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EC number: 608-319-2 | CAS number: 29126-51-0
- 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:
- 18 May 2017 - 26 June 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)
- Version / remarks:
- 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pentanedioic acid, lithium salt (1:2)
- EC Number:
- 608-319-2
- Cas Number:
- 29126-51-0
- Molecular formula:
- C5H8O4.2Li
- IUPAC Name:
- Pentanedioic acid, lithium salt (1:2)
- Test material form:
- solid: particulate/powder
- Details on test material:
- White powder
Constituent 1
- Specific details on test material used for the study:
- White powder
Source: ExxonMobil Research and Engineering (Paulsboro, NJ)
Lot#16-41779
Expiration date: 19 May 2018
In vitro test system
- Test system:
- human skin model
- Remarks:
- MatTEK EpiDerm SCT
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The 3-Dimensional Human Dermal Epithelial Model (EpiDerm™, MatTek, Ashland, MA) is made up of normal human keratinocytes in serum free medium. The cells form an epithelial tissue that consists of organized basal, spinous, granular, and cornified layers analogous to those found in vivo. The EpiDerm™ model also contains epidermis-specific differentiation markers such as pro-filaggrin, the K1/K10 cytokeratin pair, involucrin, and type I epidermal transglutaminase, as well as keratohyalin granules, tonofilament bundles, desmosomes, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns characteristic of in vivo epidermis. Each lot of tissues was Quality Assured by MatTek, Inc. according to specific QC standards including: histology (cell layers), tissue viability (MTT mean optical density) and reproducibility (SD).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The normal human-derived keratinocytes were cultured at the air-liquid interface in a chemically defined medium on a permeable polycarbonate insert (surface 0.5 cm2). They were cultured in chemically defined serum free medium to form a multi-layered epithelium similar to that found in native epidermis. 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.
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTEK EpiDerm 200-SCT
- Tissue batch number(s): 26404
- Delivery date: 23 May 2017
- Date of initiation of testing: 23 May 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 minute exposure at room temperature and 60 minute exposure at ~37°C and ~5% CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Tissues were rinsed approximately 20 times with 1 mL DPBS, and gently blotted with cotton swab.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Synergy H4 Spectrophotometer
- Wavelength: 570 nM
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: MTT QC assay result OD =1.839 ± 0.079
- Barrier function: ET-50 Asaay Result = 8.04 hrs
- Morphology: Viability and barrier function are within acceptable ranges and indicate appropriate formation of the epidermal barrier, the presence of a functional startum corneum, a viable basal cell layer and intermediate spinous and granular layers.
- Contamination: Biological contaminants not detected
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- 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:
- ~25 mg of the test substance (24.7 mg for 3 minute tissue 1, 25.2 mg for 3 minute tissue 2, 25.3 mg for 3 minute tissue 3, 24.7 mg for 60 minute tissue 1, 24.6 mg for 60 minute tissue 2 and 24.6 mg for 60 minute tissue 3)
- Duration of treatment / exposure:
- Tissues were exposed to controls and test substance for approximately 3 minutes at room temperature and approximately 60 minutes in a humidified incubator at ~37°C and ~5% CO2.
- Number of replicates:
- n=3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- 87.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes
- Value:
- 79.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in-vitro EpiDerm SCT Skin Model, the relative mean tissue viability obtained after 3-minute and 1-hour treatments with Dilithium glutarate compared to the negative control tissues was 87.8% and 79.9%, respectively. These findings do not warrant classification of Dilithium Glutarate as a Category 1 Skin Corrosive under the Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
- Executive summary:
The MatTek EpiDerm™ SCT skin model was used to assess the potential dermal corrosivity of dilithium glutarate by determining the viability of the tissues following exposure to the test substance via MTT. The objective of this study was to assess the dermal corrosivity of neat (undiluted) Dilithium glutarate. Tissues were exposed to test substance and controls for three minutes and one hour.
Pre-testing for coloration and MTT auto-reduction were negative, therefore no data corrections were necessary. The MTT data show the positive control, 8N potassium hydroxide (KOH), reduced tissue viability to 29.0% of negative control after 3 minutes exposure and to 9.6% of negative control after 1 hour exposure. The MTT data show that the test substance, dilithium glutarate reduced tissue viability to 87.8% of negative control after 3 minutes exposure and to 79.9% of negative control after 1 hour exposure. These findings do not warrant classification of Dilithium Glutarate as a Category 1 Skin Corrosive 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.
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