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EC number: 254-228-2 | CAS number: 38970-76-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 August 2017 - 17 August 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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 26 July 2013
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dilithium salicylate
- EC Number:
- 254-228-2
- EC Name:
- Dilithium salicylate
- Cas Number:
- 38970-76-2
- Molecular formula:
- C7H4Li2O3
- IUPAC Name:
- dilithium salicylate
- 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: 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: test substance was soluble in vehicle throughout duration of study
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: used as received
- Final dilution of a dissolved solid, stock liquid or gel: 200 mg/mL of dilithium salicylate in 0.9% sodium chloride
Test animals / tissue source
- Species:
- other: Isolated Bovine Cornea
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- The bovine eyes, in a Hanks’ Balance Salt Solution (HBSS) with penicillin-streptomycin, were received from Spear Products on 17 Aug 2017 and transported to MB Research in a refrigerated container.
Test system
- Vehicle:
- physiological saline
- Remarks:
- 0.9% Sodium Chloride Irrigation
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 ml of the 20% (w/v) test article formulation in saline
- Duration of treatment / exposure:
- Four hours (±10 minutes) at 32 (±1)°C
- Observation period (in vivo):
- N/A
- Duration of post- treatment incubation (in vitro):
- The solution was removed from the anterior chamber and replaced with 1.0 ml of 0.5% sodium fluorescein solution in Dulbecco's phosphate buffered saline (PBS). Each holder was then returned to the 32 (±1)°C incubator for 90 (±5) minutes.
- Number of animals or in vitro replicates:
- Three bovine corneas per group
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: The eyes were examined prior to use on the day of dosing. Any eye with a cornea exhibiting evidence of
vascularization, pigmentation, opacity, or scratches was discarded. Corneas from eyes that were free of defects were dissected from the surrounding tissues. A 2-3 mm rim of sclera was left attached to each cornea. The corneas were then placed in a container of fresh HBSS.
QUALITY CHECK OF ISOLATED CORNEAS: A pre-exposure determination of opacity was made for each cornea by measuring each against the blank
supplied by the opacitometer. Any cornea with a value greater than 7 units was discarded.
NUMBER OF REPLICATES: 3 isolated bovine corneas per group
NEGATIVE CONTROL USED: Modified Eagles Medium (MEM)
SOLVENT CONTROL USED (if applicable): 0.9% Saline
POSITIVE CONTROL USED: 20% (w/v) imidazole formulation in 0.9% saline
APPLICATION DOSE AND EXPOSURE TIME: A volume of 0.75 ml of the 20% (w/v) test article formulation in 0.9% saline for four hours (±10 minutes). All holders and corneas were placed in a horizontal position (anterior side up) in the 32 (±1)°C incubator
TREATMENT METHOD: All corneas were dosed via the closed-chamber method.
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: Test article formulation, 20% imidazole formulation, MEM or 0.9% saline was removed from the epithelium of the cornea and anterior chamber of the holder by washing with MEM solution containing phenol red. A final rinse was made with MEM without phenol red. The anterior and posterior chambers of the holders were then refilled with fresh MEM solution.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Differences in light transmission through the control and treated cornea were determined using an OP-KIT opacitometer produced by Electro-Design Corporation of Riom, France. Each treated cornea will be scored in comparison to the blanks provided with the OP-KIT opacitometer .
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD450) Milton Roy/ Spectronic 20-D Colorimeter Model: 333175 Serial No: 33241700
- Others (e.g, pertinent visual observations, histopathology): none
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
IVIS Less than or equal to 3 = GHS No Category
IVIS Greater than 3 and less than or equal to 55 = No prediction can be made
IVIS Greater than 55 = Substance causing serious eye damage (GHS Category 1)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 4 hour
- Value:
- 110.34
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- In vitro irritation score (IVIS) calculated from opacity score
- Value:
- 128.75
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- Corneal surface sloughing was reported in one of three cornea after 4 hour exposure.
The Imidazole positive control IVIS was 91.02, which fell within the acceptance range of 58.10 – 135.86 (± 2 standard deviations of the historical mean).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The mean corneal opacity, and in-vitro irritation score for Dilithium Salicylate were 110.34 and 128.75, respectively. These findings warrant classification of Dilithium Salicylate as a substance inducing serious eye damage (Category 1 Eye Irritant) under the Regulation (EC) 172/2008 on classification, labelling and packing of substances and mixtures (CLP).
- Executive summary:
Dilithium Salicylate was applied to isolated bovine cornea to assess for the potential to induce serious eye damage and irritation. Ocular damage was assessed at 4 hours post-instillation and scored through measurement of corneal opacity and permeability. The mean corneal opacity, and in-vitro irritation score for Dilithium Salicylate were 110.34 and 128.75, respectively. These findings warrant classification of Dilithium Salicylate as a substance inducing serious eye damage (Category 1 Eye Irritant) under the Regulation (EC) 172/2008 on classification, labelling and packing of substances and mixtures (CLP).
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