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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 21-May 14, 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 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- Test method is considered able to detect chemicals that cause skin sensitization when used with an integrated approach. This is an in vitro test method that does not require vertebrate testing.
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
- Details on the study design:
- Skin sensitisation (In vitro test system)
- Details on study design: The test item was dissolved in DMSO with mixing to create a stock solution of 200 mM. Dilutions were then performed from the stock solution. The final concentration of solvent in test solutions was 1% (v/v). A blank control was performed, along with a negative control of 1% (v/v) DMSO and a positive control of 4 to 64 uM of cinnamic aldehyde in DMSO (1% (v/v)). Human keratinocytes maintained at 37 degrees C and 5% CO2 were used. Dulbecco’s Modified Eagle Medium augmented with 10% fetal bovine calf serum was used for the assay. Dulbecco’s Modified Eagle Medium augmented with 1% fetal bovine calf serum was used for the test item medium.
Three replicates of the negative control and each test concentration was performed. Six replicates of the positive control were performed. 1x10^4 cells per well were added. A cell viability test was also performed with cells in transparent wells, for the other plates, luciferase was added. Cells were incubated for 24 hrs at 37 degrees C with assay medium. Assay medium was removed and 150 uL test substance medium was then added and incubation performed for 48 hrs at 37 degrees C with the plates sealed to prevent loss and cross-contamination. After incubation, wells were washed with DPBS. 50 uL of luciferase was added to wells and luciferase activity was recorded.
For the cell viability test, assay medium was replaced with 200 uL test medium and 27 uL MTT solution. The plates were then incubated for 4 hrs at 37 degrees C sealed. Test medium was then removed and replaced with 200 uL 10% SDS solution. This was incubated for the weekend sealed at 37 degrees C, and then shaken for 10 minutes. The optical density was then measured at 600 nm.
Test was considered positive if the following conditions were met in two independate replicates: 1) Imax showed a 1.5 times fold or greater and statistically significant increase over negative controls; 2) cell viability at least greater than 70% at the lowest concentration with an inducation of luciferase activity of greater than 1.5; 3) the EC1.5 value is < 1000 uM; and 4) an apparent overall dose dependent response for luciferase inducation.
The test was considered valid if the following conditions were met: 1) the luciferase inducation in the positive control is statistically significant increased 1.5 times that of at least one tested concentration; 2) the average induction of the 64 uM positive control is 2-8; 3) the EC1.5 is within two statistical deviations of the historical mean; and 4) the average coefficient of variation of the luminescence reading for the negative control is less than 20% in each repetition.
Results and discussion
- Positive control results:
- Sensitizing
In vitro / in chemico
Results
- Key result
- Run / experiment:
- other: 1 and 2
- Parameter:
- other: luciferase inducation
- Value:
- 1.58
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
Any other information on results incl. tables
Concentration |
Cell Viability (%) |
Mean Induction of Luciferase Activity Experiment 1 |
Mean Induction of Luciferase Activity Experiment 2 |
Mean Induction of Luciferase Activity |
Solvent Control |
|
|
|
|
-- |
100 |
1.00 |
1.00 |
1.00 |
Positive Control |
|
|
|
|
4.00 |
103.2 |
1.41 |
1.25 |
1.33 |
8.00 |
105.2 |
1.46 |
1.28 |
1.37 |
16.00 |
107.4 |
1.43 |
1.25 |
1.34 |
32.00 |
107.6 |
1.65 |
1.66 |
1.65 |
64.00 |
108.2 |
2.03 |
2.19 |
2.11 |
Test Substance |
|
|
|
|
0.99 |
96.6 |
1.05 |
1.01 |
1.03 |
1.97 |
112.7 |
1.49 |
1.21 |
1.35 |
3.95 |
113.6 |
1.64 |
1.24 |
1.44 |
7.90 |
111.6 |
1.80 |
1.26 |
1.53 |
15.80 |
110.8 |
2.08 |
1.40 |
1.74 |
31.59 |
114.4 |
2.23 |
1.43 |
1.83 |
63.19 |
110.8 |
2.33 |
1.45 |
1.89 |
126.38 |
104.2 |
3.11 |
1.58 |
2.34 |
252.75 |
31.8 |
2.93 |
2.76 |
2.84 |
505.50 |
0.1 |
0.00 |
0.00 |
0.00 |
1011.0 |
0.2 |
0.00 |
0.00 |
0.00 |
2022.0 |
0.2 |
0.00 |
0.00 |
0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- The test substance is potentially skin sensitizing.
- Executive summary:
The skin sensitization potential of the test substance was determined in an OECD Guideline 442D human keranitocyte test using luciferase activity. Test concentrations of 2022, 1011, 505.50, 252.75, 126.38, 63.19, 31.95, 15.80, 7.90, 3.95, 1.97, and 0.99 µM were tested along with blank, positive, and negative controls. The results of the test show that the test substance is potentially a skin sensitizer.
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