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EC number: 208-765-4 | CAS number: 541-05-9
- 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:
- key study
- Study period:
- 2009-10-12 to 2009-11-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- 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.
Test material
- Reference substance name:
- Hexamethylcyclotrisiloxane
- EC Number:
- 208-765-4
- EC Name:
- Hexamethylcyclotrisiloxane
- Cas Number:
- 541-05-9
- Molecular formula:
- C6H18O3Si3
- IUPAC Name:
- hexamethyl-1,3,5,2,4,6-trioxatrisilinane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kisslegg, GERMANY
- Age at study initiation: 4-6 wk
- Weight at study initiation: 359-445 g
- Housing: 1/Makrolon Type 4 cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 2 wk
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 2009-10-12 To: 2009-11-06
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- induction: intradermal 15%; epidermal 50%
challenge epidermal: 10%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- induction: intradermal 15%; epidermal 50%
challenge epidermal: 10%
- No. of animals per dose:
- test: 10
vehicle control: 5
postitive control: 10
pretest intradermal: 1
pretest epidermal: 2 - Details on study design:
- RANGE FINDING TESTS:
intradermal 5, 10, 15% tested in corn oil (15% was the maximum technically feasible), 1 wk following following 1:1 FCA:saline [15% was selected as highest concentration technically possible, well tolerated systemically and causing mild skin irritation.]
epidermal 10, 15, 25, 50% in corn oil (50% was the maximum technically feasible). [50% (highest techincally possible and causing mild to moderate skin irritation) was chosen for induction and 10% (the highest non-irritant concentration) was chosen for challenge.]
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal-3 paired injections, topical)
- Exposure period: topical 48h
- Test groups: 10
- Control group: +ve 10; -ve 5
- Site: two rows of 3 sites, one row either side of dorsal mid-line
- Frequency of applications: intradermal treatment day 0; topical induction day 7
- Duration: induction period continues to day 21
- Concentrations:
Intradermal - test group: 1:1 FCA saline; 15% TS in corn oil; 15% TS in 1:1 FCA:saline
Intradermal - control group: 1:1 FCA saline; corn oil; 1:1 FCA:saline
Topical - test group: 50% TS in corn oil
Topical - control group: corn oil
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (at two sites: TS and vehicle)
- Day(s) of challenge: day 22
- Exposure period: 24h
- Test groups: 10
- Control group: +ve 10; -ve 5
- Site: flank
- Concentrations: 10% TS in corn oil; corn oil
- Evaluation (hr after challenge): 24 and 48 h following patch removal - Challenge controls:
- There were no responses from any vehicle controls at challenge (see table).
- Positive control substance(s):
- yes
- Remarks:
- 3% alpha-hexylcinnamaldehyde (see table)
Results and discussion
- Positive control results:
- One of ten animals showed skin reactions following challenge with 1% alpha-hexylcinnamaldehyde in PEG 300, with no responses in the control group. Eight of ten responded to a 3% challenge at 24 h, and 9 of ten responded at 48 h, again there were no responses in the controls (see table).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% test substance in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% test substance in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% test substance in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% test substance in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- corn oil
- 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:
- corn oil
- 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:
- corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1% alpha-hexylcinnamaldehyde in PEG 300
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1% alpha-hexylcinnamaldehyde in PEG 300
- 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:
- positive control
- Dose level:
- 3% alpha-hexylcinnamaldehyde in PEG 300
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 3% alpha-hexylcinnamaldehyde in PEG 300
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table 1: Incidence of dermal response to challenge dosing
GROUP |
MATERIAL |
INTERVAL |
DERMAL SCORES* |
SENSITIZATION INCIDENCE INDEX** |
SEVERITY INDEX*** |
|||
0 |
1 |
2 |
3 |
|
|
|||
Test |
TS 10% |
24h |
10/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0 |
48h |
10/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0 |
||
Corn oil |
24h |
10/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0 |
|
48h |
10/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0 |
||
Positive control |
hexylcinnamaldehyde1% |
24h |
9/10 |
1/10 |
0/10 |
0/10 |
1/10 |
0.1 |
48h |
10/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0 |
||
hexylcinnamaldehyde3% |
24h |
2/10 |
8/10 |
0/10 |
0/10 |
8/10 |
0.8 |
|
48h |
1/10 |
9/10 |
0/10 |
0/10 |
9/10 |
0.9 |
||
Vehicle control |
TS 10% |
24h |
5/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0 |
48h |
5/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0 |
||
Corn oil |
24h |
5/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0 |
|
48h |
5/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0 |
Skin reactions were graded
0 no visible change
1 discrete or patchy erythema
2 moderate and confluent erythema
3 intense erythema and swelling
There were no signs of systemic toxicity during the study. All animals gained weight during the study and there were no significant test-article related differences in vehicle and test group mean body weight.
* Number of animals showing skin reactions at each of grades 0 -3
** Incidence Index = number of animals showing post-challenge skin reactions at either 24 or 48 hours, divided by the number of animals in the group
*** Severity Index = Sum of post-challenge test grades divided by the total number of animals tested.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vivo skin sensitisation study, conducted according to OECD Test Guideline 406 and in compliance with GLP, hexamethylcyclotrisiloxane was not sensitising to the skin of guinea pigs.
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