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EC number: 203-464-4 | CAS number: 107-12-0
- 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
- Study period:
- 10th September 1984 - 12th September 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- mammalian bone marrow chromosome aberration test
Test material
- Specific details on test material used for the study:
- Purity: 90% (adjusted to 100% for dosing purposes).
Appearance: Brown liquid.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Sprague-Dawley male and female rats were purchased from Charles River Breeding Laboratories (~46-51 days old) and allowed to acclimatise for 19 days prior to the experiment. Animals were housed individually in cages, with water and food available ad libitum. Animals were maintained in 12 hours light and dark cycle, with relative humidity levels monitored throughout the study. Animals were health checked and weights recorded pre-dosing and at 22 and 46 hours, just prior to administration of colchicine. Observations of clinical signs of toxicity were recorded twice daily. Animals were sacrificed by carbon dioxide asphyxiation.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Corn oil
- Details on exposure:
- The substance was administered via oral gavage.
- Duration of treatment / exposure:
- Single dose followed by sacrifice at 6, 24 and 48 hours post-exposure.
- Frequency of treatment:
- Single dose
- Post exposure period:
- 6, 24 and 48 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- Male rats
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Remarks:
- Female rats
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Positive control(s):
- Cyclophosphamide
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- 50 metaphase cells were examined from each rat
- Evaluation criteria:
- Number and types of chromosomal aberrations, mitotic index, chromosome number per metaphase, and location of each metaphase with chromosomal damage.
- Statistics:
- The mean mitotic indices, mean chromosome numbers, percent aberrant cells and the mean number of aberrations per cell for each group were statistically compared using the Kruskal-Wallis non-parametrical analysis of variance and nonparametric pairwise group comparisons.
Body weight data was analysed by analysis if variance (ANOVA).
All tests were evaluated at the one-tailed confidence interval (P 0.05).
Results and discussion
Test resultsopen allclose all
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Weight loss at 48 h, depressed activity, red stains on nose/eyes, wheezing, urine stains on coat and soft feces.
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Three females died prior to sacrifice after the administered dose of 200 mg/kg. Weight loss at 24 and 48 h, depressed activity, red stains on nose/eyes, wheezing, urine stains on coat and soft feces.
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
There was no significant increase in the frequency of chromosomal aberrations compared to the control values was seen in the groups administered with the substance.
There were no statistically significant differences between the mean chromosome numbers of the test group and the vehicle control.
There were no statistically significant differences between the mean mitotic indices of the test group and the vehicle control animals.
Cytogenic analysis. Summary of Aberration data- 6 hour sacrifice.
Group number | Treatment | Number of animals analysed/group | Number of metaphases analysed/group | Number of aberrant cells/group | % Aberrant cells/group | Statistical significance | Toatal number of aberrations/group | Mean aberrations/cell | Statistical significance |
1 | Corn oil | 10 | 500 | 1 | 0.20 | - | 1 | 0.002 | - |
3 | 100 mg/kg (male) | 5 | 250 | 1 | 0.40 | NS | 1 | 0.004 | NS |
4 | 200 mg/kg (female) | 5 | 250 | 1 | 0.40 | NS | 1 | 0.004 | NS |
Cytogenic analysis. Summary of Aberration data- 24 hour sacrifice.
Group number | Treatment | Number of animals analysed/group | Number of metaphases analysed/group | Number of aberrant cells/group | % Aberrant cells/group | Statistical significance | Toatal number of aberrations/group | Mean aberrations/cell | Statistical significance |
1 | Corn oil | 10 | 475 | 0 | 0.00 | - | 0 | 0.000 | - |
2 | Cyclophosphamide (40 mg/kg) | 10 | 192 | 49 | 25.52 | S | 269 | 1.40 | S |
3 | 100 mg/kg (male) | 5 | 250 | 1 | 0.40 | NS | 1 | 0.004 | NS |
4 | 200 mg/kg (female) | 5 | 250 | 1 | 0.40 | NS | 1 | 0.004 | NS |
Cytogenic analysis. Summary of Aberration data- 48 hour sacrifice.
Group number | Treatment | Number of animals analysed/group | Number of metaphases analysed/group | Number of aberrant cells/group | % Aberrant cells/group | Statistical significance | Toatal number of aberrations/group | Mean aberrations/cell | Statistical significance |
1 | Corn oil | 10 | 500 | 0 | 0.00 | - | 0 | 0.000 | - |
3 | 100 mg/kg (male) | 5 | 232 | 0 | 0.00 | - | 0 | 0.000 | - |
4 | 200 mg/kg (female) | 2 | 100 | 0 | 0.00 | - | 0 | 0.000 | - |
Chromosome number- 6 hour sacrifice.
Group number | Mean chromosome number | Standard deviation | Statistical significance |
1. Corn oil | 41.81 | 0.53 | NS |
3. 100 mg/kg (male) | 41.80 | 0.038 | NS |
4. 200 mg/kg (female) | 41.77 | 0.054 | NS |
Chromosome number- 24 hour sacrifice.
Group number | Mean chromosome number | Standard deviation | Statistical significance |
1. Corn oil | 41.75 | 0.43 | - |
2. Cyclophosphamide (40 mg/kg) | 41.63 | 0.193 | NS |
3. 100 mg/kg (male) | 41.74 | 0.086 | NS |
4. 200 mg/kg (female) | 41.78 | 0.055 | NS |
Chromosome number- 48 hour sacrifice.
Group number | Mean chromosome number | Standard deviation | Statistical significance |
1. Corn oil | 41.83 | 0.073 | - |
3. 100 mg/kg (male) | 41.84 | 0.030 | NS |
4. 200 mg/kg (female) | 41.83 | 0.071 | NS |
Mitotic index- 6 hour sacrifice.
Group number | Mean mitotic index | Standard deviation | Statistical significance |
1. Corn oil | 1.24 | 0.692 | - |
3. 100 mg/kg (male) | 0.52 | 0.335 | NS |
4. 200 mg/kg (female) | 1.20 | 0.648 | NS |
Mitotic index- 24 hour sacrifice.
Group number | Mean mitotic index | Standard deviation | Statistical significance |
1. Corn oil | 1.20 | 0.754 | - |
2. Cyclophosphamide (40 mg/kg) | 0.28 | 0.193 | S |
3. 100 mg/kg (male) | 1.60 | 0.400 | NS |
4. 200 mg/kg (female) | 1.72 | 1.942 | NS |
Mitotic index- 48 hour sacrifice.
Group number | Mean mitotic index | Standard deviation | Statistical significance |
1. Corn oil | 2.48 | 1.734 | - |
3. 100 mg/kg (male) | 2.40 | 1.744 | NS |
4. 200 mg/kg (female) | 1.30 | 0.141 | NS |
S = significant;
NS = not significant.
Applicant's summary and conclusion
- Conclusions:
- The substance is considered not to be clastogenic.
- Executive summary:
The substance was evaluated for clastogenic potential as measured by increases in numerical and structural chromosome aberrations in bone marrow cells in rats. A single dose of the substance was administered by oral gavage to two groups of 15 male rats each at levels of 0 and 100 mg/kg bw and two groups of 15 female rats each at levels of 0 and 200 mg/kg bw. Five males and five females from each group were scheduled to be sacrificed at approximately 6, 24 and 48 hours post-dosing. The results show that no statistically significant increases in the frequency of chromosomal aberrations compared to control values were observed following exposure to the substance. No statistically significant differences were seen between the mean chromosomal numbers and the mean mitotic indices of the test groups and the vehicle controls. Therefore, under the conditions of this study, the substance is considered not to be clastogenic.
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