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Diss Factsheets
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EC number: 700-268-5 | CAS number: 18143-33-4
- 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:
- 2002-07-01 until 2002-08-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Good laboratory practice guideline study (OECD).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Silane 434099 VP
- Substance type: intermediate
- Physical state: liquid
- Stability under test conditions: pure: stable, in Water: hydrolysis in water with formulation of methanol
- Storage condition of test material: room temperature in the dark
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: 350-390 g
- Housing: semi-barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3 °C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): at least ^10
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- cotton seed oil
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- No. of animals per dose:
- 10 in main study
- Details on study design:
- RANGE FINDING TESTS:
3 Animals were intradermally treated with 1% and 5% concentration of the test items. No signs of irritation or systemic toxiocity occured. 2 Animals were topically treated with 50% as well as 100 % for 24 and 48 h respectively. No signs of irritation and systemic toxicity were observed.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 7days
- Test groups: pure substance or TS 5% in Cotton seed oil
- Control group: cotton seed oil
- Site: shoulder region
- Frequency of applications: days 0, 6 and 7
- Duration: intradermally and dermally 48h occlusive
- Concentrations: 5% in cotton seed oil
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: beginning on day 20 for 3 days
- Exposure period: 24 h
- Test groups: pure substance
- Control group: cotton seed oil
- Site: shoulder region
- Concentrations: pure
- Evaluation (hr after challenge): 24, 48, and 72 h - Positive control substance(s):
- yes
- Remarks:
- Mercaptobezothiazole, CAS number 149-30-4
Results and discussion
- Positive control results:
- The reliability control worked as expected (test report)
In vivo (non-LLNA)
Resultsopen allclose all
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- pure substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: test group. Dose level: pure substance. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- pure substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 48.0. Group: test group. Dose level: pure substance. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- pure substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 72.0. Group: test group. Dose level: pure substance. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Hours after challenge:
- 72
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 72.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The substance is not sensitizing to the skin.
- Executive summary:
A guinea pig maximization test on the test substance according to OECD 406 did not show any sensitizing effects nor any sign of toxicity or irritation when applied.
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