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EC number: 291-909-3 | CAS number: 90506-47-1
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin irritation and the available information indicates that it should be classified as eye irritation (Category 2)
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10/07/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: PCAS, Batch No. 80555E094
- Expiration date of the batch: 05 December 2018
- Production date of the batch: 05 December 2017
- Purity test date: 23 January 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient - Test system:
- human skin model
- Justification for test system used:
- This test uses the EpiDerm™ reconstructed human epidermis model (MatTek) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: reconstituted three-dimensional human skin model EpiDermTM (MatTek)
- Tissue batch number: Lot No.: 28615
- Date of initiation of testing: 17/04/2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation: incubated at 37 ± 1°C,
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Then the tissues were washed by filling and emptying the inserts 15 times with DPBS using a constant stream in about 1.5 cm distance from the tissue surface, this process also occurred sequentially, e.g. in one-minute intervals. Subsequently, the inserts were completely submerged three times in 150 mL DPBS and shaken to remove rests of the test item. Finally, the inserts were rinsed once from the inside and the outside with sterile DPBS. Excess DPBS was removed by blotting the bottom with blotting paper.
- Observable damage in the tissue due to washing: no damage reported.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT stock solution: 5 mg/mL MTT (VWR; Lot 0977C002) in PBS (Gibco; Lot No.: 1943446). MTT medium: MTT stock solution was diluted 1 + 4 with DMEM-based medium (final concentration 1 mg/mL).
- Incubation time: 3 h ± 5 min
- Spectrophotometer: OD was measured at 570 nm with a filter band pass of maximum ± 30 nm without reference wavelength in a plate spectrophotometer using isopropanol as a blank.
- Wavelength: 570nm
- Filter: filter band pass of maximum ± 30 nm without reference wavelength
NUMBER OF REPLICATE TISSUES: Triplicate
CONTROLS
- Negative control: DPBS
- Positive control: 5% SDS solution
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed tissues used
- Procedure used to prepare the killed tissues: two killed tissues were treated with 30 μL of the test item (KT) and two killed tissues were left untreated as a control (KU), respectively.
- N. of replicates : 2
- Method of calculation used:
NSMTT (non-specific reduction of MTT) was calculated relative to the negative control of living tissues (NK) per treatment period according to the following formula: NSMTT = [(ODKT - ODKU)/ODNK] * 100
The true MTT metabolic conversion (TODTT) of the test item treated living tissues (TM) was corrected for each treatment period according to the following formula: TODTT = ODTM - (ODKT - ODKU)
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the viability after exposure is less or equal to 50% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied (volume): 30 μL (undiluted)
VEHICLE
applied as such.
NEGATIVE CONTROL
- Amount applied (volume): 30 μL DPBS
- Concentration: Dulbecco’s phosphate buffered saline used as such (DPBS; Gibco, Cat. No. 14040-091, Lot No.: 1838067).
POSITIVE CONTROL
- Amount applied (volume): 30 μL
- Concentration: 5% sodium dodecyl sulfate - Duration of treatment / exposure:
- Total of 60min.
After dosing of all tissues, all plates were transferred to the incubator for 35 ± 1 min. Afterwards all plates were removed from the incubator and placed under the sterile flow for the remaining time until the 60 ± 1 min incubation time of the first dosed tissue was over. - Duration of post-treatment incubation (if applicable):
- Total of 42h post-incubation.
The plates were post-incubated at 37 ± 1 °C, 5.0% CO2, humidified to 95%, for 24 ± 2 h. Following this incubation the tissues were transferred to new wells containing 0.9 mL fresh assay medium and incubated for additional 18 ± 2 h. - Number of replicates:
- The tissues were treated with each dose group in triplicate.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min of exposure
- Value:
- 3.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In this study under the given conditions the test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 50% (9.8%) after 60 min treatment and 42 h post-incubation. The controls confirmed the validity of the study.
The test item is therefore classified as “irritant” in accordance with UN GHS “Category 2”. - Executive summary:
In the present study the skin irritant potential of ARCOT 3135/384 was analysed. The EpiDerm™-Standard Model (EPI-200™), a reconstituted three-dimensional human epidermis model, was used to distinguish between UN GHS “Category 2” skin irritating test substances and not categorized test substances (“No Category”) which may be considered as non-irritant. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 60 min exposure and 42 h post-incubation period and compared to those of the concurrent negative controls.
The mixture of 30 μL test item per 1 mL MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%.
The mixture of 30 μL of the test item per 300 μl aqua dest. and per 300 μL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSC equalled 0%. No absorption was measured in the relevant range.
The test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 50% (9.8%) after 60 min treatment and 42 h post-incubation.
Result of the Test Item ARCOT 3135/384
Name |
Negative Control |
Positive Control |
Test Item |
||||||
Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
Absolute OD570 |
1.860 1.847 |
1.838 1.822 |
1.785 1.773 |
0.100 0.105 |
0.103 0.110 |
0.104 0.106 |
0.210 0.203 |
0.214 0.221 |
0.233 0.230 |
OD570 (Blank Corrected) |
1.816 1.803 |
1.793 1.777 |
1.740 1.729 |
0.056 0.060 |
0.059 0.065 |
0.060 0.061 |
0.165 0.159 |
0.170 0.177 |
0.189 0.185 |
Mean OD570of the Duplicates (Blank Corrected) |
1.810 |
1.785 |
1.735 |
0.058 |
0.062 |
0.061 |
0.162 |
0.173 |
0.187 |
Total Mean OD570of 3 Replicate Tissues (Blank Corrected) |
1.777* |
0.060 |
0.174 |
||||||
SD OD570 |
0.038 |
0.002 |
0.013 |
||||||
Relative Tissue Viability [%] |
101.9 |
100.5 |
97.6 |
3.3 |
3.5 |
3.4 |
9.1 |
9.8 |
10.5 |
Mean Relative Tissue Viability [%] |
100.0 |
3.4** |
9.8 |
||||||
SD Tissue Viability [%]*** |
2.2 |
0.1 |
0.7 |
||||||
CV [% Viabilities] |
2.2 |
3.3 |
7.2 |
* Blank-corrected mean OD570 nmof the negative control corresponds to 100% absolute tissue viability.
** Mean relative tissue viability of the three positive control tissues is ≤20%.
*** Standard deviation (SD) obtained from the three concurrently tested tissues is ≤ 18%
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.
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