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EC number: 280-192-2 | CAS number: 83137-13-7
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Rosin, reaction products with acrylic acid
- EC Number:
- 280-192-2
- EC Name:
- Rosin, reaction products with acrylic acid
- Cas Number:
- 83137-13-7
- Molecular formula:
- N.A. - UVCB substance
- IUPAC Name:
- Rosin, reaction products with acrylic acid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot 646729
- Expiration date of the lot/batch: 19 November 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature and humidity
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was used as recieved (yellow solid)
FORM AS APPLIED IN THE TEST (if different from that of starting material): The test material was used as recieved (yellow solid)
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- other: Human
- Details on animal used as source of test system:
- Source: EpiDerm™ tissues, Lot No. 26717 Kit D, were received from MatTek Corporation (Ashland, MA) on 25 Jul 2017
- Justification for test system used:
- The EpiDerm™ Skin Model closely parallels human skin, and is recommended by test guidelines. Validation studies have reported that tests employing human skin models are able to reliably discriminate between known skin corrosives and non-corrosives.
- Vehicle:
- other: Tissue Culture Water, Lot No. RNBF6962 (TCH2O)
- Details on test system:
- SKIN DISC PREPARATION
- Procedure used: MTT Reduction Assay
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37C
- Temperature of post-treatment incubation (if applicable): 37C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 2; rinsed with phosphate buffered saline (PBS)
DYE BINDING METHOD
- Dye used in the dye-binding assay: Methyl thiazole tetrazolium (MTT) (diluted in Dulbecco's Modified Eagle's Medium (DMEM))
- Spectrophotometer: Microplate reader (μQuant Plate Reader, Bio-Tek Instruments, Winooski, VT).
- Wavelength: 540 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: Tested in duplicate
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if mean viability at 3 minutes is <50% or if mean viability at 3 minutes is >/=50% and mean viability at 60 minutes is <15%.
- The test substance is considered to be non-corrosive to skin if the mean viability at 3 minutes is >/=50% and mean viability at 60 minutes is >/=15%.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 430: Cut-off points used are based on OECD protocol 431 (in vitro skin corrosion: reconstructed human epidermis (RHE) test method) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg
- Concentration (if solution): Neat
VEHICLE
- Amount(s) applied (volume or weight with unit): 25 uL tissue culture water (TCH2O)
- Lot/batch no. (if required): Lot No. RNBF6962
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 uL
- Concentration (if solution): Neat
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 uL
- Concentration (if solution): Neat - Duration of treatment / exposure:
- 3 minutes and 60 minutes
- Duration of post-treatment incubation (if applicable):
- 3 hour MTT incubation period
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 minutes
- Run / experiment:
- Test material (MTDID 28640)
- Value:
- 103.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 minutes
- Run / experiment:
- Test material (MTDID 28640)
- Value:
- 97.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 minutes
- Run / experiment:
- Tissue culture water (Negative Control)
- Value:
- 100
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 minutes
- Run / experiment:
- Tissue culture water (Negative Control)
- Value:
- 100
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 minutes
- Run / experiment:
- Potassium Hydroxide Solution, 8.0 N (Positive Control)
- Value:
- 32.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 minutes
- Run / experiment:
- Potassium Hydroxide Solution, 8.0 N (Positive Control)
- Value:
- 2.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The mean optical density of the negative control tissues was 1.721 at 3 minutes and 2.067 at 60 minutes, which met the acceptance criterion (OD >/= 0.8).
The mean relative tissue viability of the 60-minute positive control was 2.1 %, which met the acceptance criterion <15%).
Viability differences between the two identically treated tissues in all samples and controls at 3 minutes were 0.0% to 11.5%. Viability differences between the two identically treated tissues at 60 minutes were 0.1 % to 10.7%. Inter-tissue viability differences at both time pOints met the acceptance criterion (<30%).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study, the test article is not considered to be corrosive in the EpiDerm Skin Corrosivity Test (OECD 431).
- Executive summary:
The in vitro skin irritation/corrosion potential of the test article (yellow solid; Lot 646729) was evaluated using the MatTek EpiDerm Skin Corrosivity Test. The study was performed in compliance with GLP. The study design was based on the MatTek MTT Effective Time-50 (ET-50) Protocol (protocol no. 711-02). The test article was prepared in tissue culture water (TCH2O). EpiDerm samples were incubated in 6-well tissue culture plates containing assay medium for 1 hour. After incubation, 25 mg of the test article plus 25 uL TCH2O were applied to the top of each EpiDerm tissue. The test article remained in contact with the tissue for 3 and 60 minutes. A negative control (50 uL of TCH2O) and a positive control (50 uL of potassium hydroxide solution, 8.0 N) were tested in parallel. Each treatment with test article or control was conducted in triplicate. At the end of the exposure period, each EpiDerm tissue was rinsed with phosphate buffer saline (PBS) and transferred to a 24-well microplate containing 300 uL of MTT solution (1 mg/mL MTT in Dulbecco's Modified Eagle's Medium (DMEM)); a negative control, 100 uL of TCH2O was tested concurrently. Tissues were then returned to the incubator for a 3-hour MTT incubation period. Following the MTT incubation period, each EpiDerm™ tissue was rinsed with PBS and then treated overnight with 2.0 ml of extractant solution (isopropanol) per well. The absorbency of an aliquot of the extracted MTT formazan was measured in triplicate at 540 nm using a microplate reader. The mean absorbance value for each time point was calculated from the optical density (OD) of the duplicate tissues and expressed as percent viability for each sample. A mean viability at 3 minutes of greater than or equal to 50% and a mean viability at 60 minutes greater than or equal to 15% indicates the material was non-corrosive. The positive and negative controls performed as expected which indicated test validity. The cell viability for tissue treated with the test material was 103.3% and 97.7% at 3 and 60 minutes, respectively. Based on the results of the study, the test material MTDID 28640 is not considered to be corrosive in the EpiDerm Skin Corrosivity Test (OECD 431). In the absence of additional information, and to be conservative a classification of skin irritant, Category 2 was assinged.
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