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EC number: 469-070-1 | CAS number: 17861-60-8
- 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:
- 4 March 2003 to 28 March 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- September 30, 1996
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17, 1992
- Deviations:
- yes
- Remarks:
- the dose used to challenge was non-irritant
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed before LLNA was implemented.
Test material
- Reference substance name:
- -
- EC Number:
- 469-070-1
- EC Name:
- -
- Cas Number:
- 17861-60-8
- Molecular formula:
- C9H26O2Si3
- IUPAC Name:
- 4-ethyl-2,2,4,6,6-pentamethyl-3,5-dioxa-2,4,6-trisilaheptane
- Test material form:
- liquid
- Details on test material:
- Other name: Baysilone TP 3886
Constituent 1
- Specific details on test material used for the study:
- Density: 828 g/L at 20°C
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Test animals:
Age:5 weeks at study start
Weight: not reported
Acclimatisation:13 days
Housing: group housed (maximum 10 animals/cage)
Diet: standard laboratory diet ad libitum
Water: tap water ad libitum
Environmental conditions:
Temperature: 20 +/-3°C
Humidity: 30-70%
Ventilation: 10 air changes/hour
Lighting: 12 hours light/dark cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- maize oil
- Concentration / amount:
- 10%
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: FCA/test substance in vehicle 1:1
- Concentration / amount:
- 10%
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Day(s)/duration:
- 2
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- 30%
- Day(s)/duration:
- 1
- Adequacy of challenge:
- other: non-irritant concentration
- No. of animals per dose:
- Test group: 10 animals
Control group: 5 animals - Details on study design:
- The dose levels were chosen following a preliminary irritation study using two animals per treatment route:
Intradermal injections at concentrations of 1,3,10, 30 and 100% and topical treatment at 30 and 100%.
Intradermal injection at concentrations of 30 and 100% produced abscesses
Topical treatment at 100% produced moderate and confluent erythema - Challenge controls:
- Control groups were treated with FCA/physiological saline or vehicle only as appropriate during the induction phase and vehicle only during the challenge phase
- Positive control substance(s):
- yes
- Remarks:
- positive control study run concurrently using 20 and 10% dilution of hexylcinnamaldehyde in saline induced positive reactions in all animals.
Results and discussion
- Positive control results:
- The study with positive control alpha-hexylcinnamaldehyde (application of a 10% dilution) was run in March 2003 in the same test facility. All 5 test animals showed positive response at 24 and 48 hours, while the three animals in the negative control group did not show a reaction.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- negative control
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 2
- 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:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other:
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Positive control not run simultaneously
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 30 %
Signs of irritation during induction:
Moderate erythema
Evidence of sensitisation of each challenge concentration:
Control group: 2 of 5 animals showed slight erythema after
24 hours; after 48 hours no effects were observed.
Test group: 2 of 10 animals showed slight erythema after
24 hours; after 48 hours no effects were observed.
Other observations:
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guinea pig maximization study, performed according to OECD/EC guidelines and under GLP principles, none of the test animals showed positive signs of sensitisation. A positive control group demonstrated the sensitivity of the test system. Based on these findings, it is concluded that heptamethylethyltrisiloxane is not a skin sensitizer under the conditions of this study.
- Executive summary:
The skin sensitization potential of heptamethylethyltrisiloxane was evaluated in female guinea pigs using the Maximization Test. Test substance concentrations used in the main study were based on an initial irritancy screen.
The first induction was performed by intradermal injection with 10% test substance suspension in maize oil and an emulsion of Freund's complete adjuvant (FCA)/10% test substance in maize oil. One week later, a second induction was made by topical application (48 hours) under an occlusive dressing of undiluted test material. Two weeks after the second induction, the animals were challenged by topical application of 30% test substance ointment in maize oil under an occlusive dressing for 24 hours.
Both test and control animals reacted slightly to the test substance and to the vehicle alone at 24 hours after challenge. The degree and incidence were comparable for both test and control groups and considered to be signs of primary skin irritation. None of the test animals showed positive signs of sensitisation. A positive control group demonstrated the sensitivity of the test system.
Based on these findings, it is concluded that heptamethylethyltrisiloxane is not a skin sensitizer under the conditions of this study
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