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Diss Factsheets
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EC number: 209-011-7 | CAS number: 552-38-5
- 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:
- 29 Aug 2017 - 31 Aug 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:
- 2018
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
- Test material form:
- solid: particulate/powder
- Details on test material:
- Lot # 17-24168
Expiration: 20 Mar 2019
White Powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Source: ExxonMobil Research & Engineering (Paulsboro, NJ)
Lot # 17-24168
- Expiration date of the lot/batch: 20 March 2019
-Purity test date: 04 August 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: used as supplied
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Details on animal used as source of test system:
- not applicable
- 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:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek Corporation (Ashland, MA) EpiDerm™ tissues
- Tissue batch number(s): Lot No. 26787 Kit I
-Shipping Date: 28 Augst 2017
- Delivery date: 29 August 2017
- Date of initiation of testing: 30 August 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): not applicable
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: not specified
- Observable damage in the tissue due to washing: none reported
- Modifications to validated SOP: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL Dulbecco's Modified Eagle's Medium (DMEM)
- Incubation time: 3 hours
- Spectrophotometer: μQuant Plate Reader (Bio-Tek Instruments, Winooski, VT).
- Wavelength: 540 nM
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: Tissue viability was assessed with an MTT QC assay. Application of tissue culture water to the tissues for four hours produced an MTT OD value of 1.7 for Lot No. 26787 Kit I. This value met the criteria of >1.0 but < 3.0 indicating adequate viability of tissues. The historical tissue viability values from the 1996 EpiDerm Database (N=184) for water are mean= 1.47; standard deviation = 0.13; Range ± 2 standar deviatons = 1.21 - 1.73.
- Barrier function: Tissues were exposed to 1% Triton X-100 for 4, 6, 8 and 10 hours. The time of exposure required to reduce the tissue viability (ET-50) using the MTT viability assay is determined (See MatTek EpiDerm MTT ET-50 Protocol) for each lot of tissue. ET-50’s must fall within the range of the 1996 EpiDerm database of 4.77 – 8.72 hours. The ET50 for Lot No. 26787 Kit I was 7.57 hours.
- Morphology: Tissue viability and barrier function tests are wtihin the acceptable ranges and indicate appropriate formation of the epidermal barrier, the presence of a function stratum corneum, a viable basal cell layer and intermediate spinous and granular layers.
- Contamination: The cells used to produced EpiDerm tissues are screened for potential biological contaminants by the manufacturer. Tests were performed by MatTek for each of the potential biological contaminants as follows: HIV (oligonucleotide-directed amplification), Hepatitis-B (oligonucleotide-directed amplification), Hepatitis-C (oligonucleotide-directed amplification), and Bacteria, yeast and other fungi (long-term antibiotic, antimycotic free culture)
- Reproducibility: Each lot of tissues was Quality Assured by MatTek according to specific QC standards including: histology, tissue viability (MTT mean optical density), reproducibility (SD) and tissue thickness. Tissues were used consistently on the same day, i.e. following overnight storage at 4°C (Wednesday morning) to maintain reproducibility.
NUMBER OF REPLICATE TISSUES: 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - 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 of test article was applied to the top of each tissue
- Concentration (if solution): not applicable
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 microliters of test article was applied to the top of each tissue
- Concentration (if solution): not applicable
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 microliters of test article was applied to the top of each tissue
- Concentration (if solution): 8N - Duration of treatment / exposure:
- Each test article remained in contact with the EpiDerm™ tissue for 3 and 60 minutes.
- Duration of post-treatment incubation (if applicable):
- N/A
- Number of replicates:
- Duplicates
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean
- Run / experiment:
- 60 minutes
- Value:
- 13.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean
- Run / experiment:
- 3 minutes
- Value:
- 88.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Other effects / acceptance of results:
- Viability differences between the two identically treated tissues in all samples and controls at 3 minutes were 0.7% to 5.4%. Viability differences between the two identically treated tissues at 60 minutes were 0.8% to 8.9%. Inter-tissue viability differences at both time points met the acceptance criterion (<30%).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Skin corrosion is defined as the production of irreversible tissue damage in skin following the application of test material. The mean viability of Dilithium salicylate was 88.2% following a 3 minute exposure and 13.4% following a 60 minute exposure. These findings warrant classification of dilithium salicylate as a Category 1 skin corrosive substance under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
- Executive summary:
The skin corrosion potential of Dilithium salicylate was assessed MatTek EpiDerm™ SCT tissue model. Tissues were treated in duplicate with the test articles, negative control and positive control for 3 minutes and 60 minutes. Following treatment, the viability of the tissues was determined using methyl thiazole tetrazolium (MTT) uptake and conversion, and the absorbance of each tissue was measured at 540 nm. The percent viability following a 3 minute and 60 minute exposure was used to determine corrosivity potential. For mean viability ≥50% at 3 minutes and >15%, the test article is determined to be non-corrosive, and ≥50% at 3 minutes but <15% at 60 minutes, the test article is determined to be corrosive. In this case, the mean viability of dilithium salicylate was 88.2% following a 3 minute exposure and 13.4% following a 60 minute exposure. These findings warrant classification of Dilithium salicylate as a Category 1 skin corrosive substance under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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