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EC number: 309-264-4 | CAS number: 100208-62-6
- 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:
- From May 17th to 25th, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- July 28th, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Aluminum, 2-(2-quinolinyl)-1H-indene-1,3(2H)-dione sulfo derivs. complexes
- EC Number:
- 309-264-4
- EC Name:
- Aluminum, 2-(2-quinolinyl)-1H-indene-1,3(2H)-dione sulfo derivs. complexes
- Cas Number:
- 100208-62-6
- Molecular formula:
- Not applicable
- IUPAC Name:
- Aluminum, 2-(2-quinolinyl)-1H-indene-1,3(2H)-dione sulfo derivs. complexes
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- - Direct MTT reduction - functional check in tubes: 25 mg of the test item were added to 1 mL MTT medium (red) and incubated in the incubator (37±1°C, 5±1 % CO2, moistened) for 65 minutes. At the end of the exposure time, the presence and intensity of the staining was observed. The test item did not reduce MTT directly.
- Colour interference : 50 mg of the test item were added to 2 mL isopropanol and placed on a shaker for 2 hours 25 minutes at room temperature. Two 200 μL aliquots of isopropanol solutions and of pure isopropanol were transferred to a 96-well plate and the absorbance was measured with a plate reader at the MTT measurement wavelength. Colour of the test item did not interfere with the endpoint.
- MTT test: 25 mg of the test item was dosed directly on tissue (reconstructed human epidermal model EpiDerm™, EPI-200 ver. 2.0, MatTek, Bratislava, Slovakia, Lot No. 28614 kit C) previously moistened with 25 μL DPBS. The item was spread on the entire tissue surface. A single experiment, composed of three replicate tissues, was run. On the day of receipt, EpiDermTM tissues were conditioned by incubation to release transport stress related compounds and debris. Duration of pre-incubations before treatment was 60 minutes and 20 hours, 35 minutes. After pre-incubations, tissues were topically exposed to the test chemicals for 60±1 minutes (25 minutes at room temperature and the remaining 35 minutes at culture conditions). Three tissues were used per the test item, three for the the positive (PC) and three for the negative (NC) controls. Tissues were then thoroughly rinsed with PBS. Inserts were then transferred to fresh medium. After 25 hours and 14 minutes of post-incubation period, the medium was replaced by fresh one. Tissues were incubated for another 18 hours 41 minutes. Afterwards, the MTT assay was performed by transferring the tissues to 24-well plates containing MTT medium (1 mg•mL-1). After 180 minutes of MTT incubation, the blue formazan salt formed by cellular mitochondria was extracted with 2.0 mL/tissue of isopropyl alcohol (for 128 minutes, room temperature, shaking) and the optical density of the extracted formazan was determined using a spectrophotometer at 570 nm. OD570 was measured on a spectrophotometer Libra S22. Isopropyl alcohol served as a blank. Allowed band width is 2-3 nm. No external filter was used.
- Viability calculation: relative cell viability was calculated for each tissue as % of the mean of the negative control tissues. Than the mean relative tissue viability of three individual tissues exposed to the test item was calculated – this value is used for the comparison with limit. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 60±1 minutes
- Duration of post-treatment incubation (if applicable):
- approximately 42 hours
- Number of replicates:
- A single experiment, composed of three replicate tissues
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment I
- Value:
- 89.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
OD570values obtained at the MTT test, their averages, standard deviations (%) and relative viabilities
Treatment | OD570 | Avg | SD | Average viability (% NC) |
|||
1 | 2 | 3 | |||||
NC | PBS | 1.798 | 2.132 | 2.052 | 1.994 | 0.142 | 100 |
% | 90.2 | 106.9 | 102.9 | 100 | 7.141 | ||
C1 | 85/18 | 1.716 | 1.68 | 1.964 | 1.787 | 0.126 | 89.6 |
% | 86.1 | 84.3 | 98.5 | 89.6 | 6.332 | ||
PC | 5% SDS | 0.048 | 0.047 | 0.054 | 0.05 | 0.003 | 2.5 |
% | 2.4 | 2.4 | 2.7 | 2.5 | 0.155 |
Notes:
NC |
negative control |
PC |
positive control |
SDS |
sodium dodecyl sulphate |
PBS |
phosphate-buffered saline |
C1, 85/18 |
test item |
avg |
arithmetic average |
SD |
standard deviation calculated from individual % tissue viabilities |
Average viability (% NC) |
viability of single tissues compared with negative control |
Applicant's summary and conclusion
- Interpretation of results:
- other: No classification required for skin irritation according to CLP Regulation (EC) No 1272/2008
- Conclusions:
- The average viability of tissues treated by the test item, was 89.6 % of negative control average value i.e. viability was > 50 %.
The effect of the test item was negative in EpiDermTM model.
non skin irritant - Executive summary:
The test item,was assayed forin vitroskin irritation in the human epidermal model EpiDermTM.The test was performed according totheOECDTest GuidelineNo.439:In VitroSkin Irritation: Reconstructed HumanEpidermisTest Method(2015) and Protocol for: In Vitro EpiDermTMSkin Irritation Test for use with MatTek Corporation’s Reconstructed Human Epidermal Model EPI-200-SIT.
After pre-incubation of tissues,25 mg of the test item was placed directly on tissue and spread on the entire tissue surface.The length of exposure was60 minutes. Three tissues were used for the test item and for positive and negative controls.
After removal of the test item, tissues were post-incubated for approximately 42 hours. Three hours incubation with MTT and two hours extraction period with shaking followed. Optical density (OD570) of isopropyl alcohol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues.
Tests for colour interference and direct reduction did not demonstrate influence of colour or reductive properties of the test substance on study results. Thus, no steps for correction of results were performed.
Under the above-described experimental design,average viability of treated tissues was 89.6%,i.e. viability was >50 %.
The effect of the test item was negative in EpiDermTMmodel (tissues were not damaged).
According to the classification criteria,the test item,is considered to have no category with regard to skin irritation.
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