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EC number: 241-510-5 | CAS number: 17501-44-9
- 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:
- 18 Feb 2019 - 19 Feb 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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:
- 09 October 2017
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrakis(pentane-2,4-dionato-O,O')zirconium
- EC Number:
- 241-510-5
- EC Name:
- Tetrakis(pentane-2,4-dionato-O,O')zirconium
- Cas Number:
- 17501-44-9
- Molecular formula:
- C20H28O8Zr
- IUPAC Name:
- 2,4,8,8,10,10,13,15-octamethyl-1λ³,5λ³,7λ³,7λ³,11λ³,11λ³,12λ³,16λ³-octaoxa-6-zirconadispiro[5.5⁶.5⁶.5⁶]henicosa-1,4,7,7,10,10,12,15-octaene-6,6,6,6-tetrakis(ylium)-3,9,9,14-tetraide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Identification: Zirconium (IV) acetylacetonate (Zr-acac)
- Description: White to off-white powder
- Storage conditions: At room temperature
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: young cattle, obtained from the slaughterhouse
- Storage, temperature and transport conditions of ocular tissue: eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Subsequently, eyes were collected and transported in physiological saline in a suitable container under cooled conditions. The isolated corneas were stored in a petri dish with cMEM containing 1% (v/v) L-glutamine and 1% (v/v) Foetal Bovine Serum. The corneas were incubated for the minimum of 1 hour at 32 ± 1 °C.
- The eyes were checked for unacceptable defects and those exhibiting defects were discarded.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 312.2 to 333.8 mg (complete coverage of the cornea)
NEGATIVE CONTROL:
- Amount applied: 750 µL
POSITIVE CONTROL:
- Amount applied: 750 µL - Duration of treatment / exposure:
- 240 +/- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 90 +/- 5 minutes in sodium fluorescein
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- TREATMENT METHOD:
The medium from the anterior compartment was removed and 750 µL of the negative control and 20% (w/v) Imidazole solution (positive control) were introduced onto the epithelium of the cornea. The test item was weighed in a bottle and applied directly on the corneas in such a way that the cornea was completely covered (312.2 to 333.8 mg).The holder was slightly rotated, with the corneas maintained in a horizontal position, to ensure uniform distribution of the solutions over the entire cornea. Corneas were incubated in a horizontal position for 240 ± 10 minutes at 32 ± 1 °C.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: After the incubation the solutions and the test compound were removed and the epithelium was washed at least three times with MEM with phenol red.
POST-EXPOSURE INCUBATION: 90 ±5 minutes 32 ± 1 °C in sodium-fluorescein for permeability determinations.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacity meter (OP-KIT)
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a microtiter plate reader (TECAN Infinite® M200 Pro Plate Reader, OD490). OD490 values of less than 1.500 were used in the permeability calculation.
- Other: possible pH effects of the test substance on the corneas were recorded.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
A test substance that induces an IVIS ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces IVIS >55 is defined as a corrosive or severe irritant (UN GHS: category 1);
For a test substance that induces an IVIS >3 and ≤55, no prediction on irritant potency can be made.
ACCEPTABILITY CRITERIA:
The assay is considered acceptable if:
- The positive control gives an in vitro irritancy score that falls within two standard deviations of the current historical mean.
- The negative control responses should result in opacity and permeability values that are less than the upper limits of the laboratory historical range.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean of 3 replicates
- Value:
- 17
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- RESULTS OF TEST ITEM TREATMENT (details can be found in table 1, 2 and 3 under 'Any other information on results')
- Opacity scores (negative control corrected): 13, 2.7, 6.0
- Permeability scores (negative control corrected): 1.411, 0.468, 0.136
- In Vitro Irritation Scores: 34, 9.7, 8.1
OTHER:
- The corneas were translucent after the 240 minutes of treatment with the test substance.
- No pH effect of the test item was observed on the rinsing medium.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, the negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range. Individual in vitro irritancy scores for the negative controls ranged from 0.4 to 1.2. The corneas treated with the negative control item were clear after the 240 minutes of treatment.
- Acceptance criteria met for positive control: yes, the mean IVIS of the positive control was 164 and within two standard deviations of the current historical positive control mean. The corneas treated with the positive control were turbid after the 240 minutes of treatment.
Any other information on results incl. tables
Table 1 Opacity scores
Treatment |
Opacity before treatment |
Opacity after treatment |
Final Opacity1 |
Negative control corrected Final Opacity2 |
Mean Final Opacity |
||||
|
|||||||||
Negative control |
4.1 |
5.4 |
1.2 |
|
0.7 |
||||
3.4 |
3.5 |
0.1 |
|||||||
4.3 |
5.3 |
0.9 |
|||||||
|
|||||||||
Positive control |
4.6 |
160.2 |
155.6 |
155 |
137 |
||||
3.2 |
113.1 |
109.9 |
109 |
||||||
3.1 |
149.6 |
146.5 |
146 |
||||||
|
|||||||||
Zirconium (IV) acetylacetonate (ZR acac) |
4.0 |
17.8 |
13.9 |
13 |
7.3 |
||||
4.1 |
7.5 |
3.5 |
2.7 |
||||||
2.7 |
9.4 |
6.8 |
6.0 |
Calculations are made without rounding off.
1 Final Opacity = Opacity after treatment – Opacity before treatment.
2 Negative control corrected Final Opacity = Final opacity – Mean final opacity negative control
Table 2 Permeability scores (corrected)
Treatment |
Dilution factor |
Negative control corrected OD490 11 |
Negative control corrected OD490 21 |
Negative control corrected OD490 31 |
Negative control corrected OD490 Average |
Negative control corrected final OD490 |
Average OD |
|||||
|
||||||||||||
Positive control |
1 |
1.218 |
1.229 |
1.230 |
1.225 |
1.225 |
1.845 |
|||||
6 |
0.431 |
0.429 |
0.430 |
0.430 |
2.577 |
|||||||
6 |
0.289 |
0.289 |
0.290 |
0.289 |
1.733 |
|||||||
|
||||||||||||
Zirconium (IV) acetylacetonate (ZR acac) |
1 |
1.409 |
1.413 |
1.412 |
1.411 |
1.411 |
0.672 |
|||||
1 |
0.467 |
0.469 |
0.469 |
0.468 |
0.468 |
|||||||
1 |
0.136 |
0.136 |
0.137 |
0.136 |
0.136 |
Calculations are made without rounding off.
1 OD490 values corrected for the mean final negative control permeability (0.011).
Table 3 In Vitro Irritancy Score
Treatment |
Final Opacity2 |
Final OD4902 |
In vitro Irritancy Score1 |
|
|||
Negative control |
1.2 |
0.001 |
1.2 |
0.1 |
0.023 |
0.4 |
|
0.9 |
0.010 |
1.1 |
|
|
|||
Positive control |
155 |
1.225 |
173 |
109 |
2.577 |
148 |
|
146 |
1.733 |
172 |
|
|
|||
Zirconium (IV) acetylacetonate (ZR acac) |
13 |
1.411 |
34 |
2.7 |
0.468 |
9.7 |
|
6.0 |
0.136 |
8.1 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on an IVIS >3 and ≤55, no prediction for classification of Zirconium (IV) acetylacetonate (ZR acac) can be made.
- Executive summary:
The eye hazard potential of Zirconium (IV) acetylacetonate (ZR acac) was assessed in a Bovine Corneal Opacity and Permeability test (BCOP test), performed according to OECD guideline 437 and GLP principles. Three corneas from young cattle were exposed to 312.2 to 333.8 mg (complete coverage) of the test item, next to a negative control group of physiological saline (n=3) and a positive control of 20% (w/v) imidazole (n=3). Duration of treatment was approximately 240 minutes. Results of the negative and positive controls were within the historical data. Therefore, it was shown that the negative control did not induce irritancy on the corneas, the test conditions were adequate and the test systems functioned properly. Since the IVIS of the test item were > 3 ≤ 55 (13, 2.7 and 6.0), no prediction for classification of Zirconium (IV) acetylacetonate (ZR acac) for eye irritation can be made.
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