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Diss Factsheets
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EC number: 808-279-8 | CAS number: 88938-51-6
- 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:
- 25 November 2014 to 09 February 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guidelines; coherence between data, results and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disperse Blue ANT
- IUPAC Name:
- Disperse Blue ANT
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test item: Disperse Blue ANT
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- Test System: EPISKIN™ - 0.38 cm2
Supplier: SkinEthic Laboratories (4, A. Fleming – 69007 Lyon – France).
Batch : 15-EKIN-005 (alive tissue), 14-EKIN-037 and 14-EKIN-048 (killed tissues).
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 20 mg/epidermis unit, each measuring 0.38 cm2 (treatment level: 53 mg/cm2).
- Duration of treatment / exposure:
- exposure period of 15 ± 0.5 minutes followed by a 42 ± 1 hour recovery period.
- Number of animals:
- Number of replicates: 3
- Details on study design:
- Positive control item was sodium dodecyl sulphate (SDS) (SIGMA, batch 041M8713V), diluted at the final concentration of 5% (w/v) in sterile water for injection (Baxter, batch 13L0503).
Negative control item was D-PBS (GIBCO, batch 1605086).
Non specific colour (NSC) control: test item treated tissues without MTT .
Non specific MTT reduction (NSMTT) control: killed tissue treated with the test item.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: mean relative viability
- Value:
- 112.7
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42 h. Max. score: 50.0. Remarks: colorimetric measurement of MTT reduction; Mean relative viability <=50%: Irritant (UNGHS Category 2) Mean relative viability > 50%: Not irritant (UNGHS No Category). (migrated information)
In vivo
- Irritant / corrosive response data:
- A mean cell viability of 112.7%, when compared to the negative control, was obtained with test item treated tissue.
The Non Specific Colour (NSC), relative to the negative control, was 15.8% indicating the necessity of further appropriate background subtraction.
The non specific MTT reduction (NSMTT) induced by the test item was 49.2% when compared to the negative control performed with alive tissues.
Based on these results (NSMTT higher than 30%), the test method was not considered suitable for the evaluation of irritant properties of Disperse Blue ANT.
Applicant's summary and conclusion
- Interpretation of results:
- no data
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The mean cell viability of the test item treated tissues was 112.7%. However, since the NSMTT was higher than 30%, the irritation properties of the test item can not be evaluated using this method.
- Executive summary:
The potential of the test item Disperse Blue ANT to be irritant to the skin was investigated through an in vitro skin irritation study using a commercial reconstructed human epidermis (RhE) model named EPISKIN™. The experimental procedures are based on the OECD Guideline for testing of chemicals no. 439. The test item, as well as controls, were tested for their ability to impair cell viability after an exposure period of 15 minutes followed by a 42 ± 1 hour recovery period. The final endpoint of the assay is the colorimetric measurement of MTT reduction (blue formazan salt) in the test system being this reaction an index of cell viability. The test item was tested as supplied by the Sponsor. Before the Main Assay, a preliminary test was carried out to evaluate the compatibility of the test item with the test system. In a first step, the test item was assayed for the ability of reducing MTT per se; a green coloured suspension was observed at the end of the incubation period, indicating that the test item interacted directly with MTT. Green precipitate was noted. In a second step, the test item was assayed for the ability of colouring water per se; a green coloured solution was observed, which indicates a colouring capacity of the test item. Based on these results, additional controls were added in the Main Assay. In the Main Assay, the test item was applied as supplied in three replicates at the treatment level of 20 mg/epidermis unit, each measuring 0.38 cm2 (treatment level: 53 mg/cm2). Positive and negative controls [a 5% (w/v) sodium dodecyl sulphate solution in water and Dulbecco’s phosphate buffered saline (D-PBS), respectively] were concurrently tested, in the same number of replicates and test conditions at the treatment level of 20 µL/epidermis unit. The negative control gave the expected baseline value (Optical Density values of the three replicates higher than 0.6) and variability [Standard Deviation (SD) of % viability lower or equal to 18], in agreement with the guideline indications. According to the method, the mean value is considered the baseline value of the experiment and thus represents 100% of cell viability. The positive control caused the expected cell death (4% of cell viability when compared to the negative control) and variability (SD of % viability equal to 1.1). Based on the stated criteria (mean viability ≤ 40% and SD of % viability ≤18 ), the assay was regarded as valid.
In order to verify if the test item results had to be corrected, the non specific colour (NSC) was evaluated using one alive treated tissue without MTT staining and compared with the D-PBS control. Moreover, non specific MTT reduction (NSMTT) was evaluated using killed tissues and compared with negative control performed with alive tissues. Based on the results obtained (NSC=15.8% and NSMTT=49.2%), this method was not considered suitable for the evaluation of irritant properties of Disperse Blue ANT. Thus, test item Disperse Blue ANT cannot be classified.
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