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EC number: 284-943-5 | CAS number: 84989-53-7
- 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:
- 2017-05-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- 26 July 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(N,N-dimethylpropane-1,3-diamine-N)[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]cobalt(1+) chloride
- EC Number:
- 284-943-5
- EC Name:
- Bis(N,N-dimethylpropane-1,3-diamine-N)[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]cobalt(1+) chloride
- Cas Number:
- 84989-53-7
- Molecular formula:
- C42H44CoN12.Cl
- IUPAC Name:
- hydroxylamine
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- - Test system: Freshly isolated bovine cornea
- Source: abattoir A. Moksel AG, Buchloe, GermanyA. Moksel AG, Buchloe, Germany
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- Anterior compartment received the test item or vehicle or positive contril at volume of 0.75 mL on the surface of the cornea.
TEST MATERIAL
- Amount(s) applied (volume): 0.75 mL
- Concentration (if solution): test item suspended with physiological saline 0.9% NaCl to give a 20% concentration. - Duration of treatment / exposure:
- 4 hours ± 5 minutes incubation at 32 ± 1 °C.
- Duration of post- treatment incubation (in vitro):
- After illuminance measurement was performed incubated for 90 minutes at 32 ± 1 °C.
- Number of animals or in vitro replicates:
- 3 corneas per dose group
- Details on study design:
- Preparation of the Corneas
Immediately after arrival of the eyes, cornea preparation was initiated. The eyes were carefully examined for defects and any defective eyes were discarded. The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing HBSS.
Treatment of the Corneas
After the equilibration period, the medium was removed from both chambers and replaced with fresh complete RPMI. The illuminance of each cornea was read and recorded. Only corneas that had an initial illuminance reading I > I0/1.1651 lux were used for the assay.
Validity of the test
The BCOP assay is considered to be valid if the in vitro irritation score obtained with the positive control falls within the two standard deviations of the current historical mean. The negative control responses should result in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.
Evaluation of Results
The following formula was used to calculate the opacity, whereas the values a and b are equipment-specific variables empirically determined by the manufacturer: Opacity = ((Io/I)-b)/a
with a = 0.025 and b = 0.9894
The following formula was used to determine the in vitro irritation score (IVIS):
IVIS = mean opacity value + (15 x mean permeability OD490 value)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 3
- Value:
- >= 122.1
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: classified into UN GHS Category 1.
- Other effects / acceptance of results:
- The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
The negative control responses should result in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.
In vivo
- Irritant / corrosive response data:
- All 3 corneas treated with Ingrain Blue 5 showed a blue coloration of the tissue.
The following mean in vitro irritation score was calculated: 122.10
Any other information on results incl. tables
In vitro irritation score
Cornea No. | Test Item | Corrected Opacity | Permeability Corrected OD490 Value | IVIS |
1 | Negative Control | 0.89 | 0.009 | 0.59 |
2 | 0.04 | 0.009 | ||
3 | 0.04 | 0.036 | ||
MV | 0.32 | 0.018 | ||
4 | Positive Control | 90.91 | 1.417 | 121.72 |
5 | 92.93 | 2.397 | ||
6 | 89.52 | 2.307 | ||
MV | 91.12 | 2.04 | ||
7 | Test Item | 161.93 | -0.013 | 122.1 |
8 | 125.17 | -0.014 | ||
9 | 79.84 | -0.015 | ||
MV | 122.31 | -0.014 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The mean in vitro irritation score was 122.1 %. It is hence concluded that the test item can lead to irreversible eye damage.
- Executive summary:
The eye irritancy potential of Ingrain Blue 5 was investigated in the bovine corneal opacity and permeability assay according to OECD guideline 437 and in compliance to GLP. The test item was suspended with physiological saline 0.9% NaCl (see 10.2) to give a 20% concentration and 3 corneas were treated.
All 3 treated corneas treated showed a blue coloration of the tissue. The following mean in vitro irritation score was calculated: 122.10. Based on these results, the test item was classified as eye damage 1 according to CLP.
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
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