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EC number: 831-167-5 | CAS number: 2126827-44-7
- 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:
- 18th February 2019 - 19th February 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:
- Adopted October 09, 2017
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,9,16,23-tetrakis(2,5-di-tert-butyl-4-methoxyphenoxy)phthalocyanine
- EC Number:
- 831-167-5
- Cas Number:
- 2126827-44-7
- Molecular formula:
- C92H106N8O8
- IUPAC Name:
- 2,9,16,23-tetrakis(2,5-di-tert-butyl-4-methoxyphenoxy)phthalocyanine
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Batch (Lot) Number: 2715/18/01
Expiry date: 01 July 2020 (expiry date)
Physical Description: Dark green solid
Purity/Composition: 99%
Storage Conditions: At room temperature protected from light
Additional information.
Test Facility test item number: 210026/A
Purity/Composition correction factor: No correction factor required
Test item handling: Use amber glassware or wrap container in aluminum foil
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 356 to 369 mg
- Duration of treatment / exposure:
- for 240 +/- 10 minutes at 32 +/- 1 °C.
- Duration of post- treatment incubation (in vitro):
- Opacity determined directly after the treatment; Permiability determined after post-treatment incubation of 90 +/- 5 minutes at 32 +/- 1 °C.
- Number of animals or in vitro replicates:
- Triplicate.
- Details on study design:
- Test System.
Test System: Bovine eyes were used as soon as possible after slaughter.
Source:
Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, -'s Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
Transport:
Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
Preparation of Corneas.
The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.
The isolated corneas were stored in a petri dish with cMEM (Earle’s Minimum Essential Medium (Life Technologies, Bleiswijk, The Netherlands) containing 1% (v/v) L-glutamine (Life Technologies) and 1% (v/v) Fetal Bovine Serum (Life Technologies)). The isolated corneas were mounted in a corneal holder (one cornea per holder) of BASF (Ludwigshafen, Germany) with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM of 32 +/- 1 °C. The corneas were incubated for the minimum of 1 hour at 32 +/- 1 °C.
Cornea Selection and Opacity Reading.
After the incubation period, the medium was removed from both compartments and replaced with fresh cMEM. Opacity determinations were performed on each of the corneas using an opacitometer (BASF-OP3.0, BASF, Ludwigshafen, Germany). 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.
Substance Preparation.
No correction will be made for the purity/composition of the substance.
Since no workable suspension of the substance in physiological saline could be obtained, the substance was used as delivered by the sponsor and added pure on top of the corneas.
To protect the substance from light, amber-colored glassware or tubes wrapped in tin-foil were used for substance preparations.
Treatment of Corneas and Opacity Measurements.
The medium from the anterior compartment was removed and 750 ul of the negative control and 20% (w/v) Imidazole solution (positive control) were introduced onto the epithelium of the cornea. The substance was weighed in a bottle and applied directly on the corneas in such a way that the cornea was completely covered (356 to 369 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. After the incubation the solutions and the substance were removed and the epithelium was washed at least three times with MEM with phenol red (Earle’s Minimum Essential Medium Life Technologies). Possible pH effects of the substance on the corneas were recorded. Each cornea was inspected visually for dissimilar opacity patterns. The medium in the posterior compartment was removed and both compartments were refilled with fresh cMEM and the opacity determinations were performed.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 0.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 2
- Value:
- -2.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 3
- Value:
- 0.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Opacity Score.
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 |
|||
|
||||||
Substance |
3.4 |
4.3 |
1.0 |
0.2 |
-0.6 |
|
3.4 |
2.3 |
-1.1 |
-1.8 |
|||
4.5 |
5.0 |
0.5 |
-0.3 |
1 Final Opacity = Opacity after treatment – Opacity before treatment.
2 Negative control corrected Final Opacity = Final opacity – Mean final opacity negative control
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 |
|
|
|||
Substance |
-0.2 |
-0.008 |
0.1 |
-1.8 |
-0.019 |
-2.1 |
|
-0.3 |
0.072 |
0.8 |
1 In vitro irritancy score (IVIS) = opacity value + (15 x OD490 value).
2 Positive control and substance are corrected for the negative control.
Permeability Score (uncorrected).
Treatment |
Dilution factor |
OD490 1 |
OD490 2 |
OD490 3 |
Average OD |
Final OD |
Mean final negative control |
|||||
|
||||||||||||
Negative control |
1 |
0.001 |
0.001 |
0.001 |
0.001 |
0.001 |
0.011 |
|||||
1 |
0.026 |
0.028 |
0.016 |
0.023 |
0.023 |
|||||||
1 |
0.007 |
0.007 |
0.016 |
0.010 |
0.010 |
|||||||
|
|
|||||||||||
Positive control |
1 |
1.229 |
1.240 |
1.241 |
1.237 |
1.237 |
|
|||||
6 |
0.442 |
0.440 |
0.441 |
0.441 |
2.646 |
|
||||||
6 |
0.300 |
0.300 |
0.301 |
0.300 |
1.802 |
|
||||||
|
|
|||||||||||
Substance |
1 |
0.003 |
0.003 |
0.004 |
0.003 |
0.003 |
|
|||||
1 |
-0.008 |
-0.008 |
-0.007 |
-0.008 |
-0.008 |
|
||||||
1 |
0.086 |
0.082 |
0.082 |
0.083 |
0.083 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results of an eye corrosion/irritation study employing isolated bovine cornea exposed to undiluted substance for 240-minutes indicate that it is a non-irritant to the eye.
- Executive summary:
In a reliable in vitro eye irritation study, conducted according to 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’, the ability of the substance to induce opacity and permeability in an isolated bovine cornea were determined.
The substance was applied undiluted (356 - 369 mg) onto corneas (n=3) for a period of 240 minutes, followed by rinsing of the substance. The opacity of the corneas was then determined. The permeability measurements were determined after 90 minutes of incubation with fluorescein. The results of an eye corrosion/irritation study show that the mean in vitro irritance score was -0.4, indicating that that the substance is non-irritant to the eye.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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