Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 242-745-6 | CAS number: 19009-56-4
- 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:
- 06 Jan 2017 - 02 Feb 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted in accordance with international guidelines and in accordance with GLP. All guideline criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek test protocol “In vitro EpiDermTM Skin Corrosion Test (EPI-200-SCT)”, 07 November 2014
- Deviations:
- yes
- Remarks:
- For the MTT Assay: the formazan salt was extracted in the refrigerator instead of at room temperature. No impact on study outcome. 50µL test item used in MTT reduction/colour intereference AND test substance exposure, rather than 30µL
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-methyldecan-1-al
- EC Number:
- 242-745-6
- EC Name:
- 2-methyldecan-1-al
- Cas Number:
- 19009-56-4
- Molecular formula:
- C11H22O
- IUPAC Name:
- 2-methyldecanal
- Test material form:
- liquid
- Details on test material:
- Appearance: clear, colourless liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Epi-200 kits and MTT-100 assays purchased from MatTek Corporation (Bratislava, Slovakia). The EpiDerm™ tissue consisted of normal, human-derived epidermal keratinocytes, cultured to form a multilayered, highly differentiated model of the human epidermis
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SKIN DISC PREPARATION
- Procedure used: At least 1 hour before dosing, EpiDerm™ tissues were removed from the refrigerator. Under sterile conditions using sterile forceps, the inserts were transferred into 6-well plates containing the pre-warmed assay medium. A 24-well plate was prepared as holding plate containing 300 µL assay medium. The holding plate was pre warmed in an incubator (37 ± 1.5 °C, 5 ± 0.5 % CO2) until use.
- Quality control for skin discs: Robustness of the test system (or rather of the test kit) was demonstrated following treatment with 1% Triton X-100: 4.77 hours ≤ ET50 ≤ 8.72 hours
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1.5 °C
- Temperature of post-treatment incubation (if applicable): 37 ± 1.5 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: Rinsed 20 times
- Observable damage in the tissue due to washing: N/A
- Modifications to validated SOP: N/A
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: Versamax®, Molecular Devices, SoftMax Pro Enterprise (version 4.7.1)
- Wavelength: 570 nm
- Filter: no reference filter
- Filter bandwidth: N/A
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: Two
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin as follows: < 50% mean tissue viability after 3 minutes exposure and < 15% after 60 minutes exposure results in a prediciton of corrosivity.
- The test substance is considered to be non-corrosive to skin as follows: ≥ 50% mean tissue viability after 3 minutes exposure and ≥ 15% after 60 minutes exposure results in a predition of non-corrosivity.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 430: N/A - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50µL
- Concentration (if solution): N/A
VEHICLE - N/A
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50µL
- Concentration (if solution): N/A
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50µL
- Concentration (if solution): N/A - Duration of treatment / exposure:
- (Test item, negative and positive controls): 3 ± 0.5 minutes, 60 ± 5 minutes
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- Two
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Details on study design:
- TEST SITE
- Area of exposure: The EpiDerm™ tissues (surface 0.63 cm²) are cultured on specially prepared cell culture inserts (MILLICELL, 10 mm diameter).
- % coverage: Not specified
- Type of wrap if used: N/A
REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period the tissues were removed from the 6-well plate and gently rinsed using a multipipette containing PBS to remove any residual test material (20 times).
- Time after start of exposure: ('At the end of exposure', no time specified)
OBSERVATION TIME POINTS
3 ± 0.5 minutes, 60 ± 5 minutes
SCORING SYSTEM:
- Method of calculation:
The mean OD of the duplicate negative control tissues was calculated after blank correction. This value corresponds to 100% tissue viability in the current test. For each individual tissue treated with the test item or the positive control the individual relative tissue viability is calculated according to the following formula:
Relative viability (%) = [(mean OD test item/positive control)/ (mean OD negative )]x 100
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute exposure
- Value:
- 109.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minute exposure
- Value:
- 107.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: N/A
- Direct-MTT reduction: The colourless test item reduced MTT
Test for Direct MTT Reduction and Colour Interference:
Step 1
50 µL of the test item was added to 0.3 ml of deionised water (transparent glass test-tube). The mixture was incubated in the incubator (37 ± 1.5 °C, 5 ± 0.5 % CO2) for 60 min. At the end of the exposure time, the mixture was shaken and the presence and intensity of the staining (if any) was evaluated. If the solution changed colour significantly, the test item is presumed to have the potential to stain the tissue and an additional test on viable tissues (without MTT addition) should be performed (step 2). Since the test item did not dye water when mixed with it, step 2 did not have to be performed.
Step 3
All test items (including those already evaluated in step 1 and step 2) should be further evaluated for their potential to interfere with MTT. To test if an item directly reduces MTT, 50 µL of the test item was added to 1 ml of a MTT/DMEM solution (1 mg/mL) and was incubated in the incubator (37 ± 1.5 °C, 5 ± 0.5 CO2) for 60 minutes. Untreated MTT/DMEM solution (1 mg/mL) medium was used as control. Since the MTT/DMEM solution (1 mg/mL) turns blue/purple, the test item proved to reduce MTT and an additional test on freeze-killed tissues (step 4) was performed.
Step 4:
The procedure employed freeze-killed tissues that possess no metabolic activity but absorb and bind the test item similar to viable tissues.
The test item was applied to two freeze-killed tissues. In addition, two freeze killed tissues were left untreated. The entire assay protocol was performed on the frozen tissues in parallel to the assay performed with the live EpiDerm tissues.
Data correction procedure:
True viability = Viability of treated tissue – Interference from test chemical =
ODtvt – ODkt where ODkt = (mean ODtkt – mean ODukt)
tvt = treated viable tissue kt = killed tissues
tkt = treated killed tissue ukt = untreated killed tissue (NC treated tissue)
- Colour interference with MTT: The colourless test item did not change colour when mixed with deionised water.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: the mean OD of the tissue replicates treated with the negative control is ≥ 0.8 and ≤ 2.8 for every exposure time
- Acceptance criteria met for positive control: the mean viability of the tissue replicates treated with the positive control for 1 hour, is <15% compared to the negative control
- Acceptance criteria met for variability between replicate measurements: Yes
- Mean of historical values if different from the ones specified in the test guideline:
3 minutes, positive control:
Mean viability (%)= 21.60
CV (%): 9.52
Range of viabilities (%): 4.60-39.83
3 minutes, negative control:
Mean OD: 1.68
CV (OD): 4.87
Range of ODs: 1.34-1.93
60 minutes, positive control:
Mean viability (%)= 7.02
CV (%): 14.72
Range of viabilities (%): 2.80-14.77
60 minutes, negative control:
Mean OD: 1.65
CV (OD): 3.19
Range of ODs: 1.32-1.85
Any other information on results incl. tables
Table 1 details the results from all tests performed. Table 2 details the corrosivity classification based on relative mean viability.
Table 1. Results after treatment with test item and controls
DOSE GROUP |
EXPOSURE INTERVAL |
AB-SORBANCE (OD) 570 NM |
AB-SORBANCE (OD) 570 NM |
AB-SORBANCE (OD) 570 NM |
MEAN AB-SORBANCE (OD) OF 3 WELLS MINUS BLANK |
MEAN AB-SORBANCE (OD) OF 2 TISSUES |
REL. ABSORBANCE |
MEAN REL. ABSORBANCE |
CV [%] |
CORRECTED |
CORRECTED REL. ABSORBANCE [% OF NEGATIVE CONTROL]*** |
|
Blank |
|
0.046 |
0.041 |
0.035 |
0.000 |
|
|
|||||
Negative Control Tissue 1 |
3 |
1.734 |
1.538 |
1.694 |
1.615 |
1.606 |
100.5 |
100 |
0.8 |
|
||
Negative Control Tissue 2 |
1.659 |
1.624 |
1.631 |
1.597 |
99.5 |
|||||||
Positive Control Tissue 1 |
0.497 |
0.479 |
0.472 |
0.442 |
0.473 |
27.5 |
29.4 |
9.2 |
||||
Positive Control Tissue 2 |
0.540 |
0.547 |
0.546 |
0.503 |
31.3 |
|||||||
Test Item Tissue 1 |
1.675 |
1.646 |
1.653 |
1.617 |
1.723 |
100.7 |
107.3 |
8.7 |
1.723- (0.164-0.199) = 1.758 |
109.5 |
||
Test Item Tissue 2 |
1.864 |
1.877 |
1.868 |
1.829 |
113.9 |
|||||||
Negative ControlFreeze Killed TissueTissue 1 |
0.232 |
0.246 |
0.245 |
0.200 |
0.199 |
|
||||||
Negative ControlFreeze Killed TissueTissue 2 |
0.239 |
0.238 |
0.235 |
0.197 |
||||||||
Test ItemFreeze Killed TissueTissue 1 |
0.201 |
0.198 |
0.199 |
0.159 |
0.164 |
|||||||
Test ItemFreeze Killed TissueTissue 2 |
0.211 |
0.210 |
0.210 |
0.170 |
||||||||
|
|
0.035 |
0.035 |
0.034 |
0.000 |
|
|
|||||
Negative Control Tissue 1 |
60 |
1.698 |
1.625 |
1.679 |
1.633 |
1.622 |
100.7 |
100 |
1.0 |
|
||
Negative Control Tissue 2 |
1.668 |
1.648 |
1.617 |
1.610 |
99.3 |
|||||||
Positive Control Tissue 1 |
0.158 |
0.163 |
0.161 |
0.126 |
0.140 |
7.8 |
8.7 |
14.5 |
||||
Positive Control Tissue 2 |
0.195 |
0.192 |
0.182 |
0.155 |
9.5 |
|||||||
Test Item Tissue 1 |
1.753 |
1.752 |
1.714 |
1.705 |
1.756 |
105.2 |
108.3 |
4.1 |
1.756- (0.182-0.166) = 1.740 |
107.3 |
||
Test Item Tissue 2 |
1.840 |
1.850 |
1.833 |
1.807 |
111.4 |
|||||||
Negative ControlFreeze Killed TissueTissue 1 |
0.234 |
0.233 |
0.227 |
0.191 |
0.166 |
|
||||||
Negative ControlFreeze Killed TissueTissue 2 |
0.180 |
0.181 |
0.186 |
0.142 |
||||||||
Test ItemFreeze Killed TissueTissue 1 |
0.219 |
0.222 |
0.214 |
0.178 |
0.182 |
|||||||
Test ItemFreeze Killed TissueTissue 2 |
0.228 |
0.227 |
0.226 |
0.187 |
* Relative absorbance (rounded values): ( [100 x (absorbancetest item/positive control)]/ (absorbance negative control ) ) x 100
** ODtest item – (ODtest item freeze-killed – ODnegative control freeze-killed)
*** Corrected relative viability (%) = [mean OD test item - (OD test item freeze killed - OD negative control freeze killed)/mean OD negative control]x 100
Table 2. Classification of corrosivity potential based on relative viability
VIABILITY MEASURED AFTER EXPOSURE TIME POINTS |
PREDICTION TO BE CONSIDERED |
< 50% after 3 minutes exposure |
Corrosive |
≥ 50% after 3 minutes exposure AND < 15% after 60 minutes exposure |
Corrosive |
≥ 50% after 3 minutes exposureAND ≥ 15% after 60 minutes exposure |
Non-corrosive |
TEST ITEM IDENTIFIED AS CORROSIVE |
|
< 25% after 3 minutes exposure |
Optional Sub-category 1A* |
≥ 25% after 3 minutes exposure |
A combination of optional Sub-categories 1B and 1C |
*According to the data generated in view of assessing the usefulness of the RhE test methods for supporting sub-categorisation, it was shown that around 29%, 31% and 33% of the Sub-category 1A results of the EpiDERMTM test method may actually constitute Sub-category 1B or Sub-category 1C substances/mixtures (i.e. over-classifications)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is considered to be non-corrosive to skin since the viability after 3 minutes exposure is greater than 50% and the viability after 1 hour exposure is greater than 15%.
- Executive summary:
Skin corrosion potential was measured using the Human Skin Model Test with EpiDerm™tissues models, in accordance with OECD Guideline for Testing of Chemicals 431: In vitro Skin Corrosion: Human Skin Model Test (Updated Guideline adopted July 29, 2016) and the MatTek test protocol “In vitro EpiDermTM Skin Corrosion Test (EPI-200-SCT)”, 07 November 2014.
The optical pre-experiment (colour interference pre-experiment) to investigate the test item’s colour change potential in water did not led to a change in colour. Due to the test item’s MTT-reducing property, an additional test with freeze-killed tissues to determine a correction factor for true viability calculation was performed.
Independent duplicate tissues of EpiDermTM were exposed to the test item, the negative control (deionised water) or the positive control (8.0 N KOH) for 3 minutes and subsequently 1 hour.
Afterwards, the test and the control items were rinsed off the tissues, and a 3 hour incubation period (37 ± 1 °C, 5 ± 0.5 % CO2) with MTT solution followed. MTT solution was then aspirated from the wells and the wells were rinsed with DPBS. Inserts were transferred into new 24 well plates. The formazan salt was extracted for about 20.5 hours in the refrigerator.
The required acceptability criteria were met.
Exposure to the positive control induced a decrease in the relative absorbance compared to the negative control, both for the 3 minutes exposure period (29.4%) and for the 1 hour exposure period (8.7%) thus confirming the validity of the test system and the specific batch of tissue models.
After exposure to the test item, the corrected relative absorbance values were not reduced (109.4% after 3 minutes exposure, 107.3% after 1 hour exposure). The threshold for corrosivity defined to be 50% after the 3 minutes exposure and 15% after the 1 hour exposure was not affected. Therefore, the test item is not considered to be corrosive under experimental conditions, in accordance with EU CLP and UN GHS.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
