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EC number: 217-370-6 | CAS number: 1825-62-3
- 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
Endpoint summary
Administrative data
Description of key information
Buehler Test (OECD 406): not sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-01-31 to 2017-03-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OGYÉI National Institute of Pharmacy and Nutrition, Budapest, Hungary
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Buehler study was selected as the type of sensitization test since the test substance is a functional silane and the Local Lymph Node Assay as the preferred alternative has shown to provide false positive results for silicone substances.
- Species:
- guinea pig
- Strain:
- other: LAL/HA/BR
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: LAB-ÁLL Bt., Budapest, Hungary
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young adult
- Weight at study initiation: 272 – 340 g
- Housing: 5/cage in in macrolon cages size IV
- Diet: Cunigra Diet for Rabbits (produced by Bonafarm-Bábolna Takarmány Ltd., Hungary) provided ad libitum
- Water: tap water from municipal supply containing at least 50 mg/100 mL ascorbic acid provided ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.9 – 22.5
- Humidity (%): <20 – 49
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 100%
- Day(s)/duration:
- Animals were treated on Days 1, 8, and 15 for 6 hours
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 100%
- Day(s)/duration:
- Day 29 for 6 hours
- No. of animals per dose:
- 20 per test group, 10 per control group
- Details on study design:
- RANGE FINDING TESTS: The concentrations used in the preliminary test were 25, 50 (w/v) and 100% (undiluted). Two animals were used to test each dermal concentration. One concentration was used on the right side and another concentration on left side of the animals. No reaction was produced during the range finding test; therefore, animals in the main test were exposed to 100% test item (undiluted) during the induction and 100% test item (undiluted) as a challenge exposure and with 50% (w/v) test item formulated in sesame oil as a safeguard dose.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hr/day
- Test groups: treated areas were covered for 6 hours with a fully occlusive foil.
- Control group: 0.5 mL of vehicle
- Site: scapular of animals
- Frequency of applications: single application on Days 1, 8, 15
- Duration: 15 days
- Concentrations: 100% (undiluted) test item
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 6 hours on Day 29
- Test groups: treated areas were covered for 6 hours with a fully occlusive foil; 0.5 mL of 100% (undiluted) test item was applied to the left side of animals and a 50% (w/v) dilution of the maximum dermal challenge was applied on the right side
- Control group: treated areas were covered for 6 hours with a fully occlusive foil; 0.5 mL of 100% (undiluted) test item was applied to the left side of animals and a 50% (w/v) dilution of the maximum dermal challenge was applied on the right side
- Site: scapular of animals
- Concentrations: 100% (undiluted) test item with 50% (w/v) test item formulated in sesame oil as a safeguard dose
- Evaluation (hr after challenge): 24 (±2) and 48 (±2) hours after the end of the exposure period - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole at concentration of 50% (w/v)
- Positive control results:
- A positive response was seen in 16/20 animals at 24 hours observation, and in 15/20 at 48 hours observation. The mean scores were 0.80 and 0.75 according to the 24 and 48 hour results.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% (undiluted)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% (undiluted)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% (undiluted)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% (undiluted)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50% (w/v)
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- Mean erythema score was 0.80.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50% (w/v)
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- Mean erythema score was 0.75.
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
- Conclusions:
- In a Buehler test conducted to GLP and OECD 406 ethoxy(trimethyl)silane was not sensitising to the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a Buehler test conducted in compliance with GLP and according to OECD 406, ethoxy(trimethyl)silane was found to be a non-sensitizer (CiToxLAB, 2017). A group of twenty guinea pigs were dosed topically with 100% test material on Days 1, 8 and 15 for 6 hours per treatment during the induction period. On Day 29, the left side of the guinea pigs were then challenged with 100% (undiluted) of the test substance and the right side with 50% (w/v) of the test substance formulated in sesame oil as a safeguard dose. Animals were exposed again for 6 hours during the challenge period. After the challenge period, animals were observed 24 (±2) and 48 (±2) hours after the end of the exposure period. No signs of systemic toxicity were observed in any of the animals. No sensitization was noted in any of the test substance treated animals. In conclusion, under the current test conditions the test substance was not a skin sensitizer. Positive and negative controls responded appropriately.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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