Registration Dossier
Registration Dossier
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: 258-605-2 | CAS number: 53523-90-3
- 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:
- Nov 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- (2015)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tetralithium 5,5'-[vinylenebis[(3-sulphonato-4,1-phenylene)azo]]bis[3-methylsalicylate]
- EC Number:
- 258-605-2
- EC Name:
- Tetralithium 5,5'-[vinylenebis[(3-sulphonato-4,1-phenylene)azo]]bis[3-methylsalicylate]
- Cas Number:
- 53523-90-3
- Molecular formula:
- C30H20Li4N4O12S2
- IUPAC Name:
- tetralithium 5,5'-[vinylenebis[(3-sulphonato-4,1-phenylene)azo]]bis[3-methylsalicylate]
- Reference substance name:
- Unknown impurities, none of which are present at ≥1%
- Molecular formula:
- Unknown impurities, none of which are present at ≥1%
- IUPAC Name:
- Unknown impurities, none of which are present at ≥1%
- Test material form:
- liquid
Constituent 1
impurity 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The test system epiCS is commercially available and the laboratory has been validated with this test system in a multicenter validation study.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- DETAILS OF THE TEST PROCEDURE USED
The irritant potential of the test item is assessed by determination of its cytotoxic effect on an in vitro reconstructed human epidermis. The test principle is based on the MTT assay reflecting the cell viability after exposure to the topically applied test item. All tests were performed in triplets for each time point. The test item was applied unchanged, i.e. 30 mg per insert for 20 min. (room temperature), plus 30 µL saline to moisten and ensure good contact to the tissue surface. After the exposure a post-treatment incubation period of 42 h of the rinsed tissue in the incubator followed. Then, cell viability was measured by the amount of MTT reduction (calculated on the basis of optical density compared to negative control).
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: epiCS® (CellSystems, Troisdorf, Germany).
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: RT (room temperature)
- Temperature of post-treatment incubation (if applicable): 37 ± 2° C (incubator temperature)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/ml
- Incubation time: 3 hours
- Incubation conditions: 37 ± 2° C, 5 % CO2, maximum humidity
- Spectrophotometer: EL808, Bio-Tek
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3 for test substance, positive and negative control (for determination of cell viability the absorption of the isopropanol-extracts were measured in duplicates = 6 OD values for each)
DECISION CRITERIA:
- The mean optical density (OD) value obtained with the test item was used to calculate the percentage of viability relative to the negative control, which is set at 100 %.
- Classification according to UN GHS: The test substance is considered to be at least irritant to skin if the viability after 20 minutes exposure is less than or equal to 50% (Category 2 or 1; depending on outcome of corosivity test). The test substance is considered to be non-irritant to skin if the viability after 20 minutes exposure is greater than 50% . - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 mg per insert
- Duration of treatment / exposure:
- 20 min. (room temperature)
- Duration of post-treatment incubation (if applicable):
- 42 hours (37 °C)
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 80.61
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - DEMONSTRATION OF TECHNICAL PROFICIENCY:
The reliability of the test conduction was previously confirmed in an interlaboratory validation study.
Any other information on results incl. tables
Summary of results
Sample No. |
Test item | OD mean* | StdDev | % Viability |
1 -3 | Negative control (NaCl 0.9 %) | 2.33 | 0.04 | 100.00 |
4 -6 | Positive control (SDS 5 %) | 0.03 | 0.00 | 1.09 |
7 -9 | Test item, undiluted | 1.88 | 0.06 | 80.61 |
*: 6 values
Applicant's summary and conclusion
- Conclusions:
- No irritant potential to the skin is concluded when tested in an in vitro test according to OECD TG 439.
- Executive summary:
An in vitro study was performed for the assessment of skin irritation on a reconstructed human epidermis (RhE; epiCS®). The experiment was carried out in accordance to OECD TG 439 with the neat substance. 30 mg of the test item was applied topically on the RhE, plus 30 µL saline to moisten and ensure good contact with the tissue surface. After an exposure period of 20 minutes (room temperature) and a post-exposure incubation of 42 hours (37 °C, 5 % CO2, maximum humidity), the cell viability was 80.6 %, as measured by a MTT conversion assay. The test item was thus not considered to have an irritant potential to the skin.
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.
