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EC number: 477-700-1 | CAS number: 883794-93-2
- 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:
- 2007-12-21 - 1008-02-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- -
- EC Number:
- 477-700-1
- EC Name:
- -
- Cas Number:
- 883794-93-2
- Molecular formula:
- Hill formula: C18H36N2O6S2Si2 CAS formula: C18H36N2O6S2Si2
- IUPAC Name:
- 1-{3-[(3-{2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecan-1-yl}propyl)disulfanyl]propyl}-2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Lab, Kissleg, Germany
- Weight at study initiation: test group: 359.7±18.9 g and control group: 341.2±18.7 g
- Housing: 2 or 3 animals in Makrolon(r)-cages No.VI
- Diet (e.g. ad libitum): as pellet (3023 /Altromin Inten. Lage, Germany)
- Water (e.g. ad libitum): tap water
- Acclimation period: 13 days before the main experiment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12 h light/dark-cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mixture of sesame oil and acetone (4:1 w/w)
- Concentration / amount:
- induction and challange: 60 % (w/w)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mixture of sesame oil and acetone (4:1 w/w)
- Concentration / amount:
- induction and challange: 60 % (w/w)
- No. of animals per dose:
- test group: 20
control group: 10
pilot experiment: 6 - Details on study design:
- RANGE FINDING TESTS:
induction and challange: During chambers with soaked patches; either with 25%; 60%; or 80% (w/w) test substance preparation in vehicle
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 2 weeks
- Test groups: 1 (20 animals)
- Control group: 1 (6 animals)
- Site: shaved skin on the left flank
- Frequency of applications: day 0; after 7 and 14 days
- Duration: 6 h
- Concentrations: 60 % (w/w)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28 of the application period
- Exposure period: 6 h
- Test groups: 1 (20 animals)
- Control group: 1 (6 animals)
- Site: on the shaved untreated right flank
- Concentrations: 60% (w/w)
- Evaluation (hr after challenge): 24 and 48 h after patch removal - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole 98% in sesame oil/acetone 4:1 (w/w)
Results and discussion
- Positive control results:
- sensitisation rate: 25%
A total of 5 out of 20 animals were tested positive, 2 thereof showed skin reactions only during 1st reading 24 hours after challeng, 2 animals showed skin reactions only during 2nd reading 48 hours after challenge, and one animal showed skin reactions during both 1st and 2nd reading.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60 % (w/w) test substance in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 % (w/w) test substance in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60 % (w/w) test substance in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 % (w/w) test substance in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 60% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60% (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 60 % (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60 % (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 98%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 98%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 98%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 98%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: no data.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance has to be regarded as non-sensitising under the applied test conditions when exposed to the skin of experimental animals.
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