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EC number: 245-589-7 | CAS number: 23328-87-2
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 May - 27 Oct 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesleitstelle Bayern, Bayerisches Landesamt für Gesundheit, Schwabach, Deutschland
Test material
- Reference substance name:
- 2-heptadecyl-1H-imidazole
- EC Number:
- 245-589-7
- EC Name:
- 2-heptadecyl-1H-imidazole
- Cas Number:
- 23328-87-2
- Molecular formula:
- C20H38N2
- IUPAC Name:
- 2-heptadecyl-1H-imidazole
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-200, MatTek)
- Tissue batch number: 25834
- Delivery date: 2 Aug 2017
- Date of initiation of testing: 3 Aug 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature (3 min exposure), 37 ± 1 °C (60 min exposure)
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Tissues were gently rinsed using a wash bottle containing phosphate buffered saline (PBS) to remove any residual test material (20 times).
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: microplate reader
- Wavelength: 570 nm
- Filter: without reference filter
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the EpiDerm™ tissue was assessed by undertaking an MTT cell viability test. The determined OD (540 - 570 nm) was 1.866 ± 0.143 (acceptance criteria: 1.0 - 3.0).
- Barrier function: The barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon application of 100 µL of 1% Triton X-100. The ET-50 value was determined to be 6.02 h (acceptance criteria: 4.77-8.72 h).
- Contamination: The cells used to produce the EpiDerm™ tissue were screened for the presence of viruses, bacteria, yeast and other fungi. No contamination was observed.
NUMBER OF REPLICATE TISSUES: 2 replicates for each treatment condition (3 min and 60 min experiment)
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Since the test substance did not directly reduce MTT and showed no colouring as compared to the solvent, an additional test with freeze-killed or viable tissues was not performed. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 mg test subsatnce + 25 µL distilled water
NEGATIVE CONTROL
- Amount(s) applied (volume): 50 µL
POSITIVE CONTROL
- Amount(s) applied (volume): 50 µL
- Concentration: 8 N - Duration of treatment / exposure:
- 3 min and 60 min
- Number of replicates:
- The test was performed on a total of 4 tissues per dose group, two replicates for each treatment and control group
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- 100.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min exposure
- Value:
- 106.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction:
Since the test substance did not directly reduce MTT, an additional test with freeze-killed or viable tissues was not performed.
- Colour interference with MTT:
The test substance did not change colour, when mixed with deionised water and isopropanol and thus passed the colour interference pre-test.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean negative control OD, both for the 3 and 60 min exposure period, was in the range of ≥ 0.8 and ≤ 2.8 for every exposure time thereby confirming the acceptable quality of the tissues.
- Acceptance criteria met for positive control: Exposure to the positive control induced a decrease in the relative absorbance as compared to the negative control, both for the 3 min exposure period (13.3%) and for the 60 min exposure period (6.3%) thus confirming the validity of the test system and the specific batch of tissue models (acceptance criteria: mean relative tissue viability of the two positive control tissues of the 60 min treatment period is < 15%)
- Acceptance criteria met for variability between replicate measurements: The coefficient of variation in the range 20 - 100% viability between tissue replicates was ≤ 30%, thus the validity of the test system and the specific batch of the tissue models is confirmed.
Any other information on results incl. tables
Results of the Pre-experiment
The mixture of 25 mg test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple.Therefore, non-specific reduction of MTT (NSMTT) equalled 0%.
The mixture of 25 mg test item per 300 µL aqua dest.and per 90 µL isopropanolshowed no colouring as compared to the solvent.Therefore non-specifc colour (NSC) equalled 0%.
Table 3: Results of 3 min experiment
Name |
Negative Control |
Test Substance |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
1.732 |
1.762 |
1.713 |
1.834 |
0.214 |
0.322 |
1.741 |
1.845 |
1.732 |
1.840 |
0.212 |
0.334 |
|
1.794 |
1.785 |
1.742 |
1.888 |
0.223 |
0.340 |
|
OD570 - Blank Corrected |
1.688 |
1.718 |
1.669 |
1.790 |
0.170 |
0.278 |
1.697 |
1.801 |
1.688 |
1.796 |
0.168 |
0.290 |
|
1.750 |
1.741 |
1.698 |
1.844 |
0.179 |
0.296 |
|
Mean OD570 of 3 Aliquots (Blank Corrected) |
1.712 |
1.753 |
1.685 |
1.810 |
0.172 |
0.288 |
SD OD570 of 3 Aliquots |
0.034 |
0.045 |
0.027 |
0.036 |
0.025 |
0.025 |
Total Mean OD570 of 2 Replicate Tissues (Blank Corrected) |
1.733* |
1.748 |
0.230 |
|||
SD OD570 of 2 Replicate Tissues |
0.030 |
0.088 |
0.082 |
|||
Mean Relative Tissue |
100.0 |
100.9 |
13.3 |
|||
Coefficient Of Variation [%]*** |
1.7 |
5.0 |
35.5 |
* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is ≤ 30%.
SD = Standard deviation
OD = Optical density
Table 4: Result of the 60 min experiment
Name |
Negative Control |
Test Substance |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
1.777 |
1.697 |
1.900 |
1.968 |
0.164 |
0.134 |
1.884 |
1.842 |
1.834 |
1.966 |
0.176 |
0.144 |
|
1.853 |
1.748 |
1.799 |
2.002 |
0.173 |
0.137 |
|
OD570 - Blank Corrected |
1.733 |
1.653 |
1.856 |
1.924 |
0.120 |
0.090 |
1.840 |
1.798 |
1.790 |
1.922 |
0.132 |
0.100 |
|
1.809 |
1.704 |
1.755 |
1.958 |
0.129 |
0.093 |
|
Mean OD570 of 3 Aliquots (Blank Corrected) |
1.794 |
1.718 |
1.800 |
1.935 |
0.127 |
0.094 |
SD OD570 of 3 Aliquots |
0.055 |
0.070 |
0.052 |
0.030 |
0.025 |
0.024 |
Total Mean OD570 of 2 Replicate Tissues (Blank Corrected) |
1.756* |
1.867 |
0.110 |
|||
SD OD570 of 2 Replicate Tissues |
0.054 |
0.095 |
0.023 |
|||
Mean Relative Tissue |
100.0 |
106.3 |
6.3** |
|||
Coefficient Of Variation [%]*** |
3.1 |
5.1 |
21.1 |
* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
** mean relative tissue viability of the 60 min positive control < 15%,
*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is ≤ 30%.
SD = Standard deviation
OD = Optical density
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the conducted test, the test substance did not possess corrosive properties towards reconstructed human epidermis tissue in the EpiDerm™ model.
CLP: non-corrosive
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