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EC number: 200-268-0 | CAS number: 56-35-9
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: gene mutation
- Type of information:
- other: re-evaluation of expermental result
- Adequacy of study:
- supporting study
- Study period:
- 12 May 1986- 12 Nov 1986
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- A micronucleus test with TBTO was performed by the Institute of Occupational Health/Helsinki, Finland. 10 male and 10 female Balb/c mice per group were given once by gavage 30 or 60 mg TBTO/kg bw as a solutoin in olive oil. Control animals (10 males and 10 females) were given the vehicle at 20 mL/kg in the same manner. Cyclophosphamide (15 mg/kg; single i.p. treatment) served as a positive control.
5 males and 5 females from the negative and positive control and the TBTO groups were killed at intervals of 30 and 48 hours after treatment. Femur bone marrow smears were prepared and stained using May-Gruenwald and Giemsa solutions.
The coded slides were examined for the presence of micronuclei in 1000 PCE and 1000 NCE and for the ratio of PCE/NCE. - GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- tri-n-butyltin oxide
- IUPAC Name:
- tri-n-butyltin oxide
- Reference substance name:
- ZK 21.955
- IUPAC Name:
- ZK 21.955
- Details on test material:
- no data
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- 30 or 60 mg/kg
- Duration of treatment / exposure:
- single exposure
- Frequency of treatment:
- single exposure
- Post exposure period:
- Animals were sacrificed at 30 and 48 h after treatment
Doses / concentrationsopen allclose all
- Dose / conc.:
- 30 other: mg/kg (nominal)
- Dose / conc.:
- 60 other: mg/kg (nominal)
- No. of animals per sex per dose:
- 10/sex treated animals
5/sex negative and positve controls - Control animals:
- yes
- Positive control(s):
- Cyclophsophamide 15 mg/kg single ip treatment
Examinations
- Tissues and cell types examined:
- erythrocytes from femur bone marrow smears
- Details of tissue and slide preparation:
- Femur bone marrow smears were prepared and stained using May-Gruenwald and Giemsa solutions
- Evaluation criteria:
- Finish study: presence of micronuclei in 1000 PCE and 1000 NCE (polychromatic erythrocytes/normochromatic erythrocytes)
Re-evaluation: presence of micronuclei in 1000 PCE and 1000 NCE (with oil immersion high power magnification; frequency of PCE was calculated on basis of 1000 NCE - Statistics:
- Re evaluation: statistical anlayis was conducted on the following variables: P1 (proportion of micronucleated PCE), P2 (proportion of micronucleated NCE) and P3: ratio of PCE/NCE. P1 and p2 were transformed (arc sin sqare root of Pi). Analyses conducted for spearate sample times. ANOVA with factors sex and treatment was performed to assess difference tbetween positive and negative contreols with pooled values for both sexes; thereafter the postive contorl group was excluded fromfurther analysis.
Comparison between control fo each treatment group were conducted separately for the sexes. Compariosns were performed with values pooled for both sexes if no differece was observed. Pairwise comparisons were performed with one-sided t-tests (increase of P1 and P2, decrease of P3), using the error estimate of the ANVOA table. The test levels were always alpha = 0.05, (least significant differences test, LSD). Arithmetic means and std deviations included.
Results and discussion
Any other information on results incl. tables
Regarding the first sample time there were no significant findings. Regarding the second sample time, a significant treatment effect was revealed for both dose levels with respect to micronucleated PCE in females. The micronucleated NCE-counts showed - pooled for both sexes - a significant increase at the high dose level. The ratio PCE/NCE decreased significantly in males at both dose levels. The positive control group was significantly different from the control group with respect to the micronucleated PCE counts at the first sample time and the micronucleated NCE counts at both sample times.
The slight but statistically significant increases of the micronucleated PCE counts in females at both TBTO groups (3,2,3,2,1 and 1,1,2,1,0) versus the concurrent negative control (0,1,0,0,1) at the second sample time was biologically not relevant: the concurrent control values in females were unusually low compared to those of the first sample time (PCE: 1,1,2,0; NCE: 1,1,3,0) or the control values of the males (PCE: 2,1,2,0,1 and 0,2,2,1,1; NCE: 1,0,1,1,2 and 1,1,2,0,3) and moreover there was no dose response relationship at all, on the contrary, there was a decrease in the mean from 2.2 (30 mg/kg) to 1.0 (60 mg/kg) with no significant evidence of bone marrow depression. The same holds true for the increase in micronucleated NCE. The fact that there was no significant increase in micronucleated PCE in males at the second sample time as observed by the Finnish study, but on the contrary in female mice, illustrates clearly the variability of micronucleus test data obtained from the same study, if only 1000 PCE per animal were scored. According to a very recent collaborative study on sex difference in the mouse micronucleus test (Mutation Res. 172, 151-163, 1986) all twenty clastogens tested induced micronuclei in both sexes.
Applicant's summary and conclusion
- Conclusions:
- The reevaluation of the slides and statistical analysis indicates TBTO failed to show evidence of mutagenic potential when administered by gavage up to 60 mg/kg in the mouse micronucleus test.
- Executive summary:
This study was a re-evaluation of the micronucleus test completed by the Finnish Institute of Occupational Health (1984). The slides were requested for recounting because a similar study completed by Schering (dated 29 Aug1983) did not show any evidence of mutagenic activity. The Finnish study reported mutagenic activity; however, both the spontaneous background rates and mean ratio polychromatic erythorictyes/normochromatic erythrocytes ((PCE/NCE) were unusually high. Evaluation of the data after counting of 1000 PCE and 1000 NCE per animal indicates that TBTO failed to show evidence of mutagenic potential, when administered by gavage up to 60 mg/kg, in the mouse micronucleus test. Cyclophosphamide, the positive reference gave the expected mutagenic response. The result indicates that the most likely explanation for the difference to the outcome of the Finnish report is due to the limited PCE sample size (see also Ashby and Mohammed, Mutation Res. 164, 217-235, 1986). The result of the re-evaluation is in agreement with the outcome of an earlier study (Schering, Exp, Toxicology, Report No. IC 5/83, dated Aug. 29, 1983).
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