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EC number: 262-810-2 | CAS number: 61477-95-0
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Monalazone disodium
- EC Number:
- 262-810-2
- EC Name:
- Monalazone disodium
- Cas Number:
- 61477-95-0
- Molecular formula:
- C7H4ClNO4S.2Na
- IUPAC Name:
- disodium 4-[(chloroazanidyl)sulfonyl]benzoate
Constituent 1
- Specific details on test material used for the study:
- 20% Monalazone Disodium
5% Monalazone Disodium in water.
Stored at room temperature in the absence of light. The dilutions were prepared immediately prior to exposures.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The 3-Dimensional human epithelial skin model (EpiDerm™, MatTek, Ashland, MA) is made up of normal human keratinocytes cultured on a permeable synthetic membrane at the air-liquid interface in a chemically defined medium. The cells form a multilayered, highly differentiated model of the human epidermis that consists of organized basal, spinous, granular, and cornified layers and closely resembling native epidermis. Each lot of tissues is Quality Assured by MatTek, Inc. according to specific QC standards including: histology (cell layers), tissue viability (MTT mean optical density) and reproducibility (SD).
Upon receipt, the MatTek EpiDerm™ tissue cultures were placed in 0.9 mL of fresh Maintenance medium (6-well plate) for one hour. The tissues were then transferred to 6-well plates containing 0.9 mL of fresh Maintenance medium and they were incubated overnight. 30 µL of the negative control, DPBS, and positive control, 5% SDS, were added to the apical surface of tissues. 30 µL of each test material was added to the apical surface of tissues. All tissues were placed into the 37°C incubator with 5% CO2. The exposure time was 1 hour, with 35 minutes exposure in the incubator and 25 minutes at room temperature. After the 1 hour exposure, the tissues were rinsed 20 to 25 times with 1 mL of DPBS. The apical surface was gently blotted with a cotton swab. The tissues were placed in 0.9 mL of fresh Maintenance medium (6-well plate) for 24 hours. After 24 hours, the basal media was replaced with 0.9 mL of fresh Maintenance medium (6-well plate) and incubated for another 18 hours prior to performing the MTT assay.
Tissues were then evaluated for cell viability using an MTT Assay where yellow MTT is reduced to purple formazan primarily by enzymes (reductases) located in the mitochondria of living cells. According to established Cyprotex procedure, a stock solution of MTT (Sigma, M-5655) was prepared in Maintenance medium (provided with tissues) just prior to use and warmed to 37°C in a water bath. Tissues inserts were transferred to 24-well plates containing 300 µL MTT medium (1 mg/mL). After 3 hour MTT incubation, the formazan salt was extracted with 2 mL isopropanol per tissue and the optical density of the extracted formazan is determined using a spectrophotometer at 570 nm. Viable cells had the greatest amount of MTT reduction and hence the highest absorbance values. Relative cell viability was calculated for each tissue as % of the mean of the negative control tissues. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 ul
- Duration of treatment / exposure:
- 1 hour
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- Three
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 20% Monalazone disodium
- Value:
- 11.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 5% Monalazone Disodium
- Value:
- 42
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
Mean |
SD |
SEM |
%CV |
p-value |
Significant? |
|
DPBS |
100.0 |
3.6 |
2.1 |
3.6 |
|
|
5% SDS |
5.0 |
0.7 |
0.4 |
13.1 |
<0.001 |
YES |
20% monalazone disodium |
11.9 |
5.2 |
3.0 |
43.7 |
<0.001 |
YES |
Dilute (5% monalazone disodium) in Water |
42.0 |
8.3 |
4.8 |
19.8 |
0.001 |
YES |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test articles (20% monalazone disodium and 5% monalazone Disodium) were determined to be irritants to human skin as the viability of the exposed cells were <50% of control.
- Executive summary:
The MatTek EpiDerm™ model was used to assess the potential dermal irritation of the test article under three conditions by determining the viability of the tissues following exposure via MTT. The objective of this study was to assess the dermal irritation potential of the Sponsor’s submitted test article under three conditions. Pre-testing showed the test articles/conditions were not colored though one test article, 20% Monalazone Disodium did auto-reduce MTT. A small data correction was necessary as the auto-reduction was observed during the study. Tissues were exposed to test articles and controls for one hour, followed by a 42 hour post-exposure recovery period. The viability of each tissue was determined by MTT assay.
The assay passed all the quality controls. The negative control tissue OD was between 1.651 and 1.942, the positive control was within the confidence limits and was deemed an irritant, and the test article SDs were all ≤18. The MTT data show the positive control, 5% sodium dodecyl sulfate (SDS), reduced tissue viability to 5.0% of control. The mean viability of tissues after exposure to the test articles, 20% monalazone disodium and Dilute 5% monalazone disodium in water were <50% of control. Therefore, the test articles were determined to be irritants to human skin according to the OECD test guideline followed for this study.
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