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EC number: 219-786-3 | CAS number: 2530-86-1
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February - April 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40 BIS (In Vitro Skin Corrosion: In vitro Skin Corrosion: Human Skin Model Test, May 30, 2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM INVITTOX Protocol No 118: "EpiSkin™ Skin Corrosivity Test"; December 2011
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N-dimethyl-3-(trimethoxysilyl)propylamine
- EC Number:
- 219-786-3
- EC Name:
- N,N-dimethyl-3-(trimethoxysilyl)propylamine
- Cas Number:
- 2530-86-1
- Molecular formula:
- C8H21NO3Si
- IUPAC Name:
- dimethyl[3-(trimethoxysilyl)propyl]amine
- Test material form:
- liquid
- Details on test material:
- - Name (as cited in the report): SAT 170001
- Chemical Name: N,N-dimethyl-3-(trimethoxysilyl)propylamine
- CAS No.: 2530-86-1
- Batch No.: 186020160504
- Aggregate State at RT: liquid
- Colour: colourless
- Storage Conditions: room temperature
- Expiry Date: 30.08.2017
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiSkin-SM (TM)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- not specified
- Justification for test system used:
- This test uses the EPISKIN-SM™ reconstructed human epidermis model (SkinEthic) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test was carried out with the reconstituted three-dimensional human skin model EPISKIN-SM™ (SkinEthic). This skin model consists of normal human epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts. A highly differentiated and stratified epidermis model is obtained after 13-day culture period comprising the main basal, supra basal, spinous and granular layers and a functional stratum comeum.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test item was applied undiluted. 50 ± 3 μL (131.6 μL/cm2) of the test item was dispensed directly atop the EPISKIN-SM™ tissue using a positive displacement pipette. The test item was spread to match size of the tissue.
- Duration of treatment / exposure:
- 30 min, 60 min, 4 h
- Duration of post-treatment incubation (if applicable):
- 3 h MTT incubation
- Number of replicates:
- duplicate cultures per test
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- NSMTT-corrected
- Run / experiment:
- Test item / 3 min
- Value:
- 99
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- NSMTT-corrected
- Run / experiment:
- Test item / 60 min
- Value:
- 91
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- NSMTT-corrected
- Run / experiment:
- Test item / 4 h
- Value:
- 78
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
PRE-EXPERIMENTS
The mixture of 50 μL test item per 2 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) and with 0.9% NaCI; KU, respectively. NSMTT was calculated relative to the negative control of living tissues (NK) per treatment period according to the following formula:
NSMTT = [(OD(KT) - OD(KU)) / OD(NK)] * 100
NSMTT was <= 50% relative to the negative control of living epidermis. In the 3 min experiment NSMTT was 1.0%, in the 60 min experiment 2.3%, in the 4 h experiment 12.5%. The true MTT metabolic conversion [TOD(TT)] of the test item treated living tissues (TM) was corrected for each treatment period according to the following formula:
TOD(TT) = OD(TM) - [OD(KT) - OD(KU)]
The mixtures of 10 μL test item per 90 μL Aqua. dest. and per 90 μL isopropanol showed no colouring as compared to the solvent. Therefore NSCnving equaled 0%.
TEST RESULTS
3 MIN EXPERIMENT |
Negative Control |
Test Item |
Positive Control |
total mean OD570 (mean 2 replicates) |
0.850 |
0.853 |
n.a. |
mean rel. tissue viability [%] |
100 |
100 |
n.a. |
mean inter tissue viability diff. [%] |
5.7 |
8.1 |
n.a. |
60 MIN EXPERIMENT |
Negative Control |
Test Item |
Positive Control |
total mean OD570 (mean 2 replicates) |
0.821 |
0.748 |
n.a. |
mean rel. tissue viability [%] |
100 |
93 |
n.a. |
mean inter tissue viability diff. [%] |
0.2 |
5.0 |
n.a. |
4 H EXPERIMENT |
Negative Control |
Test Item |
Positive Control |
total mean OD570 (mean 2 replicates) |
0.687 |
0.623 |
0.035 |
mean rel. tissue viability [%] |
100 |
91 |
5 |
mean inter tissue viability diff. [%] |
11.4 |
9.4 |
1.2 |
The test item showed non-specific MTT-reducing potential. Therefore, additional killed tissue controls were treated with the test item to determine the non-specific reduction of MTT (NSMTT) and the results were corrected to the true MTT metabolic conversion (TOD(TT)). The test item showed no water-colouring potential.
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was >= 35% (78%, NSMTT-corrected) after 4 h treatment.
Relative mean tissue viability was reduced to 91 % after 60 min treatment and to 99% after 3 min treatment (NSMTT-corrected values).
The controls confirmed the validity of the study. The mean OD570 of the two negative control tissues was between 0.6 and 1.5 for each exposure period. The mean relative tissue viability (% negative control) of the positive control was <= 20% (5%) after 4 h treatment. The maximum inter tissue viability difference of replicate tissues of all dose groups was <= 30% (0.2% - 11.4%).
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Remarks:
- Criteria used for interpretation of results: other: OECD 431
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The relative mean tissue viability after 4 h treatment was not decreased to less than 35% of the corresponding negative control tissues. The test item is therefore classified as "non-corrosive".
- Executive summary:
In the present study the skin corrosivity potential of the test item was analysed. Since corrosive chemicals are cytotoxic after topical short-time exposure to the EPISKIN-SM ™, a reconstituted
three-dimensional human epidermis model, the cytotoxic effects of the test item were determined. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min, 60 min and 4 h exposure period and compared to those of the concurrent negative controls.
The test item showed non-specific MTT-reducing potential. The test item showed no water-colouring potential. The mean relative tissue viability (%negative control) was >= 35% (78%, NSMTTcorrected) after 4 h treatment. Relative mean tissue viability was reduced to 91 % after 60 min treatment and to 99% after 3 min treatment (NSMTT-corrected values).
Conclusion
In this study under the given conditions the test item showed no corrosive effects.
The relative mean tissue viability after 4 h treatment was not decreased to less than 35% of the corresponding negative control tissues.
The test item is therefore classified as "non-corrosive".
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