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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 Oct 2011
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 437
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- 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
- 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 / tissue source
- Species:
- other: isolated corneas from bovine
- Strain:
- other: isolated corneas from bovine
- Details on test animals or tissues and environmental conditions:
- not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 3 corneas as negative controls treated with physiological saline 0.9% NaCl; 3 corneas as positive control treated with 2-Ethoxyethanol
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL - Duration of treatment / exposure:
- First treatment: 10 min ± 30 sec
Second treatment: 120 min - Observation period (in vivo):
- 130 min
Reading time points: 10 min and 130 min - Number of animals or in vitro replicates:
- other:
3 isolated corneas from bovine for the test item were used - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item were rinsed off from the application side with saline.
- Time after start of exposure: after 10 min
SCORING SYSTEM: The following formula was used to determine the in vitro score:
In vitro score = Mean Opacity Value + (15 x Mean OD490 Value)
Evaluation of the BCOP assay:
A mean in vitro Irritation Score > 55.1 leads to a classification as corrosive / severe irritant according to OECD guideline 437.
TOOL USED TO ASSESS SCORE: opacitometer / spectrophotometer / fluorescein
Additional information:
After the first incubation phase (10 min) the test item, the positive, and the negative controls were each rinsed from the corneae. The corneae were incubated for another 120 minutes at 32 ± 1 °C in complete medium, and opacity was measured a second time (t130).
After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrcally the transfer of fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- 3/3
- Time point:
- other: 10 minutes
- Score:
- 18.51
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Relative to the negative control, the test item did not cause a relevant increase of the corneal opacity or permeability. The positive control (2-Ethoxyethanl) showed clear opacity and distinctive permeability of the corneae.
Any other information on results incl. tables
Table 1: Results after 10 minutes incubation time
Test Group |
Opacity value = Difference (t130-t0) of Opacity |
Permeability at 490 nm (OD490) |
In vitro Score |
Mean in vitro Irritation Score |
Proposed in vitro Irritation Score |
||
|
|
Mean |
|
Mean |
|
|
|
Negative Control |
0 |
0.00 |
0.086 |
0.066 |
1.29 |
0.99 |
Non corrosive |
1 |
0.056 |
1.84 |
|||||
-1 |
0.056 |
-0.16 |
|||||
Positive Control |
63.00* |
0.960* |
77.40 |
71.07 |
Corrosive |
||
62.00* |
0.401* |
68.02 |
|||||
51.00* |
1.119* |
67.79 |
|||||
Test item |
21.00* |
0.018* |
21.27 |
18.51 |
Non corrosive |
||
14.00* |
0.051* |
14.77 |
|||||
18.00* |
0.099* |
19.49 |
*corrected values
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:
The eye irritancy potential of Y-15864 was investigated in the bovine corneal opacity and permeability assay according to OECD guideline 437. The test item was tested undiluted. A mean in vitro irritation score of 18.51 was calculated. Relative to the negative (mean in vitro irritation score = 0.99) and positive (mean irritation score = 71.07) control, the test item did not cause a relevant increase of the corneal opacity or permeability.
According to OECD 437 the test item is classified as not corrosive / not severe irritant to the eye.
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