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EC number: 276-067-7 | CAS number: 71839-81-1
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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:
- other: UN GHS (2003, last rev. 2015)
- Principles of method if other than guideline:
- Based on a “Statement on the Scientific Validity of In Vitro Tests for Skin Irritation” of the European Commission (November 2008), official acceptance of the test method in the EU was achieved and implemented in EU, 2008a, Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to EC Regulation No 1907/2006 of the European Parliament and of the Council on REACH; 1st ATP 2009: EC Regulation No 761/2009 of 23 July 2009 amending, for the purpose of its ATP, EC Regulation No 440/2008 laying down test methods pursuant to EC Regulation No 1907/2006 of the European Parliament and of the Council on REACH, section B46.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzene-1-sulphonamidato(2-)]chromate(1-)
- EC Number:
- 276-067-7
- EC Name:
- Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzene-1-sulphonamidato(2-)]chromate(1-)
- Cas Number:
- 71839-81-1
- Molecular formula:
- C34H28Cl2CrN10O8S2.Na
- IUPAC Name:
- Chromate(1-), bis[3-[2-[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-(oxo-kO)-1H-pyrazol-4-yl]diazenyl-kN1]-4-(hydroxy-kO)-N-methylbenzenesulfonamidato(2-)]-, sodium (1:1)
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Other name: Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzene-1-sulphonamidato
(2-)]chromate(1-)
C.I. Index Solvent Orange 41
CAS-No.: 71839-81-1
EINECS / EC-No.: 276-067-7
Appearance: Red powder
Expiry Date: 06.01.2026
In vitro test system
- Test system:
- human skin model
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Each approximately 25 mg (~ 39 mg/cm2 according to guideline) of the test item were applied to the tissues
- Duration of treatment / exposure:
- 60 minutes.
Test animals
- Species:
- other: reconstituted human epidermis model
Test system
- Type of coverage:
- other: Topical
- Preparation of test site:
- other: Not applicable
- Vehicle:
- other: No vehicle used
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
25 mg (~ 39 mg/cm2)
NEGATIVE CONTROL
30 µL DPBS (MatTek) were used as negative control per tissue.
POSITIVE CONTROL
30 µL of a 5% SLS solution in deionized water (MatTek) were used a positive control per tissue. - Duration of treatment / exposure:
- 60 minutes
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- See table below
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- all
- Value:
- ca. 111.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The mean relative absorbance value of the test item, corresponding to the cell viability, was 111.7% after taking the correction factor gained in the above mentioned additional test with a viable tissue into consideration (threshold for irritancy: ≤ 50%), consequently the test item was not irritant to skin.
Any other information on results incl. tables
Results after treatment with the test item and the controls (exposure interval of 60 minutes):
Dose Group | Tissue No. | Absorbance 570 nm Well 1 | Absorbance 570 nm Well 2 | Absorbance 570 nm Well 3 |
Mean Absorbance of 3 wells blank corrected |
Mean Absorbance of 3 wells blank corrected |
Mean Absorbance of 3 tissues after blank correction |
Rel. Absorb. [%] Tissue 1,2,3 |
Blank Controls |
|
0.036 |
0.037 |
0.036 |
0.036 |
|||
Negative Control |
1 |
1.578 |
1.549 |
1.558 |
1.562 | 1.525 | 1.811 | 84.2 |
|
2 |
2.026 |
1.984 |
1.971 |
1.994 | 1.957 | 108.8 | |
|
3 |
2.024 |
1.971 |
1.965 |
1.986 | 1.950 | 107.7 | |
Positive Control |
1 |
0.098 |
0.097 |
0.097 |
0.097 | 0.061 | 0.078 | 3.4 |
|
2 |
0.118 |
0.121 |
0.118 |
0.119 | 0.082 | 4.6 | |
|
3 |
0.125 |
0.126 |
0.126 |
0.126 | 0.089 | 4.9 | |
Blank Test Item |
0.038 |
0.038 |
0.037 |
0.038 |
|
|
|
|
Test Item |
1 |
2.095 |
1.978 |
1.990 |
2.021 |
1.984 |
2.056
|
109.5 |
|
2 |
2.132 |
2.124 |
2.132 |
2.130 |
2.092 |
115.5 | |
|
3 |
2.140 |
2.126 |
2.127 |
2.131 |
2.094 |
115.6 |
Dose Group |
Tissue No. | Relative Standard Deviation [%] | Mean Relative Absorbance [% of Negative Control] ** | Mean Absorbance Blank corrected viable tissue without MTT (Step 2) | Mean Relative Absorbance [% of Negative Control] after colour interference and MTT reduction correction |
Blank Controls | |||||
Negative Control | 1 | ||||
2 | 13.7 | 100.0 | |||
3 | |||||
Positive Controls | 1 | ||||
2 | 19.0 | 4.3 | |||
3 | |||||
Blank Test Item | |||||
Test Item | 1 | ||||
2 | 3.1 | 113.6 | 0.034 | 111.7 | |
3 |
* relative absorbance per tissue [rounded values]
** relative absorbance per treatment group [rounded values]
The optical pre-experiment (colour interference pre-experiment) to investigate the test item’s colour change potential in water lead to a change in colour. Therefore an additional experiment for unspecific colour interference was performed and the result was used as correction factor for the evaluation of true tissue viability.
Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.
The mean relative absorbance value of the test item, corresponding to the cell viability, was 111.7% after taking the correction factor gained in the above mentioned additional test with a viable tissue into consideration (threshold for irritancy: ≤ 50%), consequently the test item was not irritant to skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to skin according to UN GHS and EU CLP regulation.
- Executive summary:
This in vitro study was performed to assess the irritation potential of the test item by means of the Human Skin Model Test.
The test item passed the MTT- pre- test. Because of possible colour interference an additional test with a viable tissue was performed and the result was used as correction factor for data evaluation in the main experiment.
Approximately 25 mg of the test item were applied to each tissue, wetted with 25 µL of DPBS, and spread to match the surface of triplicate tissues.
30 µL of either the negative control (DPBS) or the positive control (5% SLS) were applied to triplicate tissues each.
The test item and the positive and negative controls were washed off the skin tissues after 60 minutes treatment. After further incubation for about 43 hours the tissues were treated with the MTT solution for 3 hours following nearly 69 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.
After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD³0.8 and ≤ 2.8 for the 60 minutes treatment interval thus showing the quality of the tissues.
Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 4.3% thus ensuring the validity of the test system.
The relative standard deviations between the % variability values of the test item and the negative control in the main test were below 19% (threshold of the "OECD Guideline for the Testing of Chemicals 439:In vitroSkin Irritation: Reconstructed Human Epidermis Test Method”: < 18%). The slight excess of the recommended standard deviation by the positive control (19.0%) is still considered acceptable since the positive control produced a distinct positive result with very low absorbance values, and the mean OD values were within the range of historical control data.
Compared to the relative absorbance value of the negative control the mean relative absorbance value was 111.7% after exposure of the skin tissues to the test item and after taking the correction factor into consideration. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
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