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Diss Factsheets
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EC number: 467-100-8 | 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 October 2018 - 13 December 2018
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 29 July 2016
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Remarks:
- MatTek EpiDerm
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 μL (undiluted)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL distilled water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL 8 N KOH solution - Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min treatment
- Value:
- 100.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min treatment
- Value:
- 24.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The mixture of 50 μL test item per 1 mL MTT medium showed reduction of MTT as compared to the solvent. The mixture turned blue/purple.
For quantitative correction of results, the part of absorption due to the non-specific reduction of MTT (NSMTT) was determined by using killed tissues. Therefore, two tissues per treatment period were treated with the test item (KT) or left untreated (KU), respectively. NSMTT was calculated relative to the negative control of living tissues (NC) per treatment period according to the following formula:
NSMTT (3min) = [(ODKT - ODKU)/ODNC] * 100 = [(0.090 - 0.095) / 1.787] *100 = -0.3%
NSMTT (60 min) = [(ODKT - ODKU)/ODNC] * 100 = [(0.071 - 0.102) / 1.689] *100 = -1.8%
NSMTT was ≤ 30% relative to the negative control of living epidermis. In the 3 min experiment NSMTT was -0.3%, in the 60 min experiment -1.8%. This means that the test item was washed away almost completely before the addition of the MTT solution. The true MTT metabolic conversion (TODTT) of the test item treated living tissues (TM) was corrected for each treatment period according to the following formula:
TODTT (3 min) = ODTM - (ODKT - ODKU) = 1.784 – (0.090 - 0.095) = 1.789
TODTT (60 min) = ODTM - (ODKT - ODKU) = 0.379 – (0.071 - 0.102) = 0.410
The mixture of 50 μL test item per 300 μL Aqua dest. and per 90 μL isopropanol showed no colouring as compared to the solvent. Therefore NSC equaled 0%. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was ≥ 50% (100.2%, NSMTT-corrected) after 3 min treatment and ≥ 15% (24.3%, NSMTT-corrected) after 60 min treatment.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 October 2017 - 24 November 2017
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Remarks:
- MatTek EpiDerm
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 μL (undiluted)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL DPBS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 μL 5% SDS solution - Irritation / corrosion parameter:
- % tissue viability
- Value:
- 8.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The mixture of 30 μL test item per 1 mL MTT medium showed reduction of MTT compared to the solvent. The mixture turned blue/purple. The coloured test material or MTT reducing substance was classified as “Irritant” i.e. mean tissue viability is < 50%. Therefore, no correction procedures were necessary.
The mixture of 30 μL of the test item per 300 μl aqua dest. and per 300 μL isopropanol showed colouring detectable by unaided eye-assessment. Therefore, the absorption of the chemical in water and isopropanol was measured in the range of 570 ± 30 nm. No absorption was measured in the relevant range. - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
Referenceopen allclose all
See attached file for data tables.
See attached file for data tables.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 July 2017 - 18 October 2017
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted: 26 July 2013
- GLP compliance:
- yes
- Species:
- cattle
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 μL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 μL 0.9% NaCl
POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 μL 100% EtOH - Duration of treatment / exposure:
- 10 min.
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- in vitro irritation score
- Value:
- 35.32
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The mean in vitro irritation score of 35.32 falls in the range for which no prerdiction of a UN GHSS category can be made.
Reference
See attached file for data tables.
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Based on the resuls of the BCOP according to OECD TG 437 under GLP, no prediction could be made on eye irritation.
Justification for classification or non-classification
Based on the positive results of an OECD TG 439, 3-Triethoxysilyl-(1,3-dimethylbutylidene)propylamine is classified as Category 2 (irritant) for skin.
Results of an OECD TG 431 did not meet GHS criteria.
Based on the results of an OECD TG 437, no prediction could be made on eye irritation. Considering the positive OECD TG 439 test yielding a Category 2 (irritant) classification for skin as weight of evidence, 3 -Triethoxysilyl-(1,3 -dimethylbutylidene)propylamine is classified for eye irritation (Category 2).
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