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Reaction mass of 2-{[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and 2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-[2-(benzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-benzyl-2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-benzyl-N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride.
EC number: 700-961-2 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1981)
- Deviations:
- yes
- Remarks:
- Sensitivity check by using a positive control substance was performed only once a year.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- (1984)
- Deviations:
- no
- GLP compliance:
- yes
- 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:
- Reaction mass of 2-{[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and 2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-[2-(benzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-benzyl-2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-benzyl-N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride.
- Molecular formula:
- Not applicable
- IUPAC Name:
- Reaction mass of 2-{[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and 2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-[2-(benzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-benzyl-2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-benzyl-N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride.
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): ORGANOFUNCTIONAL SILANE A-1128
- Physical state: clear yellow-brown viscous liquid
- Lot/batch No.: D0674-TG-021892
- Expiration date of the lot/batch: 1993-08-31
- Stability under storage conditions: The test substance (as supplied) is stable. The purified test substance (after pretreatment) is stable for two days when stored under nitrogen.
- Storage condition of test material: at room temperature, dry in the dark
- Stability under test conditions: Stability in the vehicle (paraffin oil) is unknown
- Specific gravity: 0.942 (25 °C)
- Density of pretreated test substance: 1.11 g/ml (determined at RCC NOTOX)
- Test substance pretreatment: The test substance as provided by the sponsor contains approximately 50% (w/w) methanol. Before use, the methanol was evaporated below 30 °C using a rotary evaporator and a water jet. The flask was flushed with nitrogen before loading it with the test substance and after evaporation of the methanol. After evaporation, a reduction of 47.9% - 49.0% in weight was obtained. The test substance was used at the day of preparation.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 339-476 g
- Housing: The animals were housed under standard laboratory conditions. The animals were housed in groups of two animals per labelled metal cage with wire-mesh floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands). The animal was identified by eartags.
- Diet (ad libitum): standard guinea pig diet, including ascorbic acid (1600 mg/kg); LC 23-B, pellet diameter 4 mm (Hope Farms, Woerden, The Netherlands). In addition, hay (Broekman Institute, Someren, The Netherlands) was provided once a week. Certificates of analysis were examined and then retained in the RCC NOTOX archives.
- Water (ad libitum): tap-water diluted with decalcified water. Certificates of analysis were examined and then retained in the RCC NOTOX archives.
- Acclimation period: at least 5 days before start of treatment under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (fluctuations were observed, but were not considered to be relevant)
- Humidity (%): 55 (fluctuations were observed, but were not considered to be relevant)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 5%
- Route:
- other: epicutanoeus
- Concentration / amount:
- 50%
Challenge
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 5, 10, 25%
- No. of animals per dose:
- - 20 females (experimental group)
- 10 females (control group) - Details on study design:
- RANGE FINDING TESTS:
A preliminary study was carried out to investigate suitable irritant test substance concentrations for the induction phase and suitable non-irritant test substance concentrations for the challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 hours (epicutaneous)
- Test groups: Intradermal (3 pairs of injections):
Injection 1: the test substance diluted to 5% (w/w) with paraffin oil
Injection 2: Freund's Complete Adjuvant (FCA, Difco, Detroit, USA), 50:50 with distilled water for injection (pyrogen free, Fresenius AG, Bad Homburg, Germany)
Injection 3: the test substance, at twice the concentration used in injection 1, emulsified in a 50:50 mixture of Freund's Complete Adjuvant
Epicutaneous: 0.5 ml of the test substance (50% w/w) in paraffin oil
- Control groups: treated and assessed as described for the test groups with the omission of the test substance
- Site: an area of 4 x 6 cm of the dorsal skin from the scapular region
- Frequency of applications: every 7 days
- Duration: Day 1-8
- Concentrations: intradermal 5%, epicutaneous 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: Day 22 (two weeks after epidermal induction application)
- Exposure period: 24 h
- Test groups: test substance and vehicle only (0.05 ml each)
- Site: left flank
- Concentrations: 25, 10, and 5% test substance in vehicle
- Evaluation (hr after challenge): 24 and 48 h
OTHER: In addition to the skin reactions the following data were recorded:
- Mortality/viability/toxicity: once daily
- Body weights: prior to start and at termination of the study - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- (historical, most recent test carried out in June 1992 by using formaldehyde)
Results and discussion
- Positive control results:
- Clearly positive results were observed after treatment of Himalayan guinea pigs with the positive control substance formaldehyde, concluding that the animals were an appropriate model. One restriction was observed, as the sensitivity was only observed once a year, and not every 6 months as stated in the OECD TG 406 (adopted 1992).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- One animal showed discolouration as a sign of necrosis and one animal showed scaliness.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%, 5%, and vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- 4 animals showed discolouration as a sign of necrosis and 16 animals showed scaliness.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- 2 animals showed discolouration as a sign of necrosis and 13 animals showed scaliness.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- 4 animals showed scaliness.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%, 10%, 5%, and vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
PRELIMINARY STUDY:
No signs of systemic toxicity werre observed during the preliminary study. However, body weight loss was noted in one of the five animals.
MAIN STUDY:
Induction: None of the experimental or control animals showed erythema or edema after the 48 h occluded epidermal induction exposure.
Challenge: 24 h after challenge exposure 5 animals of the control group showed a skin reaction in response to the 25% test substance concentration only. No skin reactions were noted in response to the other concentrations. In contrast, 20, 19, and 10 animals showed a skin reaction in response to the 25, 10, and 5% test substance concentrations, respectively. These reactions were characterised by redness, signs of necrosis, swelling, and scaliness.
No symptoms of systemic toxicity were observed in the animals of the main study during the study period. No mortality occurred during this main study. The average body weight gain of experimental and control animals was similar.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS Category 1B (H317) according to Regulation (EC) No 1272/2008
- Conclusions:
- The test item was tested for skin sensitization according to the OECD TG 406 (1987, guinea pig maximisation test) and in compliance with GLP. No mortality occured and no signs of systemic toxicity were observed. After challenge exposure 20, 19 and 10 animals in the test group showed a skin reaction at the first reading in response to 25, 10, and 5% test substance concentration, respectively. Whereas only 5 animals of the control group challenged with 25% substance concentration showed skin reactions. Hence, the test item has to be classified as a sensitizer (Cat 1B) according to EC/1272/2008.
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