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EC number: 210-784-8 | CAS number: 623-27-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
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:
- Terephthalaldehyde
- EC Number:
- 210-784-8
- EC Name:
- Terephthalaldehyde
- Cas Number:
- 623-27-8
- Molecular formula:
- C8H6O2
- IUPAC Name:
- benzene-1,4-dicarbaldehyde
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch (Lot) Number: 180401
Expiry date: 01 April 2020 (retest date)
Physical Description: Light yellow powder
Purity/Composition: 99.6%
Storage Conditions: At room temperature
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- not specified
- Justification for test system used:
- In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimize the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Batch no.: 18 EKIN 039)
This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen.
The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- 16.3 to 18.2 mg per tissue
- Duration of treatment / exposure:
- 15 ± 0.5 minutes at room temperature
- Duration of post-treatment incubation (if applicable):
- 42 hours at 37°C
- Number of replicates:
- 3 (three)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- ca. 98
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Terephthaldehyde was checked for possible direct MTT reduction and color interference in the Skin corrosion test using EpiDerm as a skin model (Test Facility Study No. 20152366). Because no color changes were observed it was concluded that Terephthaldehyde did not interact with the MTT endpoint.
The mean absorption at 570 nm measured after treatment with Terephthaldehyde and controls are presented inAppendix 1,Table1.
The individual OD570measurements are presented inAppendix 2.
Table2shows the mean tissue viability obtained after 15 ± 0.5 minutes treatment with Terephthaldehyde compared to the negative control tissues. Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with Terephthaldehyde compared to the negative control tissues was 98%. Since the mean relative tissue viability for Terephthaldehyde was above 50% Terephthaldehyde is considered to be non-irritant.
The positive control had a mean cell viability after 15 ± 0.5 minutes exposure of 32%. The absolute mean OD570of the negative control tissues was within the laboratory historical control data range (SeeAppendix 3). The standard deviation value of the percentage viability of three tissues treated identically was ≤ 14%, indicating that the test system functioned properly.
Table1
Mean Absorption in theIn VitroSkin Irritation Test with Terephthaldehyde
|
A (OD570) |
B (OD570) |
C (OD570) |
Mean (OD570) |
|
SD |
Negative control |
0.963 |
0.925 |
1.034 |
0.974 |
± |
0.055 |
Terephthaldehyde |
0.966 |
0.886 |
1.019 |
0.957 |
± |
0.067 |
Positive control |
0.184 |
0.310 |
0.449 |
0.314 |
± |
0.132 |
OD = optical density
SD = Standard deviation
Triplicate exposures are indicated by A, B and C.
In this table the values are corrected for background absorption (0.043). Isopropanol was used to measure the background absorption.
Table2
Mean Tissue Viability in the In Vitro Skin Irritation Test with
Terephthaldehyde
|
Mean tissue viability (percentage of control) |
Standard deviation (percentage) |
Negative control |
100 |
5.7 |
Terephthaldehyde |
98 |
6.9 |
Positive control |
32 |
14 |
OD measurements/ tissue
|
A (OD570) |
B (OD570) |
C (OD570) |
Negative control OD570measurement 1 OD570measurement 2 |
1.0090 1.0020 |
0.9765 0.9579 |
1.0830 1.0697 |
Terephthaldehyde OD570measurement 1 OD570measurement 2 |
1.0062 1.0101 |
0.9393 0.9184 |
1.0664 1.0574 |
Positive control OD570measurement 1 OD570measurement 2 |
0.2247 0.2284 |
0.3537 0.3511 |
0.4913 0.4909 |
OD = Optical density
Triplicate exposures are indicated by A, B and C.
HIstorical control data
|
Negative control (absorption; OD570) |
Positive control (absorption; OD570) |
Range |
0.422 – 1.547 |
0.023 – 0.437 |
Mean |
0.98 |
0.13 |
SD |
0.18 |
0.08 |
n |
174 |
173 |
SD = Standard deviation
n = Number of observations
The above mentioned historical control data range of the controls were obtained by collecting all data over the period of November 2014 to November 2017.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, Terephthaldehyde is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
- Executive summary:
The objective of this study was to evaluate Terephthaldehyde for its ability to induce skin irritation on a human three dimensional epidermal model (EPISKIN Small model (EPISKIN-SMTM)). The possible skin irritation potential of Terephthaldehyde was tested through topical application for 15 minutes.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch 180401 of Terephthaldehyde was a light yellow powder. Skin tissue was moistened with 5 µL of Milli-Q water and at least 10 mg of Terephthaldehyde was applied directly on top of the skin tissue for 15 ± 0.5 minutes. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with Terephthaldehyde compared to the negative control tissues was 98%. Since the mean relative tissue viability for Terephthaldehyde was above 50% after 15 ± 0.5 minutes treatment Terephthaldehyde is considered to be non-irritant.
The positive control had a mean cell viability of 32% after 15 ± 0.5 minutes exposure. The absolute mean OD570(optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was ≤ 14%, indicating that the test system functioned properly.
In conclusion, Terephthaldehyde is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
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