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EC number: 617-849-3 | CAS number: 86404-04-8
- 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:
- 7 - 8 Dec 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- amended 9 Dec 2010
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (5R)-5-[(1S)-1,2-dihydroxyethyl]-4-ethoxy-3-hydroxy-2,5-dihydrofuran-2-one
- EC Number:
- 617-849-3
- Cas Number:
- 86404-04-8
- Molecular formula:
- C8H12O6
- IUPAC Name:
- (5R)-5-[(1S)-1,2-dihydroxyethyl]-4-ethoxy-3-hydroxy-2,5-dihydrofuran-2-one
- Details on test material:
- - Name of test material (as cited in study report): Ethyl ascorbic acid
- Storage condition of test material: in the freezer (≤ -15 °C)
- Substance type: white to very pale yellow, crystalline, powder
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Vitelco, 's Hertogenbosch, The Netherlands
- Characteristics of donor animals: Bovine eyes from young cattle
- Storage, temperature and transport conditions of ocular tissue: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
- Time interval prior to initiating testing: Bovine eyes were used as soon as possible after slaughter.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.75 mL
- Concentration: 20% (w/v)
POSITIVE CONTROL
- Amount applied: 0.75 mL
- Concentration: 20% (w/v) in physiological saline
NEGATIVE CONTROL
- Amount applied: 0.75 mL - Duration of treatment / exposure:
- 240 ± 10 min at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- in triplicates for each treatment and control group
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS:
The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.
QUALITY CHECK OF THE ISOLATED CORNEAS:
At the end of the equilibration period, the initial opacity was determined. Each cornea with a value of the initial opacity >7 was discarded.
TREATMENT METHOD:
The isolated corneas were mounted in a corneal holder (BASF, Ludwigshafen, Germany) with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM of 32 ± 1 °C. The corneas were incubated for a minimum of 1 h at 32 ± 1 °C. At the end of the equilibration period, the medium was removed from the anterior compartment and 0.75 ml of either test substance or control was applied to the epithelium of the cornea. The holder was slightly rotated, with the corneas maintained in a horizontal position, to ensure uniform distribution of the solutions over the entire cornea. Corneas were incubated in a horizontal position for 240 ± 10 minutes at 32 ± 1 °C.
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE:
After the incubation the solutions were removed and the epithelium was washed at least three times with MEM with phenol red.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity of a cornea was measured by the diminution of light passing through the cornea. Opacity determinations were performed on each of the corneas using an opacitometer (BASF-OP3.0, BASF, Ludwigshafen, Germany)
- Corneal permeability: Passage of sodium fluorescein dye measured with the aid of a microplate reader (TECAN Infinite M200 Pro Plate Reader) at 490 nm
- Others: After removal of the test substance, possible pH effects of the test substance on the corneas were recorded. Each cornea was inspected visually for dissimilar opacity patterns
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
Test substance with an IVIS > 55 was regarded as severe irritant/corrosive and labelled Category 1.
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
- Run / experiment:
- mean value of 3 corneae
- Value:
- 13
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: After the incubation period with the test substance the corneas were clear with a spot. A pH effect of the test substance was observed on the rinsing medium, the corneas were rinsed until no colour change of the medium was observed.
Any other information on results incl. tables
Table 2. Results after 240 min incubation time.
Test group |
Opacity value |
Permeability at 490 nm (OD490) |
IVIS |
Mean IVIS |
||
|
Mean |
|
Mean |
|
|
|
Negative control |
-0.7 |
-0.9 |
-0.001 |
0.000 |
-0.7 |
-0.9 |
0.6 |
-0.003 |
0.6 |
||||
-2.7 |
0.004 |
-2.6 |
||||
Positive control |
107.8 |
0.907 |
121.4 |
113.4 |
||
81.1 |
1.851 |
108.9 |
||||
87.5 |
1.501 |
110.0 |
||||
Test substance |
11.8 |
0.59 |
20.7 |
13.0 |
||
1.0 |
0.219 |
4.3 |
||||
5.1 |
0.586 |
13.9 |
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive
- Conclusions:
- The irritation potential of the test substance was assessed in the BCOP assay. Application of the test substance to bovine corneae resulted in a calculated mean IVIS of 13.0. According to OECD Guideline 437 no prediction on the irritation potential can be made but the test substance does not have to be classified as serious eye irritant (Eye Dam. Cat. 1)
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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