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EC number: 219-154-7 | CAS number: 2374-14-3
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-04-02 to 2012-05-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA GLP Standards 40 CFR 792 (TSCA)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane
- EC Number:
- 219-154-7
- EC Name:
- 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane
- Cas Number:
- 2374-14-3
- Molecular formula:
- C12H21F9O3Si3
- IUPAC Name:
- 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane
- Reference substance name:
- 002374-14-3
- Cas Number:
- 002374-14-3
- IUPAC Name:
- 002374-14-3
- Test material form:
- other: opaque solid
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Frederick, MD
- Age at study initiation: 6 weeks old
- Weight at study initiation: 29.4 - 32.5 grams (male) and 23.9 - 28.8 grams (female)
- Assigned to test groups randomly: yes (based on equalization of group mean body weights)
- Housing: Five same sex per rodent Micro-Barrier cage
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72 +/- 3F
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: To: 18 - 23 April 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: based on Sponsor information
- Concentration of test material in vehicle:
- Amount of vehicle (if gavage or dermal): 80%
- Type and concentration of dispersant aid (if powder):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 24 and 48 hours
- Frequency of treatment:
- Test compounds and controls were administered by a single oral gavage at a dose volume of 10mL/kg body weight.
- Post exposure period:
- Negative and positive controls and all three dose levels were sacrificed at 24 hours after administration of test substance. The vehicle control and highest dose level were sacrificed 48 hours after administration of test substance.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Five
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - cyclophosphamide
- Justification for choice of positive control(s): standard guideline positive control
- Route of administration: oral gavage
- Doses / concentrations: 50 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow was collected from all treatment groups and polychromatic erythrocytes (PCE's) and normochromatic erythrocytes (NCE's) were examined for micronuclei.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: limit dose
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): no further information
DETAILS OF SLIDE PREPARATION: Following euthanasia, the femurs were exposed, and the bone marrow was aspirated into syringe with foetal bovine serum. The bone marrow was centrifuged and the supernatant drawn off. The cell pellet was re-suspended and a small drop of bone marrow suspension was spread onto a clean glass slide (2 slides per mouse). The slides were air dried, fixed in methanol and stained with acridine orange.
METHOD OF ANALYSIS: Slides were coded randomly. Bone marrow cells were evaluated using a fluorescent microscope. 2000 polychromatic erythrocytes (PCEs) were scored for micronuclei per animal. The number of normochromatic erythrocytes (NCEs) and micronucleated NCEs (MNCEs) in the field of 1000 total erythrocytes was determined. The proportion of PCEs to total erythrocytes (ECs) was also determined per 1000 erythrocytes for each animal. - Evaluation criteria:
- The test article would have been considered to induce a positive response if the incidence of micronucleated polychromatic erythrocytes at one or more doses is statistically elevated relative to the vehicle control, in a dose dependent manner and exceeding the range of historical vehicle controls.
- Statistics:
- Statistical significance was determined using the Kastenbaum-Bowman tables which are based on the binomial distribution. All analyses were performed separately for each sex and sampling time.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- on PCE/EC ratios
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF DETERMINATION OF SYSTEMIC AVAILABILITY:
All animals survived until post-dose collection time point.
Dose concentration, stability and homogeneity were verified by GC/FID methods. The dose solution concentrations were determined to be within the criteria for acceptance, and to be stable for at least two days at room temperature. No extraction of the solutions was carried out prior to determining concentration.
The limit of quantitation of the GC/MS determination of test article content in plasma was 14.4 ng/g. Test article detected in plasma was significantly above the limit of detection for all dose groups at both blood collection time points.
Necroscopy: gross lesions were noted in one animal in the low dose group, these were not attributed to the test article. No gross lesions were observed in any other animal.
Any other information on results incl. tables
Summary of Bone Marrow Micronucleus Analysis
Treatment (10 ml/kg) |
Sex and time (hrs) |
Mean of PCE/Total erythrocytes |
Mean of MPCE/1000 PCE |
Number of MPCE/PCE scored |
Solvent control |
M - 24 |
0.576 |
0.2 |
2 / 1000 |
F -24 |
0.574 |
0.4 |
4 / 1000 |
|
500 mg/kg bw |
M - 24 |
0.556 |
0.5 |
5 / 1000 |
F - 24 |
0.563 |
0.2 |
2 / 1000 |
|
1000 mg/kg bw |
M - 24 |
0.412 |
0.2 |
2 / 1000 |
F - 24 |
0.587 |
0.4 |
4 / 1000 |
|
2000 mg/kg bw |
M - 24 |
0.522 |
0.2 |
2 / 1000 |
F - 24 |
0.568 |
0.5 |
5 / 1000 |
|
Positive control |
M - 24 |
0.500 |
24.4 |
**244 / 1000 |
F - 24 |
0.488 |
18.0 |
**180 / 1000 |
|
Solvent control |
M - 48 |
0.579 |
0.2 |
2 / 1000 |
F - 48 |
0.582 |
0.3 |
3 / 1000 |
|
2000 mg/kg bw |
M - 48 |
0.447 |
0.6 |
6 / 1000 |
F - 48 |
0.426 |
0.3 |
3 / 1000 |
** Statistically significant increase compared to vehicle control
Applicant's summary and conclusion
- Conclusions:
- 2,4,6-Trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane was tested in an in vivo mouse micronucleus assay conducted according to OECD Test Guideline 474 and in compliance with GLP. No evidence of test substance related induction of micronucleus was observed after oral administration by gavage at doses of 500, 1000 and 2000 mg/kg bw. No test substance related changes in the PCE/NCE ratio were observed, so it was concluded that the test substance did not inhibit erythropoiesis. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is not genotoxic under the conditions of the test.
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