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EC number: 939-559-9 | CAS number: -
- 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:
- 09 Jan 2014 - 15 Jan 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt fuer Gesundheit und Lebensmittelsicherheit, Erlangen, Germany
Test material
- Reference substance name:
- Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dehydrate
- IUPAC Name:
- Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dehydrate
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- other: cattle
- Strain:
- other: animals freshly slaughtered
- Details on test animals or tissues and environmental conditions:
- TEST METHOD
The bovine corneal opacity and permeability (BCOP) test is an in-vitro test method used for identifying i) chemicals inducing serious eye damage and ii) chemicals not requiring classification for eye irritation or serious eye damage. The potential of a test substance to cause ocular corrosivity or severe irritancy is measured by its ability to induce opacity and increased permeability in an isolated bovine cornea. The opacity and permeability assessments of the cornea are combined to derive an in-vitro irritancy score (IVIS), which is used to classify the irritancy level of the test substance.
IDENTIFICATION OF THE SOURCE OF THE EYES, STORAGE AND TRANSPORT CONDITIONS
- Source: A. Moksel AG, Buchloe, Germany
- Time interval prior to initiating testing: Cornea preparation was initiated immediately after arrival of the eyes.
- Transport medium and temperature conditions: Hanks´ Balanced Salt Solution (HBSS) on ice with penicillin/streptomycin
PREPARATION OF THE EYES (BEFORE EXPOSURE)
- Eyes free of defects (scratches, neovascularisation): yes
- Dissection of the eyes and treatment: Corneas were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in cornea holders.
- Type of cornea holder used: MC2, Clermont, France
- Description of the cornea holder: The cornea holders consist of an anterior and a posterior compartment, which are tightened with screws.
- Test medium used in the cornea holder: RPMI (without phenol red) containing 1% FBS and 2 mM L-glutamine (complete RPMI)
- Equilibration time: 1 h at 32±1 °C
- Quality check of the equilibrated corneas: corneas with an initial opacity above 7 in the opacitometer were discarded.
DETERMINATION OF THE INITIAL OPACITY
- Method: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer.
- Specification of the device: MC2, Clermont, France
Test system
- Vehicle:
- physiological saline
- Remarks:
- 0.9% NaCl
- Controls:
- other: number of eyes for the negative control: 3
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): 750 µL
- Concentration: 20% in vehicle
VEHICLE
- Substance: physiol. saline
- Concentration: 0.9% NaCl solution
- Source: Diprom
- Lot/batch no.: 13001-4
- Expiry date: 12/2015
POSITIVE SUBSTANCE
- Substance: Imidazole
- Concentration: 20% imidazole solution in physiol. saline
- Amount applied in the test: 750 µL
- Source: Sigma,
- Lot/batch no.: SLBC7446V
- Expiry date: 11/2014 - Duration of treatment / exposure:
- 4 hours±5 minutes incubation at 32±1 °C
- Observation period (in vivo):
- Not applicable.
- Number of animals or in vitro replicates:
- Number of eyes for the test item: 3
- Details on study design:
- TEST CONDITIONS
- Short description of the method used: 750 µL of the test item preparation or the control substance was introduced into the anterior chamber (closed-chamber method). Corneas were exposed for 4 h at 32±1 °C with the test substance or the controls.
POST-EXPOSURE TREATMENT
- Removal of the test substance: The test substance was removed and the epithelium washed at least three times.
- Medium for washing the corneas: EMEM containing phenol red
- Medium for final rinsing: complete RPMI (without phenol red)
DETERMINATION OF THE FINAL OPACITY
- Method: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer.
- Time of determination: After refilling complete RPMI in the anterior chamber the final opacity was measured.
DETERMINATION OF THE CORNEAL PERMEABILITY:
- Method: Sodium fluorescein solution was added to the anterior chamber of the cornea holder while the posterior chamber was filled with fresh complete RPMI. The amount of sodium fluorescein that crosses into the posterior chamber was quantitatively measured via UV/VIS spectrophotometry at 490 nm recorded as optical density (OD490).
- Amount and concentration of the dye: 1 mL sodium fluorescein solution (5 mg/mL)
- Incubation time: 90 min at 32±1 °C
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean value of 3 corneae
- Value:
- 280.15
- Vehicle controls validity:
- valid
- Remarks:
- 1.30
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- 172.12
Any other information on results incl. tables
Tab. 1: Opacity values
Parameter |
Cornea No. |
Initial opacity |
Final opacity |
Change of opacity value |
Corrected opacity value |
Negative control |
1 |
3 |
4 |
1 |
|
2 |
3 |
2 |
-1 |
||
3 |
3 |
2 |
-1 |
||
Mean |
3.00 |
2.67 |
-0.33 |
||
Positive control |
1 |
4 |
137 |
133 |
133.3 |
2 |
4 |
151 |
147 |
147.33 |
|
3 |
4 |
153 |
149 |
149.33 |
|
Mean |
4.00 |
147.00 |
143.00 |
143.33 |
|
Test substance |
1 |
3 |
330 |
327 |
327.33 |
2 |
3 |
251 |
248 |
248.33 |
|
3 |
3 |
268 |
265 |
265.33 |
|
Mean |
3.00 |
283.00 |
280.00 |
280.33 |
Tab. 2: Permeability values (optical density (OD) at 490 nm)
Parameter |
Cornea No. |
OD490 |
Corrected OD490 value |
Negative control |
1 |
0.104 |
|
2 |
0.120 |
||
3 |
0.1102 |
||
Mean |
0.109 |
||
Positive control |
1 |
2.048 |
1.939 |
2 |
2.036 |
1.927 |
|
3 |
1.999 |
1.890 |
|
Mean |
2.028 |
1.919 |
|
Test substance |
1 |
0.134 |
0.025 |
2 |
0.110 |
0.001 |
|
3 |
0.046 |
-0.063 |
|
Mean |
0.097 |
-0.012 |
Tab. 3: In-Vitro Irritancy Score (IVIS) values
Parameter |
Cornea No. |
Change of opacity value |
Corrected OD490 value |
IVIS |
Negative control |
1 |
1.00 |
0.104 |
1.30 |
2 |
-1.00 |
0.120 |
||
3 |
-1.00 |
0.1102 |
||
Mean |
-0.33 |
0.109 |
||
Positive control |
1 |
133.33 |
1.939 |
172.12 |
2 |
147.33 |
1.927 |
||
3 |
149.33 |
1.890 |
||
Mean |
143.33 |
1.919 |
||
Test substance |
1 |
327.33 |
0.025 |
280.15 |
2 |
248.33 |
0.001 |
||
3 |
265.33 |
-0.063 |
||
Mean |
280.33 |
-0.012 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- CLP: Cat. 1, H318
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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