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Diss Factsheets
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EC number: 210-370-7 | CAS number: 614-18-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethyl nicotinate
- EC Number:
- 210-370-7
- EC Name:
- Ethyl nicotinate
- Cas Number:
- 614-18-6
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- ethyl nicotinate
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Source strain:
- not specified
- Details on animal used as source of test system:
- EpiDerm™ Reconstructed Human Epidermis Model Kit
Supplier : MatTek
Date received : 15 September 2015
EpiDermTM Tissues (0.63cm
2
) lot number : 21695
Assay Medium lot number : 091015TMA
Upon receipt of the EpidermTM tissues, the sealed 24-well plate was stored in a refrigerator until
use. - Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MAttek EpiDerm
- Tissue batch number(s): 21695
- Production date:
- Shipping date:
- Delivery date: 15 Sept 2015
- Date of initiation of testing: 15 sept 2015
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 celsius
- Temperature of post-treatment incubation (if applicable): 37 cesius
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Rinsing was achieved by filling and
emptying each tissue under a constant soft stream of DPBS to gently remove any residual test
item. Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper.
- Observable damage in the tissue due to washing: not reported
- Modifications to validated SOP: none noted
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL MTT solution.
- Incubation time: 3 hours
- Spectrophotometer: Anthos 2001 microplate
reader
- Wavelength: 562nm
- Filter: not reported
- Filter bandwidth: not reported
- Linear OD range of spectrophotometer: not reported
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:
- Barrier function:
- Morphology:
- Contamination:
- Reproducibility:
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE - Not applicable
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: One
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.] - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- 50 µL (microlitres)
- Duration of treatment / exposure:
- 3 minutes and 60 minutes
- Duration of post-treatment incubation (if applicable):
- Not Applicable
- Number of replicates:
- three
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- ca. 90.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes
- Value:
- ca. 9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- 3.7 Quality Criteria
The results of the assay are considered acceptable if the following assay acceptance criteria are
achieved:
Negative Control:
The absolute OD562 of the negative control treated tissues in the MTT-test is an indicator of
tissue viability obtained in the testing laboratory after the shipping and storing procedure and
under specific conditions of the assay. The mean OD562 of the two negative control tissues
should be ≥ 0.8 and ≤ 2.8 for each exposure time, which ensures that the tissue viability meets
the acceptance criteria.
Positive Control:
Potassium Hydroxide 8.0N solution is used as a positive control. An assay meets the acceptance
criterion if mean relative tissue viability of the 60 minute positive control is < 15%.
Coefficient of Variation:
In the range 20 and 100% viability, the Coefficient of Variation between tissue replicates should
be ≤ 30%.
Any other information on results incl. tables
4.5 Quality Criteria
The mean OD562 for the negative control treated tissues was 2.078 for the 3-Minute exposure period and 2.159 for the 60-Minute exposure period. The negative control acceptance criteria were therefore satisfied.
The relative mean tissue viability for the positive control treated tissues was 3.8% relative to the negative control following the 60-Minute exposure period. The positive control acceptance criterion was therefore satisfied.
In the range 20 to 100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- The test item was classified as corrosive to the skin. The following classification criteria apply:
EU CLP and UN GHS: Hazard statement H314 Category 1B or 1C.
UN Packing Group II or III.
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