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EC number: 204-498-2 | CAS number: 121-79-9
- 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:
- 2016-11-10 to 2017-01-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Propyl 3,4,5-trihydroxybenzoate
- EC Number:
- 204-498-2
- EC Name:
- Propyl 3,4,5-trihydroxybenzoate
- Cas Number:
- 121-79-9
- Molecular formula:
- C10H12O5
- IUPAC Name:
- propyl 3,4,5-trihydroxybenzoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Source and lot/batch No.of test material: 201601004
- Expiration date of the lot/batch: 01.01.2019
- Purity: 99.93 %
- Storage condition of test material: room temperature
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- This test uses the EPISKIN-SM™ reconstructed human epidermis model (SkinEthic) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN-SM™ (SkinEthic)
- Tissue batch number(s): 16-EKIN-048
SkinEthic Kit:
- EPISKIN-SM™ plate containing 12 reconstructed epidermis units (area: 0.38 cm²); each reconstructed epidermis is attached to the base of a tissue culture insert with an O-ring set and maintained on nutritive agar for transport (Lot No.: 16-EKIN-048):
1x 12-well assay plate
1x flask of sterile maintenance medium (basic medium for incubations, Lot No.: 16-MAIN3-079)
1x flask of sterile assay medium (basic medium for use in MTT assays, Lot No.: 16-ESSC-051)
- Validity controls as provided by the supplier (SkinEthic):
Morphology:
Histology scoring (HES stained vertical paraffin sections, n = 6):
Specification ≥ 19.5
Result: 22.3 ± 0.3, CV = 1.2%
Well-differentiated epidermis consisting of a basal layer, several spinous and granular layers and a thick stratum corneum.
Barrier function:
IC50 determination (SDS concentration, MTT test, n= 14):
Specification ≥ 1.5 mg/mL
Result: 1.7 mg/mL
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Room temperature
- Temperature of post-treatment incubation (if applicable): 37 ± 1 °C, 5.0 % CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
- washed with DPBS
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT solution
MTT stock solution: 3 mg/mL MTT (Sigma; Lot No.: MKBR6576V) in PBS (Gibco; Lot No.: 1722256)
MTT medium: MTT stock solution was diluted 1 + 9 with DMEM-based medium (final concentration 0.3 mg/mL)
- Acidic isopropanol
0.04 N HCl (AppliChem; Lot No.: 0000687102) in isopropanol (AppliChem; Lot No.: 0000694025)
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 h
- Wavelength: 570 nm
- Filter bandwidth: ± 30 nm
NUMBER OF REPLICATE TISSUES: 3 tissues per dose group
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the viability after 15 minutes exposure and 42 h post-treatment incubation is less than or equal to 50%.
- The test substance is considered to be non-irritant to skin if the viability after 15 minutes exposure and 42 h post-treatment incubation is greater than 50%. - 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): 10 ± 2 mg + 5 µL aqua dest.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL DPBS (Gibco, Cat No. 14040-091, Lot No.: 1737107)
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL Sodium dodecyl sulfat (SDS; AppliChem, Art.-No. A1112,0500, CAS No.: 151-21-3, Lot No.: 40015277)
- Concentration (if solution): 5% in aqua dest. - Duration of treatment / exposure:
- 15 min ± 0.5 miin
- Duration of post-treatment incubation (if applicable):
- 42 ± 1 h
- Number of replicates:
- 3 tissues per dose group
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of three tissues
- Value:
- 70.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- For detailed results see "Any other information on results" Table 1
Any other information on results incl. tables
Results of thePre-Experiments
The mixture of 10 mg test item per 2 mL MTT medium showed reduction of MTT as compared to the solvent. The mixture turned blue/purple.
For quantitative correction of results the part of absorption due to the non-specific reduction of MTT (NSMTT) was determined by using killed tissues. Therefore, three killed tissues were treated with the test item (KT) and with the negative control DPBS (KU), respectively. NSMTT was calculated relative to the negative control of living tissues (NK) according to the following formula:
NSMTT [%] = [(ODKT- ODKU)/ODNK] * 100
Mean ODKT= 0.066
Mean ODKU= 0.032
Mean ODNK= 0.685
The calculated NSMTT was ≤ 30% (4.9%) relative to the negative control of livingepidermisand could therefore be used for determination of the true MTT metabolic conversion (TODTT) of the test item treated living tissues (TM) according to the following formula:
TODTT= ODTM- (ODKT- ODKU) (results see Table 1)
The mixtures of 10 mg of the test item per 90 µL aqua dest. and per 90 µL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSClivingequalled 0%. No additional controls were necessary.
Results of the main experiment
Table1: Result of the test Item
Name | Negative Control | Positive Control | Test Item | ||||||
Tissue | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
Absolute OD570 | 0.606 0.643 |
0.671 0.728 |
0.737 0.726 |
0.096 0.102 |
0.076 0.084 |
0.096 0.093 |
0.540 0.546 |
0.558 0.565 |
0.372 0.382 |
OD570 (Blank corrected | 0.563 0.600 |
0.628 0.685 |
0.694 0.683 |
0.053 0.059 |
0.033 0.041 |
0.053 0.050 |
0.497 0.503 |
0.515 0.522 |
0.329 0.342 |
Mean OD570 of the Duplicates (Blank corrected) | 0.582 | 0.656 | 0.689 | 0.056 | 0.037 | 0.052 | 0.500 | 0.519 | 0.336 |
Total Mean OD570 of 3 Replicate Tissues (Blank corrected) | 0.642* | 0.048 | 0.451 | ||||||
SD OD570 | 0.055 | 0.010 | 0.101 | ||||||
TODIT | - | - | 0.417 | ||||||
Relative Tissue Viabilities [%] | 90.6 | 102.2 | 107.2 | 8.7 | 5.8 | 8.0 | 77.8 | 80.7 | 52.3 |
Mean Relative Tissue Viabilities [%] | 100.0 | 7.5** | 70.3 | ||||||
SD Tissue Viabilities [%]*** | 8.5 | 1.5 | 15.7 | ||||||
CV [% Viability] | 8.5 | 20.5 | 22.3 |
*Corrected mean OD570of the negative control corresponds to 100% absolute tissue viability.
**Mean relative tissue viability of the three positive control tissues is40%.
***Standard deviation (SD) obtained from the three concurrently tested tissues is≤ 18%.
Table 2: Test Acceptance Criteria
|
Value |
Cut off |
pass/fail |
Mean OD570 nmBlank |
0.043 |
< 0.1 |
pass |
Mean Absolute OD570 nmNK |
0.685 |
0.6 ≤ NK ≤1.5 |
pass |
Mean Relative Viability [%] PC |
7.5 |
≤ 40% |
pass |
Max. SD of % Viability [%] |
15.7 |
≤ 18% |
pass |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
- Executive summary:
In the present study the skin irritant potential of Propyl gallate (> 99.93% purity) was analysed according to OECD 439 using the EPISKIN-Standard Model™ (EPISKIN-SMTM), a reconstituted three-dimensional human epidermis model to distinguish between UN GHS “Category 2” skin irritating test substances and not categorized test substances (“No Category”) which may be considered as non-irritant. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 15 min exposure and 42 h post-incubation period and compared to those of the concurrent negative controls.
In this study under the given conditions the test item showed no irritant effects (70.3% mean relative tissue viability). As the relative mean tissue viability after 15 min of exposure and 42 h post-incubation was > 50%, the test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
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