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EC number: 932-161-6 | CAS number: -
- 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
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01Aug 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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:
- adopted 09 Oct 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
Test material
- Reference substance name:
- Vinasses, residue of fermentation containing biomass of bakers yeast (Saccharomyces cerevisiae)
- EC Number:
- 932-161-6
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
- IUPAC Name:
- Vinasses, residue of fermentation containing biomass of bakers yeast (Saccharomyces cerevisiae)
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Details on test animals:
SOURCE OF COLLECTED EYES
- Source: Slaughterhouse Moksel AG, Buchloe, Germany
- Storage, temperature and transport conditions of ocular tissue: The isolated eyes were transported on ice in Hank's Buffered Salt Solution (HBSS) containing penicillin/streptomycin.
- Time interval prior to initiating testing: On the test day, fresh eyes were collected from the slaughter house. The corneae were prepared immediately after delivery.
- Indication of any existing defects or lesions in ocular tissue samples: The eyes were carefully examined for defects and defective eyes were discarded.
- Indication of any antibiotics used: penicillin/streptomycin containing HBSS was used for transport.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 µL
NEGATIVE CONTROL:
- Amount applied: 750 µL
- Concentration: 0.9% NaCl solution in deionised water
- Lot no: 18095403
POSITIVE CONTROL:
- Amount applied: 750 µL
- Concentration: 100%
- Lot no.: K50117583 - Duration of treatment / exposure:
- 10 ± 1 min at 32 ± 1 °C in a vertical position
- Duration of post- treatment incubation (in vitro):
- 2 h at 32 ± 1 °C
- Number of animals or in vitro replicates:
- triplicates for each treatment and control groups
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing Hanks’ balanced salt solution (HBSS). A specifically designed corneal holder was used to mount each cornea.
QUALITY CHECK OF THE ISOLATED CORNEAS
After an equilibration period, the initial opacity was determined. Only corneas that had an initial illuminance reading I > I0/1.1651 lux were used for the assay.
TREATMENT METHOD: Closed chamber method
The corneas were mounted in a corneal holder with the endothelial side against the O-ring of the posterior chamber. The anterior chamber was then positioned on top of the cornea and tightened with screws. Starting with the posterior chamber, both chambers of the corneal holder were then filled with complete RPMI 1640 medium and the corneas were incubated for 1 h at 32 ± 1 °C. After the equilibration period an initial illuminescence reading the test item, the positive or the negative control was introduced into the anterior chamber (closed chamber method). The corneas were incubated at 32 ± 1 °C and exposed to the appropriate test substance for 10 ± 1 min.
REMOVAL OF TEST SUBSTANCE
After the incubation either the test item or the control substance was removed and the epithelium was washed at least three times with minimum essential medium (MEM) (containing phenol red). Once the medium was free of test substance, the cornea was finally rinsed with complete RPMI medium (without phenol red).
METHODS FOR MEASURED ENDPOINTS
- Corneal opacity: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer (BASF-OP3.0, Duratec GmbH). The light was measured as illuminance (I = luminous flux per area, unit: lux).
- Corneal permeability: The passage of sodium fluorescein dye was measured with the aid of a spectrophotometer (Jenway 6405 UV/VIS) at 490 nm (OD 490).
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA
Test substance with an IVIS > 55 was considered as severe irritant/corrosive and labelled Category 1 according to CLP/EPA/GHS.
Test substance with an IVIS ≤ 3 was regarded as non-irritant and labelled in no category.
Test substance with an IVIS > 3; ≤ 55: no prediction can be made.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- mean value of 3 corneae
- Run / experiment:
- 10 min exposure
- Value:
- 1.22
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
Technical proficiency of the test system was demonstrated with 12 substances according to OECD 437.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, the negative control responses result in opacity and permeability values that are less than the established upper limits for background opacity and permeability values for bovine corneae treated with the respective negative control.
- Acceptance criteria met for positive control: Yes, the positive control resulted in an IVIS value which fell within two standard deviations of the current historical mean.
Any other information on results incl. tables
Table 1: Results on opacity
Cornea No. | Test Item | Initial Opacity | Final Opacity | Change of Corrected Opacity Value Opacity Value | |
1 | Negative | 1.92 | 2.24 | 0.32 | |
2 | 1.96 | 2.13 | 0.18 | ||
3 | 1.96 | 2.24 | 0.29 | ||
MV | 1.94 | 2.21 | 0.26 | ||
4 | Positive | 2.86 | 26.48 | 23.62 | 23.35 |
5 | 2.9 | 29.68 | 26.78 | 26.52 | |
6 | 3.42 | 31.81 | 28.39 | 28.13 | |
MV | 3.06 | 29.32 | 26.26 | 26 | |
7 | Test Item | 2.82 | 2.79 | 0.15 | -0.11 |
8 | 2.75 | 4.16 | 1.41 | 1.14 | |
9 | 2.57 | 3.61 | 1.05 | 0.78 | |
MV | 2.71 | 3.58 | 0.87 | 0.61 |
Table 2: Results on permeability
Cornea No. | Test Item | OD490 Corrected OD490 Value | |
1 | Negative | 0.004 | |
2 | 0.019 | ||
3 | 0.015 | ||
MV | 0.013 | ||
4 | Positive | 1.262 | 1.249 |
5 | 1.585 | 1.572 | |
6 | 1.289 | 1.276 | |
MV | 1.379 | 1.366 | |
7 | Test Item | 0.013 | 0 |
8 | 0.009 | -0.004 | |
9 | 0.138 | 0.125 | |
MV | 0.053 | 0.041 |
Table 3: Results in vitro irritation score (IVIS)
Cornea No. | Test Item | Corrected Opacity | Corrected OD490 Value |
IVIS |
1 | Negative | 0.32 | 0.004 | |
2 | 0.18 | 0.019 | ||
3 | 0.29 | 0.015 | ||
MV | 0.26 | 0.013 | 0.45 | |
4 | Positive | 23.35 | 1.249 | |
5 | 26.52 | 1.572 | ||
6 | 28.13 | 1.276 | ||
MV | 26 | 1.366 | 46.49 | |
7 | Test Item | -0.11 | 0 | |
8 | 1.14 | -0.004 | ||
9 | 0.78 | 0.125 | ||
MV | 0.61 | 0.041 | 1.22 |
Table 4: Historical mean In Vitro Irritation Score of the positive control
IVIS Positive Control - Ethanol 100 % | |
Mean Value (MV) | 48.41 |
Standard Deviation (SD) | 9.25 |
MV- 2xSD | 29.91 |
MV+2xSD | 66.91 |
Number of Replicates providing Historical Mean: 56 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) 1272/2008.
- Conclusions:
- CLP: not classified
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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