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EC number: 237-748-4 | CAS number: 13967-50-5
- 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:
- from 06 November 2013 to 26 November 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline test, available as an unpublished report. Reliable without restriction.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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)
- Deviations:
- yes
- Remarks:
- The control group and other common data incl. eye receipt and preparation, technical documentation, reagent record and preparation, initial opacity readings, group allocation and optical density print out were shared with study 413027735.
- Principles of method if other than guideline:
- The 'open-chamber' method was adopted. The window-locking ring and glass were removed from the chamber prior to treatment. The 'open-chamber' method was also followed for the control groups although solutions were applied. Following application the ring and glass were replaced during the exposure period until rinsing.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Potassium dicyanoaurate
- EC Number:
- 237-748-4
- EC Name:
- Potassium dicyanoaurate
- Cas Number:
- 13967-50-5
- Molecular formula:
- C2AuN2.K
- IUPAC Name:
- potassium dicyanoaurate
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): Potassium dicyanoaurate
- Physical state:soild
- Colour: white
- pH: 10.2
- Stability under test conditions: Stable under test conditions
- Storage condition of test material: Room temperature in the dark
- Other:
Constituent 1
Test animals / tissue source
- Species:
- other: Not applicable
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Eyes from adult cattle were obtained from a local abattoir as a by-product from freshly slaughtered animals.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Not applicable
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: Approximately 0.873 g of the solid test item was applied to the cornea. It covered adequately the corneal surface. - Duration of treatment / exposure:
- 240 minutes at 32±1°C
- Number of animals or in vitro replicates:
- Three corneas were allocated to the test item, three to the negative control and three to the positive control.
- Details on study design:
- Treatment of corneas
Approximately 0.873 g of the solid test item was found to adequately cover the corneal surface. 750 uL of each control item was applied to the appropriate corneas. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea. Each holder was incubated, anterior chamber uppermost, at 32± 1°C for 240 minutes. At the end of the exposure period the test item and control items were removed from the anterior chamber and the cornea was rinsed three times with fresh complete minimum essential medium (MEM) containing phenol red before a final rinse with complete MEM. the anterior and posterior chambers were refilled with fresh complete MEM. A post treatment opacity reading was taken and each cornea was visually observed.
Application of sodium fluorescein
Following the opacity measurement the permability 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 (5mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32± 1°C for 90 minutes.
Permeability determinations
After incubation the medium in the posterior chamber of each holder was decanted and retained. 360 uL of medium representing each cornea was applied to a designated well on a 96-well plate and the optical density at 492 nm (OD492) was measured using the Anthos 2001 microplate reader.
Histopathology
The corneas were retained after testing for possible conduct of histopathology. Each cornea was placed into a pre-labelled tissue cassette fitted with a histology sponge to protect the endothelial surface. The cassette was immersed in 10% neutral buffered formalin.
Opacity measurement
The change in opacity for each cornea was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting the average change in opacity observed for the negative control corneas. The mean opacity value of each treatment group was then calculated by averaging the corrected opacity values of each cornea for that treatment group.
Permeability measurement
The corrected OD492 was calculated by subtracting the mean OD492 of the negative control corneas from the OD492 value of each treated cornea. The OD492 value of each treatment group was calculated by averaging the corrected OD492 values of the treated corneas for the treatment group.
SCORING SYSTEM:
Results from the two test method endpoints, opacity and permeability, were combined in an empirically derived formula to generate an In Vitro Irritancy Score.
In Vitro Irritancy Score = mean opacity value + (15 x mean OD 492 value)
Additionally, the opacity and permeability values were evaluated independently to determine whether the test item induces a response through only one of the two endpoints.
A test item that induces an In Vitro Irritancy Score ≥55.1 is defined as an ocular corrosive or severe irritant and will be labelled EU DSD (67/548/EEC) R41 and EU CLP/UN GHS Category 1.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 240 minutes
- Value:
- 171.5
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- The test item was considered to be an ocular corrosive or severe irritant.
Any other information on results incl. tables
The corneas treated with the test item were opaque post incubation. The corneas treated with the negative control item were clear post incubation. The corneas treated with positive control item were cloudy post incubation.
The positive control In Vitro Irritancy Score was 82.1 and the negative control In Vitro Irritancy Score was 3.7.
Criterion for an Acceptable Test
The positive control In Vitro Irritancy Score was within the range of 65.9 to 140.8. The positive control acceptance criterion was therefore satisfied.
The In Vitro irritancy scores are summarized as follows:
Treatment |
In Vitro Irritancy Score |
Test Item |
171.5 |
Negative Control |
3.7 |
Positive Control |
82.1 |
Table 1. Individual and Mean Corneal Opacity and Permeability Measurements
Treatment |
Cornea Number |
Opacity |
Permeability (OD) |
In VitroIrritancy Score |
||||
Pre-Treatment |
Post-Treatment |
Post-Treatment-Pre‑Treatment |
Corrected Value |
|
Corrected Value |
|||
Negative Control |
1 |
1 |
4 |
3 |
|
0.035 |
|
|
2 |
1 |
4 |
3 |
|
0.067 |
|
|
|
3 |
2 |
5 |
3 |
|
0.028 |
|
|
|
|
|
|
3.0* |
|
0.043¨ |
|
3.7 |
|
Positive Control |
4 |
2 |
69 |
67 |
64.0 |
1.590 |
1.547 |
|
5 |
2 |
58 |
56 |
53.0 |
0.759 |
0.716 |
|
|
6 |
1 |
78 |
77 |
74.0 |
1.477 |
1.434 |
|
|
|
|
|
|
63.7· |
|
1.232· |
82.1 |
|
Test Item |
10 |
1 |
169 |
168 |
165.0 |
1.899 |
1.856 |
|
11 |
2 |
144 |
142 |
139.0 |
2.360 |
2.317 |
|
|
12 |
1 |
118 |
117 |
114.0 |
2.312 |
2.269 |
|
|
|
|
|
|
139.3· |
|
2.147· |
171.5 |
OD= Optical density; * = Mean of the post-treatment -pre‑treatment values; ¨= Mean permeability; ·= Mean corrected value
Table 2. Corneal Epithelium Condition Post Treatment
Treatment |
Cornea Number |
Observation |
Post Treatment |
||
Negative Control |
1 |
clear |
2 |
clear |
|
3 |
clear |
|
Positive Control |
4 |
cloudy |
5 |
cloudy |
|
6 |
cloudy |
|
Test Item |
10 |
opaque |
11 |
opaque |
|
12 |
opaque |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item was considered to be an ocular corrosive or severe irritant.
- Executive summary:
Potassium dicyanoaurate was tested in vitro for its ocular irritancy potential to the isolated bovine cornea. The test item was applied neat 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).
Potassium dicyanoaurate induces an In Vitro Irritancy Score of 171.5 and therefore was considered to be an ocular corrosive or severe irritant.
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