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EC number: 209-091-3 | CAS number: 555-32-8
- 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:
- 02 January 2017 - 03 January 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 26 July 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- dd 03 November 2015
Test material
- Reference substance name:
- Aluminium tribenzoate
- EC Number:
- 209-091-3
- EC Name:
- Aluminium tribenzoate
- Cas Number:
- 555-32-8
- Molecular formula:
- C7H6O2.1/3Al
- IUPAC Name:
- aluminium tribenzoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Aluminium tribenzoate
- Appearance: white powder
- Storage conditions: at room temperature
Constituent 1
- Specific details on test material used for the study:
- Purity correction factor: 1.164
The test item was tested for solubility in physiological saline. Since no workable suspension of the test item in physiological saline could be obtained, it was used as delivered by the sponsor and added pure on top of the corneas.
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: young cattle, obtained from the slaughterhouse
- Storage, temperature and transport conditions of ocular tissue: eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Subsequently, eyes were collected and transported in physiological saline in a suitable container under cooled conditions. The isolated corneas were stored in a petri dish with cMEM containing 1% (v/v) L-glutamine and 1% (v/v) Foetal Bovine Serum. The corneas were incubated for the minimum of 1 hour at 32 ± 1 °C.
- The eyes were checked for unacceptable defects and those exhibiting defects were discarded.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 317.8 to 354.9 mg (complete coverage of the cornea)
NEGATIVE CONTROL:
- Amount applied: 750 µL
POSITIVE CONTROL:
- Amount applied: 750 µL - Duration of treatment / exposure:
- 240 +/- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 90 +/- 5 minutes in sodium fluorescein
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- TREATMENT METHOD:
The medium from the anterior compartment was removed and 750 µL of the negative control and 20% (w/v) imidazole solution (positive control) were introduced onto the epithelium of the cornea. Aluminium tribenzoate was weighed and applied directly on the corneas in such a way that the cornea was completely covered (317.8 to 354.9 mg).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.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After the incubation the solutions and the test compound were removed and the epithelium was washed at least three times with MEM with phenol red.
- POST-EXPOSURE INCUBATION: 90 ±5 minutes 32 ± 1 °C in sodium-fluorescein for permeability determinations.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacity meter (OP-KIT)
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a microtiter plate reader (TECAN Infinite® M200 Pro Plate Reader, OD490). OD490 values of less than 1.500 were used in the permeability calculation.
- Other: possible pH effects of the test substance on the corneas were recorded.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
A test substance that induces an IVIS ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces IVIS >55 is defined as a corrosive or severe irritant (UN GHS: category 1);
For a test substance that induces an IVIS >3 and ≤55, no prediction on irritant potency can be made.
ACCEPTABILITY CRITERIA:
The assay is considered acceptable if:
- The positive control gives an in vitro irritancy score that falls within two standard deviations of the current historical mean.
- The negative control responses should result in opacity and permeability values that are less than the upper limits of the laboratory historical range.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Single run/mean of 3 replicates
- Value:
- -1.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- IVIS: 1.5 - 3.4
- Positive controls validity:
- valid
- Remarks:
- IVIS: 111.9 - 180.9
- Other effects / acceptance of results:
- The corneas treated with Aluminium tribenzoate showed opacity values of -2.2 and permeability values ranging from 0.023 to 0.067. IVIS scores were -1.4, -1.9 and -1.2 (n=3). The corneas were clear after the 240 minutes of treatment with Aluminium tribenzoate.
OTHER EFFECTS:
- The corneas treated with the positive control item were turbid after the 240 minutes of treatment.
- No pH effect of the test item was observed on the rinsing medium.
- The IVIS of one of the negative controls was >3. However, since the opacity, permeability and IVIS of this cornea were within the historical control data range and the test item gives a clear negative result this does not affect the study result.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, results were within historical range (e.g. 1.5 - 3.4).
- Acceptance criteria met for positive control: yes, results were within historical range (e.g. 112 - 181).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the outcome of a Bovine Corneal Opacity and Permeability test (BCOP) performed according to OECD guideline 437 and GLP principles, it is concluded that aluminium tribenzoate is not classified under GHS (IVIS ranging from -1.9 to -1.2 after 240 minutes of treatment).
- Executive summary:
The eye hazard potential of aluminium tribenzoate was assessed in a Bovine Corneal Opacity and Permeability test (BCOP test). Three corneas from young cattle were exposed to 317.8 - 354.9 mg (complete coverage) of the test item, next to a negative control group of physiological saline (n=3) and a positive control of 20% (w/v) imidazole (n=3). Duration of treatment was approximately 240 minutes. Results of the negative and positive controls were within the historical data. Therefore, it was shown that the negative control did not induce irritancy on the corneas, the test conditions were adequate and the test systems functioned properly. Aluminium tribenzoate did not induce ocular irritation, resulting in a mean in vitro irritancy score of -1.5 after 240 minutes of treatment. Based on this result (IVIS < 3), no classification for eye irritation or serious eye damage is required for aluminium tribenzoate according to GHS criteria.
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