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EC number: 247-117-5 | CAS number: 25583-20-4
- 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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:
- 2014-11-03 to 2014-12-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
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:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Titanium nitride
- EC Number:
- 247-117-5
- EC Name:
- Titanium nitride
- Cas Number:
- 25583-20-4
- Molecular formula:
- NTi
- IUPAC Name:
- titanium nitride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Titanium nitride
- Analytical purity: > 99%
- Physical state: solid
- Colour: yellow
- Lot/batch No.: 84958
- Expiration date of the lot/batch: 2016-09-16
- Storage condition of test material: at room temperature
Constituent 1
Test animals / tissue source
- Species:
- other: BCOP
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Isolated corneas obtained as a by-product from animals freshly slaughtered at the abattoir A. Moksel AG, Buchloe, Germany
Test system
- Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): test item was suspended with 0.9% NaCl to gain a 20% concentration.
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 µl - Duration of treatment / exposure:
- 4h ± 5 minutes at 32 ± 1 °C
- Observation period (in vivo):
- Opacity measurements were performed before and directly after exposure.
The optical density at 490 nm was measured upon 90 minutes of incubation with fluorescein after exposure to the test item by using a spectrophotometer. - Number of animals or in vitro replicates:
- Three corneas each for titanium nitride, negative control (physiological saline 0.9% NaCl) and positive control (20 % imidazole in physiological saline 0.9 NaCl%).
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): at least 3 times with minimum essential medium (MEM)
- Time after start of exposure: 4h ± 5 minutes
SCORING SYSTEM:
In vitro irritation score (IVIS) = mean opacity value + (15x mean permeability OD490 value)
The IVIS cut-off values for identifiying test substances as inducing serious eye damage (UN GHS Category 1) and test substances not requiring classification for eye irritation of serious eye damage (UN GHS No Category):
IVIS: ≤ 3 - UN GHS: No Category
IVIS: > 3 - ≤ 55 - UN GHS: No prediction can be made
IVIS: > 55 - UN GHS: Category 1
TOOL USED TO ASSESS SCORE:
Opacity measurement was performed with an opacitometer
Results and discussion
In vivo
Results
- Irritation parameter:
- other: In vitro irritation score (IVIS)
- Basis:
- mean
- Remarks:
- (triplicates)
- Time point:
- other: 90 minutes after 4h exposure
- Score:
- 0.03
- Max. score:
- 202
- Remarks on result:
- other: Max score= mean in vitro irritation score of positive control
Any other information on results incl. tables
Table 1: In Vitro Irritation Score |
||||
Cornea No. |
Test Item |
Corrected Opacity |
Corrected OD490 Value |
IVIS |
1 |
Negative Control |
0.00 |
0.005 |
|
2 |
1.00 |
0.009 |
|
|
3 |
0.00 |
0.023 |
|
|
MV |
0.33 |
0.012 |
0.52 |
|
4 |
Positive |
187.67 |
1.791 |
|
5 |
174.67 |
2.019 |
|
|
6 |
155.67 |
2.026 |
|
|
MV |
172.67 |
1.945 |
201.84 |
|
7 |
Test Item |
-0.33 |
-0.001 |
|
8 |
-0.33 |
0.008 |
|
|
9 |
0.67 |
-0.001 |
|
|
MV |
0.00 |
0.002 |
0.03 |
|
MV = mean value |
Table 2: Historical mean in vitro irritation score of the positive control | ||||||
IVIS (positive control) | ||||||
Mean Value (MV) | 206.77 | |||||
Standard deviation (SD) | 24.53 | |||||
MV - 2 x SD | 157.71 | |||||
MV + 2 x SD | 255.84 |
IVIS: in vitro irritation score
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: UN GHS
- Conclusions:
- In conclusion, based on the mean in vitro irritation score of 0.03 obtained in the bovine cornea opacity and permeability assay (OECD 437), titanium nitride is considered to be not irritating under the test conditions reported.
- Executive summary:
The eye irritation potential of titanium nitride (> 99% purity) was investigated in the bovine cornea opacity and permeability assay in accordance to OECD 437. The test item was suspended with 0.9% NaCl to gain a 20% concentration. The corneal opacity was measured before and after treatment (4 hours). The mean in vitro irritation score was determined with 0.03. The positive control induced the appropriate responses, indicating the validity of the assay. Based on the results obtained, titanium nitride can be considered as not irritating to the eye ( UN GHS No Category).
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