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EC number: 218-900-9 | CAS number: 2277-19-2
- 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
- Study period:
- December 20, 2019 - May 28, 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- Due to the volatility of the test substance, the incubation period was performed under a safety hood. Additional test substance also had to be sent to the testing laboratory.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (Z)-non-6-enal
- EC Number:
- 218-900-9
- EC Name:
- (Z)-non-6-enal
- Cas Number:
- 2277-19-2
- Molecular formula:
- C9H16O
- IUPAC Name:
- (Z)-non-6-enal
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Source strain:
- other: 00267
- Justification for test system used:
- The test system is designed to mimic human skin, the target organ of interest.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Normal human epidermal keratinocytes
- Tissue batch number(s): 30858
- Date of initiation of testing: Jan. 9, 2020
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 degrees C
- Temperature of post-treatment incubation (if applicable): 37 degrees C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 15 times with enough DPBS to fill the well, then submerged 3 times with 150 mL of DPBS
- Observable damage in the tissue due to washing: No
- Modifications to validated SOP:
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration:5 mg/mL in PBS
- Incubation time: 3 hour
- Wavelength: 570 nm
- Filter bandwidth: +/- 30 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 1.598
- Barrier function: 6.45 hr
- Contamination: Sterile
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- N. of replicates: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability is less than 50%.
- The test substance is considered to be non-corrosive to skin if the viability is greater than or equal to 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 uL
- Concentration (if solution): 100%
VEHICLE
- Amount(s) applied (volume or weight with unit): None
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL
- Concentration (if solution): 100% DPBS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL
- Concentration (if solution): 5% SDS - Duration of treatment / exposure:
- 25 minutes under a safety hood, then 35 minutes on a warming plate in a safety hood.
- Duration of post-treatment incubation (if applicable):
- 24 hrs, then added to new wells containing 0.9 mL incubation medium and post-incubated for an additional 18 hrs.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Average
- Value:
- 3.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
|
Relative Tissue Viability (%) |
Average Viability (%) |
Standard Deviation (%) |
Negative Control 1 |
99.6 |
100 |
7.1 |
Negative Control 2 |
93.1 |
||
Negative Control 3 |
107.3 |
||
Positive Control 1 |
3.6 |
3.7 |
0.1 |
Positive Control 2 |
3.8 |
||
Positive Control 3 |
3.7 |
||
Test Item 1 |
3.6 |
3.7 |
0.3 |
Test Item 2 |
3.4 |
||
Test Item 3 |
4.0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The tissue viability was less than 50% at one hour of treatment. The test substance is therefore considered to be an irritant to skin.
- Executive summary:
The potential for skin irritancy was studied in an OECD Guideline 439 in vitro human skin model test. Model human epidermis was exposed to the test substance for one hour. Due to volatility of the test substance, the incubation period was done under a safety hood. Three replicates were performed. The average percent viability for the test substance was 3.7%. The test substance is therefore considered to be a category 2 skin irritant.
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