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EC number: 287-722-1 | CAS number: 85567-10-8
- 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
- Study period:
- 8.-25.11.2016
- 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)
- Version / remarks:
- 2015
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2012
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid, sodium salt
- EC Number:
- 287-722-1
- EC Name:
- 4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid, sodium salt
- Cas Number:
- 85567-10-8
- Molecular formula:
- C18H13N4Na3O12S3
- IUPAC Name:
- trisodium 5-oxo-4-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-1-(4-sulfonatophenyl)-4,5-dihydro-1H-pyrazole-3-carboxylate
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: human-derived epidermal keratinocytes
- Source strain:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- - Source: MatTek Corporation (82105 Bratislava, Slovakia).
- The EpiDerm™ tissue: normal, human-derived epidermal keratinocytes which have been cultured to
form a multilayered, highly differentiated model of the human epidermis.
- Surface: 0.63 cm.
- Pre-incubation: 60 ± 5 minutes in the incubator (37 ± 1 °C, 5% CO2), then for about 18 ± 3 hours (37 ± 1 °C, 5% CO2). - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg + 25 µL DPBS
- Duration of treatment / exposure:
- 60 ± 1 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Test system
- Details on study design:
- Details of the test procedure used
- EpiDerm™ tissue of human-derived epidermal keratinocytes was used
- Conditions of exposure: 37 ± 1 °C, 5% CO2
- Washing: inserts gently rinsed with DPBS
- Number of tissue replicates used per test chemical and controls: 3
- MTT assay: incubation with 0.3 mL of MTT solution for 60 minutes at 37 ± 1 °C, 5% CO2)
- Data evaluation:
Irritant potential of the test item was predicted from the relative mean tissue viabilities compared to the negative control tissues concurrently treated with DPBS.
The test item is considered to be irritant to skin in accordance with regulation EC 1272/2008 (UN GHS “Category 2”), if the tissue viability after exposure and post-incubation is less or equal to 50%.
- Historical data positive control: Mean Viability:4.0%; Rel. Standard Deviation: 2.0%
- Historical data negative control: Mean Absorption: 1.830%; Rel. Standard Deviation:0.376%
- The test meets acceptance criteria if:
- mean absolute OD570 nm of the three negative control tissues is ≥ 0.8 and ≤ 2.8
- mean relative tissue viability of the three positive control tissues is ≤ 20%
- standard deviation (SD) of relative tissue viability obtained from each three concurrently tested tissues is ≤ 18%.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Single test with three tissues
- Value:
- >= 94.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The acceptance criteria were met
Any other information on results incl. tables
Result of the Test Item
Name |
NK |
PC |
TM |
||||||
Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
absolute OD570 |
2.021 |
1.928 |
1.971 |
0.105 |
0.107 |
0.113 |
1.895 |
1.886 |
1.790 |
2.020 |
1.959 |
2.045 |
0.114 |
0.110 |
0.118 |
1.888 |
1.932 |
1.888 |
|
OD570(blank-corrected) |
1.978 |
1.885 |
1.928 |
0.062 |
0.064 |
0.070 |
1.852 |
1.843 |
1.747 |
1.977 |
1.916 |
2.002 |
0.071 |
0.067 |
0.075 |
1.845 |
1.889 |
1.845 |
|
mean OD570of the duplicates (blank-corrected) |
1.978 |
1.900 |
1.965 |
0.067 |
0.066 |
0.073 |
1.849 |
1.866 |
1.796 |
total mean OD570of 3 replicate tissues (blank-corrected) |
1.948* |
0.068 |
1.837 |
||||||
SD OD570 |
0.042 |
0.004 |
0.036 |
||||||
relative tissue viability [%] |
101.5 |
97.6 |
100.9 |
3.4 |
3.4 |
3.7 |
94.9 |
95.8 |
92.2 |
mean relative tissue viability [%] |
100.0 |
3.5** |
94.3 |
||||||
SD tissue viability [%]*** |
2.1 |
0.2 |
1.9 |
||||||
CV [% viabilities] |
2.1 |
5.5 |
2.0 |
* Blank-corrected mean OD570 nmof 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%
NK negative control of living tissues
PC positive control
TM test item treated living tissues
Applicant's summary and conclusion
- Interpretation of results:
- other: the test item showed no irritant effects
- 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 this in vitro study the skin irritation potential of the test item Reactive Yellow 42 was assessed according to
OECD 439 Test Method and EU-Method B.46 and in compliance to GLP.
The potential of the test item to induce skin irritation was analysed by using the three-dimensional human epidermis model EpiDerm (MatTek) comprising a reconstructed epidermis with a functional stratum corneum.
In the present study Reactive Yellow 42 was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay.
Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS.
The test item showed no non-specific reduction of MTT and no colouring potential after mixture with isopropanol. The mixture of the test item with aqua dest. showed colouring in the relevant wavelength range, therefore NSClivingwas determined. Since NSClivingwas ≤ 5% (0.4%), no correction of results was necessary.
The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (94.3%) after 60 min treatment and 42 h post-incubation.
The controls confirmed the validity of the study. The mean absolute OD570of the three negative control tissues was >= 0.8 and ≤ 2.8. The mean relative tissue viability (% negative control) of the positive control was ≤ 20% (3.5%). Standard deviation of viability of replicate tissues of all dose groups was ≤ 18% (0.2% - 2.1%).
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