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EC number: 940-272-6 | CAS number: 2097734-13-7
- 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:
- 09 July 2014 - 14 July 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis[C5-(linear and branched)-alkyl] benzene-1,4-dicarboxylate
- EC Number:
- 940-272-6
- Cas Number:
- 2097734-13-7
- Molecular formula:
- C18H26O4
- IUPAC Name:
- Bis[C5-(linear and branched)-alkyl] benzene-1,4-dicarboxylate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- Epi-200 SIT
- Source species:
- human
- Cell type:
- other: epidermal keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi-200- SIT
- Tissue batch number(s): 19652 Kit G
- Date of initiation of testing: 09 July 2014
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
After the end of the treatment interval the inserts were removed immediately from the 6-well plate and tissues were gently rinsed with DPBS at least 15 times in order to remove any residual test material. After the rinsing the inserts were submerged in DPBS at least three times. Afterwards the inserts were once again rinsed with sterile DPBS from the inside and the outside. Excess DPBS was removed by gently shaking the inserts and blotting the bottom with sterile blotting paper. The tissues were carefully dried using sterile cotton tipped swap.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
On the day of testing the MTT concentrate was diluted with the MTT diluent. The 24-well plates were prepared before the end of the tissue pre-warming period. A volume of 300 µL of the MTT solution was added to each well and the plates were kept in an incubator (37 ± 1 °C, 5 ± 0.5 % CO2) until further use.
After the 42-hours incubation period was completed for all tissues and exposure groups, culture inserts were transferred from the holding plates to the MTT-plates. After a 3-hour incubation period (37 ± 1 °C, 5 ± 0.5 % CO2), the MTT solution was aspirated from the wells, and the wells were rinsed three times with DPBS. Inserts were transferred onto new 24-well plates. The inserts were immersed into extractant solution by gently pipetting 2 mL extractant solution (isopropanol) in each insert. The level rose above the upper edge of the insert, thus tissues were completely covered from both sides. The 24-well plate was sealed to inhibit the isopropanol evaporation. The formazan salt was extracted for 69 hours at room temperature.
After the extraction period was completed, the inserts were pierced with an injection needle to allow the extract to run into the well from which the insert was taken. Afterwards the insert was discarded. The 24-well plates were placed on a shaker for 15 minutes until the solution was homogeneous in colour.
Per each tissue, 3 x 200 µL aliquots of the blue formazan solution were transferred into a 96-well flat bottom microtiter plate from the 15 minutes exposure. OD was read in a microplate reader (Versamax® Molecular Devices, Softmax Pro, version 4.7.1) with a 570 ± 1 nm filter. Mean values were calculated from the 3 wells per tissue.
PREDICTION MODEL / DECISION CRITERIA
For the current test, an irritation potential of a test item according to EU classification R38 (according to directive 67/548/EEC), H315 (according to regulation (EC) 1272/2008), and GHS category 2 according to UN GHS (published 2003, last (3rd) revision 2009) is recommended if the mean relative tissue viability of three individual tissues is reduced below 50% of the negative control. - Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):30 µL of the undiluted test item
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL DPBS was used as negative control.
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL of 5% SLS solution in deionised water was used as positive control. - Duration of treatment / exposure:
- After pre-incubation of EpiDerm™ tissues was completed, medium was replaced by 0.9 mL of fresh medium per well. The negative and positive control and the test item were added into the insert atop the corresponding EpiDerm™ triplicate tissues. The 6-well plates were placed into the incubator for 35 minutes at 37 ± 1.5 °C, 5 ± 0.5 % CO2, 95 ± 5% RH. Thereafter, plates were removed from the incubator and placed into the sterile hood until the period of 60 minutes was completed.
- Number of replicates:
- 3
Test animals
- Species:
- other: human keratinocytes
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 30 µl of the undiluted test item was dispensed directly atop the EpiDerm™ tissue.
- Duration of treatment / exposure:
- 60 minutes
- Details on study design:
- This in vitro study was performed to assess the irritation potential of Di-(iso)-pentyl terephthalate (DPT) by means of the Human Skin Model Test.
Three tissues of the human skin model EpiDerm™ SIT (EPI-200) (from MatTek Corporation, Bratislava, Slovakia) were treated with the test item, the negative or the positive control for 60 minutes.Each 30 µL of the test item, of the negative control (DPBS), and of the positive control (5% SLS) were applied to each of triplicate tissue and spread to match the tissue size.
The test is followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT [3-(4,5-dimethylthiazole-2-yl)-2,5-diphenyl-tetrazoliumbromide], in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison of untreated negative controls is used to predict skin irritation potential and is used for the purpose of classification as irritating or non-irritating.
The mean OD of the three negative control tissues was calculated. 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.
For the test item and the positive control the mean relative viability +/- rel. standard deviation of the three individual tissues was calculated and used for classification according to the following prediction model:
in vitro result in vivo prediction
mean tissue viability < 50% irritant (I), H315 (category 2)
mean tissue viability > 50% non-irritant (NI)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean relative absorbance value of the test item is corresponding to the cell viability.
- Run / experiment:
- DPT
- Value:
- 80.1
- 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:
- Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.
Any other information on results incl. tables
Results after treatment with Di-(iso)-pentyl terephthalate (DPT) and the controls
Dose Group |
Treat-ment Interval |
Absor-bance 570 nm |
Absor-bance 570 nm |
Absor-bance 570 nm |
Mean Absor-bance of 3 Tissues |
Rel. Absor-bance [%] Tissue 1, 2 + 3** |
Relative Standard Deviation [%] |
Mean Rel. Absorbance [% of Negative Control]*** |
Nega-tive Control |
60 min |
1.950 |
2.003 |
2.336 |
2.096 |
93.0 |
10.0 |
100.0 |
Positive Control |
60 min |
0.096 |
0.104 |
0.112 |
0.104 |
4.6 |
7.5 |
5.0 |
Test Item |
60 min |
1.608 |
1.640 |
1.790 |
1.680 |
76.7 |
5.8 |
80.1 |
The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 80.1% (threshold for irritancy:≤50%), consequently the test item was not irritant to skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In conclusion, the test item Di-(iso)-pentyl terephthalate (DPT) is not irritant to skin according to UN GHS and EU CLP regulation in this study.
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