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EC number: - | CAS number: -
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2020 to March 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442E (In Vitro Skin Sensitisation: human Cell Line Activation Test (h-CLAT))
- Version / remarks:
- June 2018
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- human Cell Line Activation Test (h-CLAT)
Test material
- Reference substance name:
- Reaction mass of (Tetramethylcyclotetrasiloxane propylether) prop-1-enylether bisphenol A and Di(tetramethylcyclotetrasiloxane propylether) bisphenol A
- Cas Number:
- 203874-34-4
- Molecular formula:
- (OSiHxCH3)4-CH2-CH2 -CH2- O-C6H4-C(CH3)2-C6H4-0-CH2-CH2-CH2-(SiHxCH3O)4
- IUPAC Name:
- Reaction mass of (Tetramethylcyclotetrasiloxane propylether) prop-1-enylether bisphenol A and Di(tetramethylcyclotetrasiloxane propylether) bisphenol A
- Test material form:
- liquid
- Details on test material:
- Appearance: Pale yellow liquid
Constituent 1
In vitro test system
- Details of test system:
- THP-1 cell line [442E]
- Details on the study design:
- * Dose Finding Assay:
The test article working solutions or solvent controls were mixed 1:1 (v/v) with the cell suspensions in the 96-well plates. The plates were sealed and then incubated for 24±0.5 hours (incubator set to 37ºC, 5% CO2).
After the 24-hour incubation period, all cells from the 96-well flat-bottomed plate were transferred into a 96-well round-bottomed plate. The cells were washed at least twice in 200 µL of phosphate buffered saline containing 0.1% bovine serum albumin (FACS buffer) and re-suspended in 190 µL of FACS buffer. 10 µL of propidiumiodide solution (PI) was added just before FACS analysis (final concentration of PI = 0.625 µg/mL). PI uptake was analysed using flow cytometry with the acquisition channel FL-3. A total of 10,000 viable cells were acquired.
* CD86/CD54 Expression Measurement:
Two independent runs (experiments) were needed to drive a prediction. Each independent run was performed on the same day provided that for each run:
a) Independent fresh stock solutions and working solutions of the test article and antibody solutions were prepared and
b) Independently harvested cells were used (i.e. cells were collected from different culture flasks).
On the days of testing, cells harvested from the flasks were resuspended with fresh culture medium at 2 x 10E6 cells/mL. The cells were then distributed into a 24-well plate (500 µL/1 x 10E6 cells per well).
The test article working solution or solvent control was mixed 1:1 (v/v) with the cell suspensions in the 24-well plates. The plates were sealed and then incubated for 24±0.5 hours (incubator set to 37ºC, 5% CO2).
After the 24-hour incubation period, the cells were transferred into sample tubes, collected by centrifugation (approximately 250 g, 5 minutes) and washed twice with 1 mL of FACS buffer. After washing, the cells were blocked with 600 µL of blocking solution (FACS buffer containing 0.01% (w/v) globulin) on ice for 15 minutes.
After blocking, the cells were split into three aliquots of 180 µL into a 96-well plate and centrifuged (approximately 250 g, 3 minutes).
After centrifugation, the cells were stained with 50 µL of FITC-labelled anti-CD86, anti-CD54 or mouse IgG1 antibodies on ice for 30 minutes.
The stained cells were washed three times with an excess of FACS buffer, re-suspended in FACS buffer and 12.5 µg/mL PI solution was added (to give a final PI concentration of 0.625 µg/mL).
The expression levels of CD86 and CD54 and cell viability were analysed using flow cytometry. - Vehicle / solvent control:
- DMSO
- Positive control:
- dinitrochlorobenzene (DNCB) [442E]
Results and discussion
- Positive control results:
- For the positive control, RFI values were =150% for CD86 and =200% for CD54, and cell viability was >50% in each independent run.
In vitro / in chemico
Results
- Key result
- Group:
- test chemical
- Run / experiment:
- mean
- Parameter:
- EC150, CD86 [442E]
- Value:
- 314.14 µg/mL
- Cell viability:
- >50%
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Other effects / acceptance of results:
- In both experiments, the RFI values for CD86 were >150% (with cell viability >50%) at multiple concentrations and the RFI values for CD54 were <200% at all concentrations.
The EC150 value for CD86 calculated by linear regression of endpoint assay data was
314.14 µg/mL. No EC200 value was calculated for CD54 as this marker was negative in both experiments.
All assay acceptance criteria were met. The cell viabilities of medium and solvent/vehicle control were higher than 90% in each independent run. In the solvent control, RFI values of both CD86 and CD54 did not exceed the positive criteria (CD86 RFI =150% and CD54 RFI =200%).
For both medium and solvent/vehicle controls, the MFI ratio of both CD86 and CD54 to isotype control was >105% on all occasions. For the positive control, RFI values were 150% for CD86 and 200% for CD54, and cell viability was >50% in each independent run.
For the test article, the cell viability was more than 50% in all tested concentrations in each independent run.
Any other information on results incl. tables
Dose Finding Assay: Cell Viability
Viability (%) at Concentration (μg/mL) | ||||||||
Run | 7.81 | 15.63 | 31.25 | 62.5 | 125 | 250 | 500 | 1000 |
1 | 99.1 | 98.6 | 99 | 98.8 | 98.7 | 98.1 | 98.3 | 98.1 |
2 | 98.8 | 98.6 | 98.8 | 98.9 | 99 | 98.2 | 98.3 | 97.9 |
Expression Assay: MFI and Cell Viability Values
Experiment 1
Concentration (µg/mL) | MFI (Geo Mean) | Corrected MFI | Viability | |||||
CD86 | CD54 | Isotype | CD86 | CD54 | IgG | CD86 | CD54 | |
279.08 | 1425 | 575 | 481 | 944 | 94 | 97.5 | 96.6 | 97.0 |
334.90 | 1567 | 561 | 480 | 1087 | 81 | 96.4 | 96.0 | 96.2 |
401.88 | 1420 | 544 | 469 | 951 | 75 | 96.3 | 95.7 | 96.0 |
482.25 | 1224 | 557 | 463 | 761 | 94 | 97.7 | 96.5 | 95.6 |
578.70 | 1244 | 520 | 423 | 821 | 97 | 99.1 | 96.8 | 96.8 |
694.44 | 1453 | 573 | 485 | 968 | 88 | 96.7 | 95.1 | 95.4 |
833.33 | 1346 | 589 | 493 | 853 | 96 | 96.4 | 95.3 | 95.4 |
1000.00 | 1197 | 587 | 497 | 700 | 90 | 96.9 | 95.8 | 96.8 |
Culture medium | 922 | 555 | 467 | 455 | 88 | 98.9 | 98.8 | 98.5 |
DMSO 0.2% | 940 | 498 | 418 | 522 | 80 | 99.6 | 99.1 | 99.3 |
DNCB 4 μg/mL | 2475 | 1687 | 580 | 1895 | 1107 | 84.9 | 80.9 | 82.3 |
Experiment 2
Concentration (µg/mL) | MFI (Geo Mean) | Corrected MFI | Viability | |||||
CD86 | CD54 | Isotype | CD86 | CD54 | IgG | CD86 | CD54 | |
279.08 | 1139 | 591 | 502 | 637 | 89 | 95.9 | 96.2 | 94.9 |
334.90 | 1350 | 568 | 471 | 879 | 97 | 95.6 | 95.1 | 94.8 |
401.88 | 1380 | 587 | 505 | 875 | 82 | 93.1 | 95.1 | 93.5 |
482.25 | 1254 | 568 | 489 | 765 | 79 | 94.1 | 94.5 | 93.8 |
578.70 | 1350 | 583 | 511 | 839 | 72 | 94.5 | 93.6 | 93.8 |
694.44 | 1354 | 603 | 529 | 825 | 74 | 92.6 | 93.3 | 92.5 |
833.33 | 1331 | 605 | 525 | 806 | 80 | 95.4 | 92.5 | 94.2 |
1000.00 | 1207 | 604 | 510 | 697 | 94 | 97.2 | 95.5 | 94.7 |
Culture medium | 913 | 539 | 457 | 456 | 82 | 98.3 | 98.4 | 98.1 |
DMSO 0.2% | 981 | 555 | 455 | 526 | 100 | 98.7 | 98.5 | 98.3 |
DNCB 4 μg/mL | 2173 | 1115 | 569 | 1604 | 546 | 84.9 | 85.1 | 85.5 |
The relative fluorescence intensity (RFI) values:
Concentration (μg/mL) | RFI (CD86) | RFI (CD54) | ||
Exp1 | Exp2 | Exp1 | Exp2 | |
279.08 | 181 | 121 | 118 | 89 |
334.90 | 208 | 167 | 101 | 97 |
401.88 | 182 | 166 | 94 | 82 |
482.25 | 146 | 145 | 118 | 79 |
578.70 | 157 | 160 | 121 | 72 |
694.44 | 185 | 157 | 110 | 74 |
833.33 | 163 | 153 | 120 | 80 |
1000.00 | 134 | 133 | 113 | 94 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- The data can only be used as part of an integrated approach to testing and assessment (IATA) to support the discrimination between skin sensitisers and non-sensitisers for the purpose of hazard classification and labelling.
- Conclusions:
- The results of an in vitro skin sensitization test, performed according to OECD/EC guidelines and under GLP principles indicate that the test item has skin sensitizing properties.
- Executive summary:
An in vitro skin sensitisation study (human Cell Line Activation Test) was conducted to investigate the potential of the test item to activate monocytes and dendritic cells in the human monocytic leukemia cell line THP-1 by quantifying changes in the expression of cell surface markers (CD86 and CD54). For the dose finding assay, the test item was formulated in dimethyl sulphoxide (DMSO) at a concentration of 500 mg/mL giving a maximum test concentration of 1000 μg/mL. No reduction in viability was observed.
For the expression measurements, test concentrations in a range from 279.08 to 1000 μg/mL (after dilution in medium) were used. Aliquots of 500 μL of each of the working solutions were mixed 1:1 with cell suspensions at 1 x 106 cells per well. After blocking, the cells were stained with FITC-labelled anti-CD86, anti-CD54 or mouse IgG1 antibodies on ice for 30 minutes. The stained cells were washed, re-suspended in FACS buffer and propidium iodide solution was added. The expression levels of CD86 and CD54 and cell viability were analysed using flow cytometry.
In the two experiments performed, the RFI values for CD86 were >150% (with cell viability >50%) at multiple concentrations and the RFI values for CD54 were <200% at all concentrations. The EC150 value for CD86 was calculated to be 314.14 μg/mL. All acceptance criteria of the h-CLAT assay parameters were met in each experiment.
As a result, the substance was considered to be positive in the human Cell Line Activation Test.
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