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EC number: 814-114-0 | CAS number: 848318-58-1
- 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
- Remarks:
- In vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 April 2017 to 28 April 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- See'Justification for type of information'
Test material
- Reference substance name:
- Active enzyme protein of sedolisin (EC no. 848318-58-1, CAS no. 814-114-0, EC name Sedolisin, Enzyme class no 3.4.21.100 )
- Molecular formula:
- Not available
- IUPAC Name:
- Active enzyme protein of sedolisin (EC no. 848318-58-1, CAS no. 814-114-0, EC name Sedolisin, Enzyme class no 3.4.21.100 )
- Reference substance name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available
- IUPAC Name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- liquid
- Details on test material:
- - Lot/batch No.: PPF38268
- Expiration date of the lot/batch: 22-april-2025
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals / tissue source
- Species:
- human
- Strain:
- other: SkinEthic Human Corneal Epithelium (HCE)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 µL of undiluted test substance.
- Duration of treatment / exposure:
- 30 min
- Duration of post- treatment incubation (in vitro):
- 30 minutes ± 2 minutes at 37°C, 5% CO2, ≥ 95% humidity.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Performed according to In vitro Prediction Assay for Acure Ocular Irritation of Liquid Chemicals SkinEthic Human Corneal Epithelial Model (SkinEthicTM HCE).
Treatment:
Apply 30 μL of test liquid to apical side of insert.
Treat tissue with adapted intervals according to the rinsing-off intervals (3 min).
Treat negative control with PBS
Treat positive control with Methyl Acetate
Incubate for 30 minutes ± 2 minutes at 37°C, 5% CO2, ≥ 95% humidity.
Test liquid were rinsed away after exposure:
Adjust distribution to 10 mL and rinse every tissue 2 times (20 mL).
Transfer the rinsed tissue to a new well containing 750 µL fresh maintenance medium (2nd line on the plate).
Apply 750 µL fresh maintenance medium apically to the tissue.
Make sure no air bubbles are trapped underneath the inserts.
Incubate for 30 minutes ± 2 minutes at 37°C, 5% CO2, ≥ 95% humidity.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Sedolisin, batch PPF38268 tested in human corneal epithelial cells revealed a viability of 88.1%. Therefore, it is not irritating to the eye (No Category), when tested in the present model under the test conditions.
- Executive summary:
The Human Corneal Epithelium Assay (HCE) from SkinEthic (France) was used to assess the eye irritation potential of the test substance. The MTT conversion assay, which measures the NAD(P)H-dependent microsomal enzyme reduction of MTT to a blue formazan precipitate, was used to assess cellular metabolism after exposure to a test substance for the defined exposure time.
The test system and procedure described in In Vitro Prediction Assay for Acute Ocular Irritation of Liquid Chemicals SkinEthic Human Corneal Epithelial Model (SkinEthicTM HCE) was used.
Sedolisin, batch PPF38268 tested in human corneal epithelial cells revealed a viability of 88.1%. Therefore, it was not irritating to the eye (No Category), when tested in the present model under the test conditions.
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