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EC number: 680-227-5 | CAS number: 71449-78-0
- 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:
- weight of evidence
- Study period:
- 10 January 2019 - 10 January 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was performed under GLP and all relevant validity criteria were met
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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)
- Version / remarks:
- 2017
- 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:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diphenyl[4-(phenylsulfanyl)phenyl] sulfonium hexafluoroantimonate(1-)
- EC Number:
- 680-227-5
- Cas Number:
- 71449-78-0
- Molecular formula:
- C24H19F6S2Sb
- IUPAC Name:
- Diphenyl[4-(phenylsulfanyl)phenyl] sulfonium hexafluoroantimonate(1-)
- Test material form:
- solid: particulate/powder
- Remarks:
- white
- Details on test material:
- - Storage condition of test material: Room temperature, in the dark
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: Corneas from bovine eyes were obtained from a local abattoir.
- Number of animals: Not reported
- Characteristics of donor animals (e.g. age, sex, weight): typically 12 to 60 months old
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): The eyes were removed after slaughter, completely immersed in Hanks Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 μg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were prepared immediately on arrival.
- Time interval prior to initiating testing: Same day
- indication of any existing defects or lesions in ocular tissue samples: No
- Indication of any antibiotics used: Penicillin at 100 IU/mL and streptomycin at 100 µg/mL added to Hanks Balanced Salt Solution during transportation.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit): n/a
- Concentration (if solution): n/a
- Lot/batch no. (if required): n/a
- Purity: n/a
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration (if solution): undiluted
VEHICLE
- Amount(s) applied (volume or weight with unit): n/a
- Concentration (if solution): n/a
- Lot/batch no. (if required): n/a
- Purity: n/a - Duration of treatment / exposure:
- 240 minutes.
- Observation period (in vivo):
- n/a
- Duration of post- treatment incubation (in vitro):
- 90 minutes.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used. The cornea from each selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed in a dish containing HBSS until they were mounted in Bovine Corneal Opacity and Permeability (BCOP) holders.
The anterior and posterior chambers of each BCOP holder were filled with complete Eagle s Minimum Essential Medium (EMEM) without phenol red and plugged. The holders were incubated at 32 ± 1 °C for 60 minutes. At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.
QUALITY CHECK OF THE ISOLATED CORNEAS
All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used.
NUMBER OF REPLICATES
3 per treatment group
NEGATIVE CONTROL USED
The negative control substance was 0.9% sodium chloride solution (Batch; 18/10BB1B, exp: 10 April 2019) supplied by Baxter.
SOLVENT CONTROL USED (if applicable)
N/A
POSITIVE CONTROL USED
The positive control substance was Imidazole >99% (Batch; 162411, exp: 01 August 2021) Supplied by Fisher Scientific.
APPLICATION DOSE AND EXPOSURE TIME
0.75 mL applied to each cornea and incubated at 32 ± 1 °C for 240 minutes.
TREATMENT METHOD
Closed chamber
POST-INCUBATION PERIOD
Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution (5 mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 ± 1 °C for 90 minutes.
After incubation the medium in the posterior chamber of each holder was decanted and retained.
360 μL of media representing each cornea was dispensed into the appropriate wells of a pre-labeled 96-well plate. The optical density was measured (quantitative viability analysis) at 492 nm (without a reference filter) using the Labtech LT-4500 microplate reader.
The corneas were retained after testing for possible conduct of histopathology. Each cornea was placed into a pre-labeled tissue cassette fitted with a histology sponge to protect the endothelial surface. The cassette was immersed in 10% neutral buffered formalin.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: Each cornea was washed with media containing phenol red (as a pH indicator) until this indicator showed no pH effect occurring (and demonstrating that the test article had been removed successfully). The cornea was rinsed 3 times with fresh complete EMEM containing phenol red before a final rinse with complete EMEM without phenol red.
- POST-EXPOSURE INCUBATION: 90 minutes.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Labtech LT-4500 microplate reader
- Corneal permeability: Passage of sodium fluorescein dye measured with the aid of spectrophotometer (OD492)
- Others (e.g, pertinent visual observations, histopathology): (please specify) The corneas were retained after testing for possible conduct of histopathology. Each cornea was placed into a pre-labeled tissue cassette fitted with a histology sponge to protect the endothelial surface. The cassette was immersed in 10% neutral buffered formalin.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: As described in OECD 437.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 3 runs
- Value:
- 1.2
- 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:
- OTHER EFFECTS:
- Visible damage on test system: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control gave opacity and permeability values below the established upper limits. The negative control acceptance criteria were therefore satisfied.
- Acceptance criteria met for positive control: The positive control In Vitro Irritancy Score was within the acceptance range. The positive control acceptance criterion was therefore satisfied.
- Range of historical values if different from the ones specified in the test guideline: n/a
Any other information on results incl. tables
Table 1. Individual and Mean Corneal Opacity and Permeability Measurements & IVIS Score
Treatment
|
Cornea No. |
Opacity |
Permeability |
In Vitro Irritancy Score |
||||
|
|
Pre-Treatment |
Post-Treatment |
Post-Treatment - Pre-Treatment |
Corrected Value |
|
Corrected Value |
|
Negative Control |
1 |
5 |
5 |
0 |
|
0.003 |
|
|
2 |
4 |
5 |
1 |
|
0.005 |
|
|
|
3 |
5 |
6 |
1 |
|
0.004 |
|
|
|
|
|
|
0.7* |
|
0.004¨ |
|
0.7 |
|
Positive Control
|
6 |
5 |
75 |
70 |
69.3 |
1.264 |
1.260 |
|
7 |
5 |
79 |
74 |
73.3 |
1.490 |
1.486 |
|
|
8 |
3 |
68 |
65 |
64.3 |
1.810 |
1.806 |
|
|
|
|
|
|
69.0! |
|
1.517! |
91.8 |
|
Test Item |
10 |
4 |
4 |
0 |
0.0 |
0.054 |
0.050 |
|
11 |
3 |
6 |
3 |
2.3 |
0.015 |
0.011 |
|
|
12 |
6 |
7 |
1 |
0.3 |
0.003 |
0.000 |
|
|
|
|
|
|
0.9· |
|
0.020· |
1.2 |
OD = Optical density
* = Mean of the post-treatment & pre-treatment values
" = Mean permeability
! = Mean corrected value
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It was concluded that under the condition of this study, the test substance produced an IVIS score of 1.2 and therefore no categorisation for irritation could be made and the substance does not meet the criteria for classification in accordance with UN GHS or EU CLP.
- Executive summary:
OECD 437 (2019) - The Bovine Corneal Opacity and Permeability (BCOP) test was conducted using CPI-110A in accordance with 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" (2017).
The test item was applied at a concentration of 20% w/v in sodium chloride 0.9% w/v for
240 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability), were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).
Corneal opacity and corneal permeability media solutions were analysed by a spectrophotometer at 492 nanometers (OD492). The mean corrected opacity reading and permeability readings for the test item were 0.9 and 0.020, resulting in an In Vitro Irritation Score (IVIS) of 1.2
It was concluded that under the condition of this study, the test substance produced an IVIS score of 1.2 and therefore no categorisation for irritation could be made and the substance does not meet the criteria for classification in accordance with UN GHS or EU CLP.
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