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EC number: 402-140-1 | CAS number: 17865-32-6 CHMMS; CHMS; DYNASYLAN 9407; Z-6187
- 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
Endpoint summary
Administrative data
Description of key information
In the key study performed in accordance with OECD Test Guideline 406 (guinea pig maximisation test) and in compliance with GLP, with no deviations, cyclohexyl(dimethoxy)methylsilane is not considered to be a skin sensitiser (Huntingdon Research Centre Ltd, 1989b)
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:
- key study
- Study period:
- 14.03.1989 to 08.04.1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (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.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, England
- Age at study initiation: No data
- Weight at study initiation: 330-387 g
- Housing: Suspended cages with wire mesh floors.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14.03.1989 To: 08.04.1989 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Intradermal induction: 0.1 ml 50:50 FCA/water, 0.1 ml of 20% v/v test substance in Alembicol D and in 50:50 mixture of FCA and Alembicol D
Topical induction: 100% - Day(s)/duration:
- Day 1 for intradermal induction, Day 8 for epidermal induction/48h of application for the dressing
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Topical challenge: 0.2 ml of the test item in 80 and 40% v/v in Alembicol D
- Day(s)/duration:
- Day 22/24h of application
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 test females
10 control females - Details on study design:
- RANGE FINDING TESTS: The intradermal and topical irritancy of a range of dilutions of Silan PSX 854 was investigated to identify (a) irritant test substance concentrations suitable for the induction phase of the main study and (b) non-irritant concentration by the topical route of administration for the challenge phase. Based on the results the following concentrations were selected: Induction intradermal injection: 20% v/v in Alembicol D, and induction topical application: as supplied (undiluted); for the challenge phase 80% and 40% v/v in Alembicol D.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: One intradermal injection and one topical application
- Exposure period: Topical application for 48 hours
- Test groups: Intradermal injection: (1) Freund's complete adjuvant (FCA) diluted with an equal volume of water for irrigation; (2) Silan PSX 854, 20%; (3) Silan PSX 854, 20% in 50:50 mixture of FCA and Alembicol. Topical application: Patch saturated with occlusive dressing applied for 48 hours.
- Control group: Treated similarly to test animals with the exception that the test substance was omitted from the intradermal injections and topical application.
- Site: Dorsal skin on scapular region
- Frequency of applications: One week apart
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Two weeks after induction period
- Exposure period: 24 hours
- Test groups: Patch saturated with approximately 0.2 ml test substance applied to all animals
- Control group: Treated the same as the test group
- Site: Left flank
- Concentrations: 80 and 40 % v/v in Alembicol D
- Evaluation (hr after challenge): 24, 48 and 72 hours after patch removal - Challenge controls:
- A positive control was not included in this study, but historical controls for the laboratory were presented for formalin.
- Positive control substance(s):
- yes
- Positive control results:
- Historical controls confirmed sensitivity of the laboratory that conducted the test.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 40 or 80% tested
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- One animal died, three animals gave an inconclusive result. Even if these three animals are assumed to be positive there were fewer than 30% of animals affected, which means that the criteria for a positive result were not met.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 80 or 40%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- localised dermal reaction (restricted to a small area of the challenge site)
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: positive control was not included in this study but sensitivity of the strain is checked periodically with formalin, a known sensitiser
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In a guinea pig maximisation study conducted according to OECD Test Guideline 406 and in compliance with GLP (reliability score 1), cyclohexyldimethoxymethylsilane did not induce skin sensitisation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are two reliable skin sensitisation studies for cyclohexyl(dimethoxy)methylsilane. The key study gave a clear negative result. In the second study an apparent positive result was concluded. However, re-evaluation of the results revealed that the positive results were based on Grade 1 erythema after 24 hours when the undiluted substance was tested. Although this erythema appeared to be more pronounced than in the control group, the preliminary study showed Grade 2 reactions (after 1 hour, resolved by 24 hours) for the neat test substance. Therefore the low irritancy observed in this study is not consistent with the known irritating properties of this substance, which is a Category 2 skin irritant. Therefore expert evaluation of the available data concluded that the substance should not be considered a skin sensitiser
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the key in vivo skin sensitisation study, cyclohexyl(dimethoxy)methylsilane does not meet the criteria for classification as a skin sensitiser according to Regulation (EC) No 1272/2008. There are no data to suggest that classification as a respiratory sensitiser is required.
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