Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-340-6 | CAS number: 76524-94-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 439 ( In vitro skin irritation: Reconstructed human epidermis test method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Landwirtschaft und Forsten, Mainzer Straße 80, D-65189 Wiesbaden, Germany
Test material
- Reference substance name:
- N-[3-(triethoxysilyl)propyl]formamide
- EC Number:
- 700-340-6
- Cas Number:
- 76524-94-2
- Molecular formula:
- C10H23NO4Si
- IUPAC Name:
- N-[3-(triethoxysilyl)propyl]formamide
- Details on test material:
- - Name of test material (as cited in study report): Y-15864
- Physical state: liquid
- Analytical purity: 97.5% – 99.5%
- Lot/batch No.: TER00010-68-31
- Expiration date of the lot/batch: September 12, 2012
- Storage condition of test material: At room temperature in a closed container
Constituent 1
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM:
EpiSkin™ Kit Lot No.: 11-EKIN-041
Source: SkinEthic Laboratories (69007 Lyon, France).
Cells: Normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.
Culture: The EpiSkin™ tissues (surface 0.38 cm²) are cultured on specially prepared cell culture inserts.
ENVIRONMENTAL CONDITIONS
EpiSkin™ tissues were shipped with ice packs on medium-supplemented agarose gels in a 12-well plate and reached Harlan CCR on November 08, 2011. On day of experiment EpiSkin™ tissues were transferred to 12-well plates with maintenance medium.
Test system
- Type of coverage:
- open
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL - Duration of treatment / exposure:
- 15 ± 1 min
- Observation period:
- 42 hours further incubation after washing off residual test item
- Number of animals:
- Triplicates
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: after 15 minutes incubation
SCORING SYSTEM:
Cell viability was assessed by the OD derived by the MTT-Assay. The mean OD of the three negative control tissues was calculated. This value corresponds to 100% tissue viability in the current test. For each individual tissue treated with the test item or the positive control the individual relative tissue viability is calculated according to the following formula:
Relative viability [%] = (OD test item/OD negative control ) x 100
For the current test, an irritation potential of a test item according to EU classification R38 (according to directive 67/548/EEC), H315 (according to regulation (EC) 1272/2008) is recommended if the mean relative tissue viability of three individual tissues is reduced below 50% of the negative control.
CONTROLS:
Negative control: deionised water
Positive control: 5% Sodium lauryl sulfate
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: relative absorbance values
- Value:
- 88.9
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 min. Max. score: 100.0. Reversibility: other: not applicable. (migrated information)
Any other information on results incl. tables
Table 1: Results after treatment with Y-15864 and controls
Dose group
|
Treat-ment Interval |
Absorbance 570 nm Tissue 1* |
Absorbance 570 nm Tissue 2* |
Absorbance 570 nm Tissue 3* |
Mean Absorbance of 3 Tissues |
Relative Absorbance [%] Tissue 1, 2 + 3** |
Standard Deviation [%] |
Rel. Absorbance [% of Negative Control]*** |
Negative Control |
15 min |
1.335 |
1.251 |
1.299 |
1.295 |
103.1 96.6 100.3 |
3.3 |
100.0 |
Positive Control |
15 min |
0.277 |
0.254 |
0.271 |
0.268 |
21.4 19.6 21.0 |
0.9 |
20.7 |
Test Item |
15 min |
1.077 |
1.210 |
1.168 |
1.151 |
83.2 93.4 90.2 |
5.2 |
88.9 |
* Mean of two replicate wells after blank correction
** relative absorbance per tissue (rounded values)
*** relative absorbance per treatment group (rounded values)
The positive and negative control values were within the ranges of historical control data fromJuly 2007 – May 2011.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP. not classified
DSD: not classified - Executive summary:
An in vitro skin irritation test was performed according to OECD guideline 439 (In vitroSkin Irritation: Reconstructed Human Epidermis Test Method). Tissue samples were treated in triplicates with Y-15864, deionised water (negative control) and 5% sodium lauryl sulfate (positive control) for 15 minutes. Test items were washed off and after further 42 hours incubation the viability of the cells was determined by the OD570 in a MTT-Assay. After treatment with the test item Y-15864 the relative absorbance values decreased to 88.9%. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.