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EC number: 221-906-4 | CAS number: 3277-26-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 January 2006 to 10 April 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- (temporary deviations from the minimum level of relative humidity occurred (27%, a minimum of 30% is recommended))
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines (2000), including the most recent partial revisions at time of reporting
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,1,3,3-tetramethyldisiloxane
- EC Number:
- 221-906-4
- EC Name:
- 1,1,3,3-tetramethyldisiloxane
- Cas Number:
- 3277-26-7
- Molecular formula:
- C4H14OSi2
- IUPAC Name:
- 1,1,3,3-tetramethyldisiloxane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 12 weeks
- Weight at study initiation: not exceeding ± 20% of the mean
- Fasting period before study: food withheld overnight (a maximum of 20 hours) prior to dosing until 3-4 hours after test substance administration
- Housing: in groups of three in labelled Macrolon cages (MIV type)
- Diet (e.g. ad libitum): standard diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 to 22.6
- Humidity (%): 27 to 63
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17 January 2006 To: 2 February 2006
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.667 ml/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 (3 females in first and second set)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (dosing on day 1, observation until day 15)
- Frequency of observations and weighing: clinical signs monitored "at periodic intervals on the day of dosing", apparently 0, 2 and 4 hours after treatment, and then once daily until day 15. Body weights were recorded on days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was performed
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- mortality
- Remarks on result:
- other: no mortality at 2000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- other: OECD Test Guideline 423
- Remarks on result:
- other: No mortalities in a 2-step test starting with 2000 mg/kg bw suggests an LD50 cut-off value of at least 5000 mg/kg bw, according to the OECD guideline
- Mortality:
- No mortality occurred over the course of the study.
- Clinical signs:
- other: Piloerection or hunched posture was seen in two animals on day 1.
- Gross pathology:
- No macroscopic abnormalities found at post mortem.
- Other findings:
- - Organ weights: not examined
- Histopathology: not examined
- Potential target organs: not examined
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The key acute oral toxicity study, conducted according to OECD Test Guideline 423 and in compliance with GLP, concluded an LD50 value of >2000 mg/kg bw.
- Executive summary:
The test substance was tested for acute oral toxicity to rats in study conducted according to OECD Test Guideline 423 and in compliance with GLP.
Three female Wistar rats were given a single oral gavage administration of 2000 mg/kg bw 1,1,3,3-tetramethyldisiloxane. The rats were then observed for fourteen days, after which they were sacrificed and subject to gross necropsy. This process was then repeated with a further three female rats.
Over the course of the study, there were no deaths or overt signs of systemic toxicity, besides piloerection and hunched posture, each seen in one animal on day 1. No significant, treatment-related effect on body weight was reported, and no macroscopic abnormalities were detected at post mortem examination.
The acute oral LD50 in rats was determined to be greater than 2000 mg/kg bw.
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