Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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
- 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:
- September 18, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
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:
- 09 October 2017
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [(2-hydroxyacetyl)oxy](oxo) vanadium 2-hydroxyacetate]
- IUPAC Name:
- [(2-hydroxyacetyl)oxy](oxo) vanadium 2-hydroxyacetate]
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: Bos taurus
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: bovine eyes obtained from freshly slaughtered cattle at the abattoir EVA, Saint Pierre sur Dives, France.
- Characteristics of donor animals (e.g. age, sex, weight): bovine cattle up to 12 months old (typically, 5 to 8 months old)
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): the eyes were immerged in containers filled with cooled buffered Hanks medium and placed into a cooling-box with a sufficient amount of ice packs to ensure cooling until arrival at Citoxlab France. Containers with smooth internal surfaces were used for the transport to avoid damage to the corneas. Hank’s medium contained an antibiotic [Hank’s Balanced Salts Solution (HBSS) plus penicillin/streptomycin (100 units/100 µg/mL final)].
- Time interval prior to initiating testing: upon arrival at Citoxlab France, the selection and preparation of corneas was performed as soon as possible.
- indication of any existing defects or lesions in ocular tissue samples: : a careful macroscopic examination was performed on all eyes to detect the presence of any defects (opacity, scratches, pigmentation, etc). Any eyes with defects were discarded. The examination was performed under a lamp, using HBSS in order to keep the eyes moistened and shiny. Particular attention was paid to the corneas and the eyes were swivelled in order to observe the fringe areas and any scratches directly under the light.
- Indication of any antibiotics used: Hank’s medium contained an antibiotic [Hank’s Balanced Salts Solution (HBSS) plus penicillin/streptomycin (100 units/100 µg/mL final)]
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 20% (w/v) in the vehicle (i.e. NaCl 0.9%)
VEHICLE
- Amount(s) of formulation (test item + vehicle) applied (volume or weight with unit): 750 mg (± 75 mg) - Duration of treatment / exposure:
- 4 hours (± 5 minutes)
- Number of animals or in vitro replicates:
- three replicates for test item, vehicle control and positive control
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Upon arrival at Citoxlab France, the selection and preparation of corneas was performed as soon as possible. At each step of the preparation procedure, care was taken to avoid touching the corneas in order not to damage them.
Preparation of the selected corneas: the tissues surrounding the eyeball were carefully pulled away and the cornea, surrounded by approximately 2 to 3 mm of sclera, was dissected out. The isolated corneas were stored in HBSS until all corneas had been prepared. The corneas were used immediately.
QUALITY CHECK OF THE ISOLATED CORNEAS
A careful macroscopic examination was performed on all eyes to detect the presence of any defects (opacity, scratches, pigmentation, etc). Any eyes with defects were discarded. The examination was performed under a lamp, using HBSS in order to keep the eyes moistened and shiny. Particular attention was paid to the corneas and the eyes were swivelled in order to observe the fringe areas and any scratches directly under the light.
NUMBER OF REPLICATES
Three replicates for test item, for vehicle and positive controls
NEGATIVE CONTROL USED (VEHICLE CONTROL)
0.9% NaCl
POSITIVE CONTROL USED
20% imidazole solution in 0.9% NaCl (w/v)
APPLICATION DOSE AND EXPOSURE TIME
750 mg (± 75 mg) for 4-hour treatment
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least three time for the corneas treated with the test item formulations and the vehicle control; and four times for corneas treated with the positive control
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: measured by an opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a Spectrophotometer UV/VIS Cary100 (OD490)
- Others (e.g, pertinent visual observations, histopathology): after permeability determination, the corneas were removed from the holders and observed for opaque spots, other irregularities and any separation of the epithelium
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: decision criteria as indicated in the TG was used.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 118
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- No notable opaque spots or irregularities were observed on vehicle control-treated corneas.
Opacity, fluorescein fixation and blue colouration of the corneas were observed all corneas treated with the test item formulation.
Opacity, fluorescein fixation and thickening of the corneas were observed on those treated with the positive control
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye corrosive
- Remarks:
- Acoording to the criteria set up in the OECD guideline 437
- Conclusions:
- Eye corrosive
- Executive summary:
Method
The objective of this study was to evaluate the potential irritant and corrosive properties of the test item, to the eye. The design of this study was based on the OECD Test Guideline 437.
Corneas obtained from freshly slaughtered calves were mounted in corneal holders. Both chambers of the corneal holder were filled with complemented MEM culture media (cMEM) and pre-incubated for 1 hour and 5 minutes (± 5 minutes) at +32°C.
A single experiment was performed using three corneas for each treated series (test item, positive control and vehicle control).
Before the treatment, a first opacity measurement was performed on each cornea using an opacitometer.
The test item, applied at the concentration of 20% (w/v) in the vehicle (i.e.NaCl 0.9%) and both vehicle and positive controls were tested using a treatment 4 hours(± 5 minutes)and the closed‑chamber treatment method. At the completion of the treatment period, all items were removed from the front opening of the anterior chamber and the epithelia were rinsed. A second opacity measurement was then performed.
After the second opacity measurement, the medium of the anterior chamber was removed and filled with a fluorescein solution. The holders were then incubated vertically for 90 minutes (± 5 minutes) at + 32 °C.
At the end of the incubation period, the Optical Density of the solution from the posterior chamber of each holder was measured in order to determine the permeability of the cornea. Each cornea was then observed for opaque spots and other irregularities.
Results
Macroscopic examination
Opacity, fluorescein fixation and blue colouration of the corneas were observed all corneas treated with the test item formulation.
In VitroIrritancy Score
All acceptance criteria were fulfilled. The study was therefore considered as valid.
The mean In Vitro Irritancy Score (IVIS) of the corneas treated with the test item formulation was 118.
Conclusion
Under the experimental conditions of this study, the test item was identified asinducing serious eye damage.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.