Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 276-771-4 | CAS number: 72705-26-1
- 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:
- other: experimental data on similar substance
- Adequacy of study:
- key study
- Study period:
- 2016-11-30 to 2016-01-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
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)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Commission Regulation (EU) No 640/2012 of 6 July 2012
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ammonium sodium 2-[4-[[1-[[(2-methoxy-5-methyl-4-sulphonatophenyl)amino]carbonyl]-2-oxopropyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonate
- EC Number:
- 276-770-9
- EC Name:
- Ammonium sodium 2-[4-[[1-[[(2-methoxy-5-methyl-4-sulphonatophenyl)amino]carbonyl]-2-oxopropyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonate
- Cas Number:
- 72705-24-9
- Molecular formula:
- C26H24N4O9S3.H3N.Na
- IUPAC Name:
- ammonium sodium 2-[4-({1-[(2-methoxy-5-methyl-4-sulfonatophenyl)carbamoyl]-2-oxopropyl}diazenyl)phenyl]-6-methyl-1,3-benzothiazole-7-sulfonate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDerm™ 200 kit: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
containing: 24 EPI-200 tissues (reconstructed epidermis): surface 0.6 cm²
cultured in Millicells® diameter 1 cm
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C ± 1°C
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 1x after 1 hour application
- Observable damage in the tissue due to washing: no
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm
- Filter: without reference filter - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 25 μL sterile PBS was applied first. Thereafter, a bulk volume of ca. 25 μL of the solid test
material was applied with a sharp spoon and homogeneously distributed together with the fluid.
NEGATIVE CONTROL
- Amount applied: 30 μL of sterile Dulbecco's phosphate buffered saline (PBS)
POSITIVE CONTROL
- Amount applied: 30 μL of SDS
- Concentration: 5% - Duration of treatment / exposure:
- 1 hour
- Duration of post-treatment incubation (if applicable):
- After 24 ± 2 hours for additional 18 ± 2 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 1
- Value:
- 97.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 2
- Value:
- 125.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 3
- Value:
- 90.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: Based on the results of the pretest it was judged, that application of color control tissues is not necessary.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
- Range of historical values if different from the ones specified in the test guideline: no
Test substance
identification Tissue 1 Tissue 2 Tissue3 mean SD CV [%]
NC mean OD570 2.128 2.338 1.997 2.152
viability
[% of NC] 98.8 108.5 92.7 100.0 8.0 8.0
Test substance mean OD570 2.102 2.698 1.956 2.252
viability
[% of NC] 97.6 125.2 90.8 104.5 18.3 17.5
PC mean OD570 0.071 0.076 0.069 0.072
viability
[% of NC] 3.3 3.5 3.2 3.3 0.2 4.7
Any other information on results incl. tables
Table 1: Decision criteria for evaluation of results of irritation test
Mean tissue viability (% of negative control) |
Prediction |
< 45 |
Irritant |
45 - 55 |
Borderline |
> 55 |
Non-irritant |
The „borderline“-evaluation (50 ± 5%) was determined statistically using historic BASF data and hence considers the variance of the test method. This evaluation is confirming the borderline range provided in OECD Guideline 439.
Table 2: Results
Test substance identification |
|
Tissue 1 |
Tissue 2 |
Tissue 3 |
mean |
SD |
CV [%] |
NC |
mean OD570 |
2.128 |
2.338 |
1.997 |
2.152 |
|
|
|
viability [% of NC] |
98.8 |
108.5 |
92.7 |
100.0 |
8.0 |
8.0 |
Test substance |
mean OD570 |
2.102 |
2.698 |
1.956 |
2.252 |
|
|
|
viability [% of NC] |
97.6 |
125.2 |
90.8 |
104.5 |
18.3 |
17.5 |
PC |
mean OD570 |
0.071 |
0.076 |
0.069 |
0.072 |
|
|
|
viability [% of NC] |
3.3 |
3.5 |
3.2 |
3.3 |
0.2 |
4.7 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not skin irritant
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.