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EC number: 700-661-1 | CAS number: -
- 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 / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-07-31 to 2012-09-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld, Germany
- Age at study initiation: 9 - 12 weeks
- Weight at study initiation (mean ± SD): 304.5 ± 10.6 g
- Assigned to test groups randomly: yes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 45 - 100 %
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: the vehicle was chosen due to its relative non-toxicity - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
On the day of the experiment, the test material was dissolved in sterile water. All animals received a single standard volume (10 mL/kg bw) orally. The pH of the formulation was adjusted to 5 using NaOH.
At the beginning of treatment the animals were weighed and the individual volume to be administered was adjusted to the animal's body weight. - Duration of treatment / exposure:
- Sinlge administration
- Post exposure period:
- 24 and 48 hours
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
300, 1000, 1500, 2000 mg/kg bw (prelminary toxicity study)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 500, 1000, 2000 mg/kg bw (main study)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 2 males and 2 females (prelminary toxicity study)
7 males per dose group and sampling time (main study) - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
Examinations
- Tissues and cell types examined:
- Femur bone marrow
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION:
At the scheduled sacrifice time, seven animals were sacrificed. The femora were removed, the epiphyses were cut off and the marrow was flushed out with foetal calf serum. The nucleated cells were separated from the erythrocytes. The cell suspensions were then briefly passed through a column consisting of α cellulose and cellulose. The cell suspension was centrifuged at 1500 rpm for 10 minutes and the supernatant was discarded. The pellet was re-suspended in a small drop of foetal calf serum and spread on slides. The smear was air-dried and then stained with May-Grünwald/Giemsa. Cover slips were mounted with EUKITT. At least one slide was made from each bone marrow sample. - Evaluation criteria:
- Evaluation of the slides was performed using NIKON microscopes with100X oil immersion objectives. Per animals at least 2000 polychromatic erythrocytes (PCE) were analysed for micronuclei. To describe a cytotoxic effect the ratio between polychromatic and normochromatic erythrocytes was determined in the same sample and expressed in polychromatic erythrocytes per 2000 erythrocytes. The analysis was performed with coded slides.
The test material was considered positive if it induced either a dose-related increase in the number of micronucleated polychromatic erythrocytes or a statistical positive response for at least one of the test points. A test material producing neither a dose-related increase in the number of micronucleated polychomatic erythrocytes nor a statistically significant positive response at any of the test points was considered to give a negative result in this test system. - Statistics:
- Statistical significance was determined by means of the nonparametric Mann-Whitney test.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- PRELIMINARY TOXICITY STUDY
- No signs of toxicity were observed in animals dosed 300 mg/kg bw. Animals dosed at 1000 mg/kg bw and above exhibited articulation, breath sounds and diarrhoea from 24 hours post-treatment. Animals dosed at 2000 mg/kg bw were also observed to have ruffled fur and reduced spontaneous activity from 1 hour post-treatment onwards.
- On the basis of these data 2000 mg/kg bw was estimated to be suitable as the highest test material treatment dose.
MAIN STUDY
-Toxic symptoms in the main study were confined to ruffled fur in 7 males dosed at 2000 mg/kg bw 2-4 and 6 hours post-administration.
- After treatment with the test material the number of PCEs per 2000 erythrocytes was not substantially decreased as compared to the mean value of PCEs per 2000 erythrocytes of the vehicle control, thus indicating that the test material did not exert cytotoxic effects in the bone marrow.
- In comparison to the corresponding vehicle controls there were no biologically relevant or statistically significant enhancement in the frequency of the detected micronuclei at any preparation interval after administration of the test material with any dose level. The mean values of micronuclei observed after treatment with test material were below or identical to the value of the vehicle control group and within the historical vehicle control range.
- 20 mg/kg bw cyclophosphamide administered once orally was used as positive control which showed a significant increase in micronucleus frequency.
Any other information on results incl. tables
Table 2: Summary of Micronucleus Test Results
Test group |
Dose (mg/kg bw) |
Sampling time (h) |
PCEs with micronuclei (%) |
Range |
PCE per 2000 erythrocytes |
Vehicle |
0 |
24 |
0.121 |
1 - 4 |
981 |
Test material |
500 |
24 |
0.107 |
0 - 7 |
887 |
1000 |
24 |
0.121 |
1 - 5 |
975 |
|
2000 |
24 |
0.114 |
0 - 4 |
877 |
|
Positive control |
20 |
24 |
0.714 |
9 - 19 |
551 |
Test material |
2000 |
48 |
0.093 |
1 - 3 |
942 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of the test, the test material did not induce a significant increase in the incidence of micronucleated polychromatic erythrocytes in bone marrow and was concluded to be negative in the micronucleus test using male rats. - Executive summary:
The genetic toxicity of the test material was investigated in vivo in accordance with the standardised guideline OECD 474. The test material was dissolved in water, which was also used as the vehicle control. The pH was adjusted to 5 with NaOH. The volume administered orally was 10 mL/kg bw. 24 and 48 hours after a single administration of test material the bone marrow cells were collected for micronuclei analysis. Seven males per test group were evaluated for the occurrence of micronuclei. At least 2000 polychromatic erythrocytes were scored for micronuclei per animal.
After treatment with the test material the number of PCEs per 2000 erythrocytes was not substantially decreased as compared to the mean value of PCEs per 2000 erythrocytes of the vehicle control, thus indicating that the test material did not exert cytotoxic effects in the bone marrow. In comparison to the corresponding vehicle controls there were no biologically relevant or statistically significant enhancement in the frequency of the detected micronuclei at any preparation interval after administration of the test material with any dose level. The mean values of micronuclei observed after treatment with test material were below or identical to the value of the vehicle control group and within the historical vehicle control range. The positive control showed a significant increase in micronucleus frequency.
In conclusion, it can be stated that under the conditions of the study, the test material did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the rat. Therefore, the test material is considered to be non-mutagenic in this micronucleus assay.
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