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EC number: 238-518-6 | CAS number: 14513-34-9
- 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:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- 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.
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 121177-93-3
- Details on test material:
- - Name of test material (as cited in study report): Silane 434096 VP (CAS 121177-93-3)
- Physical state: colourless liquid
- Storage condition of test material: at room temperature protected from light
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: Harlan Winkelmann GmbH, D-33178
- Weight at study initiation: 300-500 g
- Housing: the animals were barrier maintained (semi-barrier) in an air conditioned room, max 10 animals per cage
- Diet: Altromin 3122 maintenance diet for guinea pigs, rich in crude fibre, ad libitum
- Water: tap water, ad libitum
- Acclimation period: described as 'adequate'
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 55 +/-10
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- For the intradermal injection (induction - first stage) the test item was applied at a 5% concentration (diluted in corn oil). For the topical application (induction - second stage) the test item was applied as a 100% concentration. For the topical application (challenge) the test item was applied at a 100% concentration.
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- For the intradermal injection (induction - first stage) the test item was applied at a 5% concentration (diluted in corn oil). For the topical application (induction - second stage) the test item was applied as a 100% concentration. For the topical application (challenge) the test item was applied at a 100% concentration.
- No. of animals per dose:
- 10/5 (test/control)
- Details on study design:
- RANGE FINDING TESTS: For the justification of dose levels a preliminary test was performed. Two animals were intradermally treated with 1% and 5% concentration of the test item. For the 1% as well as the 5% concentration slight signs of erythema (grade 1) were recorded 24h as well as 48h after application. For both concentrations no signs of irritation and systemic toxicity were recorded at the 72 hours reading. Therefore the concentration of 5% was chosen for the intradermal induction. Two animals were topically treated with 50% as well as 100% for 24h and 48 hours, respectively. No signs of irritation and systemic toxicity were recorded during the observation time for the animals. Therefore the 100% concentration was chosen for the topical induction as well as for the challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
FIRST STAGE, INTRADERMAL INJECTION
Test group: Day 0
Injection 1: Freund's Adjuvant Complete, 1+1 (v/v) diluted with isotonic saline
Injection 2: Prepared test item at a concentration of 50% (v/v) in Freund's Adjuvant Complete, 1+1 (v/v) diluted with isotonic saline
Control group: Day 0
Injection 1: Freund's Adjuvant Complete, 1+1 (v/v) diluted with isotonic saline
Injection 2: Vehicle
Injection 3: Vehicle at concentration of 50% (v/v) in Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Injections 1 and 2 were given close to each other and nearest to the head, while 3 is given toward the caudal part of the test area.
SECOND STAGE, TOPICAL APPLICATION
Test and control group: Day 6
Approximately 24 hours before the topical induction application the test are, after close clipping, was painted with 0.5ml of 10% sodium lauryl sulfate in vaseline, in order to create a local irritation.
Test group: Day 7
A patch was loaded with 0.5ml of the prepared test item, applied to the test area and held in contact by an occlusive dressing for 48 hours.
Control group: Day 7
A patch was loaded with 0.5ml of the vehicle and applied to the test area and held in contact by an occlusive dressing for 48 hours.
B. CHALLENGE EXPOSURE
TOPICAL APPLICATION
The flanks of treated and control animals were cleared of hair by closely clipping and the use of depilation cream.
Test and control group: Day 20
A patch loaded with 0.5ml of the prepared test item was applied to the left flank of the animals and a patch loaded with 0.5ml vehicle tot he right flank (intraspecific control), respectively. The patched were held in contact by an occlusive dressing for 24 hours.
OBSERVATION
Approximately 21 hours after removing the patch the challenge area was cleaned and cleared of hair. Approximately 24 hours after removing of the patch the skin reaction was observed and recorded according to the grades shown below. Two more observations were recorded 48 and 72 hours after patch removal. Additionally all animals have been observed for signs of toxicity at least once daily during the test period. - Positive control substance(s):
- yes
- Remarks:
- 10% sodium lauryl sulfate in vaseline
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Mercaptobenzothiazole, 15% in vaseline
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Mercaptobenzothiazole, 15% in vaseline
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was found to be not sensitising to skin in the guinea pig maximisation test. The study was compliant with GLP.
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