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EC number: 604-112-6 | CAS number: 139147-73-2
- 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:
- 1997-01-03 until 1997-04-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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 CP 2
- Physical state: liquid
- Analytical purity: 96.3% (GC)
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 10466 QB
- Expiration date of the lot/batch: 1997-12-01
- Stability under test conditions: stable in corn oil; unknown in Freud's Complete adjuvant
- Storage condition of test material: in original container, at room temperature, in the dark
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: main test: 339 - 373 (control and test group)
- Housing: standard laboratory conditions
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: main test: one week under test conditions after health examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- Test group
Intradermal induction: 5% dilution of the test substance in corn oil and in an emulsion with Freund's Complete Adjuvant
Epicutaneous induction: 25% dilution of test substance in corn oil
Epicutaneous challenge 15% dilution of the test substance in corn oil
Control Group
Animals were induced with corn oil and Freund's Complete Adjuvant and challenged similarly as those of the test group
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Test group
Intradermal induction: 5% dilution of the test substance in corn oil and in an emulsion with Freund's Complete Adjuvant
Epicutaneous induction: 25% dilution of test substance in corn oil
Epicutaneous challenge 15% dilution of the test substance in corn oil
Control Group
Animals were induced with corn oil and Freund's Complete Adjuvant and challenged similarly as those of the test group
- No. of animals per dose:
- Test group: 10
Control: 5
Intradermal pretest: 1
Epidermal pretest: 2 - Details on study design:
- RANGE FINDING TESTS:
Intradermal: 5, 3 and 1% of test article in corn oil - 5% test substance solution was selected for main test.
Epidermal: 75%, 50%, 25% and 15% of test substance in corn oil - Concentration selected for the induction period and challenge procedure was 25% and 15% test substance in corn oil, respectively.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: intradermal exposure on test day 1; epidermal exposure on test day 8
- Exposure period: 8 days
- Test groups: one test group
- Control group: one control group (corn oil)
- Site: scapular region
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: test day 22
- Exposure period: 24 hours
- Test group: 15% test substance in corn oil
- Control group: 15% test substance in corn oil
- Site: left and right flank
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- In this study 70% of the animals of the test group were observed with positive skin reactions after treatment with an non-irritant test substance concentration of 25% in polyethylene glycol. No skin reactions were observed in the control group.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15% test substance in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs. One animal was found dead on test day 12.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 15% test substance in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs. One animal was found dead on test day 12..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15% test substance in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs has been observed. One animal was found dead on test day 12.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 15% test substance in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs has been observed. One animal was found dead on test day 12..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No clinical signs were observed. One animal was found dead on test day 9.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No clinical signs were observed. One animal was found dead on test day 9..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No clinical signs have been observed. One animal was found dead on test day 9.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No clinical signs have been observed. One animal was found dead on test day 9..
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The substance is not sensitizing to the skin.
- Executive summary:
In order to assess the cutaneous allergenic potential of Silane CP 2, the maximization test in accordance with OECD Guideline 406 was carried out on 15 (10 test and 5 control) male albino guinea pigs. Maximally tolerated concentrations of the test substance suitable for the induction phase of the main study and a suitable non-irritant concentration of the test substance, by the topical route of administration , for the challenge application have been defined based on pretest results.
In this study 0% of the animals of the test group were observed with positive skin reactions after treatment with an non-irritant test substance concentration in corn oil. No skin reaction were observed in the control group. Therefore, the test substance is considered to be not a skin sensitzer in this test.
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