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EC number: 942-492-8 | 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17-22/02/2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 18 June 2019, corrected 26 June 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate
- Molecular formula:
- Substance is a UVCB and cannot be defined by molecular and structural information
- IUPAC Name:
- Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- EC Number: 942-492-8
Batch: 02 November 2020
Purity: UVCB (Substance of Unknown or Variable
composition, Complex reaction products or Biological
materials)
In vitro test system
- Test system:
- human skin model
- Source species:
- other: EPISKIN™ Reconstructed Human Epidermis Model Kit
- Cell type:
- other: adult human-derived epidermal keratinocytes
- Cell source:
- other: three-dimensional reconstructed human epidermis model consisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen.
- Justification for test system used:
- Following a full validation study (ECVAM, 2009) the EpiSkinTM reconstructed human epidermis model showed evidence of being a reliable and relevant stand-alone test for predicting rabbit skin irritation when the endpoint is measured by MTT reduction and for being used as a replacement for the Draize Skin Irritation Test for the purpose of distinguishing between Irritating and Non-Irritating test items.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKINTM
- Tissue batch number(s): 21-EKIN-007
- Data received: 17/02/2021
- suggested expiration date: 22/02/2021
- Date of initiation of testing: 17/02/2021
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature / 15 minutes
- Temperature of post-treatment incubation (if applicable):The rinsed tissues were incubated at 37 °C, 5% CO2 in air for 42 hours.
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: each tissue was removed from the well using forceps and
rinsed using a wash bottle containing DPBS with Ca++ and Mg++. Rinsing was achieved by
filling and emptying each tissue insert for approximately 40 seconds using a constant soft
stream of DPBS to gently remove any residual test item.
- Observable damage in the tissue due to washing: not specified
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 2 mL of a 0.3 mg/mL MTT solution, freshly prepared in assay medium, was pipetted into the third column of 3 wells of the 12-well plates
- Incubation time: 3 hours at 37 °C, 5% CO2 in air
- Spectrophotometer: The optical density (OD570) was measured (quantitative viability
analysis) at 570 nm (without a reference filter) using the Labtech LT-4500 microplate reader.
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues
- Procedure used to prepare the killed tissues (if applicable):
- N. of replicates : 3
- Method of calculation used:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- 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 no treatment
- Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied:10 μL (26.3 μL/cm2)
VEHICLE
N/A
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 μL of DPBS served as the negative controls
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 μL of SDS 5% w/v served as the positive controls- Duration of treatment / exposure:
- Triplicate tissues were treated with the test item for an exposure period of 15 minutes.
To
ensure satisfactory contact with the positive control item the SDS solution was spread over
the entire surface of the epidermis using a pipette tip (taking particular care to cover the
center). After a 7-Minute contact time the SDS solution was re-spread with a pipette tip to
maintain the distribution of the SDS for the remainder of the contact period (re-spreading is
not required for the negative control or test item). The plates were kept in the biological
safety cabinet at room temperature for 15 minutes. - Duration of post-treatment incubation (if applicable):
- At the end of the exposure period, each tissue was removed from the well using forceps and
rinsed using a wash bottle containing DPBS with Ca++ and Mg++. Rinsing was achieved by
filling and emptying each tissue insert for approximately 40 seconds using a constant soft
stream of DPBS to gently remove any residual test item. The rinsed tissues were transferred to the second column of 3 wells containing 2 mL of maintenance medium in each well. The
rinsed tissues were incubated at 37 °C, 5% CO2 in air for 42 hours. - Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- >= 105.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: none
- Direct-MTT reduction: The MTT solution containing the test item did not turn blue or purple which indicated that the test item did not directly reduce MTT.
- Colour interference with MTT: The solution containing the test item was colorless. It was therefore unnecessary to run color correction tissues.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD570 for the negative control treated tissues was 0.918 and the standard deviation value of the viability was 6.4%. The negative control acceptance criteria were therefore satisfied.
- Acceptance criteria met for positive control: The relative mean tissue viability for the positive control treated tissues was 4.4% relative to
the negative control treated tissues and the standard deviation value of the viability was 2.3%.
The positive control acceptance criteria were therefore satisfied.
- Acceptance criteria met for variability between replicate measurements: The standard deviation calculated from individual tissue viabilities of the three identically test
item treated tissues was 4.8%. The test item acceptance criterion was therefore satisfied.
- Range of historical values if different from the ones specified in the test guideline: N/A
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study and under the experimental conditions reported, the test item was classified as
non-irritant - Executive summary:
A GLP-compliant skin irritation study in vitro was carried out for the test item using EPISKINTM reconstructed human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The experiment was performed in line with OECD Guideline 439 and EU Method B46.
Triplicate tissues were treated with the test item for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labeled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT-loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues. At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 μL samples were transferred to the appropriate wells of a pre-labeled 96-well plate. The optical density was measured at 570 nm.
The relative mean viability of the test item treated tissues was 105.4% after the 15-Minute exposure period and 42-Hours post-exposure incubation period.
The criteria required for acceptance of results in the test were satisfied.
In this study and under the experimental conditions reported, the test item was classified as non-irritant.
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