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EC number: 246-618-6 | CAS number: 25103-54-2
- 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:
- 15 August 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:
- Adopted July 26 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Zinc isodecyl phosphorodithioate
- EC Number:
- 246-618-6
- EC Name:
- Zinc isodecyl phosphorodithioate
- Cas Number:
- 25103-54-2
- Molecular formula:
- C20H43O2PS2.1/2Zn
- IUPAC Name:
- zinc bis[O,O-bis(8-methylnonyl) dithiophosphate]
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: Slaughterhouse (Vitelco’s, Hertogenbosch, The Netherlands)
- Number of animals: Not specified.
- Characteristics of donor animals (e.g. age, sex, weight): Young cattle.
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
- Time interval prior to initiating testing: 1 hour
- indication of any existing defects or lesions in ocular tissue samples: The eyes were checked for unacceptable defects by removing them from the physiological saline and holding them up to the light. Those exhibiting defects were discarded.
- Indication of any antibiotics used: Not applicable.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL was introduced onto the epithelium of the cornea
- Concentration (if solution): Test material was tested neat. - Duration of treatment / exposure:
- The test consisted of topical application of the test item on the epithelium of the bovine cornea for 10 minutes. After exposure the cornea was thoroughly rinsed to remove the test item and incubated for 2 hours with fresh medium followed by opacity measurement and the permeability of the corneas was determined after a 90 minutes incubation period with sodium fluorescein.
- Duration of post- treatment incubation (in vitro):
- 90 +- 5 minutes at 32 +-1°C
- Number of animals or in vitro replicates:
- Three test replicates
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Preparation: The eyes were checked for defects such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. The isolated corneas were then stored in a petri dish with Earle’s Minimum Essential Medium (cMEM) containing 1% (v/v) L-glutamine and 1% (v/v) Foetal Bovine Serum. The isolated corneas were mounted in a corneal holder. The anterior half of the holder was positioned on top of the cornea and tighten with screws. The compartments of the corneal holder were filled with cMEM at 32 +/- 1 °C.
Selection: The corneas were incubated for a minimum of 1 hour at 32 +/-1 °C. The opacity of each cornea was read against a cMEM filled chamber, and the initial opacity reading thus determined was recorded. Corneas that had an initial opacity reading higher than 7 were not used. Three corneas were selected at random for each treatment group.
QUALITY CHECK OF THE ISOLATED CORNEAS
The eyes were checked for defects such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. The opacity of each cornea was read against a cMEM filled chamber, and the initial opacity reading thus determined was recorded. Corneas that had an initial opacity reading higher than 7 were not used.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: Physiological saline
SOLVENT CONTROL USED (if applicable): Not applicable
POSITIVE CONTROL USED: Ethanol
APPLICATION DOSE AND EXPOSURE TIME: 750 μl of test item was applied to the epithelium of the bovine cornea for 10 minutes.
TREATMENT METHOD: Closed chamber
POST-INCUBATION PERIOD: 90 minutes
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: Not specified
POST-EXPOSURE INCUBATION: 2 hours
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity of a cornea was measured by the diminution of light passing through the cornea.
The light was measured as illuminance (I = luminous flux per area, unit: lux) by a Opacitometer.
- Corneal permeability: Microtiter plate reader (OD490)
- Others (e.g, pertinent visual observations, histopathology): Not specified.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value)
In vitro score range UN GHS
≤ 3 No Category
> 3; ≤ 55 No prediction can be made
>55 Category 1
DECISION CRITERIA: please specify if the decision criteria as indicated in the TG was used.
The decision criteria for the IVIS cut-off values for identifying test chemicals as inducing serious eye damage was used for the study.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 2.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 2
- Value:
- -0.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 3
- Value:
- 1.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Permeability
- Run / experiment:
- Mean
- Value:
- 0.03
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
A summary of Opacity, Permeability and In Vitro Scores
Treatment |
Mean Opacity |
Mean Permeability |
Mean In vitro Irritation Score |
Negative control |
-0.1 |
-0.005 |
-0.2 |
Positive control (Ethanol) |
27 |
0.802 |
39 |
Test item
|
0.5 |
0.030 |
1.0 |
Historical control data for the BCOP Studies
Negative Control |
Positive control |
|||
|
Opacity |
Permeability |
In vitro Irritancy Score |
In vitro Irritancy Score |
Range |
-2.9-3.0 |
-0.016-0.042 |
-2.8-3.0 |
34.7-78.2 |
Mean |
0.08 |
0.01 |
0.17 |
56.01 |
SD |
1.04 |
0.01 |
1.14 |
12.51 |
n |
84 |
77 |
78 |
55 |
SD= Standard deviation
N= Number of observations
The above mentioned historical control data range of the controls were obtained by collecting all data over the period of August 2014 to August 2017.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not an eye irritant under the conditions of the bovine corneal opacity and permeability test guideline.
- Executive summary:
The study is assigned a reliability score of 1 (reliable without restrictions) as it followed OECD Guideline 437: Bovine Corneal Opacity and Permeability Test Method and is also compliant with GLP. 750 µL of the undiluted test item was applied directly on top of the corneas for 10 minutes.
The positive control mean in vitro irritancy score (39) was within two standard deviations of the current historical positive control mean. The negative control values for opacity and permeability were less than the upper limits of the laboratory historical range. The validity criteria for the study were therefore met.
The test item induced an In vitro irritancy score of less than 3, which concludes no classification is required for eye irritation or serious eye damage.
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