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EC number: 612-028-6 | CAS number: 607724-47-0
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- EU Method B.40-BIS
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3,8-bis[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, trisodium salt
- EC Number:
- 612-028-6
- Cas Number:
- 607724-47-0
- Molecular formula:
- C26H22N5Na3O16S5
- IUPAC Name:
- 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3,8-bis[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, trisodium salt
- Test material form:
- solid: particulate/powder
- Details on test material:
- 1 MATERIALS AND METHODS
1.2 Test Item
Designation in Test Facility: 17031402G
Date of Receipt: 14. Mar. 2017
Condition at Receipt Room temperature, in proper conditions
1.2.1 Specification.
Name Blendazol Red Blendwell
Batch no. E 328
Appearance Dark Red Powder
Composition 2-Naphtalenesulfonic acid, 7-amino-4-hydroxy-3,8-bis[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, triso dium salt
Purity 95 % by HPLC
Homogeneity homogeneous
Expiry date 17. Feb. 2019
Storage Room Temperature: (20 ± 5°C); Keep away from humidity
CAS No. 607724-47-0
EINECS-No. 612-028-6
Chemical Class not stated
Stability H2O: 96h; EtOH: unknown; acetone: unknown CH3CN: unknown; DMSO: unknown
Solubility H2O: to be determined*; EtOH: unknown; acetone: unknown CH3CN: unknown; DMSO: unknown
* Will be determined in another GLP-study at LAUS GmbH and will be stated in the final report, this
This information is not provided by the sponsor but determined at LAUS GmbH.
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- other: The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell cul-tures inserts
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Brati-slava.
Designation of the kit: EPI-200-SCT
Day of delivery: 16. May 2017
Batch: 25812 - Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25.4 mg
- Concentration (if solution):
VEHICLE MTT
- Amount(s) applied (volume or weight with unit):2 ml
- Concentration (if solution):1mg/L
- Lot/batch no. (if required):
- Purity:
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): Demineralised water
- Concentration (if solution): 50µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50µL of KOH
- Concentration (if solution): 8M Solution in demineralised water - Duration of treatment / exposure:
- 3 min
1 h - Duration of post-treatment incubation (if applicable):
- 55 min
- Number of replicates:
- 2 experiments
Test system
- Type of coverage:
- other: The test item was applied to each tissue and spread to match the tissue size.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):25.4 mg +/-0.1mg
- Concentration (if solution):
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): Demineralised water
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight): KOH, CAS No. 1310-58-3, solution in demineralised water (8 M), batch no: 20150617.
- Concentration (if solution): 8M - Duration of treatment / exposure:
- 3MIN
1H - Details on study design:
- TEST SITE
- Area of exposure: The test item was applied to each tissue and spread to match the tissue size.
- % coverage: 100%
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Dulbecco’s Phosphate-Buffered Saline”; Solution was used for the rinsing of the tissues
- Time after start of exposure: 55 min
OBSERVATION TIME POINTS : “3 minutes” and “1 hour”
SCORING SYSTEM:
- Method of calculation:
The photometric absorbance of the negative controls was considered as 100%. For the mean of the 3 replicates of test item and positive control, tissue viability was calculated as % photometric absorbance compared to the negative control.
Note: All calculations are performed with unrounded values. Therefore, re-calculation with rounded values may lead to slightly different results
% tissue viability = (OD 1 replicate test item resp. positive control)*100%
OD mean of negative controls
1OD= Optical Density
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min/ 1 hour
- Value:
- >= 93 - <= 109.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
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:- OTHER EFFECTS:
- Visible damage on test system: NO
- Direct-MTT reduction:
- Colour interference with MTT: NO
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:
The criterion for optical density of the negative control (≥ 0.8 and ≤ 2.8) was fulfilled: opti-cal density was 1.8 (3 minutes) resp. 1.9 (1 hour).
- Acceptance criteria met for positive control:
The positive control showed clear corrosive effects. The criterion for the viability of the 1 hour experiment, expressed as % of the negative control (< 15%), was fulfilled, too. The viability was 8.4 %
- Acceptance criteria met for variability between replicate measurements: YES
Any other information on results incl. tables
For the test item and the positive control, the following percentage values of mean tissue viability were calculated in comparison to the mean of the negative controls:
Table8.2‑a % Tissue Viability
Test Item |
Positive Control |
Incubation |
109.7% |
23.2% |
3 min |
93.0% |
8.4% |
1 h |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- non-corrosive to skin.
- Conclusions:
- The relative absorbance values of the test item were increased to 109.7% after 3 minutes treatment. This value is above the threshold for corrosivity (50%). After 1 hour treatment, the relative absorbance values of the test item were reduced to 93.0%, lying above the threshold for corrosivity (15%). Therefore, the test item is considered as non-corrosive to skin.
- Executive summary:
The Determination of Skin Corrosion Potential of Blendazol Red Blendwell in the Reconstructed Human Epidermis (RhE)
Test Method was determined following OECD Guideline 431and EU-Method B.40-BIS
One valid experiment was performed.
Two tissues of the human skin model EpiDermTMwere treated with the test itemBlendazol Red Blendwell for 3 minutes and 1 hour, respectively. The test item was applied to each tissue and spread to match the tissue size.
Demineralised water was used as negative control, 8 M KOH was used as positive control.
After treatment, the respective substance was rinsed from the tissues. Then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to a blue formazan. Formazan production was evaluated by measuring the optical density (OD) of the resulting solution.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for both treatment intervals thus showing the quality of the tissues. The OD was 1.8 (3 minutes experiment) and 1.9 (1 hour experiment). The positive control showed clear corrosive effects for both treatment intervals. The relative absorbance value was reduced to 8.4 % for the 1 hour treatment.
After 3 minutes treatment with the test item, the relative absorbance values were increased to 109.7 %. This value is above the threshold for corrosion potential (50%). After 1 hour treatment, relative absorbance values were reduced to 93.0 %. This value, too, is above the threshold for corrosion potential (15%). In the guideline, values greater or equal to the threshold are considered as “non-corrosive to skin”.
Therefore, Blendazol Red Blendwell is considered as
non-corrosive to skin in the Reconstructed Human Epidermis (RhE) Test Method
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