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EC number: 220-099-6 | CAS number: 2627-95-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- June 1998 - November 1998
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to guideline, however, it did not test the sensitisation potential of the registered substance. The negative control substance used in the study is the registered substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- The negative control substance used in the study is the registered substance.
- Principles of method if other than guideline:
- The registration substance, 1,1,3,3-tetramethyl-1,3-divinyldisiloxane (CAS 2627-95-4) is the negative (vehicle) control used in the study.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Test material
- Reference substance name:
- 1,1,3,3-tetramethyl-1,3-divinyldisiloxane
- EC Number:
- 220-099-6
- EC Name:
- 1,1,3,3-tetramethyl-1,3-divinyldisiloxane
- Cas Number:
- 2627-95-4
- Molecular formula:
- C8H18OSi2
- IUPAC Name:
- ethenyl[(ethenyldimethylsilyl)oxy]dimethylsilane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Vehicle control: 1,1,3,3-tetramethyl-1,3-divinyldisiloxane Positive control vehicle: propylene glycol
- Concentration / amount:
- test group animals: 5% test substance in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane); saline/FCA; test substance/FCA/saline
vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) control group: 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane); saline/FCA; vehicle/FCA/saline
positive control group animals: DNCB/PG (propylene glycol); saline/FCA; DNCB/FCA/saline
crosslinker (CL) control group: CL/Vehicle; saline/FCA; CL/FCA/saline - Day(s)/duration:
- single intradermal injection
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vehicle control: 1,1,3,3-tetramethyl-1,3-divinyldisiloxane Positive control vehicle: propylene glycol
- Concentration / amount:
- test group animals: 100% test substance
vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) control group: 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane)
positive control group animals: 0.1% DNCB in propylene glycol (PG)
crosslinker (CL) control group: 100% test substance - Day(s)/duration:
- 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vehicle control: 1,1,3,3-tetramethyl-1,3-divinyldisiloxane Positive control vehicle: propylene glycol
- Concentration / amount:
- - Test group: 100% test substance and 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane)
- Vehicle control group: 100% test substance and 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane)
- Positive control group: 0.1% DNCB/PG and 100% PG
- Crosslinker controls: 100% CL substance and 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) - Day(s)/duration:
- 24 hours
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vehicle control: 1,1,3,3-tetramethyl-1,3-divinyldisiloxane Positive control vehicle: propylene glycol
- Concentration / amount:
- - Test group: 50% test substance and 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane)
- Vehicle control group: 50% test substance and 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane)
- Crosslinker controls: 50% CL substance and 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) - Day(s)/duration:
- 24 hours
- No. of animals per dose:
- 20 test substance, 10 vehicle control, 10 positive control, 10 crosslinker control
- Details on study design:
- RANGE FINDING TESTS:
Based on the preliminary topical applications, a 5% test substance in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) was found to be the optimal concentration for the first (intradermal) induction, undiluted (100%) TS for the second induction and the first challenge and a 50% test substance in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) for the second challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal induction on day 1 followed by a topical induction on day 8)
- Exposure period: Intradermal induction on day 1 followed by a topical induction on day 8
INTRADERMAL INDUCTION: The first induction was performed on day 1, when the fur over the scapula of each animal in an area of approximately 4x6 cm was shaved and six intradermal injections (three pairs) of 0.1 ml of the dosing formulations were made flanking the dorsal midline.
The following intradermal injections were made on the test group animals:
- left dorsal flank: 5% test substance in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane); saline/FCA; test substance/FCA/saline
- right flank: 5% test substance in vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane); saline/FCA; test substance/FCA/saline
The following intradermal injections were made on the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) control group:
- left dorsal flank: 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane); saline/FCA; vehicle/FCA/saline
- right flank: 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane); saline/FCA; vehicle/FCA/saline
The following intradermal injections were made on the positive control group animals:
- left dorsal flank: DNCB/PG (propylene glycol); saline/FCA; DNCB/FCA/saline
- right flank: DNCB/PG; saline/FCA; DNCB/FCA/saline
The following intradermal injections were made on the crosslinker (CL) control group animals:
- left dorsal flank: CL (different substannce)/Vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane); saline/FCA; CL/FCA/saline
- right flank: CL (different substannce)/Vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane); saline/FCA; CL/FCA/saline
TOPICAL INDUCTION: Since no signs of dermal irritation were observed using several different concentrations of the test substance during the preliminary study, the area of that had received the i.d. injections was shaved and 0.5 ml of a 10% aqueous SLS formulation was applied on day 7 to induce dermal irritation. On day 8 topical induction was performed on the test, vehicle control and positive control animals. The test item or control substances were applied onto the dorsal flanks for 48 hours.
- The neat test substance was applied topically over the six injection sites of each test-substance-treated animals or crosslinker animals.
- Undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) was applied on the flanks of vehicle control animals
- 0.1% DNCB in propylene glycol (PG) was applied onto the flanks of the positive control animals.
B. CHALLENGE EXPOSURE
FIRST CHALLENGE: On day 22, two weeks following the application of the last induction dose. Applied for 24 hours. Sensitisation reactions were evaluated at 24 and 48 hours
- Test group: 0.3 ml of 100% test substance formulation was applied to the shaved upper left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) was applied to the shaved upper right flank of each of the 20 test group animals.
- Vehicle control group: 0.3 ml of 100% test substance formulation was applied to the shaved upper left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) was applied to the shaved upper right flank of each of the 20 test group animals.
- Positive control group: 0.3 ml of 0.1% DNCB/PG were applied on the upper left flank and 100% PG was applied on the upper right flank.
- Crosslinker controls: 0.3 ml of 100% CL substance formulation was applied to the shaved upper left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) was applied to the shaved upper right flank of each of the 20 test group animals.
SECOND CHALLENGE: On day 29, one week following the first challenge dosing. Applied for 24 hours. Sensitisation reactions were evaluated at 24 and 48 hours. Second challenge was performed for the test, vehicle control and crosslinker control groups.
- Test group: 0.3 ml of 50% test substance formulation was applied to the shaved lower left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) was applied to the shaved lower right flank of each of the 20 test group animals.
- Vehicle control group: 0.3 ml of 50% test substance formulation was applied to the shaved lower left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) was applied to the shaved lower right flank of each of the 20 test group animals.
- Crosslinker controls: 0.3 ml of 50% CL substance formulation was applied to the shaved lower left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) was applied to the shaved lower right flank of each of the 20 test group animals. - Challenge controls:
- FIRST CHALLENGE:
- Vehicle control group: 0.3 ml of 100% test substance formulation was applied to the shaved upper left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) was applied to the shaved upper right flank of each of the 20 test group animals.
- Positive control group: 0.3 ml of 0.1% DNCB/PG were applied on the upper left flank and 100% PG was applied on the upper right flank.
- Crosslinker controls: 0.3 ml of 100% CL substance formulation was applied to the shaved upper left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) was applied to the shaved upper right flank of each of the 20 test group animals.
SECOND CHALLENGE:
- Vehicle control group: 0.3 ml of 50% test substance formulation was applied to the shaved lower left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) was applied to the shaved lower right flank of each of the 20 test group animals.
- Crosslinker controls: 0.3 ml of 50% CL substance formulation was applied to the shaved lower left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) was applied to the shaved lower right flank of each of the 20 test group animals. - Positive control substance(s):
- yes
- Remarks:
- DNCB
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% test substance on the left flank
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% test substance on the left flank
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% test substance on the left flank
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Second challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% test substance on the left flank
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Second challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Second challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Second challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% test substance on the left flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% test substance on the left flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% test substance on the left flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Second challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% test substance on the left flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Second challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Second challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Second challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% DNCB/PG on the left flank
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% DNCB/PG were applied on the upper left flank
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100% propylene glycol on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100% propylene glycol on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: crosslinker control
- Dose level:
- 100% CL substance on the left flank
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: crosslinker control
- Dose level:
- 100% CL substance on the left flank
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: crosslinker control
- Dose level:
- 50% CL substance on the left flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Second challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: crosslinker control
- Dose level:
- 50% CL substance on the left flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Second challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: crosslinker control
- Dose level:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: crosslinker control
- Dose level:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- First challenge
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: crosslinker control
- Dose level:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Second challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: crosslinker controls
- Dose level:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the right flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Second challenge
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- The registration substance, 1,1,3,3-tetramethyl-1,3-divinyldisiloxane (CAS 2627-95-4) was used as the negative (vehicle) control in the study and was concluded to be not a sensitising to skin.
- Conclusions:
- In the in vivo skin sensitisation study, conducted according to OECD Test Guideline 406 and in compliance with GLP, the negative/vehicle control substance used is the registration substance, 1,1,3,3-tetramethyl-1,3-divinyldisiloxane (CAS 2627-95-4). The substance was concluded to be not sensitising to skin when applied undiluted during the first and second challenge.
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