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EC number: 245-659-7 | CAS number: 23432-62-4
- 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:
- weight of evidence
- Study period:
- 11 Aug 2003 - 02 Oct 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)
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The current accepted and preferred method for skin sensitisation testing according to the REACH legislation (EC no 1907/2006) and CLP Regulation (EC No 1272/2008) is the murine local lymph node assay (LLNA). A validated test method, OECD TG 429 (OECD 2002) is available for the LLNA. The guideline acknowledges the limits of the LLNA, and states that there are instances where test substance classes or substances containing functional groups shown to act as potential confounders make the use of guinea pig tests more appropriate. It is concluded that the LLNA is not applicable where the properties of the test material cause interference in the accuracy of the LLNA (OECD 2002). The statement in the OECD TG 429 is given with reference to the findings of Basketter et al. (2009a), who demonstrated false positives in silicone based substances which had previously been demonstrated to be non-sensitisers in the guinea pig maximisation test (GPMT). The importance of available evidence from guinea pig results, consideration of chemical reactivity, epidermal bioavailability and clinical and experimental human data are emphasised as central to reaching appropriate regulatory decisions for substances which have been shown to fall outside the specificity of the LLNA (Basketter et al., 2009b). The non-applicability of the LLNA for silicone based substances has also been demonstrated by Petry et al. (2012). The sensitisation potential of polyfunctional silicone materials was tested in a comparative study investigating the GPMT and the LLNA assays, which found the five tested substances to be negative in the GPMT whereas they were concluded to be weak to moderate skin sensitisers in the LLNA (Petry et al., 2012).
Test material
- Reference substance name:
- 23432-64-6
- Cas Number:
- 23432-64-6
- IUPAC Name:
- 23432-64-6
- Details on test material:
- - Name of test material (as cited in study report): Silane 449007 VP
- Physical state: liquid
- Storage condition of test material: 5±3°C, 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, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: 300-500 g
- Fasting period before study: no
- Housing: animals were barrier maintained (semi-barrier) in an air-conditioned room, animals were kept in groups in Terluran-cages on Altromin saw fiber bedding
- Diet: Altromin 3122 maintenance diet for guinea pigs (totally pathogen-free, rich in crude fiber), ad libitum
- Water: tap water, ad libitum
- Acclimation period: adequate acclimatisation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 10%
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Day(s)/duration:
- 2
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Range-finding assay: 4
Main test: 5 controls and 10 test animals - Details on study design:
- RANGE FINDING TESTS:
2 animals were intradermally treated with 1%, 5%, 10%, 25%, 50% of the test item (diluted in corn oil). For the 50% concentration erythema grade 3 and necrosis (0.5 cm diameter) were observed at both 24 and 48 h post-exposure. For the 25% concentration erythema grade 2 and necrosis (0.3 cm diameter) were observed at both 24 and 48 h post exposure. For the 10% concentration erythema grade 1 was observed 24 h only. For 5% and 1% no signs of irritation or toxicity were observed. Therefore the concentration of 10% was chosen for the intradermal induction.
2 further animals were topically treated with 50% and 100% concentration for 24 and 48 h, 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
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/isotonic saline
Injection 2: test substance in corn oil
Injection 3: test substance in a 1:1 mixture (v/v) FCA/isotonic saline
Epicutaneous: test substance (undiluted)
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/isotonic saline
Injection 2: Corn oil
Injection 3: Corn oil at 50% (w/v) in a 1:1 mixture (v/v) FCA/isotonic saline
Epicutaneous: Corn oil
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-9
- Concentrations:
Test item: intradermal 10%, epicutaneous 100%
Control: intradermal 0%, epicutaneous corn oil
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 20
- Exposure period: 24 h
- Test groups: 0.5 ml of the undiluted test item
- Control group: 0.5 ml of the undiluted test item
- Site: left flank (test item), right flank (vehicle)
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48, and 72 - Challenge controls:
- The control group is actually a challenge control
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
Results and discussion
- Positive control results:
- The positive control substance (15% mercaptobenzothiazole in Vaseline) induced positive reactions in 8/10 animals (80%), thus meeting the reliability criteria for the GPMT test (≥ 15% positive response). Positive control substances are used periodically as a reliability check (last check before study May 2013) and not during the study itself.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 10%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 10%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Induction: 2%; challenge: 15%
- No. with + reactions:
- 8
- Total no. in group:
- 10
Any other information on results incl. tables
Induction readings: 7 animals showed erythema grade 1 at 24 h (induction first stage). No signs of irritation were observed after the topical application (induction second stage). No signs of irritation and no signs of general toxicity were observed after challenge. Body weights were comparable within the test and control groups and the historical controls.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In a GPMT according to OECD guideline 406 and in compliance with GLP, the test item was not sensitising. Induction (intradermal: 10%; topical: 100%) and challenge (100%) with the test item revealed no skin reactions in any of the 10 animals. Furthermore no skin reactions were observed in the negative controls (induction with corn oil, topical challenge with 100% test item).
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