Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 943-282-9 | CAS number: -
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Remarks:
- patch test
- Principles of method if other than guideline:
- An informed condent document in compliance with FDA regulations (21 CFR 50) was obtained from each subject prior to entering the study.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silane
- Molecular formula:
- CH3(CH2)17OSi(CH3)3
- IUPAC Name:
- Reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silane
- Test material form:
- other: liquid or wax
Constituent 1
Method
- Type of population:
- not specified
- Ethical approval:
- not applicable
- Subjects:
- male and female human at age 18+
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: semiocclusive
- Concentration at induction: Dow Corning Silmogen Carrier - 0.2 mol; Dow Corning Dimethiconol Blend 20 - 0.2 ml; Dow Corning Silky Wax 10 - 0.2 g; Dow Corning Emulsifier 10 - 0.2 ml; Dow Corning Silicone Fluid Q7-9180, 1 cSt. (Supplied as Dow Corning 200 Fluidd, 1 cSt) - 0.2 ml; Dow Corning Silicone Fluid Q7-9180, 1.5 cSt. (Supplied as Dow Corning 200 Fluidd, 1.5 cSt)
- Concentration at challenge: Dow Corning Silmogen Carrier - 0.2 mol; Dow Corning Dimethiconol Blend 20 - 0.2 ml; Dow Corning Silky Wax 10 - 0.2 g; Dow Corning Emulsifier 10 - 0.2 ml; Dow Corning Silicone Fluid Q7-9180, 1 cSt. (Supplied as Dow Corning 200 Fluidd, 1 cSt) - 0.2 ml; Dow Corning Silicone Fluid Q7-9180, 1.5 cSt. (Supplied as Dow Corning 200 Fluidd, 1.5 cSt)
- Description of patch:
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 24 hours
- Test sites: Prior to application of the patches, the sites were outlined with a skin marker e.g. genitan violet. The subjects were requid to remove the patches approximately 24 hours after application, The returned to the facility at 48-hour intervals to have the sites evaluated and identical patches were appl ied to the same sites.
- Control site: When the positive control site had a grade of +D, application of the SLS control was discontinued
- Site: infrascapular area of the back
- Frequency of applications: 48 hour intervals (Patches applied on Friday were removed by subjects after 24 hours and sites were evaluated 72 hours after application on the following Monday) - Duration: 3 weeks - Concentrations:
12-14 day REST PERIOD
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Week 6
- Exposure period: 24 hours
- Test sites: Identical patches were applied to sites previously unexposed to the study material. Patches were removed by subjects after 24 hours and the sites graded after additional 24 and 48 hour periods. - Control group:
- Site: infrascapular area of the back- Concentrations:
- Evaluation (hr after challenge): 48 and 72 hours
OTHER: Rechallenge was not required.
Results and discussion
- Results of examinations:
- 5 subjects exhibited minimal or doubtful erythema with a papular response > 50% to Dow Corning Silky Wax 10 during induction.
Applicant's summary and conclusion
- Conclusions:
- In a well conducted human patch test conducted according to GLP trimethyl(octadecyloxy)silane was not sensitising to the skin of human volunteers.
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