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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Standard tox study design
- GLP compliance:
- yes
- Limit test:
- no
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
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Langshaw Farms, Augusta, Michigan
- Age at study initiation: approx 5 weeks old
- Weight at study initiation: not stated
- Housing: standard stainless steel cages
- Diet: PURINA Rabbit Chow (ad libitum)
- Water: fresh water (ad libitum)
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 50-60
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated
IN-LIFE DATES: From: To: not stated
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: not stated
- % coverage: not stated
- Type of wrap if used: impervious sleeve of plastic material
- Time intervals for shavings or clippings: at least 24 hours before initial application, as needed thereafter
REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm water
- Time after start of exposure: 6 hours
TEST MATERIAL
- Amount applied (volume or weight with unit): not stated
- Concentration: 100%
- Constant volume or concentration used: not stated
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6 hours per day
- Frequency of treatment:
- 5 days per week for 3 weeks
Doses / concentrationsopen allclose all
- Dose / conc.:
- 40 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, sham-exposed
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least twice daily after application of test material
DETAILED CLINICAL OBSERVATIONS: No data
DERMAL IRRITATION (if dermal study): No data
BODY WEIGHT: Yes
- Time schedule for examinations: Day 1, 4, 8, 12, 16 and 21
FOOD CONSUMPTION: Yes
- Time schedule for examinations: Day 1, 4, 8, 12, 16 and 21
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at termination
- Anaesthetic used for blood collection: Yes (methoxyflurane)
- Animals fasted: No data
- How many animals: All
- Parameters not stated
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at termination
- Animals fasted: No data
- How many animals: All
- Parameters not stated
URINALYSIS: Yes
- Time schedule for collection of urine: for 16 hours prior to termination
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters not stated
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, performed on all major tissues, organs, orifices, cranial, thoracic, abdominal and pelvic cavities and their viscera.
ORGAN WEIGHT: A complete set of organs and tissues were weighed
HISTOPATHOLOGY: Yes, a complete set of organs and tissues were removed and preserved. - Statistics:
- Statistical comparisons between control and test groups were carried out where applicable. The data were analysed by employing Dunnett multiple t-test. Where appropriate, a non-parametric analysis of variance by ranks was used to evaluate these parameters. The 95% (p<0.05) confidence level was used as the criteria of significance.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- There were no remarkable clinical signs. Three male and 2 females died during the treatment period at 400 mg/kg/day. One female at 200 mg/kg/day died as a result of acute pneumonia.
- Dermal irritation:
- not specified
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant reduction in body weight gain was noted for females at 200 and 400 mg/kg/day, similar, but less marked, effects on body weight were noted for males at the same doses.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Lower food consumption was recorded at 200 and 400 mg/kg/day during the treatment period.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- There was no effect of treatment.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Serum alkaline phosphatase activity was significantly lower at 200 or 400 mg/kg/day. Significantly higher serum glutamic-pyruvic transaminase and serum glutamic oxalacetic transaminase were noted in males at 200 or 400 mg/kg/day. For females, only serum glutamic oxalacetic transaminase was higher at 200 mg/kg/day.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- There was no effect of treatment.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Relative liver weight was lower in females at all doses and to a lesser extent males.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No remarkable findings.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No effect of treatment.
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- System:
- gastrointestinal tract
- Organ:
- liver
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Dermal administration of 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane to rabbits at 40, 200 or 400 mg/kg bw/day (5 days a week for 3 weeks) resulted in mortality at 400 mg/kg bw/day and lower body weight gain, food consumption, serum alkaline phosphatase activity and relative organ weight and increased serum glutamic-pyruvic transaminase and glutamic oxalacetic transaminase at 200 and 400 mg/kg bw/day. The no-observed-adverse-effect-level was considered to be 40 mg/kg bw/day.
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