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Diss Factsheets
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EC number: 500-086-4 | CAS number: 35238-34-7
- 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 / corrosion
- Remarks:
- other: in vitro skin irritation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.46 (Skin Irritation)
- Deviations:
- yes
- Remarks:
- As amended for in vitro study.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Acetone, polymer with phenol
- EC Number:
- 500-086-4
- EC Name:
- 2-Acetone, polymer with phenol
- Cas Number:
- 35238-34-7
- Molecular formula:
- (C6H6O.C3H6O)x
- IUPAC Name:
- 2-Propanone, polymer with phenol
- Reference substance name:
- : 2-Acetone polymer with phenol
- IUPAC Name:
- : 2-Acetone polymer with phenol
- Reference substance name:
- BPA-Tars
- IUPAC Name:
- BPA-Tars
- Details on test material:
- As per IUCLID5 Sections 1.1. - 1.4.
Constituent 1
Constituent 2
Constituent 3
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Details on animal used as source of test system:
- in vitro reconstructed human epidermis EST-1000 (Cell Systems, St. Katharinen, Germany)
- Justification for test system used:
- The model used for this study has a functional statum corneum with an underlying layer of living cells. The barrier function of the stratum corneum is adequate, as has been shown by the supplier.
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- 30 mg test substance per insert plus 50 µl 0.9% NaCl to moisten and ensure good contact with the skin (three replicates)
- Duration of treatment / exposure:
- 20 min
- Duration of post-treatment incubation (if applicable):
- 42 hours post-treatment incubation period
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 1.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- 2-Acetone polymer with phenol (BPA-Tars) was characterised by a significant impact on cell viability reducing survival to 1.8% relative to control. Thus, BPA-Tars should be regarded as skin irritant according to UN GHS category 2.
Any other information on results incl. tables
Bisphenolharz spezial was characterised by a significant impact on cell viability. Thus, Bisphenolharz spezial should be regarded as skin irritant according to UN GHS category 2.
Sample No. | Test item | % Viability |
1 -3 | Negative Control (0.9% NaCl) | 100.00 |
4 -6 | Positive Control (0.5% SDS) | 1.71 |
7 -9 | Bisphenolharz spezial | 1.83 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- BPA-Tars induced a relative cell viability of 1.8%. Therefore, it is considered a skin irritant, Category 2.
- Executive summary:
The test item was tested in an in vitro skin irritation test on reconstructed human epidermis (EST-1000) according to EU method B.46 (Skin Irritation) as amended. The EST-1000 model provides a functional stratum corneum with an underlying layer of living cells. The test item, 2 -Acetone polymer with phenol (BPA-Tars) was applied as pure powder, moistened with physiological saline, for 20 min followed by a 42 hour incubation time. Cell viability was determined by the MTT reduction method. BPA-Tars was characterised by a significant impact on cell viability in this in vitro skin irritation study. Cell viability was reduced to 1.8% compared to negative control cultures (100%). Thus, BPA-Tars should be regarded as skin irritant according to UN GHS category 2.
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