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EC number: 235-426-8 | CAS number: 12225-08-0
- 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:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 437), performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- as of September, 2009
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2,5-dimethoxy-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide
- EC Number:
- 235-426-8
- EC Name:
- N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2,5-dimethoxy-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide
- Cas Number:
- 12225-08-0
- Molecular formula:
- C27H24N6O7S
- IUPAC Name:
- 4-{[2,5-dimethoxy-4-(methylsulfamoyl)phenyl]diazenyl}-3-hydroxy-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)-2-naphthamide
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
Test system
- Amount / concentration applied:
- A 20% (w/v) suspension of the test item in physiological saline was prepared. Each 0.75 mL of the suspension were applied to three bovine corneas.
- Duration of treatment / exposure:
- The corneas were exposed to the test item suspension for 240 minutes.
- Details on study design:
- After a first opacity measurement of the fresh bovine corneae (t0), 0.75 mL per cornea of a 20% (w/v) suspension in saline (0.9% (w/v) NaCl in deionised water) of the test item, the positive, and the negative controls were applied to corneae and incubated for 240 minutes at 32 ± 1 °C. The posterior chamber contained MEM medium supplemented with sodium bicarbonate and L-glutamine and 1% fetal calf serum (FCS) (complete medium =cMEM). After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t240).
After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically (OD 490) the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 2.46
- Other effects / acceptance of results:
- Relative to the negative control, the test item did not cause any increase of the corneal permeability, and only very slight opacity occurred. The calculated mean in vitro irritation score of 2.46 was below the threshold of = 55.1. Therefore the test item is not corrosive / not severe irritant to the eye according to OECD 437. With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed. The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity of the corneae corresponding to a corrosive / severe irritant to the eye.
Any other information on results incl. tables
Results after 240 Minutes Incubation Time
Test Group |
Opacity value = Difference (t240-t0) of Opacity |
Permeability at 490 nm (OD490) |
In vitro Score |
Mean in vitro irritation score |
Proposed in vitro Irritation Scale |
||
|
|
Mean |
|
Mean |
|
|
|
Negative Control |
1 |
1.00 |
0.049 |
0.057 |
1.73 |
1.86 |
Non corrosive / not severe irritant |
1 |
0.079 |
2.19 |
|||||
1 |
0.044 |
1.66 |
|||||
Positive Control |
174.00* |
0.009* |
174.13 |
183.48 |
Corrosive / severe irritant |
||
175.00* |
0.028* |
175.42 |
|||||
201.00* |
- 0.007* |
200.89 |
|||||
Test item |
3.00* |
0.014* |
3.21 |
2.46 |
Non corrosive / not severe irritant |
||
2.00* |
- 0.001* |
1.98 |
|||||
2.00* |
0.014* |
2.21 |
*corrected values
Applicant's summary and conclusion
- Conclusions:
- In conclusion, according to the current study and under the experimental conditions reported, the test item is not corrosive / not severely irritating to the eye.
- Executive summary:
This in vitro study was performed to assess the corneal irritation and damage potential of the test item by means of the BCOP assay using fresh bovine corneas (OECD 437: bovine corneal opacity and permeability assay; GLP).
Prior to the application, opacity of the fresh bovine corneas was measured (t0), and 600.91 mg of the test item were suspended in 3.0 mL saline (20% (w/v)) using ultrasonic technique for five minutes. Since the test item could not be suspended homogeneously, each 0.75 mL of the so prepared suspension was distributed to each cornea. Thereby it was taken care of that the corneas were evenly covered with the test item. The positive control was 10% (w/v) Benzalkonium chloride in saline. Saline was used as negative control item.
The exposed corneas were incubated for 240 minutes at 32 +/- 1 °C in complete medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneas and opacity was measured again (t240).
After the opacity measurements permeability of the corneas was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 +/- 1 °C.
With the negative control (saline) neither an increase of opacity nor permeability of the corneas could be observed (mean in vitro irritation score 1.86).
The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity effects (mean in vitro irritation score 183.48) corresponding to a corrosive /severe irritant to the eye.
Relative to the negative control, the test item did not cause any increase of the corneal permeability, and only very slight opacity occurred. The calculated mean in vitro irritation score of 2.46 was below the threshold of >= 55.1. Therefore the test item is not corrosive / not severe irritant to the eye according to OECD 437.
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