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EC number: 225-751-3 | CAS number: 5053-06-5
- 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:
- april 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This test is designed to measure the opacity of the cornea by quantifying the ability of light to pass through it. The permeability, as a result of the irritation potential of the test item, is determined using Na-fluorescein solution. The comparison of the opacity before and after the
exposure to the test item and the determination of the permeability after the treatment provide an indication of the damaging effect of the test item.
For this purpose the induction of opacity and increased permeability in an isolated bovine cornea after application of the test item was measured. The results of both criteria were combined. The resulting in vitro irritation factor was compared with the classification “no Category (GHS)”, “no prediction can be made”, and "serious eye damaging" (CLP/EPA/GHS (Cat 1)).
The purpose of this study was to assess the possible corneal damage potential when fresh bovine corneae are exposed to the test item.
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 Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fenspiride
- EC Number:
- 225-751-3
- EC Name:
- Fenspiride
- Cas Number:
- 5053-06-5
- Molecular formula:
- C15H20N2O2
- IUPAC Name:
- 8-(2-phenylethyl)-1-oxa-3,8-diazaspiro[4.5]decan-2-one
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch: 18115637
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Freshly isolated bovine eyes of at least 9 month old donor cattle were collected from the
abattoir. Excess tissue was removed from the excised eyes. The isolated eyes were stored in
HBSS containing 1% (v/v) Penicillin/Streptomycin (100 units/mL penicillin and 100 μg/mL
streptomycin) in the cooled slaughter-house until transportation on the same morning to the
laboratory using a Styrofoam box. The corneae were isolated on the same day after delivery
of the eyes.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 20% (w/v) suspension in saline (0.9% (w/v) NaCl in deionised water) of the test item 428 BASE BRUTE
- Duration of treatment / exposure:
- 240 minutes
- Duration of post- treatment incubation (in vitro):
- 90 minutes
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 22.48
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
After a first opacity measurement of the fresh bovine corneae (t0), the 20% (w/v) suspension in saline (0.9% (w/v) NaCl in deionised water) of the test item 428 BASE BRUTE, the positive and the negative controls were applied to corneae fixed in an incubation chamber in horizontal position and incubated for 240 minutes at 32 ± 1 °C. The posterior chamber contained incubation medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t240). After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C.
With the negative control (physiological saline) neither an increase of opacity nor permeability of the corneae could be observed.
The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity and distinctive permeability of the corneae corresponding to a classification as serious eye
damage (CLP/EPA/GHS (Cat 1)).
Relative to the negative control, the test item 428 BASE BRUTE caused an increase of the corneal opacity and permeability. The calculated mean in vitro irritancy score was 22.48.
According to OECD 437 (see table in chapter 3.8.3) the test item is not classified as serious eye damaging (CLP/EPA/GHS (Cat 1) but the test item’s hazard for eye damaging cannot be predicted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Relative to the negative control, the test item 428 BASE BRUTE caused an increase of the corneal opacity and permeability. The calculated mean in vitro irritancy score was 22.48.
According to OECD 437 (see table in chapter 3.8.3) the test item is not classified as serious eye damaging (CLP/EPA/GHS (Cat 1) but the test item’s hazard for eye damaging cannot be predicted.
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