, a total of about 10 % of the administered radioactivity was excreted in the
urine, while 89 % of the dose was excreted in the feces. So at this time about 99.9 % of the
oral administered radioactivity was recovered from excreta. A half-life value of 8.9 days was
estimated from the fecal excretion of radioactivity. The urinary excretion of radioactivity
appeared to be independent of the body burden, since the daily urinary excretion of
radioactivity was nearly constant during the 25 days experimental period after both oral and
i.v. administration."
Source: Question N° EFSA-Q-2003-110
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