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EC number: 213-928-8 | CAS number: 1067-33-0
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study did not identify if it was conducted in accordance with Good Laboratory Practices (GLP); however, quality assurance was equivalent. Purity of test material not reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Internal Method No. 185.3, Experimental Toxicology+
References:
- Schmid, W., The micronucleus test for cytogenetic analysis In: Hollaender, A. (ed.) Chemical Mutagens, vol. 4, Plenum Press, New York, 1976, p.31-53.
- Schmid, W., The micronucleus test In: Handbook of mutagenicity test procedures B.J. Kilbey et al. (eds.), Elsevier, Amsterdam, New York, Oxford, 1977, p.235-242. - GLP compliance:
- no
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 26385
- IUPAC Name:
- 26385
- Reference substance name:
- di-n-butyltin oxide
- IUPAC Name:
- di-n-butyltin oxide
- Details on test material:
- - Name of test material (as cited in study report): Di-n-butyltin oxide, ZK Number 26385
- Supplier: Witco GmbH, Bergkamen, Germany
- Physical state: Suspended in tap water
- Analytical purity: 99.38%
- Lot/batch No.: W 98/43
- Expiration date of the lot/batch: At least until May 1999 (according to information provided by sponsor)
- Stability under test conditions: At least until May 1999 (according to information provided by sponsor)
- Storage condition of test material: the tin-carbon bonds of the butyltin compound are stable in aqueous solutions
Water solubility : 4 mg/l at 20 degrees Celsius (according to information provided by sponsor)
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Test material vehicle:
- Vehicle(s)/solvent(s) used: arachis oil
- Justification for choice of solvent/vehicle: nda
- Concentration of test material in vehicle: 5, 10 and 20 mg/ml
- Amount of vehicle (if gavage or dermal): 10 ml/kg
- Lot/batch no.: 82207/2
Positive control vehicle:
- Vehicle(s)/solvent(s) used: physiol. saline
- Justification for choice of solvent/vehicle: nda
- Concentration of test material in vehicle: 0.015 mg/ml
- Amount of vehicle (if gavage or dermal): 10 ml/kg
- Lot/batch no. (if required): NAW 04 B
- Purity - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test material was dissolved in arachis oil.
Dosing concentrations are 50, 100 and 200 mg/kg. They were given by oral gavage once in the morning to 15 or 18 (3 reserve animals of each sex for the high-dose group) randomly selected male and female mice. Control animals (15 males and 15 females) were given the vehicles at 10 ml/kg in the same manner.
It was assumed from a preceeding acute toxicity study that 200 mg/kg would be a dose level at which toxic effects might be noted. - Duration of treatment / exposure:
- 5 males and 5 females from each of the negative control and the test material groups were killed by cervical dislocation 24, 48 or 72 hours after treatment (the positive control animals were killed 24 hours after treatment)
- Frequency of treatment:
- Single oral dose
- Post exposure period:
- Observed until termination
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 other: mg/kg actual ingested
- Dose / conc.:
- 100 other: mg/kg actual ingested
- Dose / conc.:
- 200 other: mg/kg actual ingested
- No. of animals per sex per dose:
- 15 males and 15 females (30 in total). 3 additional reserve animals of each sex for the high-dose group were also us
- Control animals:
- yes
- Positive control(s):
- - Positive control substance: Triaziquone
- Justification for choice of positive control(s): nda
- Route of administration: single i.p. treatment
- Doses / concentrations: 0.15 mg/kg, 10 ml/k
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
It was assumed from a preceeding acute toxicity study that 200 mg/kg would be a dose level at which toxic effects might be noted.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
Single oral doses of the concentrations were 50, 100 and 200 mg/kg. 5 males and 5 females from each the negative control and the test material groups were killed by cervical dislocation 24, 48 or 72 hours after treatment (the positive control animals were killed 24 hours after treatment)
DETAILS OF SLIDE PREPARATION:
Both femurs were dissected out from each animal. The bone marrow was flushed/aspirated into fetal calf serum. The resulting cell suspensions were centrifuged and smears were prepared from drops of the cell pellets which had been resuspended in a few drops of serum. The slides were air-dried and stained using May-Gruenwald and Giemsa solutions.
METHOD OF ANALYSIS:
The slides were coded and analyzed "blind" in random order. The stained smears were examined using oil immersion, high power magnification in regions where cells were well spread and stained. The slides were examined for the incidence of micronucleated cells per 2000 polychromatic (PCE) and 1000 normochromatic (NCE) erythrocytes per animal. The ratio of polychromatic to normochromatic erythrocytes was calculated on the basis of 1000 NCE scored. - Evaluation criteria:
- Any toxic effect of the test material on the immature nucleated cells may lead either to a reduction in cell division or to cell death. These effects in turn lead to a reduction in cell numbers and to compensate for this, peripheral blood is shunted into the bone marrow. Therefore, a decrease in the frequency of polychromatic erythrocytes is taken as being indicative of toxicity.
- Statistics:
- The statistical analysis was conducted for each of the following variables:
p1: proportion of micronucleated PCE
p2: proportion of micronucleated NCE
p3: ratio of PCE/NCE
The analyses were conducted separately for the sample times. Regarding the first sample time one-sided t-tests were performed to assess the difference between positive and negative controls with pooled values for both sexes; thereafter the positive control group was excluded from further analysis. Thereafter in a two-factorial ANOVA (factors "sex", "treatment") for each sample time it was investigated as to whether any treatment effect was present. In case of significant interactions, comparisons between the control and each of the treatment groups were conducted separately for each sex. Where no significant interactions occurred, but a global treatment effect, comparisons were performed with values pooled for both sexes. The pair-wise comparisons were performed with one-sided t-tests (increase in p1 and p2, decrease in p3), using the error estimate of the ANOVA table. The test levels were always a = 0.05 (least significant differences test-LSD).
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
From the results obtained, it is concluded that the test material failed to produce any increase in the number of micronucleated polychromatic erythrocytes in male and female mice and so failed to show any evidence of mutagenic potential up to 200 mg/kg
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