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EC number: 701-295-5 | CAS number: -
- 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
- Remarks:
- Turnkey Testing Strategy
- Adequacy of study:
- weight of evidence
- Study period:
- Aug 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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 Jul 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt Rheinland-Pfalz
Test material
- Reference substance name:
- Reaction mass of (4Z,8E)-dodeca-4,8,11-trienal and (4E,8Z)-dodeca-4,8,11-trienal
- EC Number:
- 701-295-5
- Molecular formula:
- C12 H18 O
- IUPAC Name:
- Reaction mass of (4Z,8E)-dodeca-4,8,11-trienal and (4E,8Z)-dodeca-4,8,11-trienal
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: V15 Trienal-Dest. F.4-7+V16 Trienal-Dest.F4-8
- Purity: Around 92 area-% as isomeric mixture determined by GC on an RTX-1701 capillary
- Physical state / color: Liquid / colorless, clear
- Expiry date: May 2020
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room tempreature
- Storage stability: guaranteed by the sponsor
FORM AS APPLIED IN TEST:
- The test substance was applied undiluted
OTHER SPECIFICS:
- Homogeneity: homogeneous by visual inspection
- pH value: Ca. 5 (undiluted test substance, determined in the lab prior to start of the GLP study)
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 200
- Detailed information: surface 0.6 cm²; cultured in Millicells® ∅ 1 cm
- Date of initiation of testing: 16 Aug 2018
- Evaluation of cell viability: 23 Aug 2018
- Tissue model: EPI-200
- Tissue Lot Number: 28646 (Certificate of Analysis see Appendix)
- Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 min at room temperature or 1 h in the incubator
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing procedure: The tissues were washed with sterile PBS 3 min or 1h after start of application treatment
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- Incubation time: 3h
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm
- Filter: No reference filter
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed tissues
- Procedure used to prepare the killed tissues (if applicable): Freezing at –20°C
- N. of replicates : 2
- Method of calculation used: Calculation of mean corrected OD570 KC by subtracting the OD570 KC of the NC from the OD570 KC of the test substance
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%.
- The test substance is considered to be non-corrosive to skin if complete, e.g. the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - 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): 50 µL undiluted test substance
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL deionized water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL 8 N potassium hydroxide solution - Duration of treatment / exposure:
- 3 min and 1h (for treatments with an viability of ≥ 50% after 3 min)
- Number of replicates:
- 2
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL undiluted test substance
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL deionized water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL 8 N potassium hydroxide solution
: - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with PBS
- Time after start of exposure: 3min or 1h
OBSERVATION TIME POINTS
- 3 min and 1h
SCORING SYSTEM:
- Method of calculation: The individual tissue OD570 is calculated by subtracting the
mean blank value of the respective microtiter plate from the respective individual tissue OD570 value; KC correction was performend to assess the final relative mean viability
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Exposure period 3min
- Value:
- 104.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Exposure period 1h
- Value:
- 101.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: yes; KC tissues were applied in parallel and the mean viability was corrected
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Range of historical values if different from the ones specified in the test guideline: The historical control data demonstrate the reproducibility of results and
robustness of the procedures.
Any other information on results incl. tables
Tab. 2: Exposure period 3 min: Individual and mean OD570 values, individual and mean viability values,
standard deviations and coefficient of variation
Exposure period: 3 min |
|||||||
Testsubstance identification |
|
|
tissue 1 |
tissue 2 |
mean |
SD |
CV [%] |
NC |
viable tissues |
mean OD570 |
2.071 |
2.098 |
2.084 |
||
viability [% of NC] |
99.4 |
100.6 |
100.0 |
0.9 |
0.9 |
||
KC tissues |
mean OD570 |
0.146 |
0.127 |
0.137 |
|||
viability [% of NC] |
7.0 |
6.1 |
6.5 |
0.6 |
9.8 |
||
18/0072-2 |
viable tissues |
mean OD570 |
2.273 |
2.231 |
2.252 |
||
viability [% of NC] |
109.1 |
107.0 |
108.0 |
1.4 |
1.3 |
||
KC tissues |
mean OD570KC NC corrected |
0.065 |
0.098 |
0.081 |
|||
viability [% of NC] |
3.1 |
4.7 |
3.9 |
1.1 |
29.2 |
||
Final relative mean viability of tissues after KC correction [% of NC]: |
104.2 |
||||||
PC |
viable tissues |
mean OD570 |
0.167 |
0.235 |
0.201 |
||
viability [% of NC] |
8.0 |
11.3 |
9.6 |
2.3 |
23.8 |
Due to the ability of the test substance to reduce MTT directly, KC tissues were applied in
parallel. The results of the KC tissues indicate an increased MTT reduction (relative mean
viability 3.9% of NC). Thus, for the test substance, the final relative mean viability is given after KC correction.
Tab. 3: Exposure period 1 h: Individual and mean OD570 values, individual and mean viability values,
standard deviations and coefficient of variation
Exposure period: 1 h |
|||||||
Testsubstance identification |
|
|
tissue 1 |
tissue 2 |
mean |
SD |
CV [%] |
NC |
viable tissues |
mean OD570 |
2.043 |
2.084 |
2.063 |
||
viability [% of NC] |
99.0 |
101.0 |
100.0 |
1.4 |
1.4 |
||
KC tissues |
mean OD570 |
0.116 |
0.122 |
0.119 |
|||
viability [% of NC] |
5.6 |
5.9 |
5.8 |
0.2 |
3.6 |
||
18/0072-2 |
viable tissues |
mean OD570 |
2.358 |
2.155 |
2.256 |
||
viability [% of NC] |
114.3 |
104.4 |
109.3 |
7.0 |
6.4 |
||
KC tissues |
mean OD570KC NC corrected |
0.199 |
0.134 |
0.166 |
|||
viability [% of NC] |
9.6 |
6.5 |
8.1 |
2.2 |
27.9 |
||
Final relative mean viability of tissues after KC correction [% of NC]: |
101.3 |
||||||
PC |
viable tissues |
mean OD570 |
0.122 |
0.139 |
0.130 |
||
viability [% of NC] |
5.9 |
6.7 |
6.3 |
0.6 |
9.5 |
Due to the ability of the test substance to reduce MTT directly, KC tissues were applied in
parallel. The results of the KC tissues indicate an increased MTT reduction (relative mean
viability 3.9% of NC). Thus, for the test substance, the final relative mean viability is given after KC correction.
Tab. 4: Historic control data of NC and PC of corrosion test
Historic Range of NC |
|
||||
OD570 |
|||||
Exposure Time |
Period |
Mean OD |
SD |
Mean + 2 SD |
Mean - 2 SD |
3 minutes |
Jan 2016 - Jul 2018 |
1.751 |
0.217 |
2.184 |
1.318 |
60 minutes |
Jan 2016 - Jul 2018 |
1.723 |
0.225 |
2.172 |
1.273 |
Historic Range of PC |
|
|
|
|
|
OD570 |
|
|
|
|
|
Exposure Time |
Period |
Mean OD |
SD |
Mean + 2 SD |
Mean - 2 SD |
3 minutes |
Jan 2016 - Jul 2018 |
0.238 |
0.080 |
0.398 |
0.078 |
60 minutes |
Jan 2016 - Jul 2018 |
0.093 |
0.019 |
0.130 |
0.055 |
Relative Viability (%) |
|
|
|
|
|
Exposure Time |
Period |
Mean % |
SD |
Mean + 2 SD |
Mean - 2 SD |
3 minutes |
Jan 2016 - Jul 2018 |
13.6 |
4.3 |
22.3 |
5.0 |
60 minutes |
Jan 2016 - Jul 2018 |
5.4 |
1.1 |
7.6 |
3.2 |
Applicant's summary and conclusion
- Interpretation of results:
- other: no indication of skin corrosion
- Conclusions:
- No prediction can be made for skin irritation according to GHS criteria based on the results on this in vitro study alone. According to the results of the present study, the substance shows no potential of skin corrosion.
- Executive summary:
The objective was to assess the skin irritation and corrosion potential of the test substance. Using the methods currently available, a single in vitro assay is not sufficient to cover the full range of skin irritating/corrosion potential. Therefore, two in vitro assays were part of this in vitro skin irritation and corrosion test strategy:
The Skin Corrosion Test (SCT) and Skin Irritation Test (SIT).
In the SCT the potential of the test substance to cause dermal corrosion was assessed by a
single topical application of 50 μL undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™).
For the corrosion test, two EpiDerm™ tissues were incubated with the test substance for 3 minutes and 1 hour, each.
Due to the intense smell of the test substance, the plates were sealed with an adhesive protective foil immediately after application.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation by using a colorimetric test. The reduction of mitochondrial
dehydrogenase activity measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the epidermal
tissues treated with the test substance is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The test substance is able to reduce MTT directly. Therefore, an additional MTT reduction control KC (freeze-killed control tissues) was introduced.
The final relative mean viability of the tissues treated with the test substance determined after an exposure period of 3 minutes was 104.2%, and it was 101.3% after an exposure period of
1 hour. Based on the results of the skin corrosion test no skin corrosion potential can be concluded.
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