Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 234-746-5 | CAS number: 12030-88-5
- 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
Endpoint summary
Administrative data
Description of key information
The substance is considered to be corrosive to skin and causing irreversible damage to rabbit eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5) and the available information indicates that it should be classified as skin corrosion (Category 1, 1A, 1B or 1C)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is a strong acid (pH <= 2.0) or base (pH => 11.5) and the available information indicates that it should be classified as serious eye damage (Category 1)
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- Perfusion of rabbit corneal endothelial cells with a Krebs Ringer bicarbonate solution to which the test substance had been added.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- Corneal endothelial cells mounted in a specular microscope
- Vehicle:
- other: Krebs Ringer bicarbonate solution containing 28 mM glucose
- Remarks:
- without adenosine and glutathione
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- Concentrations of 0.3, 0.5, 0.7 and 1.0 mM
- Duration of treatment / exposure:
- 1 hour (at a perfusion rate of 1 mL/h) after a rapid perfusion with 10 mL of the solution
- Duration of post- treatment incubation (in vitro):
- one half hour
- Number of animals or in vitro replicates:
- 5 corneas per experimental group
- Details on study design:
- Perfusion of rabbit corneal endothelial cells (at 37°C, 15 mm Hg,1 mL/h) with a Krebs Ringer bicarbonate solution (bubbled mixture of 97% oxygen - 3% CO2, mean osmolarity: 308mOsm, pH: 7.3) to which the test substance had been added (with in addition: SOD, catalase, ascorbic acid, D-mannitol, EDTA, DETAPAC, EDTA + FeCL2, or DMSO). Silicone oil (Dow Corning 360 Medical Fluid) was placed on the epithelial surface to prevent dehydration.
After an 1 hour stabilization period with a perfusion of KBR, the corneal thickness was recorded. KBR was then added to the pulverized potassium superoxide. Immediately after, corneas were perfused rapidly with 10 ml of the KO2 solution to completely replace the KBR into the microscope perfusing chamber. The perfusion with the KO2 solution continued for 1 hour at a rate of 1 ml/h and was followed by an one-half hour perfusion with KBR.
Tissues were prepared for either electron microscopy or determination of intracellular glutathione. The concentration of H2O2 was detrmined by spectrophotometric assay using dichlorophenol-indophenol. The reduction of nitroblue tetrazolium was used to establish the generation of oxygen free radicals by the KO2 solution.
The corneal swelling rate was determined by linear regression analysis. A comparison of experimental and control regression lines was made by analysis of covariance (Snedecor GW and Cochran WG 1967). Variance in the data was expressed as the mean +/- 95% confidence limits. - Irritation parameter:
- other: corneal swelling
- Run / experiment:
- corneal thickness measurement
- Value:
- 0.5
- Vehicle controls validity:
- valid
- Other effects / acceptance of results:
- Perfusion with solutions containing different concentrations of the test substance led to O2- production and subsequent H2O2 generation through the dismutation reaction.
Concentrations of the test substance of 0.5 mM and higher resulted in severe anatomic and physiologic alteration (disrupted morphology) of endothelial cells that resulted in corneal swelling (dose- and time-dependent patterns). Perfusion with 0.3 mM test substance resulted in an initial corneal swelling the first one-half hour, but a recovery thereafter.
The addition of catalase to the perfusion medium containing KO2 prevented both anatomic alteration of endothelial cells and corneal swelling. The addition of SOD, ascorbic acid, D-mannitol, EDTA, DETAPAC, EDTA + FeCL2, or DMSO did not modify the corneal swelling rate induced by perfusion with the KO2 solution.
Endothelial intracellular glutathione levels and redox state were unaffected by perfusion with 0.3 mM of the test substance. - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the study conditions, the test substance was found to be irritating to rabbit corneas.
- Executive summary:
A study was conducted to evaluate the eye irritation potential of the test substance in rabbit corneas. The study was performed following the protocol of McCarey BE et al., 1973, i.e. ''Perfusion of ex vivo rabbit corneas''. Rabbit corneal endothelial cells were perfused with a Krebs Ringer bicarbonate solution to which the test substance (at 0.3 to 1.0 mM) had been added along with superoxide dismutase, ascorbic acid, DETAPAC, EDTA, EDTA-FeCl2, or DMSO. Concentrations of test substance of 0.5 mM and higher resulted in severe anatomic and physiologic alteration of endothelial cells that resulted in corneal swelling. Catalase offered protection whereas the toxic effect was unaltered by superoxide dismutase, ascorbic acid, DETAPAC, EDTA, EDTA-FeCl2, or DMSO. Under the study conditions, the test substance was found to be irritating to rabbit corneas (Hull, 1984).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
The available information indicates the substance to be considered as Skin Corrosive 1A - H314 according to the EU CLP (1272/2008) criteria.
Eye irritation (weight of evidence):
A study was conducted to evaluate the eye irritation potential of the test substance in rabbit corneas. The study was performed following the protocol of McCarey BE et al., 1973, i.e. ''Perfusion of ex vivo rabbit corneas''. Rabbit corneal endothelial cells were perfused with a Krebs Ringer bicarbonate solution to which the test substance (at 0.3 to 1.0 mM) had been added along with superoxide dismutase, ascorbic acid, DETAPAC, EDTA, EDTA-FeCl2, or DMSO. Concentrations of test substance of 0.5 mM and higher resulted in severe anatomic and physiologic alteration of endothelial cells that resulted in corneal swelling. Catalase offered protection whereas the toxic effect was unaltered by superoxide dismutase, ascorbic acid, DETAPAC, EDTA, EDTA-FeCl2, or DMSO. Under the study conditions, the test substance was found to be irritating to rabbit corneas (Hull, 1984).
Justification for classification or non-classification
The available information indicates the substance to be considered as Skin Corrosive 1A - H314 according to the EU CLP (1272/2008) criteria.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.