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EC number: 258-548-3 | CAS number: 53423-65-7
- 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:
- 05 February 2018 - 23 February 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- Sodium 2,4,5-trichlorobenzenesulphonate
- EC Number:
- 258-548-3
- EC Name:
- Sodium 2,4,5-trichlorobenzenesulphonate
- Cas Number:
- 53423-65-7
- Molecular formula:
- C6H2Cl3O3S.Na
- IUPAC Name:
- sodium 2,4,5-trichlorobenzenesulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Name:STB-FR
CAS No.: 53423-65-7
Batch No.: 1710-06
Aggregate State at RT: solid, powder
Color: white
Storage Conditions: room temperature
Purity: 90.5%
Expiry Date: October 2019
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: cultured on chemically modified, collagen-coated cell culture inserts.
- Source strain:
- not specified
- Vehicle:
- physiological saline
- Details on test system:
- Test system consisted of normal human epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell). The EpiDerm epidermis model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum analogous to patterns found in vivo.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- 25 mg (39 mg/cm2)
- Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test Item
- Value:
- 97.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Result of the Test Item STB-FR:
Name |
Negative Control |
Positive Control |
Test Item |
||||||
Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
Absolute OD570 |
2.070 |
1.785 |
2.187 |
0.100 |
0.101 |
0.100 |
1.975 |
1.853 |
1.989 |
2.045 |
1.789 |
2.133 |
0.103 |
0.107 |
0.100 |
2.010 |
1.891 |
1.992 |
|
OD570(Blank Corrected) |
2.027 |
1.741 |
2.144 |
0.057 |
0.057 |
0.056 |
1.932 |
1.809 |
1.945 |
2.002 |
1.746 |
2.090 |
0.060 |
0.063 |
0.057 |
1.966 |
1.847 |
1.948 |
|
Mean OD570of the Duplicates (Blank Corrected) |
2.014 |
1.743 |
2.117 |
0.058 |
0.060 |
0.056 |
1.949 |
1.828 |
1.947 |
Total Mean OD570of 3 Replicate Tissues (Blank Corrected) |
1.958* |
0.058 |
1.908 |
||||||
SD OD570 |
0.193 |
0.002 |
0.069 |
||||||
Relative Tissue Viability [%] |
102.9 |
89.0 |
108.1 |
3.0 |
3.1 |
2.9 |
99.5 |
93.4 |
99.4 |
Mean Relative Tissue Viability [%] |
100.0 |
3.0** |
97.4 |
||||||
SD Tissue Viability [%]*** |
9.8 |
0.1 |
3.5 |
||||||
CV [% Viabilities] |
9.8 |
3.2 |
3.6 |
*Blank-corrected mean OD-570 mm of the negative control corresponds to 100% absolute tissue viability.
**Mean relative tissue viability of the three positive control tissues is </= 20%.
***Standard deviation (SD) obtained from the three concurrently tested tissues is </= 18%
Quality Criteria:
|
Value |
Cut off |
pass/fail |
Mean Absolute OD570 nmNK |
2.002 |
0.8 ≤ NK ≤2.8 |
pass |
Mean Relative Viability [%] PC |
3.0 |
≤ 20% |
pass |
SD Viability[%] |
0.1% - 9.8% |
≤ 18% |
pass |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed no irritant effects.
- Executive summary:
In this GLP guideline study conducted according to OECD test method 439 and EC method B.46 using the EpiDerm Standard Model (EPI-200) utilizing a reconstituted three-dimensional human epidermis, the test item showed no irritant effects. The relative mean tissue viability after 60 min of exposure and 42 h post-incubation was 97.4% and, thus, the test item can be classified as “non-irritant” in accordance with UN GHS.
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