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EC number: 610-203-1 | CAS number: 446299-81-6
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 May 2020 - 12 June 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
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:
- Boronic acid, [6-(benzoylmethylamino)-5-methyl-3-pyridinyl]-
- Cas Number:
- 446299-81-6
- Molecular formula:
- C14H15BN2O3
- IUPAC Name:
- Boronic acid, [6-(benzoylmethylamino)-5-methyl-3-pyridinyl]-
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- (EpiDermTM model)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The EpiDermTM model has been validated for irritation testing and its use is recommended by the relevant OECD guideline for irritation testing (OECD No. 439); therefore, it was considered to be suitable for this study.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM model
- Tissue batch number(s): 30872.
- Production date: N/A
- Shipping date: 09.06.2020
- Delivery date: 09.06.2020
- Date of initiation of testing: 10.06.2020
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 35 minutes at 37ºC and 25 minutes at room temperature.
- Temperature of post-treatment incubation (if applicable): 37ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 15 x 1 mL of DPBS
- Observable damage in the tissue due to washing: no
- Modifications to validated SOP: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 300 µL of a MTT solution at 1.0 mg/mL
- Incubation time: 3 hours at 37ºC, 5% CO2
- Spectrophotometer: ELx800 absorbance microplate reader (BioTek)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: O.D. = 1.971 (Acceptance criterion: 1.0-3.0). Historical negative control mean OD range = 0.530-1.211 (OD measured after 1:2 dilution in isopropanol; acceptability criteria should be in the range ≥ 0.4 and ≤1.4)
- Barrier function: 6.35 h (Acceptance criterion: 4.77h < ET50< 8.72h)
- Morphology: Tissue viability and barrier function test are within the acceptable ranges and indicate appropriate formation of the epidermal barrier, the presence of a functinal stratum corneum, a viable basal cell layer and intermediate spinous and granular layers.
- Contamination: No.
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE: there is no direct interaction between the test item and MTT.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test item is considered as non-irritant to skin if the mean percent viability after 60 minutes exposure and 42 hours of post-treatment incubation is > 50%.
- The test item is identified as requiring classification and labelling according to UN GHS (Category 2) if the mean percent tissue viability after 60 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and the result of a skin corrosion test is “non corrosive”.
- The test item is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after 60 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and in absence of information on a skin corrosion test. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg (39 mg/cm2)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): 5% SDS - Duration of treatment / exposure:
- 35 min at 37ºC and 25 min at room temperature.
- Duration of post-treatment incubation (if applicable):
- 43 hours and 45 minutes
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 96
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (distilled water)
- Positive controls validity:
- valid
- Remarks:
- 3.6% viability (5% SDS)
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes. A full demonstration of proficiency was performed for the EpiSkin model, plus a reduced validation with the EpiDerm model, having into account that both models are very similar. Adequate results were obtained for the evaluated chemicals.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, mean OD = 0.957 (OD measured after 1:2 dilution in isopropanol; acceptability criteria should be in the range ≥ 0.4 and ≤1.4).
- Acceptance criteria met for positive control: yes, mean viability = 3.6% (acceptability criteria should be < 20%).
- Acceptance criteria met for variability between replicate measurements: yes. SD of negative, positive and test item replicates were 12.6, 0.3 and 1.8% respectively (acceptablility criteria, SD ≤ 18%).
Any other information on results incl. tables
Table 1. Table of results
Well ID | OD | Mean OD / disc (#) |
Mean OD / product |
Viability % |
Mean viability % |
SD viability |
Conclusion | |
Negative control |
SPL 1 | 0.729 | 0.818 | 0.957 | 85.5 | 100.0 | 12.6 | |
0.925 | ||||||||
0.802 | ||||||||
SPL 2 | 1.012 | 1.029 | 107.6 | |||||
1.031 | ||||||||
1.045 | ||||||||
SPL 3 | 0.964 | 1.023 | 106.9 | |||||
1.049 | ||||||||
1,057 | ||||||||
Positive control |
SPL 4 | 0.032 | 0.032 | 0.035 | 3.3 | 3.6 | 0.3 | Irritant |
0.033 | ||||||||
0.031 | ||||||||
SPL 5 | 0.030 | 0.034 | 3.6 | |||||
0.035 | ||||||||
0.039 | ||||||||
SPL 6 | 0.037 | 0.038 | 4.0 | |||||
0.042 | ||||||||
0.036 | ||||||||
Test item PH-20/0316 |
SPL 13 | 0.876 | 0.907 | 0.918 | 94.8 | 96.0 | 1.8 | Non irritant |
0.956 | ||||||||
0.890 | ||||||||
SPL 14 | 0.914 | 0.938 | 98.0 | |||||
0.937 | ||||||||
0.964 | ||||||||
SPL 15 | 0.902 | 0.910 | 95.1 | |||||
0.911 | ||||||||
0.917 |
# mean of 3 values (triplicate of the same extract).
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The test substance can be considered as not irritant to skin as the mean percent viability of the treated tissues was found 96.0% in the in vitro RhE test.
- Executive summary:
An in vitro skin irritation test was conducted for the test item in a reconstructed human epidermis model ( EpiDerm™) according to OECD TG 439 (GLP study). Three epidermis units, previously moistened with 25 μL of distilled water, were treated with 25 mg test item for 35 minutes at 37ºC, 5% CO2 then during 25 minutes at room temperature. Exposure of the test item was terminated by rinsing with 15 x 1 mL of DPBS. The epidermis units were then incubated for a 24 hours post-treatment incubation period in 6 wells culture plate filled with 900 μL of fresh medium at 37ºC, 5% CO2, then placed into 900 μL of fresh new assay medium during 19 hours and 45 minutes, at 37ºC, 5% CO2. The viability of each disk was assessed by incubating the tissues with MTT, extracting the precipitated formazan crystals using isopropanol during 2 hours under gentle agitation in the dark, and measuring the concentration of formazan by determining the OD at 570 nm, just after dilution of the extracts 1:2 in isopropanol. Under the test conditions, the mean percent viability of the treated tissues was 96.0%, versus 3.6% in the positive control (5% Sodium Dodecyl Sulfate). Therefore, the test item is considered as not irritant to the skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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