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EC number: 205-492-2 | CAS number: 141-63-9
- 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:
- 10/09/1991 to 13/01/1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- 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:
- Hexamethyldisiloxane
- EC Number:
- 203-492-7
- EC Name:
- Hexamethyldisiloxane
- Cas Number:
- 107-46-0
- Molecular formula:
- C6H18OSi2
- IUPAC Name:
- hexamethyldisiloxane
- Test material form:
- other: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratory
- Age at study initiation: No data
- Weight at study initiation: 338-387 g
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: 09/10/1991 To: 02/11/1991
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: ethanol and saline (unchanged (at challange))
- Concentration / amount:
- Various concentrations used in the induction phase, and HMDS was undiluted in the challenge phase.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol and saline (unchanged (at challange))
- Concentration / amount:
- Various concentrations used in the induction phase, and HMDS was undiluted in the challenge phase.
- No. of animals per dose:
- 15; 10 males in the test group and 5 males in the negative control group.
- Details on study design:
- Preliminary test:
The hair of both flanks was clipped prior to dosing. Various concentrations (25, 50, 75 and 100%) of L2 were applied to the cotton pads of Hilltop Chambers and then applied to the flank skin. The sites were then wrapped with adhesive tape and unwrapped after approximately 24 hours and evaluated for erythema and oedema.
Main study:
For the first stage of induction, an area over the shoulder region was clipped on each animal. Three pairs of intradermal injections (0.1 ml each) were made simultaneously on previously identified sites (A, B and C), so that there was a row of three injections on each side of the spine. The injection sites were just within the boundaries of a 2x4 cm patch which was applied one week later. Injections were administered as follows:
Test substance:
A: 0.1 ml of a 50% suspension of FCA in saline.
B: 0.1 ml of 5% HMDS in 80% ethanol (suspension).
C: 0.1 ml of 10% HMDS in 80% ethanol + 50% FCA in saline (suspension).
Negative controls:
A: 0.1 ml of 50% suspension of FCA in saline.
B: 0.1 ml of 80% ethanol (solution).
C: 0.1 ml of 80% ethanol + 50% FCA in saline (suspension).
On day 7 the area of injections was clipped in preparation for the second induction. Patches of filter paper were saturated with the following solutions: a) test group - undiluted L2 and b) negative controls - 80% ethanol. The patches were positioned on the intradermal injection sites and secured in place with an occlusive bandage for 48 hours and then unwrapped.
The challenge phase began two weeks following topical induction. The animals were prepared by clipping a 5x5 cm area on both flanks. For dosing, 0.3 ml of the test (100%) or control ethanol solutions were applied to a Hilltop Chamber (occlusive) and the chamber applied to the flank area and wrapped with gauze dressing and adhesive tape for 24 hours.
The wrappings were removed 24 hours later and the readings were made at 24 and 48 hours after patch removal and scored for erythema and oedema. Body weights were taken at the beginning of the study and at 7, 14 and 21 days. Erythema or oedema at least two grades higher than that seen in the negative control group was considered evidence of an allergic response. - Challenge controls:
- Ethanol solution
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No evidence of skin irritation or sensitization following challenge phase. Intradermal injection sites showed necrosis and scabbing typical of Freund's Complete Adjuvant response. No obvious effects on body weight gain or food consumption.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: not included in the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guinea pig maximisation study conducted using a study protocol comparable with OECD 406 and to GLP (reliability score 1) L2 was not sensitising to the skin.
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