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EC number: 620-400-4 | CAS number: 12031-65-1
- 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
Endpoint summary
Administrative data
Description of key information
Based on the results of the EpiDerm™ in vitro skin irritation and
corrosion test strategy including transport classification, it was
concluded that Lithium nickel dioxide shows a corrosive potential.
Based on the results of the BCOP and EpiOcular Tests, it was concluded
that the test material shows serious eye damage in the in vitro eye
irritation test strategy.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Version / remarks:
- 28 July 2015
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier): BASF SE, Batch: 8800315
- Purity: approx. 99.8 g/100 g
- Expiration date of the batch: 12 Aug 2021
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: guaranteed by the sponsor
FORM AS APPLIED IN THE TEST: undiluted solid test substance
OTHER SPECIFICS:
- Pysical state/color: solid/anthracite
- pH: ca. 12 (undiluted test substance moistened with deionized water, determined in the lab prior to start of the GLP study) - Test system:
- artificial membrane barrier model
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- MATERIAL:
Corrositex® kit:
InVitro International, Irvine CA, USA, containing: reagents required for qualification and categorization screen, biobarrier matrix powder and diluent, membrane discs and vials containing the Chemical Detection System.
Controls:
Negative control (NC): 10% citric acid
Positive control (PC): Sodium hydroxide (solid)
EXPERIMENTAL PROCEDURE:
- Test substance compatibility with the assay (qualification screen):
For the qualification screen, 100 mg test substance were added to the CDS screening tube. If the test substance failed to produce a color change in the CDS within one minute, the test substance could not be analyzed in this system, and no further testing was required.
- Categorization screen:
The categorization screen was used to assess the appropriate scoring scale for the test substance. The categorization screen was performed by adding 100 mg test substance to tube A and B each. Each tube was mixed, and the resulting color was observed. If required, 2 drops of the "confirm" reagent were added to tube B, the tube was mixed and the resulting color observed. The categorization kit and color chart provided by InVitro International were used to determine
the category. The test substance was scored as category 1 (high acid/alkaline reserve) or category 2 (low acid/alkaline reserve) as described in section 3.9.3.
- Bio barrier preparation:
The entire content of the biobarrier diluent vial was added slowly to the vial containing the bio barrier matrix powder. The vial containing the mixture was placed in a water bath at 64 – 68°C with a magnetic stirrer. The stir bar rotated slowly enough to avoid foaming until complete and uniform solubilisation. 200 μL solubilized matrix were pipetted into each of the membrane discs.
The membrane discs were then refrigerated for at least 2 hours at 2 – 8°C.
The bio barriers were wrapped and stored at 2 – 8°C for a maximum of 7 days.
Any remaining matrix solution was stored at 2 – 8°C for up to 30 days for preparation of additional bio barrier membrane discs.
- Corrositex® assay:
Following the acceptance of the positive control, the Corrositex® assay was performed for the test substance. Four vials containing the CDS were used for the test substance. In addition, one vial was used for the PC, the NC and the color control (blank) each. A membrane disc coated with the bio barrier matrix was placed into one vial containing the CDS, and approximately 500 mg test substance were added onto the membrane disc. An electronic time clock was started with the application. The vial was observed for three minutes for any change in the CDS. If no color change was observed within three minutes, the membranes remaining were treated with the test substance. An electronic time clock was started with each application. The vials were observed continuously for the first ten minutes. Thereafter, the vials were observed for
approximately ten minutes around the time points relevant for evaluation or until breakthrough of the test substance. The elapsed time between test substance
application and the first change in the indicator solution (i.e. barrier penetration) was recorded.
The positive control vial was prepared as described above and contained one pellet of sodium hydroxide on top of the membrane disc. This vial was monitored continuously until breakthrough.
The negative control vial was prepared as described above and contained 500 μL 10% citric acid monohydrate. This vial was observed for 60 minutes and evaluated as “non-corrosive” if no reaction had been observed.
ACCEPTANCE CRITERIA:
The Corrositex® assay was accepted if the breakthrough time for the positive control substance was in the historic control range (mean ± 2-3x standard deviations). The expected breakthrough time of the concurrent positive control (Sodium Hydroxide solid) should be between 8 - 16 min. In order to demonstrate the functional integrity of the membrane barrier, the acceptance criterium for the negative control was not to induce membrance breakthrough within a 60- minute observation period. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 500 mg test substance
- Duration of treatment / exposure:
- max. 3 minutes
- Number of replicates:
- 4
- Irritation / corrosion parameter:
- other: mean breakthrough time through Corrositex® Biobarrier Membrane in minutes
- Run / experiment:
- Mean of 4 vials
- Value:
- 58.39
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: corrosive subcategory 1C
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
The qualification screen demonstrated that the test substance is able to
react with the CDS and produce a visible color change. Therefore, the
membrane barrier test method was determined to be suitable for the
evaluation of the corrosive potential of the test substance.
A timescale category test was carried out to distinguish between weak
and strong acids or bases. The test substance was assigned to timescale
category 2 (having a low acid/alkaline reserve).
The mean breakthrough time of the test substance determined in the
actual Corrositex® assay was 58 minutes and 39 seconds (single break
through times of the four vials [min:s]: 59:59, 67:301, 59:22 and
56:37). The second vial treated with the test substance showed a
breakthrough time above 60 minutes, indicating no corrosive potential.
However, break through times below 60 minutes were noted in the other
three vials, thus, the test material is classified as corrosive.
The breakthrough times of three vials, indicated that the test substance
has a weak corrosive potential and should be assigned to UN GHS skin
corrosivity subcategories 1C or UN Transport Packing Group III as
specified in the cited OECD TG 435 and Instruction Manual.
The negative control, 10% citric acid monohydrate, did not produce any reaction within 60 minutes after application. Sodium hydroxide (solid) applied as positive control showed a breakthrough time of 15 minutes and 55 seconds and was assigned accordingly. Thus, the controls fulfill the acceptance criteria and demonstrate the validity of the assay.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- other: part of a testing strategy
- 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
- 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:
- 09.12.2010
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: 8800315
- Content: approx. 99.8 g/100 g
- Homogeneity: the test item appeared to be homogeneous
- Appearance: solid, anthracite
- Expiry Date: 12 August 2021
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, under N2
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item (non-surfactant) was tested as suspension in deionised water using sonication for 10 minutes. Before each removal the test item was resuspended.
- Form of application: 20% (w/v) suspention in deionized water - Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Freshly isolated bovine cornea; supplier: AB Schlachthof GmbH & Co. KG, 63739 Aschaffenburg, Germany
- Characteristics of donor animals: age of the animals: 14 month old
- indication of any existing defects or lesions in ocular tissue samples: Corneas free of defects (opacity, scratches, pigmentation etc.) - Vehicle:
- water
- Remarks:
- deionized
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 20% (w/v) solution in de-ionized water
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µL of de-ionized water
POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 μL of 20% (w/v) solution of imidazole in deionized wateror - Duration of treatment / exposure:
- 4 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: Corneas free of defects (opacity, scratches, pigmentation etc.) were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in cornea holders that consists of anterior and posterior chambers. Both chambers were filled to excess with pre-warmed Eagle’s MEM (without phenol red) and then equilibrated in a vertical position at about 32°C for at least 1 hour. After the equilibration period, the medium in both chambers was replaced by fresh pre-warmed medium and initial corneal opacity readings were taken for each cornea with an opacitometer.
QUALITY CHECK OF THE ISOLATED CORNEAS: Any corneas that showed macroscopic tissue damage or an opacity value < 550 opacity units were discarded. The remaining corneas were then distributed into negative control, positive control and treatment groups.(According to OECD TG 437, corneas that have an opacity value >7 or equivalent for the opacitometer and cornea holders used after an initial one-hour equilibration period are to be discarded. In the test facility´s opacitometer in combination with the used cornea holder set 2013-22 and 2013-24, the maximal initial opacity of >7 arises from I= 550 lux with Io= 641 lux).
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: Yes
POSITIVE CONTROL USED: Yes
APPLICATION DOSE AND EXPOSURE TIME: Application of 750 µL of the 20% (w/v) test-substance preparation, 4 hours exposure time
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least 3 times.
- POST-EXPOSURE INCUBATION: no
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Yes.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader: Yes, OD490, OP_KiT opacitometer (Electro Design, 63-Riom France).
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
IVIS ≤ 3, Prediction: No Category
IVIS > 3; ≤ 55, Prediction: No prediction can be made
IVIS > 55, Prediction: Category 1 - Irritation parameter:
- in vitro irritation score
- Remarks:
- IVIS
- Run / experiment:
- Run 1, mean of three single corneas
- Value:
- 355.13
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Cathegory 1, serious eye damage
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No.
DEMONSTRATION OF TECHNICAL PROFICIENCY: Proficiency given
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
Reference
Table 1: Results of the BCOP Test, in vitro irritancy score (IVIS) of the test substance, the NC and the PC.
Opacity value per cornea | Permeability at 490 nm (OD490) | IVIS | |||
substance identification | per cornea | per group | |||
mean | SD | ||||
400.00* | 0.889* | 413.34 | |||
Test substance | 326.00* | 1.201* | 344.02 | 355.13 | 53.52 |
291.00* | 1.136* | 308.04 | |||
0 | 0.066 | 0.99 | |||
NC (Saline) | 0 | 0.078 | 1.17 | 1.08 | 0.09 |
0 | 0.072 | 1.08 | |||
** | ** | ** | |||
NC (deionised water) | 2.00 | 0.078* | 2.00 | 1.00 | 1.41 |
0.00 | 0.061* | 0.00 | |||
81.00* | 0.605* | 90.08 | |||
PC (10% (w/v) Benzalkonium chloride in saline) | 68.00* | 0.471* | 75.07 | 80.11 | 8.63 |
67.00* | 0.545* | 75.18 | |||
88.00* | 0.771* | 99.57 | |||
PC (20 % Imidazole in saline) | 97.00* | 1.239* | 115.59 | 97.04 | 19.93 |
65.00* | 0.731* | 75.97 |
*Correction was performed with the values of the Negative Control Saline.
** not taken into the evaluation since this value is declared as an outlier.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
The objective was to assess the skin corrosion and irritation potential
of the test substance. Using the currently available methods a single in
vitro assay is not sufficient to cover the full range of skin
irritating/corrosion potential including transport classification.
Therefore, three in vitro assays were proposed for this in vitro skin
irritation and corrosion test strategy including transport
classification: The Skin Corrosion Test (SCT), Skin Irritation Test
(SIT) and In vitro Membrane Barrier Test (Corrositex®).
Based on the results observed it was concluded that Lithium nickel
dioxide shows a corrosive potential in the EpiDerm™ in vitro skin
irritation and corrosion test strategy including transport
classification under the test conditions chosen.
The mean breakthrough time determined in the In vitro Membrane Barrier
Test (Corrositex®) was 58 minutes and 39 seconds. The breakthrough times
of three vials of the category 2 chemical, indicated that the test
substance has a weak corrosive potential and should be assigned to UN
GHS skin corrosivity subcategories 1C or UN Transport Packing Group III
as specified in the cited OECD TG 435 and Instruction Manual.
Eye irritation:
The objective was to assess the eye irritating potential of the test
material. By using the methods currently available a
single in vitro assay is not sufficient to cover the full range
of eye irritating potential. Therefore, two in vitro assays
conducted under GLP conditions were part of this in vitro eye
irritation test strategy: The Bovine Corneal Opacity and Permeability
Test (BCOP Test) (according to OECD guideline 437) and EpiOcular Eye
Irritation Test (according to OECD guideline 492).
In the EpiOcular Test, the test substance was assessed to have an eye
irritating potential (relative mean viability of the tissues treated
with the test substances was 1.3%). However, no prediction can be made
between GHS categories 1 and 2.
In the following BCOP Test the mean IVIS of the corneas treated with the
test substance was 355.13, indicationg serious eye damage.
Based on the results of the BCOP and EpiOcular Tests, it was concluded
that Lithium nickel dioxide shows serious eye damage in the in vitro
irritation test strategy under the test conditions chosen.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008 (CLP Regulation).
To assess the skin corrosion and irritation potential of Lithium nickel dioxide, three in vitro assays were proposed for this in vitro skin irritation and corrosion test strategy including transport classification: The Skin Corrosion Test (SCT), the Skin Irritation Test (SIT) and the In vitro Membrane Barrier Test (Corrositex®). The test results indicated that the test substance has a weak corrosive potential and should be assigned to UN GHS skin corrosivity subcategories 1C or UN Transport Packing Group III as specified in the cited OECD TG 435 and Instruction Manual.
According to OECD 437 Lithium nickel dioxide showed serious eye damage.
As a result the substance Lithium nickel dioxide is considered to be classified for skin corrosion (Cat. 1C) and eye damage (Cat. 1) under Regulation (EC) No 1272/2008.
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