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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
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- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Nanomaterial specific surface area
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- Endpoint summary
- Stability
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- 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
Endpoint summary
Administrative data
Description of key information
Three studies have been included as weight of evidence for the sensitisation endpoint.
Two of the studies are in guinea pig (Dow Corning Corporation, 1996; 1998) and use the registered substance, 1,1,3,3-tetramethyl-1,3-divinyldisiloxane, as negative control substance, therefore supporting the conclusion that 1,1,3,3-tetramethyl-1,3-divinyldisiloxane is not a skin sensitiser.
In addition, a human patch test study conducted in compliance with GLP
for the structural analogue hexamethyldisiloxane (HMDS; CAS 107-46-0)
has been included as weight of evidence. Hexamethyldisiloxane was
concluded to be not sensitising to the skin of human volunteers (TKL
Research, 1992).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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.
- 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.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- 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
- 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
- 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
- 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.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 18 April 1996 - 30 April 1996
- 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.
- 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 (incl. QA statement)
- 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.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Sasco, Inc., Madison WI
- Age at study initiation: 3 weeks
- Weight at study initiation: 210-276g
- Housing: Individual stainless steel cages (23.9x17.8x39.8cm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: min. 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24
- Humidity (%): 25-72
- Photoperiod (hrs dark / hrs light):12/12 - Route:
- intradermal
- Vehicle:
- other: Vehicle control: 1,1,3,3-tetramethyl-1,3-divinyldisiloxane Positive control vehicle: propylene glycol
- Concentration / amount:
- Test group: 5% test substance in vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane); saline/FCA; test substance/FCA/saline
Vehicle control group: vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane); saline/FCA; vehicle/FCA/saline
Positive control group: DNCB/PG (propylene glycol); saline/FCA; DNCB/FCA/saline - Day(s)/duration:
- single intraderaml 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: 100% test substance
Vehicle control group: Undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane)
Positive control group: 0.1% DNCB in PG - Day(s)/duration:
- 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- 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: 50% test material in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) and 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane)
- Vehicle control group:50% test material in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) and 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane)
- Positive control group: 0.1% DNCB in PG and 100% PG - Day(s)/duration:
- 24-hour application
- 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 material in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) and 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane)
- Vehicle control group:50% test material in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) and 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane)
- Positive control group: 0.1% DNCB in PG and 100% PG - Day(s)/duration:
- 24-hour application
- No. of animals per dose:
- test: 20 males
vehicle control group: 10 males
positive control group: 10 males - Details on study design:
- RANGE FINDING TESTS:
Based on the preliminary topical applications, a 5% suspension was found to be the optimal concentration for the first (intradermal) induction, undiluted (100%) TS for the second induction, and a 50% suspension for the first and second challenges.
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: test substance in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane); saline/FCA; test substance/FCA/saline
- right flank: 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: vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane); saline/FCA; vehicle/FCA/saline
- right flank: 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
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.
- Undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) was applied on the flanks of vehicle control animals
- 0.1% DNCB in 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 the test substance formulation at a concentration of 50% in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) 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: The vehicle control animals received 0.3 ml of the test substance formulation at a concentration of 50% in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the upper left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the upper right flank.
- 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.
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
- Test group: 0.3 ml of the test substance formulation at a concentration of 50% in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) 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: The vehicle control animals received 0.3 ml of the test substance formulation at a concentration of 50% in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the lower left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the lower right flank. - Challenge controls:
- FIRST CHALLENGE: The vehicle control animals received 0.3 ml of the test substance formulation at a concentration of 50% in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the upper left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the upper right flank.
SECOND CHALLENGE: The vehicle control animals received 0.3 ml of the test substance formulation at a concentration of 50% in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the lower left flank and 0.3 ml of the undiluted vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on the lower right flank.
None of the vehicle control animals exhibited positive reactions at the test substance-challenge site (left flank) and no positive reactions were observed at the vehicle challenge site (right flank) in animal for all groups during the study. - Positive control substance(s):
- yes
- Remarks:
- DNCB
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% test material in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on left flank
- No. with + reactions:
- 2
- 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:
- 50% test material in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on left flank
- No. with + reactions:
- 6
- 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:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on 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 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:
- 50% test material in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on left flank
- No. with + reactions:
- 9
- 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:
- 50% test material in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane)
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Second challenhe
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on 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 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:
- 50% test material in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on 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:
- 50% test material in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on 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:
- 100% vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on 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 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:
- 50% test material in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on 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 material in the vehicle (1,1,3,3-tetramethyl-1,3-divinyldisiloxane) on 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 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 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 in PG on 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 in PG on 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% PG on 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% PG on right flank
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- First challenge
- 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.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No standard study was available for skin sensitisation. However two reliable, OECD compliant studies were available in which the registered substance, 1,1,3,3-tetramethyl-1,3-divinyldisiloxane, was used as the negative control (Dow Corning Corporation, 1996, 1998). The studies have been included as weight of evidence to support the conclusion that the registered substance is not a skin sensitiser. Additionally, the key study from the structurally analogous substance hexamethyldisiloxane (HMDS; CAS 107-46-0) is included as weight of evidence. In the study hexamethyldisiloxane was tested on the skin of human volunteers and it was concluded to be not sensitising to human skin (TKL Research, 1992).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information, no classification for skin sensitisation is proposed for 1,1,3,3-tetramethyl-1,3-divinyldisiloxane according to Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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